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On 1 September 2020, we took on the roles of co-editors-in-chief for BMJ Quality and Safety, generic renova prices and want to take this opportunity to introduce ourselves and renova tretinoin cream reviews our vision for the journal. We represent two different continents, two different professions and two different sets of research expertise. What we have in common is a passion for conducting and publishing high-quality research and quality improvement work to benefit the quality and safety of patient care, as well as encouraging others to do likewise.We assume leadership of the journal during a major worldwide crisis brought on by the skin care products renova, which has affected almost every aspect of generic renova prices society. Response to the renova is requiring engagement from every part of our health care systems—government policy, public health, ambulatory care, inpatient and long-term care, every type of healthcare worker, and of course patients and their care partners. Most journals, including ours, have seen a substantial generic renova prices increase in manuscript submissions.

We have published several articles related to skin care products that address quality and safety issues central to the journal’s interests—including staffing levels, teamwork, how the renova has exposed weaknesses in healthcare systems, and how it may even stimulate efforts to address deficiencies in quality and safety.1–5We take note of the renova not only because of its significance but also because, like the renova, quality and safety problems are international issues that affect and require engagement from all parts of our healthcare systems and from all stakeholders. These stakeholders include patients and their care partners, every type of healthcare worker, organisational leaders, policy makers and, of course, researchers and quality improvement teams. Improving quality and safety generic renova prices also requires engagement from experts from other disciplines and industries whose research and practice can inform our efforts to improve care.As new co-editors-in-chief, we find this comprehensive view of the stakeholders for quality and safety to be both necessary to improve care and intellectually stimulating. Of course, with so many stakeholders, there needs to be some additional focus, and we find that on BMJ Quality and Safety’s masthead6. €˜The journal integrates the academic generic renova prices and clinical aspects of quality and safety in healthcare by encouraging academics to create evidence and knowledge valued by clinicians, and clinicians to value using evidence and knowledge to improve quality’.We will continue to publish research and opinion that creates ‘evidence and knowledge valued by clinicians’.

To accomplish this, we will maintain high methodological standards, along with collegial communications between the journal and authors. We will also build on the current interdisciplinary focus of the journal, both from within and outside the healthcare disciplines, and are considering special articles on new methods or ideas from other areas generic renova prices and how they can be adapted and used within the healthcare setting. We recognise that a strength of the journal is its international focus, although the majority of published papers are currently from North America and the UK. We would like to encourage a wider range of international submissions that meet our high standards for methodological quality and relevance for an international readership. We would generic renova prices like to further increase our social media presence, building on the blogs and Tweets already being led by our two social media editors.

We also want to maintain the journal’s current reputation for constructive peer review and timely publication, in which editors aim to provide personalised, specific and constructive feedback not just for papers for which revision is invited but also for those that are rejected.These are promising times for the journal. The previous co-editors-in-chief, Kaveh generic renova prices Shojania and Mary Dixon-Woods, are handing over a journal with a stellar reputation for rigorous research, thoughtful and challenging commentary, and timely and constructive peer review. We therefore end with our thanks to Mary and Kaveh for their strong leadership and vision, together with an incredibly strong team of senior editors, associate editors and reviewers. We are sure that readers of BMJ Quality and generic renova prices Safety will echo our thanks.Patients entrust their lives to healthcare providers. Healthcare providers, in turn, aim to promote wellness, heal what can be healed and relieve suffering, all with comfort and compassion.

Yet, when patients are harmed by their healthcare, too often they experience defensiveness and disregard that actually exacerbates their suffering, adding insult to injury.1 2 Communication and resolution programmes (CRP) can mitigate this further harm and avoid pouring salt on the wounds of patients whom the healthcare system has hurt instead of helped. These programmes strive to ensure that patients and families injured by medical care receive prompt attention, honest and empathic explanations, sincere expressions of reconciliation including financial and non-financial restitution, and reassurance from efforts to prevent future harm to others.3 Decades of study and interest in CRPs seem to be resulting in increased implementation with the hope that supporting patients, families and caregivers after harm could become the norm generic renova prices rather than the exception.4Yet a central problem looms, and unless effective solutions are enacted, the potential of CRPs may go largely unrealised. The field is rife with inconsistent implementation, which often reflects a selective focus on claims resolution rather than a fully implemented (‘authentic’) CRP.5 Inconsistent CRP implementation means that fewer patients and families benefit from this model and opportunities for improving quality and safety are missed. Authentic CRPs, generic renova prices in contrast, are comprehensive, systematic and principled programmes motivated by fundamental culture change which prioritises patient safety and learning. In an authentic CRP, honesty and transparency after patient harm are viewed as integral to the clinical mission, not as selective claims management devices.6 CRPs appear to improve patient and provider experiences, patient safety, and in many settings lower defence and liability costs in the short term and improve peer review and stimulate quality and safety over time.7–10 While the claims savings often associated with a CRP are welcome, authentic CRPs focus on a more ambitious goal.

Fostering an accountable culture. Nurturing accountability produces better and safer care generic renova prices which serves the overall clinical mission, happily accomplishing more durable claims reduction along the way.Two thoughtful papers in this issue of BMJ Quality &. Safety highlight barriers to effective CRP implementation and offer important insights to aid in the spread of this critical model.11 12 Below we outline four suggested strategies for realising the vision of authentic CRPs.Strategy 1. Make CRPs a critical organisational priority grounded in the clinical missionThe most important cause of inconsistent CRP implementation is the failure of institutional leaders, including boards and senior executives (‘C-suites’), to recognise them as a mission-critical component of modern generic renova prices healthcare. As a result, even at organisations professing to embrace accountability and transparency after patient harm, CRPs rarely receive overt leadership support or the resources and performance expectations associated with other mission-critical initiatives.13The reasons why CRPs have not been elevated to mission-critical status at healthcare organisations are complex.

Competing and generic renova prices distracting clinical and financial priorities abound. But a central challenge that has hampered CRPs is the tendency of many C-suites to rely on their liability insurance, risk and legal partners to direct the response to injured patients. Neither the insurance industry nor the legal profession naturally shares the same values and mission as healthcare organisations.14 Healthcare leaders need to insist that responses to injured patients align with their organisations’ clinical missions. In the absence of such generic renova prices C-suite insistence, ‘deny and defend’ will remain the dominant response to injured patients.This C-suite deference to the claims expertise of the insurance industry and legal profession has additional causes, including. (A) resignation that unintended adverse outcomes will happen even with reasonable care.

(B) acceptance of generic renova prices litigation as unavoidable and a cost of doing business. (C) reluctance of chief executive officers/board members (who are not trial lawyers) to challenge worst-case scenarios painted by defence lawyers and insurance claims professionals. And (D) human nature that avoids confrontation and exaggerates generic renova prices the potential challenges of dealing with injured patients. These factors inform the attitude of some health systems that no adverse events deserve compensation and that the caregivers/organisations are the real victims.While it is encouraging to see a few large liability insurers developing CRPs and even incentivising their adoption,15 more insurers are engaging with CRPs as passive observers, with others remaining actively opposed. Insurers and attorneys will align as CRP partners only when healthcare organisations identify CRPs as a mission-critical priority.Strategy 2.

Compel institutional leaders to recognise the critical importance of CRPsWhat would persuade boards and C-suites generic renova prices to prioritise a CRP?. The study by Prentice et al suggests the answer lies in making institutional leaders recognise the necessity of CRPs through engagement with injured patients and their families.11Prentice and colleagues report the first truly population-based assessment of the impact of medical errors on patients. Their results highlight the continuing emotional toll that patients and generic renova prices their families suffer from preventable injuries. On an encouraging note, they also document the potential that open and honest communication has for reducing emotional harm. While over half of the patients who reported experiencing medical errors 3–6 years ago described at least one emotional impact from the event, those who reported the greatest generic renova prices degree of open communication with healthcare providers after an error were less likely to experience persisting sadness, depression or feelings of abandonment and betrayal.

Open and honest communication after an error also predicted less doctor/facility avoidance.When boards and C-suites acknowledge the additional emotional harm inflicted on injured patients and their families (not to mention staff) when a CRP is not used or is poorly implemented, the mission-critical nature of CRPs will become paramount.16 17 The emotions of patients and families who have been harmed can be complex, intense and intimidating.18 It has been all too easy for board members and senior executives to look away and avoid direct involvement when their organisations harm the very patients they exist to serve. Patients and their families, of course, cannot enjoy the luxury of looking away.19While boards are sometimes made aware of selected high-value harm events, these cases represent only the tip of the iceberg. Cases of patient harm that are less than catastrophic are rarely shared with boards, but represent a large reservoir of patient and family suffering as generic renova prices well as opportunities for learning. Many patients who experience injuries hesitate to complain, fearing their ongoing care may be adversely affected.20 21 Patients who have experienced serious harm may have difficulty garnering representation from a qualified plaintiff attorney especially if their claim is deemed to be worth under $500 000. Boards aware only of a few high-value cases will fail to appreciate the magnitude of harm caused by substandard care and falsely believe that their organisation is responding optimally to the few they know about.Engaging generic renova prices a patient as soon as possible after an unplanned clinical event is a CRP hallmark.

Listening, with the explicit goal of understanding the experiences of patients and families who have been harmed, is invaluable to any organisation striving for patient centricity and generates insights not available to ‘deny and defend’ adherents. Partnering with patients who have had unplanned clinical outcomes changes the way healthcare organisations value informed consent, transitions of care and communication in general. As patient engagement is normalised across organisations, generic renova prices boards and C-suites will readily recognise the importance to their clinical mission and the value of the return on investment in the CRP model beyond financial gains. The accountable culture which emerges has the potential to generate other benefits unthinkable in a defensive environment. Improved staff morale with better staff retention, an open environment which generic renova prices values speaking up for safety, accelerated and more effective clinical outcomes and evidence-based peer review, to name a few.Strategy 3.

Invest in CRP implementation tools and resourcesEquating CRPs to early claims resolution predictably yields inconsistent and selective application of the model and, worse, a failure to realise its full potential for cultural improvement.22 Even as boards and C-suites accept the mission-critical status of CRPs (the ‘why’), they may not appreciate the importance of the ‘how’. The second CRP-related paper in this issue of BMJ Quality and Safety emphasises how successful CRPs rely on the development of systems and standard work generic renova prices to promote consistent application.12 Mello and colleagues describe the work of the Massachusetts Alliance for Communication and Resolution after Medical Injury (MACRMI) and articulate the most important elements of their success to date. Their findings reinforce other papers that emphasize the critical nature of having the right people, processes and systems in place.23One essential element of the MACRMI model is the commitment to a process of reviewing unplanned clinical outcomes eligible for a CRP approach. Normalising a triaged review and then faithfully using the CRP for all eligible cases, regardless of whether that case might become a claim, allows the CRP to meet patient, family and caregiver needs, as well as to drive process improvements faster on a much broader group of harm events. This systematic approach to case selection also demonstrates to clinical audiences that the CRP is not premised primarily on saving money, but is a norm expected within the clinical mission.The MACRMI experience also highlights the importance of devoting sufficient resources to planning and executing a CRP generic renova prices.

Many organisations focus most of their CRP efforts around training different teams to enact key steps in the CRP process. While trainings generic renova prices may be a necessary element, reproducible workflows and simple tools are far more important. With clear leadership support, these tools and processes must be developed with and by the people in the organisation who will actually use them, rather than imposing approaches that may have worked in another system that is organised differently. Organisations should understand that potential generic renova prices litigation is an ever-present reality. Sometimes, despite the CRP’s principled assessment and engagement, reasonable minds may still differ, and in a small minority of cases litigation is required.

Because the motivation for CRPs is to instil the accountable culture required for continual clinical improvement, success cannot be contingent on erasing the threat of litigation altogether.Finally, a significant element of MACRMI’s success involved a shared learning community in which organisational leaders and key managers came together to discuss CRP cases supported by unfiltered patient experiences, clinical and patient safety findings and measures of implementation. The community acquired a moral authority generic renova prices which encouraged accountability, consistent application of CRP principles, and ultimately demonstrated broad results of the favourable impact on patients, providers, system learning and liability costs.Strategy 4. Deploy CRP metrics to govern CRP and track progressMetrics matter. Organisations measure what they deem important.5 At present it is rare that organisations know how many unintended clinical events occurred in the previous year, how many of the affected patients generic renova prices and families were treated with honesty and transparency, how many of those deemed worthy of compensation actually received it, how many of the affected providers received care, or how many of those cases resulted in clinical improvements. The absence of these data makes it nearly impossible to assign appropriate leadership accountabilities for CRPs and to understand how well a CRP is functioning in service to the organisational mission.

Measuring mainly claims and costs signals a preoccupation with money, not continual clinical improvement, and certainly generic renova prices not patient centricity or care for the caregiver workforce. A comprehensive suite of national CRP measures is currently being developed and refined jointly by the Collaborative for Accountability and Improvement and Ariadne Labs, and should be ready for widespread dissemination by the end of this year.ClosingHealthcare organisations exist to serve with compassion and clinical excellence the patients and their families who entrust them with their lives. Our society expects no less. The privilege of delivering healthcare, a practice that is intrinsically dangerous, carries a generic renova prices heavy responsibility to minimise the risk of harm. When patients are harmed, CRPs honour patients’ trust and caregivers’ selfless dedication with honesty, transparency, best efforts at reconciliation for all and relentless determination to improve.

One thing is generic renova prices clear. Shedding ‘deny and defend’ in favour of a transition to an authentic CRP undoubtedly requires leadership from boards and C-suites focused on their organisations’ clinical mission. If healthcare organisations are sincere in striving to attain their clinical goals, they will insist on nothing less than elevating their CRPs to mission-critical status and using the requisite tools and resources to ensure consistent application of this model.AcknowledgmentsMany thanks to Gary S Kaplan, MD, for contributing to the concepts presented in this paper, and to Paulina H Osinska, MPH, for her assistance with manuscript preparation..

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Elon Musk on Friday unveiled a coin-sized http://herlifefranchise.com/buy-zithromax-over-the-counter prototype of a brain implant developed by his startup Neuralink to enable people who are paralyzed to operate smartphones and robotic limbs with their thoughts — and said the company had worked to “dramatically simplify” the device since presenting an earlier version last summer.In an event live-streamed on renova under eyes YouTube to more than 150,000 viewers at one point, the company staged a demonstration in which it trotted out a pig named Gertrude that was said to have had the company’s device implanted in its head two months ago. The live stream showed what Musk claimed to be Gertrude’s real-time brain activity as it sniffed around a pen. At no point, though, did he provide evidence that the signals — rendered in beeps and bright blue wave patterns on screen — were, in fact, emanating from the pig’s brain.A pig presented at a Neuralink demonstration was said to renova under eyes have one of the company’s brain implants in its head.

YouTube screenshot“This is obviously sounding increasingly like a Black Mirror episode,” Musk said at one point during the event as he responded affirmatively to a question about whether the company’s implant could eventually be used to save and replay memories. €œThe future’s going to be weird.”advertisement Musk said that in July Neuralink received a breakthrough device designation from the Food and Drug Administration — a regulatory pathway that renova under eyes could allow the company to soon start a clinical trial in people with paraplegia and tetraplegia. The big reveal came after four former Neuralink employees told STAT that the company’s leaders have long fostered an internal culture characterized by rushed timelines and the “move fast and break things” ethos of a tech company — a pace sometimes at odds with the slow and incremental pace that’s typical of medical device development.

Advertisement Friday’s renova under eyes event began, 40 minutes late, with a glossy video about the company’s work — and then panned to Musk, standing in front of a blue curtain beside a gleaming new version of the company’s surgical “sewing machine” robot that could easily have been mistaken for a giant Apple device. Musk described the event as a “product demo” and said its primary purpose was to recruit potential new employees. It was unclear whether the demonstration was taking place at the company’s Fremont, Calif., headquarters renova under eyes or elsewhere.

Musk proceeded to reveal the new version of Neuralink’s brain implant, which he said was designed to fit snugly into the top of the skull. Neuralink’s technological design has renova under eyes changed significantly since its last big update in July 2019. At that time, the company’s brain implant system involved a credit-card sized device designed to be positioned behind the back of a person’s ear, with several wires stretching to the top of the skull.

After demonstrating the pig’s brain activity at Friday’s event, Musk showed video footage of a pig walking on a treadmill and said Neuralink’s device could be used to “predict the position of limbs with high accuracy.” That capability would be critical to allowing someone renova under eyes using the device to do something like controlling a prosthetic limb, for example.Neuralink for months has signaled that it initially plans to develop its device for people who are paralyzed. It said at its July 2019 event that it wanted to start human testing by the end of 2020. Receiving the breakthrough device designation from the FDA — renova under eyes designed to speed up the lengthy regulatory process — is a step forward, but it by no means guarantees that a device will receive a green light, either in a short or longer-term time frame.

After Musk’s presentation, a handful of the company’s employees — all wearing masks, but seated only inches apart — joined him to take questions submitted on Twitter or from the small audience in the room.In typical fashion for a man who in 2018 sent a Tesla Roadster into space, Musk didn’t hesitate to use the event to cross-promote his electric car company. Asked whether the Neuralink chip would allow people to summon their Tesla renova under eyes telepathically, Musk responded. €œDefinitely — of course.”Matthew MacDougall, the company’s head neurosurgeon, appearing in scrubs, said the company had so far only implanted its technology into the brain’s cortical surface, the coaster-width layer enveloping the brain, but added that it hoped to go deeper in the future.

Still, Musk renova under eyes said. €œYou could solve blindness, you could solve paralysis, you could solve hearing — you can solve a lot just by interfacing with the cortex.”Musk and MacDougall said they hoped to eventually implant Neuralink’s devices — which they referred to on stage simply as “links” — in the deeper structures of the brain, such as in the hypothalamus, which is believed to play a critical role in mental illnesses including depression, anxiety, and PTSD.There were no updates at the event of Neuralink’s research in monkeys, which the company has been conducting in partnership with the University of California, Davis since 2017. At last July’s event, Musk said — without providing evidence — that a monkey had controlled a computer with its brain.At that same July 2019 event, Neuralink released renova under eyes a preprint paper — published a few months later — that claimed to show that a series of Neuralink electrodes implanted in the brains of rats could record neural signals.

Critically, the work did not show where in the brain the implanted electrodes were recording from, for how long they were recording, or whether the recordings could be linked to any of the rats’ bodily movements.In touting Friday’s event — and Neuralink’s technological capabilities — on Twitter in recent weeks, Musk spoke of “AI symbiosis while u wait” and referenced the “matrix in the matrix” — a science-fiction reference about revealing the true nature of reality. The progress renova under eyes the company reported on Friday fell far short of that. Neuralink’s prototype is ambitious, but it has yet to show evidence that it can match up to the brain-machine interfaces developed by academic labs and other companies.

Other groups have shown that they can listen in on neural activity and allow primates and people to control a computer cursor with their brain — so-called “read-out” technology — and have also shown that they can use electrical stimulation to input information, such as a renova under eyes command or the heat of a hot cup of coffee, using “write-in” technology. Neuralink said on Friday that its technology would have both read-out and write-in capabilities.Musk acknowledged that Neuralink still has a long way to go. In closing renova under eyes the event after more than 70 minutes, Musk said.

€œThere’s a tremendous amount of work to be done to go from here to a device that is widely available and affordable and reliable.”Following the news this week of what appears to have been the first confirmed case of a skin care products re, other researchers have been coming forward with their own reports. One in Belgium, another in the renova under eyes Netherlands. And now, one in Nevada.What caught experts’ attention about the case of the 25-year-old Reno man was not that he appears to have contracted skin care (the name of the renova that causes skin care products) a second time.

Rather, it’s that his renova under eyes second bout was more serious than his first.Immunologists had expected that if the immune response generated after an initial could not prevent a second case, then it should at least stave off more severe illness. That’s what occurred with the first known re case, in a 33-year-old Hong Kong man.advertisement Still, despite what happened to the man in Nevada, researchers are stressing this is not a sky-is-falling situation or one that should result in firm conclusions. They always presumed people renova under eyes would become vulnerable to skin care products again some time after recovering from an initial case, based on how our immune systems respond to other respiratory renovaes, including other skin carees.

It’s possible that these early cases of re are outliers and have features that won’t apply to the tens of millions of other people who have already shaken off skin care products.“There are millions and millions of cases,” said Michael Mina, an epidemiologist at Harvard’s T.H. Chan School renova under eyes of Public Health. The real question that should get the most focus, Mina said, is, “What happens to most people?.

€advertisement But renova under eyes with more re reports likely to make it into the scientific literature soon, and from there into the mainstream press, here are some things to look for in assessing them.What’s the deal with the Nevada case?. The Reno resident in question first tested positive for skin care in April after coming down with a sore throat, cough, and headache, as well as nausea and diarrhea. He got better over time and renova under eyes later tested negative twice.

But then, some 48 days later, the man started experiencing headaches, cough, and other symptoms again. Eventually, he became so sick that he had to be hospitalized and was found to have pneumonia.Researchers sequenced renova samples from both of his s and found they were different, providing evidence that this was a new distinct from the first. What happens when renova under eyes we get skin care products in the first case?.

Researchers are finding that, generally, people who get skin care products develop a healthy immune response replete with both antibodies (molecules that can block pathogens from infecting cells) and T cells (which help wipe out the renova). This is what happens after other viral s.In addition to fending off the renova the first time, that immune response also creates memories of the renova, should it try renova under eyes to invade a second time. It’s thought, then, that people who recover from skin care products will typically be protected from another case for some amount of time.

With other skin carees, protection is thought to last for perhaps a little less than a renova under eyes year to about three years.But researchers can’t tell how long immunity will last with a new pathogen (like skin care) until people start getting reinfected. They also don’t know exactly what mechanisms provide protection against skin care products, nor do they know what levels of antibodies or T cells are required to signal that someone is protected through a blood test. (These are called the “correlates of protection.”) Why do experts expect second cases to be milder? renova under eyes.

With other renovaes, protective immunity doesn’t just vanish one day. Instead, it wanes over time renova under eyes. Researchers have then hypothesized that with skin care, perhaps our immune systems might not always be able to prevent it from getting a toehold in our cells — to halt entirely — but that it could still put up enough of a fight to guard us from getting really sick.

Again, this is what happens with other respiratory pathogens.And it’s why some researchers actually looked at the Hong Kong case with relief renova under eyes. The man had mild to moderate skin care products symptoms during the first case, but was asymptomatic the second time. It was a demonstration, experts said, of what renova under eyes you would want your immune system to do.

(The case was only detected because the man’s sample was taken at the airport when he arrived back in Hong Kong after traveling in Europe.)“The fact that somebody may get reinfected is not surprising,” Malik Peiris, a virologist at the University of Hong Kong, told STAT earlier this week about the first re. €œBut the re didn’t cause disease, so that’s the first point.”The Nevada case, then, provides a counterexample to that renova under eyes. What kind of immune response did the person who was reinfected generate initially?.

Earlier, we described the robust immune response that most people renova under eyes who have skin care products seem to mount. But that was a generalization. s and the immune responses they renova under eyes induce in different people are “heterogeneous,” said Sarah Cobey, an epidemiologist and evolutionary biologist at the University of Chicago.Older people often generate weaker immune responses than younger people.

Some studies have also indicated that milder cases of skin care products induce tamer immune responses that might not provide as lasting or as thorough of a defense as stronger immune responses. The man in Hong Kong, for example, did not generate antibodies to the renova after his first , at least to the level that could be detected by blood tests renova under eyes. Perhaps that explains why he contracted the renova again just about 4 1/2 months after recovering from his initial .In the Nevada case, researchers did not test what kind of immune response the man generated after the first case.“ is not some binary event,” Cobey said.

And with re, “there’s going to be some viral replication, but the question is how renova under eyes much is the immune system getting engaged?. €What might be broadly meaningful is when people who mounted robust immune responses start getting reinfected, and how severe their second cases are. Are people who have renova under eyes skin care products a second time infectious?.

As discussed, immune memory can prevent re. If it can’t, it might stave off renova under eyes serious illness. But there’s a third aspect of this, too.“The most important question for re, with the most serious implications for controlling the renova, is whether reinfected people can transmit the renova to others,” Columbia University virologist Angela Rasmussen wrote in Slate this week.Unfortunately, neither the Hong Kong nor the Reno studies looked at this question.

But if most people who get reinfected don’t spread the renova, that’s renova under eyes obviously good news. What happens when people broadly become susceptible again?. Whether it’s six months after the first or nine months or a year or longer, at some point, renova under eyes protection for most people who recover from skin care products is expected to wane.

And without the arrival of a treatment and broad uptake of it, that could change the dynamics of local outbreaks.In some communities, it’s thought that more than 20% of residents have experienced an initial skin care products case, and are thus theoretically protected from another case for some time. That is still below the point of herd immunity — when renova under eyes enough people are immune that transmission doesn’t occur — but still, the fewer vulnerable people there are, the less likely spread is to occur.On the flip side though, if more people become susceptible to the renova again, that could increase the risk of transmission. Modelers are starting to factor that possibility into their forecasts.A crucial question for which there is not an answer yet is whether what happened to the man in Reno, where the second case was more severe than the first, remains a rare occurrence, as researchers expect and hope.

As the Nevada researchers wrote, “the generalizability of this finding is unknown.”An advocacy group has asked the Department of Defense to investigate what it called “an apparent failure” by Moderna (MRNA) to disclose millions of dollars in awards received from the Defense Advanced Research Projects Agency in patent applications the company filed for treatments.In a letter to the agency, Knowledge Ecology International explained that a review of dozens of patent applications found the company received approximately $20 million from the federal government in grants several years ago renova under eyes and the funds “likely” led to the creation of its treatment technology. This was used to develop treatments to combat different renovaes, such as Zika and, later, the renova that causes skin care products.In arguing for an investigation, the advocacy group maintained Moderna is obligated under federal law to disclose the grants that led to nearly a dozen specific patent applications and explained the financial support means the U.S. Government would have certain rights over renova under eyes the patents.

In other words, U.S. Taxpayers would have an ownership stake in treatments developed by the company.advertisement “This clarifies the public’s right in the inventions,” said Jamie renova under eyes Love, who heads Knowledge Ecology International, a nonprofit that tracks patents and access to medicines issues. €œThe disclosure (also) changes the narrative about who has financed the inventive activity, often the most risky part of development.” advertisement One particular patent assigned to Moderna concerns methods and compositions that can be used specifically against skin carees, including skin care products.

The patent names a Moderna scientist and a former Moderna scientist as inventors, both of which acknowledged performing work under the DARPA awards in two academic papers, according to the report by the advocacy group.The group examined the 126 patents assigned to Moderna or ModernaTx as well as 154 patent applications. €œDespite the evidence that multiple inventions were conceived in the course of research supported by the DARPA awards, not a single one of the patents or applications assigned renova under eyes to Moderna disclose U.S. Federal government funding,” the report stated.We asked Moderna and the Department of Defense for comment and will update you accordingly.The missive to the Department of Defense follows a recent analysis by Public Citizen, another advocacy group, indicating the National Institutes of Health may own mRNA-1273, the Moderna treatment candidate for skin care products.

The advocacy group noted the federal government filed multiple patents covering the treatment and two patent applications, in particular, list federal scientists as co-inventors.The analyses are part renova under eyes of a larger campaign among advocacy groups and others in the U.S. And elsewhere to ensure that skin care products medical products are available to poor populations around the world. The concern renova under eyes reflects the unprecedented global demand for therapies and treatments, and a race among wealthy nations to snap up supplies from treatment makers.

In the U.S., the effort has focused on the extent to which the federal government has provided taxpayer dollars to different companies to help fund their discoveries. In some cases, renova under eyes advocates argue that federal funding matters because it clarifies the rights that the U.S. Government has to ensure a therapy or treatment is available to Americans on reasonable terms.One example has been remdesivir, the Gilead Sciences (GILD) treatment being given to hospitalized skin care products patients.

The role renova under eyes played by the U.S. Government in developing remdesivir to combat skin carees involved contributions from government personnel at such agencies as the U.S. Army Medical Research Institute of Infectious Diseases.As for the Moderna treatment, earlier this month, the company was awarded renova under eyes a $1.525 billion contract by the Department of Defense and the Department of Health and Human Services to manufacture and deliver 100 million doses of its skin care products treatment.

The agreement also includes an option to purchase another 400 million doses, although the terms were not disclosed. In announcing the agreement, the government said it would ensure Americans receive the skin care products treatment at no cost, although they may be charged by health care providers for administering a shot.In this instance, however, Love said the “letter is not about price or renova under eyes profits. It’s about (Moderna) not owning up to DARPA funding inventions.

If the U.S renova under eyes. Wants to pay for all of the development of Moderna’s treatment, as Moderna now acknowledges, and throw in a few more billion now, and an option to spend billions more, it’s not unreasonable to have some transparency over who paid for their inventions.”This is not the first time Moderna has been accused of insufficient disclosure. Earlier this month, Knowledge Ecology International and Public Citizen maintained the company failed to disclose development costs in a $955 million contract awarded by BARDA for its skin care products renova under eyes treatment.

In all, the federal government has awarded the company approximately $2.5 billion to develop the treatment.The coming few weeks represent a crucial moment for an ambitious plan to try to secure skin care products treatments for roughly 170 countries around the world without the deep pockets to compete for what will be scarce initial supplies.Under the plan, countries that want to pool resources to buy treatments must notify the World Health Organization and other organizers — Gavi, the treatment Alliance, as well as the Coalition for Epidemic Preparedness Innovations — of their intentions by Monday. That means it’s fish-or-cut-bait time for the so-called COVAX facility.Already, wealthy countries — the United States, the United renova under eyes Kingdom, Japan, Canada, and Australia, among others, as well as the European Union — have opted to buy their own treatment, signing bilateral contracts with manufacturers that have secured billions of doses of treatment already. That raises the possibility that less wealthy countries will be boxed out of supplies.advertisement And yet Richard Hatchett, the CEO of CEPI, insists there is a path to billions of doses of treatment for the rest of the world in 2021.

STAT spoke renova under eyes with Hatchett this week. A transcript of the conversation, lightly edited for clarity and length, follows. You said this is a critical time for CEPI renova under eyes.

Can you explain what needs to happen between now and mid-September for this joint purchasing approach to be a success?. Advertisement The critical moment is now for countries to commit to the COVAX facility, because that will enable us renova under eyes to secure ample quantities of treatment and then to be able to convey when that treatment is likely to become available based on current information.What we’re now here asking countries to do is to indicate their intent to participate by Aug. 31, and to make a binding commitment by Sept.

18. And to provide funds in support of that binding commitment by early October. Our negotiations with companies are already taking place and it will be important for us from a planning purpose that countries indicate their intent to participate.Those binding commitments we think will be sufficient to allow us to then secure the advance purchase agreements, particularly with those companies that don’t have a prior contractual obligation to COVAX.

And then obviously, we need the funds to live up to those advance purchase agreements.Is it possible this thing could still fall apart?. There appears to be some concern COVAX has been boxed out by rich countries. There was always a possibility that there wouldn’t be sufficient uptake.

But I think we’re very encouraged at this point by the level of commitment, both from countries that would be beneficiaries of the advance market commitment — that’s the lower-income, lower-middle-income countries — as well as the self-financing countries. To have over 170 countries expressing interest in participating — they see the value.We’re much more encouraged now that it’s not going to fall apart. We still need to bring it off to maximize its value.

And we’re right at the crunch moment where countries are going to have to make these commitments. So, the next month is really absolutely critical to the facility. I am confident at this point that the world recognizes the value and wants it to work.I’ve been keeping tabs on advance purchase agreements that have been announced.

And at this point, a small number of rich countries have nailed down a lot of treatment — more than 3 billion doses. How hard does that make your job?. The fact that they’re doing it creates anxiety among other countries.

And that in itself can accelerate the pace. So, I’m not going to say that we’re not watching that with concern.I will say that for COVAX and the facility, this is absolutely critical moment. I think we still have a window of opportunity between now and mid-September — when we’re asking that the self-financing countries to make their commitments — to make the facility real and to make it work.

Between doses that are committed to COVAX through the access agreements and other agreements — these are discussions with partners that CEPI has funded as well as partners that CEPI has not funded — we still see a pathway for COVAX to well over 3 billion doses in 2021.I think it’s really important to bear in mind is that there are at least a few countries — and I think the U.S. And the U.K. Most publicly — that may be in a situation of significant oversupply.

I believe the U.S. And U.K. Numbers, if you add them together, would result in enough treatment for 600 million people to receive two doses of treatment each.

And, you know, there is no possible way that the U.S. Or the U.K. Can use that much treatment.So, there may be a lot of extra supply that looks like it’s been tied up sloshing around later.

I don’t think that the bilateral deals that have been struck are going to prevent COVAX from achieving its goals.But if so much treatment has been pre-ordered by rich countries, can countries in the COVAX pool get enough for their needs?. One of the things that we’ve argued through COVAX is that to control the renova or to end the acute phase of the renova to allow normalcy to start to reassert itself, you don’t have to vaccinate 100% of your population.You need to vaccinate those at greatest risk for bad outcomes and you need to vaccinate certain critical workers, particularly your health care workforce. And if you can achieve that goal, which for most countries means vaccinating between 20% and maybe 30% of the population, then you can transform the renova into something that is much more manageable.

Then you can buy yourself time to vaccinate everybody who wants to be vaccinated.We’ve argued the COVAX facility really offers the world the best shot at doing that globally in the fastest possible way, as well as providing for equitable access. This is a case where doing the equitable thing is also doing the efficient thing.CEPI has provided funding to nine treatments. Is it true that all those manufacturers aren’t required to provide the COVAX facility with treatment?.

That is correct. One of the things that we did, and I think it was an important role that CEPI played early on, was that we moved money very, very quickly, in small increments. You know, some of the early contracts were only $5 million or $10 million, to get programs up and running while we potentially put in place much larger-scale, longer-term contracts.If you were doing it over again, would you have given money without strings attached?.

Yes, I think I would have. I think that was critically important to initiating programs.Our contract with Moderna was established in about 48 hours. And that provided critical funding to them to manufacture doses that got them into clinical trials within nine weeks of the genetic sequences [of the skin care renova] being released.And if you look at the nine programs that we’ve invested in, seven are in clinical trials.

Two — the AstraZeneca program now and the Moderna program — are among the handful in Phase 3 clinical trials. And, I think the number of projects that that we funded initially, which started in kind of a biotech or academic phase that have now been picked up by large multinational corporations, there’s at least four. The Themis program being picked up by Merck, Oxford University by AstraZeneca, the University of Queensland by CSL, and Clover being in partnership with GSK, I think that speaks to the quality of the programs that we selected.So, I think that combination of rapid review, speed of funding, getting those programs started, getting them oriented in the right direction, I think all of that is critical to where we are now.Companies that got money from CEPI to build out production capacity — that money came with strings attached, right?.

Yes, exactly. So, where CEPI has made investments that create manufacturing, or secure manufacturing capacity, the commitment has been that the capacity that is attributable to the CEPI investment is committed — at least right of first refusal — to the global procurement facility.WASHINGTON — The Trump administration removed a top Food and Drug Administration communications official from her post on Friday in the wake of several controversial agency misstatements, a senior administration official confirmed to STAT.The spokeswoman, Emily Miller, had played a lead role in defending the FDA commissioner, Stephen Hahn, after he misrepresented data regarding the use of blood plasma from recovered skin care products patients. The New York Times first reported Miller’s ouster.

Miller’s tenure at as the top FDA spokeswoman lasted only 11 days. Her appointment was viewed with alarm by agency officials who felt her presence at the agency was emblematic of broader political pressure from the Trump administration, STAT first reported earlier this week.advertisement Before joining the FDA, Miller had no experience in health or medicine. Her former role as assistant commissioner for media affairs is typically not an appointment filled by political appointees.

The FDA’s communications arm typically maintains a neutral, nonpolitical tone.Miller’s appointment particularly alarmed FDA staff and outside scientists given her history in right-wing political advocacy and conservatism journalism. Her résumé included a stint as a Washington Times columnist, where she penned columns with titles that include “New Obamacare ads make young women look like sluts,” and a 2013 book on gun rights titled “Emily Gets Her Gun. But Obama Wants to Take Yours.”advertisement She also worked as a reporter for One America News Network, a right-wing cable channel that frequently espouses conspiracy theories and has declared an open alliance with President Trump.Miller quickly made her presence known at the FDA.

In the wake of Hahn’s misstatements on blood plasma, she aggressively defended the commissioner, falsely claiming in a tweet that the therapy “has shown to be beneficial for 35% of patients.” An FDA press release on blood plasma, issued less than a week after her appointment, similarly alarmed agency insiders by trumpeting the emergency authorization as “Another Achievement in Administration’s Fight Against [the] renova.”.

Elon Musk on Friday unveiled a coin-sized prototype of a brain implant developed by his startup Neuralink to enable people who are paralyzed to operate smartphones and robotic limbs with their thoughts — and said the company had worked to “dramatically simplify” the device since presenting an earlier version last summer.In an generic renova prices event live-streamed on YouTube to more than 150,000 viewers at one point, the company staged a demonstration in which it trotted out a pig named Gertrude that was said to have had the company’s device implanted in its head two months ago. The live stream showed what Musk claimed to be Gertrude’s real-time brain activity as it sniffed around a pen. At no point, though, did he provide evidence that the signals — rendered in beeps and bright blue wave patterns on screen — were, in fact, emanating from the generic renova prices pig’s brain.A pig presented at a Neuralink demonstration was said to have one of the company’s brain implants in its head. YouTube screenshot“This is obviously sounding increasingly like a Black Mirror episode,” Musk said at one point during the event as he responded affirmatively to a question about whether the company’s implant could eventually be used to save and replay memories.

€œThe future’s going to be weird.”advertisement Musk said that in July Neuralink received a breakthrough device designation from the Food and Drug Administration — a regulatory pathway that could allow the company to soon start a generic renova prices clinical trial in people with paraplegia and tetraplegia. The big reveal came after four former Neuralink employees told STAT that the company’s leaders have long fostered an internal culture characterized by rushed timelines and the “move fast and break things” ethos of a tech company — a pace sometimes at odds with the slow and incremental pace that’s typical of medical device development. Advertisement Friday’s generic renova prices event began, 40 minutes late, with a glossy video about the company’s work — and then panned to Musk, standing in front of a blue curtain beside a gleaming new version of the company’s surgical “sewing machine” robot that could easily have been mistaken for a giant Apple device. Musk described the event as a “product demo” and said its primary purpose was to recruit potential new employees.

It was unclear whether the demonstration was generic renova prices taking place at the company’s Fremont, Calif., headquarters or elsewhere. Musk proceeded to reveal the new version of Neuralink’s brain implant, which he said was designed to fit snugly into the top of the skull. Neuralink’s technological design has changed generic renova prices significantly since its last big update in July 2019. At that time, the company’s brain implant system involved a credit-card sized device designed to be positioned behind the back of a person’s ear, with several wires stretching to the top of the skull.

After demonstrating the pig’s brain activity at Friday’s event, Musk showed video footage of a pig walking on a treadmill and said Neuralink’s device could be used generic renova prices to “predict the position of limbs with high accuracy.” That capability would be critical to allowing someone using the device to do something like controlling a prosthetic limb, for example.Neuralink for months has signaled that it initially plans to develop its device for people who are paralyzed. It said at its July 2019 event that it wanted to start human testing by the end of 2020. Receiving the breakthrough device designation from the FDA — designed to speed up generic renova prices the lengthy regulatory process — is a step forward, but it by no means guarantees that a device will receive a green light, either in a short or longer-term time frame. After Musk’s presentation, a handful of the company’s employees — all wearing masks, but seated only inches apart — joined him to take questions submitted on Twitter or from the small audience in the room.In typical fashion for a man who in 2018 sent a Tesla Roadster into space, Musk didn’t hesitate to use the event to cross-promote his electric car company.

Asked whether generic renova prices the Neuralink chip would allow people to summon their Tesla telepathically, Musk responded. €œDefinitely — of course.”Matthew MacDougall, the company’s head neurosurgeon, appearing in scrubs, said the company had so far only implanted its technology into the brain’s cortical surface, the coaster-width layer enveloping the brain, but added that it hoped to go deeper in the future. Still, Musk generic renova prices said. €œYou could solve blindness, you could solve paralysis, you could solve hearing — you can solve a lot just by interfacing with the cortex.”Musk and MacDougall said they hoped to eventually implant Neuralink’s devices — which they referred to on stage simply as “links” — in the deeper structures of the brain, such as in the hypothalamus, which is believed to play a critical role in mental illnesses including depression, anxiety, and PTSD.There were no updates at the event of Neuralink’s research in monkeys, which the company has been conducting in partnership with the University of California, Davis since 2017.

At last July’s event, Musk said — without providing evidence — that a monkey had controlled a computer with its brain.At that same July 2019 event, Neuralink released a preprint paper — published a few months later — generic renova prices that claimed to show that a series of Neuralink electrodes implanted in the brains of rats could record neural signals. Critically, the work did not show where in the brain the implanted electrodes were recording from, for how long they were recording, or whether the recordings could be linked to any of the rats’ bodily movements.In touting Friday’s event — and Neuralink’s technological capabilities — on Twitter in recent weeks, Musk spoke of “AI symbiosis while u wait” and referenced the “matrix in the matrix” — a science-fiction reference about revealing the true nature of reality. The progress the company reported on Friday generic renova prices fell far short of that. Neuralink’s prototype is ambitious, but it has yet to show evidence that it can match up to the brain-machine interfaces developed by academic labs and other companies.

Other groups have shown that they can listen in on neural activity and allow primates and people to control a computer cursor with their brain — so-called “read-out” technology — and have also shown that they can use electrical stimulation to input information, such as generic renova prices a command or the heat of a hot cup of coffee, using “write-in” technology. Neuralink said on Friday that its technology would have both read-out and write-in capabilities.Musk acknowledged that Neuralink still has a long way to go. In closing the event after more than 70 generic renova prices minutes, Musk said. €œThere’s a tremendous amount of work to be done to go from here to a device that is widely available and affordable and reliable.”Following the news this week of what appears to have been the first confirmed case of a skin care products re, other researchers have been coming forward with their own reports.

One in generic renova prices Belgium, another in the Netherlands. And now, one in Nevada.What caught experts’ attention about the case of the 25-year-old Reno man was not that he appears to have contracted skin care (the name of the renova that causes skin care products) a second time. Rather, it’s that his second bout was more serious than his first.Immunologists generic renova prices had expected that if the immune response generated after an initial could not prevent a second case, then it should at least stave off more severe illness. That’s what occurred with the first known re case, in a 33-year-old Hong Kong man.advertisement Still, despite what happened to the man in Nevada, researchers are stressing this is not a sky-is-falling situation or one that should result in firm conclusions.

They always presumed people would become vulnerable to skin care products again some time after generic renova prices recovering from an initial case, based on how our immune systems respond to other respiratory renovaes, including other skin carees. It’s possible that these early cases of re are outliers and have features that won’t apply to the tens of millions of other people who have already shaken off skin care products.“There are millions and millions of cases,” said Michael Mina, an epidemiologist at Harvard’s T.H. Chan School generic renova prices of Public Health. The real question that should get the most focus, Mina said, is, “What happens to most people?.

€advertisement But with more re reports likely to make it into the scientific literature soon, and from there into the mainstream generic renova prices press, here are some things to look for in assessing them.What’s the deal with the Nevada case?. The Reno resident in question first tested positive for skin care in April after coming down with a sore throat, cough, and headache, as well as nausea and diarrhea. He got better over time and later tested negative twice generic renova prices. But then, some 48 days later, the man started experiencing headaches, cough, and other symptoms again.

Eventually, he became so sick that he had to be hospitalized and was found to have pneumonia.Researchers sequenced renova samples from both of his s and found they were different, providing evidence that this was a new distinct from the first. What happens when we get skin care products in generic renova prices the first case?. Researchers are finding that, generally, people who get skin care products develop a healthy immune response replete with both antibodies (molecules that can block pathogens from infecting cells) and T cells (which help wipe out the renova). This is what happens after generic renova prices other viral s.In addition to fending off the renova the first time, that immune response also creates memories of the renova, should it try to invade a second time.

It’s thought, then, that people who recover from skin care products will typically be protected from another case for some amount of time. With other generic renova prices skin carees, protection is thought to last for perhaps a little less than a year to about three years.But researchers can’t tell how long immunity will last with a new pathogen (like skin care) until people start getting reinfected. They also don’t know exactly what mechanisms provide protection against skin care products, nor do they know what levels of antibodies or T cells are required to signal that someone is protected through a blood test. (These are called the “correlates of protection.”) Why do experts expect second cases generic renova prices to be milder?.

With other renovaes, protective immunity doesn’t just vanish one day. Instead, it generic renova prices wanes over time. Researchers have then hypothesized that with skin care, perhaps our immune systems might not always be able to prevent it from getting a toehold in our cells — to halt entirely — but that it could still put up enough of a fight to guard us from getting really sick. Again, this is what happens with generic renova prices other respiratory pathogens.And it’s why some researchers actually looked at the Hong Kong case with relief.

The man had mild to moderate skin care products symptoms during the first case, but was asymptomatic the second time. It was a demonstration, generic renova prices experts said, of what you would want your immune system to do. (The case was only detected because the man’s sample was taken at the airport when he arrived back in Hong Kong after traveling in Europe.)“The fact that somebody may get reinfected is not surprising,” Malik Peiris, a virologist at the University of Hong Kong, told STAT earlier this week about the first re. €œBut the re didn’t cause disease, so that’s the first point.”The Nevada case, then, provides a counterexample to that generic renova prices.

What kind of immune response did the person who was reinfected generate initially?. Earlier, we described the robust immune response that most people who have generic renova prices skin care products seem to mount. But that was a generalization. s and the immune responses they induce in different people are “heterogeneous,” said generic renova prices Sarah Cobey, an epidemiologist and evolutionary biologist at the University of Chicago.Older people often generate weaker immune responses than younger people.

Some studies have also indicated that milder cases of skin care products induce tamer immune responses that might not provide as lasting or as thorough of a defense as stronger immune responses. The man in Hong Kong, for example, did not generate antibodies to the renova after his first generic renova prices , at least to the level that could be detected by blood tests. Perhaps that explains why he contracted the renova again just about 4 1/2 months after recovering from his initial .In the Nevada case, researchers did not test what kind of immune response the man generated after the first case.“ is not some binary event,” Cobey said. And with re, “there’s going to be some viral replication, but the generic renova prices question is how much is the immune system getting engaged?.

€What might be broadly meaningful is when people who mounted robust immune responses start getting reinfected, and how severe their second cases are. Are people who have skin care products generic renova prices a second time infectious?. As discussed, immune memory can prevent re. If it generic renova prices can’t, it might stave off serious illness.

But there’s a third aspect of this, too.“The most important question for re, with the most serious implications for controlling the renova, is whether reinfected people can transmit the renova to others,” Columbia University virologist Angela Rasmussen wrote in Slate this week.Unfortunately, neither the Hong Kong nor the Reno studies looked at this question. But if most people who generic renova prices get reinfected don’t spread the renova, that’s obviously good news. What happens when people broadly become susceptible again?. Whether it’s six months after the first or nine generic renova prices months or a year or longer, at some point, protection for most people who recover from skin care products is expected to wane.

And without the arrival of a treatment and broad uptake of it, that could change the dynamics of local outbreaks.In some communities, it’s thought that more than 20% of residents have experienced an initial skin care products case, and are thus theoretically protected from another case for some time. That is still below the point of herd immunity — when enough people are immune that transmission doesn’t occur — but still, the fewer vulnerable people there are, the less likely spread is to generic renova prices occur.On the flip side though, if more people become susceptible to the renova again, that could increase the risk of transmission. Modelers are starting to factor that possibility into their forecasts.A crucial question for which there is not an answer yet is whether what happened to the man in Reno, where the second case was more severe than the first, remains a rare occurrence, as researchers expect and hope. As the Nevada researchers wrote, “the generalizability of this finding is unknown.”An advocacy group has asked the Department of Defense to investigate what it called “an apparent failure” by Moderna (MRNA) to disclose millions of dollars in awards received from the Defense Advanced Research Projects Agency in patent applications the company filed for treatments.In a letter to the agency, generic renova prices Knowledge Ecology International explained that a review of dozens of patent applications found the company received approximately $20 million from the federal government in grants several years ago and the funds “likely” led to the creation of its treatment technology.

This was used to develop treatments to combat different renovaes, such as Zika and, later, the renova that causes skin care products.In arguing for an investigation, the advocacy group maintained Moderna is obligated under federal law to disclose the grants that led to nearly a dozen specific patent applications and explained the financial support means the U.S. Government would generic renova prices have certain rights over the patents. In other words, U.S. Taxpayers would have an ownership generic renova prices stake in treatments developed by the company.advertisement “This clarifies the public’s right in the inventions,” said Jamie Love, who heads Knowledge Ecology International, a nonprofit that tracks patents and access to medicines issues.

€œThe disclosure (also) changes the narrative about who has financed the inventive activity, often the most risky part of development.” advertisement One particular patent assigned to Moderna concerns methods and compositions that can be used specifically against skin carees, including skin care products. The patent names a Moderna scientist and a former Moderna scientist as inventors, both of which acknowledged performing work under the DARPA awards in two academic papers, according to the report by the advocacy group.The group examined the 126 patents assigned to Moderna or ModernaTx as well as 154 patent applications. €œDespite the evidence that multiple inventions were conceived in the course of research supported by the DARPA awards, not a single one of the patents or applications assigned to Moderna disclose U.S generic renova prices. Federal government funding,” the report stated.We asked Moderna and the Department of Defense for comment and will update you accordingly.The missive to the Department of Defense follows a recent analysis by Public Citizen, another advocacy group, indicating the National Institutes of Health may own mRNA-1273, the Moderna treatment candidate for skin care products.

The advocacy group noted the federal government filed multiple patents covering the treatment generic renova prices and two patent applications, in particular, list federal scientists as co-inventors.The analyses are part of a larger campaign among advocacy groups and others in the U.S. And elsewhere to ensure that skin care products medical products are available to poor populations around the world. The concern reflects the unprecedented global demand for therapies and generic renova prices treatments, and a race among wealthy nations to snap up supplies from treatment makers. In the U.S., the effort has focused on the extent to which the federal government has provided taxpayer dollars to different companies to help fund their discoveries.

In some cases, advocates generic renova prices argue that federal funding matters because it clarifies the rights that the U.S. Government has to ensure a therapy or treatment is available to Americans on reasonable terms.One example has been remdesivir, the Gilead Sciences (GILD) treatment being given to hospitalized skin care products patients. The role played by the U.S generic renova prices. Government in developing remdesivir to combat skin carees involved contributions from government personnel at such agencies as the U.S.

Army Medical Research Institute of Infectious Diseases.As for generic renova prices the Moderna treatment, earlier this month, the company was awarded a $1.525 billion contract by the Department of Defense and the Department of Health and Human Services to manufacture and deliver 100 million doses of its skin care products treatment. The agreement also includes an option to purchase another 400 million doses, although the terms were not disclosed. In announcing the agreement, the government said it would ensure Americans receive the skin care products treatment at no cost, although they may be charged by health care providers for administering generic renova prices a shot.In this instance, however, Love said the “letter is not about price or profits. It’s about (Moderna) not owning up to DARPA funding inventions.

If the U.S generic renova prices. Wants to pay for all of the development of Moderna’s treatment, as Moderna now acknowledges, and throw in a few more billion now, and an option to spend billions more, it’s not unreasonable to have some transparency over who paid for their inventions.”This is not the first time Moderna has been accused of insufficient disclosure. Earlier this month, Knowledge Ecology International generic renova prices and Public Citizen maintained the company failed to disclose development costs in a $955 million contract awarded by BARDA for its skin care products treatment. In all, the federal government has awarded the company approximately $2.5 billion to develop the treatment.The coming few weeks represent a crucial moment for an ambitious plan to try to secure skin care products treatments for roughly 170 countries around the world without the deep pockets to compete for what will be scarce initial supplies.Under the plan, countries that want to pool resources to buy treatments must notify the World Health Organization and other organizers — Gavi, the treatment Alliance, as well as the Coalition for Epidemic Preparedness Innovations — of their intentions by Monday.

That means it’s fish-or-cut-bait time for the so-called COVAX facility.Already, wealthy countries — the United States, the United Kingdom, Japan, Canada, and Australia, among others, as well as the European Union — have opted to buy their own treatment, signing bilateral contracts generic renova prices with manufacturers that have secured billions of doses of treatment already. That raises the possibility that less wealthy countries will be boxed out of supplies.advertisement And yet Richard Hatchett, the CEO of CEPI, insists there is a path to billions of doses of treatment for the rest of the world in 2021. STAT spoke with generic renova prices Hatchett this week. A transcript of the conversation, lightly edited for clarity and length, follows.

You said this generic renova prices is a critical time for CEPI. Can you explain what needs to happen between now and mid-September for this joint purchasing approach to be a success?. Advertisement The critical moment is now for countries to commit to the COVAX facility, because that will enable us to secure ample quantities of treatment and then to be able to convey when that treatment is likely to become available based on current information.What we’re now here asking countries to generic renova prices do is to indicate their intent to participate by Aug. 31, and to make a binding commitment by Sept.

18. And to provide funds in support of that binding commitment by early October. Our negotiations with companies are already taking place and it will be important for us from a planning purpose that countries indicate their intent to participate.Those binding commitments we think will be sufficient to allow us to then secure the advance purchase agreements, particularly with those companies that don’t have a prior contractual obligation to COVAX. And then obviously, we need the funds to live up to those advance purchase agreements.Is it possible this thing could still fall apart?.

There appears to be some concern COVAX has been boxed out by rich countries. There was always a possibility that there wouldn’t be sufficient uptake. But I think we’re very encouraged at this point by the level of commitment, both from countries that would be beneficiaries of the advance market commitment — that’s the lower-income, lower-middle-income countries — as well as the self-financing countries. To have over 170 countries expressing interest in participating — they see the value.We’re much more encouraged now that it’s not going to fall apart.

We still need to bring it off to maximize its value. And we’re right at the crunch moment where countries are going to have to make these commitments. So, the next month is really absolutely critical to the facility. I am confident at this point that the world recognizes the value and wants it to work.I’ve been keeping tabs on advance purchase agreements that have been announced.

And at this point, a small number of rich countries have nailed down a lot of treatment — more than 3 billion doses. How hard does that make your job?. The fact that they’re doing it creates anxiety among other countries. And that in itself can accelerate the pace.

So, I’m not going to say that we’re not watching that with concern.I will say that for COVAX and the facility, this is absolutely critical moment. I think we still have a window of opportunity between now and mid-September — when we’re asking that the self-financing countries to make their commitments — to make the facility real and to make it work. Between doses that are committed to COVAX through the access agreements and other agreements — these are discussions with partners that CEPI has funded as well as partners that CEPI has not funded — we still see a pathway for COVAX to well over 3 billion doses in 2021.I think it’s really important to bear in mind is that there are at least a few countries — and I think the U.S. And the U.K.

Most publicly — that may be in a situation of significant oversupply. I believe the U.S. And U.K. Numbers, if you add them together, would result in enough treatment for 600 million people to receive two doses of treatment each.

And, you know, there is no possible way that the U.S. Or the U.K. Can use that much treatment.So, there may be a lot of extra supply that looks like it’s been tied up sloshing around later. I don’t think that the bilateral deals that have been struck are going to prevent COVAX from achieving its goals.But if so much treatment has been pre-ordered by rich countries, can countries in the COVAX pool get enough for their needs?.

One of the things that we’ve argued through COVAX is that to control the renova or to end the acute phase of the renova to allow normalcy to start to reassert itself, you don’t have to vaccinate 100% of your population.You need to vaccinate those at greatest risk for bad outcomes and you need to vaccinate certain critical workers, particularly your health care workforce. And if you can achieve that goal, which for most countries means vaccinating between 20% and maybe 30% of the population, then you can transform the renova into something that is much more manageable. Then you can buy yourself time to vaccinate everybody who wants to be vaccinated.We’ve argued the COVAX facility really offers the world the best shot at doing that globally in the fastest possible way, as well as providing for equitable access. This is a case where doing the equitable thing is also doing the efficient thing.CEPI has provided funding to nine treatments.

Is it true that all those manufacturers aren’t required to provide the COVAX facility with treatment?. That is correct. One of the things that we did, and I think it was an important role that CEPI played early on, was that we moved money very, very quickly, in small increments. You know, some of the early contracts were only $5 million or $10 million, to get programs up and running while we potentially put in place much larger-scale, longer-term contracts.If you were doing it over again, would you have given money without strings attached?.

Yes, I think I would have. I think that was critically important to initiating programs.Our contract with Moderna was established in about 48 hours. And that provided critical funding to them to manufacture doses that got them into clinical trials within nine weeks of the genetic sequences [of the skin care renova] being released.And if you look at the nine programs that we’ve invested in, seven are in clinical trials. Two — the AstraZeneca program now and the Moderna program — are among the handful in Phase 3 clinical trials.

And, I think the number of projects that that we funded initially, which started in kind of a biotech or academic phase that have now been picked up by large multinational corporations, there’s at least four. The Themis program being picked up by Merck, Oxford University by AstraZeneca, the University of Queensland by CSL, and Clover being in partnership with GSK, I think that speaks to the quality of the programs that we selected.So, I think that combination of rapid review, speed of funding, getting those programs started, getting them oriented in the right direction, I think all of that is critical to where we are now.Companies that got money from CEPI to build out production capacity — that money came with strings attached, right?. Yes, exactly. So, where CEPI has made investments that create manufacturing, or secure manufacturing capacity, the commitment has been that the capacity that is attributable to the CEPI investment is committed — at least right of first refusal — to the global procurement facility.WASHINGTON — The Trump administration removed a top Food and Drug Administration communications official from her post on Friday in the wake of several controversial agency misstatements, a senior administration official confirmed to STAT.The spokeswoman, Emily Miller, had played a lead role in defending the FDA commissioner, Stephen Hahn, after he misrepresented data regarding the use of blood plasma from recovered skin care products patients.

The New York Times first reported Miller’s ouster. Miller’s tenure at as the top FDA spokeswoman lasted only 11 days. Her appointment was viewed with alarm by agency officials who felt her presence at the agency was emblematic of broader political pressure from the Trump administration, STAT first reported earlier this week.advertisement Before joining the FDA, Miller had no experience in health or medicine. Her former role as assistant commissioner for media affairs is typically not an appointment filled by political appointees.

The FDA’s communications arm typically maintains a neutral, nonpolitical tone.Miller’s appointment particularly alarmed FDA staff and outside scientists given her history in right-wing political advocacy and conservatism journalism. Her résumé included a stint as a Washington Times columnist, where she penned columns with titles that include “New Obamacare ads make young women look like sluts,” and a 2013 book on gun rights titled “Emily Gets Her Gun. But Obama Wants to Take Yours.”advertisement She also worked as a reporter for One America News Network, a right-wing cable channel that frequently espouses conspiracy theories and has declared an open alliance with President Trump.Miller quickly made her presence known at the FDA. In the wake of Hahn’s misstatements on blood plasma, she aggressively defended the commissioner, falsely claiming in a tweet that the therapy “has shown to be beneficial for 35% of patients.” An FDA press release on blood plasma, issued less than a week after her appointment, similarly alarmed agency insiders by trumpeting the emergency authorization as “Another Achievement in Administration’s Fight Against [the] renova.”.

What side effects may I notice from Renova?

Side effects that you should report to your doctor or health care professional as soon as possible:

• darkening or lightening of the treated areas
• severe burning, itching, crusting, or swelling of the treated areas

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• increased sensitivity to the sun
• itching
• mild stinging
• red, inflamed, and irritated skin, the skin may peel after a few days

This list may not describe all possible side effects.

Renova christmas paper towels

Dear Reader, renova christmas paper towels Thank you for following http://www.maxmosscrop.com/blog/following-ralph-watson/ the Me&MyDoctor blog. I'm writing to let you know we are moving the public health stories authored by Texas physicians, residents, and medical students, and patients to the Texas Medical Association's social media channels. Be sure to follow us on all our social media accounts (Facebook, Twitter, Instagram) as well as Texas Medicine Today to access these stories and more. We look forward to seeing you there.Best, Olivia Suarez Me&My Doctor Editor.

Dear Reader, Thank you generic renova prices for following the http://www.ec-westhoffen.ac-strasbourg.fr/?p=20 Me&MyDoctor blog. I'm writing to let you know we are moving the public health stories authored by Texas physicians, residents, and medical students, and patients to the Texas Medical Association's social media channels. Be sure to follow us on all our social media accounts (Facebook, Twitter, Instagram) as well as Texas Medicine Today to access these stories and more. We look forward to seeing you there.Best, Olivia Suarez Me&My Doctor Editor.

Renova cost

In this edition Open enrollment is underway nationwideAlthough the election has been at the top of many Americans’ minds this week, open enrollment renova cost for 2021 individual and family health insurance started last Sunday and is now underway nationwide. This enrollment window is for people who need to buy their own health insurance. (They don’t get coverage renova cost from an employer or from a government-run program such as Medicaid or Medicare.)Our 2021 Open Enrollment Guide.

Everything you need to know to enroll in an affordable individual-market health plan.The annual Medicare open enrollment period is also ongoing, but it follows a slightly different schedule.If you’ve got questions about the individual and family open enrollment period, we’ve got a comprehensive guide that will likely answer them. In most states, open enrollment will renova cost end on December 15, although Washington, DC and 10 states have later enrollment deadlines. It’s important to understand that the annual open enrollment period is your only chance to purchase individual major medical coverage for 2021 — through the exchange or outside the exchange — unless you experience a qualifying event during the year.Georgia will no longer have a health insurance exchange as of 2023On Sunday, the same day that open enrollment started and just two days before the election, the Trump administration formally approved Georgia’s proposal to stop having a health insurance exchange as of 2023.

Georgia is using renova cost a 1332 waiver for this change, and is also incorporating a reinsurance program, which will take effect in 2022. Nearly all of the other states that have received approval for 1332 waivers have used them for reinsurance programs, but Georgia’s plans are much more significant.As of 2023, Georgia will no longer use HealthCare.gov. But unlike other states (Nevada, Pennsylvania, renova cost and New Jersey) that have transitioned away from HealthCare.gov in recent years, Georgia has no plans to create a state-run health insurance exchange platform.

Instead, the state will rely on existing web brokers, insurance companies, and local agents and brokers to help Georgians enroll in health coverage.The majority of the public comments that were submitted regarding this change were opposed to it, and consumer advocates are concerned that Georgia residents will inadvertently enroll in non-ACA-compliant plans such as short-term health coverage. (Short-term plans cannot be purchased via HealthCare.gov, but can be purchased via many of the web brokers, insurers, and agents/brokers who will serve as the only enrollment platforms in Georgia as of 2023.) There renova cost are also concerns that these enrollment entities will have little incentive to help people enroll in Medicaid or CHIP, since there are no commissions for those types of coverage.Insurance commissioners elected in five statesEach state in the U.S. Has an insurance commissioner who leads the state’s regulatory department that oversees insurance in the state, including health insurance as well as other lines of coverage.

In five states, insurance renova cost commissioners were on the ballot in yesterday’s election. Here’s how the results stacked up:Delaware. Trinidad Navarro, renova cost the incumbent Democrat, won re-election.Montana.

Troy Downing, a Republican, won the election for Montana’s commissioner of securities and insurance, state auditor. Montana’s current commissioner, Matt Rosendale, did not run for renova cost re-election, as he ran instead for the state’s at-large U.S. House of Representatives seat, which was being vacated by Greg Gianforte in his bid for governor.

Both Rosendale and renova cost Gianforte won their respective races.North Carolina. Mike Causey, the incumbent Republican, won re-election, defeating Democrat Wayne Goodwin for the second time. Last month, Causey noted that “I obviously favor competition and free markets more so than government control of insurance, but I think the Affordable Care renova cost Act has been a blessing to a lot of people.”North Dakota.

Jon Godfread, the incumbent Republican, was unopposed and easily won re-election.Washington. Mike Kreidler, renova cost the incumbent Democrat, won re-election. Kreidler has been instrumental in implementing strong consumer protections in Washington related to short-term health plans, as well as ensuring continuous coverage availability in the state’s ACA-compliant market over the last several years and shepherding the implementation of the state’s new standardized and public option plans.

Three healthcare ballot measures rejected by voters, one approvedLast week, we told you about some healthcare ballot measures to watch in this renova cost election. Here’s how voters decided on those issues:Oklahoma State Question 814 was rejected by voters. It would have changed the way the state uses tobacco settlement money in order to provide the legislature with additional funding that could be used for the state’s share of the cost of Medicaid expansion, which takes effect next summer in Oklahoma (thanks to another ballot measure that was approved by voters earlier this year).

Although the measure did not pass, Emma Morris of the Oklahoma Policy Institute explained earlier this year that there are a variety of other funding options that renova cost the legislature can use.Colorado Proposition 118 was approved by voters. It will create a paid family/medical leave program that will be funded by a tax split between employers and employees.Colorado Proposition 115 was rejected by voters. It would renova cost have prohibited abortions after 22 weeks.

Colorado is one of seven states with no gestational age limits on abortion.California Proposition 23 was rejected by voters. It would have imposed various new state regulations on dialysis clinics, and was supported renova cost by the Service Employees International Union-United Healthcare Workers West (SEIU-UHW West). Public charge rule vacated by a federal judge, but order was stayed on appeal and the rule can continue to be implementedThe Trump administration’s updated “public charge” rule change, which began to be implemented in February of this year, was vacated by a federal judge in Illinois this week, with the judge’s order applying nationwide.

That change was short-lived however, as the Seventh Circuit Court of Appeals stayed the decision two days later, allowing the Trump administration’s version of the public charge rule to renova cost continue to be implemented while litigation on the case proceeds.Here’s more about what the public charge rule change entails, as well as details on the administration’s separate health insurance requirements for immigrants, which has also been blocked by the courts.Under the Trump administration’s public charge rule, Medicaid, SNAP, and TANF benefits have all been added to the list of benefits that can result in an immigrant being labeled as a “public charge” and thus denied lawful permanent residency or entry into the United States. Premium subsidies in the exchange and CHIP coverage are not on the list of public charge benefits, but there is a “heavily weighted positive factor” for immigrants who do not rely on premium subsidies. The intent and effect of the public charge rule are to reduce various public benefits, including health coverage, for immigrants.Trump administration’s healthcare transparency rule aims to make pricing information publicLast week, the Trump renova cost administration issued a final rule on price transparency in healthcare.

The new rule is intended to make it easier for consumers to learn how much their out-of-pocket costs will be before a procedure is performed – instead of having to wait for an explanation of benefits after the fact. The rule also requires insurers to publicize the rates they pay in-network providers, how much out-of-network providers bill and are paid renova cost during a specified time period, and prescription drug pricing. At Health Affairs, Katie Keith has an excellent, detailed overview of the new transparency rule.The transparency rule is slated to be phased in, from 2022 to 2024, and would apply to nearly all private health insurance, including employer-sponsored plans and individual market plans.

The rule applies to grandmothered plans and self-insured plans, renova cost but not grandfathered plans. And it also doesn’t apply to coverage that’s not regulated by the Affordable Care Act, including healthcare sharing ministries and short-term health plans. It’s noteworthy renova cost that the authority for this new rule comes from ACA Section 1311(e)(3), which has to do with transparency and reporting.

But while issuing this rule, the Trump administration is simultaneously working to overturn the entire ACA in court, in a lawsuit that the Supreme Court will hear next week.The idea behind the new transparency rule is to help consumers avoid surprise medical bills, to make comparison shopping easier and drive consumers to the providers who offer the best value, and to increase competition and reduce healthcare costs. But America’s Health Insurance Plans (AHIP) quickly expressed opposition to the new transparency rule, arguing that public disclosure of privately negotiated prices will drive healthcare costs higher rather than renova cost lower. And as this thread from Kaiser Family Foundation’s Nisha Kurani illustrates, consumers have been fairly slow to utilize existing price transparency tools that some states have already created.Pricing transparency in healthcare has long been a priority for the Trump administration, and this rule follows a similar rule that was issued last fall, requiring hospitals to make their charges publicly available.

The American Hospital Association sued to block that rule, and the case is renova cost currently being appealed. Assuming it’s not overturned on appeal, it will take effect in January 2021.What’s next for the ACA and health policy?. The results of the presidential election are still pending in many renova cost areas, but the likely scenario we’re facing as of January is a Biden/Harris White House, a Democratic-led House of Representatives, and a Republican-led Senate.

That divided structure – and the increasingly wide gulf between the two political parties – appears unlikely to result in any substantial healthcare reform legislation being enacted in the near future. But as Andrew Sprung explains, there is a lot that a Biden administration could do to improve access to affordable health coverage and care.If you’re curious about where we go from here – with a federal government that will continue to be divided for renova cost the time being and a variety of pressing healthcare reform needs – you’ll also want to read this piece from Charles Gaba and this one from Dave Anderson, as well as this Twitter thread from Larry Levitt.Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006. She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org.

Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

In this edition Open enrollment is underway nationwideAlthough the election has been generic renova prices at the top of many Americans’ minds this week, open enrollment for 2021 individual her latest blog and family health insurance started last Sunday and is now underway nationwide. This enrollment window is for people who need to buy their own health insurance. (They don’t get coverage from an employer or from a generic renova prices government-run program such as Medicaid or Medicare.)Our 2021 Open Enrollment Guide. Everything you need to know to enroll in an affordable individual-market health plan.The annual Medicare open enrollment period is also ongoing, but it follows a slightly different schedule.If you’ve got questions about the individual and family open enrollment period, we’ve got a comprehensive guide that will likely answer them. In most states, open enrollment will end on December 15, although Washington, DC and 10 generic renova prices states have later enrollment deadlines.

It’s important to understand that the annual open enrollment period is your only chance to purchase individual major medical coverage for 2021 — through the exchange or outside the exchange — unless you experience a qualifying event during the year.Georgia will no longer have a health insurance exchange as of 2023On Sunday, the same day that open enrollment started and just two days before the election, the Trump administration formally approved Georgia’s proposal to stop having a health insurance exchange as of 2023. Georgia is using a 1332 waiver for generic renova prices this change, and is also incorporating a reinsurance program, which will take effect in 2022. Nearly all of the other states that have received approval for 1332 waivers have used them for reinsurance programs, but Georgia’s plans are much more significant.As of 2023, Georgia will no longer use HealthCare.gov. But unlike other states (Nevada, Pennsylvania, and New Jersey) that have transitioned away from HealthCare.gov in recent years, Georgia generic renova prices has no plans to create a state-run health insurance exchange platform. Instead, the state will rely on existing web brokers, insurance companies, and local agents and brokers to help Georgians enroll in health coverage.The majority of the public comments that were submitted regarding this change were opposed to it, and consumer advocates are concerned that Georgia residents will inadvertently enroll in non-ACA-compliant plans such as short-term health coverage.

(Short-term plans cannot be purchased via HealthCare.gov, but can be purchased via many of the web brokers, insurers, and agents/brokers who will serve as the only enrollment platforms in Georgia as of 2023.) There are also concerns that these enrollment entities will have little incentive to help people enroll in Medicaid or CHIP, since there are no commissions for those types of coverage.Insurance commissioners elected in generic renova prices five statesEach state in the U.S. Has an insurance commissioner who leads the state’s regulatory department that oversees insurance in the state, including health insurance as well as other lines of coverage. In five states, insurance commissioners were on the ballot in yesterday’s generic renova prices election. Here’s how the results stacked up:Delaware. Trinidad Navarro, the generic renova prices incumbent Democrat, won re-election.Montana.

Troy Downing, a Republican, won the election for Montana’s commissioner of securities and insurance, state auditor. Montana’s current commissioner, Matt generic renova prices Rosendale, did not run for re-election, as he ran instead for the state’s at-large U.S. House of Representatives seat, which was being vacated by Greg Gianforte in his bid for governor. Both Rosendale and generic renova prices Gianforte won their respective races.North Carolina. Mike Causey, the incumbent Republican, won re-election, defeating Democrat Wayne Goodwin for the second time.

Last month, Causey noted that “I obviously favor competition and free markets more so than government generic renova prices control of insurance, but I think the Affordable Care Act has been a blessing to a lot of people.”North Dakota. Jon Godfread, the incumbent Republican, was unopposed and easily won re-election.Washington. Mike Kreidler, generic renova prices the incumbent Democrat, won re-election. Kreidler has been instrumental in implementing strong consumer protections in Washington related to short-term health plans, as well as ensuring continuous coverage availability in the state’s ACA-compliant market over the last several years and shepherding the implementation of the state’s new standardized and public option plans. Three healthcare ballot measures rejected by voters, one approvedLast week, we told you about some healthcare ballot measures to watch in this generic renova prices election.

Here’s how voters decided on those issues:Oklahoma State Question 814 was rejected by voters. It would have changed the way the state uses tobacco settlement money in order to provide the legislature with additional funding that could be used for the state’s share of the cost of Medicaid expansion, which takes effect next summer in Oklahoma (thanks to another ballot measure that was approved by voters earlier this year). Although the measure did not pass, Emma Morris of the Oklahoma Policy Institute explained earlier this year that there generic renova prices are a variety of other funding options that the legislature can use.Colorado Proposition 118 was approved by voters. It will create a paid family/medical leave program that will be funded by a tax split between employers and employees.Colorado Proposition 115 was rejected by voters. It would have prohibited abortions after 22 generic renova prices weeks.

Colorado is one of seven states with no gestational age limits on abortion.California Proposition 23 was rejected by voters. It would have imposed various new generic renova prices state regulations on dialysis clinics, and was supported by the Service Employees International Union-United Healthcare Workers West (SEIU-UHW West). Public charge rule vacated by a federal judge, but order was stayed on appeal and the rule can continue to be implementedThe Trump administration’s updated “public charge” rule change, which began to be implemented in February of this year, was vacated by a federal judge in Illinois this week, with the judge’s order applying nationwide. That change was short-lived however, as the Seventh Circuit Court of Appeals stayed the decision two days later, allowing the Trump administration’s version of the public charge rule to continue to be implemented while litigation on the case proceeds.Here’s more about what the public charge rule change entails, as well as details on the administration’s separate health insurance requirements for immigrants, which has also been blocked by the courts.Under the Trump administration’s public charge rule, Medicaid, SNAP, and TANF benefits have all been added to the list of benefits generic renova prices that can result in an immigrant being labeled as a “public charge” and thus denied lawful permanent residency or entry into the United States. Premium subsidies in the exchange and CHIP coverage are not on the list of public charge benefits, but there is a “heavily weighted positive factor” for immigrants who do not rely on premium subsidies.

The intent and effect of the generic renova prices public charge rule are to reduce various public benefits, including health coverage, for immigrants.Trump administration’s healthcare transparency rule aims to make pricing information publicLast week, the Trump administration issued a final rule on price transparency in healthcare. The new rule is intended to make it easier for consumers to learn how much their out-of-pocket costs will be before a procedure is performed – instead of having to wait for an explanation of benefits after the fact. The rule also requires insurers to publicize the rates they pay in-network providers, how much out-of-network providers generic renova prices bill and are paid during a specified time period, and prescription drug pricing. At Health Affairs, Katie Keith has an excellent, detailed overview of the new transparency rule.The transparency rule is slated to be phased in, from 2022 to 2024, and would apply to nearly all private health insurance, including employer-sponsored plans and individual market plans. The rule applies to grandmothered generic renova prices plans and self-insured plans, but not grandfathered plans.

And it also doesn’t apply to coverage that’s not regulated by the Affordable Care Act, including healthcare sharing ministries and short-term health plans. It’s noteworthy that the authority for this new rule comes from ACA Section 1311(e)(3), generic renova prices which has to do with transparency and reporting. But while issuing this rule, the Trump administration is simultaneously working to overturn the entire ACA in court, in a lawsuit that the Supreme Court will hear next week.The idea behind the new transparency rule is to help consumers avoid surprise medical bills, to make comparison shopping easier and drive consumers to the providers who offer the best value, and to increase competition and reduce healthcare costs. But America’s Health Insurance Plans (AHIP) quickly expressed opposition to generic renova prices the new transparency rule, arguing that public disclosure of privately negotiated prices will drive healthcare costs higher rather than lower. And as this thread from Kaiser Family Foundation’s Nisha Kurani illustrates, consumers have been fairly slow to utilize existing price transparency tools that some states have already created.Pricing transparency in healthcare has long been a priority for the Trump administration, and this rule follows a similar rule that was issued last fall, requiring hospitals to make their charges publicly available.

The American Hospital Association sued to block that rule, and the case is currently generic renova prices being appealed. Assuming it’s not overturned on appeal, it will take effect in January 2021.What’s next for the ACA and health policy?. The results of the generic renova prices presidential election are still pending in many areas, but the likely scenario we’re facing as of January is a Biden/Harris White House, a Democratic-led House of Representatives, and a Republican-led Senate. That divided structure – and the increasingly wide gulf between the two political parties – appears unlikely to result in any substantial healthcare reform legislation being enacted in the near future. But as Andrew Sprung explains, there is a lot that a Biden administration could do to improve access to affordable health coverage and care.If you’re curious about where we go from here – with a federal government that will continue to be divided for the time being and a variety of pressing healthcare reform needs – you’ll also want generic renova prices to read this piece from Charles Gaba and this one from Dave Anderson, as well as this Twitter thread from Larry Levitt.Louise Norris is an individual health insurance broker who has been writing about health insurance and health reform since 2006.

She has written dozens of opinions and educational pieces about the Affordable Care Act for healthinsurance.org. Her state health exchange updates are regularly cited by media who cover health reform and by other health insurance experts..

Renova spa punta cana

This edition renova spa punta cana of the Emergency Medicine Journal has ‘something for everyone’ (as always), and at least one article that will be of renova zero cost interest to everyone (I think). The two main themes in this edition are ‘the difficult airway’ and Paediatric Emergency Medicine. However, we begin this Primary Survey by talking about renova spa punta cana gender.Gender differences in Emergency MedicineTwo articles look at gender disparity in Emergency Medicine (EM). A short report by Partiali et al looks at the proportion of female speakers, and the length of time these speakers are given to deliver their talks, at a major EM academic conference.

Although both proportion and ‘speaking-time’ are renova spa punta cana increasing over the period reviewed, there remains a large gender difference. In the paper by Parsons et al, the worldwide difference in academic representation between the genders is discussed, and is especially interesting given the fact that more females matriculate from medical school in both the USA (since 2017) and the UK (since 1996–7). The authors then go on to look at gender differences renova spa punta cana in medical leadership in EM in the USA. The discrepancy revealed in this paper will, unfortunately, be unsurprising.Whilst writing this ‘Primary Survey’ my bedtime reading is a novel by the late-Victorian writer George Gissing, who in many of his novels explored the position of women in the late nineteenth century.

One of the characters opines “Woman is still enslaved, though men nowadays think renova spa punta cana it necessary to disguise it.” Having read these two articles it may be that the medical profession has evolved little in this regard over the last 150 years.The difficult airwayThree papers in this edition look at difficult airways and their management. In a paper from Japan by Takahashi et al, there is a review of a database from a large observational study on emergency airway management. This has revealed an increase in major (but not minor) adverse events in the older population undergoing emergency intubation, largely due to post-intubation hypotension renova spa punta cana. From the Helicopter Emergency Medical Service in London, there is a 20 year review of emergency cricothyroidotomy which reveals a very low rate of requirement for surgical airways in the pre-hospital environmentWhen performed, it is often due to blood in the airway preventing laryngoscopy.

Gaffar et al have looked at trauma CT scans and calculated the average cricothyroid membrane depth, and factors associated with a greater depth renova spa punta cana. Some of these factors might be surprising, however these ought to be considered by those preparing to perform an emergency surgical airway.Paediatric Emergency MedicineThere are several papers looking at issues in Paediatric Emergency Medicine. The results from a Paediatric Emergency registry in Nicaragua (reviewed in Bressan et al) is sobering, and the use of point-of-care EEG in an ED (described by Simma et al) in intriguing." data-icon-position data-hide-link-title="0">Two further papers particularly catch the eye. The Editors Choice this renova spa punta cana month is a paper looking at the likely cervical spine imaging in a Paediatric population, when using three different clinical decision rules (CDRs) (Philips et al).

There were large differences between cervical spine injury rates and imaging rates. However the use of CDRs would have increased the rate of imaging renova spa punta cana. The second paper is the short report by Cameron et al, highlighting the dangers of travel cups to children. Of interest renova spa punta cana to all of those who use them.Other articles of interestThe problem of pre-hospital ‘missed stroke’ is considered in the systematic review by Jones et al, and reading this paper reveals the challenges faced by clinicians ‘in the field’.

The clinical impact of this, and the potential for improving sensitivity of tools to identify stroke pre-hospital is discussed.Two original research papers relating to skin care products are of interest. Lyall and Lone look at the effect on non-skin care products admissions during the first lockdown in Scotland, while Bertaina et al look at non-invasive ventilation in acute respiratory failure due renova spa punta cana to skin care products.And finally…And the article I think will be of interest to everyone?. This is the Best Evidence topic report on homemade or cloth facemasks as a preventative measure for respiratory renova transmission- an evidence review on a topic that, is affecting all our lives.‘Tis a lesson you should heedTry, try again.If at first you don’t succeed,Try, try again.— Thomas H Palmer Teacher’s ManualPaediatric cervical spine injuries are rare events, particularly in young children. An individual emergency provider may see less than a handful in her entire career, even as she is continuously presented with patients renova spa punta cana considered at risk for injury.

In the same career, each provider will likely expose thousands of children to significant doses of radiation with an indeterminate but finite risk of inducing a downstream malignancy. Thus, with the increasing awareness of the cumulative risks associated with radiation exposure, the decision as to which patient should be radiographically studied and at what threshold often becomes an uncomfortable one.Useful clinical decision rules (CDRs) for identifying cervical spine renova spa punta cana injuries have been derived, validated and are broadly embraced for adult patients. The National Emergency X-Radiography Utilization Study (NEXUS) from the US and the Canadian C-Spine Rules (CCR).1 2 No comparable, validated paediatric decision-making tools have been created and medical providers have been largely left to extrapolate the findings of adult studies to their paediatric patients whose injuries and risks differ mechanistically and physiologically from their future selves. In an effort to provide better guidance to emergency providers, the investigators of the NEXUS trial analysed a paediatric subset with a very limited sample size (n=3065 with 30 cervical spine injuries), while the Pediatric Emergency Care Applied Research Network (PECARN) attempted to tackle the problem differently through a case-controlled methodology.3 4 Both of these paediatric efforts suffer significant limitations compared with the afore-mentioned large prospective observational studies.In a side-by-side comparison of these three decision tools, ….

This edition of the Emergency Medicine Journal has ‘something for everyone’ generic renova prices (as always), and at more information least one article that will be of interest to everyone (I think). The two main themes in this edition are ‘the difficult airway’ and Paediatric Emergency Medicine. However, we begin this Primary Survey by talking about gender.Gender differences in Emergency generic renova prices MedicineTwo articles look at gender disparity in Emergency Medicine (EM).

A short report by Partiali et al looks at the proportion of female speakers, and the length of time these speakers are given to deliver their talks, at a major EM academic conference. Although both proportion and ‘speaking-time’ generic renova prices are increasing over the period reviewed, there remains a large gender difference. In the paper by Parsons et al, the worldwide difference in academic representation between the genders is discussed, and is especially interesting given the fact that more females matriculate from medical school in both the USA (since 2017) and the UK (since 1996–7).

The authors then go on to look at gender differences generic renova prices in medical leadership in EM in the USA. The discrepancy revealed in this paper will, unfortunately, be unsurprising.Whilst writing this ‘Primary Survey’ my bedtime reading is a novel by the late-Victorian writer George Gissing, who in many of his novels explored the position of women in the late nineteenth century. One of the characters opines “Woman is still enslaved, though men nowadays think it generic renova prices necessary to disguise it.” Having read these two articles it may be that the medical profession has evolved little in this regard over the last 150 years.The difficult airwayThree papers in this edition look at difficult airways and their management.

In a paper from Japan by Takahashi et al, there is a review of a database from a large observational study on emergency airway management. This has revealed an increase in major (but not minor) adverse events in the generic renova prices older population undergoing emergency intubation, largely due to post-intubation hypotension. From the Helicopter Emergency Medical Service in London, there is a 20 year review of emergency cricothyroidotomy which reveals a very low rate of requirement for surgical airways in the pre-hospital environmentWhen performed, it is often due to blood in the airway preventing laryngoscopy.

Gaffar et al have looked at trauma CT scans and calculated the average cricothyroid generic renova prices membrane depth, and factors associated with a greater depth. Some of these factors might be surprising, however these ought to be considered by those preparing to perform an emergency surgical airway.Paediatric Emergency MedicineThere are several papers looking at issues in Paediatric Emergency Medicine. The results from a Paediatric Emergency registry in Nicaragua (reviewed in Bressan et al) is sobering, and the use of point-of-care EEG in an ED (described by Simma et al) in intriguing." data-icon-position data-hide-link-title="0">Two further papers http://jakkicarey.com/exhibitions/ particularly catch the eye.

The Editors Choice this month is a paper generic renova prices looking at the likely cervical spine imaging in a Paediatric population, when using three different clinical decision rules (CDRs) (Philips et al). There were large differences between cervical spine injury rates and imaging rates. However the use of CDRs would have increased the rate of generic renova prices imaging.

The second paper is the short report by Cameron et al, highlighting the dangers of travel cups to children. Of interest to all of generic renova prices those who use them.Other articles of interestThe problem of pre-hospital ‘missed stroke’ is considered in the systematic review by Jones et al, and reading this paper reveals the challenges faced by clinicians ‘in the field’. The clinical impact of this, and the potential for improving sensitivity of tools to identify stroke pre-hospital is discussed.Two original research papers relating to skin care products are of interest.

Lyall and Lone look at the effect on non-skin care products admissions during the first lockdown in Scotland, while Bertaina et al look at non-invasive ventilation in generic renova prices acute respiratory failure due to skin care products.And finally…And the article I think will be of interest to everyone?. This is the Best Evidence topic report on homemade or cloth facemasks as a preventative measure for respiratory renova transmission- an evidence review on a topic that, is affecting all our lives.‘Tis a lesson you should heedTry, try again.If at first you don’t succeed,Try, try again.— Thomas H Palmer Teacher’s ManualPaediatric cervical spine injuries are rare events, particularly in young children. An individual emergency provider may see less than a handful in her entire career, even as she is continuously presented with patients considered at generic renova prices risk for injury.

In the same career, each provider will likely expose thousands of children to significant doses of radiation with an indeterminate but finite risk of inducing a downstream malignancy. Thus, with the increasing awareness of the cumulative risks associated with radiation exposure, the decision as to which patient should be radiographically studied and at what threshold often becomes an uncomfortable one.Useful clinical decision rules (CDRs) for identifying cervical spine injuries have been derived, validated and are generic renova prices broadly embraced for adult patients. The National Emergency X-Radiography Utilization Study (NEXUS) from the US and the Canadian C-Spine Rules (CCR).1 2 No comparable, validated paediatric decision-making tools have been created and medical providers have been largely left to extrapolate the findings of adult studies to their paediatric patients whose injuries and risks differ mechanistically and physiologically from their future selves.

In an effort to provide better guidance to emergency providers, the investigators of the NEXUS trial analysed a paediatric subset with a very limited sample size (n=3065 with 30 cervical spine injuries), while the Pediatric Emergency Care Applied Research Network (PECARN) attempted to tackle the problem differently through a case-controlled methodology.3 4 Both of these paediatric efforts suffer significant limitations compared with the afore-mentioned large prospective observational studies.In a side-by-side comparison of these three decision tools, ….

Renova foundation

Start Preamble Start Printed renova foundation Page 19700 Centers for Medicare & http://www.maxmosscrop.com/blog/following-ralph-watson/. Medicaid Services (CMS), HHS. Proposed rule renova foundation. This rule proposes updates to the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022. This rule proposes changes to the labor shares of the hospice payment rates, proposes clarifying regulations text changes to the election statement addendum that was implemented on October 1, 2020, includes information on hospice utilization trends and solicits comments regarding hospice utilization and spending patterns.

In addition, this rule proposes to make permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the skin care products public health emergency and updates the hospice conditions of participation renova foundation. The proposed rule would update the Hospice Quality Reporting Program. The proposed rule requests information on advancing to digital quality measurement, the use of Fast Healthcare Interoperability Resources, addresses the White House Executive Order related to health equity in the Hospice Quality Reporting Program and provides updates to advancing Health Information Exchange. Finally, this rule proposes changes beginning with the January 2022 public reporting for the Home Health Quality Reporting Program to address renova foundation exceptions related to the skin care products public health emergency. To be assured consideration, comments must be received at one of the addresses provided below by June 7, 2021.

In commenting, refer to file code CMS-1754-P. Comments, including mass comment submissions, renova foundation must be submitted in one of the following three ways (choose only one of the ways listed). 1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov renova foundation.

Follow the “Submit a comment” instructions. 2. By regular renova foundation mail. You may mail written comments to the following address ONLY. Centers for renova foundation Medicare &.

Medicaid Services, Department of Health and Human Services, Attention. CMS-1754-P, P.O. Box 8010, Baltimore, MD 21244-1850 renova foundation. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3.

By express or overnight renova foundation mail. You may send written comments to the following address ONLY. Centers for Medicare &. Medicaid Services, renova foundation Department of Health and Human Services, Attention. CMS-1754-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info   For general questions about renova foundation hospice payment policy, send your inquiry via email to. Hospicepolicy@cms.hhs.gov. For questions regarding the CAHPS® Hospice Survey, contact Debra Dean-Whittaker at (410) 786-0848. For questions regarding the hospice conditions of participation (CoPs), contact Mary Rossi-Coajou at renova foundation (410)786-6051.

For questions regarding the home health public reporting, contact Charles Padgett (410) 786-2811. For questions regarding the hospice quality reporting program, renova foundation contact Cindy Massuda at (410) 786-0652. End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment renova foundation period on the following website as soon as possible after they have been received.

Http://www.regulations.gov. Follow the search instructions on that website to view public comments. Wage index addenda will be available renova foundation only through the internet on our website at. (https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Hospice-Wage-Index.html.) I. Executive Summary A.

Purpose This rule proposes updates to renova foundation the hospice wage index, payment rates, and cap amount for Fiscal Year (FY) 2022 as required under section 1814(i) of the Social Security Act (the Act). In addition, this rule proposes to rebase the labor shares of the hospice payment rates and proposes clarifying regulations text changes to the election statement addendum requirements finalized in the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484). This rule also includes information on hospice utilization trends and solicits comments regarding hospice utilization and spending patterns. In addition, this rule proposes to make permanent selected regulatory blanket waivers for renova foundation hospice agencies during the skin care products Public Health Emergency (PHE) and proposes revisions to the hospice conditions of participation (CoPs). This rule proposes changes to the Hospice Quality Reporting Program (HQRP), requests information on advancing to digital quality measurement and the use of Fast Healthcare Interoperability Resources (FHIR), addresses the White House Executive Order related to health equity in the HQRP and provides updates on advancing the Health Information Exchange.

Finally, this rule proposes changes to the Home Health Quality Reporting Program (HH QRP) to address the January 2022 refresh in accordance with sections 1895(b)(3)(B)(v)(III) and 1899(B)(f) of the Act. B. Summary of the Major Provisions Section III.A of this proposed rule includes data analysis on historical hospice utilization trends. The analysis includes data on the number of beneficiaries using the hospice benefit, live discharges, reported diagnoses on hospice claims, Medicare hospice spending, and Parts A, B and D non-hospice spending during a hospice election. In this section, we also solicit comments from the public, including hospice providers as well as patients and advocates, regarding the presented analysis on hospice utilization and spending patterns.

We also include questions related to non-hospice spending during a hospice election. Section III.B of this proposed rule proposes to rebase and revise the labor shares for continuous home care (CHC), routine home care (RHC), inpatient respite care (IRC), and general inpatient care (GIP) using 2018 Medicare cost report (MCR) data for freestanding hospice facilities. Section III.C proposes updates to the hospice wage index and makes the application of the updated wage data budget neutral for all four levels of hospice care. In section III.C of this rule, we also discuss the proposed FY 2022 hospice payment update percentage of 2.3 percent, updates to the hospice payment rates, as well as the updates to Start Printed Page 19701the hospice cap amount for FY 2022 by the hospice payment update percentage of 2.3 percent. Section III.D proposes clarifying regulations text changes regarding the election statement addendum requirements that were finalized in the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38484).

Section III.E proposes to make permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the skin care products PHE. We are proposing to revise hospice aide requirements to allow the use of the pseudo-patient for conducting hospice aide competency evaluations. We are also proposing to revise the provisions at § 418.76(h)(1)(iii) to state that if a hospice verifies during an on-site visit the finding of a supervising nurse regarding an area of concern in the performance of a hospice aide, the hospice must conduct and the hospice aide must complete a competency evaluation related to the deficient and related skill(s), in accordance with § 418.76(c). In section III.F of this rule, we discuss proposals to the HQRP including the addition of claims-based Hospice Care Index (HCI) measure, and Hospice Visits in the Last Days of Life (HVLDL) measure for public reporting. Removal of the seven Hospice Item Set (HIS) measures because a more broadly applicable measure, the NQF 3235 HIS Comprehensive Assessment Measure for the particular topic is available and already publicly reported.

And further development of, Hospice Outcome and Patient Evaluation (HOPE) assessment instrument. We also provide updates on the public reporting change for one refresh cycle to report less than the standard quarters of data due to the skin care products PHE exemptions and adding the Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospice Survey Star ratings. Additionally, there are requests for information (RFI) on advancing to digital quality measurement and the use of Fast Healthcare Interoperability Resources (FHIR) and on addressing the White House Executive Order related to health equity in the HQRP. In addition, this rule provides updates to advancing Health Information Exchange (HIE). The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care and patient access to their health information.

Finally, in section III.G of this rule, we are proposing changes to the HH QRP to establish that, beginning with the January 2022 through the July 2024 public reporting refresh cycle, we will report fewer quarters of data due to skin care products PHE exceptions granted on March 27, 2020. We include this Home Health proposal in this rule because we plan to resume public reporting for the HH QRP with the January 2022 refresh of Care Compare. In order to accommodate the exception of 2020 Q1 and Q2 data, we are proposing to resume public reporting using 3 out of 4 quarters of data for the January 2022 refresh. In order to finalize this proposal in time to release the required preview report related to the refresh, which we release 3 months prior to any given refresh (October 2021), we need the rule containing this proposal to finalize by October 2021. C.

Summary of Impacts The overall economic impact of this proposed rule is estimated to be $530 million in increased payments to hospices for FY 2022. II. Background A. Hospice Care Hospice care is a comprehensive, holistic approach to treatment that recognizes the impending death of a terminally ill individual and warrants a change in the focus from curative care to palliative care for relief of pain and for symptom management. Medicare regulations define “palliative care” as patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering.

Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice (42 CFR 418.3). Palliative care is at the core of hospice philosophy and care practices, and is a critical component of the Medicare hospice benefit. The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, nursing, social, psychological, emotional, and spiritual services through a collaboration of professionals and other caregivers, with the goal of making the beneficiary as physically and emotionally comfortable as possible. Hospice is compassionate beneficiary and family/caregiver-centered care for those who are terminally ill.

As referenced in our regulations at § 418.22(b)(1), to be eligible for Medicare hospice services, the patient's attending physician (if any) and the hospice medical director must certify that the individual is “terminally ill,” as defined in section 1861(dd)(3)(A) of the Act and our regulations at § 418.3. That is, the individual has a medical prognosis that his or her life expectancy is 6 months or less if the illness runs its normal course. The regulations at § 418.22(b)(2) require that clinical information and other documentation that support the medical prognosis accompany the certification and be filed in the medical record with it and those at § 418.22(b)(3) require that the certification and recertification forms include a brief narrative explanation of the clinical findings that support a life expectancy of 6 months or less. Under the Medicare hospice benefit, the election of hospice care is a patient choice and once a terminally ill patient elects to receive hospice care, a hospice interdisciplinary group is essential in the seamless provision of primarily home-based services. The hospice interdisciplinary group works with the beneficiary, family, and caregivers to develop a coordinated, comprehensive care plan.

Reduce unnecessary diagnostics or ineffective therapies. And maintain ongoing communication with individuals and their families about changes in their condition. The beneficiary's care plan will shift over time to meet the changing needs of the individual, family, and caregiver(s) as the individual approaches the end of life. If, in the judgment of the hospice interdisciplinary team, which includes the hospice physician, the patient's symptoms cannot be effectively managed at home, then the patient is eligible for general inpatient care (GIP), a more medically intense level of care. GIP must be provided in a Medicare-certified hospice freestanding facility, skilled nursing facility, or hospital.

GIP is provided to ensure that any new or worsening symptoms are intensively addressed so that the beneficiary can return to his or her home and continue to receive routine home care. Limited, short-term, intermittent, inpatient respite care (IRC) is also available because of the absence or need for relief of the family or other caregivers. Additionally, an individual can receive continuous home care (CHC) during a period of crisis in which an individual requires continuous care to achieve palliation or management of acute medical symptoms so that the Start Printed Page 19702individual can remain at home. Continuous home care may be covered for as much as 24 hours a day, and these periods must be predominantly nursing care, in accordance with the regulations at § 418.204. A minimum of 8 hours of nursing care, or nursing and aide care, must be furnished on a particular day to qualify for the continuous home care rate (§ 418.302(e)(4)).

Hospices must comply with applicable civil rights laws,[] including section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act, under which covered entities must take appropriate steps to ensure effective communication with patients and patient care representatives with disabilities, including the provisions of auxiliary aids and services. Additionally, they must take reasonable steps to ensure meaningful access for individuals with limited English proficiency, consistent with Title VI of the Civil Rights Act of 1964. Further information about these requirements may be found at. Http://www.hhs.gov/​ocr/​civilrights. B.

Services Covered by the Medicare Hospice Benefit Coverage under the Medicare hospice benefit requires that hospice services must be reasonable and necessary for the palliation and management of the terminal illness and related conditions. Section 1861(dd)(1) of the Act establishes the services that are to be rendered by a Medicare-certified hospice program. These covered services include. Nursing care. Physical therapy.

Occupational therapy. Speech-language pathology therapy. Medical social services. Home health aide services (called hospice aide services). Physician services.

Homemaker services. Medical supplies (including drugs and biologicals). Medical appliances. Counseling services (including dietary counseling). Short-term inpatient care in a hospital, nursing facility, or hospice inpatient facility (including both respite care and procedures necessary for pain control and acute or chronic symptom management).

Continuous home care during periods of crisis, and only as necessary to maintain the terminally ill individual at home. And any other item or service which is specified in the plan of care and for which payment may otherwise be made under Medicare, in accordance with Title XVIII of the Act. Section 1814(a)(7)(B) of the Act requires that a written plan for providing hospice care to a beneficiary who is a hospice patient be established before care is provided by, or under arrangements made by, the hospice program. And that the written plan be periodically reviewed by the beneficiary's attending physician (if any), the hospice medical director, and an interdisciplinary group (section 1861(dd)(2)(B) of the Act). The services offered under the Medicare hospice benefit must be available to beneficiaries as needed, 24 hours a day, 7 days a week (section 1861(dd)(2)(A)(i) of the Act).

Upon the implementation of the hospice benefit, the Congress also expected hospices to continue to use volunteer services, though Medicare does not pay for these volunteer services (section 1861(dd)(2)(E) of the Act). As stated in the FY 1983 Hospice Wage Index and Rate Update proposed rule (48 FR 38149), the hospice must have an interdisciplinary group composed of paid hospice employees as well as hospice volunteers, and that “the hospice benefit and the resulting Medicare reimbursement is not intended to diminish the voluntary spirit of hospices.” This expectation supports the hospice philosophy of community based, holistic, comprehensive, and compassionate end of life care. C. Medicare Payment for Hospice Care Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of the Act, and the regulations in 42 CFR part 418, establish eligibility requirements, payment standards and procedures. Define covered services.

And delineate the conditions a hospice must meet to be approved for participation in the Medicare program. Part 418, subpart G, provides for a per diem payment based on one of four prospectively-determined rate categories of hospice care (RHC, CHC, IRC, and GIP), based on each day a qualified Medicare beneficiary is under hospice care (once the individual has elected). This per diem payment is meant to cover all of the hospice services and items needed to manage the beneficiary's care, as required by section 1861(dd)(1) of the Act. While payments made to hospices is to cover all items, services, and drugs for the palliation and management of the terminal illness and related conditions, Federal funds cannot be used for the prohibited activities, even in the context of a per diem payment. While recent news reports [] have brought to light the potential role hospices could play in medical aid in dying (MAID) where such practices have been legalized in certain states, we wish to remind hospices that The Assisted Suicide Funding Restriction Act of 1997 (Pub.

L. 105-12) prohibits the use of Federal funds to provide or pay for any health care item or service or health benefit coverage for the purpose of causing, or assisting to cause, the death of any individual including mercy killing, euthanasia, or assisted suicide. However, the prohibition does not pertain to the provision of an item or service for the purpose of alleviating pain or discomfort, even if such use may increase the risk of death, so long as the item or service is not furnished for the specific purpose of causing or accelerating death. 1. Omnibus Budget Reconciliation Act of 1989 Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989 (Pub.

L. 101-239) amended section 1814(i)(1)(C) of the Act and provided changes in the methodology concerning updating the daily payment rates based on the hospital market basket percentage increase applied to the payment rates in effect during the previous Federal fiscal year. 2. Balanced Budget Act of 1997 Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L.

105-33) established that updates to the hospice payment rates beginning FY 2002 and subsequent FYs be the hospital market basket percentage increase for the FY. Section 4442 of the BBA amended section 1814(i)(2) of the Act, effective for services furnished on or after October 1, 1997, to require that hospices submit claims for payment for hospice care furnished in an individual's home only on the basis of the geographic location at which the service is furnished. Previously, local wage index values were applied based on the geographic location of the hospice provider, regardless of where the hospice care was furnished. Section 4443 of the BBA amended sections 1812(a)(4) and 1812(d)(1) of the Act to provide for hospice benefit periods of two 90-day periods, followed by an unlimited number of 60-day periods. 3.

FY 1998 Hospice Wage Index Final Rule The FY 1998 Hospice Wage Index final rule (62 FR 42860), implemented a new methodology for calculating the Start Printed Page 19703hospice wage index and instituted an annual Budget Neutrality Adjustment Factor (BNAF) so aggregate Medicare payments to hospices would remain budget neutral to payments calculated using the 1983 wage index. 4. FY 2010 Hospice Wage Index Final Rule The FY 2010 Hospice Wage Index and Rate Update final rule (74 FR 39384) instituted an incremental 7-year phase-out of the BNAF beginning in FY 2010 through FY 2016. The BNAF phase-out reduced the amount of the BNAF increase applied to the hospice wage index value, but was not a reduction in the hospice wage index value itself or in the hospice payment rates. 5.

The Affordable Care Act Starting with FY 2013 (and in subsequent FYs), the market basket percentage update under the hospice payment system referenced in sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act are subject to annual reductions related to changes in economy-wide productivity, as specified in section 1814(i)(1)(C)(iv) of the Act. In addition, sections 1814(i)(5)(A) through (C) of the Act, as added by section 3132(a) of the Patient Protection and Affordable Care Act (PPACA) (Pub. L. 111-148), required hospices to begin submitting quality data, based on measures specified by the Secretary of the Department of Health and Human Services (the Secretary), for FY 2014 and subsequent FYs. Since FY 2014, hospices that fail to report quality data have their market basket percentage increase reduced by 2 percentage points.

Note that with the passage of the Consolidated Appropriations Act, 2021 (hereafter referred to as CAA 2021) (Pub. L. 116-260), the reduction changes to 4 percentage points beginning in FY 2024. Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2) of the PPACA, required, effective January 1, 2011, that a hospice physician or nurse practitioner have a face-to-face encounter with the beneficiary to determine continued eligibility of the beneficiary's hospice care prior to the 180th day recertification and each subsequent recertification, and to attest that such visit took place. When implementing this provision, the Centers for Medicare &.

Medicaid Services (CMS) finalized in the FY 2011 Hospice Wage Index final rule (75 FR 70435) that the 180th day recertification and subsequent recertifications would correspond to the beneficiary's third or subsequent benefit periods. Further, section 1814(i)(6) of the Act, as added by section 3132(a)(1)(B) of the PPACA, authorized the Secretary to collect additional data and information determined appropriate to revise payments for hospice care and other purposes. The types of data and information suggested in the PPACA could capture accurate resource utilization, which could be collected on claims, cost reports, and possibly other mechanisms, as the Secretary determined to be appropriate. The data collected could be used to revise the methodology for determining the payment rates for RHC and other services included in hospice care, no earlier than October 1, 2013, as described in section 1814(i)(6)(D) of the Act. In addition, CMS was required to consult with hospice programs and the Medicare Payment Advisory Commission (MedPAC) regarding additional data collection and payment revision options.

6. FY 2012 Hospice Wage Index Final Rule In the FY 2012 Hospice Wage Index final rule (76 FR 47308 through 47314) it was announced that beginning in 2012, the hospice aggregate cap would be calculated using the patient-by-patient proportional methodology, within certain limits. Existing hospices had the option of having their cap calculated through the original streamlined methodology, also within certain limits. As of FY 2012, new hospices have their cap determinations calculated using the patient-by-patient proportional methodology. If a hospice's total Medicare payments for the cap year exceed the hospice aggregate cap, then the hospice must repay the excess back to Medicare.

7. IMPACT Act of 2014 The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185) became law on October 6, 2014. Section 3(a) of the IMPACT Act mandated that all Medicare certified hospices be surveyed every 3 years beginning April 6, 2015 and ending September 30, 2025.

In addition, section 3(c) of the IMPACT Act requires medical review of hospice cases involving beneficiaries receiving more than 180 days of care in select hospices that show a preponderance of such patients. Section 3(d) of the IMPACT Act contains a new provision mandating that the cap amount for accounting years that end after September 30, 2016, and before October 1, 2025 be updated by the hospice payment percentage update rather than using the consumer price index for urban consumers (CPI-U) for medical care expenditures. 8. FY 2015 Hospice Wage Index and Payment Rate Update Final Rule The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50452) finalized a requirement that the Notice of Election (NOE) be filed within 5 calendar days after the effective date of hospice election. If the NOE is filed beyond this 5-day period, hospice providers are liable for the services furnished during the days from the effective date of hospice election to the date of NOE filing (79 FR 50474).

As with the NOE, the claims processing system must be notified of a beneficiary's discharge from hospice or hospice benefit revocation within 5 calendar days after the effective date of the discharge/revocation (unless the hospice has already filed a final claim) through the submission of a final claim or a Notice of Termination or Revocation (NOTR). The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50479) also finalized a requirement that the election form include the beneficiary's choice of attending physician and that the beneficiary provide the hospice with a signed document when he or she chooses to change attending physicians. In addition, the FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50496) provided background, described eligibility criteria, identified survey respondents, and otherwise implemented the Hospice Experience of Care Survey for informal caregivers. Hospice providers were required to begin using this survey for hospice patients as of 2015. Finally, the FY 2015 Hospice Wage Index and Rate Update final rule required providers to complete their aggregate cap determination not sooner than 3 months after the end of the cap year, and not later than 5 months after, and remit any overpayments.

Those hospices that fail to submit their aggregate cap determinations on a timely basis will have their payments suspended until the determination is completed and received by the Medicare contractor (79 FR 50503). 9. FY 2016 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47142), CMS finalized two different payment rates for RHC. A higher per diem base payment rate for the first 60 days of hospice care and a reduced per diem base payment rate for subsequent days of hospice care. CMS also finalized a service intensity add-on (SIA) Start Printed Page 19704payment payable for certain services during the last 7 days of the beneficiary's life.

A service intensity add-on payment will be made for the social worker visits and nursing visits provided by a registered nurse (RN), when provided during routine home care in the last 7 days of life. The SIA payment is in addition to the routine home care rate. The SIA payment is provided for visits of a minimum of 15 minutes and a maximum of 4 hours per day (80 FR 47172). In addition to the hospice payment reform changes discussed, the FY 2016 Hospice Wage Index and Rate Update final rule implemented changes mandated by the IMPACT Act, in which the cap amount for accounting years that end after September 30, 2016 and before October 1, 2025 would be updated by the hospice payment update percentage rather than using the CPI-U (80 FR 47186). In addition, we finalized a provision to align the cap accounting year for both the inpatient cap and the hospice aggregate cap with the FY for FY 2017 and thereafter.

Finally, the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47144) clarified that hospices would have to report all diagnoses on the hospice claim as a part of the ongoing data collection efforts for possible future hospice payment refinements. 10. FY 2017 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52160), CMS finalized several new policies and requirements related to the HQRP. First, CMS codified the policy that if the National Quality Forum (NQF) made non-substantive changes to specifications for HQRP measures as part of the NQF's re-endorsement process, CMS would continue to utilize the measure in its new endorsed status, without going through new notice-and-comment rulemaking. CMS would continue to use rulemaking to adopt substantive updates made by the NQF to the endorsed measures adopted for the HQRP.

Determinations about what constitutes a substantive versus non-substantive change would be made on a measure-by-measure basis. Second, we finalized two new quality measures for the HQRP for the FY 2019 payment determination and subsequent years. Hospice Visits when Death is Imminent Measure Pair and Hospice and Palliative Care Composite Process Measure-Comprehensive Assessment at Admission (81 FR 52173). The data collection mechanism for both of these measures is the Hospice Item Set (HIS), and the measures were effective April 1, 2017. Regarding the CAHPS® Hospice Survey, CMS finalized a policy that hospices that receive their CMS Certification Number (CCN) after January 1, 2017 for the FY 2019 Annual Payment Update (APU) and January 1, 2018 for the FY 2020 APU will be exempted from the Hospice CAHPS® requirements due to newness (81 FR 52182).

The exemption is determined by CMS and is for 1 year only. 11. FY 2020 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38484), we finalized rebased payment rates for CHC and GIP and set those rates equal to their average estimated FY 2019 costs per day. We also rebased IRC per diem rates equal to the estimated FY 2019 average costs per day, with a reduction of 5 percent to the FY 2019 average cost per day to account for coinsurance. We finalized the FY 2020 proposal to reduce the RHC payment rates by 2.72 percent to offset the increases to CHC, IRC, and GIP payment rates to implement this policy in a budget-neutral manner in accordance with section 1814(i)(6) of the Act (84 FR 38496).

In addition, we finalized a policy to use the current year's pre-floor, pre-reclassified hospital inpatient wage index as the wage adjustment to the labor portion of the hospice rates. Finally, in the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38505), we finalized modifications to the hospice election statement content requirements at § 418.24(b) by requiring hospices, upon request, to furnish an election statement addendum effective beginning in FY 2021. The addendum must list those items, services, and drugs the hospice has determined to be unrelated to the terminal illness and related conditions, increasing coverage transparency for beneficiaries under a hospice election. 12. Consolidated Appropriations Act, 2021 Division CC, section 404 of the CAA 2021 amended section 1814(i)(2)(B) of the Act and extended the provision that currently mandates the hospice cap be updated by the hospice payment update percentage (hospital market basket update reduced by the multifactor productivity adjustment) rather than the CPI-U for accounting years that end after September 30, 2016 and before October 1, 2030.

Prior to enactment of this provision, the hospice cap update was set to revert to the original methodology of updating the annual cap amount by the CPI-U beginning on October 1, 2025. Division CC, section 407 of CAA 2021 revises section 1814(i)(5)(A)(i) to increase the payment reduction for hospices who fail to meet hospice quality measure reporting requirements from two percent to four percent beginning with FY 2024. III. Provisions of the Proposed Rule A. Hospice Utilization and Spending Patterns CMS provides analysis as it relates to hospice utilization such as Medicare spending, utilization by level of care, lengths of stay, live discharge rates, and skilled visits during the last days of life using the most recent, complete claims data.

Stakeholders report that such data can be used to educate hospices on Medicare policies to help ensure compliance. Moreover, in response to the Office of Inspector General (OIG) reports highlighting vulnerabilities in the Medicare hospice benefit including hospices engaging in inappropriate billing, not providing needed services and crucial information to beneficiaries in order for them to make informed decisions about their care, [] we continue to monitor both hospice and non-hospice spending during a hospice election. We are still analyzing the effects of the skin care products PHE as it relates to the following routine monitoring analysis and whether those effects are likely to be temporary or permanent and if such effects vary significantly across hospice providers. Therefore, for the purposes of providing routine analysis on utilization and spending, in this proposed rule, we used the most complete data we have from FY 2019. 1.

General Hospice Utilization Trends Since the implementation of the hospice benefit in 1983, there has been substantial growth in hospice utilization. The number of Medicare beneficiaries receiving hospice services has grown from 584,438 in FY 2001 to over 1.6 million in FY 2019. Medicare hospice expenditures have risen from $3.5 billion in FY 2001 to approximately $20 billion in FY 2019.[] CMS' Office of the Actuary (OACT) projects that aggregate hospice expenditures are expected to continue to increase, by approximately 7.6 percent annually. We note that the Start Printed Page 19705average spending per beneficiary has also increased between FY 2010 and FY 2019 from approximately $11,158 in FY 2010 to $12,687 in FY 2019.[] The percentage of Medicare decedents who died while receiving services under the Medicare hospice benefit has increased as shown in Table 1. Similar to the increase in the number of beneficiaries using the benefit, the total number of organizations offering hospice services also continues to grow, with for-profit providers entering the market at higher rates than not-for-profit providers.

In its March 2020 Report to the Congress, MedPAC stated that for more than a decade, the increasing number of hospice providers is due almost entirely to the entry of for-profit providers. MedPAC also stated that long stays in hospice have been very profitable and this has attracted new provider entrants with revenue-generating strategies specifically targeting those patients expected to have longer lengths of stay.[] Freestanding hospices continue to dominate the market as a whole. In FY 2019, 68 percent (3,254 out of 4,811) of hospices were for-profit and 21 percent (987 out of 4,811) were non-profit, whereas in FY 2014, 61 percent (2,513 out of 4,108) were for-profit and 25 percent (1,029 out of 4,108) of hospices were non-profit. In FY 2019, for-profit hospices provided approximately 58 percent of all hospice days while non-profit hospices provided 31 percent of all hospice days.[] Hospices that listed their ownership status as “Other”, “Government” or had an unknown ownership status accounted for the remaining percentage of hospice days. There have been notable changes in the pattern of diagnoses among Medicare hospice enrollees since the implementation of the Medicare hospice benefit from primarily cancer diagnoses to neurological diagnoses, including Alzheimer's disease and other related dementias (80 FR 25839).

Our ongoing analysis of diagnosis reporting finds that neurological and organ-based failure conditions remain the top-reported principal diagnoses. Beneficiaries with these terminal conditions tend to have longer hospice stays, which have historically been more profitable than shorter stays.[] Table 2 shows the top 20 most frequently reported principal diagnoses on FY 2019 hospice claims. Start Printed Page 19706 Hospice Utilization by Level of Care Our analysis shows that there have only been slight changes over time in how hospices have been utilizing the different levels of care. RHC consistently represents the highest percentage of total hospice days as well as the highest percentage of total hospice payments as shown in Tables 3 and 4). Start Printed Page 19707 In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38496), we rebased the payment rates for the CHC, IRC, and GIP levels of care to better align hospice payment with the costs of providing care.

We will continue to monitor the effects of these rebased rates to determine if there are any notable shifts in the provision of care or any other perverse utilization patterns that would warrant any program integrity or survey actions. 2. Trends in Hospice Length of Stay, Live Discharges and Skilled Visits in the Last Days of Life Analysis Eligibility under the Medicare hospice benefit is predicated on the individual being certified as terminally ill. Medicare regulations at § 418.3 define “terminally ill” to mean that the individual has a medical prognosis that his or her life expectancy is 6 months or less if the illness runs its normal course. However, we recognize that a beneficiary may be under a hospice election longer than 6 months, as long as there remains a reasonable expectation that the individuals have a life expectancy of 6 months or less.

It has always been our expectation that the certifying physicians will use their best clinical judgment, in accordance with the regulations at §§ 418.22 and 418.25, to determine if the individual has a life expectancy of 6 months or less with each certification and recertification. Hospice Length of Stay We examined hospice length of stay in three ways. (1) Average length of election, meaning the number of hospice days during a single hospice election at the time of live discharge or death. (2) the median lifetime length of stay, which represents the 50th percentile, and. (3) average lifetime length of stay, which includes the sum of all days of hospice care across all hospice elections.

Extremely long lengths of stay influence both the average length of election and average lifetime length of stay. Table 5 shows the average length of election, the median and average lifetime lengths of stay from FYs 2016 through 2019. Length of stay estimates vary based on the reported principal diagnosis Table 6 lists the top six clinical categories of principal diagnoses reported on hospice claims in FY 2019 along with the corresponding number of hospice discharges. Patients with neurological and organ-based failure conditions (with the exception of kidney disease/kidney failure) tend to have much longer lengths of stay compared to patients with cancer diagnoses. Start Printed Page 19708 Hospice Live Discharges Federal regulations limit the circumstances in which a Medicare hospice provider may discharge a patient from its care.

In accordance with § 418.26, discharge from hospice care is permissible when the patient moves out of the provider's service area, is determined to be no longer terminally ill, or for cause. Hospices may not discharge the patient at their discretion, even if the care may be costly or inconvenient for the hospice. Additionally, an individual or representative may revoke the individual's election of hospice care at any time during an election period in accordance with the regulations at § 418.28. However, at any time thereafter, the beneficiary may re-elect hospice coverage at any other hospice election period that they are eligible to receive. Immediately upon hospice revocation, Medicare coverage resumes for those Medicare benefits previously waived with the hospice election.

Only the beneficiary (or representative) can revoke the hospice election. A revocation must be in writing and must specify the effective date of the revocation. A hospice cannot revoke a beneficiary's hospice election, nor is it appropriate for hospices to encourage, request, or demand that the beneficiary or his or her representative revoke his or her hospice election. From FY 2014 through FY 2019, the average live discharge rate has been approximately 17 percent per year. Of the live discharges in FY 2019, 37.5 percent were because of revocations, 37.2 percent were because the beneficiary was determined to no longer be terminally ill, 10.7 percent were because beneficiaries moved out of the service area without transferring hospices, and 12.9 percent were because beneficiaries transferred to another hospice (see Figure 1).

The remaining 1.6 percent were discharged for cause.[] Figure 1 shows the average annual rates of live discharge rates from FYs 2010 through 2019. Start Printed Page 19709 Finally, we looked at the distribution of live discharges by length of stay intervals. Figure 2 shows the live discharge rates by length of stay intervals from FY 2016 through FY 2019. We found that the majority of live discharges occur in the first 30 days of hospice care and after 180 days of hospice care. The proportion of live discharges occurring between the lengths of stay intervals was relatively constant from FY 2016 to FY 2019 where approximately 25 percent of live discharges occurred within 30 days of the start of hospice care, and approximately 32 percent occurred after a length of stay over 180 days of hospice care.

Start Printed Page 19710 Service Intensity Add-On (SIA) Payment A hospice's costs typically follow a U-shaped curve, with higher costs at the beginning and end of a stay, and lower costs in the middle of the stay. This cost curve reflects hospices' higher service intensity at the time of the patient's admission and the time surrounding the patient's death.[] In the period immediately preceding death, patient needs typically surge and more intensive services are typically warranted, and where the provision of care would proportionately escalate to meet the increased clinical, emotional, and other needs of the hospice beneficiary and his or her family and caregiver(s). In the FY 2016 Hospice Rate Update final rule (80 FR 47142), we established two different payment rates for RHC to reflect the cost of providing hospice care throughout the course of a hospice election. We finalized a higher base payment rate for the first 60 days of hospice care and a reduced base payment rate for days 61 and later. (80 FR 47172).

To reflect higher costs associated with the last 7 days of life, in FY 2016, we implemented the service intensity add-on payment (SIA) for RHC when direct patient care is provided by a RN or social worker during the last 7 of the beneficiary's life. The SIA payment is equal to the CHC hourly rate multiplied by the hours of nursing or social work provided on the day of service (up to 4 hours), if certain criteria are met (80 FR 47177). This effort represented meaningful advances in encouraging visits to hospice beneficiaries during the time preceding death and where patient and family needs typically intensify. To examine the effects of the SIA payment, we analyzed claims since the implementation of the SIA payment to determine if there was an increase in RN and social worker visits in the last seven days of life. In CY 2015 (the year preceding the SIA payment), the percentage of beneficiaries who did not receive a skilled nursing or social worker visit on the last day of life (when the last day of life was RHC) was nearly 23 percent.

Our analysis shows a slight decline in the number of beneficiaries who did not receive an RN or social worker visit on the last day of life (when the last day of life was RHC) where the percentage trended downward to just over 19 percent in CYs 2017 to 2019. This trend is similar for the 4 days leading up to the end of life (when the last 4 days of life were RHC), meaning beneficiaries are receiving more skilled nursing and social worker visits during the last days of life since implementation of the SIA payment. Table 7 shows the percentage of decedents not receiving skilled visits at the end of life for CY 2015 through CY 2019. Start Printed Page 19711 SIA payments have increased from FY 2016 through FY 2019 from $88 million to $150 million respectively as shown in Figure 3. Start Printed Page 19712 To further evaluate the impact of the SIA, we examined the total amount of minutes provided by skilled nurses and social workers in the last 7 days of life and overall there were only modest changes from CY 2015 to CY 2019, as shown in Table 8.[] MedPAC had examined skilled nurse and social worker minutes in the last 7 days of life from CY 2015 through 2018 in their March 2020 Report to Congress and similarly found little change overall.[] Start Printed Page 19713 3.

Non-Hospice Spending During a Hospice Election The Medicare hospice per diem payment amounts were developed to cover all services needed for the palliation and management of the terminal illness and related conditions, as described in section 1861(dd)(1) of the Act. Hospice services provided under a written plan of care (POC) should reflect patient and family goals and interventions based on the problems identified in the initial, comprehensive, and updated comprehensive assessments. As referenced in our regulations at § 418.64 and section II.B of this rule, a hospice must routinely provide all core services directly by hospice employees and they must be provided in a manner consistent with acceptable standards of practice. Under the current payment system, hospices are paid for each day that a beneficiary is enrolled in hospice care, regardless of whether services are rendered on any given day. Additionally, when a beneficiary elects the Medicare hospice benefit, he or she waives the right to Medicare payment for services related to the treatment of the terminal illness and related conditions, except for services provided by the designated hospice and the attending physician.

The comprehensive nature of the services covered under the Medicare hospice benefit is structured such that hospice beneficiaries should not have to routinely seek items, services, and/or medications beyond those provided by hospice. We believe that it would be unusual and exceptional to see services provided outside of hospice for those individuals who are approaching the end of life and we have reiterated since 1983 that “virtually all” care needed by the terminally ill individual would be provided by the hospice. In examining overall non-hospice spending during a hospice election, Medicare paid over $1 billion in non-hospice spending during a hospice election in FY 2019 for items and services under Parts A, B, and D. Medicare payments for non-hospice Part A and Part B items and services received by hospice beneficiaries during a hospice election increased from $583 million in FY 2016 to $692 million in FY 2019 (see Figure 4). This represents an increase in non-hospice Medicare spending for Parts A and B of 18.7 percent.

Whereas there is minimal beneficiary cost sharing under the Medicare hospice benefit,[] non-hospice services received outside of the Medicare hospice benefit are subject to beneficiary cost sharing. In FY 2019, the total beneficiary cost sharing amount was $170 million for Parts A and B.[] Start Printed Page 19714 We also examined non-hospice spending during a hospice election by claim type for Parts A and B, as shown in Table 9. Start Printed Page 19715 Hospices are responsible for covering drugs and biologicals related to the palliation and management of the terminal illness and related conditions while the patient is under hospice care. For a prescription drug to be covered under Part D for an individual enrolled in hospice, the drug must be for treatment completely unrelated to the terminal illness or related conditions. After a hospice election, many maintenance drugs or drugs used to treat or cure a condition are typically discontinued as the focus of care shifts to palliation and comfort measures.

However, those same drugs may be appropriate to continue as they may offer symptom relief for the palliation and management of the terminal prognosis.[] Similar to the increase in non-hospice spending during a hospice election for Medicare Parts A and B items and services, non-hospice spending for Part D drugs increased in from $353 million in FY 2016 to $499 million in FY 2019 (Figure 5). Start Printed Page 19716 Analysis of Part D prescription drug events (PDEs) data suggests that the current use of prior authorization (PA) by Part D sponsors has reduced Part D program payments for drugs in four targeted categories (analgesics, anti-nauseants, anti-anxiety, and laxatives), which are typically used to treat common symptoms experienced during the end of life. However, under Medicare Part D there has been an increase in hospice beneficiaries filling prescriptions for a separate category of drugs we refer to as maintenance drugs (https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Downloads/​2016-11-15-Part-D-Hospice-Guidance.pdf). Under CMS's current policy, Part D sponsors are not expected to place hospice PA requirements on categories of drugs (other than the four targeted categories listed above) or take special measures beyond their normal compliance and utilization review activities. Under this policy, sponsors are not expected to place PA requirements on maintenance drugs, for beneficiaries under a hospice election, though these drugs may still be subject to standard Part D formulary management practices.

This policy was put in place in recognition of the operational challenges associated with requiring PA on all drugs for beneficiaries who have elected hospice and because of the potential barriers to access that could be created by requiring PA on all drugs.[] Examples of maintenance drugs are those used to treat high blood pressure, heart disease, asthma and diabetes. These categories include beta blockers, calcium channel blockers, corticosteroids, and insulin. Table 10 details the various components of Part D spending for patients receiving hospice care for FY 2019. The portion of the FY 2019 Part D spending that was paid by Medicare is the sum of the Low Income Cost-Sharing Subsidy and the Covered Drug Plan Paid Amount, approximately $499 million. The beneficiary cost sharing amount was approximately $59 million.[] Start Printed Page 19717 Comment Solicitation on Analysis of Hospice Utilization and Spending Patterns We are soliciting comments on all aspects of the analysis presented in this proposed rule regarding hospice utilization and spending patterns.

Our ongoing monitoring and analysis have shown that the hospice benefit has evolved. Originally providing services primarily to patients with cancer, to now primarily patients with neurological conditions and organ-based failure. We are particularly interested in how this change in patient characteristics may have influenced any changes in the provision of hospice services. As mentioned in the above analysis, after the implementation of the SIA in FY 2016, the number of beneficiaries who did not receive an RN or social worker visit on the last day of has decreased. We are soliciting comments regarding skilled visits in the last week of life, particularly, what factors determine how and when visits are made as an individual approaches the end of life.

Given the comprehensive and holistic nature of the services covered under the Medicare hospice benefit, we continue to expect that hospices are providing virtually all of the care needed by terminally ill individuals. However, the analysis of non-hospice spending during a hospice election indicates a continuing trend where there is a potential “unbundling” of items, services, and drugs from the Medicare hospice benefit. That is, there may be items, services, and drugs that should be covered under the Medicare hospice benefit but are being paid under other Medicare benefits. We are soliciting comments as to how hospices make determinations as to what items, services and drugs are related versus unrelated to the terminal illness and related conditions. That is, how do hospices define what is unrelated to the terminal illness and related conditions when establishing a hospice plan of care.

Likewise, we are soliciting comments on what other factors may influence whether or how certain services are furnished to hospice beneficiaries. Finally, we are interested in stakeholder feedback as to whether the hospice election statement addendum has changed the way hospices make care decisions and how the addendum is used to prompt discussions with beneficiaries and non-hospice providers to ensure that the care needs of beneficiaries who have elected the hospice benefit are met. B. FY 2022 Proposed Labor Shares 1. Background The labor share for CHC and RHC of 68.71 percent was established with the FY 1984 Hospice benefit implementation based on the wage/nonwage proportions specified in Medicare's limit on home health agency costs (48 FR 38155 through 38156).

The labor shares for IRC and GIP are currently 54.13 percent and 64.01 percent, respectively. These proportions were based on skilled nursing facility wage and nonwage cost limits and skilled nursing facility costs per day (48 FR 38155 through 38156. 56 FR 26917). For the FY 2022 proposed rule, we are proposing to rebase and revise the labor shares for CHC, RHC, IRC and GIP using MCR data for freestanding hospices (CMS Form 1984-14, OMB NO. 0938-0758 [] ) for 2018.

We are proposing to continue to establish separate labor shares for CHC, RHC, IRC, and GIP and base them on the calculated compensation cost weights for each level of care from the 2018 MCR data. We describe our proposed methodology for deriving the compensation cost weights for each level of care using the MCR data below. We note that we did explore the possibility of using facility-based hospice MCR data to calculate the compensation cost weights. However, very few providers passed the Level I edits (as described in more detail below) and so these reports were not usable. 1.

Proposed Methodology for Calculating Compensation Costs We are proposing to derive a compensation cost weight for each level of care that consists of five major components. (1) Direct patient care salaries and contract labor costs, (2) direct patient care benefits costs, (3) other patient care salaries, (4) overhead salaries, and (5) overhead benefits costs. For each level of care, we are proposing to use the same methodology to derive the components. However, for the (1) Start Printed Page 19718direct patient care salaries and (3) other patient care salaries, we are proposing to use the MCR worksheet that is specific to that level of care (that is, Worksheet A-1 for CHC, Worksheet A-2 for RHC, Worksheet A-3 for IRC, and Worksheet A-4 for GIP). (1) Direct Patient Care Salaries and Contract Labor Costs Direct patient care salaries and contract labor costs are costs associated with medical services provided by medical personnel including but not limited to physician services, nurse practitioners, registered nurses, and hospice aides.

We are proposing to define direct patient care salaries and contract labor costs to be equal to costs reported on Worksheet A-1 (for CHC) or Worksheet A-2 (for RHC) or Worksheet A-3 (for IRC) or Worksheet A-4 (for GIP), column 7, for lines 26 through 37. (2) Direct Patient Care Benefits Costs We are proposing that direct patient care benefits costs for CHC would be equal to Worksheet B, column 3, line 50, for RHC are equal to Worksheet B, column 3, line 51, for IRC are equal to Worksheet B, column 3, line 52, and for GIP are equal to Worksheet B, column 3, line 53. (3) Other Patient Care Salaries Other patient care salaries are those salaries attributable to patient services including but not limited to patient transportation, labs, and imaging services. These salaries, reflecting all levels of care, are reported on Worksheet A, column 1, lines 38 through 46 and then are further disaggregated for CHC, RHC, IRC, and GIP on Worksheets A-1, A-2, A-3, and A-4, respectively, on column 1 (salaries), lines 38 through 46. Our analysis, however, found that many providers were not reporting salaries on the detailed level of care worksheets (A-1, A-2, A-3, A-4, column 1), but rather reporting total costs (reflecting salary and non-salary costs) for these services for each level of care on Worksheets A-1, A-2, A-3, A-4, column 7.

Therefore, we are proposing to estimate other patient care salaries attributable to CHC, RHC, IRC, and GIP by first calculating the ratio of total facility (reflecting all levels of care) other patient care salaries (Worksheet A, column 1, lines 38 through 46) to total facility other patient care total costs (Worksheet A, column 7, lines 38 through 46). For CHC, we are proposing to then multiply this ratio by other patient care total costs for CHC (Worksheet A-1 column 7, lines 38 through 46). For RHC, we are proposing to multiply this ratio by total other patient care costs for RHC (Worksheet A-2, column 7, lines 38 through 46). For IRC, we are proposing to multiply this ratio by total other patient care costs for IRC (Worksheet A-3, column 7, lines 38 through 46). For GIP, we are proposing to multiply this ratio by total other patient care costs for GIP (Worksheet A-4, column 7, lines 38 through 46).

This proposed methodology assumes that the proportion of salary costs to total costs for other patient care services is consistent for each of the four levels of care. (4) Overhead Salaries The MCR captures total overhead costs (including but not limited to administrative and general, plant operations and maintenance, and housekeeping) attributable to each of the four levels of care. To estimate overhead salaries for each level of care, we first propose to calculate noncapital non-benefit overhead costs for each level of care to be equal to Worksheet B, column 18, less the sum of Worksheet B, columns 0 through 3, for line 50 (CHC), or line 51 (RHC) or line 52 (IRC) or line 53 (GIP). We then are proposing to multiply these non-capital non-benefit overhead costs for each level of care times the ratio of total facility overhead salaries (Worksheet A, column 1, lines 4 through 16) to total facility non-capital non-benefit overhead costs (which is equal to Worksheet B, column 18 (total costs), line 101 less the sum of Worksheet B, columns 0 (direct patient care costs), column 1 (fixed capital), column 2 (moveable capital) and column 3 (employee benefits), line 101). (5) Overhead Benefits Costs To estimate overhead benefits costs for each level of care, we are proposing a similar methodology to overhead salaries.

For each level of care, we are proposing to calculate noncapital overhead costs for each level of care to be equal to Worksheet B, column 18, less the sum of Worksheet B, columns 0 through 2, for line 50 (CHC), or line 51 (RHC) or line 52 (IRC) or line 53 (GIP). We then are proposing to multiply these non-capital overhead costs for each level of care times the ratio of total facility overhead benefits (Worksheet B, column 3, lines 4 through 16) to total facility noncapital overhead costs (Worksheet B, column 18, line 101 less the sum of Worksheet B, columns 0 through 2, line 101). This proposed methodology assumes the ratio of total overhead benefit costs to total noncapital overhead costs is consistent among all four levels of care. (6) Total Compensation Costs and Total Costs To calculate the compensation costs for each provider, we are proposing to then sum each of the costs estimated in steps (1) through (5) to derive total compensation costs for CHC, RHC, IRC, and GIP. We are proposing that total costs for CHC are equal to Worksheet B, column 18, line 50, for RHC are equal to Worksheet B, column 18, line 51, for IRC would be equal to Worksheet B, column 18, line 52, and for GIP are equal to Worksheet B, column 18, line 53.

2. Proposed Methodology for Deriving Compensation Cost Weights To derive the compensation cost weights for each level of care, we first are proposing to begin with a sample of providers who met new Level I edit conditions that required freestanding hospices to fill out certain parts of their cost reports effective for freestanding hospice cost reports with a reporting period that ended on or after December 31, 2017.[] Specifically, we required the following costs to be greater than zero. Fixed capital costs (Worksheet B, column 0, line 1), movable capital costs (Worksheet B, column 0, line 2), employee benefits (Worksheet B, column 0, line 3), administrative and general (Worksheet B, column 0, line 4), volunteer service coordination (Worksheet B, column 0, line 13), pharmacy and drugs charged to patients (sum of Worksheet B, column 0, line 14 and Worksheet A, column 7, line 42.50), registered nurse costs (Worksheet A, column 7, line 28), medical social service costs (Worksheet A, column 7, line 33), hospice aide and homemaker services costs (Worksheet A, column 7, line 37), and durable medical equipment (Worksheet A, column 7, line 38). Applying these Level I edits to the 2018 freestanding hospice MCRs resulted in 3,345 providers that passed the edits (four were excluded). Then, for each level of care separately, we are proposing to further trim the sample of MCRs.

We outline our proposed trimming methodology using CHC as an example. Specifically, for CHC, we propose that total CHC costs (Worksheet B, column 18, line 50) and CHC compensation costs to be greater than zero. We also propose that CHC direct patient care salaries and contract labor costs per day would be greater Start Printed Page 19719than 1. We also propose to exclude those providers whose CHC compensation costs were greater than total CHC costs. For the IRC and GIP compensation cost weights, we are proposing to only use those MCRs from providers that provided inpatient services in their facility.

Therefore, we are proposing to exclude providers that reported costs greater than zero on Worksheet A-3, column 7, line 25 (Inpatient Care—Contracted) for IRC and Worksheet A-4, column 7, line 25 (Inpatient Care—Contracted) for GIP. The facilities that remained after this trim reported detailed direct patient care costs and other patient care costs for which we could then derive direct patient care salaries and other patient care salaries per the methodology described earlier. This additional trim resulted in a sample that consists of approximately 20 percent of IRP providers and 28 percent of GIP providers that passed both the Level I edits and the trims that required total costs and compensation costs to be greater than zero, and direct patient care salaries and contract labor costs per day to be greater than 1, as well as total costs to be greater than compensation costs. Finally, to derive the proposed compensation cost weights for each level of care for each provider, we are proposing to divide compensation costs for each level of care by total costs for each level of care. We are proposing to then trim the data for each level of care separately to remove outliers.

Following our example for CHC, we are proposing to simultaneously remove those providers whose total CHC costs per day fall in the top and bottom one percent of total CHC costs per day for all CHC providers as well remove those providers whose compensation cost weight falls in the top and bottom five percent of compensation cost weights for all CHC providers. We then sum the CHC compensation costs and total CHC costs of the remaining providers, yielding a proposed compensation cost weight for CHC. Since we have to limit our sample for IRC and GIP compensation cost weights to those hospices providing inpatient services in their facility, we conducted sensitivity analysis to test for the representative of this sample by reweighting compensation cost weights using data from the universe of freestanding providers that reported either IRC or GIP total costs. For example, we calculated reweighted compensation cost weights by ownership-type (proprietary, government and nonprofit), by size (based on RHC days) and by region. Our reweighted compensation cost weights for IRC and GIP were similar (less than one percentage point in absolute terms) to our proposed compensation cost weights for IRC and GIP (as shown in Table 11) and, therefore, we believe our sample is representative of freestanding hospices providing inpatient hospice care.

Table 11 provides the proposed labor share for each level of care based on the compensation cost weights we derived using our proposed methodology described previously. We are proposing the labor shares be equal to three decimal places consistent with the labor shares used in other Prospective Payment Systems (PPS) (such as the inpatient prospective payment system (IPPS) and the Home Health Agency PPS). We invite comments on our proposed methodology to derive the labor shares for each level of care. C. Proposed Routine FY 2022 Hospice Wage Index and Rate Update 1.

Proposed FY 2022 Hospice Wage Index The hospice wage index is used to adjust payment rates for hospices under the Medicare program to reflect local differences in area wage levels, based on the location where services are furnished. The hospice wage index utilizes the wage adjustment factors used by the Secretary for purposes of section 1886(d)(3)(E) of the Act for hospital wage adjustments. Our regulations at § 418.306(c) require each labor market to be established using the most current hospital wage data available, including any changes made by the Office of Management and Budget (OMB) to the Metropolitan Statistical Areas (MSAs) definitions. In general, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census. However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses.

On March 6, 2020, OMB issued Bulletin No. 20-01, which provided updates to and superseded OMB Bulletin No. 18-04 that was issued on September 14, 2018. The attachments to OMB Bulletin No. 20-01 provided detailed information on the update to statistical areas since September 14, 2018, and were based on the application of the 2010 Standards for Delineating Metropolitan and Micropolitan Statistical Areas to Census Bureau population estimates for July 1, 2017 and July 1, 2018.

(For a copy of this bulletin, we refer readers to the following website. Https://www.whitehouse.gov/​wp-content/​uploads/​2020/​03/​Bulletin-20-01.pdf). In OMB Bulletin No. 20-01, OMB announced one new Micropolitan Statistical Area, one new component of an existing Combined Statistical Are and changes to New England City and Town Area (NECTA) delineations. In the FY 2021 Hospice Wage Index final rule (85 FR 47070) we stated that if appropriate, we would propose any updates from OMB Bulletin No.

20-01 in future rulemaking. After reviewing OMB Bulletin No. 20-01, we have determined that the changes in Bulletin 20-01 encompassed delineation changes Start Printed Page 19720that would not affect the Medicare wage index for FY 2022. Specifically, the updates consisted of changes to NECTA delineations and the redesignation of a single rural county into a newly created Micropolitan Statistical Area. The Medicare wage index does not utilize NECTA definitions, and, as most recently discussed in the FY 2021 Hospice Wage Index final rule (85 FR 47070), we include hospitals located in Micropolitan Statistical areas in each state's rural wage index.

Therefore, while we are proposing to adopt the updates set forth in OMB Bulletin No. 20-01 consistent with our longstanding policy of adopting OMB delineation updates, we note that specific wage index updates would not be necessary for FY 2022 as a result of adopting these OMB updates. In other words, these OMB updates would not affect any geographic areas for purposes of the wage index calculation for FY 2022. In the FY 2020 Hospice Wage Index final rule (84 FR 38484), we finalized the proposal to use the current FY's hospital wage index data to calculate the hospice wage index values. In the FY 2021 Hospice Wage Index final rule (85 FR 47070), we finalized the proposal to adopt the revised OMB delineations with a 5 percent cap on wage index decreases, where the estimated reduction in a geographic area's wage index would be capped at 5 percent in FY 2021 and no cap would be applied to wage index decreases for the second year (FY 2022).

For FY 2022, the proposed hospice wage index would be based on the FY 2022 hospital pre-floor, pre-reclassified wage index for hospital cost reporting periods beginning on or after October 1, 2017 and before October 1, 2018 (FY 2018 cost report data). The proposed FY 2022 hospice wage index would not include a cap on wage index decreases and would not take into account any geographic reclassification of hospitals, including those in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the Act. The appropriate wage index value is applied to the labor portion of the hospice payment rate based on the geographic area in which the beneficiary resides when receiving RHC or CHC. The appropriate wage index value is applied to the labor portion of the payment rate based on the geographic location of the facility for beneficiaries receiving GIP or IRC. In the FY 2006 Hospice Wage Index final rule (70 FR 45135), we adopted the policy that, for urban labor markets without a hospital from which hospital wage index data could be derived, all of the Core-Based Statistical Areas (CBSAs) within the state would be used to calculate a statewide urban average pre-floor, pre-reclassified hospital wage index value to use as a reasonable proxy for these areas.

For FY 2022, the only CBSA without a hospital from which hospital wage data can be derived is 25980, Hinesville-Fort Stewart, Georgia. The FY 2022 adjusted wage index value for Hinesville-Fort Stewart, Georgia is 0.8649. There exist some geographic areas where there were no hospitals, and thus, no hospital wage data on which to base the calculation of the hospice wage index. In the FY 2008 Hospice Wage Index final rule (72 FR 50217 through 50218), we implemented a methodology to update the hospice wage index for rural areas without hospital wage data. In cases where there was a rural area without rural hospital wage data, we use the average pre-floor, pre-reclassified hospital wage index data from all contiguous CBSAs, to represent a reasonable proxy for the rural area.

The term “contiguous” means sharing a border (72 FR 50217). Currently, the only rural area without a hospital from which hospital wage data could be derived is Puerto Rico. However, for rural Puerto Rico, we would not apply this methodology due to the distinct economic circumstances that exist there (for example, due to the close proximity to one another of almost all of Puerto Rico's various urban and non-urban areas, this methodology would produce a wage index for rural Puerto Rico that is higher than that in half of its urban areas). Instead, we would continue to use the most recent wage index previously available for that area. For FY 2022, we propose to continue to use the most recent pre-floor, pre-reclassified hospital wage index value available for Puerto Rico, which is 0.4047, subsequently adjusted by the hospice floor.

As described in the August 8, 1997 Hospice Wage Index final rule (62 FR 42860), the pre-floor and pre-reclassified hospital wage index is used as the raw wage index for the hospice benefit. These raw wage index values are subject to application of the hospice floor to compute the hospice wage index used to determine payments to hospices. As previously discussed, the adjusted pre-floor, pre-reclassified hospital wage index values below 0.8 will be further adjusted by a 15 percent increase subject to a maximum wage index value of 0.8. For example, if County A has a pre-floor, pre-reclassified hospital wage index value of 0.3994, we would multiply 0.3994 by 1.15, which equals 0.4593. Since 0.4593 is not greater than 0.8, then County A's hospice wage index would be 0.4593.

In another example, if County B has a pre-floor, pre-reclassified hospital wage index value of 0.7440, we would multiply 0.7440 by 1.15, which equals 0.8556. Because 0.8556 is greater than 0.8, County B's hospice wage index would be 0.8. The proposed hospice wage index applicable for FY 2022 (October 1, 2021 through September 30, 2022) is available on our website at. https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Hospice-Wage-Index.html. 2.

Proposed FY 2022 Hospice Payment Update Percentage Section 4441(a) of the BBA (Pub. L. 105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were to be updated by a factor equal to the inpatient hospital market basket percentage increase set out under section 1886(b)(3)(B)(iii) of the Act, minus 1 percentage point. Payment rates for FYs since 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs must be the inpatient market basket percentage increase for that FY.

CMS currently uses 2014-based IPPS operating and capital market baskets to update the market basket percentage. In the FY 2022 IPPS proposed rule [] CMS is proposing to rebase and revise the IPPS market baskets to reflect a 2018 base year. We refer stakeholders to the FY 2022 IPPS proposed rule for further information. Section 3401(g) of the Affordable Care Act mandated that, starting with FY 2013 (and in subsequent FYs), the hospice payment update percentage would be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity (MFP).

The proposed hospice payment update percentage for FY 2022 is based on the current estimate of the proposed inpatient hospital market basket update of 2.5 percent (based on IHS Global Inc.'s fourth-quarter 2020 forecast with historical data through the third quarter 2020). Due to the requirements at sections 1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v) of the Act, the proposed inpatient hospital market basket update Start Printed Page 19721for FY 2022 of 2.5 percent must be reduced by a MFP adjustment as mandated by Affordable Care Act (currently estimated to be 0.2 percentage points for FY 2022). In effect, the proposed hospice payment update percentage for FY 2022 would be 2.3 percent. If more recent data becomes available after the publication of this proposed rule and before the publication of the final rule (for example, more recent estimates of the inpatient hospital market basket update and MFP adjustment), we would use such data, if appropriate, to determine the hospice payment update percentage for FY 2022 in the final rule. Currently, the labor portion of the hospice payment rates are as follows.

For RHC, 68.71 percent. For CHC, 68.71 percent. For GIP, 64.01 percent. And for IRC, 54.13 percent. As discussed in section III.B of this proposed rule, we are proposing to rebase and revise the labor shares for RHC, CHC, GIP and IRC using MCR data for freestanding hospices (CMS Form 1984-14, OMB Control Number 0938-0758) for 2018.

We are proposing the labor portion of the payment rates to be. For RHC, 64.7 percent. For CHC, 74.6 percent. For GIP, 62.8 percent. And for IRC, 60.1 percent.

The non-labor portion is equal to 100 percent minus the labor portion for each level of care. Therefore, we are proposing the non-labor portion of the payment rates to be as follows. For RHC, 35.3 percent. For CHC, 25.4 percent. For GIP, 37.2 percent.

And for IRC, 39.9 percent. 3. Proposed FY 2022 Hospice Payment Rates There are four payment categories that are distinguished by the location and intensity of the hospice services provided. The base payments are adjusted for geographic differences in wages by multiplying the labor share, which varies by category, of each base rate by the applicable hospice wage index. A hospice is paid the RHC rate for each day the beneficiary is enrolled in hospice, unless the hospice provides CHC, IRC, or GIP.

CHC is provided during a period of patient crisis to maintain the patient at home. IRC is short-term care to allow the usual caregiver to rest and be relieved from caregiving. And GIP is to treat symptoms that cannot be managed in another setting. As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47172), we implemented two different RHC payment rates, one RHC rate for the first 60 days and a second RHC rate for days 61 and beyond. In addition, in that final rule, we implemented a SIA payment for RHC when direct patient care is provided by an RN or social worker during the last 7 days of the beneficiary's life.

The SIA payment is equal to the CHC hourly rate multiplied by the hours of nursing or social work provided (up to 4 hours total) that occurred on the day of service, if certain criteria are met. In order to maintain budget neutrality, as required under section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were adjusted by a service intensity add-on budget neutrality factor (SBNF). The SBNF is used to reduce the overall RHC rate in order to ensure that SIA payments are budget-neutral. At the beginning of every FY, SIA utilization is compared to the prior year in order calculate a budget neutrality adjustment. In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52156), we initiated a policy of applying a wage index standardization factor to hospice payments in order to eliminate the aggregate effect of annual variations in hospital wage data.

Typically, the wage index standardization factor is calculated using the most recent, complete hospice claims data available. However, due to the skin care products PHE, we looked at using the previous fiscal year's hospice claims data (FY 2019) to determine if there were significant differences between utilizing 2019 and 2020 claims data. The difference between using FY 2019 and FY 2020 hospice claims data was minimal. Therefore, we will continue our practice of using the most recent, complete hospice claims data available. That is we are using FY 2020 claims data for the FY 2022 payment rate updates.

In order to calculate the wage index standardization factor, we simulate total payments using FY 2020 hospice utilization claims data with the FY 2021 wage index (pre-floor, pre-reclassified hospital wage index with the hospice floor, and a 5 percent cap on wage index decreases) and FY 2021 payment rates (that include the current labor shares) and compare it to our simulation of total payments using the FY 2022 hospice wage index (with hospice floor, without the 5 percent cap on wage index decreases) and FY 2021 payment rates (that include the current labor shares). By dividing payments for each level of care (RHC days 1 through 60, RHC days 61+, CHC, IRC, and GIP) using the FY 2021 wage index and payment rates for each level of care by the FY 2022 wage index and FY 2021 payment rates, we obtain a wage index standardization factor for each level of care. In order to calculate the labor share standardization factor we simulate total payments using FY 2020 hospice utilization claims data with the FY 2022 hospice wage index and the current labor shares and compare it to our simulation of total payments using the FY 2022 hospice wage index with the proposed revised labor shares. The wage index and labor share standardization factors for each level of care are shown in the Tables 12 and 13. The proposed FY 2022 RHC rates are shown in Table 12.

The proposed FY 2022 payment rates for CHC, IRC, and GIP are shown in Table 13. Start Printed Page 19722 Sections 1814(i)(5)(A) through (C) of the Act require that hospices submit quality data, based on measures to be specified by the Secretary. In the FY 2012 Hospice Wage Index and Rate Update final rule (76 FR 47320 through 47324), we implemented a HQRP as required by those sections. Hospices were required to begin collecting quality data in October 2012, and submit that quality data in 2013. Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements with respect to that FY.

The proposed FY 2022 rates for hospices that do not submit the required quality data would be updated by the proposed FY 2022 hospice payment update percentage of 2.3 percent minus 2 percentage points. These rates are shown in Tables 14 and 15. Start Printed Page 19723 4. Proposed Hospice Cap Amount for FY 2022 As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47183), we implemented changes mandated by the IMPACT Act of 2014 (Pub. L.

113-185). Specifically, we stated that for accounting years that end after September 30, 2016 and before October 1, 2025, the hospice cap is updated by the hospice payment update percentage rather than using the CPI-U. Division CC, section 404 of the CAA 2021 has extended the accounting years impacted by the adjustment made to the hospice cap calculation until 2030. Therefore, for accounting years that end after September 30, 2016 and before October 1, 2030, the hospice cap amount is updated by the hospice payment update percentage rather than using the CPI-U. As a result of the changes mandated by Division CC, section 404 of the CAA 2021, we are proposing conforming regulation text changes at § 418.309 to reflect the new language added to section 1814(i)(2)(B) of the Act.

The proposed hospice cap amount for the FY 2022 cap year will be $31,389.66, which is equal to the FY 2021 cap amount ($30,683.93) updated by the proposed FY 2022 hospice payment update percentage of 2.3 percent. D. Proposed Clarifying Regulation Text Changes for the Hospice Election Statement Addendum In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484), we finalized modifications to the hospice election statement content requirements at § 418.24(b) to increase coverage transparency for patients under a hospice election. These changes included a new condition for payment requiring a hospice, upon request, to provide the beneficiary (or representative) an election statement addendum (hereafter called “the addendum”) outlining the items, services, and drugs that the hospice has determined are unrelated to the terminal illness and related conditions. We stated in that final rule that the addendum is intended to complement the Hospice Conditions of Participation (CoPs) at § 418.52(a), which require hospices to verbally inform beneficiaries, at the time of hospice election, of the services covered under the Medicare hospice benefit, as well as the limitations of such services (84 FR 38509).

The requirements at §§ 418.24(b) and 418.52(a) ensure that beneficiaries are aware of any items, services, or drugs they would have to seek outside of the benefit, as well as their potential out-of-pocket costs for hospice care, such as co-payments and/or coinsurance. Section 418.24(c) sets forth the elements that must be included on the addendum. 1. The addendum must be titled “Patient Notification of Hospice Non-Covered Items, Services, and Drugs”. 2.

Name of the hospice. 3. Beneficiary's name and hospice medical record identifier. 4. Identification of the beneficiary's terminal illness and related conditions.

5. A list of the beneficiary's current diagnoses/conditions present on hospice admission (or upon plan of care update, as applicable) and the associated items, services, and drugs, not covered by the hospice because they have been determined by the hospice to be unrelated to the terminal illness and related conditions. 6. A written clinical explanation, in language the beneficiary and his or her representative can understand, as to why the identified conditions, items, services, and drugs are considered unrelated to the terminal illness and related conditions and not needed for pain or symptom management. This clinical explanation must be accompanied by a general statement that the decision as to what conditions, items, services, or drugs are unrelated is made for each individual patient, and that the beneficiary should share this clinical explanation with other health care providers from which he or she seeks services unrelated to his or her terminal illness and related conditions.

7. References to any relevant clinical practice, policy, or coverage guidelines. 8. Information on the following. A.

Purpose of the addendum b. Patient's right to immediate advocacy 9. Name and signature of the Medicare hospice beneficiary (or representative) and date signed, along with a statement that signing this addendum (or its updates) is only acknowledgement of receipt of the addendum (or its updates) and not necessarily the beneficiary's agreement with the hospice's determinations. The hospice is required to furnish the addendum in writing in an accessible format,[] so the beneficiary (or representative) can understand the information provided, make treatment decisions based on that information, and share such information with non-hospice providers rendering un-related items and services to the beneficiary. Therefore, the format of the addendum Start Printed Page 19724must be usable for the beneficiary and/or representative.

Although we stated in the FY 2020 Hospice Wage Index and Payment Rate Update that hospices may develop their own election statement addendum (84 FR 38507), we posted a modified model election statement and addendum on the Hospice Center web page,[] along with the publication of the FY 2021 Hospice Wage Index and Payment Rate Update final rule (85 FR 47070). The intent was to provide an illustrative example as hospices can modify and develop their own forms to meet the content requirements. In the FY 2021 Hospice Wage Index and Payment Rate Update final rule, we stated that most often we would expect the addendum would be in a hard copy format the beneficiary or representative can keep for his or her own records, similar to how hospices are required by the hospice CoPs at § 418.52(a)(3) to provide the individual a copy of the notice of patient rights and responsibilities (85 FR 47091). The hospice CoPs at § 418.104(a)(2) state that the patient's record must include “signed copies of the notice of patient rights in accordance with § 418.52.” Likewise, since the addendum is part of the election statement as set forth in § 418.24(b)(6), then it is required to be part of the patient's record (if requested by the beneficiary or representative). The signed addendum is only acknowledgement of the beneficiary's (or representative's) receipt of the addendum (or its updates) and the payment requirement is considered met if there is a signed addendum (and any signed updates) in the requesting beneficiary's medical record with the hospice.

We believe that a signed addendum connotes that the hospice discussed the addendum and its contents with the beneficiary (or representative). Additionally, in the event that a beneficiary (or representative) does not request the addendum, we expect hospices to document, in some fashion, that an addendum has been discussed with the patient (or representative) at the time of election, similar to how other patient and family discussions are documented in the hospice's clinical record. It is necessary for the hospice to document that the addendum was discussed and whether or not it was requested, in order to prevent potential claims denials related to any absence of an addendum (or addendum updates) in the medical record. Though we did not propose any changes to the election statement addendum content requirements at § 418.24(c), or the October 1, 2020 effective date, in the FY 2021 Hospice Wage Index and Payment Rate Update proposed rule, we solicited comments on the usefulness of the modified model election statement and addendum posted on the Hospice Center web page (85 FR 20949). In the FY 2021 Hospice Wage Index and Payment Rate Update final rule (85 FR 47093), we responded to comments received, and stated that, as finalized in the FY 2020 Hospice Wage Index and Payment Rate Update final rule, the hospice election statement addendum will remain a condition for payment that is met when there is a signed addendum (and its updates) in the beneficiary's hospice medical record.

Since its implementation on October 1, 2020, CMS has received additional inquiries from stakeholders asking for clarification on certain aspects of the addendum. We appreciate and understand the importance of provider input and involvement in ensuring that this document is effective in increasing coverage transparency for beneficiaries. Therefore, we are providing clarification on, and proposing modifications to, certain signature and timing requirements and proposing corresponding clarifying regulations text changes. Currently the regulations at § 418.24(c) require that if a beneficiary or his or her representative requests the addendum at the time of the initial hospice election (that is, at the time of admission to hospice), the hospice must provide this information, in writing, to the individual (or representative) within 5 days from the date of the election. Hospices have reported that beneficiaries or representatives sometimes do not request the addendum at the time of election, but rather within the 5 days after the effective date of the election.

In these situations, the regulations require the hospice to provide the addendum within 3 days, as the beneficiary requested the addendum during the course of care. However, in accordance with § 418.54(b), the hospice interdisciplinary group (IDG), in consultation with the individual's attending physician (if any), must complete the hospice comprehensive assessment no later than 5 calendar days after the election of hospice care. In some instances, this may mean that the hospice must furnish the addendum prior to completion of the comprehensive assessment. The comprehensive assessment includes all areas of hospice care related to the palliation and management of a beneficiary's terminal illness. This assessment is necessary because it provides an overview of the items, services and drugs that the patient is already utilizing as well as helps determine what the hospice may need to add in order to treat the patient throughout the dying process.

If the addendum is completed prior to the comprehensive assessment, the hospice may not have a complete patient profile, which could potentially result in the hospice incorrectly anticipating the extent of covered and non-covered services and lead to an inaccurate election statement addendum. Hospice providers are only able to discern what items, services, and drugs they will not cover once they have a beneficiary's comprehensive assessment. We are proposing to allow the hospice to furnish the addendum within 5 days from the date of a beneficiary or representative request, if the request is within 5 days from the date of a hospice election. For example, if the patient elects hospice on December 1st and requests the addendum on December 3rd, the hospice would have until December 8th to furnish the addendum. Additionally, hospices have noted that there is not a timeframe in regulations regarding the patient signature on the addendum.

Section 418.24(c)(9) requires the beneficiary's signature (or his/her representative's signature) as well as the date the document was signed. We noted in the FY 2021 Hospice Wage Index &. Payment Rate Update final rule that because the beneficiary signature is an acknowledgement of receipt of the addendum, this means the beneficiary would sign the addendum when the hospice provides it, in writing, to the beneficiary or representative (85 FR 47092). Additionally, obtaining the required signatures on the election statement has been a longstanding regulatory requirement. Therefore, we expect that hospices already have processes and procedures in place to ensure that required signatures are obtained, either from the beneficiary, or from the representative in the event the beneficiary is unable to sign.

We anticipate that hospices would use the same procedures for obtaining signatures on the addendum. However, we understand that some beneficiaries or representatives may request an emailed addendum or request more time to review the addendum before signing, in which case the date that the hospice furnished the addendum to the beneficiary (or representative) may differ from the date that the beneficiary Start Printed Page 19725or representative signs the addendum. This means the hospice may furnish the addendum within the required timeframe. However, the signature date may be beyond the required timeframe. Therefore, we propose to clarify in regulation that the “date furnished” must be within the required timeframe (that is, 3 or 5 days of the beneficiary or representative request, depending on when such request was made), rather than the signature date.

At § 418.24(c)(10), we propose that the hospice would include the “date furnished” in the patient's medical record and on the addendum itself. In the FY 2021 Hospice Wage Index and Payment Rate Update final rule, we addressed a concern regarding a potential situation wherein the beneficiary or representative refuses to sign the addendum (85 FR 47088). We reiterated that the signature on the addendum is only acknowledgement of receipt and not a tacit agreement of its contents, and that we expect the hospice to inform the beneficiary of the purpose of the addendum and rationale for the signature. However, we recognized that there might be rare instances in which the beneficiary (or representative) refuses to sign the addendum. We noted that we would consider whether this issue would require future rulemaking.

We have subsequently received this question from stakeholders post implementation, therefore, in this proposed rule, we are clarifying that if a patient or representative refuses to sign the addendum, the hospice must document clearly in the medical record (and on the addendum itself) the reason the addendum is not signed in order to mitigate a claims denial for this condition for payment. In such a case, although the beneficiary has refused to sign the addendum, the “date furnished” must still be within the required timeframe (that is, within 3 or 5 days of the beneficiary or representative request, depending on when such request was made), and noted in the chart and on the addendum itself. Stakeholders again requested that CMS clarify whether a non-hospice provider is required to sign the addendum in the event that the non-hospice provider requests the addendum rather than the beneficiary or representative. Therefore, if only a non-hospice provider or Medicare contractor requests the addendum (and not the beneficiary or representative) we would not expect a signed copy in the patient's medical record. Hospices can develop processes (including how to document such requests from non-hospice providers and Medicare contractors) to address circumstances in which the non-hospice provider or Medicare contractor requests the addendum, and the beneficiary or representative does not.

As such, we are proposing to clarify in regulation that if a non-hospice provider requests the addendum, rather than the beneficiary or representative, the non-hospice provider is not required to sign the addendum. There may be instances in which the beneficiary or representative requests the addendum and the beneficiary dies, revokes, or is discharged prior to signing the addendum. While we stated in the FY 2020 Hospice Wage Index and Payment Rate Update final rule, that if the beneficiary requests the election statement addendum at the time of hospice election but dies within 5 days, the hospice would not be required to furnish the addendum as the requirement would be deemed as being met in this circumstance (84 FR 38521), this policy was not codified in regulation. Therefore, we are proposing conforming regulations text changes at § 418.24(c) to reflect this policy. Furthermore, we propose to clarify at § 418.24(d)(4) that if the patient revokes or is discharged within the required timeframe (3 or 5 days after a request, depending upon when such request was made), but the hospice has not yet furnished the addendum, the hospice is not required to furnish the addendum.

Similarly, we are proposing to clarify at § 418.24(d)(5) that in the event that a beneficiary requests the addendum and the hospice furnishes the addendum within 3 or 5 days (depending upon when the request for the addendum was made), but the beneficiary dies, revokes, or is discharged prior to signing the addendum, a signature from the individual (or representative) is no longer required. We would continue to expect that the hospice would note the date furnished in the patient's medical record and on the addendum, if the hospice has already completed the addendum, as well as an explanation in the patient's medical record noting that the patient died, revoked, or was discharged prior to signing the addendum. Finally, we are proposing conforming regulations text changes at § 418.24(c) in alignment with subregulatory guidance indicating that hospices have “3 days,” rather than “72 hours” to meet the requirement when a patient requests the addendum during the course of a hospice election. Hospices must furnish the addendum no later than 3 calendar days after a beneficiary's (or representative's) request during the course of a hospice election. This means that hospice providers must furnish the addendum to the beneficiary or representative on or before the third day after the date of the request.

For example, if a beneficiary (or representative) requests the addendum on February 22nd, then the hospice will have until February 25th to furnish the addendum, regardless of what time the addendum was requested on February 22nd. The intent of this clarification is to better align with the requirement for furnishing an election statement addendum when the addendum is requested within 5 days of the date of election, which also uses “days” rather than “hours”. We are soliciting comments on these proposed clarifications and conforming regulation text changes. E. Hospice Waivers Made Permanent Conditions of Participation 1.

Background In order to support provider and supplier communities due to the skin care products PHE, CMS has issued an unprecedented number of regulatory waivers under our statutory authority set forth at section 1135 of the Act. Under section 1135 of the Act, the Secretary may temporarily waive or modify certain Medicare, Medicaid, and Children's Health Insurance Program (CHIP) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the programs in the emergency area and time periods, and that providers who furnish such services in good faith, but who are unable to comply with one or more requirements as described under section 1135(b) of the Act, can be reimbursed and exempted from sanctions for violations of waived provisions (absent any determination of fraud or abuse). The intent of these waivers was to expand healthcare system capacity while continuing to maintain public and patient safety, and to hold harmless providers and suppliers unable to comply with existing regulations after a good faith effort. While some of these waivers simply delay certain administrative deadlines, others directly affect the provision of patient care. The utilization and application of these waivers pushed us to consider whether permanent changes would be beneficial to patients, providers, and professionals.

We identified selected waivers as appropriate candidates for formal regulatory changes. Those proposed changes and their respective histories and background information are discussed in detail in section II. E of this rule. We are also proposing regulatory Start Printed Page 19726changes that are not directly related to PHE waivers but would clarify or align some policies that have been raised as concerns by stakeholders. We are proposing the following revisions to the hospice Conditions of Participation (CoPs).

2. Hospice Aide Training and Evaluation—Using Pseudo-Patients Hospice aides deliver a significant portion of direct care. Aides are usually trained by an employer, such as a hospice, home health agency (HHA) or nursing home and may already be certified as an aide prior to being hired. The competency of new aides must be evaluated by the hospice to ensure appropriate care can be provided by the aide. Aide competency evaluations should be conducted in a way that identifies and meets training needs of the aide as well as the patient's needs.

These evaluations are a critical part of providing safe, quality care. In September of 2019, we published a final rule that allows the use of the pseudo-patient for conducting home health aide competency evaluations (“Medicare and Medicaid Programs. Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction. Fire Safety Requirements for Certain Dialysis Facilities. Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care” (84 FR 51732)).

The ability to use pseudo-patients during aide competency evaluations allows greater flexibility and may reduce burden on suppliers. We believe that hospices and their patients would also benefit from the ability to use pseudo-patients in aide training. The current hospice aide competency standard regulations at § 418.76(c)(1) requires the aide to be evaluated by observing an aide's performance of the task with a patient. We propose to make similar changes to hospice aide competency standards to those already made with respect to HHAs (see § 484.80(c)) in our hospice regulations at § 418.76(c)(1)), which describes the process for conducting hospice aide competency evaluations, and propose to define both “pseudo-patient” and “simulation” at § 418.3. Thus, we are proposing to permit skill competencies to be assessed by observing an aide performing the skill with either a patient or a pseudo-patient as part of a simulation.

The proposed definitions are as follows. “Pseudo-patient” means a person trained to participate in a role-play situation, or a computer-based mannequin device. A pseudo-patient must be capable of responding to and interacting with the hospice aide trainee, and must demonstrate the general characteristics of the primary patient population served by the hospice in key areas such as age, frailty, functional status, cognitive status and care goals. €œSimulation” means a training and assessment technique that mimics the reality of the homecare environment, including environmental distractions and constraints that evoke or replicate substantial aspects of the real world in a fully interactive fashion, in order to teach and assess proficiency in performing skills, and to promote decision making and critical thinking. These proposed changes would allow hospices to utilize pseudo-patients, such as a person trained to participate in a role-play situation or a computer-based mannequin device, instead of actual patients, in the competency testing of hospice aides for those tasks that must be observed being performed on a patient.

This could increase the speed of performing competency testing and would allow new aides to begin serving patients more quickly while still protecting patient health and safety. 3. Hospice Aid Training and Evaluation—Targeting Correction of Deficiencies We are also proposing to amend the requirement at § 418.76(h)(1)(iii) to specify that if an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation of the deficient skill and all related skill(s) in accordance with § 418.76(c). This proposed change would permit the hospice to focus on the hospice aides' specific deficient and related skill(s) instead of completing another full competency evaluation. We believe when a deficient area(s) in the aide's care is assessed by the RN, there may be additional related competencies that may also lead to additional deficient practice areas.

For example, if a patient's family informed the nurse that the patient almost fell when the aide was transferring the patient to a chair. The nurse could assess the aide's transferring technique to determine whether there was any improper form. The hospice must also conduct, and the hospice aide must complete, a competency evaluation related to the deficient and related transferring skills. Such as transferring from bed to bedside commode or shower chair. We request public comment on our proposed changes to allow for the use of the pseudo patient for conducting hospice aide competency testing, and the proposed change to allow the hospice to focus on the hospice aides' specific deficient skill(s) instead of completing a full competency evaluation.

We especially welcome comments from hospices that implemented the use of pseudo-patients during the skin care products PHE and the additional proposal, that if an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation related to the deficient and related skill(s). F. Proposals and Updates to the Hospice Quality Reporting Program 1. Background and Statutory Authority The Hospice Quality Reporting Program (HQRP) specifies reporting requirements for both the Hospice Item Set (HIS) and Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospice Survey. Section 1814(i)(5) of the Act requires the Secretary to establish and maintain a quality reporting program for hospices.

Section 1814(i)(5)(A)(i) of the Act was amended by section 407(b) of Division CC, Title IV of the CAA 2021 (Pub. L. 116-260) to change the payment reduction for failing to meet hospice quality reporting requirements from 2 to 4 percentage points. This policy will apply beginning with FY 2024 annual payment update (APU). Specifically, the Act requires that, beginning with FY 2014 through FY 2023, the Secretary shall reduce the market basket update by 2 percentage points and beginning with the FY 2024 APU and for each subsequent year, the Secretary shall reduce the market basket update by 4 percentage points for any hospice that does not comply with the quality data submission requirements for that FY.

In addition, section 407(a)(2) of the CAA 2021 removes the prohibition on public disclosure of hospice surveys performed be a national accreditation agency in section 1865(b) of the Act, thus allowing the Secretary to disclose such accreditation surveys. In addition, section 407(a)(1) of the CAA 2021 adds new requirements in newly added section 1822(a)(2) to require each state and local survey agency, and each national accreditation body with an approved hospice accreditation program, to submit information respecting any survey or certification made with respect to a hospice program. Such information shall include any inspection report made by such survey agency or body with respect to such survey or certification, any enforcement Start Printed Page 19727actions taken as a result of such survey or certification, and any other information determined appropriate by the Secretary. This information will be published publicly on our website, such as Care Compare, in a manner that is easily accessible, readily understandable, and searchable no later than October 1, 2022. In addition, national accreditation bodies with approved hospice accreditation programs described above are required to use the same survey form used by state and local survey agencies, which is currently the Form CMS-2567, on or after October 1, 2021.

Depending on the amount of the annual update for a particular year, a reduction of 2 percentage points through FY 2023 or 4 percentage points beginning in FY 2024 could result in the annual market basket update being less than zero percent for a FY and may result in payment rates that are less than payment rates for the preceding FY. Any reduction based on failure to comply with the reporting requirements, as required by section 1814(i)(5)(B) of the Act, would apply only for the specified year. Any such reduction would not be cumulative nor be taken into account in computing the payment amount for subsequent FYs. Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. The data must be submitted in a form, manner, and at a time specified by the Secretary.

Any measures selected by the Secretary must have been endorsed by the consensus-based entity which holds a performance measurement contract with the Secretary under section 1890(a) of the Act. This contract is currently held by the National Quality Forum (NQF). However, section 1814(i)(5)(D)(ii) of the Act provides that in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the consensus-based entity, the Secretary may specify measures that are not endorsed, as long as due consideration is given to measures that have been endorsed or adopted by a consensus-based organization identified by the Secretary. Section 1814(i)(5)(D)(iii) of the Act requires that the Secretary publish selected measures applicable with respect to FY 2014 no later than October 1, 2012. In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48234), and in compliance with section 1814(i)(5)(C) of the Act, we finalized the specific collection of data items that support the seven NQF-endorsed hospice measures described in Table 1.

In addition, we finalized the Hospice Visits When Death is Imminent measure pair (HVWDII, Measure 1 and Measure 2) in the FY 2017 Hospice Wage Index and Payment Rate Update final rule, effective April 1, 2017. We refer the public to the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52144) for a detailed discussion. The CAHPS Hospice Survey is a component of the CMS HQRP, which is used to collect data on the experiences of hospice patients and their family caregivers listed in their hospice records. Readers who want more information about the development of the survey, originally called the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78 FR 48261. National implementation of the CAHPS Hospice Survey commenced January 1, 2015, as stated in the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452).

The CAHPS Hospice Survey measures received NQF endorsement on October 26, 2016 and was re-endorsed November 20, 2020 (NQF #2651). NQF endorsed six composite measures and two overall measures from the CAHPS Hospice Survey. Along with nine HIS-based quality measures, the CAHPS Hospice Survey measures are publicly reported on a designated CMS website that is currently Care Compare. Table 16 lists all quality measures currently adopted for the HQRP. Start Printed Page 19728 Start Printed Page 19729 The Hospice and Palliative Care Composite Process Measure—HIS-Comprehensive Assessment at Admission measure (hereafter referred to as “the HIS Comprehensive Assessment Measure”) underwent an off-cycle review by the NQF Palliative and End-of-Life Standing Committee and successfully received NQF endorsement in July 2017 (NQF 3235).

The HIS Comprehensive Assessment Measure captures whether multiple key care processes were delivered upon patients' admissions to hospice in one measure as described in the Table 1. NQF 3235 does not require NQF's endorsements of the previous components to remain valid. Thus, if the components included in NQF 3235 do not individually maintain endorsement, the endorsement status of NQF 3235, as a single measure, will not change. In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47142), we finalized the policy for retention of HQRP measures adopted for previous payment determinations and seven factors for measure removal. In that same final rule, we discussed that we will issue public notice, through rulemaking, of measures under consideration for removal, suspension, or replacement.

However, if there is reason to believe continued collection of a measure raises potential safety concerns, we will take immediate action to remove the measure from the HQRP and will not wait for the annual rulemaking cycle. Such measures will be promptly removed and we will immediately notify hospices and the public of our decision through the usual HQRP communication channels, including but not limited to listening sessions, email notification, Open Door Forums, HQRP Forums, and Web postings. In such instances, the removal of a measure will be formally announced in the next annual rulemaking cycle. In the FY 2019 Hospice Wage Index and Rate Update final rule (83 FR 38622), we also adopted an eighth factor for removal of a measure. This factor aims to promote improved health outcomes for beneficiaries while minimizing the overall costs associated with the program.

These costs are multifaceted and include the burden associated with complying with the program. The finalized reasons for removing quality measures are. 1. Measure performance among hospices is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. 2.

Performance or improvement on a measure does not result in better patient outcomes. 3. A measure does not align with current clinical guidelines or practice. 4. A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.

5. A measure that is more proximal in time to desired patient outcomes for the particular topic is available. 6. A measure that is more strongly associated with desired patient outcomes for the particular topic is available. 7.

Collection or public reporting of a measure leads to negative unintended consequences. Or 8. The costs associated with a measure outweighs the benefit of its continued use in the program. On August 31, 2020, we added correcting language to the FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. Correcting Amendment (85 FR 53679) hereafter referred to as the FY 2021 HQRP Correcting Amendment.

In this final rule, we made correcting amendments to 42 CFR 418.312 to correct technical errors Start Printed Page 19730identified in the FY 2016 Hospice Wage Index and Payment Rate Update final rule. Specifically, the FY 2021 HQRP Correcting Amendment (85 FR 53679) adds paragraph (i) to § 418.312 to reflect our exemptions and extensions requirements, which were referenced in the preamble but inadvertently omitted from the regulations text. Thus, these exemptions or extensions can occur when a hospice encounters certain extraordinary circumstances. As stated in the FY 2019 Hospice Wage Index and Rate Update final rule (83 FR 38622), we launched the Meaningful Measures initiative (which identifies high priority areas for quality measurement and improvement) to improve outcomes for patients, their families, and providers while also reducing burden on clinicians and providers. More information about the Meaningful Measures initiative can be found at.

Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​QualityInitiativesGenInfo/​MMF/​General-info-Sub-Page.html. In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484), we discussed our interest in developing quality measures using claims data, to expand data sources for quality measure development. While we acknowledged in that rule the limitations with using claims data as a source for measure development, there are several advantages to using claims data as part of a robust HQRP as discussed previously in the FY 2020 rule. We also discussed developing the Hospice Outcomes &. Patient Evaluation (HOPE), a new patient assessment instrument that is planned to replace the HIS.

See an update on HOPE development in section III.F.6, Update regarding the Hospice Outcomes &. Patient Evaluation (HOPE) development. We also discussed our interest in outcome quality measure development. Unlike process measures, outcome measures capture the results of care as experienced by patients, which can include aspects of a patient's health status and their experiences in the health system. The portfolio of quality measures in the HQRP will include outcome measures that reflect the results of care.

2. Proposal To Remove the Seven “Hospice Item Set Process Measures” From HQRP Beginning FY 2022 In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48234), and in compliance with section 1814(i)(5)(C) of the Act, we finalized the specific collection of standardized data items, known as the HIS, that support the following NQF-endorsed measures. NQF #1617 Patients Treated with an Opioid who are Given a Bowel Regimen NQF #1634 Pain Screening NQF #1637 Pain Assessment NQF #1638 Dyspnea Treatment NQF #1639 Dyspnea Screening NQF #1641 Treatment Preferences NQF #1647 Beliefs/Values Addressed (if desired by the patient) These measures were adopted to increase public awareness of key components of hospice care, such as pain and symptom management and non-clinical care needs. Consistent with our policy for measure retention and removal, finalized in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47142), we reviewed these measures against the factors for removal. Our analysis found that they meet factor 4.

€œA more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.” We determined that the NQF #3235 HIS Comprehensive Assessment Measure, discussed in detail in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52144), is a more broadly applicable measure and continues to provide, in a single measure, meaningful differences between hospices regarding overall quality in addressing the physical, psychosocial, and spiritual factors of hospice care upon admission. The HIS Comprehensive Assessment Measure's “all or none” criterion requires hospices to perform all seven care processes in order to receive credit. In this way, it is different from an average-based composite measure and sets a higher bar for performance. This single measure differentiates hospices and holds them accountable for completing all seven process measures to ensure core services of the hospice comprehensive assessment are completed for all hospice patients. Therefore, the HIS Comprehensive Assessment Measure continues to encourage hospices to improve and maintain high performance in all seven processes simultaneously, rather than rely on its component measures to demonstrate quality hospice care in a way that may be hard to interpret for consumers.

The individual measures show performance for only one process and do not demonstrate whether the hospice provides high-quality care overall, as an organization. For example, a hospice may perform extremely well assessing treatment preferences, but poorly on addressing pain. High-quality hospice care not only manages pain and symptoms of the terminal illness, but assesses non-clinical needs of the patient and family caregivers, which is a hallmark of patient-centered care. Since the HIS Comprehensive Assessment Measure captures all seven processes collectively, we believe that public display of the individual component measures are not necessary. The interdisciplinary, holistic scope of the NQF #3235 HIS Comprehensive Assessment Measure aligns with the public's expectations for hospice care.

In addition, the measure supports alignment across our programs and with other public and private initiatives. The seven individual components address care processes around hospice admission that are clinically recommended or required in the hospice CoPs. The Medicare Hospice CoPs require that hospice comprehensive assessments identify patients' physical, psychosocial, emotional, and spiritual needs and address them to promote the hospice patient's comfort throughout the end-of-life process. Furthermore, the person-centered, family, and caregiver perspective align with the domains identified by the CoPs and the National Consensus Project [] as patients and their family caregivers also place value on physical symptom management and spiritual/psychosocial care as important factors at the end-of-life. The HIS Comprehensive Assessment Measure is a composite measure that serves to ensure all hospice patients receive a comprehensive assessment for both physical and psychosocial needs at admission.

In addition, MedPAC's Report to Congress. Medicare Payment Policy [] over the past few years notes that the HIS Comprehensive Assessment Measure differentiates the hospice's overall ability to address care processes better than the seven individual HIS process measures. In this way, it provides consumers viewing data on Care Compare with a streamlined way to Start Printed Page 19731assess the extent to which a hospice follows care processes. We are not proposing any revisions to the HIS Comprehensive Assessment Measure in this proposed rule because the single measure continues to provide value to patients, their families, and providers. Because the HIS Comprehensive Assessment Measure is a more broadly applicable measure, we propose to remove the seven individual HIS process measures from the HQRP, no longer publicly reporting them as individual measures on Care Compare beginning with FY 2022.

In addition, we are proposing to remove the “7 measures that make up the HIS Comprehensive Assessment Measure” section of Care Compare, which displays the seven HIS measures. We propose to make these changes removing the seven HIS process measures as individual measures from HQRP no earlier than May 2022. Although this proposal removes the seven individual HIS process measures, it does not propose any changes to the requirement to submit the HIS admission assessment. Since the HIS Comprehensive Assessment Measure is a composite of the seven HIS process measures, the burden and requirement to report the HIS data remain unchanged in the time, manner, and form finalized in the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52144). Hospices which do not report HIS data used for the HIS Comprehensive Assessment Measure will not meet the requirements for compliance with the HQRP.

We are soliciting public comment on the proposal to remove the seven HIS process quality measures as individual measures from the HQRP no earlier than May 2022, and to continue including the seven HIS process measures in the confidential quality measure (QM) Reports which are available to hospices. The seven HIS process measures are also available by visiting the data catalogue at https://data.cms.gov/​provider-data/​topics/​hospice-care. We are also seeking public comment on the technical correction to the regulation at § 418.312(b) effective October 1, 2021. 3. Proposal To Add a “Claims-Based Index Measure”, the Hospice Care Index We are proposing a new hospice quality measure, called the Hospice Care Index (HCI), which will provide more information to better reflect several processes of care during a hospice stay, and better empower patients and family caregivers to make informed health care decisions.

The HCI is a single measure comprising ten indicators calculated from Medicare claims data. The index design of the HCI simultaneously monitors all ten indicators. Collectively these indicators represent different aspects of hospice service and thereby characterize hospices comprehensively, rather than on just a single care dimension. Therefore, the HCI composite yields a more reliable provider ranking. The HCI indicators, through the composite, would add new information to HQRP that was either directly recommended for CMS to publicly report by Federal stakeholders [] or identified as areas for improvement during information gathering activities.

Furthermore, each indicator represents either a domain of hospice care recommended by leading hospice and quality experts [] for CMS to publicly report, or a requirement included in the hospice CoPs. The indicators required to calculate the single composite are discussed in the “Specifications for the HCI Indicators Selected” section below. These specifications list all the information required to calculate each indicator, including the numerator and denominator definitions, different thresholds for receiving credit toward the overall HCI score, and explanations for those thresholds. Indicators reflect practices or outcomes hospices should pursue, thereby awarding points based on the criterion. The HCI scoring example in Table 16 illustrates how points are awarded based on meeting the criterion of the indicator.

For example, Gaps in Nursing Visits have a criterion of “lower than the 90th percentile,” and supports the hospice CoPs that require a member of the interdisciplinary team to ensure ongoing assessment of patient and caregiver needs and plan of care implementation. Other indicators, such as nurse visits on weekends or near death, have a criterion of “higher than the 10th percentile,” identifying hospice care delivery during the most vulnerable periods during a hospice stay. Each indicator equally affects the single HCI score, reflecting the equal importance of each aspect of care delivered from admission to discharge. A hospice is awarded a point for meeting each criterion for each of the 10 indicators. The sum of the points earned from meeting the criterion of each indictor results in the hospice's HCI score, with 10 as the highest hospice score.

The ten indicators, aggregated into a single HCI score, convey a broad overview of the quality of hospice care provision and validates well with CAHPS Willingness to Recommend and Rating of this Hospice. The HCI will help to identify whether hospices have aggregate performance trends that indicate higher or lower quality of care relative to other hospices. Together with other measures already publicly reported in the HQRP, HCI scores will help patients and family caregivers better decide between hospice providers based on the factors that matter most to them. Additionally, creating a comprehensive quality measure capturing a variety of related care processes and outcomes in a single metric will provide consumers and providers an efficient way to assess the overall quality of hospice care, which can be used to meaningfully and easily compare hospice providers to make a better-informed health care decision. The HCI will complement the existing HIS Comprehensive Measure and does not replace any existing reported measures.

Both the HCI and the HIS Comprehensive Measure are composite measures in that they act as single measures that capture multiple areas of hospice care. Because the indicators comprising the HCI differ in data source from the HIS Comprehensive Measure, the HCI and the HIS Comprehensive Measure can together provide a meaningful and efficient way to inform patients and family caregivers, and support their selection of hospice care providers. As a claims-based measure, the HCI measure would not impose any new collection of information requirements. To learn more about the background of the HCI, please watch this video. Https://youtu.be/​by68E9E2cZc.

A. Measure Importance The FY 2019 Hospice Wage Index and Payment Rate Update final rule (83 FR 38622) introduced the Meaningful Measure Initiative to hospice providers to identify high priority areas for quality measurement and improvement. The Meaningful Measure Initiative areas are intended to increase measure alignment across programs and other public and private initiatives. Additionally, the initiative points to high priority areas where there may be informational gaps in available quality measures, while helping guide our efforts to develop and implement quality measures to fill those gaps, and develop those concepts towards quality measures that meet standards for public reporting. The goal of HQRP quality measure development is to identify measures from a variety of data sources that provide a window into Start Printed Page 19732hospice care throughout the dying process, fit well with the hospice business model, and meet the objectives of the Meaningful Measures initiative.

To that end, the HCI seeks to add value to the HQRP by filling informational gaps in aspects of hospice service not addressed by the current measure set. Consistent with the Meaningful Measure Initiative, we conducted a number of information gathering activities to identify informational gaps. Our information gathering activities included soliciting feedback from hospice stakeholders such as providers and family caregivers. Seeking input from hospice and quality experts through a Technical Expert Panel (TEP). Interviews with hospice quality experts.

Considering public comments received in response to previous solicitations on claims-based hospice quality initiatives. And a review of quality measurement recommendations offered by the OIG, MedPAC, and the peer-reviewed literature. We found that hospices currently underutilize HQRP measures to inform their quality improvement, mainly because of gaps in relevant quality information within the HQRP measure set. In particular, the existing HQRP measure set, calculated using data collected from the HIS and the CAHPS Hospice survey, does not assess quality of hospice care during a hospice election (between admission and discharge). Moreover, the current measure set does not directly address the full range of hospice services or outcomes.

Therefore, we have identified a need for a new quality measure to address this gap and reflect care delivery processes during the hospice stay using available data without increasing data collection burden. Claims data are the best available data source for measuring care during the hospice stay and present an opportunity to bridge the quality measurement gap that currently exists between the HIS and CAHPS Hospice Survey. Medicare claims are administrative records of health care services provided and payments which Medicare (and beneficiaries as applicable) made for those services. Claims are a rich and comprehensive source about many care processes and aspects of health care utilization. As such, they are a valuable source of information that can be used to measure the quality of care provided to beneficiaries for several reasons.

Claims data are readily-available and reduce provider burden for implementation, as opposed to data collection through patient assessments or surveys, which require additional effort from clinicians, patients, and family caregivers before they can be submitted and used by CMS. Claims data are collected based on care delivered, providing a more direct reflection of care delivery decisions and actions than patient assessments or surveys. Claims data are considered a reliable source of standardized data about the services provided, because providers must comply with Medicare payment and claims processing policy. Currently, CMS does publicly report several pieces of information derived from hospice claims data in the HQRP on Care Compare, including (i) the levels of care the hospice provided, (ii) the primary diagnoses the hospice served, (iii) the sites of service hospices provided care, and (iv) the hospice's daily census. In the FY2018 Hospice Wage Index &.

Payment Rate proposed rule (82 FR 20750), we solicited public comment on two high-priority claims-based measure concepts being considered at the time, one which looked at transitions from hospice and another which examined access to higher levels of hospice care. In response to this solicitation, CMS received public comments highlighting the potential limitations of a single concept claims-based measure. In particular, a single-concept claims-based measure may not adequately account for all relevant circumstances that might influence a hospice's performance. While external circumstances could justify a hospice's poor performance on a single claims-based indicator, it would be unlikely for external circumstances to impact multiple claims-based indicators considered simultaneously. Therefore, the results of a multi-indicator claims-based index, such as HCI, is more likely to differentiate hospices than a single claims-based indicator.

Taking this public feedback into consideration, we designed the HCI and developed the specifications based on simulated reporting periods. B. Specifications for the HCI Indicators Selected The specifications for the ten indicators required to calculate the single HCI score are described in this section. These component indicators reflect various elements and outcomes of care provided between admission and discharge. The HCI uses information from all ten indicators to collectively represent a hospice's ability to address patients' needs, best practices hospices should observe, and/or care outcomes that matter to consumers.

Each indicator is a key component of the HCI measure that we are proposing, and all ten are necessary to derive the HCI score. We use analytics, based on a variety of data files, to specify the indicators and measure. These data files include. Medicare fee-for-service (FFS) hospice claims with through dates on and between October 1, 2016 and September 30, 2019 to determine information such as hospice days by level of care, provision of visits, live discharges, hospice payments, and dates of hospice election. Medicare fee-for-service inpatient claims with through dates on and between January 1, 2016 and December 31, 2019 to determine dates of hospitalization.

Medicare beneficiary summary file to determine dates of death. Provider of Services (POS) File to examine trends in the scores of the HCI and its indicators, including by decade by which the hospice was certified for Medicare, ownership status, facility type, census regions, and urban/rural status. CAHPS Hospice Survey to examine alignment between the survey outcomes and the HCI. We acquired all claims data from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center (VRDC). We obtained the hospice claims and the Medicare beneficiary summary file in May 2020, and the inpatient data in August 2020.

We obtained the POS file data via. Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Downloadable-Public-Use-Files/​Provider-of-Services. We obtained the Hospice-aggregate CAHPS Hospice Survey outcome data via. Https://data.cms.gov/​provider-data. We performed analyses using Stata/MP Version 16.1.

Table 17 indicates the number of hospice days, hospice claims, beneficiaries enrolled in hospices and hospices with at least one claim represented in each year of our analysis. Analysis for each year was based on the FY calendar. For example, FY 2019 covers claims with dates of services on or between October 1, 2018 and September 30, 2019. For these analyses, we exclude claims from hospices with 19 or fewer discharges [] within a FY. The table reports the sample size before and after exclusion.[] Start Printed Page 19733 The rest of this section presents the component indicators and their specifications.

Although we describe each component indicator separately, the HCI is a composite that can only be calculated using all 10 indicators combined. We believe that, composed of this set of ten indicators, the HCI will strengthen the HQRP by comprehensively, reflecting hospices' performance across all ten indicators. (1). Indicator One. Continuous Home Care (CHC) or General Inpatient (GIP) Provided Medicare Hospice Conditions of Participation (CoPs) require hospices to be able to provide both CHC and GIP levels of care, if needed to manage more intense symptoms.[] However, a 2013 OIG report [] found that 953 hospice programs did not provide any GIP level of care services, and it was unclear if dying patients at such hospices were receiving appropriate pain control or symptoms management (a similar concern exists for hospice services at the CHC level).

To consider the provision of adequate services needed to manage patients' symptoms, the HCI measure includes an indicator for whether hospice programs provided any CHC or GIP service days. This indicator identifies hospices that provided at least one day of hospice care under the CHC or the GIP levels of care during the period examined. The provision of CHC and GIP is identified on hospice claims by the presence of revenue center codes 0652 (CHC) and 0656 (GIP). The specifications for Indicator One, CHC or GIP services provided, are as follows. Numerator.

The total number of CHC or GIP services days provided by the hospice within a reporting period. Denominator. The total number of hospice service days provided by the hospice at any level of care within a reporting period. Index Earned Point Criterion. Hospices earn a point towards the HCI if they provided at least one CHC or GIP service day within a reporting period.

(2). Indicator Two. Gaps in Nursing Visits The Medicare Hospice CoPs require a member of the interdisciplinary team to ensure ongoing assessment of patient and caregiver needs and plan of care implementation.[] The OIG has found instances of infrequent visits by nurses to hospice patients.[] To assess patients' receipt of adequate oversight, one HCI indicator examines hospices that have a high rate of patients who are not seen at least once a week by nursing staff. This indicator identifies whether a hospice is below the 90th percentile in terms of how often hospice stays of at least 30 days contain at least one gap of eight or more days without a nursing visit. Days of hospice service are identified based on the presence of revenue center codes 0651 (routine home care (RHC)), 0652 (CHC), 0655 (inpatient respite care (IRC)), and 0656 (GIP) on hospice claims.

We identify the dates billed for RHC, IRC, and GIP by examining the corresponding revenue center date (which identifies the first day in the sequence of days by level of care) and the revenue center units (which identify the number of days (including the first day) in the sequence of days by level of care). We identify the dates billed for CHC by examining the revenue center date.[] We define a hospice stay by a sequence of consecutive days for a particular beneficiary that are billed under the hospice benefit. A gap of at least 1 day without hospice ends the sequence. For this indicator, we identified hospice stays that included 30 or more consecutive days of hospice. Once we identified those hospice stays, we examined the timing of the provision of nursing visits within those stays.

We identified nursing visits if we observed any of the following criteria. The presence of revenue center code 055x (Skilled Nursing) on the hospice claim. The date of the visit is recorded in the corresponding revenue center date. The presence of revenue code 0652 (CHC) on the hospice claim. Days billed as CHC require more than half the hours provided be nursing hours.

The presence of revenue code 0656 (GIP) on the hospice claim. We assume that days billed as GIP will include nursing visits. We make that assumption instead of looking at the visits directly because Medicare does not require hospices to record all visits on the claim for the GIP level of care. Based on the above information, if within a hospice stay, we find eight or more consecutive days where no nursing visits are provided, no CHC is provided, and no GIP is provided, then we identify the hospice stay as having a gap in nursing visits greater than 7 days. This indicator helps the HCI to capture patients' receipt of adequate oversight through nurse visits and direct patient care, which is an important aspect of hospice care.

For each hospice, we divide the number of stays with at least one gap of eight or more days without a nursing visit (for stays of 30 or more days) by the number of stays of 30 or more days. We only consider the days within the period being examined. The specifications for Indicator Two, Gaps in Nursing Visits, are as follows:Start Printed Page 19734 Numerator. The number of elections with the hospice where the patient experienced at least one gap between nursing visits exceeding 7 days, excluding hospice elections where the patient elected hospice for less than 30 days within a reporting period. Denominator.

The total number of elections with the hospice, excluding hospice elections where the patient elected hospice for less than 30 days within a reporting period. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for gaps in nursing visits greater than 7 days falls below the 90th percentile ranking among hospices nationally. (3). Indicator Three.

Early Live Discharges Prior work has identified various concerning patterns of live discharge from hospice. High rates of live discharge suggest concerns in hospices' care processes, their advance care planning to prevent hospitalizations, or their discharge processes.[] As MedPAC noted,[] “Hospice providers are expected to have some rate of live discharges because some patients change their mind about using the hospice benefit and dis-enroll from hospice or their condition improves and they no longer meet the hospice eligibility criteria. However, providers with substantially higher percent of live discharge than their peers could signal a potential concern with quality of care or program integrity. An unusually high rate of live discharges could indicate that a hospice provider is not meeting the needs of patients and families or is admitting patients who do not meet the eligibility criteria.” Our live discharge indicators included in the HCI, like MedPAC's, comprise discharges for all reasons. They include instances where the patient was no longer found terminally ill and revocations due to the patient's choice.

MedPAC explains their rationale for including all discharge as follows:[] “Some stakeholders argue that live discharges initiated by the beneficiary—such as when the beneficiary revokes his or her hospice enrollment—should not be included in a live-discharge measure because, some stakeholders assert, these discharges reflect beneficiary preferences and are not in the hospice's control. Because beneficiaries may choose to revoke hospice for a variety of reasons, which in some cases are related to the hospice provider's business practices or quality of care, we include revocations in our analysis.” This indicator identifies whether a hospice is below the 90th percentile in terms of the percentage of live discharges that occur within 7 days of hospice admission during the fiscal year examined. Live discharges occur when the patient discharge status code on a hospice claim does not equal a code from the following list. €œ30”, “40”, “41”, “42”, “50”, “51”. We measure whether a live discharge occurs during the first 7 days of hospice by looking at a patient's lifetime length of stay in hospice.[] For each hospice, we divide the number of live discharges in the first 7 days of hospice by the number of live discharges.

Live discharges are assigned to a particular reporting period based on the date of the live discharge (which corresponds to the through date on the claim indicating the live discharge). The specifications for Indicator Three, Early Live Discharges, are as follows. Numerator. The total number of live discharges from the hospice occurring within the first 7 days of hospice within a reporting period. Denominator.

The total number of all live discharge from the hospice within a reporting period. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual percentage of live discharges on or before the seventh day of hospice falls below the 90th percentile ranking among hospices nationally. (4). Indicator Four.

Late Live Discharges The rate of live discharge that occurred 180 days or more after hospice enrollment identifies another potentially concerning pattern of live discharge from hospice. Both indicator three and indicator four of the HCI recognize concerning patterns of live discharge impacting patient experience and quality of care. MedPAC, in descriptive analyses of hospices exceeding the Medicare annual payment cap, noted that “if some hospices have rates of discharging patients alive that are substantially higher than most other hospices it raises concerns that some hospices may be pursuing business models that seek out patients likely to have long stays who may not meet the hospice eligibility criteria”.[] Because of quality implications for hospices who pursue such business models, the live discharge after long hospice enrollments was included in the index. This indicator identifies whether a hospice is below the 90th percentile in terms of the percentage of live discharges that occur on or after the 180th day of hospice. Live discharges occur when the patient discharge status code does not equal a value from the following list.

€œ30”, “40”, “41”, “42”, “50”, “51”. We measure whether a live discharge occurs on or after the 180th day of hospice by looking at a patient's lifetime length of stay in hospice. For each hospice, we divide the number of live discharges that occur on or after the 180th day of hospice by the number of live discharges. Live discharges are assigned to a particular reporting period based on the date of the live discharge (which corresponds to the through date on the claim). The specifications for Indicator Four, Late Live Discharges, are as follows.

Numerator. The total number of live discharges from the hospice occurring on or after 180 days of enrollment in hospice within a reporting period. Denominator. The total number of all live discharge from the hospice within a reporting period. Index Earned Point Criterion.

Hospices earn a point towards the HCI if their individual hospice score for live discharges on or after the 180th day of hospice falls below the 90th percentile ranking among hospices nationally. (5). Indicator Five. Burdensome Transitions (Type 1)—Live Discharges From Hospice Followed by Hospitalization and Subsequent Hospice Readmission The Type 1 burdensome transitions reflects hospice live discharge with a hospital admission within 2 days of hospice discharge, and then hospice readmission within 2 days of hospital discharge. This pattern of transitions may lead to fragmented care and may be associated with concerning care processes.

For example, Type 1 burdensome transitions may arise from a deficiency in advance care planning to prevent hospitalizations or a discharge process that does not appropriately identify a hospice patient whose conditions are stabilized prior to discharge.[] Start Printed Page 19735 This indicator identifies whether a hospice is below the 90th percentile in terms of the percentage of live discharges that are followed by a hospitalization (within 2 days of hospice discharge) and then followed by a hospice readmission (within 2 days of hospitalization) during the FY examined. Live discharges occur when the patient discharge status code does not equal a value from the following list. €œ30”, “40”, “41”, “42”, “50”, “51”. Hospitalizations are found by looking at all fee-for-service Medicare inpatient claims. Overlapping inpatient claims were combined to determine the full length of a hospitalization (looking at the earliest from date and latest through date from a series of overlapping inpatient claims for a beneficiary).

In order to be counted, the “from” date of the hospitalization had to occur no more than 2 days after the date of hospice live discharge.[] From there, we found all beneficiaries that ended their hospitalization and were readmitted back to hospice no more than 2 days after the last date of the hospitalization. To calculate the percentage, for each hospice we divided the number of live discharges that are followed by a hospitalization (within 2 days of hospice discharge) and then followed by a hospice readmission (within 2 days of hospitalization) in a given reporting period by the number of live discharges in that same period. The specifications for Indicator Five, Burdensome Transitions Type 1, are as follows. Numerator. The total number of live discharges from the hospice followed by hospital admission within 2 days, then hospice readmission within 2 days of hospital discharge within a reporting period.

Denominator. The total number of all live discharge from the hospice within a reporting period. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for Type 1 burdensome transitions falls below the 90th percentile ranking among hospices nationally. (6).

Indicator Six. Burdensome Transitions (Type 2)—Live Discharges From Hospice Followed by Hospitalization With the Patient Dying in the Hospital Death in a hospital following live discharge in another concerning pattern in hospice use. Thus, we believe that indicators five and indicator six of the HCI are necessary to differentiate concerning behaviors affecting patient care. This indicator reflects hospice live discharge followed by hospitalization within 2 days with the patient dying in the hospital, referred to as Type 2 burdensome transitions. This pattern of transitions may be associated with a discharge process that does not appropriately assess the stability of a hospice patient's conditions prior to live discharge.[] This indicator identifies whether a hospice is below the 90th percentile in terms of the percentage of live discharges that are followed by a hospitalization (within two days of hospice discharge) and then the patient dies in the hospital.

Live discharges occur when the patient discharge status code does not equal a value from the following list. €œ30”, “40”, “41”, “42”, “50”, “51”. Hospitalizations are found by looking at all inpatient claims. Overlapping inpatient claims were combined to determine a full length of a hospitalization (looking at the earliest from date and latest through date from a series of overlapping inpatient claims). To be counted, the “from” date of the hospitalization had to occur no more than 2 days after the date of hospice live discharge.

From there, we identified all beneficiaries whose date of death is listed as occurring during the dates of the hospitalization. To calculate the percentage, for each hospice we divided the number of live discharges that are followed by a hospitalization (within 2 days of hospice discharge) and then the patient dies in the hospital in a given FY by the number of live discharges in that same reporting period. The specifications for Indicator Six, Burdensome Transitions Type 2, are as follows. Numerator. The total number of live discharges from the hospice followed by a hospitalization within 2 days of live discharge with death in the hospital within a reporting year.

Denominator. The total number of all live discharge from the hospice within a reporting year. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for Type 2 burdensome transitions falls below the 90th percentile ranking among hospices nationally. (7).

Indicator Seven. Per-Beneficiary Medicare Spending Estimates of per-beneficiary spending are endorsed by NQF (#2158) [] and publicly reported by CMS for other care settings. Because the Medicare hospice benefit pays a per diem rate, an important determinant of per-beneficiary spending is the length of election. MedPAC reported that nearly half of Medicare hospice expenditures are for patients that have had at least 180 or more days on hospice, and expressed a concern that some programs do not appropriately discharge patients whose medical condition makes them no longer eligible for hospice services, or, that that hospices selectively enroll patients with non-cancer diagnoses and longer predicted lengths of stay in hospice.[] The other determinant of per-beneficiary spending is the level of care at which services are billed. In a 2016 report, the OIG has expressed concern at the potentially inappropriate billing of GIP care.[] For these reasons the HCI includes one indicator for per-beneficiary spending.

Lower rates of per beneficiary spending may identify hospices that provide efficient care at a lower cost to Medicare. This indicator identifies whether a hospice is below the 90th percentile in terms of the average Medicare hospice payments per beneficiary. Hospice payments per beneficiary are determined by summing together all payments on hospice claims for a particular reporting year for a particular hospice. The number of beneficiaries a hospice serves in a particular year is determined by counting the number of unique beneficiaries on all hospice claims in the same period for a particular hospice. Medicare spending per beneficiary is then calculated by dividing the total payments by the total number of unique beneficiaries.

The specifications for Indicator Seven, Per-Beneficiary Medicare Spending, are as follows:Start Printed Page 19736 Numerator. Total Medicare hospice payments received by a hospice within a reporting period. Denominator. Total number of beneficiaries electing hospice with the hospice within a reporting period. Index Earned Point Criterion.

Hospices earn a point towards the HCI if their average Medicare spending per beneficiary falls below the 90th percentile ranking among hospices nationally. (8). Indicator Eight. Nurse Care Minutes per Routine Home Care (RHC) Day Medicare Hospice CoPs require a member of the interdisciplinary team to ensure ongoing assessment of patient and caregiver needs.[] Such assessment is necessary to ensure the successful preparation, implementation, and refinements for the plan of care. Hospices must also ensure that patients and caregivers receive education and training as appropriate to their responsibilities for the care and services identified in the plan of care.

To assess adequate oversight, the HCI includes this indicator assessing the average number of skilled nursing minutes per day during RHC days to differentiate hospices that are providing assessment throughout the hospice stay. This indicator identifies whether a hospice is above the 10th percentile in terms of the average number of nursing minutes provided on RHC days during the reporting period examined. We identify RHC days by the presence of revenue code 0651 on the hospice claim. We identify the dates of RHC service by the corresponding revenue center date (which identifies the first day of RHC) and the revenue center units (which identifies the number of days of RHC (including the first day of RHC)). We identify nursing visits by the presence of revenue code 055x (Skilled Nursing) on the claim.

We count skilled nursing visits where the corresponding revenue center date overlaps with one of the days of RHC previously identified. We then count the minutes of skilled nursing visits by taking the corresponding revenue center units (that is, one unit is 15 minutes) and multiplying by 15. For each hospice, we sum together all skilled nursing minutes provided on RHC days and divide by the sum of RHC days. The specifications for Indicator Eight, Nurse Care Minutes per RHC Day, are as follows. Numerator.

Total skilled nursing minutes provided by a hospice on all RHC service days within a reporting period. Denominator. The total number of RHC days provided by a hospice within a reporting period. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for Nursing Minutes per RHC day falls above the 10th percentile ranking among hospices nationally.

(9). Indicator Nine. Skilled Nursing Minutes on Weekends Our regulations at § 418.100(c)(2) require that “[n]ursing services, physician services, and drugs and biologicals. . .

Be made routinely available on a 24-hour basis seven days a week”.[] Ongoing assessment of patient and caregiver needs and plan of care implementation are necessary for adequate hospice care oversight. Fewer observed hospice services on weekends (relative to that provided on weekdays) is not itself an indication of a lack of access. In fact, on weekends, patients' caregivers are more likely to be around and could prefer privacy from hospice staff. However, patterns of variation across providers could signal less service provider availability and access for patients on weekends. Thus, the HCI includes this indicator to further differentiate whether care is available to patients on weekends.

To assess hospice service availability, this indicator includes minutes of care provided by skilled nurses on weekend RHC days. This indicator identifies whether a hospice is at or above the 10th percentile in terms of the percentage of skilled nursing minutes performed on weekends compared to all days during the reporting period examined. We identify RHC days by the presence of revenue code 0651 on the hospice claim. We identify the dates of RHC service by the corresponding revenue center date (which identifies the first day of RHC) and the revenue center units (which identifies the number of days of RHC (including the first day of RHC)). We identify nursing visits by the presence of revenue code 055x (Skilled Nursing) on the claim.

We count skilled nursing visits where the corresponding revenue center date overlaps with one of the days of RHC previously identified. We then count the minutes of skilled nursing visits by taking the corresponding revenue center units and multiplying by 15. For each hospice, we sum together all skilled nursing minutes provided on RHC days that occur on a Saturday or Sunday and divide by the sum of all skilled nursing minutes provided on all RHC days. The specifications for Indicator Nine, Skilled Nursing Minutes on Weekends, are as follows. Numerator.

Total sum of minutes provided by the hospice during skilled nursing visits during RHC services days occurring on Saturdays or Sunday within a reporting period. Denominator. Total skilled nursing minutes provided by the hospice during RHC service days within a reporting period. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for percentage of skilled nursing minutes provided during the weekend is above the 10th percentile ranking among hospices nationally.

(10). Indicator Ten. Visits Near Death The end of life is typically the period in the terminal illness trajectory with the highest symptom burden. Particularly during the last few days before death, patients (and caregivers) experience many physical and emotional symptoms, necessitating close care and attention from the integrated hospice team and drawing increasingly on hospice team resources.[] Physical symptoms of actively dying can often be identified within three days of death in some patients.[] This indicator identifies whether a hospice is at or above the 10th percentile in terms of the percentage of beneficiaries with a nurse and/or medical social services visit in the last 3 days of life. For this indicator, we first Start Printed Page 19737determine if a beneficiary was in hospice for at least 1 day during their last 3 days of life by comparing days of hospice enrollment from hospice claims to their date of death.

We identify nursing visits and medical social service visits by the presence of revenue code 055x (Skilled Nursing) and 056x (Medical Social Services) on the claim. We identify the dates of those visits by the revenue center date for those revenue codes. Additionally, we assume that days billed as GIP (revenue code 0656) will include nursing visits. We make that assumption instead of looking at the visits directly because Medicare does not require hospices to record all visits on the claim for the GIP level of care. For each hospice, we divide the number of beneficiaries with a nursing or medical social service visits on a hospice claim during the last 3 days of life by the number of beneficiaries with at least 1 day of hospice during the last 3 days of life.

The specifications for Indicator Ten, Visits Near Death, are as follows. Numerator. The number of decedent beneficiaries receiving a visit by a skilled nurse or social worker staff for the hospice in the last 3 days of the beneficiary's life within a reporting period. Denominator. The number of decedent beneficiaries served by the hospice within a reporting period.

Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for percentage of decedents receiving a visit by a skilled nurse or social worked in the last 3 days of life falls above the 10th percentile ranking among hospices nationally. (11). Hospice Care Index Scoring Example As discussed during the NQF's January 2021 MAP meeting, the HCI summarizes information from ten indicators with each indicator representing key components of the hospice care recognizing care delivery and processes. Hospices receive a single HCI score, which reflects the information from all ten indicators.

Specifically, a hospice's HCI score is based on its collective performance on the ten performance indicators detailed above, all of which must be included to calculate the score and meaningfully distinguish between hospices' relative performance. The HCI's component indicators are assigned a criterion determined by statistical analysis of an individual hospice's indicator score relative to national hospice performance. Table 18 illustrates how a hypothetical hospice's score is determined across all ten indicators, and how the ten indicators' scores determine the overall HCI score. Start Printed Page 19738 Start Printed Page 19739 c. Measure Reportability, Variability, and Validity As part of developing the HCI, we conducted reportability, variability, and validity testing using claims data from FY 2019.

Reportability analyses found a high proportion of hospices (over 85 percent) that would yield reportable measure scores over 1 year (for more on reportability analysis, see section (2) Update on Use of Q4 2019 Data and Data Freeze for Refreshes in 2021.). Variability analyses confirmed that HCI demonstrates sufficient ability to differentiate hospices. Hospices' scores on the HCI can range from zero to ten. During measure testing, we observed that hospices achieved scores between three and ten. In testing, 37.1 percent of hospices scored ten out of ten, 30.4 percent scored nine out of ten, 17.9 percent scored eight out of ten, 9.6 percent scored seven out of ten, and 5.0 percent scored six or lower, as shown in Figure 6.

Validity analyses showed that hospices' HCI scores align with family caregivers' perceptions of hospice quality, as measured by CAHPS Hospice survey responses (NQF endorsed quality measure #2651). Hospices with higher HCI scores generally achieve better caregiver ratings as measured by CAHPS Hospice scores, and hospices with lower HCI scores generally achieve poorer CAHPS Hospice scores. As measured by Pearson's correlation coefficients, the correlation between the CAHPS hospice overall rating and the HCI is +0.0675, and the correlation between the CAHPS hospice recommendation outcome and the HCI score is +0.0916. As such, HCI scores are consistent with CAHPS Hospice caregiver ratings, supporting the index as a valid measurement of hospice care. We also conducted a stability analysis by comparing index scores calculated for the same hospice using claims from Federal FY 2017 and 2019.

The analysis found that 82.8 percent of providers' scores changed by, at most, one point over the 2 years. These results serve as evidence of the measure's reliability by indicating that a hospice's HCI scores would not normally fluctuate a great deal from one year to the next. D. Stakeholder Support A TEP convened by our measure development contractor, in April 2020, provided input on this measure concept. Additionally, during the summer of 2020, CMS convened five listening sessions with national hospice provider organizations to discuss the HCI concept with the goals of engaging stakeholders and receiving feedback early in the measure's development.

In October 2020, our contractor, Abt Associates, convened a workgroup of family caregivers whose family members have received hospice care to provide input on this measure concept from the family and caregiver perspective. Finally, the NQF Measures Application Partnership (MAP) met on January 11, 2021 and provided input to CMS. The MAP conditionally supports the HCI for rulemaking contingent on NQF endorsement. The “2020-2021 MAP 2020 Final Recommendations” can be found at. Http://www.qualityforum.org/​WorkArea/​linkit.aspx?.

€‹LinkIdentifier=​id&​ItemID=​94893. Stakeholders were generally supportive of a quality measure based on multiple indicators using claims data for public reporting. Several hospice providers expressed support for the measure's ability to demonstrate greater variation in hospice performance than the component indicators taken individually. Hospice caregivers also welcomed the addition of new quality measures to HQRP to better differentiate between hospices. In particular, family caregivers stated that there might be a need for several HCI indicators, such as nursing availability on weekends and average Medicare per-beneficiary spending, to be included on Care Compare as additional information.

Some stakeholders raised concerns that claims data may not adequately express the quality of care provided, and may be better suited as an indicator for program integrity or compliance issues. Hospice providers suggested that claims may lack sufficient information to adequately reflect individual patient needs or the full array of hospice Start Printed Page 19740practices. In particular, claims do not fully capture patients' clinical conditions, patient and caregiver preferences, or hospice activities such as telehealth, chaplain visits, and specialized services such as massage or music therapy. After much consideration of the input received, we believe the benefits of proposing adoption of the HCI outweigh its limitations. The HCI would not be intended to account for all potentially valuable aspects of hospice care, nor would it be expected to entirely close the information gaps presently found in the HQRP.

Rather, the HCI would serve as a useful measure to add value to the HQRP by providing more information to patients and family caregivers and better empowering them to make informed health care decisions. We view the HCI as an opportunity to add value to the HQRP, augmenting the current measure set with an index of indicators compiled from currently available claims data. This will provide new and useful information to patients and family caregivers without further burden to them, or to providers. Stakeholders also suggested several valuable exploratory analyses, improvements for the indicators presented, and ideas for eventual public display for CMS to consider. We further refined the HCI based on this feedback, focusing on those indicators with the strongest consistency with CAHPS Hospice scores and/or which quality experts have identified as salient issues for measurement and observation.

We also revised and refined how the HCI will be publicly displayed on Care Compare in response to family caregiver input. E. Form, Manner and Timing of Data Collection and Submission The data source for this HCI measure will be Medicare claims data that are already collected and submitted to CMS. We propose to begin reporting this measure using existing data items no earlier than May 2022. For more details, see section (3).

Proposal to Publicly Report the Hospice Care Index and Hospice Visits in the Last Days of Life Claims-based Measures. In addition, to help hospices understand the HCI and their hospice's performance, we will revise the confidential QM report to include claims-based measure scores, including agency and national rates through the Certification and Survey Provider Enhanced Reports (CASPER) or replacement system. The QM report will also include results of the individual indicators used to calculate the single HCI score, and provide details on the indicators and HCI overall score to support hospices in interpreting the information. The HCI indicators will be available by visiting the Provider Data Catalog at https://data.cms.gov/​provider-data/​topics/​hospice-care. We are soliciting public comment on the proposal to add the composite HCI measure to the HQRP starting in FY 2022.

We are also soliciting comments on the proposal to add the HCI to the program for public reporting beginning no earlier than May 2022. 4. Update on the Hospice Visits in the Last Days of Life (HVLDL) and Hospice Item Set V3.00 On August 13, 2020, we sought public comment in an information collection request to remove Section O “Service Utilization” (hereafter referred to as Section O) of the HIS discharge assessment. Removal of Section O is the sole change from HIS V2.01 and in effect eliminate the HVWDII quality measure pair. In Paperwork Reduction Act package (PRA), CMS-10390 (OMB control number.

0938-1153), we also proposed to replace the HVWDII measure pair with the HVLDL. This means that we will no longer report HVWDII with patient discharges and will start publicly reporting HVLDL no earlier than May 2022. The Office of Management and Budget (OMB) approved the collection of information to remove Section O of the HIS expiring on February 29, 2024, (OMB Control Number. 0938-1153, CMS-10390). We direct the public to review the PRA at https://www.cms.gov/​regulations-and-guidancelegislationpaperworkreductionactof1995pra-listing/​cms-10390 and HVWDII report at https://www.cms.gov/​files/​document/​hqrphospice-visits-when-death-imminent-testing-re-specification-reportoctober-2020.pdf.

As a claims-based measure, the HVLDL measure would not impose any new collection of information requirements. The HVLDL measure, as a replacement, will continue to fill an important area in hospice care previously filled by the HVWDII measure pair. We discussed the analysis with a TEP convened by our measure development contractor in November 2019 and with the MAP, hosted by the NQF in December 2019 [] for inclusion in the HQRP. During these meetings, the discussions reflecting on the analysis generally supported the replacement of HVWDII with a claims-based HVLDL measure. The November 2019 TEP report can be found in the downloads section at Hospice QRP Provider Engagement Opportunities and final recommendations and presentation of the HVLDL measure before NQF's MAP can be found at Quality Forum—Post-Acute Care, https://www.qualityforum.org/​Publications/​2020/​02/​MAP_​2020_​Considerations_​for_​Implementing_​Measures_​Final_​Report_​-_​PAC_​LTC.aspx.

OMB approved the proposal to replace the HVWDII measure with the HVLDL measure and remove Section O from the discharge assessment on February 16, 2021. The HIS V3.00 became effective on February 16, 2021 and expires on February 29, 2024. OMB control number 0938-1153. 5. Proposal To Revise § 418.312(b) Submission of Hospice Quality Reporting Program Data To address the inclusion of administrative data, such as Medicare claims used for hospice claims-based measures like the HVLDL and HCI in the HQRP and correct technical errors identified in the FY 2016 and 2019 Hospice Wage Index and Payment Rate Update final rules, we propose to revise the regulation at § 418.312(b) by adding paragraphs (b)(1) through (3).

As proposed, paragraph (b)(1) would now include the existing language on the standardized set of admission and discharge items. Paragraph (b)(2) would require collection of Administrative Data, such as Medicare claims data, used for hospice quality measures to capture services throughout the hospice stay. And these data automatically meet the HQRP requirements for § 418.306(b)(2). Paragraph (b)(3) would be a technical correction to address errors identified in the FY 2016 and FY 2019 Hospice Wage Index and Payment Rate Update final rules, (80 FR 47186 and 83 FR 38636). In the FY 2016 Hospice final rule (80 FR 47186) adopted seven factors for measure removal, and in the FY 2019 Hospice final rule (83 FR 38636) adopted the eighth factor for measure removal.

In those final rules, we referenced the measure removal factors in the preamble but inadvertently omitted them from the regulations text. Thus, these measure removal factors identify how measures are removed from the HQRP. Section 418.312(b)(3) would include the eight measure removal factors as follows. CMS may remove a quality measure from the Hospice QRP based on one or more of the following factors:Start Printed Page 19741 (1) Measure performance among hospices is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. (2) Performance or improvement on a measure does not result in better patient outcomes.

(3) A measure does not align with current clinical guidelines or practice. (4) The availability of a more broadly applicable (across settings, populations, or conditions) measure for the particular topic. (5) The availability of a measure that is more proximal in time to desired patient outcomes for the particular topic. (6) The availability of a measure that is more strongly associated with desired patient outcomes for the particular topic. (7) Collection or public reporting of a measure leads to negative unintended consequences other than patient harm.

(8) The costs associated with a measure outweigh the benefit of its continued use in the program. We solicit public comment on our proposal to revise the regulation at § 418.312(b) to add paragraphs (b)(1) through (3) to include administrative data as part of the HQRP, and correct technical errors identified in the FY 2016 and 2019 Hospice Wage Index and Payment Rate Update final rules. 6. Update Regarding the Hospice Outcomes &. Patient Evaluation (HOPE) Development As finalized in the FY 2020 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements final rule (84 FR 38484), we are developing a hospice patient assessment instrument identified as the HOPE.

This tool is intended to help hospices better understand care needs throughout the patient's dying process and contribute to the patient's plan of care. It will assess patients in real-time, based on interactions with the patient. The HOPE will support quality improvement activities and calculate outcome and other types of quality measures in a way that mitigates burden on hospice providers and patients. Our two primary objectives for the HOPE are to provide quality data for the HQRP requirements through standardized data collection, and to provide additional clinical data that could inform future payment refinements. We anticipate that the HOPE will replace the HIS.

The HIS is not a patient assessment instrument. HIS data collection “consists of selecting responses to HIS items in conjunction with patient assessment activities or via abstraction from the patient's clinical record.” (HIS Manual v.2.01). In contrast, the HOPE is a patient assessment instrument, designed to capture patient and family care needs in real-time during patient interactions throughout the patient's hospice stay, with the flexibility to accommodate patients with varying clinical needs. The HOPE will enable CMS and hospices to understand the care needs of people through the dying process, supporting provider care planning and quality improvement efforts, and ensuring the safety and comfort of individuals enrolled in hospice nationwide. The HOPE will include key items from the HIS along with Standardized Patient Assessment Data Elements (SPADEs), and demographics like gender and race.

This approach to include key aspects of SPADES and demographics supports hospice feedback provided in the FYs 2017 and 2018 Hospice Wage Index and Payment Rate Update final rule (81 FR 52171 and 82 FR 36669) and CMS' goals for a hospice assessment instrument, as stated in the FY 2018 Hospice Wage Index and Payment Rate Update final rule. The HOPE assessment instrument would facilitate communication among providers and to measure the care of patient populations across settings. While the standardization of measures required for adoption under the IMPACT Act of 2014 is not applicable to hospices, it makes reasonable sense to include those standardized elements and items that appropriately and feasibly apply to hospice. After all, some patients may move through the healthcare system to hospice so capturing and tracking key SPADES and social risk factor items that apply to hospice, including some of the categories of SPADES identified in the IMPACT Act of 2014, may help CMS achieve our goals for continuity of care, overall patient care and well-being, interoperability, and health equity that are also discussed in this rule. The draft HOPE has undergone cognitive and pilot testing, and will undergo field testing to establish reliability, validity and feasibility of the assessment instrument.

We anticipate proposing the HOPE in future rulemaking after testing is complete. We will continue development of the HOPE assessment in accordance with the Blueprint for the CMS Measures Management System. Development of the HOPE is grounded in extensive information gathering activities to identify and refine hospice assessment domains and candidate assessment items. We appreciate the industry's and national associations' engagement in providing input through information sharing activities, including expert interviews, key stakeholder interviews, and focus groups to support the HOPE development. As CMS proceeds with field testing the HOPE, we will continue to engage with stakeholders through sub-regulatory channels.

In particular, we will continue to host HQRP Forums to allow hospices and other interested parties to engage with us on the latest updates and ask questions on the development of the HOPE and related quality measures. We also have a dedicated email account, HospiceAssessment@cms.hhs.gov, for comments about the HOPE. We will use field test results to create a final version of the HOPE to propose in future rulemaking for national implementation. We will continue to engage all stakeholders throughout this process. We appreciate the support for the HOPE and reiterate our commitment to providing updates and engaging stakeholders through sub-regulatory means.

Future updates and engagement opportunities regarding HOPE can be found at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​HOPE.html. 7. Update on Quality Measure Development for Future Years In the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52160), we finalized new policies and requirements related to the HQRP, including how we would provide updates related to the development of new quality measures. Information on the current HQRP quality measures can be found at.

Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​Current-Measures. In this proposed rule, we are continuing to provide updates for both HOPE-based and claims-based quality measure development. To support new measure development, our contractor, Abt Associates, convened TEP meetings in 2020 to provide feedback on several measure concepts. In 2020, the TEP explored potential quality measure constructs that could be derived from the HOPE and their specifications. Specifically, for HOPE-based measure development, the TEP focused on pain and other symptom outcome measure concepts that could be calculated from the HOPE.

Input from initial TEP workgroups held in spring 2020 informed follow-up information-gathering activities related to pain in general and neuropathic pain in particular. The 2020 Information Start Printed Page 19742Gathering Summary report is available at https://www.cms.gov/​files/​document/​12042020-information-gathering-oy1508.pdf. During fall 2020, the TEP reviewed measure concepts focusing on pain and symptom outcomes that could be calculated from HOPE items. The TEP supported further exploration and development of these measures. As described in the 2020 TEP Summary Report, the TEP generally supports the following measure concepts that are calculated using HOPE items.

Timely Reduction of Pain Impact, Reduction in Pain Severity, and Timely Reduction of Symptoms. The candidate measure Timely Reduction of Pain Impact reports the percentage of patients who experienced a reduction in the impact of moderate or severe pain. HOPE items assessing Symptom Impact, and Patient Desired Tolerance Level for Symptoms or Patient Preferences for Symptom Management were used to calculate this measure. The candidate measure Reduction in Pain Severity reports the percentage of patients who had a reduction in reported pain severity. The primary HOPE items used to calculate this measure include Pain Screening, Pain Active Problem, and Patient Desired Tolerance Level for Symptoms or Patient Preferences for Symptom Management.

The last candidate measure discussed by the TEP was Timely Reduction of Symptoms which measures the percentage of patients who experience a reduction in the impact of symptoms other than pain. The HOPE items assessing Symptom Impact, and Patient Desired Tolerance Level for Symptoms or Patient Preferences for Symptom Management were used to calculate this measure. The HOPE items for all three measure are collected at multiple time points across a patient's stay, including at Admission, Symptom Reassessment, Level of Care Change, and Recertification. Overall, the TEP supported each candidate measure and agreed that they were viable for distinguishing hospice quality. We continue to develop all three candidate quality measures.

We are interested in exploring patient preferences for symptom management, addressing patient spiritual and psychosocial needs, and medication management in outcomes of care in development of quality measures. We seek public comment, methods, instruments, or brief summaries on hospice quality initiatives related to goal attainment, patient preferences, spiritual needs, psychosocial needs, and medication management. Information about the TEP feedback on these quality measures concepts and future measure concepts can be obtained via. Https://www.cms.gov/​files/​document/​2020-hqrp-tep-summary-report.pdf. Related to the outcome measures and in order to have HOPE pain and symptom measures in the program as soon as possible, we plan to develop process measures, including on pain and symptom management.

These process measures may support or complement the outcome measures. We solicit comments on current HOPE-based quality measure development and recommendations for future process and outcome measure constructs. In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484) and as discussed below, we are interested in claims-based quality measures in order to leverage the multiple data sources currently available to support quality measure development. Specifically, we intend to develop additional claims-based measures that may enable beneficiaries and their family caregivers to make more informed choices about hospice care and to hold hospices more accountable for the care they provide. As discussed in this section, the HVLDL and HCI claims-based measures support the Meaningful Measures initiative and address gaps in HQRP.

Additional claim-based measure concepts we are considering for development include hospice services on weekends, transitions after hospice live discharge, Medicare expenditures per beneficiary (including the share of non-hospice spending during hospice election, and the share for hospice care prior to the last year of life), and post-mortem visits as measures of hospice quality. We intend to submit additional claims-based measures for future consideration and solicit public comment. We solicit public comment on the aforementioned HOPE- and claims-based quality measures to distinguish between high- and low-quality hospices, support healthcare providers in quality improvement efforts, and provide support to hospice consumers in helping to select a hospice provider. We solicit public comment on how the candidate measures may achieve those goals. We are also considering developing hybrid quality measures that would be calculated using claims, assessment (HOPE), or other data sources.

Hybrid quality measures allow for a more comprehensive set of information about care processes and outcomes than can be calculated using claims data alone. Assessment data can be used to support risk-adjustment. We seek public comment on quality measure concepts and considerations for developing hybrid measures based on a combination of data sources. 8. CAHPS Hospice Survey Participation Requirements for the FY 2023 APU and Subsequent Years a.

Background and Description of the CAHPS Hospice Survey The CAHPS Hospice Survey is a component of the CMS HQRP which is used to collect data on the experiences of hospice patients and the primary caregivers listed in their hospice records. Readers who want more information about the development of the survey, originally called the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78 FR 48261. National implementation of the CAHPS Hospice Survey commenced January 1, 2015 as stated in the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452). B. Overview of the “CAHPS Hospice Survey Measures” The CAHPS Hospice Survey measures was re-endorsed by NQF on November 20, 2020.

The re-endorsement can be found on the NQF website at. Https://www.qualityforum.org/​Measures_​Reports_​Tools.aspx. Use the QPS tool and search for NQF number 2651. The survey received its initial NQF endorsement on October 26, 2016 (NQF #2651). We adopted 8 survey based measures for the CY 2018 data collection period and for subsequent years.

These eight measures are publicly reported on a designated CMS website, Care Compare, https://www.medicare.gov/​care-compare/​. c. Data Sources We previously finalized the participation requirements for the CAHPS Hospice Survey, (84 FR 38484). We propose no changes to these requirements going forward. D.

Public Reporting of CAHPS Hospice Survey Results We began public reporting of the results of the CAHPS Hospice Survey on Hospice Compare as of February 2018. Prior to the skin care products public health emergency (PHE), we reported the most recent 8 quarters of data on the basis of a rolling average, with the most recent quarter of data being added and the oldest quarter of data removed from the averages for each data refresh. Given the exemptions provided due to skin care products PHE in the March 27, 2020 Guidance Memorandum,[] public reporting will Start Printed Page 19743continue to be the most recent 8 quarters of data, excluding the exempted quarters. Quarter 1 and Quarter 2 of CY 2020. More information about this is detailed in the section entitled.

Proposal for Public Reporting CAHPS-based measures with Fewer than Standard Numbers of Quarters Due to PHE Exemptions. E. Volume-Based Exemption for CAHPS Hospice Survey Data Collection and Reporting Requirements We previously finalized a volume-based exemption for CAHPS Hospice Survey Data Collection and Reporting requirements for FY 2021 and every year thereafter (84 FR 38526). We propose no changes to this exemption. The exemption request form is available on the official CAHPS Hospice Survey website.

Http://www.hospiceCAHPSsurvey.org. Hospices that intend to claim the size exemption are required to submit to CMS their completed exemption request form by December 31, of the data collection year. Hospices that served a total of fewer than 50 survey-eligible decedent/caregiver pairs in the year prior to the data collection year are eligible to apply for the size exemption. Hospices may apply for a size exemption by submitting the size exemption request form as outlined above. The size exemption is only valid for the year on the size exemption request form.

If the hospice remains eligible for the size exemption, the hospice must complete the size exemption request form for every applicable FY APU period, as shown in table 19. f. Newness Exemption for CAHPS Hospice Survey Data Collection and Public Reporting Requirements We previously finalized a one-time newness exemption for hospices that meet the criteria as stated in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52181). In the FY 2019 Hospice Wage Index and Payment Rate Update final rule (83 FR 38642), we continued the newness exemption for FY 2023, and all subsequent years. We encourage hospices to keep the letter they receive providing them with their CMS Certification Number (CCN).

The letter can be used to show when you received your number. G. Survey Participation Requirements We previously finalized survey participation requirements for FY 2022 through FY 2025 as stated in the FY 2018 and FY 2019 Hospice Wage Index and Payment Rate Update final rules (82 FR 36670 and 83 FR 38642 through 38643). We also continued those requirements in all subsequent years (84 FR 38526). Table 20 restates the data submission dates for FY 2023 through FY 2025.

Start Printed Page 19744 For further information about the CAHPS Hospice Survey, we encourage hospices and other entities to visit. Https://www.hospiceCAHPSsurvey.org. For direct questions, contact the CAHPS Hospice Survey Team at hospiceCAHPSsurvey@HCQIS.org or call 1-(844) 472-4621. H. Proposal To Add CAHPS Hospice Survey Star Ratings to Public Reporting CMS currently publishes CAHPS star ratings for several of its public reporting programs including Home Health CAHPS and Hospital CAHPS.

The intention in doing so is to provide a simple, easy to understand, method for summarizing CAHPS scores. Star ratings benefit the public in that they can be easier for some to understand than absolute measure scores, and they make comparisons between hospices more straightforward. The public's familiarity with a 1 through 5 star rating system, given its use by other programs, is also a benefit to using this system. We propose to introduce Star Ratings for public reporting of CAHPS Hospice Survey results on the Care Compare or successor websites no sooner than FY 2022. We propose that the calculation and display of the CAHPS Hospice Survey Star Ratings be similar to that of other CAHPS Star Ratings programs such as Hospital CAHPS and Home Health CAHPS.

The stars would range from one star (worst) to five stars (best). We propose that the stars be calculated based on “top-box” scores for each of the eight CAHPS Hospice Survey measures. Specifically, individual-level responses to survey items would be scored such that the most favorable response is scored as 100 and all other responses are scored as 0. A hospice-level score for a given survey item would then be calculated as the average of the individual-level responses, with adjustment for differences in case mix and mode of survey administration. For a measure composed of multiple items, the hospice-level measure score is the average of the hospice-level scores for each item within the measure.

Similar to other CAHPS programs, we propose that the cut-points used to determine the stars be constructed using statistical clustering procedures that minimize the score differences within a star category and maximize the differences across star categories. We propose to use a two-stage approach to calculate these cut-points. In the first stage, we would determine initial cut-points by calculating the clustering algorithm among hospices with 30 or more completed surveys over 2 quarters (that is, 6 months). Restricting these calculations to hospices that meet a minimum sample size promotes stability of cut-points. Depending on whether hospices that meet this minimum sample size have different score patterns than smaller hospices, the initial cut-points may be too high or too low.

To ensure that cut-points reflect the full distribution of measure performance, in the second stage, we would compare mean measure scores for the bigger hospices used in the first stage to all other hospices, and update cut-points by adjusting the initial cut-points to reflect the normalized difference between bigger and smaller hospices. This two-stage approach allows for calculation of stable cut-points that reflect the full range of hospice performance. We propose that hospice star ratings for each measure be assigned based on where the hospice-level measure score falls within these cut-points. We further propose to calculate a summary or overall CAHPS Hospice Survey Star Rating by averaging the Star Ratings across the 8 measures, with a weight of 1/2 for Rating of the Hospice, a weight of 1/2 for Willingness to Recommend the Hospice, and a weight of 1 for each of the other measures, and then rounding to a whole number. We propose that only the overall Star Rating be publicly reported and that hospices must have a minimum of 75 completed surveys in order to be assigned a Star Rating.

We propose to publish the details of the Star Ratings methodology on the CAHPS Hospice Survey website, www.hospicecahpssurvey.org. CMS requires no additional resources to create and display CAHPS star ratings. We solicit comments on these proposals for CAHPS Star Ratings and included in public reporting no sooner than FY 2022.Start Printed Page 19745 9. Form, Manner, and Timing of Quality Data Submission a. Background Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary.

Such data must be submitted in a form and manner, and at a time specified by the Secretary. Section 1814(i)(5)(A)(i) of the Act was amended by the CAA 2021 and the payment reduction for failing to meet hospice quality reporting requirements is increased from 2 percent to 4 percent beginning with FY 2024. The Act requires that, beginning with FY 2014 through FY 2023, the Secretary shall reduce the market basket update by 2 percentage points and then beginning in FY 2024 and for each subsequent year, the Secretary shall reduce the market basket update by 4 percentage points for any hospice that does not comply with the quality data submission requirements for that FY. B. Compliance HQRP Compliance requires understanding three timeframes for both HIS and CAHPS.

(1) The relevant Reporting Year, payment FY and the Reference Year. The “Reporting Year” (HIS)/“Data Collection Year” (CAHPS). This timeframe is based on the CY. It is the same CY for both HIS and CAHPS. If the CAHPS Data Collection year is CY 2022, then the HIS reporting year is also CY 2022.

(2) The APU is subsequently applied to FY payments based on compliance in the corresponding Reporting Year/Data Collection Year. (3) For the CAHPS Hospice Survey, the Reference Year is the CY prior to the Data Collection Year. The Reference Year applies to hospices submitting a size exemption from the CAHPS survey (there is no similar exemption for HIS). For example, for the CY 2022 data collection year, the Reference Year, is CY 2021. This means providers seeking a size exemption for CAHPS in CY 2022 would base it on their hospice size in CY 2021.

Submission requirements are codified in § 418.312. For every CY, all Medicare-certified hospices are required to submit HIS and CAHPS data according to the requirements in § 418.312. Table 21 summarizes the three timeframes described above. It illustrates how the CY interacts with the FY payments, covering the CY 2020 through CY 2023 data collection periods and the corresponding APU application from FY 2022 through FY 2025. As illustrated in Table 21, CY 2020 data submissions compliance impacts the FY 2022 APU.

CY 2021 data submissions compliance impacts the FY 2023 APU. CY 2022 data submissions compliance impacts FY 2024 APU. This CY data submission impacting FY APU pattern follows for subsequent years. C. Submission Data and Requirements As finalized in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47192), hospices' compliance with HIS requirements beginning with the FY 2020 APU determination (that is, based on HIS-Admission and Discharge records submitted in CY 2018) are based on a timeliness threshold of 90 percent.

This means CMS requires that hospices submit 90 percent of all required HIS records within 30-days of the event (that is, patient's admission or discharge). The 90-percent threshold is hereafter referred to as the timeliness compliance threshold. Ninety percent of all required HIS records must be submitted and accepted within the 30-day submission deadline to avoid the statutorily-mandated payment penalty. To comply with CMS' quality reporting requirements for CAHPS, hospices are required to collect data monthly using the CAHPS Hospice Survey. Hospices comply by utilizing a CMS-approved third-party vendor.

Approved Hospice CAHPS vendors must successfully submit data on the hospice's behalf to the CAHPS Hospice Survey Data Center. A list of the approved vendors can be found on the CAHPS Hospice Survey website. Www.hospicecahpssurvey.org. Table 22. HQRP Compliance Checklist illustrates the APU and timeliness threshold requirements.

Start Printed Page 19746 Most hospices that fail to meet HQRP requirements do so because they miss the 90 percent threshold. We offer many training and education opportunities through our website, which are available 24/7, 365 days per year, to enable hospice staff to learn at the pace and time of their choice. We want hospices to be successful with meeting the HQRP requirements. We encourage hospices to use this website at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​Hospice-Quality-Reporting-Training-Training-and-Education-Library.

For more information about HQRP Requirements, please visit the frequently-updated HQRP website and especially the Best Practice, Education and Training Library, and Help Desk web pages at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting. We also encourage members of the public to go to the HQRP web page and sign-up for the Hospice Quality ListServ to stay informed about HQRP. D. Update on Transition to iQIES In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484), we finalized the proposal to migrate our systems for submitting and processing assessment data.

Hospices are currently required to submit HIS data to CMS using the Quality Improvement and Evaluation System (QIES) Assessment and the Submission Processing (ASAP) system. The FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484) finalized the proposal to migrate to a new internet Quality Improvement and Evaluation System (iQIES) that will enable us to make real-time upgrades. We are designating that system as the data submission system for the Hospice QRP. We will notify the public about any system migration updates using subregulatory mechanisms such as web page postings, listserv messaging, and webinars. 10.

Public Display of “Quality Measures” and Other Hospice Data for the HQRP a. Background Under section 1814(i)(5)(E) of the Act, the Secretary is required to establish procedures for making any quality data submitted by hospices available to the public. These procedures shall ensure that individual hospices have the opportunity to review their data prior to these data being made public on our designated public website. To meet the Act's requirement for making quality measure data public, we launched Hospice Compare in August 2017. This website allows consumers, providers, and other stakeholders to search for all Medicare-certified hospice providers and view their information and quality measure scores.

In September 2020, CMS transitioned Hospice Compare to the Care Compare website. Hospice Compare was discontinued in December 2020. Care Compare supports all Medicare settings and fulfills the Act's requirements for the HQRP. For more information about Care Compare, please see the Update on the Hospice Quality Reporting Requirements for FY 2022 in section D. Since 2017, we have increased and improved available information about the care hospices provide for consumers.

To indicate the quality of care hospices provide, we first posted the seven HIS Measures (NQF #1641, NQF #1647, NQF #1634, NQF #1637, NQF #1639, NQF #1638, and NQF #1617) in 2017, and then added the CAHPS Hospice Survey measure (NQF #2651) and the HIS Comprehensive Assessment at Admission (NQF #3235) in 2018. In 2019, we added the Hospice Visits When Death is Imminent (Measure 1) to the website. As discussed above, we propose to remove the seven HIS Measures from public reporting on Care Compare no earlier than May 2022. The Hospice Item Set V3.00 PRA Submission replaced the HVWDII measure with a more robust version. The claims-based measure HVLDL.

We propose to publicly report the HVLDL no earlier than May 2022. We are also proposing to publicly report the HCI, another claims-based measure no earlier than May 2022. In addition to the publicly-reported quality measure data, in 2019 we added to public reporting, information about the hospices' characteristics, taking raw data available from the Medicare Public Use File and other publicly-available government data sources and making them more consumer friendly and accessible for people seeking hospice care for themselves or family members, (83 FR 38649). This publicly reported information currently includes diagnoses, location of care, and levels of care provided.Start Printed Page 19747 b. Proposal Regarding Data Collection and Reporting During a Public Health Emergency (1).

Background. skin care products Public Health Emergency Temporary Exemption and Its Impact on the Public Reporting Schedule Under authority of section 319 of the Public Health Service (PHS) Act, the Secretary declared a Public Health Emergency (PHE) effective as of January 27, 2020. On March 13, 2020, the President declared a national state of emergency under the Stafford Act, effective March 1, 2020, allowing the Secretary to invoke section 1135(b) of the Act (42 U.S.C. 1320b-5) to waive or modify the requirements of titles XVIII, XIX, and XXI of the Act and regulations to the extent necessary to address the skin care products PHE. Many waivers and modifications were made effective as of March 1, 2020 [] in accordance with the president's declaration.

On March 27, 2020, we sent a guidance memorandum under the subject title, “Exceptions and Extensions for Quality Reporting Requirements for Acute Care Hospitals, PPS-Exempt Cancer Hospitals, Inpatient Psychiatric Facilities, Skilled Nursing Facilities, Home Health Agencies, Hospices, Inpatient Rehabilitation Facilities, Long-Term Care Hospitals, Ambulatory Surgical Centers, Renal Dialysis Facilities, and MIPS Eligible Clinicians Affected by skin care products” [] to the Medicare Learning Network (MLN) Connects Newsletter and Other Program-Specific Listserv Recipients,[] hereafter referred to as the March 27, 2020 CMS Guidance Memorandum. In that memo, which applies to HIS and CAHPS Hospice Survey, CMS granted an exemption to the HQRP reporting requirements for Quarter 4 (Q4) 2019 (October 1, 2019 through December 31, 2019), Quarter 1 (Q1) 2020 (January 1, 2020 through March 30, 2020), and Quarter 2 (Q2) 2020 (April 1, 2020 through June 30, 2020). We discuss the impact to the HIS here, and the impact to the CAHPS Hospice Survey further below. For HIS, the quarters are defined based on submission of HIS admission or discharge assessments. The exemption has impacted the public reporting schedule.

Since launching Hospice Compare in 2017, HIS-measures have been reported using 4 quarters of data. The 4 quarters included are the most recent data that have gone through Review and Correct processes, have been issued in a provider preview report, and have time allotted for addressing requests for data suppression before being publicly reported. As discussed in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52183), CMS requires at least 4 quarters of data to establish the scientific acceptability for our HIS-based quality measures. For CAHPS-based measures, we have reported CAHPS measures using eight rolling quarters of data on Hospice Compare since 2018. In the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52143), we stated that we would continue CAHPS reporting with eight rolling quarters on an ongoing basis.

This original public reporting schedule included the exempted quarters of Q4 2019 and Q1 and Q2 2020 in six refreshes for HIS and 11 refreshes for CAHPS. Table 23 displays the original schedule for public reporting prior to the skin care products PHE. Start Printed Page 19748 During the spring and summer of 2020, we conducted testing to inform decisions about publicly reporting data for those refreshes which include exempt data. The testing helped us develop a plan for posting data as early as possible, for as many hospices as possible, and with scientific acceptability similar to standard threshold for public reporting. The following sections provide the results of our testing and explain how we used the results to develop a plan that we believe allows us to achieve these objectives as best as possible.

(2). Update on Use of Q4 2019 Data and Data Freeze for Refreshes in 2021 In the March 27, 2020 Guidance Memorandum, we stated that we should not include any post-acute care (PAC) quality data that are greatly impacted by the exemption in the quality reporting programs. Given the timing of the PHE onset, we determined that we would use any data that was submitted for Q4 2019. We conducted analyses of those data to ensure that their use was appropriate. In the original schedule (Table 23) the November 2020 refresh includes Q4 2019 data for HIS- and CAHPS-based measures (Q1 through Q4 2019 for HIS data and Q1 2018 through Q4 2019 for CAHPS data) and is the last refresh before Q1 2020 data are included.

Before proceeding with the November 2020 refresh, we conducted testing to ensure that, even though we made an exception to reporting requirements for Q4 2019 in March 2020, public reporting would still allow us to publicly report data for a similar number of hospice providers, as compared to standard reporting. Specifically, we compared submission rates in Q4 2019 to average annual rates (Q4 2018 through Q3 2019) to assess the extent to which hospices had taken advantage of the exemption, and thus the extent to which data and measure scores might be affected. We observed that the HIS data submission rate for Q4 2019 was in fact 1.8 percent higher than the previous CY (Q4 2018). For the CAHPS Hospice Survey, 2.1 percent more hospices submitted data in Q4 2019 than in Q4 2018. We note that Q4 2019 ended before the onset of the skin care products PHE in the United States (U.S.).

Thus, we proceeded with including these data in measure calculations for the November 2020 refresh. As for Q1 and Q2 2020, we determined that we would not use HIS or CAHPS data from these quarters for public reporting given the timing of the PHE onset. All refreshes, during which we decided to hold these data constant, included more than 2 quarters of data that were affected by the CMS-issued skin care products reporting exceptions. Thus we did not have an adequate amount of data to reliably calculate and publicly display provider measures scores. Consequently, we determined to freeze the data displayed, that is, holding data constant after the November 2020 refresh without subsequently updating the data through November 2021.

This decision was communicated to the public in a Public Reporting Tip Sheet, which is located at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​HQRP-Requirements-and-Best-Practices. Start Printed Page 19749 (3). Proposal for Public Reporting of HIS-Based Measures With Fewer Than Standard Numbers of Quarters Due to PHE Exemption in February 2022 As noted above, we used Q4 2019 data for public reporting in November 2020 and froze that data for the February, May, August, and November 2021 refreshes. This addressed five of the six PHE-affected quarters for HIS-based measures, and five of the 11 PHE-affected quarters of CAHPS-based measures.

Because November 2020 refresh data will become increasingly out-of-date and thus less useful for consumers, we analyzed whether it would be possible to use fewer quarters of data for the last refresh affected by the exemption (February 2022) and thus more quickly resume public reporting with updated quality data. Using fewer quarters of more recent data, the first option, would require that (1) a sufficient percentage of providers would still likely have enough assessment data to report quality measures (reportability). And (2) fewer quarters would likely produce similar measure scores for hospices, and thus not unfairly represent the quality of care hospices provide during the period reported in a given refresh (reliability). To assess these criteria, we conducted reportability and reliability analysis using 3 quarters of data in a refresh, instead of the standard 4 quarters of data for reporting HIS-based measures. Specifically, we used historical data to calculate HIS-based quality measures under two scenarios.

Standard Public Reporting (SPR) Scenario. We used data from the four quarters of CY 2019, which represent CY 2020 public reporting in the absence of the temporary exemption from the submission of PAC quality data, as the basis for comparing simulated alternatives. For HIS-based measures, we used quarters Q1 through Q4 2019. skin care products PHE Affected Reporting (CAR) Scenario. We calculated quality measures using Q2 2019, Q3 2019, and Q4 2019 data, to simulate using only Q3 2020, Q4 2020, and Q1 2021 data for public reporting.

The HIS Comprehensive Assessment Measure is based on the receipt of care processes at the time of admission. Therefore for the skin care products Affected Reporting (CAR) Scenario, we excluded data for patient stays with admission dates in Q1 2019. For each scenario, we calculated the reportability as the percent of hospices meeting the 20-case minimum for public reporting (the public reporting threshold). To test the reliability of restricting the providers included in the Standard Public Reporting (SPR) Scenario to those included in the CAR Scenario, we performed three tests. First, we evaluated measure correlation using the Pearson and Spearman correlation coefficients, which assess the alignment of hospices' HIS Comprehensive Assessment Measure scores between scenarios.

Second, for each scenario, we conducted a split-half reliability analysis and estimated intra-class correlation (ICC) scores, where higher scores imply better internal reliability. Modest differences in ICC scores between scenarios would suggest that using fewer quarters of data does not impact the internal reliability of the results. Third, we estimated reliability scores. A higher value in these scores indicates that HIS Comprehensive Assessment Measure values are relatively consistent for patients admitted to the same hospice and variation in the measure reflects true differences across providers. Testing results show that the CAR scenario—specifically using 3 quarters of data for the HIS Comprehensive Assessment Measure—demonstrates acceptable levels of reportability and reliability.

As displayed in Table 24, the number of providers who met the public reporting threshold for the HIS Comprehensive Assessment Measure decreases by 236 (or by 5.2 percentage points) when reporting three versus four quarters of data. In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48234) we stated that reportability of 71 percent through 90 percent is acceptable. Therefore using 3 quarters of data for the HIS Comprehensive Assessment Measure would achieve acceptable reportability shown in Table 24. Table 24 indicates that the reliability of the HIS Comprehensive Assessment Measure scores is similar for the CAR and SPR scenarios. Testing also yielded correlation coefficients above 0.9, indicating a high degree of agreement between hospices' HIS Comprehensive Assessment Measure scores when using 3 or 4 quarters of data.

The results also show that the HIS Comprehensive Assessment Measure's ICC for CAR and SPR scenarios are similar, with only a 0.02 difference. This implies high internal reliability of the measure in both scenarios. The median reliability scores for the HIS Comprehensive Assessment Measure are also very similar in both CAR and SPR scenarios. This indicates that scores estimated using 3 quarters of data continue to capture provider-level differences and that admission-level scores remain consistent within hospices. Start Printed Page 19750 In Table 25, we explore changes in hospices' relative rankings between the SPR and CAR scenarios.

For each scenario, we divided hospices in quintiles based on their HIS Comprehensive Assessment Measure score, such that higher scores are in a higher quintile. Changes in a hospices' quintile from the SPR to CAR scenario would indicate a re-ranking of hospices when using 3 quarters compared to 4 quarters. Over 93 percent of hospices remain in the same quintile, suggesting that the ranking of hospices is fairly stable between the SPR and CAR scenarios. We also used the results presented in Table 26 to assess the option of reporting Q4 2019, Q3 2020, Q4 2020, and Q1 2021 for the February 2022 refresh. This option maintains requirements in the FY 2017 Hospice Wage Index and Payment Update final rule for publicly reporting 4 quarters of data, but it requires using some data that are more than 2 years old.

Also, the relatively high number of hospices that meet the public reporting threshold in the CAR scenario, relative to the SPR scenario, with just 3 quarters of data justify the use of 3 quarters in the unusual circumstances of the PHE and its associated exemptions. We propose that, in the skin care products PHE, we would use 3 quarters of HIS data for the final affected refresh, the February 2022 public reporting refresh of Care Compare for the Hospice setting. Using 3 quarters of data for the February 2022 refresh would allow us to begin displaying Q3 2020, Q4 2020, and Q1 2021 data in February 2022, rather than continue displaying November 2020 data (Q1 2019 through Q4 2019). We believe that updating the data in February 2022 by more than a year relative to the November 2020 freeze data would assist consumers by providing more relevant quality data and allow hospices to demonstrate more recent performance. Our testing results indicate we can achieve these positive impacts while maintaining high standards for reportability and reliability.

Table 27 summarizes the comparison between the original schedule for public reporting with the revised schedule (that is, frozen data) and with the proposed schedule that is, using 3 quarters in the February 2022 refresh. We seek public comment on this proposal to use 3 quarters of HIS data for the February 2022 public reporting refresh. Start Printed Page 19751 (4). Proposal for Public Reporting of “CAHPS Hospice Survey-Based Measures” Due to PHE Exemption Prior to skin care products PHE, the CAHPS Hospice Survey publicly reported the most recent eight rolling quarters of data. We propose to continue to report the most recent 8 quarters of available data after the freeze, but not to include the data from the exempted quarters of Q1 and Q2 of 2020 as issued in the March 27, 2020 Guidance Memorandum with the effected quarters discussed above.

The optional data submission for Q4 2019 results in publicly reporting of that data since the CAHPS Hospice Survey from that quarter were not impacted. The data submitted for Q4 2019 referred to deaths that occurred prior to COIVD-19. For the CAHPS Hospice Survey, 2.1 percent more hospices submitted data in Q4 2019 than in the same quarter a year earlier. Like HIS, our goal is to report as much of the most recent CAHPS Hospice Survey data as possible, to display data for as many hospices as possible, and to maintain the reliability of the data. Similar to HIS, the CAHPS Hospice Survey reviewed the data for reportability using fewer quarters than normal.

However, we found that using fewer than 8 quarters of data would have two important negative impacts on public reporting. First, it would reduce the proportion of hospices that would have CAHPS Hospice Survey data displayed on Care Compare. An analysis of the 8 quarters of data from Q1 2018 through Q4 2019 (publicly reported in November 2020) shows there were 5,041 active hospices. Of these hospices. 2,941 (58.3 percent) had 30+ completes for those 8 quarters, and had scores publicly reported.

Fewer hospices, 2,328 (46.2 percent), would have had 30+ completes if 4 quarters of data were used to calculate scores and 1,970 (39.1 percent) would have 30+ completes if 3 quarters were used to calculate scores. In addition, the overall reliability of the CAHPS scores would decline with fewer quarters of data. For these reasons, we determined the best course of action would be to continue to publicly report the most recent 8 quarters of data, but exempting Q1 and Q2 2020. This will allow us to maximize the number of hospices that will have CAHPS scores displayed on Care Compare, protect the reliability of the data, and report as much of the most recent data as possible. CMS froze CAHPS data starting with the November 2020 refresh and concluding with the November 2021 refresh.

We propose that starting with the February 2022 refresh, CMS will display the most recent 8 quarters of CAHPS Hospice Survey data, excluding Q1 and Q2 2020. We will resume public reporting by displaying 3 quarters of post-exemption data, plus five quarters of pre-exemption data. (Please see Table 28.) We propose that in each refresh subsequent to February 2022, we will report one more post-exemption quarter of data and one fewer pre-exemption quarter of data until we reach eight quarters of post-exemption data in May of 2023. We further propose that as of August 2023, we will resume reporting a rolling average of the most recent 8 quarters of data. Table 28 specifies the quarters for each refresh.

This will allow us to report the maximum amount of new data, maintain reliability of the data, and permit the maximum number of hospices to receive scores. In addition, Table 28 shows the proposed CAHPS public reporting schedule during and after the data freeze. Start Printed Page 19752 We seek public comment on this proposal to publicly report the most-recently available 8 quarters of CAHPS data starting with the February 2022 refresh and going through the May 2023 refresh on Care Compare because we cannot publicly report Q1 2020 and Q2 2020 data due to the skin care products PHE. C. Quality Measures To Be Displayed on Care Compare in FY 2022 and Beyond (1).

Proposal To Remove Seven “Hospice Item Set Process Measures” From Public Reporting As discussed earlier, we are proposing to remove the seven HIS process measures from the HQRP as individual measures, and no longer applying them to the FY 2024 APU and thereafter. We propose to remove the seven HIS process measures no earlier than May 2022 refresh from public reporting on Care Compare and from the Preview Reports but continue to have it publicly available in the data catalogue at https://data.cms.gov/​provider-data/​topics/​hospice-care. We are seeking public comment on this proposal to remove the seven HIS process measures from public reporting on Care Compare. (2). Proposals for Calculating and Publicly Reporting “Claims-Based Measure” as Part of the HQRP In the HIS V3.00 Paperwork Reduction Act Submission (OMB control number.

0938-1153, CMS-10390), we finalized a proposal to adopt HVLDL into the HQRP for FY 2021. We are also proposing in this rule, discussed above, to adopt the HCI into the HQRP for FY2022. In this section, we present four proposals related to calculating and reporting claims-based measures, with specific application to HVLDL and HCI. First, we propose to extract claims data to calculate claims-based measures at least 90 days after the last discharge date in the applicable period, which we will use for quality measure calculations and public reporting on Care Compare. For example, if the last discharge date in the applicable period for a measure is December 31, 2022, for data collection January 1, 2022, through December 31, 2022, we would create the data extract on approximately March 31, 2023, at the earliest.

We would use those data to calculate and publicly report the claims-based measures for the CY2022 reporting period. This proposal is similar to those finalized in other PAC settings, including the CY 2017 Home Health Prospective Payment System final rule (81 FR 76702), FY 2017 Inpatient Rehabilitation Facility Prospective Payment System final rule (81 FR 52056), and the FY 2017 Long Term Care Hospital Prospective Payment System final rule (81 FR 56762). The proposed timeframe allows us to balance providing timely information to the public with calculating the claims-based measures using as complete a data set as possible. We recognize that the proposed approximately 90-day “run-out” period is shorter than the Medicare program's current timely claims filing policy under which providers have up to 1 year from the date of discharge to submit claims. However, several months lead-time is necessary after acquiring the data to conduct the claims-based calculations.

If we were to delay our data extraction point to 12 months after the last date of the last discharge in the applicable period, we would not be able to deliver the calculations to hospices sooner than 18 to 24 months after the last discharge. To implement this process, hospices would not be able to submit corrections to the underlying claims snapshot or add claims (for those claims-based measures) to this data set at the Start Printed Page 19753conclusion of the 90-day period following the last date of discharge used in the applicable period. Therefore, we would consider the hospice claims data to be complete for purposes of calculating the claims-based measures at this point. Thus, it is important that hospices ensure the completeness and correctness of their claims prior to the claims “snapshot.” Second, we propose that we will update the claims-based measures used for the HQRP annually. Specifically, we will refresh claims-based measure scores on Care Compare, in preview reports, and in the confidential CASPER QM preview reports annually.

This periodicity of updates aligns with most claims-based measures across PAC settings. Third, we propose that we will calculate claims-based measure scores based on one or more years of data. We considered several factors to determine the number of years to include in measure calculations. Using only 1 year (4 quarters) of data, as is currently done for HIS-based quality measures reported on Care Compare, allows us to share with the public only the most up-to-date information and best reflects current realities. Having only the most recent data can also help incentivize hospices with lower scores to make changes and have the results of their effort be reflected in better scores.

At the same time, we want to report measures scores to the public for as many hospices as possible, including small hospices. Currently, only Medicare-certified hospices with more than 20 discharges each year have quality measure results publicly available on Care Compare. This public reporting threshold protects the privacy of patients who seek care at smaller hospices. However, due to the threshold, at least some hospices will not achieve the minimum patient discharges within 1 year. This means that their scores will not be displayed on Care Compare, and consumers will not have information about them to inform their decisions about selecting a hospice.

Using more years of data allows more of these hospices to meet this threshold. We conducted reportability testing for HCI and HVLDL to help us consider how best to balance the need for recent data with the need for transparency in reporting the HQRP claims-based measures. Specifically, we conducted a simulation using 2 years of data. We then calculated the change in the number of hospices which achieved the minimum reporting standard. We also compared the measure scores of the hospices that meet the reporting threshold when we use 2 years of data with hospices that meet the threshold using only 1 year of data.

Results for both HCI and HVLDL indicate that using 2 years of data increases reportability. For HVLDL, combining 2 years of data (FY 2018 to FY 2019) allows an additional 326 hospices to share measure scores, or 33.8 percent of the hospices that do not meet the reporting threshold in FY 2019 alone. For HCI, combining 2 years of data (FY 2018 to FY 2019 data) allows an additional 277 to report HCI measure scores on Care Compare, or 43.2 percent of the hospices that do not meet the reporting threshold in FY 2019 alone. Our simulations indicate that the hospices that only meet the reporting threshold when using 2 years of data have performance scores substantially lower than average. For HVLDL, where higher scores indicate better quality of care, the national average score was 65.5 percent in FY 2019, where 965 hospices did not meet the reportability threshold.

After pooling data using FY 2018 to FY 2019, 326 additional hospices met the reportability threshold, or 33.8 percent of those previously missing. Those addition 326 hospices had an average HVLDL score of just 43.3 percent, about 20 percentage points lower than the hospices meeting the reportability threshold using FY 2019 alone national average score for this HVLDL measure. The results for HCI similarly show that the hospices with reportable data when using two-pooled years of data had lower HCI scores compared to the national average when using just FY 2019 data. Higher HCI scores indicate better performance. As Figure 7 shows, a larger numbers of hospices among the 277 hospices that only meet the reporting threshold when using 2 years of data had HCI scores between four and eight, while a larger number of hospices in the FY 2019 population had a perfect score of 10.

Start Printed Page 19754 Given these findings, we propose using 2 years of data to publicly report HCI and HVLDL in 2022. The use of 2 years or 8 quarters of quality data is already publicly reported for the quality measures related to the CAHPS Hospice Survey so hospices are familiar with this approach. We plan to consider multiple years of data, like the 2 years of data, for other claims-based measures proposed in subsequent years. We believe it is important to support consumers by sharing information on the performance of hospices that have lower scores, and to incentivize those hospices to improve. The results demonstrate that using multiple years of data help include more hospices that have lower performance rates for HVLDL and HCI in public reporting on Care Compare.

While using more years of data would allow us to report measures for even more hospices, it would involve sharing data that are no longer relevant, and display scores that do not reflect recent hospice improvement efforts. We are soliciting public comment on these proposals related to the using 2 years of data for claims-based measures and public reporting of claims measures in general and their application to HVLDL and HCI specifically. (3). Proposal To Publicly Report the Hospice Care Index and “Hospice Visits in the Last Days of Life” Claims-Based Measures As discussed previously, we are proposing to publicly report the HCI and HVLDL using 2 years, which is 8 quarters of Medicare claims data. We propose to publicly report the HCI and HVLDL beginning no earlier than May 2022 using FY2021 Medicare hospice claims data, and to include it in the Preview Reports no sooner than the May 2022 refresh.

The publicly-reported version of HCI on Care Compare will only include the final HCI score, and not the component indicators. The Preview Reports will reflect the HCI as publicly reported. We are seeking public comment on this proposal for HCI and HVLDL public reporting on Care Compare no sooner than May 2022. (4). Update on Publicly Reporting for the “Hospice Visits When Death is Imminent (HVWDII) Measure 1” and the “Hospice Visits in the Last Days of Life (HVLDL) Measure” As discussed earlier, the HIS V3.00 PRA Submission, CMS-10390 (OMB control number.

0938-1153), finalized the proposal to replace the HVWDII measure pair with a re-specified version called HVLDL, which is a single measure based on Medicare claims. Relatedly, in the HIS V3.00 PRA Submission, CMS-10390 (OMB control number. 0938-1153), we finalized the proposal to remove Section O from the HIS. As stated in section 1814(i)(5)(E) of the Act, we establish procedures for making all quality data submitted by hospices under § 418.312 available to the public. Thus, we would have continued to publicly report HVWDII Measure 1 data through the November 2021 refresh.

Because of the data freeze detailed above, HVWDII Measure 1 data from the November 2020 refresh, covering HIS admissions during Q1 through Q4 2019, will be publicly displayed for all calendar year 2021 refreshes. We may retain the November 2020 refresh for HVWDII Measure 1 for one or more refreshes in 2022, when there will be no HIS Section O data, if doing so will allow us to consolidate changes and thus operate more efficiently. D. Update on Transition From Hospice Compare to Care Compare and Provider Data Catalog In September 2020, we launched Care Compare, a streamlined redesign of eight existing CMS healthcare compare tools available on Medicare.gov, including Hospice Compare. Care Compare provides a single user-friendly interface that patients and family caregivers can use to make informed Start Printed Page 19755decisions about healthcare based on cost, quality of care, volume of services, and other data.

With just one click, patients can find information that is easy to understand about doctors, hospitals, nursing homes, and other health care services instead of searching through multiple tools. For the last six years, Medicare's Hospice Compare has served as the cornerstone for publicizing quality care information for patients, family caregivers, consumers, and the healthcare community. The new website builds on the eMedicare initiative to deliver simple tools and information to current and future Medicare beneficiaries. Drawing on lessons learned through research and stakeholder feedback, Care Compare includes features and functionalities that appeal to Hospice Compare consumers. By offering an accessible and user-friendly interface and a simple design that is optimized for mobile and tablet use, it is easier than ever to find information that is important to patients when shopping for healthcare.

Enhancements for mobile use will give practical benefits like accessing the tool using a smartphone that can initiate phone calls to providers simply by clicking on the provider's phone number. In conjunction with the Care Compare launch, we have made additional improvements to other CMS data tools, to help Medicare beneficiaries compare costs. Specifically, the Provider Data Catalog (PDC) better serves innovators and stakeholders who are interested in detailed CMS data and use interactive and downloadable datasets like those currently available on data.Medicare.gov. The PDC now makes quality datasets available through an improved Application Programming Interface (API), allowing innovators in the field to easily access and analyze the CMS publicly-reported data and make it useful for patients. E.

Update on Additional Information on Hospices for Public Reporting In the FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements final rule (83 FR 38622), we finalized plans to publicly post information from the Medicare Provider Utilization and Payment Data. Hospice Public Use File (PUF) and other publicly-available CMS data to Hospice Compare or another CMS website. Hospice PUF data are available for CY 2014 through CY 2016. Beginning with CY 2017 data, hospice PUF data are public as part of the Post-Acute Care and Hospice Provider Utilization and Payment PUF (hereafter PAC PUF). For more information, please visit the PAC PUF web page at.

Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Statistics-Trends-and-Reports/​Medicare-Provider-Charge-Data/​PAC2017. Both the Hospice and PAC PUFs provide information on services provided to Medicare beneficiaries by hospice providers. Specifically, they contain information on utilization, payment (Medicare payment and standard payment), submitted charges, primary diagnoses, sites of service, and beneficiary demographics organized by CCN (6-digit provider identification number) and state. PUF data, along with clear text explaining the purpose and uses of this information and suggesting consumers discuss this information with their healthcare provider, first displayed in a consumer-friendly format on Hospice Compare in May 2019. Beginning May 2021, we will begin to display additional information from the PAC PUF on Care Compare.

This additional information includes hospices' beneficiary characteristics such as the percentage of patients enrolled in Medicare Advantage. In addition, consumers will see whether a hospice provided services to Medicare Advantage enrollees or patients who have coverage under both Medicaid and Medicare, also called dual eligible patients. The data for these additional characteristics are pulled directly from the PAC PUF file and provide potential hospice service patients and family caregivers with more detail prior to selecting a hospice. As finalized in the FY 2019 Hospice Wage Index and Payment Update final rule (83 FR 38622), we also improved access to publicly-available information about hospices' compliance with Hospice QRP requirements. Specifically, we already post the annual Hospice APU Compliant List on the HQRP Requirements and Best Practices web page.

This document displays the CCN, name, and address of every hospice that successfully met quality reporting program requirements for the fiscal year. Hospices are only considered compliant if they meet the standards for HIS and CAHPS reporting, as codified in § 418.312. Consumers can now access the Hospice APU compliance file from Care Compare, enabling them to determine if a particular hospice is compliant with CMS' quality reporting requirements. G. Proposal for the January 2022 HH QRP Public Reporting Display Schedule With Fewer Than Standard Number of Quarters Due to skin care products Public Health Emergency Exemptions 1.

Background and Statutory Authority We include this Home Health proposal in this rule because we plan to resume public reporting for the HH QRP with the January 2022 refresh of Care Compare. In order to accommodate the exception of 2020 Q1 and Q2 data, we are proposing to resume public reporting using 3 out of 4 quarters of data for the January 2022 refresh. In order to finalize this proposal in time to release the required preview report related to the refresh, which we release 3 months prior to any given refresh (October 2021), we need the rule containing this proposal to finalize by October 2021. The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. Section 1895(b)(3)(B)(v)(II) of the Act requires that for 2007 and subsequent years, each HHA submit to the Secretary in a form and manner, and at a time, specified by the Secretary, such data that the Secretary determines are appropriate for the measurement of health care quality.

To the extent that an HHA does not submit data in accordance with this clause, the Secretary shall reduce the home health market basket percentage increase applicable to the HHA for such year by 2 percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act, depending on the market basket percentage increase applicable for a particular year, the reduction of that increase by 2 percentage points for failure to comply with the requirements of the HH QRP and further reduction of the increase by the productivity adjustment (except in 2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act may result in the home health market basket percentage increase being less than 0.0 percent for a year, and may result in payment rates under the Home Health PPS for a year being less than payment rates for the preceding year. For more information on the policies we have adopted for the HH QRP, we refer readers to the following rules. 2. Public Display of Home Health Quality Data for the HH QRP Section 1895(b)(3)(B)(v)(III) of the Act requires the Secretary to establish procedures for making HH QRP data, including data submitted under sections 1899B(c)(1) and 1899B(d)(1) of the Act, available to the public.

Such public display procedures must ensure that HHAs have the opportunity to review the data that will be made public with respect to each HHA prior to such data being made public. Section 1899B(g) of the Act requires that data and information regarding PAC provider performance on quality measures and resource use or other measures be made publicly available beginning not later than 2 years after the applicable specified “application date”. We established our HH QRP Public Display Policy in the CY 2016 HH PPS final rule (80 FR 68709 through 68710). In that final rule, we noted that the procedures for HHAs to review and correct their data on a quarterly basis is performed through CASPER along with our procedure to post the data for the public on our Care Compare website. We have communicated our public display schedule, which supports our Public Display Policy, on our websites whereby the quarters of data included are announced.

3. Proposal To Modify HH QRP Public Reporting To Address CMS' Guidance To Except Data During the skin care products PHE Beginning January 2022 Through July 2024 We are proposing to modify our public display schedule to display fewer quarters of data than what we previously finalized for certain HH QRP measures for the January 2022 refreshes. Under authority of section 319 of the PHS Act, the Secretary declared a PHE effective as of January 27, 2020. On March 13, 2020, the President declared a national state of emergency under the Stafford Act, effective March 1, 2020, allowing the Secretary to invoke section 1135(b) of the Act (42 U.S.C. 1320b-5) to waive or modify the requirements of titles XVIII, XIX, and XXI of the Act and regulations to the extent necessary to address the skin care products PHE.

Many waivers and modifications were made effective as of March 1, 2020 in accordance with the President's declaration.[] On March 27, 2020, we sent a guidance memorandum under the subject title, “Exceptions and Extensions for Quality Reporting Requirements for Acute Care Hospitals, PPS-Exempt Cancer Hospitals, Inpatient Psychiatric Facilities, Skilled Nursing Facilities, Home Health Agencies (HHAs), Hospices, Inpatient Rehabilitation Facilities, Long-Term Care Hospitals, Ambulatory Surgical Centers, Renal Dialysis Facilities, and MIPS Eligible Clinicians Affected by skin care products” to the MLN Connects Newsletter and Other Program-Specific Listserv Recipients,[] hereafter referred to as the March 27, 2020 CMS Guidance Memorandum. In the March 27, 2020 CMS Guidance Memo, we granted an exception to the HH QRP reporting requirements under the HH QRP exceptions and extension requirements for Quarter 4 (Q4) 2019 (October 1, 2019 through December 31, 2019), Q1 2020 (January 1, 2020 through March 30, 2020), and Q2 2020 (April 1, 2020 through June 30, 2020). The HH QRP exception applied to the HH QRP Outcome and Assessment Information Set (OASIS)-based measures, claims-based measures, and HH CAHPS Survey. We discuss the impact to the OASIS and claims here, and discuss to the HH CAHPS further in section III.G. 4, Update on Use of Q4 2019 HH QRP Data and Data Freeze for Refreshes in 2021.

For the OASIS, the exempted quarters are based upon admission and discharge assessments. A subset of the HH QRP measures has been publicly displayed on Home Health Compare (HH Compare) since 2003. Under the current HH QRP public display policy, Home Health Compare uses 4 quarters of data to publicly display OASIS-based measures, and 4 or more quarters of data to publicly display claims-based measures. We use four rolling quarters of data to publicly display Home Health Care Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) Survey measures on Care Compare. As of September 2020, HH QRP OASIS, claims-based, and HHCAHPS Survey measures are reported on the www.medicare.gov's Care Compare website.

As of December 2020, the data is no longer reported on the www.medicare.gov's Home Health Compare website. The exception granted under the March 27, 2020 CMS Guidance Memo impacted the HH QRP public display schedule. We will resume publicly displaying HH QRP claims-based measures in January 2022 based upon the quarters of data specified for each of the claims-based measures. Table 30 displays the original schedule for public reporting of OASIS and HHCAHPS Survey measures prior to the Q1 and Q2 2020 data impacted by the skin care products PHE. Start Printed Page 19757 Start Printed Page 19758 During the spring and summer of 2020, we conducted testing to inform decisions about publicly displaying HH QRP data for those refreshes which include data from the exception period of October 1, 2019 through June 30, 2020 (hereafter “excepted data”).

The testing helped us develop a plan for displaying HH QRP data that are as up-to-date as possible and that also meet scientifically-acceptable standards for publicly displaying those data. We believe that the plan allows us to provide consumers with helpful information on the quality of home health care, while also making the necessary adjustments to accommodate the exception granted to HHAs. The following sections provide the results of our testing for OASIS and claims and explain how we used the results to inform a proposal for accommodating excepted data in public reporting. HH CAHPS discussion is further in section III.G.4. 4.

Update on Use of Q4 2019 HH QRP Data and Data Freeze for Refreshes in 2021 In the March 27, 2020 Guidance Memorandum, we stated that we should not include any PAC quality data that are greatly impacted by the exception granted in the quality reporting programs. Given the timing of the PHE onset, we determined that we would not use HH QRP OASIS, claims, or HHCAHPS data from Q1 and Q2 of 2020 for public reporting, and that we would assess the impact of the skin care products PHE on HH QRP data from Q4 2019. In the original schedule (Table 30), the October 2020 refresh included Q4 2019 measure based on OASIS and HHCAHPS data and is the last refresh before Q1 2020 data are included. Before proceeding with the October 2020 refresh, we conducted testing to ensure that publicly displaying Q4 2019 data would still meet our standards despite granting an exception to HH QRP reporting requirements for Q4 2019. Specifically, we compared submission rates in Q4 2019 to average rates in other quarters to assess the extent to which HHAs had taken advantage of the exemption, and thus the extent to which data and measure scores might be affected.

We observed that the quality data submission rate for Q4 2019 was in fact 0.4 percent higher than the previous calendar year (Q4 2018). We note that Q4 2019 ended before the onset of the skin care products renova in the U.S. Thus, we proceeded with including Q4 2019 data in measure calculations for the October 2020 refresh. Because we excepted HHAs from the HH QRP reporting requirements for Q1 and Q2 2020, we did not use OASIS, claims, or HHCAHPS data from these quarters. All refreshes, during which we decided to hold this data constant, included more than 2 quarters of data that were affected by the CMS-issued skin care products reporting exceptions, thus we did not have an adequate amount of data to reliably calculate and publicly display provider measures scores.

Consequently, we determined to freeze the data displayed, that is, holding data constant after the October 2020 refresh without subsequently updating the data through October 2021. We communicated this in a Public Reporting Tip Sheet, which is located at. Https://www.cms.gov/​files/​document/​hhqrp-pr-tip-sheet081320final-cx-508.pdf. 5. Proposal To Use the skin care products PHE Affected Reporting (CAR) Scenario To Publicly Display Certain HH QRP Measures (Beginning in January 2022 through July 2024) Due to the skin care products PHE We are also proposing to use the CAR scenario for refreshes for January 2022 for OASIS and for refreshes from January 2022 through July 2024 for some claims-based measures.

There are several forthcoming HH QRP refreshes Start Printed Page 19759for which the original public reporting schedule included other quarters from the quality data submission exception. These refreshes for claims-based measures, OASIS-based measures, and for HHCAHPS Survey measures are outlined above (Table 30). Because October 2020 refresh data will become increasingly out-of-date and thus less useful for the public, we analyzed whether it would be possible to use fewer quarters of data for one or more refreshes and thus reduce the number of refreshes that continue to display October 2020 data. Using fewer quarters of more up-to-date data requires that. (1) A sufficient percentage of HHAs would still likely have enough OASIS data to report quality measures (reportability).

And (2) using fewer quarters of data to calculate measures would likely produce similar measure scores for HHAs, and thus not unfairly represent the quality of care HHAs provided during the period reported in a given refresh (reliability). To assess these criteria, we conducted reportability and reliability analysis excluding the skin care products affected quarters of data in a refresh instead of the standard number of quarters of data for reporting for each HH QRP measure to model the impact of not using Q1 or Q2 2020. Specifically, we used historical data to calculate HH quality measures under two scenarios. Standard Public Reporting (SPR) Scenario. We used HH QRP data from CY 2017 through 2019 to build the standard reported measures, to represent as a proxy CY 2020 public reporting in the absence of the temporary exemptions from the submission of OASIS quality data, as the basis for comparing simulated alternatives.

This entails using 4 quarters of CY 2019 HH QRP data to model the OASIS based measures that are normally calculated using 4 quarters of data. This also entailed using 4 quarters of HH QRP data from CY 2019 for the all-cause hospitalization and emergency department use claims-based measures, 8 quarters of HH QRP data from CY2018 and CY2019 for Medicare spending per beneficiary (MSPB) and discharge to community (DTC) claims-based measures. And or 12 quarters from January 2017 to December 2019 for the potentially preventable readmission claims-based measure. skin care products Affected Reporting (CAR) Scenario. We calculated OASIS-based measures using 3 quarters of HH QRP CY 2019 data to simulate using only Q3 2020, Q4 2020, and Q1 2021 data for public reporting.

We calculated claims-based measures using HH QRP CY 2017 to 2019 data, to simulate using the most recent data while excluding the same quarters (Q1 and Q2) that are relevant from the PHE exception. We used 3 quarters of HH QRP data from CY 2019 for the all-cause hospitalization and emergency department use claims-based measures and 6 quarters of data from HH QRP CY 2018 and CY 2019 were used for both the Medicare spending per beneficiary and discharge to community claims-based measures. We used 10 quarters of HH QRP data from CY 2017 to 2019 to calculate the CAR scenario for the potentially preventable readmissions claims-based measure. For both claims and OASIS-based measures, the quarters used in our analysis were the most recently available data that exclude the same quarters (Q1 and Q2) as that are relevant from the PHE exception, and thus take seasonality into consideration. The OASIS-based measures are based on the start of care and calculated using admission dates.

Therefore, under the CAR scenario we excluded data for OASIS-based measures for HHA patient stays with admission dates in Q1 and Q2 2019. To assess performance in these scenarios, we calculated the reportability as the percent of HHAs meeting the 20-case minimum for public reporting (the public reporting threshold, or “PRT”). We evaluated measure reliability using the Pearson and Spearman correlation coefficients, which assess the alignment of HHs measure scores between scenarios. To calculate the reliability results, we restricted the HHAs included in the SPR Scenario to those included in the CAR Scenario. Testing results showed that using the CAR scenario would achieve scientifically acceptable quality measure scores for the HH QRP.

As displayed in Table 31, the percentage of HHAs that met the public display threshold for the OASIS-based measure decreases by 5.5 percentage points or less for all but one QM, the Influenza Immunization for the Current Flu Season in the CAR scenario versus SPR scenario. CMS has traditionally used a reportability threshold of 70 percent, meaning at least 70 percent of HHAs are able to report at least 20 episodes for a given measure, as the standard to determine whether a measure should be publicly reported. By this standard, we consider a decrease of 5.5 percentage points or less scientifically acceptable. The change in reportability for the Influenza Immunization for the Current Flu Season measure is related to the seasonality of this measure, which includes cases that occur during the flu season only. Under the CAR scenario, the January 2022 refresh data would cover Q3 and Q4 of 2020 and Q1 of 2021, which occur during the flu season.

This simulation included Q2 through Q4 of 2019, which crosses the flu season. Thus, the reportability of the actual data used is likely to be better than this simulation. Therefore, in general, using CAR scenario for the OASIS and claims-based measures would achieve acceptable reportability for the HH QRP measures. Testing also yielded correlation coefficients above 0.85, indicating a high degree of agreement between HH measure scores when using the CAR scenario or the SPR scenario. Start Printed Page 19760 Start Printed Page 19761 We are proposing to use the CAR scenario for the last of the refreshes affecting OASIS-based measures, which will occur in January 2022.

We are also proposing to use the CAR scenario for refreshes from January 2022 through July 2024 for some claims-based measures. Our proposal of the CAR scenario for the January 2022 refresh would allow us to begin displaying recent data in January 2022, rather than continue displaying October 2020 data (Q1 2019 Start Printed Page 19762through Q4 2019). We believe that updating the data in January 2022 by more than a year relative to the October 2020 freeze data can assist the public by providing more relevant quality data and allow CMS to display more recent HHA performance. Similarly, using fewer than standard numbers of quarters for claims-based measures that typically use eight or twelve months of data for reporting between January 2022 and July 2024 will allow us to begin providing more relevant data sooner. Our testing results indicate we can achieve these positive impacts while maintaining high standards for reportability and reliability.

Table 32 and Table 33 summarize the comparison between the original schedule for public reporting with the revised schedule (that is, frozen data) and also with the proposed public display schedule under the CAR scenario (that is, using 3 quarters in the January 2022 refresh), for OASIS- and claims-based measures respectively. Start Printed Page 19763 We are soliciting public comments on the proposal to use the CAR scenario to publicly report HH OASIS in January 2022 and claims-based measures beginning with the January 2022 through July 2024 refreshes. 6. Update to the Public Display of HHCAHPS Measures Due to the skin care products PHE Exception Since April 2012, we have publicly displayed four quarters of HHCAHPS data every quarter, in the months of January, April, July, and October. The skin care products PHE Exception applied to Q1 and Q2 of 2020.

Those excepted quarters cannot be publicly displayed and resulted in the freezing of the public display using Q1 2019 through Q4 2019 data for the refreshes that would have occurred from October 2020 through October 2021, as shown in Table 34. Beginning with January 2022, we will resume reporting four quarters of HHCAHPS data. The data for the January 2022 refresh are Q3 2020 through Q2 2021. These are the same quarters that would have been publicly Start Printed Page 19764displayed despite the skin care products PHE. Table 34 summarizes this discussion.

IV. Requests for Information A. Fast Healthcare Interoperability Resources (FHIR) in Support of Digital Quality Measurement in Post-Acute Care Quality Reporting Programs—Request for Information 1. Background A goal of the HQRP is to improve the quality of health care for beneficiaries through measurement, transparency, and public reporting of data. The HQRP contributes to improvements in health care, enhancing patient outcomes, and informing consumer choice.

In October 2017, we launched the Meaningful Measures Framework. This framework captures our vision to address health care quality priorities and gaps, including emphasizing digital quality measurement (dQM), reducing measurement burden, and promoting patient perspectives, while also focusing on modernization and innovation. The scope of the Meaningful Measures Framework has evolved to Meaningful Measure 2.0 to accommodate the changes in the health care environment, initially focusing on measure and burden reduction to include the promotion of innovation and modernization of all aspects of quality.[] There is a need to streamline our approach to data collection, calculation, and reporting to fully leverage clinical and patient-centered information for measurement, improvement, and learning. In alignment with the Meaningful Measure 2.0, we are seeking feedback on our future plans to define digital quality measures for the HQRP. We also are seeking feedback on the potential use of Fast Healthcare Interoperable Resources (FHIR) for dQMs within the HQRP aligning where possible with other quality programs.

FHIR is an open source standards framework (in both commercial and government settings) created by Health Level Seven International (HL7®) that establishes a common language and process for all health information technology. 2. Definition of Digital Quality Measures We are considering adopting a standardized definition of Digital Quality Measures (dQMs) in alignment across QRPs. We are considering in the future to propose the adoption within the HQRP the following definition. Digital Quality Measures (dQMs) are quality measures that use one or more sources of health information that are captured and can be transmitted electronically via interoperable Start Printed Page 19765systems.[] A dQM includes software that processes digital data to produce a measure score or measure scores.

Data sources for dQMs may include administrative systems, electronically submitted clinical assessment data, case management systems, electronic health records (EHRs), instruments (for example, medical devices and wearable devices), patient portals or applications (for example, for collection of patient-generated health data), health information exchanges (HIEs) or registries, and other sources. As an example, the quality measures calculated from patient assessment data submitted electronically to CMS would be considered digital quality measures. 3. Use of FHIR for Future dQMs in HQRP Over the past two years in other programs, we have focused on opportunities to streamline and modernize quality data collection and reporting processes, such as exploring HL7® FHIR® (http://hl7.org/​fhir) for quality reporting programs. One of the first areas CMS has identified relative to improving our digital strategy is through the use of FHIR-based standards to exchange clinical information through application programming interfaces (APIs), allowing clinicians to digitally submit quality information one time that can then be used in many ways.

We believe that in the future proposing such a standard within the HQRP could potentially enable collaboration and information sharing, which is essential for delivering high-quality care and better outcomes at a lower cost. We are currently evaluating the use of FHIR based APIs to access assessment data collected and maintained through the Quality Improvement and Evaluation System (QIES) and internet QIES (iQIES) health information systems and are working with healthcare standards organizations to assure that their evolving standards fully support our assessment instrument content. Further, as more hospice providers are adopting EHRs including hospices, we are evaluating using the FHIR interfaces for accessing patient data (including standard assessments) directly from hospice EHRs. Accessing data in this manner could also enable the exchange of data for purposes beyond data reporting to CMS, such as care coordination further increasing the value of EHR investments across the healthcare continuum. Once providers map their EHR data to a FHIR API in standard FHIR formats it could be possible to send and receive the data needed for measures and other uses from their EHRs through FHIR APIs.

4. Future Alignment of Measures Across Reporting Programs, Federal and State Agencies, and the Private Sector We are committed to using policy levers and working with stakeholders to achieve interoperable data exchange and to transition to full digital quality measurement in our quality programs. We are considering the future potential development and staged implementation of a cohesive portfolio of dQMs across our regulated programs, including HQRP, agencies, and private payers. This cohesive portfolio would require, where possible, alignment of. (1) Measure concepts and specifications including narrative statements, measure logic, and value sets, and (2) the individual data elements used to build these measure specifications and calculate the measures.

Further, the required data elements would be limited to standardized, interoperable elements to the fullest extent possible. Hence, part of the alignment strategy will be the consideration and advancement of data standards and implementation guides for key data elements. We would coordinate closely with quality measure developers, Federal and state agencies, and private payers to develop and to maintain a cohesive dQM portfolio that meets our programmatic requirements and that fully aligns across Federal and state agencies and payers to the extent possible. We intend this coordination to be ongoing and allow for continuous refinement to ensure quality measures remain aligned with evolving healthcare practices and priorities (for example, patient reported outcomes (PROs), disparities, care coordination), and track with the transformation of data collection. This includes conformance with standards and health IT module updates, future adoption of technologies incorporated within the ONC Health IT Certification Program and may also include standards adopted by ONC (for example, standards-based APIs).

The coordination would build on the principles outlined in HHS' Nation Health Quality Roadmap.[] It would focus on the quality domains of safety, timeliness, efficiency, effectiveness, equitability, and patient-centeredness. It would leverage several existing Federal and public-private efforts including our Meaningful Measures 2.0 Framework. The Federal Electronic Health Record Modernization (DoD/VA). The Core Quality Measure Collaborative, which convenes stakeholders from America's Health Insurance Plans (AHIP), CMS, NQF, provider organizations, private payers, and consumers and develops consensus on quality measures for provider specialties. And the NQF-convened Measure Applications Partnership (MAP), which recommends measures for use in public payment and reporting programs.

We would coordinate with HL7's ongoing work to advance FHIR resources in critical areas to support patient care and measurement such as social determinants of health. Through this coordination, we would identify which existing measures could be used or evolved to be used as dQMs, in recognition of current healthcare practice and priorities. This multi-stakeholder, joint Federal, state, and industry effort, made possible and enabled by the pending advances towards interoperability, would yield a significantly improved quality measurement enterprise. The success of the dQM portfolio would be enhanced by the degree to which the measures achieve our programmatic requirements as well as the requirements of other agencies and payers. 5.

Solicitation of Comments We seek input on the following steps that would enable transformation of CMS' quality measurement enterprise to be fully digital. A. What EHR/IT systems do you use and do you participate in a health information exchange (HIE)?. b. How do you currently share information with other providers and are there specific industry best practices for integrating SDOH screening into EHR's?.

c. What ways could we incentivize or reward innovative uses of health information technology (IT) that could reduce burden for post-acute care settings, including but not limited to hospices?. d. What additional resources or tools would post-acute care settings, including but not limited to hospices and health IT vendors find helpful to support testing, implementation, collection, and reporting of all measures using FHIR standards via secure APIs to reinforce the sharing of patient health information between care settings?. e.

Would vendors, including those that service post-acute care settings, including but not limited to hospices, be interested in or willing to participate in pilots or models of alternative approaches to quality measurement that Start Printed Page 19766would align standards for quality measure data collection across care settings to improve care coordination, such as sharing patient data via secure FHIR API as the basis for calculating and reporting digital measures?. f. What could be the potential use of FHIR dQMs that could be adopted across all QRPs?. We plan to continue working with other agencies and stakeholders to coordinate and to inform our transformation to dQMs leveraging health IT standards. While we will not be responding to specific comments submitted in response to this Request for Information in the FY 2022 Hospice final rule, we will actively consider all input as we develop future regulatory proposals or future sub-regulatory policy guidance.

Any updates to specific program requirements related to quality measurement and reporting provisions would be addressed through separate and future notice- and-comment rulemaking, as necessary. B. Closing the Health Equity Gap in Post-Acute Care Quality Reporting Programs—Request for Information 1. Background Significant and persistent inequities in health outcomes exist in the United States. In recognition of persistent health disparities and the importance of closing the health equity gap, we request information on expanding several related CMS programs to make reporting of health disparities based on social risk factors and race and ethnicity more comprehensive and actionable for providers and patients.

Belonging to a racial or ethnic minority group. Living with a disability. Being a member of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community. Or being near or below the poverty level, is often associated with worse health outcomes.[] Such disparities in health outcomes are the result of number of factors, but importantly for CMS programs, although not the sole determinant, poor access and provision of lower quality health care contribute to health disparities. For instance, numerous studies have shown that among Medicare beneficiaries, racial and ethnic minority individuals often receive lower quality of care, report lower experiences of care, and experience more frequent hospital readmissions and operative complications.[] Readmission rates for common conditions in the Hospital Readmissions Reduction Program are higher for black Medicare beneficiaries and higher for Hispanic Medicare beneficiaries with Congestive Heart Failure and Acute Myocardial Infarction.[] Studies have also shown that African Americans are significantly more likely than white Americans to die prematurely from heart disease and stroke.[] The skin care products renova has further illustrated many of these longstanding health inequities with higher rates of , hospitalization, and mortality among black, Latino, and Indigenous and Native American persons relative to white persons.[] As noted by the Centers for Disease Control “long-standing systemic health and social inequities have put many people from racial and ethnic minority groups at increased risk of getting sick and dying from skin care products”.[] One important strategy for addressing these important inequities is by improving data collection to allow for better measurement and reporting on equity across our programs and policies.

We are committed to achieving equity in health care outcomes for our beneficiaries by supporting providers in quality improvement activities to reduce health inequities, enabling beneficiaries to make more informed decisions, and promoting provider accountability for health care disparities.[] For the purposes of this rule, we are using a definition of equity established in Executive Order 13985, as “the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color. Members of religious minorities. Lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons. Persons with disabilities. Persons who live in rural areas.

And persons otherwise adversely Start Printed Page 19767affected by persistent poverty or inequality.” [] We note that this definition was recently established by the current administration, and provides a useful, common definition for equity across different areas of government, although numerous other definitions of equity exist. Our ongoing commitment to closing the equity gap in CMS quality programs is demonstrated by a portfolio of programs aimed at making information on the quality of health care providers and services, including disparities, more transparent to consumers and providers. The CMS Equity Plan for Improving Quality in Medicare aims to support Quality Improvement Networks and Quality Improvement Organizations (QIN-QIOs). Federal, state, local, and tribal organizations. Providers.

Researchers. Policymakers. Beneficiaries and their families. And other stakeholders in activities to achieve health equity. The CMS Equity Plan includes three core elements.

(1) Increasing understanding and awareness of disparities. (2) developing and disseminating solutions to achieve health equity. And (3) implementing sustainable actions to achieve health equity.[] The CMS Quality Strategy and Meaningful Measures Framework [] include elimination of racial and ethnic disparities as a fundamental principle. Our ongoing commitment to closing the health equity gap in the HQRP is demonstrated by the sharing of information from the Medicare PAC PUF on Care Compare and seeking to adopt through future rulemaking aspects of the standardized patient assessment data elements (SPADEs) that apply to hospice which include several social determinants of health (SDOH). We continue to work with Federal and private partners to better collect and leverage data on social risk to improve our understanding of how these factors can be better measured in order to close the health equity gap.

Among other things, we have developed an Inventory of Resources for Standardized Demographic and Language Data Collection [] and supported collection of specialized International Classification of Disease, 10th Edition, Clinical Modification (ICD-10-CM) codes for describing the socioeconomic, cultural, and environmental determinants of health. We continue to work to improve our understanding of this important issue and to identify policy solutions that achieve the goals of attaining health equity for all patients. 2. Solicitation of Public Comment While hospice is not included in the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 (Pub. L.

113-185), we look at measures adopted based on that Act, like SPADES and if aspects apply to hospice then we would consider including it in the HQRP. This helps with continuity of care since patients may transition from different PAC settings to hospice and it would address a gap in hospice care. We are seeking comment on the possibility of expanding measure development, and adding aspects of SPADEs that could apply to hospice and address gaps in health equity in the HQRP. Any potential health equity data collection or measure reporting within a CMS program that might result from public comments received in response to this solicitation would be addressed through a separate notice- and-comment rulemaking in the future. Specifically, we are inviting public comment on the following.

Recommendations for quality measures, or measurement domains that address health equity, for use in the HQRP. Suggested parts of SDOH SPADEs adoption that could apply to hospice in alignment with national data collection and interoperable exchange standards. This could include collecting information on certain SDOH, including race, ethnicity, preferred language, interpreter services, health literacy, transportation and social isolation. CMS is seeking guidance on any additional items, including SPADEs that could be used to assess health equity in the care of hospice patients, for use in the HQRP. Ways CMS can promote health equity in outcomes among hospice patients.

We are also interested in feedback regarding whether including facility-level quality measure results stratified by social risk factors and social determinants of health (for example, dual eligibility for Medicare and Medicaid, race) in confidential feedback reports could allow facilities to identify gaps in the quality of care they provide. (For example, methods similar or analogous to the CMS Disparity Methods [] which provide hospital-level confidential results stratified by dual eligibility for condition-specific readmission measures currently included in the Hospital Readmission Reduction Program (84 FR 42496 through 42500)). Methods that commenters or their organizations use in employing data to reduce disparities and improve patient outcomes, including the source(s) of data used, as appropriate. Given the importance of structured data and health IT standards for the capture, use, and exchange of relevant health data for improving health equity, the existing challenges providers' encounter for effective capture, use, and exchange of health information, such as data on race, ethnicity, and other social determinants of health, to support care delivery and decision making. While we will not be responding to specific comments submitted in response to this Request for Information in the FY 2022 Hospice Wage Index final rule, we intend to use this input to inform future policy development.

We look forward to receiving feedback on these topics, and note for readers that responses to the RFI will not directly impact payment decisions. We also note our intention for an additional RFI or rulemaking on this topic in the future. We look forward to receiving feedback on these topics, and note for readers that responses to the RFI should focus on how they could be applied to the quality reporting program requirements. V. Advancing Health Information Exchange The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care and patient access to their health information.

To further interoperability in post-acute care settings, the Centers for Medicare &. Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) participate in the Post-Acute Care Interoperability Workgroup (PACIO) (https://pacioproject.org/​) to facilitate collaboration with industry stakeholders to develop Fast Healthcare Interoperability Resources (FHIR) Start Printed Page 19768standards. These standards could support the exchange and reuse of patient assessment data derived from the minimum data set (MDS), inpatient rehabilitation facility patient assessment instrument (IRF-PAI), long term care hospital continuity assessment record and evaluation (LCDS), outcome and assessment information set (OASIS), and other sources, including HOPE if implemented in HQRP through future rulemaking. The PACIO Project has focused on FHIR implementation guides for functional status, cognitive status and new use cases on advance directives and speech, and language pathology. We encourage PAC provider and health IT vendor participation as these efforts advance.

The CMS Data Element Library (DEL) continues to be updated and serves as the authoritative resource for PAC assessment data elements and their associated mappings to health IT standards such as Logical Observation Identifiers Names and Codes and Systematized Nomenclature of Medicine. The DEL furthers CMS' goal of data standardization and interoperability. These interoperable data elements can reduce provider burden by allowing the use and exchange of healthcare data. Supporting provider exchange of electronic health information for care coordination, person-centered care. And supporting real-time, data driven, clinical decision making.

Standards in the Data Element Library (https://del.cms.gov/​DELWeb/​pubHome) can be referenced on the CMS website and in the ONC Interoperability Standards Advisory (ISA). The 2021 ISA is available at https://www.healthit.gov/​isa. The 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted December 13, 2016) requires HHS to take new steps to enable the electronic sharing of health information ensuring interoperability for providers and settings across the care continuum.

The Cures Act includes a trusted exchange framework and common agreement (TEFCA) provision [] that will enable the nationwide exchange of electronic health information across health information networks and provide an important way to enable bi-directional health information exchange in the future. For more information on current developments related to TEFCA, we refer readers to https://www.healthit.gov/​topic/​interoperability/​trusted-exchange-framework-and-common-agreement and https://rce.sequoiaproject.org/​. On May 1, 2020, ONC published a final rule in the Federal Register entitled “21st Century Cures Act. Interoperability, Information Blocking, and the ONC Health IT Certification Program” (85 FR 25642) that established policies related to information blocking as authorized under section 4004 of the 21st Century Cures Act. Information blocking is generally defined as a practice by a health IT developer of certified health IT, health information network, health information exchange, or health care provider that, except as required by law or specified by the Secretary of HHS as a reasonable and necessary activity, is likely to interfere with access, exchange, or use of electronic health information.

The definition of information blocking includes a knowledge standard, which is different for health care providers than for health IT developers of certified health IT and health information networks or health information exchanges. A healthcare provider must know that the practice is unreasonable as well as likely to interfere with access, exchange, or use of electronic health information. To deter information blocking, health IT developers of certified health IT, health information networks and health information exchanges whom the HHS Inspector General determines, following an investigation, have committed information blocking, are subject to civil monetary penalties of up to $1 million per violation. Appropriate disincentives for health care providers are expected to be established by the Secretary through future rulemaking. Stakeholders can learn more about information blocking at https://www.healthit.gov/​curesrule/​final-rule-policy/​information-blocking.

ONC has posted information resources including fact sheets (https://www.healthit.gov/​curesrule/​resources/​fact-sheets), frequently asked questions (https://www.healthit.gov/​curesrule/​resources/​information-blocking-faqs), and recorded webinars (https://www.healthit.gov/​curesrule/​resources/​webinars). We invite providers to learn more about these important developments and how they could affect hospices. VI. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues.

The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of these issues for the following sections of this rule that contain information collection requirements.

A. ICRs Regarding Hospice QRP The HQRP proposals would not change provider burden or costs. For the proposal to remove the 7 HIS measures from the HQRP, we do not propose any changes to the requirement to submit the HIS admission assessment since we continue to collect the data for these 7 HIS measures in order to calculate the more broadly applicable NQF # 3235, the Hospice and Palliative Care Composite Process Measure—HIS-Comprehensive Assessment Measure at Admission. The proposal to add the HCI also would not change provider burden or costs since it is a claims-based measure that CMS calculates from the Medicare claims data. Likewise, the proposal to publicly report the claims-based HVLDL quality measure would not result in reduced provider burden and related costs.

The reduction in provider burden and costs occurred when we replaced the HIS-based HVWDII quality measure via the HIS-PRA package that OMB approved on February 16, 2021 (OMB Control Number. 0938-1153, CMS-10390). Finally, the Home Health Rider proposal would not change provider burden or costs since it only affects the number of quarters used in the calculation of certain claims-based measures for the public display for certain refresh cycles. B. ICRs Regarding Hospice CoPs We are proposing to revise the provisions at § 418.76(c)(1) that requires the hospice aide to be evaluated by observing an aide's performance of the task with a patient.

This proposed revision is subject to the PRA. However, the information collection burden associated with the existing requirements at § 418.76(c)(1) are Start Printed Page 19769accounted for under the information collection request currently approved OMB control number 0938-1067. The proposed revision's addition of the use of a “pseudo patient” allow for greater flexibility and may minimally reduce burden on the hospice. We request public comment on our determination that the time and effort necessary to comply with implementing the use of the pseudo-patient for hospice aide training at § 418.76(c)(1), may reduce burden on the provider. We are also proposing to revise the provisions at § 418.76(h)(1)(iii) to state that if an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation related to the deficient and related skill(s) in accordance with § 418.76(c).

We believe this could increase the speed with which hospices perform competency testing and could allow new aides to begin serving patients more quickly as these proposed changes will allow the hospice to focus on specific aide skills when a skill deficiency is assessed. In accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2), we believe that both the existing requirements and the proposed revisions to the requirements at § 418.76(h) are exempt from the PRA. We believe competency evaluations are a usual and customary business practice and we state as such in the information collection request associated with the Hospice Conditions of Participation (0938-1067). Therefore, we are not proposing to seek PRA approval for any information collection or recordkeeping activities that may be conducted in connection with the proposed revisions to § 418.76(h), but we request public comment on our determination that the time and effort necessary to comply with these evaluation requirements is usual and customary, and would be incurred by hospice staff even absent this regulatory requirement. C.

Submission of PRA-Related Comments We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection and recordkeeping requirements. The requirements are not effective until they have been approved by OMB. We invite public comments on these information collection requirements. If you wish to comment, please identify the rule (CMS-1754-P) and, where applicable, the preamble section, and the ICR section. See this rule's DATES and ADDRESSES sections for the comment due date and for additional instructions and OMB control number 0938-1153 (CMS-10390) or OMB control number 0938-1067 (CMS-10277).

VII. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. VIII. Regulatory Impact Analysis A.

Statement of Need This proposed rule meets the requirements of our regulations at § 418.306(c) and (d), which require annual issuance, in the Federal Register, of the hospice wage index based on the most current available CMS hospital wage data, including any changes to the definitions of CBSAs or previously used MSAs, as well as any changes to the methodology for determining the per diem payment rates. This proposed rule would also update payment rates for each of the categories of hospice care, described in § 418.302(b), for FY 2022 as required under section 1814(i)(1)(C)(ii)(VII) of the Act. The payment rate updates are subject to changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. B. Overall Impacts We estimate that the aggregate impact of the payment provisions in this proposed rule would result in an estimated increase of $530 million in payments to hospices, resulting from the hospice payment update percentage of 2.3 percent for FY 2022.

The impact analysis of this proposed rule represents the projected effects of the changes in hospice payments from FY 2021 to FY 2022. Using the most recent complete data available at the time of rulemaking, in this case FY 2020 hospice claims data as of January 15, 2021, we apply the current FY 2021 wage index with the current labor shares. Using the same FY 2020 data, we apply the FY 2022 wage index and the current labor share values to simulate FY 2022 payments. We then apply a budget neutrality adjustment so that the aggregate simulated payments do not increase or decrease due to changes in the wage index. Then, using the same FY 2020 data, we apply the FY 2022 wage index and the current labor share values to simulate FY 2022 payments and compare simulated payments using the FY 2022 wage index and the proposed revised labor shares.

We then apply a budget neutrality adjustment so that the aggregate simulated payments do not increase or decrease due to changes in the labor share values. Certain events may limit the scope or accuracy of our impact analysis, because such an analysis is susceptible to forecasting errors due to other changes in the forecasted impact time period. The nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to predict accurately the full scope of the impact upon hospices. We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L.

96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule. (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”). (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency. (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof.

Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with Start Printed Page 19770economically significant effects ($100 million or more in any 1 year). We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability presents the costs and benefits of the rulemaking. C.

Anticipated Effects The RFA requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The great majority of hospitals and most other health care providers and suppliers are small entities by meeting the Small Business Administration (SBA) definition of a small business (in the service sector, having revenues of less than $8.0 million to $41.5 million in any 1 year), or being nonprofit organizations. For purposes of the RFA, we consider all hospices as small entities as that term is used in the RFA. The Department of Health and Human Services practice in interpreting the RFA is to consider effects economically “significant” only if greater than 5 percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs. The effect of the FY 2022 hospice payment update percentage results in an overall increase in estimated hospice payments of 2.3 percent, or $530 million.

The distributional effects of the proposed FY 2022 hospice wage index do not result in a greater than 5 percent of hospices experiencing decreases in payments of 3 percent or more of total revenue. Therefore, the Secretary has determined that this rule will not create a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a MSA and has fewer than 100 beds.

This rule will only affect hospices. Therefore, the Secretary has determined that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals (see table 34). Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. The 2021 UMRA threshold is $158 million. This rule is not anticipated to have an effect on state, local, or tribal governments, in the aggregate, or on the private sector of $158 million or more.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. We have reviewed this rule under these criteria of Executive Order 13132, and have determined that it will not impose substantial direct costs on state or local governments. If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's proposed rule will be the number of reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this proposed rule.

It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this proposed rule. Using the wage information from the Bureau of Labor Statistics (BLS) for medical and health service managers (Code 11-9111). We estimate that the cost of reviewing this rule is $114.24 per hour, including overhead and fringe benefits (https://www.bls.gov/​oes/​current/​oes_​nat.htm). This proposed rule consists of approximately 55,000 words.

Assuming an average reading speed of 250 words per minute, it would take approximately 1.83 hours for the staff to review half of it. For each hospice that reviews the rule, the estimated cost is $209.06 (1.83 hour × $114.24). Therefore, we estimate that the total cost of reviewing this regulation is $11,080.18 ($209.06 × 53 reviewers). D. Detailed Economic Analysis 1.

Proposed Hospice Payment Update for FY 2022 The FY 2022 hospice payment impacts appear in Table 34. We tabulate the resulting payments according to the classifications (for example, provider type, geographic region, facility size), and compare the difference between current and future payments to determine the overall impact. The first column shows the breakdown of all hospices by provider type and control (non-profit, for-profit, government, other), facility location, facility size. The second column shows the number of hospices in each of the categories in the first column. The third column shows the effect of using the FY 2022 updated wage index data.

This represents the effect of moving from the FY 2021 hospice wage index to the FY 2022 hospice wage index. The fourth column shows the effect of the proposed rebased labor shares. The aggregate impact of the changes in column three and four is zero percent, due to the hospice wage index standardization factor and the labor share standardization factor. However, there are distributional effects of the FY 2022 hospice wage index. The fifth column shows the effect of the hospice payment update percentage as mandated by section 1814(i)(1)(C) of the Act, and is consistent for all providers.

The 2.3 hospice payment update percentage is based on the 2.5 percent inpatient hospital market basket update, reduced by a 0.2 percentage point productivity adjustment. The sixth column shows the effect of all the proposed changes on FY 2022 hospice payments. It is projected aggregate payments would increase by 2.3 percent. Assuming hospices do not change their billing practices. As illustrated in Table 35, the combined effects of all the proposals vary by specific types of providers and by location.

In addition, we are providing a provider-specific impact analysis file, which is available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Hospice-Regulations-and-Notices.html. We note that simulated payments are based on utilization in FY 2020 as seen on Medicare hospice claims (accessed from the CCW in January of 2021) and only include payments related to the level of care and do not include payments related to the service intensity add-on. As illustrated in Table 35, the combined effects of all the proposals vary by specific types of providers and by location. Start Printed Page 19771 Start Printed Page 19772 E. Alternatives Considered For the FY 2022 Hospice Wage Index and Rate Update proposed rule, we considered alternatives to the calculations of the wage index standardization factor and the labor share standardization factor.

Typically, the wage index standardization factor is calculated using the most recent, complete hospice claims data available at the time of rulemaking. However, due to the skin care products PHE, we looked at using FY 2019 claims data to determine if there were significant differences between utilizing FY 2019 and FY 2020 claims data for the calculation of the wage index and labor share standardization factors. The wage index standardization factors and labor share standardization factors for each level of care calculated using the FY 2020 claims data that was available at the time of rulemaking did not show significant differences compared to those calculated using FY 2019 claims data. As such, the differences between using FY 2019 and FY 2020 claims data for rate-setting were minimal. Therefore, we will continue our practice of using the most recent, complete hospice claims data to available at the time of rulemaking to set payment rates.

F. Accounting Statement As required by OMB Circular A-4 (available at https://www.whitehouse.gov/​sites/​whitehouse.gov/​files/​omb/​circulars/​A4/​a-4.pdf), in Table 36, we have prepared an accounting statement showing the classification of the expenditures associated with the provisions of this proposed rule. Table 36 provides our best estimate of the possible changes in Medicare payments under the hospice benefit as a result of the policies in this proposed rule. This estimate is based on the data for 4,957 hospices in our impact analysis file, which was constructed using FY 2020 claims available in January 2021. All Start Printed Page 19773expenditures are classified as transfers to hospices.

G. Conclusion We estimate that aggregate payments to hospices in FY 2022 will increase by $530 million as a result of the market basket update, compared to payments in FY 2021. We estimate that in FY 2022, hospices in urban areas will experience, on average, 2.2 percent increase in estimated payments compared to FY 2021. While hospices in rural areas will experience, on average, 2.6 percent increase in estimated payments compared to FY 2021. Hospices providing services in the Outlying and South Atlantic regions would experience the largest estimated increases in payments of 4.4 percent and 2.9 percent, respectively.

Hospices serving patients in areas in the New England and Middle Atlantic regions would experience, on average, the lowest estimated increase of 1.4 percent in FY 2022 payments. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. Start List of Subjects Health facilitiesHospice careMedicareReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services proposes to amend 42 CFR chapter IV as set forth below. Start Part End Part Start Amendment Part1.

The authority citation for part 418 continues to read as follows. End Amendment Part Start Authority 42 U.S.C. 1302 and 1395hh. End Authority Start Amendment Part2. Section 418.3 is amended by adding definitions for “Pseudo-patient” and “Simulation” in alphabetical order to read as follows.

End Amendment Part Definitions. * * * * * Pseudo-patient means a person trained to participate in a role-play situation, or a computer-based mannequin device. A pseudo-patient must be capable of responding to and interacting with the hospice aide trainee, and must demonstrate the general characteristics of the primary patient population served by the hospice in key areas such as age, frailty, functional status, cognitive status and care goals. * * * * * Simulation means a training and assessment technique that mimics the reality of the homecare environment, including environmental distractions and constraints that evoke or replicate substantial aspects of the real world in a fully interactive fashion, in order to teach and assess proficiency in performing skills, and to promote decision making and critical thinking. * * * * * Start Amendment Part3.

Section 418.24 is amended by. End Amendment Part Start Amendment Parta. Revising paragraphs (c) introductory text and (c)(9). End Amendment Part Start Amendment Partb. Adding paragraph (c)(10).

End Amendment Part Start Amendment Partc. Redesignating paragraphs (d) through (g) as paragraphs (e) through (h). And End Amendment Part Start Amendment Partd. Adding a new paragraph (d). End Amendment Part The revisions and additions read as follows.

Election of hospice care. * * * * * (c) Content of hospice election statement addendum. For hospice elections beginning on or after October 1, 2020, in the event that the hospice determines there are conditions, items, services, or drugs that are unrelated to the individual's terminal illness and related conditions, the individual (or representative), non-hospice providers furnishing such items, services, or drugs, or Medicare contractors may request a written list as an addendum to the election statement. The election statement addendum must include the following. * * * * * (9) Name and signature of the individual (or representative) and date signed, along with a statement that signing this addendum (or its updates) is only acknowledgement of receipt of the addendum (or its updates) and not the individual's (or representative's) agreement with the hospice's determinations.

If a non-hospice provider or Medicare contractor requests the addendum, the non-hospice provider or Medicare contractor are not required to sign the addendum. (10) Date the hospice furnished the addendum. (d) Timeframes for the hospice election statement addendum. (1) If the addendum is requested within the first 5 days of a hospice election (that is, in the first 5 days of the hospice election date), the hospice must provide this information, in writing, to the individual (or representative), non-hospice provider, or Medicare contractor within 5 days from the date of the request. (2) If the addendum is requested during the course of hospice care (that is, after the first 5 days of the hospice election date), the hospice must provide this information, in writing, within 3 days of the request to the requesting individual (or representative), non-hospice provider, or Medicare contractor.

(3) If there are any changes to the plan of care during the course of hospice care, the hospice must update the addendum and provide these updates, in writing, to the individual (or representative) in order to communicate these changes to the individual (or representative). (4) If the individual dies, revokes, or is discharged within the required timeframe for furnishing the addendum (as outlined in paragraphs (d)(1) and (2) Start Printed Page 19774of this section, and before the hospice has furnished the addendum, the addendum would not be required to be furnished to the individual (or representative). The hospice must note the reason the addendum was not furnished to the patient and the addendum would become part of the patient's medical record if the hospice has completed it at the time of discharge, revocation, or death. (5) If the beneficiary dies, revokes, or is discharged prior to signing the addendum (as outlined in paragraphs (d)(1) and (2) of this section), the addendum would not be required to be furnished to the individual (or representative). The hospice must note the reason the addendum was not signed and the addendum would become part of the patient's medical record.

* * * * * Start Amendment Part4. Section 418.76 is amended by revising paragraphs (c)(1) and (h)(1)(iii) to read as follows. End Amendment Part Condition of participation. Hospice aide and homemaker services. * * * * * (c) * * * (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section.

Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient. The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a hospice aide with a patient or a pseudo-patient during a simulation. * * * * * (h) * * * (1) * * * (iii) If an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation of the deficient skill and all related skill(s) in accordance with paragraph (c) of this section. * * * * * Start Amendment Part5. Section 418.309 is amended by revising paragraphs (a)(1) and (2) to read as follows.

End Amendment Part Hospice aggregate cap. * * * * * (a) * * * (1) For accounting years that end on or before September 30, 2016 and end on or after October 1, 2030, the cap amount is adjusted for inflation by using the percentage change in the medical care expenditure category of the Consumer Price Index (CPI) for urban consumers that is published by the Bureau of Labor Statistics. This adjustment is made using the change in the CPI from March 1984 to the fifth month of the cap year. (2) For accounting years that end after September 30, 2016, and before October 1, 2030, the cap amount is the cap amount for the preceding accounting year updated by the percentage update to payment rates for hospice care for services furnished during the fiscal year beginning on the October 1 preceding the beginning of the accounting year as determined pursuant to section 1814(i)(1)(C) of the Act (including the application of any productivity or other adjustments to the hospice percentage update). * * * * * Start Amendment Part6.

Section 418.312 is amended by revising paragraph (b) to read as follows. End Amendment Part Data submission requirements under the hospice quality reporting program. * * * * * (b) Submission of Hospice Quality Reporting Program data. (1) Standardized set of admission and discharge items Hospices are required to complete and submit an admission Hospice Item Set (HIS) and a discharge HIS for each patient to capture patient-level data, regardless of payer or patient age. The HIS is a standardized set of items intended to capture patient-level data.

(2) Administrative data, such as Medicare claims data, used for hospice quality measures to capture services throughout the hospice stay, are required and automatically meet the HQRP requirements for § 418.306(b)(2). (3) CMS may remove a quality measure from the Hospice QRP based on one or more of the following factors. (i) Measure performance among hospices is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. (ii) Performance or improvement on a measure does not result in better patient outcomes. (iii) A measure does not align with current clinical guidelines or practice.

(iv) The availability of a more broadly applicable (across settings, populations, or conditions) measure for the particular topic. (v) The availability of a measure that is more proximal in time to desired patient outcomes for the particular topic. (vi) The availability of a measure that is more strongly associated with desired patient outcomes for the particular topic. (vii) Collection or public reporting of a measure leads to negative unintended consequences other than patient harm. (viii) The costs associated with a measure outweigh the benefit of its continued use in the program.

* * * * * Start Signature Dated. March 29, 2021. Elizabeth Richter, Acting Administrator, Centers for Medicare &. Medicaid Services. Dated.

April 6, 2021. Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information BILLING CODE 4120-?. ?. -PBILLING CODE 4120-?.

?. -CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-C[FR Doc. 2021-07344 Filed 4-8-21. 4:15 pm]BILLING CODE 4120-01-P.

Start Preamble Start renova cost online Printed Page 19700 generic renova prices Centers for Medicare &. Medicaid Services (CMS), HHS. Proposed rule generic renova prices.

This rule proposes updates to the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022. This rule proposes changes to the labor shares of the hospice payment rates, proposes clarifying regulations text changes to the election statement addendum that was implemented on October 1, 2020, includes information on hospice utilization trends and solicits comments regarding hospice utilization and spending patterns. In addition, this rule proposes to make permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the skin care products public health emergency and updates the generic renova prices hospice conditions of participation.

The proposed rule would update the Hospice Quality Reporting Program. The proposed rule requests information on advancing to digital quality measurement, the use of Fast Healthcare Interoperability Resources, addresses the White House Executive Order related to health equity in the Hospice Quality Reporting Program and provides updates to advancing Health Information Exchange. Finally, this rule proposes changes beginning with the January 2022 public generic renova prices reporting for the Home Health Quality Reporting Program to address exceptions related to the skin care products public health emergency.

To be assured consideration, comments must be received at one of the addresses provided below by June 7, 2021. In commenting, refer to file code CMS-1754-P. Comments, including mass comment submissions, must be submitted in generic renova prices one of the following three ways (choose only one of the ways listed).

1. Electronically. You may submit electronic comments on generic renova prices this regulation to http://www.regulations.gov.

Follow the “Submit a comment” instructions. 2. By regular generic renova prices mail.

You may mail written comments to the following address ONLY. Centers for Medicare generic renova prices &. Medicaid Services, Department of Health and Human Services, Attention.

CMS-1754-P, P.O. Box 8010, generic renova prices Baltimore, MD 21244-1850. Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or generic renova prices overnight mail. You may send written comments to the following address ONLY.

Centers for Medicare &. Medicaid Services, generic renova prices Department of Health and Human Services, Attention. CMS-1754-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. Start Further Info   For general questions about hospice payment policy, send your inquiry generic renova prices via email to. Hospicepolicy@cms.hhs.gov.

For questions regarding the CAHPS® Hospice Survey, contact Debra Dean-Whittaker at (410) 786-0848. For questions regarding the hospice conditions of participation (CoPs), contact Mary Rossi-Coajou at (410)786-6051 generic renova prices. For questions regarding the home health public reporting, contact Charles Padgett (410) 786-2811.

For questions generic renova prices regarding the hospice quality reporting program, contact Cindy Massuda at (410) 786-0652. End Further Info End Preamble Start Supplemental Information Inspection of Public Comments. All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment.

We post all generic renova prices comments received before the close of the comment period on the following website as soon as possible after they have been received. Http://www.regulations.gov. Follow the search instructions on that website to view public comments.

Wage index addenda will be available only through the internet on our website at generic renova prices. (https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Hospice-Wage-Index.html.) I. Executive Summary A.

Purpose This rule proposes generic renova prices updates to the hospice wage index, payment rates, and cap amount for Fiscal Year (FY) 2022 as required under section 1814(i) of the Social Security Act (the Act). In addition, this rule proposes to rebase the labor shares of the hospice payment rates and proposes clarifying regulations text changes to the election statement addendum requirements finalized in the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484). This rule also includes information on hospice utilization trends and solicits comments regarding hospice utilization and spending patterns.

In addition, this rule proposes to make permanent selected regulatory blanket waivers for hospice agencies during the skin care products Public Health Emergency generic renova prices (PHE) and proposes revisions to the hospice conditions of participation (CoPs). This rule proposes changes to the Hospice Quality Reporting Program (HQRP), requests information on advancing to digital quality measurement and the use of Fast Healthcare Interoperability Resources (FHIR), addresses the White House Executive Order related to health equity in the HQRP and provides updates on advancing the Health Information Exchange. Finally, this rule proposes changes to the Home Health Quality Reporting Program (HH QRP) to address the January 2022 refresh in accordance with sections 1895(b)(3)(B)(v)(III) and 1899(B)(f) of the Act.

B. Summary of the Major Provisions Section III.A of this proposed rule includes data analysis on historical hospice utilization trends. The analysis includes data on the number of beneficiaries using the hospice benefit, live discharges, reported diagnoses on hospice claims, Medicare hospice spending, and Parts A, B and D non-hospice spending during a hospice election.

In this section, we also solicit comments from the public, including hospice providers as well as patients and advocates, regarding the presented analysis on hospice utilization and spending patterns. We also include questions related to non-hospice spending during a hospice election. Section III.B of this proposed rule proposes to rebase and revise the labor shares for continuous home care (CHC), routine home care (RHC), inpatient respite care (IRC), and general inpatient care (GIP) using 2018 Medicare cost report (MCR) data for freestanding hospice facilities.

Section III.C proposes updates to the hospice wage index and makes the application of the updated wage data budget neutral for all four levels of hospice care. In section III.C of this rule, we also discuss the proposed FY 2022 hospice payment update percentage of 2.3 percent, updates to the hospice payment rates, as well as the updates to Start Printed Page 19701the hospice cap amount for FY 2022 by the hospice payment update percentage of 2.3 percent. Section III.D proposes clarifying regulations text changes regarding the election statement addendum requirements that were finalized in the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38484).

Section III.E proposes to make permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the skin care products PHE. We are proposing to revise hospice aide requirements to allow the use of the pseudo-patient for conducting hospice aide competency evaluations. We are also proposing to revise the provisions at § 418.76(h)(1)(iii) to state that if a hospice verifies during an on-site visit the finding of a supervising nurse regarding an area of concern in the performance of a hospice aide, the hospice must conduct and the hospice aide must complete a competency evaluation related to the deficient and related skill(s), in accordance with § 418.76(c).

In section III.F of this rule, we discuss proposals to the HQRP including the addition of claims-based Hospice Care Index (HCI) measure, and Hospice Visits in the Last Days of Life (HVLDL) measure for public reporting. Removal of the seven Hospice Item Set (HIS) measures because a more broadly applicable measure, the NQF 3235 HIS Comprehensive Assessment Measure for the particular topic is available and already publicly reported. And further development of, Hospice Outcome and Patient Evaluation (HOPE) assessment instrument.

We also provide updates on the public reporting change for one refresh cycle to report less than the standard quarters of data due to the skin care products PHE exemptions and adding the Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospice Survey Star ratings. Additionally, there are requests for information (RFI) on advancing to digital quality measurement and the use of Fast Healthcare Interoperability Resources (FHIR) and on addressing the White House Executive Order related to health equity in the HQRP. In addition, this rule provides updates to advancing Health Information Exchange (HIE).

The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care and patient access to their health information. Finally, in section III.G of this rule, we are proposing changes to the HH QRP to establish that, beginning with the January 2022 through the July 2024 public reporting refresh cycle, we will report fewer quarters of data due to skin care products PHE exceptions granted on March 27, 2020. We include this Home Health proposal in this rule because we plan to resume public reporting for the HH QRP with the January 2022 refresh of Care Compare.

In order to accommodate the exception of 2020 Q1 and Q2 data, we are proposing to resume public reporting using 3 out of 4 quarters of data for the January 2022 refresh. In order to finalize this proposal in time to release the required preview report related to the refresh, which we release 3 months prior to any given refresh (October 2021), we need the rule containing this proposal to finalize by October 2021. C.

Summary of Impacts The overall economic impact of this proposed rule is estimated to be $530 million in increased payments to hospices for FY 2022. II. Background A.

Hospice Care Hospice care is a comprehensive, holistic approach to treatment that recognizes the impending death of a terminally ill individual and warrants a change in the focus from curative care to palliative care for relief of pain and for symptom management. Medicare regulations define “palliative care” as patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice (42 CFR 418.3).

Palliative care is at the core of hospice philosophy and care practices, and is a critical component of the Medicare hospice benefit. The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, nursing, social, psychological, emotional, and spiritual services through a collaboration of professionals and other caregivers, with the goal of making the beneficiary as physically and emotionally comfortable as possible.

Hospice is compassionate beneficiary and family/caregiver-centered care for those who are terminally ill. As referenced in our regulations at § 418.22(b)(1), to be eligible for Medicare hospice services, the patient's attending physician (if any) and the hospice medical director must certify that the individual is “terminally ill,” as defined in section 1861(dd)(3)(A) of the Act and our regulations at § 418.3. That is, the individual has a medical prognosis that his or her life expectancy is 6 months or less if the illness runs its normal course.

The regulations at § 418.22(b)(2) require that clinical information and other documentation that support the medical prognosis accompany the certification and be filed in the medical record with it and those at § 418.22(b)(3) require that the certification and recertification forms include a brief narrative explanation of the clinical findings that support a life expectancy of 6 months or less. Under the Medicare hospice benefit, the election of hospice care is a patient choice and once a terminally ill patient elects to receive hospice care, a hospice interdisciplinary group is essential in the seamless provision of primarily home-based services. The hospice interdisciplinary group works with the beneficiary, family, and caregivers to develop a coordinated, comprehensive care plan.

Reduce unnecessary diagnostics or ineffective therapies. And maintain ongoing communication with individuals and their families about changes in their condition. The beneficiary's care plan will shift over time to meet the changing needs of the individual, family, and caregiver(s) as the individual approaches the end of life.

If, in the judgment of the hospice interdisciplinary team, which includes the hospice physician, the patient's symptoms cannot be effectively managed at home, then the patient is eligible for general inpatient care (GIP), a more medically intense level of care. GIP must be provided in a Medicare-certified hospice freestanding facility, skilled nursing facility, or hospital. GIP is provided to ensure that any new or worsening symptoms are intensively addressed so that the beneficiary can return to his or her home and continue to receive routine home care.

Limited, short-term, intermittent, inpatient respite care (IRC) is also available because of the absence or need for relief of the family or other caregivers. Additionally, an individual can receive continuous home care (CHC) during a period of crisis in which an individual requires continuous care to achieve palliation or management of acute medical symptoms so that the Start Printed Page 19702individual can remain at home. Continuous home care may be covered for as much as 24 hours a day, and these periods must be predominantly nursing care, in accordance with the regulations at § 418.204.

A minimum of 8 hours of nursing care, or nursing and aide care, must be furnished on a particular day to qualify for the continuous home care rate (§ 418.302(e)(4)). Hospices must comply with applicable civil rights laws,[] including section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act, under which covered entities must take appropriate steps to ensure effective communication with patients and patient care representatives with disabilities, including the provisions of auxiliary aids and services. Additionally, they must take reasonable steps to ensure meaningful access for individuals with limited English proficiency, consistent with Title VI of the Civil Rights Act of 1964.

Further information about these requirements may be found at. Http://www.hhs.gov/​ocr/​civilrights. B.

Services Covered by the Medicare Hospice Benefit Coverage under the Medicare hospice benefit requires that hospice services must be reasonable and necessary for the palliation and management of the terminal illness and related conditions. Section 1861(dd)(1) of the Act establishes the services that are to be rendered by a Medicare-certified hospice program. These covered services include.

Nursing care. Physical therapy. Occupational therapy.

Speech-language pathology therapy. Medical social services. Home health aide services (called hospice aide services).

Physician services. Homemaker services. Medical supplies (including drugs and biologicals).

Medical appliances. Counseling services (including dietary counseling). Short-term inpatient care in a hospital, nursing facility, or hospice inpatient facility (including both respite care and procedures necessary for pain control and acute or chronic symptom management).

Continuous home care during periods of crisis, and only as necessary to maintain the terminally ill individual at home. And any other item or service which is specified in the plan of care and for which payment may otherwise be made under Medicare, in accordance with Title XVIII of the Act. Section 1814(a)(7)(B) of the Act requires that a written plan for providing hospice care to a beneficiary who is a hospice patient be established before care is provided by, or under arrangements made by, the hospice program.

And that the written plan be periodically reviewed by the beneficiary's attending physician (if any), the hospice medical director, and an interdisciplinary group (section 1861(dd)(2)(B) of the Act). The services offered under the Medicare hospice benefit must be available to beneficiaries as needed, 24 hours a day, 7 days a week (section 1861(dd)(2)(A)(i) of the Act). Upon the implementation of the hospice benefit, the Congress also expected hospices to continue to use volunteer services, though Medicare does not pay for these volunteer services (section 1861(dd)(2)(E) of the Act).

As stated in the FY 1983 Hospice Wage Index and Rate Update proposed rule (48 FR 38149), the hospice must have an interdisciplinary group composed of paid hospice employees as well as hospice volunteers, and that “the hospice benefit and the resulting Medicare reimbursement is not intended to diminish the voluntary spirit of hospices.” This expectation supports the hospice philosophy of community based, holistic, comprehensive, and compassionate end of life care. C. Medicare Payment for Hospice Care Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of the Act, and the regulations in 42 CFR part 418, establish eligibility requirements, payment standards and procedures.

Define covered services. And delineate the conditions a hospice must meet to be approved for participation in the Medicare program. Part 418, subpart G, provides for a per diem payment based on one of four prospectively-determined rate categories of hospice care (RHC, CHC, IRC, and GIP), based on each day a qualified Medicare beneficiary is under hospice care (once the individual has elected).

This per diem payment is meant to cover all of the hospice services and items needed to manage the beneficiary's care, as required by section 1861(dd)(1) of the Act. While payments made to hospices is to cover all items, services, and drugs for the palliation and management of the terminal illness and related conditions, Federal funds cannot be used for the prohibited activities, even in the context of a per diem payment. While recent news reports [] have brought to light the potential role hospices could play in medical aid in dying (MAID) where such practices have been legalized in certain states, we wish to remind hospices that The Assisted Suicide Funding Restriction Act of 1997 (Pub.

L. 105-12) prohibits the use of Federal funds to provide or pay for any health care item or service or health benefit coverage for the purpose of causing, or assisting to cause, the death of any individual including mercy killing, euthanasia, or assisted suicide. However, the prohibition does not pertain to the provision of an item or service for the purpose of alleviating pain or discomfort, even if such use may increase the risk of death, so long as the item or service is not furnished for the specific purpose of causing or accelerating death.

1. Omnibus Budget Reconciliation Act of 1989 Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L.

101-239) amended section 1814(i)(1)(C) of the Act and provided changes in the methodology concerning updating the daily payment rates based on the hospital market basket percentage increase applied to the payment rates in effect during the previous Federal fiscal year. 2. Balanced Budget Act of 1997 Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub.

L. 105-33) established that updates to the hospice payment rates beginning FY 2002 and subsequent FYs be the hospital market basket percentage increase for the FY. Section 4442 of the BBA amended section 1814(i)(2) of the Act, effective for services furnished on or after October 1, 1997, to require that hospices submit claims for payment for hospice care furnished in an individual's home only on the basis of the geographic location at which the service is furnished.

Previously, local wage index values were applied based on the geographic location of the hospice provider, regardless of where the hospice care was furnished. Section 4443 of the BBA amended sections 1812(a)(4) and 1812(d)(1) of the Act to provide for hospice benefit periods of two 90-day periods, followed by an unlimited number of 60-day periods. 3.

FY 1998 Hospice Wage Index Final Rule The FY 1998 Hospice Wage Index final rule (62 FR 42860), implemented a new methodology for calculating the Start Printed Page 19703hospice wage index and instituted an annual Budget Neutrality Adjustment Factor (BNAF) so aggregate Medicare payments to hospices would remain budget neutral to payments calculated using the 1983 wage index. 4. FY 2010 Hospice Wage Index Final Rule The FY 2010 Hospice Wage Index and Rate Update final rule (74 FR 39384) instituted an incremental 7-year phase-out of the BNAF beginning in FY 2010 through FY 2016.

The BNAF phase-out reduced the amount of the BNAF increase applied to the hospice wage index value, but was not a reduction in the hospice wage index value itself or in the hospice payment rates. 5. The Affordable Care Act Starting with FY 2013 (and in subsequent FYs), the market basket percentage update under the hospice payment system referenced in sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act are subject to annual reductions related to changes in economy-wide productivity, as specified in section 1814(i)(1)(C)(iv) of the Act.

In addition, sections 1814(i)(5)(A) through (C) of the Act, as added by section 3132(a) of the Patient Protection and Affordable Care Act (PPACA) (Pub. L. 111-148), required hospices to begin submitting quality data, based on measures specified by the Secretary of the Department of Health and Human Services (the Secretary), for FY 2014 and subsequent FYs.

Since FY 2014, hospices that fail to report quality data have their market basket percentage increase reduced by 2 percentage points. Note that with the passage of the Consolidated Appropriations Act, 2021 (hereafter referred to as CAA 2021) (Pub. L.

116-260), the reduction changes to 4 percentage points beginning in FY 2024. Section 1814(a)(7)(D)(i) of the Act, as added by section 3132(b)(2) of the PPACA, required, effective January 1, 2011, that a hospice physician or nurse practitioner have a face-to-face encounter with the beneficiary to determine continued eligibility of the beneficiary's hospice care prior to the 180th day recertification and each subsequent recertification, and to attest that such visit took place. When implementing this provision, the Centers for Medicare &.

Medicaid Services (CMS) finalized in the FY 2011 Hospice Wage Index final rule (75 FR 70435) that the 180th day recertification and subsequent recertifications would correspond to the beneficiary's third or subsequent benefit periods. Further, section 1814(i)(6) of the Act, as added by section 3132(a)(1)(B) of the PPACA, authorized the Secretary to collect additional data and information determined appropriate to revise payments for hospice care and other purposes. The types of data and information suggested in the PPACA could capture accurate resource utilization, which could be collected on claims, cost reports, and possibly other mechanisms, as the Secretary determined to be appropriate.

The data collected could be used to revise the methodology for determining the payment rates for RHC and other services included in hospice care, no earlier than October 1, 2013, as described in section 1814(i)(6)(D) of the Act. In addition, CMS was required to consult with hospice programs and the Medicare Payment Advisory Commission (MedPAC) regarding additional data collection and payment revision options. 6.

FY 2012 Hospice Wage Index Final Rule In the FY 2012 Hospice Wage Index final rule (76 FR 47308 through 47314) it was announced that beginning in 2012, the hospice aggregate cap would be calculated using the patient-by-patient proportional methodology, within certain limits. Existing hospices had the option of having their cap calculated through the original streamlined methodology, also within certain limits. As of FY 2012, new hospices have their cap determinations calculated using the patient-by-patient proportional methodology.

If a hospice's total Medicare payments for the cap year exceed the hospice aggregate cap, then the hospice must repay the excess back to Medicare. 7. IMPACT Act of 2014 The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub.

L. 113-185) became law on October 6, 2014. Section 3(a) of the IMPACT Act mandated that all Medicare certified hospices be surveyed every 3 years beginning April 6, 2015 and ending September 30, 2025.

In addition, section 3(c) of the IMPACT Act requires medical review of hospice cases involving beneficiaries receiving more than 180 days of care in select hospices that show a preponderance of such patients. Section 3(d) of the IMPACT Act contains a new provision mandating that the cap amount for accounting years that end after September 30, 2016, and before October 1, 2025 be updated by the hospice payment percentage update rather than using the consumer price index for urban consumers (CPI-U) for medical care expenditures. 8.

FY 2015 Hospice Wage Index and Payment Rate Update Final Rule The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50452) finalized a requirement that the Notice of Election (NOE) be filed within 5 calendar days after the effective date of hospice election. If the NOE is filed beyond this 5-day period, hospice providers are liable for the services furnished during the days from the effective date of hospice election to the date of NOE filing (79 FR 50474). As with the NOE, the claims processing system must be notified of a beneficiary's discharge from hospice or hospice benefit revocation within 5 calendar days after the effective date of the discharge/revocation (unless the hospice has already filed a final claim) through the submission of a final claim or a Notice of Termination or Revocation (NOTR).

The FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50479) also finalized a requirement that the election form include the beneficiary's choice of attending physician and that the beneficiary provide the hospice with a signed document when he or she chooses to change attending physicians. In addition, the FY 2015 Hospice Wage Index and Rate Update final rule (79 FR 50496) provided background, described eligibility criteria, identified survey respondents, and otherwise implemented the Hospice Experience of Care Survey for informal caregivers. Hospice providers were required to begin using this survey for hospice patients as of 2015.

Finally, the FY 2015 Hospice Wage Index and Rate Update final rule required providers to complete their aggregate cap determination not sooner than 3 months after the end of the cap year, and not later than 5 months after, and remit any overpayments. Those hospices that fail to submit their aggregate cap determinations on a timely basis will have their payments suspended until the determination is completed and received by the Medicare contractor (79 FR 50503). 9.

FY 2016 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47142), CMS finalized two different payment rates for RHC. A higher per diem base payment rate for the first 60 days of hospice care and a reduced per diem base payment rate for subsequent days of hospice care. CMS also finalized a service intensity add-on (SIA) Start Printed Page 19704payment payable for certain services during the last 7 days of the beneficiary's life.

A service intensity add-on payment will be made for the social worker visits and nursing visits provided by a registered nurse (RN), when provided during routine home care in the last 7 days of life. The SIA payment is in addition to the routine home care rate. The SIA payment is provided for visits of a minimum of 15 minutes and a maximum of 4 hours per day (80 FR 47172).

In addition to the hospice payment reform changes discussed, the FY 2016 Hospice Wage Index and Rate Update final rule implemented changes mandated by the IMPACT Act, in which the cap amount for accounting years that end after September 30, 2016 and before October 1, 2025 would be updated by the hospice payment update percentage rather than using the CPI-U (80 FR 47186). In addition, we finalized a provision to align the cap accounting year for both the inpatient cap and the hospice aggregate cap with the FY for FY 2017 and thereafter. Finally, the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47144) clarified that hospices would have to report all diagnoses on the hospice claim as a part of the ongoing data collection efforts for possible future hospice payment refinements.

10. FY 2017 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52160), CMS finalized several new policies and requirements related to the HQRP. First, CMS codified the policy that if the National Quality Forum (NQF) made non-substantive changes to specifications for HQRP measures as part of the NQF's re-endorsement process, CMS would continue to utilize the measure in its new endorsed status, without going through new notice-and-comment rulemaking.

CMS would continue to use rulemaking to adopt substantive updates made by the NQF to the endorsed measures adopted for the HQRP. Determinations about what constitutes a substantive versus non-substantive change would be made on a measure-by-measure basis. Second, we finalized two new quality measures for the HQRP for the FY 2019 payment determination and subsequent years.

Hospice Visits when Death is Imminent Measure Pair and Hospice and Palliative Care Composite Process Measure-Comprehensive Assessment at Admission (81 FR 52173). The data collection mechanism for both of these measures is the Hospice Item Set (HIS), and the measures were effective April 1, 2017. Regarding the CAHPS® Hospice Survey, CMS finalized a policy that hospices that receive their CMS Certification Number (CCN) after January 1, 2017 for the FY 2019 Annual Payment Update (APU) and January 1, 2018 for the FY 2020 APU will be exempted from the Hospice CAHPS® requirements due to newness (81 FR 52182).

The exemption is determined by CMS and is for 1 year only. 11. FY 2020 Hospice Wage Index and Payment Rate Update Final Rule In the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38484), we finalized rebased payment rates for CHC and GIP and set those rates equal to their average estimated FY 2019 costs per day.

We also rebased IRC per diem rates equal to the estimated FY 2019 average costs per day, with a reduction of 5 percent to the FY 2019 average cost per day to account for coinsurance. We finalized the FY 2020 proposal to reduce the RHC payment rates by 2.72 percent to offset the increases to CHC, IRC, and GIP payment rates to implement this policy in a budget-neutral manner in accordance with section 1814(i)(6) of the Act (84 FR 38496). In addition, we finalized a policy to use the current year's pre-floor, pre-reclassified hospital inpatient wage index as the wage adjustment to the labor portion of the hospice rates.

Finally, in the FY 2020 Hospice Wage Index and Rate Update final rule (84 FR 38505), we finalized modifications to the hospice election statement content requirements at § 418.24(b) by requiring hospices, upon request, to furnish an election statement addendum effective beginning in FY 2021. The addendum must list those items, services, and drugs the hospice has determined to be unrelated to the terminal illness and related conditions, increasing coverage transparency for beneficiaries under a hospice election. 12.

Consolidated Appropriations Act, 2021 Division CC, section 404 of the CAA 2021 amended section 1814(i)(2)(B) of the Act and extended the provision that currently mandates the hospice cap be updated by the hospice payment update percentage (hospital market basket update reduced by the multifactor productivity adjustment) rather than the CPI-U for accounting years that end after September 30, 2016 and before October 1, 2030. Prior to enactment of this provision, the hospice cap update was set to revert to the original methodology of updating the annual cap amount by the CPI-U beginning on October 1, 2025. Division CC, section 407 of CAA 2021 revises section 1814(i)(5)(A)(i) to increase the payment reduction for hospices who fail to meet hospice quality measure reporting requirements from two percent to four percent beginning with FY 2024.

III. Provisions of the Proposed Rule A. Hospice Utilization and Spending Patterns CMS provides analysis as it relates to hospice utilization such as Medicare spending, utilization by level of care, lengths of stay, live discharge rates, and skilled visits during the last days of life using the most recent, complete claims data.

Stakeholders report that such data can be used to educate hospices on Medicare policies to help ensure compliance. Moreover, in response to the Office of Inspector General (OIG) reports highlighting vulnerabilities in the Medicare hospice benefit including hospices engaging in inappropriate billing, not providing needed services and crucial information to beneficiaries in order for them to make informed decisions about their care, [] we continue to monitor both hospice and non-hospice spending during a hospice election. We are still analyzing the effects of the skin care products PHE as it relates to the following routine monitoring analysis and whether those effects are likely to be temporary or permanent and if such effects vary significantly across hospice providers.

Therefore, for the purposes of providing routine analysis on utilization and spending, in this proposed rule, we used the most complete data we have from FY 2019. 1. General Hospice Utilization Trends Since the implementation of the hospice benefit in 1983, there has been substantial growth in hospice utilization.

The number of Medicare beneficiaries receiving hospice services has grown from 584,438 in FY 2001 to over 1.6 million in FY 2019. Medicare hospice expenditures have risen from $3.5 billion in FY 2001 to approximately $20 billion in FY 2019.[] CMS' Office of the Actuary (OACT) projects that aggregate hospice expenditures are expected to continue to increase, by approximately 7.6 percent annually. We note that the Start Printed Page 19705average spending per beneficiary has also increased between FY 2010 and FY 2019 from approximately $11,158 in FY 2010 to $12,687 in FY 2019.[] The percentage of Medicare decedents who died while receiving services under the Medicare hospice benefit has increased as shown in Table 1.

Similar to the increase in the number of beneficiaries using the benefit, the total number of organizations offering hospice services also continues to grow, with for-profit providers entering the market at higher rates than not-for-profit providers. In its March 2020 Report to the Congress, MedPAC stated that for more than a decade, the increasing number of hospice providers is due almost entirely to the entry of for-profit providers. MedPAC also stated that long stays in hospice have been very profitable and this has attracted new provider entrants with revenue-generating strategies specifically targeting those patients expected to have longer lengths of stay.[] Freestanding hospices continue to dominate the market as a whole.

In FY 2019, 68 percent (3,254 out of 4,811) of hospices were for-profit and 21 percent (987 out of 4,811) were non-profit, whereas in FY 2014, 61 percent (2,513 out of 4,108) were for-profit and 25 percent (1,029 out of 4,108) of hospices were non-profit. In FY 2019, for-profit hospices provided approximately 58 percent of all hospice days while non-profit hospices provided 31 percent of all hospice days.[] Hospices that listed their ownership status as “Other”, “Government” or had an unknown ownership status accounted for the remaining percentage of hospice days. There have been notable changes in the pattern of diagnoses among Medicare hospice enrollees since the implementation of the Medicare hospice benefit from primarily cancer diagnoses to neurological diagnoses, including Alzheimer's disease and other related dementias (80 FR 25839).

Our ongoing analysis of diagnosis reporting finds that neurological and organ-based failure conditions remain the top-reported principal diagnoses. Beneficiaries with these terminal conditions tend to have longer hospice stays, which have historically been more profitable than shorter stays.[] Table 2 shows the top 20 most frequently reported principal diagnoses on FY 2019 hospice claims. Start Printed Page 19706 Hospice Utilization by Level of Care Our analysis shows that there have only been slight changes over time in how hospices have been utilizing the different levels of care.

RHC consistently represents the highest percentage of total hospice days as well as the highest percentage of total hospice payments as shown in Tables 3 and 4). Start Printed Page 19707 In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38496), we rebased the payment rates for the CHC, IRC, and GIP levels of care to better align hospice payment with the costs of providing care. We will continue to monitor the effects of these rebased rates to determine if there are any notable shifts in the provision of care or any other perverse utilization patterns that would warrant any program integrity or survey actions.

2. Trends in Hospice Length of Stay, Live Discharges and Skilled Visits in the Last Days of Life Analysis Eligibility under the Medicare hospice benefit is predicated on the individual being certified as terminally ill. Medicare regulations at § 418.3 define “terminally ill” to mean that the individual has a medical prognosis that his or her life expectancy is 6 months or less if the illness runs its normal course.

However, we recognize that a beneficiary may be under a hospice election longer than 6 months, as long as there remains a reasonable expectation that the individuals have a life expectancy of 6 months or less. It has always been our expectation that the certifying physicians will use their best clinical judgment, in accordance with the regulations at §§ 418.22 and 418.25, to determine if the individual has a life expectancy of 6 months or less with each certification and recertification. Hospice Length of Stay We examined hospice length of stay in three ways.

(1) Average length of election, meaning the number of hospice days during a single hospice election at the time of live discharge or death. (2) the median lifetime length of stay, which represents the 50th percentile, and. (3) average lifetime length of stay, which includes the sum of all days of hospice care across all hospice elections.

Extremely long lengths of stay influence both the average length of election and average lifetime length of stay. Table 5 shows the average length of election, the median and average lifetime lengths of stay from FYs 2016 through 2019. Length of stay estimates vary based on the reported principal diagnosis Table 6 lists the top six clinical categories of principal diagnoses reported on hospice claims in FY 2019 along with the corresponding number of hospice discharges.

Patients with neurological and organ-based failure conditions (with the exception of kidney disease/kidney failure) tend to have much longer lengths of stay compared to patients with cancer diagnoses. Start Printed Page 19708 Hospice Live Discharges Federal regulations limit the circumstances in which a Medicare hospice provider may discharge a patient from its care. In accordance with § 418.26, discharge from hospice care is permissible when the patient moves out of the provider's service area, is determined to be no longer terminally ill, or for cause.

Hospices may not discharge the patient at their discretion, even if the care may be costly or inconvenient for the hospice. Additionally, an individual or representative may revoke the individual's election of hospice care at any time during an election period in accordance with the regulations at § 418.28. However, at any time thereafter, the beneficiary may re-elect hospice coverage at any other hospice election period that they are eligible to receive.

Immediately upon hospice revocation, Medicare coverage resumes for those Medicare benefits previously waived with the hospice election. Only the beneficiary (or representative) can revoke the hospice election. A revocation must be in writing and must specify the effective date of the revocation.

A hospice cannot revoke a beneficiary's hospice election, nor is it appropriate for hospices to encourage, request, or demand that the beneficiary or his or her representative revoke his or her hospice election. From FY 2014 through FY 2019, the average live discharge rate has been approximately 17 percent per year. Of the live discharges in FY 2019, 37.5 percent were because of revocations, 37.2 percent were because the beneficiary was determined to no longer be terminally ill, 10.7 percent were because beneficiaries moved out of the service area without transferring hospices, and 12.9 percent were because beneficiaries transferred to another hospice (see Figure 1).

The remaining 1.6 percent were discharged for cause.[] Figure 1 shows the average annual rates of live discharge rates from FYs 2010 through 2019. Start Printed Page 19709 Finally, we looked at the distribution of live discharges by length of stay intervals. Figure 2 shows the live discharge rates by length of stay intervals from FY 2016 through FY 2019.

We found that the majority of live discharges occur in the first 30 days of hospice care and after 180 days of hospice care. The proportion of live discharges occurring between the lengths of stay intervals was relatively constant from FY 2016 to FY 2019 where approximately 25 percent of live discharges occurred within 30 days of the start of hospice care, and approximately 32 percent occurred after a length of stay over 180 days of hospice care. Start Printed Page 19710 Service Intensity Add-On (SIA) Payment A hospice's costs typically follow a U-shaped curve, with higher costs at the beginning and end of a stay, and lower costs in the middle of the stay.

This cost curve reflects hospices' higher service intensity at the time of the patient's admission and the time surrounding the patient's death.[] In the period immediately preceding death, patient needs typically surge and more intensive services are typically warranted, and where the provision of care would proportionately escalate to meet the increased clinical, emotional, and other needs of the hospice beneficiary and his or her family and caregiver(s). In the FY 2016 Hospice Rate Update final rule (80 FR 47142), we established two different payment rates for RHC to reflect the cost of providing hospice care throughout the course of a hospice election. We finalized a higher base payment rate for the first 60 days of hospice care and a reduced base payment rate for days 61 and later.

(80 FR 47172). To reflect higher costs associated with the last 7 days of life, in FY 2016, we implemented the service intensity add-on payment (SIA) for RHC when direct patient care is provided by a RN or social worker during the last 7 of the beneficiary's life. The SIA payment is equal to the CHC hourly rate multiplied by the hours of nursing or social work provided on the day of service (up to 4 hours), if certain criteria are met (80 FR 47177).

This effort represented meaningful advances in encouraging visits to hospice beneficiaries during the time preceding death and where patient and family needs typically intensify. To examine the effects of the SIA payment, we analyzed claims since the implementation of the SIA payment to determine if there was an increase in RN and social worker visits in the last seven days of life. In CY 2015 (the year preceding the SIA payment), the percentage of beneficiaries who did not receive a skilled nursing or social worker visit on the last day of life (when the last day of life was RHC) was nearly 23 percent.

Our analysis shows a slight decline in the number of beneficiaries who did not receive an RN or social worker visit on the last day of life (when the last day of life was RHC) where the percentage trended downward to just over 19 percent in CYs 2017 to 2019. This trend is similar for the 4 days leading up to the end of life (when the last 4 days of life were RHC), meaning beneficiaries are receiving more skilled nursing and social worker visits during the last days of life since implementation of the SIA payment. Table 7 shows the percentage of decedents not receiving skilled visits at the end of life for CY 2015 through CY 2019.

Start Printed Page 19711 SIA payments have increased from FY 2016 through FY 2019 from $88 million to $150 million respectively as shown in Figure 3. Start Printed Page 19712 To further evaluate the impact of the SIA, we examined the total amount of minutes provided by skilled nurses and social workers in the last 7 days of life and overall there were only modest changes from CY 2015 to CY 2019, as shown in Table 8.[] MedPAC had examined skilled nurse and social worker minutes in the last 7 days of life from CY 2015 through 2018 in their March 2020 Report to Congress and similarly found little change overall.[] Start Printed Page 19713 3. Non-Hospice Spending During a Hospice Election The Medicare hospice per diem payment amounts were developed to cover all services needed for the palliation and management of the terminal illness and related conditions, as described in section 1861(dd)(1) of the Act.

Hospice services provided under a written plan of care (POC) should reflect patient and family goals and interventions based on the problems identified in the initial, comprehensive, and updated comprehensive assessments. As referenced in our regulations at § 418.64 and section II.B of this rule, a hospice must routinely provide all core services directly by hospice employees and they must be provided in a manner consistent with acceptable standards of practice. Under the current payment system, hospices are paid for each day that a beneficiary is enrolled in hospice care, regardless of whether services are rendered on any given day.

Additionally, when a beneficiary elects the Medicare hospice benefit, he or she waives the right to Medicare payment for services related to the treatment of the terminal illness and related conditions, except for services provided by the designated hospice and the attending physician. The comprehensive nature of the services covered under the Medicare hospice benefit is structured such that hospice beneficiaries should not have to routinely seek items, services, and/or medications beyond those provided by hospice. We believe that it would be unusual and exceptional to see services provided outside of hospice for those individuals who are approaching the end of life and we have reiterated since 1983 that “virtually all” care needed by the terminally ill individual would be provided by the hospice.

In examining overall non-hospice spending during a hospice election, Medicare paid over $1 billion in non-hospice spending during a hospice election in FY 2019 for items and services under Parts A, B, and D. Medicare payments for non-hospice Part A and Part B items and services received by hospice beneficiaries during a hospice election increased from $583 million in FY 2016 to $692 million in FY 2019 (see Figure 4). This represents an increase in non-hospice Medicare spending for Parts A and B of 18.7 percent.

Whereas there is minimal beneficiary cost sharing under the Medicare hospice benefit,[] non-hospice services received outside of the Medicare hospice benefit are subject to beneficiary cost sharing. In FY 2019, the total beneficiary cost sharing amount was $170 million for Parts A and B.[] Start Printed Page 19714 We also examined non-hospice spending during a hospice election by claim type for Parts A and B, as shown in Table 9. Start Printed Page 19715 Hospices are responsible for covering drugs and biologicals related to the palliation and management of the terminal illness and related conditions while the patient is under hospice care.

For a prescription drug to be covered under Part D for an individual enrolled in hospice, the drug must be for treatment completely unrelated to the terminal illness or related conditions. After a hospice election, many maintenance drugs or drugs used to treat or cure a condition are typically discontinued as the focus of care shifts to palliation and comfort measures. However, those same drugs may be appropriate to continue as they may offer symptom relief for the palliation and management of the terminal prognosis.[] Similar to the increase in non-hospice spending during a hospice election for Medicare Parts A and B items and services, non-hospice spending for Part D drugs increased in from $353 million in FY 2016 to $499 million in FY 2019 (Figure 5).

Start Printed Page 19716 Analysis of Part D prescription drug events (PDEs) data suggests that the current use of prior authorization (PA) by Part D sponsors has reduced Part D program payments for drugs in four targeted categories (analgesics, anti-nauseants, anti-anxiety, and laxatives), which are typically used to treat common symptoms experienced during the end of life. However, under Medicare Part D there has been an increase in hospice beneficiaries filling prescriptions for a separate category of drugs we refer to as maintenance drugs (https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Downloads/​2016-11-15-Part-D-Hospice-Guidance.pdf). Under CMS's current policy, Part D sponsors are not expected to place hospice PA requirements on categories of drugs (other than the four targeted categories listed above) or take special measures beyond their normal compliance and utilization review activities.

Under this policy, sponsors are not expected to place PA requirements on maintenance drugs, for beneficiaries under a hospice election, though these drugs may still be subject to standard Part D formulary management practices. This policy was put in place in recognition of the operational challenges associated with requiring PA on all drugs for beneficiaries who have elected hospice and because of the potential barriers to access that could be created by requiring PA on all drugs.[] Examples of maintenance drugs are those used to treat high blood pressure, heart disease, asthma and diabetes. These categories include beta blockers, calcium channel blockers, corticosteroids, and insulin.

Table 10 details the various components of Part D spending for patients receiving hospice care for FY 2019. The portion of the FY 2019 Part D spending that was paid by Medicare is the sum of the Low Income Cost-Sharing Subsidy and the Covered Drug Plan Paid Amount, approximately $499 million. The beneficiary cost sharing amount was approximately $59 million.[] Start Printed Page 19717 Comment Solicitation on Analysis of Hospice Utilization and Spending Patterns We are soliciting comments on all aspects of the analysis presented in this proposed rule regarding hospice utilization and spending patterns.

Our ongoing monitoring and analysis have shown that the hospice benefit has evolved. Originally providing services primarily to patients with cancer, to now primarily patients with neurological conditions and organ-based failure. We are particularly interested in how this change in patient characteristics may have influenced any changes in the provision of hospice services.

As mentioned in the above analysis, after the implementation of the SIA in FY 2016, the number of beneficiaries who did not receive an RN or social worker visit on the last day of has decreased. We are soliciting comments regarding skilled visits in the last week of life, particularly, what factors determine how and when visits are made as an individual approaches the end of life. Given the comprehensive and holistic nature of the services covered under the Medicare hospice benefit, we continue to expect that hospices are providing virtually all of the care needed by terminally ill individuals.

However, the analysis of non-hospice spending during a hospice election indicates a continuing trend where there is a potential “unbundling” of items, services, and drugs from the Medicare hospice benefit. That is, there may be items, services, and drugs that should be covered under the Medicare hospice benefit but are being paid under other Medicare benefits. We are soliciting comments as to how hospices make determinations as to what items, services and drugs are related versus unrelated to the terminal illness and related conditions.

That is, how do hospices define what is unrelated to the terminal illness and related conditions when establishing a hospice plan of care. Likewise, we are soliciting comments on what other factors may influence whether or how certain services are furnished to hospice beneficiaries. Finally, we are interested in stakeholder feedback as to whether the hospice election statement addendum has changed the way hospices make care decisions and how the addendum is used to prompt discussions with beneficiaries and non-hospice providers to ensure that the care needs of beneficiaries who have elected the hospice benefit are met.

B. FY 2022 Proposed Labor Shares 1. Background The labor share for CHC and RHC of 68.71 percent was established with the FY 1984 Hospice benefit implementation based on the wage/nonwage proportions specified in Medicare's limit on home health agency costs (48 FR 38155 through 38156).

The labor shares for IRC and GIP are currently 54.13 percent and 64.01 percent, respectively. These proportions were based on skilled nursing facility wage and nonwage cost limits and skilled nursing facility costs per day (48 FR 38155 through 38156. 56 FR 26917).

For the FY 2022 proposed rule, we are proposing to rebase and revise the labor shares for CHC, RHC, IRC and GIP using MCR data for freestanding hospices (CMS Form 1984-14, OMB NO. 0938-0758 [] ) for 2018. We are proposing to continue to establish separate labor shares for CHC, RHC, IRC, and GIP and base them on the calculated compensation cost weights for each level of care from the 2018 MCR data.

We describe our proposed methodology for deriving the compensation cost weights for each level of care using the MCR data below. We note that we did explore the possibility of using facility-based hospice MCR data to calculate the compensation cost weights. However, very few providers passed the Level I edits (as described in more detail below) and so these reports were not usable.

1. Proposed Methodology for Calculating Compensation Costs We are proposing to derive a compensation cost weight for each level of care that consists of five major components. (1) Direct patient care salaries and contract labor costs, (2) direct patient care benefits costs, (3) other patient care salaries, (4) overhead salaries, and (5) overhead benefits costs.

For each level of care, we are proposing to use the same methodology to derive the components. However, for the (1) Start Printed Page 19718direct patient care salaries and (3) other patient care salaries, we are proposing to use the MCR worksheet that is specific to that level of care (that is, Worksheet A-1 for CHC, Worksheet A-2 for RHC, Worksheet A-3 for IRC, and Worksheet A-4 for GIP). (1) Direct Patient Care Salaries and Contract Labor Costs Direct patient care salaries and contract labor costs are costs associated with medical services provided by medical personnel including but not limited to physician services, nurse practitioners, registered nurses, and hospice aides.

We are proposing to define direct patient care salaries and contract labor costs to be equal to costs reported on Worksheet A-1 (for CHC) or Worksheet A-2 (for RHC) or Worksheet A-3 (for IRC) or Worksheet A-4 (for GIP), column 7, for lines 26 through 37. (2) Direct Patient Care Benefits Costs We are proposing that direct patient care benefits costs for CHC would be equal to Worksheet B, column 3, line 50, for RHC are equal to Worksheet B, column 3, line 51, for IRC are equal to Worksheet B, column 3, line 52, and for GIP are equal to Worksheet B, column 3, line 53. (3) Other Patient Care Salaries Other patient care salaries are those salaries attributable to patient services including but not limited to patient transportation, labs, and imaging services.

These salaries, reflecting all levels of care, are reported on Worksheet A, column 1, lines 38 through 46 and then are further disaggregated for CHC, RHC, IRC, and GIP on Worksheets A-1, A-2, A-3, and A-4, respectively, on column 1 (salaries), lines 38 through 46. Our analysis, however, found that many providers were not reporting salaries on the detailed level of care worksheets (A-1, A-2, A-3, A-4, column 1), but rather reporting total costs (reflecting salary and non-salary costs) for these services for each level of care on Worksheets A-1, A-2, A-3, A-4, column 7. Therefore, we are proposing to estimate other patient care salaries attributable to CHC, RHC, IRC, and GIP by first calculating the ratio of total facility (reflecting all levels of care) other patient care salaries (Worksheet A, column 1, lines 38 through 46) to total facility other patient care total costs (Worksheet A, column 7, lines 38 through 46).

For CHC, we are proposing to then multiply this ratio by other patient care total costs for CHC (Worksheet A-1 column 7, lines 38 through 46). For RHC, we are proposing to multiply this ratio by total other patient care costs for RHC (Worksheet A-2, column 7, lines 38 through 46). For IRC, we are proposing to multiply this ratio by total other patient care costs for IRC (Worksheet A-3, column 7, lines 38 through 46).

For GIP, we are proposing to multiply this ratio by total other patient care costs for GIP (Worksheet A-4, column 7, lines 38 through 46). This proposed methodology assumes that the proportion of salary costs to total costs for other patient care services is consistent for each of the four levels of care. (4) Overhead Salaries The MCR captures total overhead costs (including but not limited to administrative and general, plant operations and maintenance, and housekeeping) attributable to each of the four levels of care.

To estimate overhead salaries for each level of care, we first propose to calculate noncapital non-benefit overhead costs for each level of care to be equal to Worksheet B, column 18, less the sum of Worksheet B, columns 0 through 3, for line 50 (CHC), or line 51 (RHC) or line 52 (IRC) or line 53 (GIP). We then are proposing to multiply these non-capital non-benefit overhead costs for each level of care times the ratio of total facility overhead salaries (Worksheet A, column 1, lines 4 through 16) to total facility non-capital non-benefit overhead costs (which is equal to Worksheet B, column 18 (total costs), line 101 less the sum of Worksheet B, columns 0 (direct patient care costs), column 1 (fixed capital), column 2 (moveable capital) and column 3 (employee benefits), line 101). (5) Overhead Benefits Costs To estimate overhead benefits costs for each level of care, we are proposing a similar methodology to overhead salaries.

For each level of care, we are proposing to calculate noncapital overhead costs for each level of care to be equal to Worksheet B, column 18, less the sum of Worksheet B, columns 0 through 2, for line 50 (CHC), or line 51 (RHC) or line 52 (IRC) or line 53 (GIP). We then are proposing to multiply these non-capital overhead costs for each level of care times the ratio of total facility overhead benefits (Worksheet B, column 3, lines 4 through 16) to total facility noncapital overhead costs (Worksheet B, column 18, line 101 less the sum of Worksheet B, columns 0 through 2, line 101). This proposed methodology assumes the ratio of total overhead benefit costs to total noncapital overhead costs is consistent among all four levels of care.

(6) Total Compensation Costs and Total Costs To calculate the compensation costs for each provider, we are proposing to then sum each of the costs estimated in steps (1) through (5) to derive total compensation costs for CHC, RHC, IRC, and GIP. We are proposing that total costs for CHC are equal to Worksheet B, column 18, line 50, for RHC are equal to Worksheet B, column 18, line 51, for IRC would be equal to Worksheet B, column 18, line 52, and for GIP are equal to Worksheet B, column 18, line 53. 2.

Proposed Methodology for Deriving Compensation Cost Weights To derive the compensation cost weights for each level of care, we first are proposing to begin with a sample of providers who met new Level I edit conditions that required freestanding hospices to fill out certain parts of their cost reports effective for freestanding hospice cost reports with a reporting period that ended on or after December 31, 2017.[] Specifically, we required the following costs to be greater than zero. Fixed capital costs (Worksheet B, column 0, line 1), movable capital costs (Worksheet B, column 0, line 2), employee benefits (Worksheet B, column 0, line 3), administrative and general (Worksheet B, column 0, line 4), volunteer service coordination (Worksheet B, column 0, line 13), pharmacy and drugs charged to patients (sum of Worksheet B, column 0, line 14 and Worksheet A, column 7, line 42.50), registered nurse costs (Worksheet A, column 7, line 28), medical social service costs (Worksheet A, column 7, line 33), hospice aide and homemaker services costs (Worksheet A, column 7, line 37), and durable medical equipment (Worksheet A, column 7, line 38). Applying these Level I edits to the 2018 freestanding hospice MCRs resulted in 3,345 providers that passed the edits (four were excluded).

Then, for each level of care separately, we are proposing to further trim the sample of MCRs. We outline our proposed trimming methodology using CHC as an example. Specifically, for CHC, we propose that total CHC costs (Worksheet B, column 18, line 50) and CHC compensation costs to be greater than zero.

We also propose that CHC direct patient care salaries and contract labor costs per day would be greater Start Printed Page 19719than 1. We also propose to exclude those providers whose CHC compensation costs were greater than total CHC costs. For the IRC and GIP compensation cost weights, we are proposing to only use those MCRs from providers that provided inpatient services in their facility.

Therefore, we are proposing to exclude providers that reported costs greater than zero on Worksheet A-3, column 7, line 25 (Inpatient Care—Contracted) for IRC and Worksheet A-4, column 7, line 25 (Inpatient Care—Contracted) for GIP. The facilities that remained after this trim reported detailed direct patient care costs and other patient care costs for which we could then derive direct patient care salaries and other patient care salaries per the methodology described earlier. This additional trim resulted in a sample that consists of approximately 20 percent of IRP providers and 28 percent of GIP providers that passed both the Level I edits and the trims that required total costs and compensation costs to be greater than zero, and direct patient care salaries and contract labor costs per day to be greater than 1, as well as total costs to be greater than compensation costs.

Finally, to derive the proposed compensation cost weights for each level of care for each provider, we are proposing to divide compensation costs for each level of care by total costs for each level of care. We are proposing to then trim the data for each level of care separately to remove outliers. Following our example for CHC, we are proposing to simultaneously remove those providers whose total CHC costs per day fall in the top and bottom one percent of total CHC costs per day for all CHC providers as well remove those providers whose compensation cost weight falls in the top and bottom five percent of compensation cost weights for all CHC providers.

We then sum the CHC compensation costs and total CHC costs of the remaining providers, yielding a proposed compensation cost weight for CHC. Since we have to limit our sample for IRC and GIP compensation cost weights to those hospices providing inpatient services in their facility, we conducted sensitivity analysis to test for the representative of this sample by reweighting compensation cost weights using data from the universe of freestanding providers that reported either IRC or GIP total costs. For example, we calculated reweighted compensation cost weights by ownership-type (proprietary, government and nonprofit), by size (based on RHC days) and by region.

Our reweighted compensation cost weights for IRC and GIP were similar (less than one percentage point in absolute terms) to our proposed compensation cost weights for IRC and GIP (as shown in Table 11) and, therefore, we believe our sample is representative of freestanding hospices providing inpatient hospice care. Table 11 provides the proposed labor share for each level of care based on the compensation cost weights we derived using our proposed methodology described previously. We are proposing the labor shares be equal to three decimal places consistent with the labor shares used in other Prospective Payment Systems (PPS) (such as the inpatient prospective payment system (IPPS) and the Home Health Agency PPS).

We invite comments on our proposed methodology to derive the labor shares for each level of care. C. Proposed Routine FY 2022 Hospice Wage Index and Rate Update 1.

Proposed FY 2022 Hospice Wage Index The hospice wage index is used to adjust payment rates for hospices under the Medicare program to reflect local differences in area wage levels, based on the location where services are furnished. The hospice wage index utilizes the wage adjustment factors used by the Secretary for purposes of section 1886(d)(3)(E) of the Act for hospital wage adjustments. Our regulations at § 418.306(c) require each labor market to be established using the most current hospital wage data available, including any changes made by the Office of Management and Budget (OMB) to the Metropolitan Statistical Areas (MSAs) definitions.

In general, OMB issues major revisions to statistical areas every 10 years, based on the results of the decennial census. However, OMB occasionally issues minor updates and revisions to statistical areas in the years between the decennial censuses. On March 6, 2020, OMB issued Bulletin No.

20-01, which provided updates to and superseded OMB Bulletin No. 18-04 that was issued on September 14, 2018. The attachments to OMB Bulletin No.

20-01 provided detailed information on the update to statistical areas since September 14, 2018, and were based on the application of the 2010 Standards for Delineating Metropolitan and Micropolitan Statistical Areas to Census Bureau population estimates for July 1, 2017 and July 1, 2018. (For a copy of this bulletin, we refer readers to the following website. Https://www.whitehouse.gov/​wp-content/​uploads/​2020/​03/​Bulletin-20-01.pdf).

In OMB Bulletin No. 20-01, OMB announced one new Micropolitan Statistical Area, one new component of an existing Combined Statistical Are and changes to New England City and Town Area (NECTA) delineations. In the FY 2021 Hospice Wage Index final rule (85 FR 47070) we stated that if appropriate, we would propose any updates from OMB Bulletin No.

20-01 in future rulemaking. After reviewing OMB Bulletin No. 20-01, we have determined that the changes in Bulletin 20-01 encompassed delineation changes Start Printed Page 19720that would not affect the Medicare wage index for FY 2022.

Specifically, the updates consisted of changes to NECTA delineations and the redesignation of a single rural county into a newly created Micropolitan Statistical Area. The Medicare wage index does not utilize NECTA definitions, and, as most recently discussed in the FY 2021 Hospice Wage Index final rule (85 FR 47070), we include hospitals located in Micropolitan Statistical areas in each state's rural wage index. Therefore, while we are proposing to adopt the updates set forth in OMB Bulletin No.

20-01 consistent with our longstanding policy of adopting OMB delineation updates, we note that specific wage index updates would not be necessary for FY 2022 as a result of adopting these OMB updates. In other words, these OMB updates would not affect any geographic areas for purposes of the wage index calculation for FY 2022. In the FY 2020 Hospice Wage Index final rule (84 FR 38484), we finalized the proposal to use the current FY's hospital wage index data to calculate the hospice wage index values.

In the FY 2021 Hospice Wage Index final rule (85 FR 47070), we finalized the proposal to adopt the revised OMB delineations with a 5 percent cap on wage index decreases, where the estimated reduction in a geographic area's wage index would be capped at 5 percent in FY 2021 and no cap would be applied to wage index decreases for the second year (FY 2022). For FY 2022, the proposed hospice wage index would be based on the FY 2022 hospital pre-floor, pre-reclassified wage index for hospital cost reporting periods beginning on or after October 1, 2017 and before October 1, 2018 (FY 2018 cost report data). The proposed FY 2022 hospice wage index would not include a cap on wage index decreases and would not take into account any geographic reclassification of hospitals, including those in accordance with section 1886(d)(8)(B) or 1886(d)(10) of the Act.

The appropriate wage index value is applied to the labor portion of the hospice payment rate based on the geographic area in which the beneficiary resides when receiving RHC or CHC. The appropriate wage index value is applied to the labor portion of the payment rate based on the geographic location of the facility for beneficiaries receiving GIP or IRC. In the FY 2006 Hospice Wage Index final rule (70 FR 45135), we adopted the policy that, for urban labor markets without a hospital from which hospital wage index data could be derived, all of the Core-Based Statistical Areas (CBSAs) within the state would be used to calculate a statewide urban average pre-floor, pre-reclassified hospital wage index value to use as a reasonable proxy for these areas.

For FY 2022, the only CBSA without a hospital from which hospital wage data can be derived is 25980, Hinesville-Fort Stewart, Georgia. The FY 2022 adjusted wage index value for Hinesville-Fort Stewart, Georgia is 0.8649. There exist some geographic areas where there were no hospitals, and thus, no hospital wage data on which to base the calculation of the hospice wage index.

In the FY 2008 Hospice Wage Index final rule (72 FR 50217 through 50218), we implemented a methodology to update the hospice wage index for rural areas without hospital wage data. In cases where there was a rural area without rural hospital wage data, we use the average pre-floor, pre-reclassified hospital wage index data from all contiguous CBSAs, to represent a reasonable proxy for the rural area. The term “contiguous” means sharing a border (72 FR 50217).

Currently, the only rural area without a hospital from which hospital wage data could be derived is Puerto Rico. However, for rural Puerto Rico, we would not apply this methodology due to the distinct economic circumstances that exist there (for example, due to the close proximity to one another of almost all of Puerto Rico's various urban and non-urban areas, this methodology would produce a wage index for rural Puerto Rico that is higher than that in half of its urban areas). Instead, we would continue to use the most recent wage index previously available for that area.

For FY 2022, we propose to continue to use the most recent pre-floor, pre-reclassified hospital wage index value available for Puerto Rico, which is 0.4047, subsequently adjusted by the hospice floor. As described in the August 8, 1997 Hospice Wage Index final rule (62 FR 42860), the pre-floor and pre-reclassified hospital wage index is used as the raw wage index for the hospice benefit. These raw wage index values are subject to application of the hospice floor to compute the hospice wage index used to determine payments to hospices.

As previously discussed, the adjusted pre-floor, pre-reclassified hospital wage index values below 0.8 will be further adjusted by a 15 percent increase subject to a maximum wage index value of 0.8. For example, if County A has a pre-floor, pre-reclassified hospital wage index value of 0.3994, we would multiply 0.3994 by 1.15, which equals 0.4593. Since 0.4593 is not greater than 0.8, then County A's hospice wage index would be 0.4593.

In another example, if County B has a pre-floor, pre-reclassified hospital wage index value of 0.7440, we would multiply 0.7440 by 1.15, which equals 0.8556. Because 0.8556 is greater than 0.8, County B's hospice wage index would be 0.8. The proposed hospice wage index applicable for FY 2022 (October 1, 2021 through September 30, 2022) is available on our website at.

https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Hospice-Wage-Index.html. 2. Proposed FY 2022 Hospice Payment Update Percentage Section 4441(a) of the BBA (Pub.

L. 105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were to be updated by a factor equal to the inpatient hospital market basket percentage increase set out under section 1886(b)(3)(B)(iii) of the Act, minus 1 percentage point.

Payment rates for FYs since 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs must be the inpatient market basket percentage increase for that FY. CMS currently uses 2014-based IPPS operating and capital market baskets to update the market basket percentage. In the FY 2022 IPPS proposed rule [] CMS is proposing to rebase and revise the IPPS market baskets to reflect a 2018 base year.

We refer stakeholders to the FY 2022 IPPS proposed rule for further information. Section 3401(g) of the Affordable Care Act mandated that, starting with FY 2013 (and in subsequent FYs), the hospice payment update percentage would be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide private nonfarm business multifactor productivity (MFP).

The proposed hospice payment update percentage for FY 2022 is based on the current estimate of the proposed inpatient hospital market basket update of 2.5 percent (based on IHS Global Inc.'s fourth-quarter 2020 forecast with historical data through the third quarter 2020). Due to the requirements at sections 1886(b)(3)(B)(xi)(II) and 1814(i)(1)(C)(v) of the Act, the proposed inpatient hospital market basket update Start Printed Page 19721for FY 2022 of 2.5 percent must be reduced by a MFP adjustment as mandated by Affordable Care Act (currently estimated to be 0.2 percentage points for FY 2022). In effect, the proposed hospice payment update percentage for FY 2022 would be 2.3 percent.

If more recent data becomes available after the publication of this proposed rule and before the publication of the final rule (for example, more recent estimates of the inpatient hospital market basket update and MFP adjustment), we would use such data, if appropriate, to determine the hospice payment update percentage for FY 2022 in the final rule. Currently, the labor portion of the hospice payment rates are as follows. For RHC, 68.71 percent.

For CHC, 68.71 percent. For GIP, 64.01 percent. And for IRC, 54.13 percent.

As discussed in section III.B of this proposed rule, we are proposing to rebase and revise the labor shares for RHC, CHC, GIP and IRC using MCR data for freestanding hospices (CMS Form 1984-14, OMB Control Number 0938-0758) for 2018. We are proposing the labor portion of the payment rates to be. For RHC, 64.7 percent.

For CHC, 74.6 percent. For GIP, 62.8 percent. And for IRC, 60.1 percent.

The non-labor portion is equal to 100 percent minus the labor portion for each level of care. Therefore, we are proposing the non-labor portion of the payment rates to be as follows. For RHC, 35.3 percent.

For CHC, 25.4 percent. For GIP, 37.2 percent. And for IRC, 39.9 percent.

3. Proposed FY 2022 Hospice Payment Rates There are four payment categories that are distinguished by the location and intensity of the hospice services provided. The base payments are adjusted for geographic differences in wages by multiplying the labor share, which varies by category, of each base rate by the applicable hospice wage index.

A hospice is paid the RHC rate for each day the beneficiary is enrolled in hospice, unless the hospice provides CHC, IRC, or GIP. CHC is provided during a period of patient crisis to maintain the patient at home. IRC is short-term care to allow the usual caregiver to rest and be relieved from caregiving.

And GIP is to treat symptoms that cannot be managed in another setting. As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47172), we implemented two different RHC payment rates, one RHC rate for the first 60 days and a second RHC rate for days 61 and beyond. In addition, in that final rule, we implemented a SIA payment for RHC when direct patient care is provided by an RN or social worker during the last 7 days of the beneficiary's life.

The SIA payment is equal to the CHC hourly rate multiplied by the hours of nursing or social work provided (up to 4 hours total) that occurred on the day of service, if certain criteria are met. In order to maintain budget neutrality, as required under section 1814(i)(6)(D)(ii) of the Act, the new RHC rates were adjusted by a service intensity add-on budget neutrality factor (SBNF). The SBNF is used to reduce the overall RHC rate in order to ensure that SIA payments are budget-neutral.

At the beginning of every FY, SIA utilization is compared to the prior year in order calculate a budget neutrality adjustment. In the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52156), we initiated a policy of applying a wage index standardization factor to hospice payments in order to eliminate the aggregate effect of annual variations in hospital wage data. Typically, the wage index standardization factor is calculated using the most recent, complete hospice claims data available.

However, due to the skin care products PHE, we looked at using the previous fiscal year's hospice claims data (FY 2019) to determine if there were significant differences between utilizing 2019 and 2020 claims data. The difference between using FY 2019 and FY 2020 hospice claims data was minimal. Therefore, we will continue our practice of using the most recent, complete hospice claims data available.

That is we are using FY 2020 claims data for the FY 2022 payment rate updates. In order to calculate the wage index standardization factor, we simulate total payments using FY 2020 hospice utilization claims data with the FY 2021 wage index (pre-floor, pre-reclassified hospital wage index with the hospice floor, and a 5 percent cap on wage index decreases) and FY 2021 payment rates (that include the current labor shares) and compare it to our simulation of total payments using the FY 2022 hospice wage index (with hospice floor, without the 5 percent cap on wage index decreases) and FY 2021 payment rates (that include the current labor shares). By dividing payments for each level of care (RHC days 1 through 60, RHC days 61+, CHC, IRC, and GIP) using the FY 2021 wage index and payment rates for each level of care by the FY 2022 wage index and FY 2021 payment rates, we obtain a wage index standardization factor for each level of care.

In order to calculate the labor share standardization factor we simulate total payments using FY 2020 hospice utilization claims data with the FY 2022 hospice wage index and the current labor shares and compare it to our simulation of total payments using the FY 2022 hospice wage index with the proposed revised labor shares. The wage index and labor share standardization factors for each level of care are shown in the Tables 12 and 13. The proposed FY 2022 RHC rates are shown in Table 12.

The proposed FY 2022 payment rates for CHC, IRC, and GIP are shown in Table 13. Start Printed Page 19722 Sections 1814(i)(5)(A) through (C) of the Act require that hospices submit quality data, based on measures to be specified by the Secretary. In the FY 2012 Hospice Wage Index and Rate Update final rule (76 FR 47320 through 47324), we implemented a HQRP as required by those sections.

Hospices were required to begin collecting quality data in October 2012, and submit that quality data in 2013. Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements with respect to that FY. The proposed FY 2022 rates for hospices that do not submit the required quality data would be updated by the proposed FY 2022 hospice payment update percentage of 2.3 percent minus 2 percentage points.

These rates are shown in Tables 14 and 15. Start Printed Page 19723 4. Proposed Hospice Cap Amount for FY 2022 As discussed in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47183), we implemented changes mandated by the IMPACT Act of 2014 (Pub.

L. 113-185). Specifically, we stated that for accounting years that end after September 30, 2016 and before October 1, 2025, the hospice cap is updated by the hospice payment update percentage rather than using the CPI-U.

Division CC, section 404 of the CAA 2021 has extended the accounting years impacted by the adjustment made to the hospice cap calculation until 2030. Therefore, for accounting years that end after September 30, 2016 and before October 1, 2030, the hospice cap amount is updated by the hospice payment update percentage rather than using the CPI-U. As a result of the changes mandated by Division CC, section 404 of the CAA 2021, we are proposing conforming regulation text changes at § 418.309 to reflect the new language added to section 1814(i)(2)(B) of the Act.

The proposed hospice cap amount for the FY 2022 cap year will be $31,389.66, which is equal to the FY 2021 cap amount ($30,683.93) updated by the proposed FY 2022 hospice payment update percentage of 2.3 percent. D. Proposed Clarifying Regulation Text Changes for the Hospice Election Statement Addendum In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484), we finalized modifications to the hospice election statement content requirements at § 418.24(b) to increase coverage transparency for patients under a hospice election.

These changes included a new condition for payment requiring a hospice, upon request, to provide the beneficiary (or representative) an election statement addendum (hereafter called “the addendum”) outlining the items, services, and drugs that the hospice has determined are unrelated to the terminal illness and related conditions. We stated in that final rule that the addendum is intended to complement the Hospice Conditions of Participation (CoPs) at § 418.52(a), which require hospices to verbally inform beneficiaries, at the time of hospice election, of the services covered under the Medicare hospice benefit, as well as the limitations of such services (84 FR 38509). The requirements at §§ 418.24(b) and 418.52(a) ensure that beneficiaries are aware of any items, services, or drugs they would have to seek outside of the benefit, as well as their potential out-of-pocket costs for hospice care, such as co-payments and/or coinsurance.

Section 418.24(c) sets forth the elements that must be included on the addendum. 1. The addendum must be titled “Patient Notification of Hospice Non-Covered Items, Services, and Drugs”.

Beneficiary's name and hospice medical record identifier. 4. Identification of the beneficiary's terminal illness and related conditions.

5. A list of the beneficiary's current diagnoses/conditions present on hospice admission (or upon plan of care update, as applicable) and the associated items, services, and drugs, not covered by the hospice because they have been determined by the hospice to be unrelated to the terminal illness and related conditions. 6.

A written clinical explanation, in language the beneficiary and his or her representative can understand, as to why the identified conditions, items, services, and drugs are considered unrelated to the terminal illness and related conditions and not needed for pain or symptom management. This clinical explanation must be accompanied by a general statement that the decision as to what conditions, items, services, or drugs are unrelated is made for each individual patient, and that the beneficiary should share this clinical explanation with other health care providers from which he or she seeks services unrelated to his or her terminal illness and related conditions. 7.

References to any relevant clinical practice, policy, or coverage guidelines. 8. Information on the following.

A. Purpose of the addendum b. Patient's right to immediate advocacy 9.

Name and signature of the Medicare hospice beneficiary (or representative) and date signed, along with a statement that signing this addendum (or its updates) is only acknowledgement of receipt of the addendum (or its updates) and not necessarily the beneficiary's agreement with the hospice's determinations. The hospice is required to furnish the addendum in writing in an accessible format,[] so the beneficiary (or representative) can understand the information provided, make treatment decisions based on that information, and share such information with non-hospice providers rendering un-related items and services to the beneficiary. Therefore, the format of the addendum Start Printed Page 19724must be usable for the beneficiary and/or representative.

Although we stated in the FY 2020 Hospice Wage Index and Payment Rate Update that hospices may develop their own election statement addendum (84 FR 38507), we posted a modified model election statement and addendum on the Hospice Center web page,[] along with the publication of the FY 2021 Hospice Wage Index and Payment Rate Update final rule (85 FR 47070). The intent was to provide an illustrative example as hospices can modify and develop their own forms to meet the content requirements. In the FY 2021 Hospice Wage Index and Payment Rate Update final rule, we stated that most often we would expect the addendum would be in a hard copy format the beneficiary or representative can keep for his or her own records, similar to how hospices are required by the hospice CoPs at § 418.52(a)(3) to provide the individual a copy of the notice of patient rights and responsibilities (85 FR 47091).

The hospice CoPs at § 418.104(a)(2) state that the patient's record must include “signed copies of the notice of patient rights in accordance with § 418.52.” Likewise, since the addendum is part of the election statement as set forth in § 418.24(b)(6), then it is required to be part of the patient's record (if requested by the beneficiary or representative). The signed addendum is only acknowledgement of the beneficiary's (or representative's) receipt of the addendum (or its updates) and the payment requirement is considered met if there is a signed addendum (and any signed updates) in the requesting beneficiary's medical record with the hospice. We believe that a signed addendum connotes that the hospice discussed the addendum and its contents with the beneficiary (or representative).

Additionally, in the event that a beneficiary (or representative) does not request the addendum, we expect hospices to document, in some fashion, that an addendum has been discussed with the patient (or representative) at the time of election, similar to how other patient and family discussions are documented in the hospice's clinical record. It is necessary for the hospice to document that the addendum was discussed and whether or not it was requested, in order to prevent potential claims denials related to any absence of an addendum (or addendum updates) in the medical record. Though we did not propose any changes to the election statement addendum content requirements at § 418.24(c), or the October 1, 2020 effective date, in the FY 2021 Hospice Wage Index and Payment Rate Update proposed rule, we solicited comments on the usefulness of the modified model election statement and addendum posted on the Hospice Center web page (85 FR 20949).

In the FY 2021 Hospice Wage Index and Payment Rate Update final rule (85 FR 47093), we responded to comments received, and stated that, as finalized in the FY 2020 Hospice Wage Index and Payment Rate Update final rule, the hospice election statement addendum will remain a condition for payment that is met when there is a signed addendum (and its updates) in the beneficiary's hospice medical record. Since its implementation on October 1, 2020, CMS has received additional inquiries from stakeholders asking for clarification on certain aspects of the addendum. We appreciate and understand the importance of provider input and involvement in ensuring that this document is effective in increasing coverage transparency for beneficiaries.

Therefore, we are providing clarification on, and proposing modifications to, certain signature and timing requirements and proposing corresponding clarifying regulations text changes. Currently the regulations at § 418.24(c) require that if a beneficiary or his or her representative requests the addendum at the time of the initial hospice election (that is, at the time of admission to hospice), the hospice must provide this information, in writing, to the individual (or representative) within 5 days from the date of the election. Hospices have reported that beneficiaries or representatives sometimes do not request the addendum at the time of election, but rather within the 5 days after the effective date of the election.

In these situations, the regulations require the hospice to provide the addendum within 3 days, as the beneficiary requested the addendum during the course of care. However, in accordance with § 418.54(b), the hospice interdisciplinary group (IDG), in consultation with the individual's attending physician (if any), must complete the hospice comprehensive assessment no later than 5 calendar days after the election of hospice care. In some instances, this may mean that the hospice must furnish the addendum prior to completion of the comprehensive assessment.

The comprehensive assessment includes all areas of hospice care related to the palliation and management of a beneficiary's terminal illness. This assessment is necessary because it provides an overview of the items, services and drugs that the patient is already utilizing as well as helps determine what the hospice may need to add in order to treat the patient throughout the dying process. If the addendum is completed prior to the comprehensive assessment, the hospice may not have a complete patient profile, which could potentially result in the hospice incorrectly anticipating the extent of covered and non-covered services and lead to an inaccurate election statement addendum.

Hospice providers are only able to discern what items, services, and drugs they will not cover once they have a beneficiary's comprehensive assessment. We are proposing to allow the hospice to furnish the addendum within 5 days from the date of a beneficiary or representative request, if the request is within 5 days from the date of a hospice election. For example, if the patient elects hospice on December 1st and requests the addendum on December 3rd, the hospice would have until December 8th to furnish the addendum.

Additionally, hospices have noted that there is not a timeframe in regulations regarding the patient signature on the addendum. Section 418.24(c)(9) requires the beneficiary's signature (or his/her representative's signature) as well as the date the document was signed. We noted in the FY 2021 Hospice Wage Index &.

Payment Rate Update final rule that because the beneficiary signature is an acknowledgement of receipt of the addendum, this means the beneficiary would sign the addendum when the hospice provides it, in writing, to the beneficiary or representative (85 FR 47092). Additionally, obtaining the required signatures on the election statement has been a longstanding regulatory requirement. Therefore, we expect that hospices already have processes and procedures in place to ensure that required signatures are obtained, either from the beneficiary, or from the representative in the event the beneficiary is unable to sign.

We anticipate that hospices would use the same procedures for obtaining signatures on the addendum. However, we understand that some beneficiaries or representatives may request an emailed addendum or request more time to review the addendum before signing, in which case the date that the hospice furnished the addendum to the beneficiary (or representative) may differ from the date that the beneficiary Start Printed Page 19725or representative signs the addendum. This means the hospice may furnish the addendum within the required timeframe.

However, the signature date may be beyond the required timeframe. Therefore, we propose to clarify in regulation that the “date furnished” must be within the required timeframe (that is, 3 or 5 days of the beneficiary or representative request, depending on when such request was made), rather than the signature date. At § 418.24(c)(10), we propose that the hospice would include the “date furnished” in the patient's medical record and on the addendum itself.

In the FY 2021 Hospice Wage Index and Payment Rate Update final rule, we addressed a concern regarding a potential situation wherein the beneficiary or representative refuses to sign the addendum (85 FR 47088). We reiterated that the signature on the addendum is only acknowledgement of receipt and not a tacit agreement of its contents, and that we expect the hospice to inform the beneficiary of the purpose of the addendum and rationale for the signature. However, we recognized that there might be rare instances in which the beneficiary (or representative) refuses to sign the addendum.

We noted that we would consider whether this issue would require future rulemaking. We have subsequently received this question from stakeholders post implementation, therefore, in this proposed rule, we are clarifying that if a patient or representative refuses to sign the addendum, the hospice must document clearly in the medical record (and on the addendum itself) the reason the addendum is not signed in order to mitigate a claims denial for this condition for payment. In such a case, although the beneficiary has refused to sign the addendum, the “date furnished” must still be within the required timeframe (that is, within 3 or 5 days of the beneficiary or representative request, depending on when such request was made), and noted in the chart and on the addendum itself.

Stakeholders again requested that CMS clarify whether a non-hospice provider is required to sign the addendum in the event that the non-hospice provider requests the addendum rather than the beneficiary or representative. Therefore, if only a non-hospice provider or Medicare contractor requests the addendum (and not the beneficiary or representative) we would not expect a signed copy in the patient's medical record. Hospices can develop processes (including how to document such requests from non-hospice providers and Medicare contractors) to address circumstances in which the non-hospice provider or Medicare contractor requests the addendum, and the beneficiary or representative does not.

As such, we are proposing to clarify in regulation that if a non-hospice provider requests the addendum, rather than the beneficiary or representative, the non-hospice provider is not required to sign the addendum. There may be instances in which the beneficiary or representative requests the addendum and the beneficiary dies, revokes, or is discharged prior to signing the addendum. While we stated in the FY 2020 Hospice Wage Index and Payment Rate Update final rule, that if the beneficiary requests the election statement addendum at the time of hospice election but dies within 5 days, the hospice would not be required to furnish the addendum as the requirement would be deemed as being met in this circumstance (84 FR 38521), this policy was not codified in regulation.

Therefore, we are proposing conforming regulations text changes at § 418.24(c) to reflect this policy. Furthermore, we propose to clarify at § 418.24(d)(4) that if the patient revokes or is discharged within the required timeframe (3 or 5 days after a request, depending upon when such request was made), but the hospice has not yet furnished the addendum, the hospice is not required to furnish the addendum. Similarly, we are proposing to clarify at § 418.24(d)(5) that in the event that a beneficiary requests the addendum and the hospice furnishes the addendum within 3 or 5 days (depending upon when the request for the addendum was made), but the beneficiary dies, revokes, or is discharged prior to signing the addendum, a signature from the individual (or representative) is no longer required.

We would continue to expect that the hospice would note the date furnished in the patient's medical record and on the addendum, if the hospice has already completed the addendum, as well as an explanation in the patient's medical record noting that the patient died, revoked, or was discharged prior to signing the addendum. Finally, we are proposing conforming regulations text changes at § 418.24(c) in alignment with subregulatory guidance indicating that hospices have “3 days,” rather than “72 hours” to meet the requirement when a patient requests the addendum during the course of a hospice election. Hospices must furnish the addendum no later than 3 calendar days after a beneficiary's (or representative's) request during the course of a hospice election.

This means that hospice providers must furnish the addendum to the beneficiary or representative on or before the third day after the date of the request. For example, if a beneficiary (or representative) requests the addendum on February 22nd, then the hospice will have until February 25th to furnish the addendum, regardless of what time the addendum was requested on February 22nd. The intent of this clarification is to better align with the requirement for furnishing an election statement addendum when the addendum is requested within 5 days of the date of election, which also uses “days” rather than “hours”.

We are soliciting comments on these proposed clarifications and conforming regulation text changes. E. Hospice Waivers Made Permanent Conditions of Participation 1.

Background In order to support provider and supplier communities due to the skin care products PHE, CMS has issued an unprecedented number of regulatory waivers under our statutory authority set forth at section 1135 of the Act. Under section 1135 of the Act, the Secretary may temporarily waive or modify certain Medicare, Medicaid, and Children's Health Insurance Program (CHIP) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the programs in the emergency area and time periods, and that providers who furnish such services in good faith, but who are unable to comply with one or more requirements as described under section 1135(b) of the Act, can be reimbursed and exempted from sanctions for violations of waived provisions (absent any determination of fraud or abuse). The intent of these waivers was to expand healthcare system capacity while continuing to maintain public and patient safety, and to hold harmless providers and suppliers unable to comply with existing regulations after a good faith effort.

While some of these waivers simply delay certain administrative deadlines, others directly affect the provision of patient care. The utilization and application of these waivers pushed us to consider whether permanent changes would be beneficial to patients, providers, and professionals. We identified selected waivers as appropriate candidates for formal regulatory changes.

Those proposed changes and their respective histories and background information are discussed in detail in section II. E of this rule. We are also proposing regulatory Start Printed Page 19726changes that are not directly related to PHE waivers but would clarify or align some policies that have been raised as concerns by stakeholders.

We are proposing the following revisions to the hospice Conditions of Participation (CoPs). 2. Hospice Aide Training and Evaluation—Using Pseudo-Patients Hospice aides deliver a significant portion of direct care.

Aides are usually trained by an employer, such as a hospice, home health agency (HHA) or nursing home and may already be certified as an aide prior to being hired. The competency of new aides must be evaluated by the hospice to ensure appropriate care can be provided by the aide. Aide competency evaluations should be conducted in a way that identifies and meets training needs of the aide as well as the patient's needs.

These evaluations are a critical part of providing safe, quality care. In September of 2019, we published a final rule that allows the use of the pseudo-patient for conducting home health aide competency evaluations (“Medicare and Medicaid Programs. Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction.

Fire Safety Requirements for Certain Dialysis Facilities. Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care” (84 FR 51732)). The ability to use pseudo-patients during aide competency evaluations allows greater flexibility and may reduce burden on suppliers.

We believe that hospices and their patients would also benefit from the ability to use pseudo-patients in aide training. The current hospice aide competency standard regulations at § 418.76(c)(1) requires the aide to be evaluated by observing an aide's performance of the task with a patient. We propose to make similar changes to hospice aide competency standards to those already made with respect to HHAs (see § 484.80(c)) in our hospice regulations at § 418.76(c)(1)), which describes the process for conducting hospice aide competency evaluations, and propose to define both “pseudo-patient” and “simulation” at § 418.3.

Thus, we are proposing to permit skill competencies to be assessed by observing an aide performing the skill with either a patient or a pseudo-patient as part of a simulation. The proposed definitions are as follows. “Pseudo-patient” means a person trained to participate in a role-play situation, or a computer-based mannequin device.

A pseudo-patient must be capable of responding to and interacting with the hospice aide trainee, and must demonstrate the general characteristics of the primary patient population served by the hospice in key areas such as age, frailty, functional status, cognitive status and care goals. €œSimulation” means a training and assessment technique that mimics the reality of the homecare environment, including environmental distractions and constraints that evoke or replicate substantial aspects of the real world in a fully interactive fashion, in order to teach and assess proficiency in performing skills, and to promote decision making and critical thinking. These proposed changes would allow hospices to utilize pseudo-patients, such as a person trained to participate in a role-play situation or a computer-based mannequin device, instead of actual patients, in the competency testing of hospice aides for those tasks that must be observed being performed on a patient.

This could increase the speed of performing competency testing and would allow new aides to begin serving patients more quickly while still protecting patient health and safety. 3. Hospice Aid Training and Evaluation—Targeting Correction of Deficiencies We are also proposing to amend the requirement at § 418.76(h)(1)(iii) to specify that if an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation of the deficient skill and all related skill(s) in accordance with § 418.76(c).

This proposed change would permit the hospice to focus on the hospice aides' specific deficient and related skill(s) instead of completing another full competency evaluation. We believe when a deficient area(s) in the aide's care is assessed by the RN, there may be additional related competencies that may also lead to additional deficient practice areas. For example, if a patient's family informed the nurse that the patient almost fell when the aide was transferring the patient to a chair.

The nurse could assess the aide's transferring technique to determine whether there was any improper form. The hospice must also conduct, and the hospice aide must complete, a competency evaluation related to the deficient and related transferring skills. Such as transferring from bed to bedside commode or shower chair.

We request public comment on our proposed changes to allow for the use of the pseudo patient for conducting hospice aide competency testing, and the proposed change to allow the hospice to focus on the hospice aides' specific deficient skill(s) instead of completing a full competency evaluation. We especially welcome comments from hospices that implemented the use of pseudo-patients during the skin care products PHE and the additional proposal, that if an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation related to the deficient and related skill(s). F.

Proposals and Updates to the Hospice Quality Reporting Program 1. Background and Statutory Authority The Hospice Quality Reporting Program (HQRP) specifies reporting requirements for both the Hospice Item Set (HIS) and Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospice Survey. Section 1814(i)(5) of the Act requires the Secretary to establish and maintain a quality reporting program for hospices.

Section 1814(i)(5)(A)(i) of the Act was amended by section 407(b) of Division CC, Title IV of the CAA 2021 (Pub. L. 116-260) to change the payment reduction for failing to meet hospice quality reporting requirements from 2 to 4 percentage points.

This policy will apply beginning with FY 2024 annual payment update (APU). Specifically, the Act requires that, beginning with FY 2014 through FY 2023, the Secretary shall reduce the market basket update by 2 percentage points and beginning with the FY 2024 APU and for each subsequent year, the Secretary shall reduce the market basket update by 4 percentage points for any hospice that does not comply with the quality data submission requirements for that FY. In addition, section 407(a)(2) of the CAA 2021 removes the prohibition on public disclosure of hospice surveys performed be a national accreditation agency in section 1865(b) of the Act, thus allowing the Secretary to disclose such accreditation surveys.

In addition, section 407(a)(1) of the CAA 2021 adds new requirements in newly added section 1822(a)(2) to require each state and local survey agency, and each national accreditation body with an approved hospice accreditation program, to submit information respecting any survey or certification made with respect to a hospice program. Such information shall include any inspection report made by such survey agency or body with respect to such survey or certification, any enforcement Start Printed Page 19727actions taken as a result of such survey or certification, and any other information determined appropriate by the Secretary. This information will be published publicly on our website, such as Care Compare, in a manner that is easily accessible, readily understandable, and searchable no later than October 1, 2022.

In addition, national accreditation bodies with approved hospice accreditation programs described above are required to use the same survey form used by state and local survey agencies, which is currently the Form CMS-2567, on or after October 1, 2021. Depending on the amount of the annual update for a particular year, a reduction of 2 percentage points through FY 2023 or 4 percentage points beginning in FY 2024 could result in the annual market basket update being less than zero percent for a FY and may result in payment rates that are less than payment rates for the preceding FY. Any reduction based on failure to comply with the reporting requirements, as required by section 1814(i)(5)(B) of the Act, would apply only for the specified year.

Any such reduction would not be cumulative nor be taken into account in computing the payment amount for subsequent FYs. Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. The data must be submitted in a form, manner, and at a time specified by the Secretary.

Any measures selected by the Secretary must have been endorsed by the consensus-based entity which holds a performance measurement contract with the Secretary under section 1890(a) of the Act. This contract is currently held by the National Quality Forum (NQF). However, section 1814(i)(5)(D)(ii) of the Act provides that in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the consensus-based entity, the Secretary may specify measures that are not endorsed, as long as due consideration is given to measures that have been endorsed or adopted by a consensus-based organization identified by the Secretary.

Section 1814(i)(5)(D)(iii) of the Act requires that the Secretary publish selected measures applicable with respect to FY 2014 no later than October 1, 2012. In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48234), and in compliance with section 1814(i)(5)(C) of the Act, we finalized the specific collection of data items that support the seven NQF-endorsed hospice measures described in Table 1. In addition, we finalized the Hospice Visits When Death is Imminent measure pair (HVWDII, Measure 1 and Measure 2) in the FY 2017 Hospice Wage Index and Payment Rate Update final rule, effective April 1, 2017.

We refer the public to the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52144) for a detailed discussion. The CAHPS Hospice Survey is a component of the CMS HQRP, which is used to collect data on the experiences of hospice patients and their family caregivers listed in their hospice records. Readers who want more information about the development of the survey, originally called the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78 FR 48261.

National implementation of the CAHPS Hospice Survey commenced January 1, 2015, as stated in the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452). The CAHPS Hospice Survey measures received NQF endorsement on October 26, 2016 and was re-endorsed November 20, 2020 (NQF #2651). NQF endorsed six composite measures and two overall measures from the CAHPS Hospice Survey.

Along with nine HIS-based quality measures, the CAHPS Hospice Survey measures are publicly reported on a designated CMS website that is currently Care Compare. Table 16 lists all quality measures currently adopted for the HQRP. Start Printed Page 19728 Start Printed Page 19729 The Hospice and Palliative Care Composite Process Measure—HIS-Comprehensive Assessment at Admission measure (hereafter referred to as “the HIS Comprehensive Assessment Measure”) underwent an off-cycle review by the NQF Palliative and End-of-Life Standing Committee and successfully received NQF endorsement in July 2017 (NQF 3235).

The HIS Comprehensive Assessment Measure captures whether multiple key care processes were delivered upon patients' admissions to hospice in one measure as described in the Table 1. NQF 3235 does not require NQF's endorsements of the previous components to remain valid. Thus, if the components included in NQF 3235 do not individually maintain endorsement, the endorsement status of NQF 3235, as a single measure, will not change.

In the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47142), we finalized the policy for retention of HQRP measures adopted for previous payment determinations and seven factors for measure removal. In that same final rule, we discussed that we will issue public notice, through rulemaking, of measures under consideration for removal, suspension, or replacement. However, if there is reason to believe continued collection of a measure raises potential safety concerns, we will take immediate action to remove the measure from the HQRP and will not wait for the annual rulemaking cycle.

Such measures will be promptly removed and we will immediately notify hospices and the public of our decision through the usual HQRP communication channels, including but not limited to listening sessions, email notification, Open Door Forums, HQRP Forums, and Web postings. In such instances, the removal of a measure will be formally announced in the next annual rulemaking cycle. In the FY 2019 Hospice Wage Index and Rate Update final rule (83 FR 38622), we also adopted an eighth factor for removal of a measure.

This factor aims to promote improved health outcomes for beneficiaries while minimizing the overall costs associated with the program. These costs are multifaceted and include the burden associated with complying with the program. The finalized reasons for removing quality measures are.

1. Measure performance among hospices is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. 2.

Performance or improvement on a measure does not result in better patient outcomes. 3. A measure does not align with current clinical guidelines or practice.

4. A more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available. 5.

A measure that is more proximal in time to desired patient outcomes for the particular topic is available. 6. A measure that is more strongly associated with desired patient outcomes for the particular topic is available.

7. Collection or public reporting of a measure leads to negative unintended consequences. Or 8.

The costs associated with a measure outweighs the benefit of its continued use in the program. On August 31, 2020, we added correcting language to the FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. Correcting Amendment (85 FR 53679) hereafter referred to as the FY 2021 HQRP Correcting Amendment.

In this final rule, we made correcting amendments to 42 CFR 418.312 to correct technical errors Start Printed Page 19730identified in the FY 2016 Hospice Wage Index and Payment Rate Update final rule. Specifically, the FY 2021 HQRP Correcting Amendment (85 FR 53679) adds paragraph (i) to § 418.312 to reflect our exemptions and extensions requirements, which were referenced in the preamble but inadvertently omitted from the regulations text. Thus, these exemptions or extensions can occur when a hospice encounters certain extraordinary circumstances.

As stated in the FY 2019 Hospice Wage Index and Rate Update final rule (83 FR 38622), we launched the Meaningful Measures initiative (which identifies high priority areas for quality measurement and improvement) to improve outcomes for patients, their families, and providers while also reducing burden on clinicians and providers. More information about the Meaningful Measures initiative can be found at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​QualityInitiativesGenInfo/​MMF/​General-info-Sub-Page.html.

In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484), we discussed our interest in developing quality measures using claims data, to expand data sources for quality measure development. While we acknowledged in that rule the limitations with using claims data as a source for measure development, there are several advantages to using claims data as part of a robust HQRP as discussed previously in the FY 2020 rule. We also discussed developing the Hospice Outcomes &.

Patient Evaluation (HOPE), a new patient assessment instrument that is planned to replace the HIS. See an update on HOPE development in section III.F.6, Update regarding the Hospice Outcomes &. Patient Evaluation (HOPE) development.

We also discussed our interest in outcome quality measure development. Unlike process measures, outcome measures capture the results of care as experienced by patients, which can include aspects of a patient's health status and their experiences in the health system. The portfolio of quality measures in the HQRP will include outcome measures that reflect the results of care.

2. Proposal To Remove the Seven “Hospice Item Set Process Measures” From HQRP Beginning FY 2022 In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48234), and in compliance with section 1814(i)(5)(C) of the Act, we finalized the specific collection of standardized data items, known as the HIS, that support the following NQF-endorsed measures. NQF #1617 Patients Treated with an Opioid who are Given a Bowel Regimen NQF #1634 Pain Screening NQF #1637 Pain Assessment NQF #1638 Dyspnea Treatment NQF #1639 Dyspnea Screening NQF #1641 Treatment Preferences NQF #1647 Beliefs/Values Addressed (if desired by the patient) These measures were adopted to increase public awareness of key components of hospice care, such as pain and symptom management and non-clinical care needs.

Consistent with our policy for measure retention and removal, finalized in the FY 2016 Hospice Wage Index and Rate Update final rule (80 FR 47142), we reviewed these measures against the factors for removal. Our analysis found that they meet factor 4. €œA more broadly applicable measure (across settings, populations, or conditions) for the particular topic is available.” We determined that the NQF #3235 HIS Comprehensive Assessment Measure, discussed in detail in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52144), is a more broadly applicable measure and continues to provide, in a single measure, meaningful differences between hospices regarding overall quality in addressing the physical, psychosocial, and spiritual factors of hospice care upon admission.

The HIS Comprehensive Assessment Measure's “all or none” criterion requires hospices to perform all seven care processes in order to receive credit. In this way, it is different from an average-based composite measure and sets a higher bar for performance. This single measure differentiates hospices and holds them accountable for completing all seven process measures to ensure core services of the hospice comprehensive assessment are completed for all hospice patients.

Therefore, the HIS Comprehensive Assessment Measure continues to encourage hospices to improve and maintain high performance in all seven processes simultaneously, rather than rely on its component measures to demonstrate quality hospice care in a way that may be hard to interpret for consumers. The individual measures show performance for only one process and do not demonstrate whether the hospice provides high-quality care overall, as an organization. For example, a hospice may perform extremely well assessing treatment preferences, but poorly on addressing pain.

High-quality hospice care not only manages pain and symptoms of the terminal illness, but assesses non-clinical needs of the patient and family caregivers, which is a hallmark of patient-centered care. Since the HIS Comprehensive Assessment Measure captures all seven processes collectively, we believe that public display of the individual component measures are not necessary. The interdisciplinary, holistic scope of the NQF #3235 HIS Comprehensive Assessment Measure aligns with the public's expectations for hospice care.

In addition, the measure supports alignment across our programs and with other public and private initiatives. The seven individual components address care processes around hospice admission that are clinically recommended or required in the hospice CoPs. The Medicare Hospice CoPs require that hospice comprehensive assessments identify patients' physical, psychosocial, emotional, and spiritual needs and address them to promote the hospice patient's comfort throughout the end-of-life process.

Furthermore, the person-centered, family, and caregiver perspective align with the domains identified by the CoPs and the National Consensus Project [] as patients and their family caregivers also place value on physical symptom management and spiritual/psychosocial care as important factors at the end-of-life. The HIS Comprehensive Assessment Measure is a composite measure that serves to ensure all hospice patients receive a comprehensive assessment for both physical and psychosocial needs at admission. In addition, MedPAC's Report to Congress.

Medicare Payment Policy [] over the past few years notes that the HIS Comprehensive Assessment Measure differentiates the hospice's overall ability to address care processes better than the seven individual HIS process measures. In this way, it provides consumers viewing data on Care Compare with a streamlined way to Start Printed Page 19731assess the extent to which a hospice follows care processes. We are not proposing any revisions to the HIS Comprehensive Assessment Measure in this proposed rule because the single measure continues to provide value to patients, their families, and providers.

Because the HIS Comprehensive Assessment Measure is a more broadly applicable measure, we propose to remove the seven individual HIS process measures from the HQRP, no longer publicly reporting them as individual measures on Care Compare beginning with FY 2022. In addition, we are proposing to remove the “7 measures that make up the HIS Comprehensive Assessment Measure” section of Care Compare, which displays the seven HIS measures. We propose to make these changes removing the seven HIS process measures as individual measures from HQRP no earlier than May 2022.

Although this proposal removes the seven individual HIS process measures, it does not propose any changes to the requirement to submit the HIS admission assessment. Since the HIS Comprehensive Assessment Measure is a composite of the seven HIS process measures, the burden and requirement to report the HIS data remain unchanged in the time, manner, and form finalized in the FY 2017 Hospice Wage Index and Rate Update final rule (81 FR 52144). Hospices which do not report HIS data used for the HIS Comprehensive Assessment Measure will not meet the requirements for compliance with the HQRP.

We are soliciting public comment on the proposal to remove the seven HIS process quality measures as individual measures from the HQRP no earlier than May 2022, and to continue including the seven HIS process measures in the confidential quality measure (QM) Reports which are available to hospices. The seven HIS process measures are also available by visiting the data catalogue at https://data.cms.gov/​provider-data/​topics/​hospice-care. We are also seeking public comment on the technical correction to the regulation at § 418.312(b) effective October 1, 2021.

3. Proposal To Add a “Claims-Based Index Measure”, the Hospice Care Index We are proposing a new hospice quality measure, called the Hospice Care Index (HCI), which will provide more information to better reflect several processes of care during a hospice stay, and better empower patients and family caregivers to make informed health care decisions. The HCI is a single measure comprising ten indicators calculated from Medicare claims data.

The index design of the HCI simultaneously monitors all ten indicators. Collectively these indicators represent different aspects of hospice service and thereby characterize hospices comprehensively, rather than on just a single care dimension. Therefore, the HCI composite yields a more reliable provider ranking.

The HCI indicators, through the composite, would add new information to HQRP that was either directly recommended for CMS to publicly report by Federal stakeholders [] or identified as areas for improvement during information gathering activities. Furthermore, each indicator represents either a domain of hospice care recommended by leading hospice and quality experts [] for CMS to publicly report, or a requirement included in the hospice CoPs. The indicators required to calculate the single composite are discussed in the “Specifications for the HCI Indicators Selected” section below.

These specifications list all the information required to calculate each indicator, including the numerator and denominator definitions, different thresholds for receiving credit toward the overall HCI score, and explanations for those thresholds. Indicators reflect practices or outcomes hospices should pursue, thereby awarding points based on the criterion. The HCI scoring example in Table 16 illustrates how points are awarded based on meeting the criterion of the indicator.

For example, Gaps in Nursing Visits have a criterion of “lower than the 90th percentile,” and supports the hospice CoPs that require a member of the interdisciplinary team to ensure ongoing assessment of patient and caregiver needs and plan of care implementation. Other indicators, such as nurse visits on weekends or near death, have a criterion of “higher than the 10th percentile,” identifying hospice care delivery during the most vulnerable periods during a hospice stay. Each indicator equally affects the single HCI score, reflecting the equal importance of each aspect of care delivered from admission to discharge.

A hospice is awarded a point for meeting each criterion for each of the 10 indicators. The sum of the points earned from meeting the criterion of each indictor results in the hospice's HCI score, with 10 as the highest hospice score. The ten indicators, aggregated into a single HCI score, convey a broad overview of the quality of hospice care provision and validates well with CAHPS Willingness to Recommend and Rating of this Hospice.

The HCI will help to identify whether hospices have aggregate performance trends that indicate higher or lower quality of care relative to other hospices. Together with other measures already publicly reported in the HQRP, HCI scores will help patients and family caregivers better decide between hospice providers based on the factors that matter most to them. Additionally, creating a comprehensive quality measure capturing a variety of related care processes and outcomes in a single metric will provide consumers and providers an efficient way to assess the overall quality of hospice care, which can be used to meaningfully and easily compare hospice providers to make a better-informed health care decision.

The HCI will complement the existing HIS Comprehensive Measure and does not replace any existing reported measures. Both the HCI and the HIS Comprehensive Measure are composite measures in that they act as single measures that capture multiple areas of hospice care. Because the indicators comprising the HCI differ in data source from the HIS Comprehensive Measure, the HCI and the HIS Comprehensive Measure can together provide a meaningful and efficient way to inform patients and family caregivers, and support their selection of hospice care providers.

As a claims-based measure, the HCI measure would not impose any new collection of information requirements. To learn more about the background of the HCI, please watch this video. Https://youtu.be/​by68E9E2cZc.

A. Measure Importance The FY 2019 Hospice Wage Index and Payment Rate Update final rule (83 FR 38622) introduced the Meaningful Measure Initiative to hospice providers to identify high priority areas for quality measurement and improvement. The Meaningful Measure Initiative areas are intended to increase measure alignment across programs and other public and private initiatives.

Additionally, the initiative points to high priority areas where there may be informational gaps in available quality measures, while helping guide our efforts to develop and implement quality measures to fill those gaps, and develop those concepts towards quality measures that meet standards for public reporting. The goal of HQRP quality measure development is to identify measures from a variety of data sources that provide a window into Start Printed Page 19732hospice care throughout the dying process, fit well with the hospice business model, and meet the objectives of the Meaningful Measures initiative. To that end, the HCI seeks to add value to the HQRP by filling informational gaps in aspects of hospice service not addressed by the current measure set.

Consistent with the Meaningful Measure Initiative, we conducted a number of information gathering activities to identify informational gaps. Our information gathering activities included soliciting feedback from hospice stakeholders such as providers and family caregivers. Seeking input from hospice and quality experts through a Technical Expert Panel (TEP).

Interviews with hospice quality experts. Considering public comments received in response to previous solicitations on claims-based hospice quality initiatives. And a review of quality measurement recommendations offered by the OIG, MedPAC, and the peer-reviewed literature.

We found that hospices currently underutilize HQRP measures to inform their quality improvement, mainly because of gaps in relevant quality information within the HQRP measure set. In particular, the existing HQRP measure set, calculated using data collected from the HIS and the CAHPS Hospice survey, does not assess quality of hospice care during a hospice election (between admission and discharge). Moreover, the current measure set does not directly address the full range of hospice services or outcomes.

Therefore, we have identified a need for a new quality measure to address this gap and reflect care delivery processes during the hospice stay using available data without increasing data collection burden. Claims data are the best available data source for measuring care during the hospice stay and present an opportunity to bridge the quality measurement gap that currently exists between the HIS and CAHPS Hospice Survey. Medicare claims are administrative records of health care services provided and payments which Medicare (and beneficiaries as applicable) made for those services.

Claims are a rich and comprehensive source about many care processes and aspects of health care utilization. As such, they are a valuable source of information that can be used to measure the quality of care provided to beneficiaries for several reasons. Claims data are readily-available and reduce provider burden for implementation, as opposed to data collection through patient assessments or surveys, which require additional effort from clinicians, patients, and family caregivers before they can be submitted and used by CMS.

Claims data are collected based on care delivered, providing a more direct reflection of care delivery decisions and actions than patient assessments or surveys. Claims data are considered a reliable source of standardized data about the services provided, because providers must comply with Medicare payment and claims processing policy. Currently, CMS does publicly report several pieces of information derived from hospice claims data in the HQRP on Care Compare, including (i) the levels of care the hospice provided, (ii) the primary diagnoses the hospice served, (iii) the sites of service hospices provided care, and (iv) the hospice's daily census.

In the FY2018 Hospice Wage Index &. Payment Rate proposed rule (82 FR 20750), we solicited public comment on two high-priority claims-based measure concepts being considered at the time, one which looked at transitions from hospice and another which examined access to higher levels of hospice care. In response to this solicitation, CMS received public comments highlighting the potential limitations of a single concept claims-based measure.

In particular, a single-concept claims-based measure may not adequately account for all relevant circumstances that might influence a hospice's performance. While external circumstances could justify a hospice's poor performance on a single claims-based indicator, it would be unlikely for external circumstances to impact multiple claims-based indicators considered simultaneously. Therefore, the results of a multi-indicator claims-based index, such as HCI, is more likely to differentiate hospices than a single claims-based indicator.

Taking this public feedback into consideration, we designed the HCI and developed the specifications based on simulated reporting periods. B. Specifications for the HCI Indicators Selected The specifications for the ten indicators required to calculate the single HCI score are described in this section.

These component indicators reflect various elements and outcomes of care provided between admission and discharge. The HCI uses information from all ten indicators to collectively represent a hospice's ability to address patients' needs, best practices hospices should observe, and/or care outcomes that matter to consumers. Each indicator is a key component of the HCI measure that we are proposing, and all ten are necessary to derive the HCI score.

We use analytics, based on a variety of data files, to specify the indicators and measure. These data files include. Medicare fee-for-service (FFS) hospice claims with through dates on and between October 1, 2016 and September 30, 2019 to determine information such as hospice days by level of care, provision of visits, live discharges, hospice payments, and dates of hospice election.

Medicare fee-for-service inpatient claims with through dates on and between January 1, 2016 and December 31, 2019 to determine dates of hospitalization. Medicare beneficiary summary file to determine dates of death. Provider of Services (POS) File to examine trends in the scores of the HCI and its indicators, including by decade by which the hospice was certified for Medicare, ownership status, facility type, census regions, and urban/rural status.

CAHPS Hospice Survey to examine alignment between the survey outcomes and the HCI. We acquired all claims data from the Chronic Conditions Warehouse (CCW) Virtual Research Data Center (VRDC). We obtained the hospice claims and the Medicare beneficiary summary file in May 2020, and the inpatient data in August 2020.

We obtained the POS file data via. Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Downloadable-Public-Use-Files/​Provider-of-Services. We obtained the Hospice-aggregate CAHPS Hospice Survey outcome data via.

Https://data.cms.gov/​provider-data. We performed analyses using Stata/MP Version 16.1. Table 17 indicates the number of hospice days, hospice claims, beneficiaries enrolled in hospices and hospices with at least one claim represented in each year of our analysis.

Analysis for each year was based on the FY calendar. For example, FY 2019 covers claims with dates of services on or between October 1, 2018 and September 30, 2019. For these analyses, we exclude claims from hospices with 19 or fewer discharges [] within a FY.

The table reports the sample size before and after exclusion.[] Start Printed Page 19733 The rest of this section presents the component indicators and their specifications. Although we describe each component indicator separately, the HCI is a composite that can only be calculated using all 10 indicators combined. We believe that, composed of this set of ten indicators, the HCI will strengthen the HQRP by comprehensively, reflecting hospices' performance across all ten indicators.

(1). Indicator One. Continuous Home Care (CHC) or General Inpatient (GIP) Provided Medicare Hospice Conditions of Participation (CoPs) require hospices to be able to provide both CHC and GIP levels of care, if needed to manage more intense symptoms.[] However, a 2013 OIG report [] found that 953 hospice programs did not provide any GIP level of care services, and it was unclear if dying patients at such hospices were receiving appropriate pain control or symptoms management (a similar concern exists for hospice services at the CHC level).

To consider the provision of adequate services needed to manage patients' symptoms, the HCI measure includes an indicator for whether hospice programs provided any CHC or GIP service days. This indicator identifies hospices that provided at least one day of hospice care under the CHC or the GIP levels of care during the period examined. The provision of CHC and GIP is identified on hospice claims by the presence of revenue center codes 0652 (CHC) and 0656 (GIP).

The specifications for Indicator One, CHC or GIP services provided, are as follows. Numerator. The total number of CHC or GIP services days provided by the hospice within a reporting period.

Denominator. The total number of hospice service days provided by the hospice at any level of care within a reporting period. Index Earned Point Criterion.

Hospices earn a point towards the HCI if they provided at least one CHC or GIP service day within a reporting period. (2). Indicator Two.

Gaps in Nursing Visits The Medicare Hospice CoPs require a member of the interdisciplinary team to ensure ongoing assessment of patient and caregiver needs and plan of care implementation.[] The OIG has found instances of infrequent visits by nurses to hospice patients.[] To assess patients' receipt of adequate oversight, one HCI indicator examines hospices that have a high rate of patients who are not seen at least once a week by nursing staff. This indicator identifies whether a hospice is below the 90th percentile in terms of how often hospice stays of at least 30 days contain at least one gap of eight or more days without a nursing visit. Days of hospice service are identified based on the presence of revenue center codes 0651 (routine home care (RHC)), 0652 (CHC), 0655 (inpatient respite care (IRC)), and 0656 (GIP) on hospice claims.

We identify the dates billed for RHC, IRC, and GIP by examining the corresponding revenue center date (which identifies the first day in the sequence of days by level of care) and the revenue center units (which identify the number of days (including the first day) in the sequence of days by level of care). We identify the dates billed for CHC by examining the revenue center date.[] We define a hospice stay by a sequence of consecutive days for a particular beneficiary that are billed under the hospice benefit. A gap of at least 1 day without hospice ends the sequence.

For this indicator, we identified hospice stays that included 30 or more consecutive days of hospice. Once we identified those hospice stays, we examined the timing of the provision of nursing visits within those stays. We identified nursing visits if we observed any of the following criteria.

The presence of revenue center code 055x (Skilled Nursing) on the hospice claim. The date of the visit is recorded in the corresponding revenue center date. The presence of revenue code 0652 (CHC) on the hospice claim.

Days billed as CHC require more than half the hours provided be nursing hours. The presence of revenue code 0656 (GIP) on the hospice claim. We assume that days billed as GIP will include nursing visits.

We make that assumption instead of looking at the visits directly because Medicare does not require hospices to record all visits on the claim for the GIP level of care. Based on the above information, if within a hospice stay, we find eight or more consecutive days where no nursing visits are provided, no CHC is provided, and no GIP is provided, then we identify the hospice stay as having a gap in nursing visits greater than 7 days. This indicator helps the HCI to capture patients' receipt of adequate oversight through nurse visits and direct patient care, which is an important aspect of hospice care.

For each hospice, we divide the number of stays with at least one gap of eight or more days without a nursing visit (for stays of 30 or more days) by the number of stays of 30 or more days. We only consider the days within the period being examined. The specifications for Indicator Two, Gaps in Nursing Visits, are as follows:Start Printed Page 19734 Numerator.

The number of elections with the hospice where the patient experienced at least one gap between nursing visits exceeding 7 days, excluding hospice elections where the patient elected hospice for less than 30 days within a reporting period. Denominator. The total number of elections with the hospice, excluding hospice elections where the patient elected hospice for less than 30 days within a reporting period.

Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for gaps in nursing visits greater than 7 days falls below the 90th percentile ranking among hospices nationally. (3).

Indicator Three. Early Live Discharges Prior work has identified various concerning patterns of live discharge from hospice. High rates of live discharge suggest concerns in hospices' care processes, their advance care planning to prevent hospitalizations, or their discharge processes.[] As MedPAC noted,[] “Hospice providers are expected to have some rate of live discharges because some patients change their mind about using the hospice benefit and dis-enroll from hospice or their condition improves and they no longer meet the hospice eligibility criteria.

However, providers with substantially higher percent of live discharge than their peers could signal a potential concern with quality of care or program integrity. An unusually high rate of live discharges could indicate that a hospice provider is not meeting the needs of patients and families or is admitting patients who do not meet the eligibility criteria.” Our live discharge indicators included in the HCI, like MedPAC's, comprise discharges for all reasons. They include instances where the patient was no longer found terminally ill and revocations due to the patient's choice.

MedPAC explains their rationale for including all discharge as follows:[] “Some stakeholders argue that live discharges initiated by the beneficiary—such as when the beneficiary revokes his or her hospice enrollment—should not be included in a live-discharge measure because, some stakeholders assert, these discharges reflect beneficiary preferences and are not in the hospice's control. Because beneficiaries may choose to revoke hospice for a variety of reasons, which in some cases are related to the hospice provider's business practices or quality of care, we include revocations in our analysis.” This indicator identifies whether a hospice is below the 90th percentile in terms of the percentage of live discharges that occur within 7 days of hospice admission during the fiscal year examined. Live discharges occur when the patient discharge status code on a hospice claim does not equal a code from the following list.

€œ30”, “40”, “41”, “42”, “50”, “51”. We measure whether a live discharge occurs during the first 7 days of hospice by looking at a patient's lifetime length of stay in hospice.[] For each hospice, we divide the number of live discharges in the first 7 days of hospice by the number of live discharges. Live discharges are assigned to a particular reporting period based on the date of the live discharge (which corresponds to the through date on the claim indicating the live discharge).

The specifications for Indicator Three, Early Live Discharges, are as follows. Numerator. The total number of live discharges from the hospice occurring within the first 7 days of hospice within a reporting period.

Denominator. The total number of all live discharge from the hospice within a reporting period. Index Earned Point Criterion.

Hospices earn a point towards the HCI if their individual percentage of live discharges on or before the seventh day of hospice falls below the 90th percentile ranking among hospices nationally. (4). Indicator Four.

Late Live Discharges The rate of live discharge that occurred 180 days or more after hospice enrollment identifies another potentially concerning pattern of live discharge from hospice. Both indicator three and indicator four of the HCI recognize concerning patterns of live discharge impacting patient experience and quality of care. MedPAC, in descriptive analyses of hospices exceeding the Medicare annual payment cap, noted that “if some hospices have rates of discharging patients alive that are substantially higher than most other hospices it raises concerns that some hospices may be pursuing business models that seek out patients likely to have long stays who may not meet the hospice eligibility criteria”.[] Because of quality implications for hospices who pursue such business models, the live discharge after long hospice enrollments was included in the index.

This indicator identifies whether a hospice is below the 90th percentile in terms of the percentage of live discharges that occur on or after the 180th day of hospice. Live discharges occur when the patient discharge status code does not equal a value from the following list. €œ30”, “40”, “41”, “42”, “50”, “51”.

We measure whether a live discharge occurs on or after the 180th day of hospice by looking at a patient's lifetime length of stay in hospice. For each hospice, we divide the number of live discharges that occur on or after the 180th day of hospice by the number of live discharges. Live discharges are assigned to a particular reporting period based on the date of the live discharge (which corresponds to the through date on the claim).

The specifications for Indicator Four, Late Live Discharges, are as follows. Numerator. The total number of live discharges from the hospice occurring on or after 180 days of enrollment in hospice within a reporting period.

Denominator. The total number of all live discharge from the hospice within a reporting period. Index Earned Point Criterion.

Hospices earn a point towards the HCI if their individual hospice score for live discharges on or after the 180th day of hospice falls below the 90th percentile ranking among hospices nationally. (5). Indicator Five.

Burdensome Transitions (Type 1)—Live Discharges From Hospice Followed by Hospitalization and Subsequent Hospice Readmission The Type 1 burdensome transitions reflects hospice live discharge with a hospital admission within 2 days of hospice discharge, and then hospice readmission within 2 days of hospital discharge. This pattern of transitions may lead to fragmented care and may be associated with concerning care processes. For example, Type 1 burdensome transitions may arise from a deficiency in advance care planning to prevent hospitalizations or a discharge process that does not appropriately identify a hospice patient whose conditions are stabilized prior to discharge.[] Start Printed Page 19735 This indicator identifies whether a hospice is below the 90th percentile in terms of the percentage of live discharges that are followed by a hospitalization (within 2 days of hospice discharge) and then followed by a hospice readmission (within 2 days of hospitalization) during the FY examined.

Live discharges occur when the patient discharge status code does not equal a value from the following list. €œ30”, “40”, “41”, “42”, “50”, “51”. Hospitalizations are found by looking at all fee-for-service Medicare inpatient claims.

Overlapping inpatient claims were combined to determine the full length of a hospitalization (looking at the earliest from date and latest through date from a series of overlapping inpatient claims for a beneficiary). In order to be counted, the “from” date of the hospitalization had to occur no more than 2 days after the date of hospice live discharge.[] From there, we found all beneficiaries that ended their hospitalization and were readmitted back to hospice no more than 2 days after the last date of the hospitalization. To calculate the percentage, for each hospice we divided the number of live discharges that are followed by a hospitalization (within 2 days of hospice discharge) and then followed by a hospice readmission (within 2 days of hospitalization) in a given reporting period by the number of live discharges in that same period.

The specifications for Indicator Five, Burdensome Transitions Type 1, are as follows. Numerator. The total number of live discharges from the hospice followed by hospital admission within 2 days, then hospice readmission within 2 days of hospital discharge within a reporting period.

Denominator. The total number of all live discharge from the hospice within a reporting period. Index Earned Point Criterion.

Hospices earn a point towards the HCI if their individual hospice score for Type 1 burdensome transitions falls below the 90th percentile ranking among hospices nationally. (6). Indicator Six.

Burdensome Transitions (Type 2)—Live Discharges From Hospice Followed by Hospitalization With the Patient Dying in the Hospital Death in a hospital following live discharge in another concerning pattern in hospice use. Thus, we believe that indicators five and indicator six of the HCI are necessary to differentiate concerning behaviors affecting patient care. This indicator reflects hospice live discharge followed by hospitalization within 2 days with the patient dying in the hospital, referred to as Type 2 burdensome transitions.

This pattern of transitions may be associated with a discharge process that does not appropriately assess the stability of a hospice patient's conditions prior to live discharge.[] This indicator identifies whether a hospice is below the 90th percentile in terms of the percentage of live discharges that are followed by a hospitalization (within two days of hospice discharge) and then the patient dies in the hospital. Live discharges occur when the patient discharge status code does not equal a value from the following list. €œ30”, “40”, “41”, “42”, “50”, “51”.

Hospitalizations are found by looking at all inpatient claims. Overlapping inpatient claims were combined to determine a full length of a hospitalization (looking at the earliest from date and latest through date from a series of overlapping inpatient claims). To be counted, the “from” date of the hospitalization had to occur no more than 2 days after the date of hospice live discharge.

From there, we identified all beneficiaries whose date of death is listed as occurring during the dates of the hospitalization. To calculate the percentage, for each hospice we divided the number of live discharges that are followed by a hospitalization (within 2 days of hospice discharge) and then the patient dies in the hospital in a given FY by the number of live discharges in that same reporting period. The specifications for Indicator Six, Burdensome Transitions Type 2, are as follows.

Numerator. The total number of live discharges from the hospice followed by a hospitalization within 2 days of live discharge with death in the hospital within a reporting year. Denominator.

The total number of all live discharge from the hospice within a reporting year. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for Type 2 burdensome transitions falls below the 90th percentile ranking among hospices nationally.

(7). Indicator Seven. Per-Beneficiary Medicare Spending Estimates of per-beneficiary spending are endorsed by NQF (#2158) [] and publicly reported by CMS for other care settings.

Because the Medicare hospice benefit pays a per diem rate, an important determinant of per-beneficiary spending is the length of election. MedPAC reported that nearly half of Medicare hospice expenditures are for patients that have had at least 180 or more days on hospice, and expressed a concern that some programs do not appropriately discharge patients whose medical condition makes them no longer eligible for hospice services, or, that that hospices selectively enroll patients with non-cancer diagnoses and longer predicted lengths of stay in hospice.[] The other determinant of per-beneficiary spending is the level of care at which services are billed. In a 2016 report, the OIG has expressed concern at the potentially inappropriate billing of GIP care.[] For these reasons the HCI includes one indicator for per-beneficiary spending.

Lower rates of per beneficiary spending may identify hospices that provide efficient care at a lower cost to Medicare. This indicator identifies whether a hospice is below the 90th percentile in terms of the average Medicare hospice payments per beneficiary. Hospice payments per beneficiary are determined by summing together all payments on hospice claims for a particular reporting year for a particular hospice.

The number of beneficiaries a hospice serves in a particular year is determined by counting the number of unique beneficiaries on all hospice claims in the same period for a particular hospice. Medicare spending per beneficiary is then calculated by dividing the total payments by the total number of unique beneficiaries. The specifications for Indicator Seven, Per-Beneficiary Medicare Spending, are as follows:Start Printed Page 19736 Numerator.

Total Medicare hospice payments received by a hospice within a reporting period. Denominator. Total number of beneficiaries electing hospice with the hospice within a reporting period.

Index Earned Point Criterion. Hospices earn a point towards the HCI if their average Medicare spending per beneficiary falls below the 90th percentile ranking among hospices nationally. (8).

Indicator Eight. Nurse Care Minutes per Routine Home Care (RHC) Day Medicare Hospice CoPs require a member of the interdisciplinary team to ensure ongoing assessment of patient and caregiver needs.[] Such assessment is necessary to ensure the successful preparation, implementation, and refinements for the plan of care. Hospices must also ensure that patients and caregivers receive education and training as appropriate to their responsibilities for the care and services identified in the plan of care.

To assess adequate oversight, the HCI includes this indicator assessing the average number of skilled nursing minutes per day during RHC days to differentiate hospices that are providing assessment throughout the hospice stay. This indicator identifies whether a hospice is above the 10th percentile in terms of the average number of nursing minutes provided on RHC days during the reporting period examined. We identify RHC days by the presence of revenue code 0651 on the hospice claim.

We identify the dates of RHC service by the corresponding revenue center date (which identifies the first day of RHC) and the revenue center units (which identifies the number of days of RHC (including the first day of RHC)). We identify nursing visits by the presence of revenue code 055x (Skilled Nursing) on the claim. We count skilled nursing visits where the corresponding revenue center date overlaps with one of the days of RHC previously identified.

We then count the minutes of skilled nursing visits by taking the corresponding revenue center units (that is, one unit is 15 minutes) and multiplying by 15. For each hospice, we sum together all skilled nursing minutes provided on RHC days and divide by the sum of RHC days. The specifications for Indicator Eight, Nurse Care Minutes per RHC Day, are as follows.

Numerator. Total skilled nursing minutes provided by a hospice on all RHC service days within a reporting period. Denominator.

The total number of RHC days provided by a hospice within a reporting period. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for Nursing Minutes per RHC day falls above the 10th percentile ranking among hospices nationally.

(9). Indicator Nine. Skilled Nursing Minutes on Weekends Our regulations at § 418.100(c)(2) require that “[n]ursing services, physician services, and drugs and biologicals.

. . Be made routinely available on a 24-hour basis seven days a week”.[] Ongoing assessment of patient and caregiver needs and plan of care implementation are necessary for adequate hospice care oversight.

Fewer observed hospice services on weekends (relative to that provided on weekdays) is not itself an indication of a lack of access. In fact, on weekends, patients' caregivers are more likely to be around and could prefer privacy from hospice staff. However, patterns of variation across providers could signal less service provider availability and access for patients on weekends.

Thus, the HCI includes this indicator to further differentiate whether care is available to patients on weekends. To assess hospice service availability, this indicator includes minutes of care provided by skilled nurses on weekend RHC days. This indicator identifies whether a hospice is at or above the 10th percentile in terms of the percentage of skilled nursing minutes performed on weekends compared to all days during the reporting period examined.

We identify RHC days by the presence of revenue code 0651 on the hospice claim. We identify the dates of RHC service by the corresponding revenue center date (which identifies the first day of RHC) and the revenue center units (which identifies the number of days of RHC (including the first day of RHC)). We identify nursing visits by the presence of revenue code 055x (Skilled Nursing) on the claim.

We count skilled nursing visits where the corresponding revenue center date overlaps with one of the days of RHC previously identified. We then count the minutes of skilled nursing visits by taking the corresponding revenue center units and multiplying by 15. For each hospice, we sum together all skilled nursing minutes provided on RHC days that occur on a Saturday or Sunday and divide by the sum of all skilled nursing minutes provided on all RHC days.

The specifications for Indicator Nine, Skilled Nursing Minutes on Weekends, are as follows. Numerator. Total sum of minutes provided by the hospice during skilled nursing visits during RHC services days occurring on Saturdays or Sunday within a reporting period.

Denominator. Total skilled nursing minutes provided by the hospice during RHC service days within a reporting period. Index Earned Point Criterion.

Hospices earn a point towards the HCI if their individual hospice score for percentage of skilled nursing minutes provided during the weekend is above the 10th percentile ranking among hospices nationally. (10). Indicator Ten.

Visits Near Death The end of life is typically the period in the terminal illness trajectory with the highest symptom burden. Particularly during the last few days before death, patients (and caregivers) experience many physical and emotional symptoms, necessitating close care and attention from the integrated hospice team and drawing increasingly on hospice team resources.[] Physical symptoms of actively dying can often be identified within three days of death in some patients.[] This indicator identifies whether a hospice is at or above the 10th percentile in terms of the percentage of beneficiaries with a nurse and/or medical social services visit in the last 3 days of life. For this indicator, we first Start Printed Page 19737determine if a beneficiary was in hospice for at least 1 day during their last 3 days of life by comparing days of hospice enrollment from hospice claims to their date of death.

We identify nursing visits and medical social service visits by the presence of revenue code 055x (Skilled Nursing) and 056x (Medical Social Services) on the claim. We identify the dates of those visits by the revenue center date for those revenue codes. Additionally, we assume that days billed as GIP (revenue code 0656) will include nursing visits.

We make that assumption instead of looking at the visits directly because Medicare does not require hospices to record all visits on the claim for the GIP level of care. For each hospice, we divide the number of beneficiaries with a nursing or medical social service visits on a hospice claim during the last 3 days of life by the number of beneficiaries with at least 1 day of hospice during the last 3 days of life. The specifications for Indicator Ten, Visits Near Death, are as follows.

Numerator. The number of decedent beneficiaries receiving a visit by a skilled nurse or social worker staff for the hospice in the last 3 days of the beneficiary's life within a reporting period. Denominator.

The number of decedent beneficiaries served by the hospice within a reporting period. Index Earned Point Criterion. Hospices earn a point towards the HCI if their individual hospice score for percentage of decedents receiving a visit by a skilled nurse or social worked in the last 3 days of life falls above the 10th percentile ranking among hospices nationally.

(11). Hospice Care Index Scoring Example As discussed during the NQF's January 2021 MAP meeting, the HCI summarizes information from ten indicators with each indicator representing key components of the hospice care recognizing care delivery and processes. Hospices receive a single HCI score, which reflects the information from all ten indicators.

Specifically, a hospice's HCI score is based on its collective performance on the ten performance indicators detailed above, all of which must be included to calculate the score and meaningfully distinguish between hospices' relative performance. The HCI's component indicators are assigned a criterion determined by statistical analysis of an individual hospice's indicator score relative to national hospice performance. Table 18 illustrates how a hypothetical hospice's score is determined across all ten indicators, and how the ten indicators' scores determine the overall HCI score.

Start Printed Page 19738 Start Printed Page 19739 c. Measure Reportability, Variability, and Validity As part of developing the HCI, we conducted reportability, variability, and validity testing using claims data from FY 2019. Reportability analyses found a high proportion of hospices (over 85 percent) that would yield reportable measure scores over 1 year (for more on reportability analysis, see section (2) Update on Use of Q4 2019 Data and Data Freeze for Refreshes in 2021.).

Variability analyses confirmed that HCI demonstrates sufficient ability to differentiate hospices. Hospices' scores on the HCI can range from zero to ten. During measure testing, we observed that hospices achieved scores between three and ten.

In testing, 37.1 percent of hospices scored ten out of ten, 30.4 percent scored nine out of ten, 17.9 percent scored eight out of ten, 9.6 percent scored seven out of ten, and 5.0 percent scored six or lower, as shown in Figure 6. Validity analyses showed that hospices' HCI scores align with family caregivers' perceptions of hospice quality, as measured by CAHPS Hospice survey responses (NQF endorsed quality measure #2651). Hospices with higher HCI scores generally achieve better caregiver ratings as measured by CAHPS Hospice scores, and hospices with lower HCI scores generally achieve poorer CAHPS Hospice scores.

As measured by Pearson's correlation coefficients, the correlation between the CAHPS hospice overall rating and the HCI is +0.0675, and the correlation between the CAHPS hospice recommendation outcome and the HCI score is +0.0916. As such, HCI scores are consistent with CAHPS Hospice caregiver ratings, supporting the index as a valid measurement of hospice care. We also conducted a stability analysis by comparing index scores calculated for the same hospice using claims from Federal FY 2017 and 2019.

The analysis found that 82.8 percent of providers' scores changed by, at most, one point over the 2 years. These results serve as evidence of the measure's reliability by indicating that a hospice's HCI scores would not normally fluctuate a great deal from one year to the next. D.

Stakeholder Support A TEP convened by our measure development contractor, in April 2020, provided input on this measure concept. Additionally, during the summer of 2020, CMS convened five listening sessions with national hospice provider organizations to discuss the HCI concept with the goals of engaging stakeholders and receiving feedback early in the measure's development. In October 2020, our contractor, Abt Associates, convened a workgroup of family caregivers whose family members have received hospice care to provide input on this measure concept from the family and caregiver perspective.

Finally, the NQF Measures Application Partnership (MAP) met on January 11, 2021 and provided input to CMS. The MAP conditionally supports the HCI for rulemaking contingent on NQF endorsement. The “2020-2021 MAP 2020 Final Recommendations” can be found at.

Http://www.qualityforum.org/​WorkArea/​linkit.aspx?. €‹LinkIdentifier=​id&​ItemID=​94893. Stakeholders were generally supportive of a quality measure based on multiple indicators using claims data for public reporting.

Several hospice providers expressed support for the measure's ability to demonstrate greater variation in hospice performance than the component indicators taken individually. Hospice caregivers also welcomed the addition of new quality measures to HQRP to better differentiate between hospices. In particular, family caregivers stated that there might be a need for several HCI indicators, such as nursing availability on weekends and average Medicare per-beneficiary spending, to be included on Care Compare as additional information.

Some stakeholders raised concerns that claims data may not adequately express the quality of care provided, and may be better suited as an indicator for program integrity or compliance issues. Hospice providers suggested that claims may lack sufficient information to adequately reflect individual patient needs or the full array of hospice Start Printed Page 19740practices. In particular, claims do not fully capture patients' clinical conditions, patient and caregiver preferences, or hospice activities such as telehealth, chaplain visits, and specialized services such as massage or music therapy.

After much consideration of the input received, we believe the benefits of proposing adoption of the HCI outweigh its limitations. The HCI would not be intended to account for all potentially valuable aspects of hospice care, nor would it be expected to entirely close the information gaps presently found in the HQRP. Rather, the HCI would serve as a useful measure to add value to the HQRP by providing more information to patients and family caregivers and better empowering them to make informed health care decisions.

We view the HCI as an opportunity to add value to the HQRP, augmenting the current measure set with an index of indicators compiled from currently available claims data. This will provide new and useful information to patients and family caregivers without further burden to them, or to providers. Stakeholders also suggested several valuable exploratory analyses, improvements for the indicators presented, and ideas for eventual public display for CMS to consider.

We further refined the HCI based on this feedback, focusing on those indicators with the strongest consistency with CAHPS Hospice scores and/or which quality experts have identified as salient issues for measurement and observation. We also revised and refined how the HCI will be publicly displayed on Care Compare in response to family caregiver input. E.

Form, Manner and Timing of Data Collection and Submission The data source for this HCI measure will be Medicare claims data that are already collected and submitted to CMS. We propose to begin reporting this measure using existing data items no earlier than May 2022. For more details, see section (3).

Proposal to Publicly Report the Hospice Care Index and Hospice Visits in the Last Days of Life Claims-based Measures. In addition, to help hospices understand the HCI and their hospice's performance, we will revise the confidential QM report to include claims-based measure scores, including agency and national rates through the Certification and Survey Provider Enhanced Reports (CASPER) or replacement system. The QM report will also include results of the individual indicators used to calculate the single HCI score, and provide details on the indicators and HCI overall score to support hospices in interpreting the information.

The HCI indicators will be available by visiting the Provider Data Catalog at https://data.cms.gov/​provider-data/​topics/​hospice-care. We are soliciting public comment on the proposal to add the composite HCI measure to the HQRP starting in FY 2022. We are also soliciting comments on the proposal to add the HCI to the program for public reporting beginning no earlier than May 2022.

4. Update on the Hospice Visits in the Last Days of Life (HVLDL) and Hospice Item Set V3.00 On August 13, 2020, we sought public comment in an information collection request to remove Section O “Service Utilization” (hereafter referred to as Section O) of the HIS discharge assessment. Removal of Section O is the sole change from HIS V2.01 and in effect eliminate the HVWDII quality measure pair.

In Paperwork Reduction Act package (PRA), CMS-10390 (OMB control number. 0938-1153), we also proposed to replace the HVWDII measure pair with the HVLDL. This means that we will no longer report HVWDII with patient discharges and will start publicly reporting HVLDL no earlier than May 2022.

The Office of Management and Budget (OMB) approved the collection of information to remove Section O of the HIS expiring on February 29, 2024, (OMB Control Number. 0938-1153, CMS-10390). We direct the public to review the PRA at https://www.cms.gov/​regulations-and-guidancelegislationpaperworkreductionactof1995pra-listing/​cms-10390 and HVWDII report at https://www.cms.gov/​files/​document/​hqrphospice-visits-when-death-imminent-testing-re-specification-reportoctober-2020.pdf.

As a claims-based measure, the HVLDL measure would not impose any new collection of information requirements. The HVLDL measure, as a replacement, will continue to fill an important area in hospice care previously filled by the HVWDII measure pair. We discussed the analysis with a TEP convened by our measure development contractor in November 2019 and with the MAP, hosted by the NQF in December 2019 [] for inclusion in the HQRP.

During these meetings, the discussions reflecting on the analysis generally supported the replacement of HVWDII with a claims-based HVLDL measure. The November 2019 TEP report can be found in the downloads section at Hospice QRP Provider Engagement Opportunities and final recommendations and presentation of the HVLDL measure before NQF's MAP can be found at Quality Forum—Post-Acute Care, https://www.qualityforum.org/​Publications/​2020/​02/​MAP_​2020_​Considerations_​for_​Implementing_​Measures_​Final_​Report_​-_​PAC_​LTC.aspx. OMB approved the proposal to replace the HVWDII measure with the HVLDL measure and remove Section O from the discharge assessment on February 16, 2021.

The HIS V3.00 became effective on February 16, 2021 and expires on February 29, 2024. OMB control number 0938-1153. 5.

Proposal To Revise § 418.312(b) Submission of Hospice Quality Reporting Program Data To address the inclusion of administrative data, such as Medicare claims used for hospice claims-based measures like the HVLDL and HCI in the HQRP and correct technical errors identified in the FY 2016 and 2019 Hospice Wage Index and Payment Rate Update final rules, we propose to revise the regulation at § 418.312(b) by adding paragraphs (b)(1) through (3). As proposed, paragraph (b)(1) would now include the existing language on the standardized set of admission and discharge items. Paragraph (b)(2) would require collection of Administrative Data, such as Medicare claims data, used for hospice quality measures to capture services throughout the hospice stay.

And these data automatically meet the HQRP requirements for § 418.306(b)(2). Paragraph (b)(3) would be a technical correction to address errors identified in the FY 2016 and FY 2019 Hospice Wage Index and Payment Rate Update final rules, (80 FR 47186 and 83 FR 38636). In the FY 2016 Hospice final rule (80 FR 47186) adopted seven factors for measure removal, and in the FY 2019 Hospice final rule (83 FR 38636) adopted the eighth factor for measure removal.

In those final rules, we referenced the measure removal factors in the preamble but inadvertently omitted them from the regulations text. Thus, these measure removal factors identify how measures are removed from the HQRP. Section 418.312(b)(3) would include the eight measure removal factors as follows.

CMS may remove a quality measure from the Hospice QRP based on one or more of the following factors:Start Printed Page 19741 (1) Measure performance among hospices is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. (2) Performance or improvement on a measure does not result in better patient outcomes. (3) A measure does not align with current clinical guidelines or practice.

(4) The availability of a more broadly applicable (across settings, populations, or conditions) measure for the particular topic. (5) The availability of a measure that is more proximal in time to desired patient outcomes for the particular topic. (6) The availability of a measure that is more strongly associated with desired patient outcomes for the particular topic.

(7) Collection or public reporting of a measure leads to negative unintended consequences other than patient harm. (8) The costs associated with a measure outweigh the benefit of its continued use in the program. We solicit public comment on our proposal to revise the regulation at § 418.312(b) to add paragraphs (b)(1) through (3) to include administrative data as part of the HQRP, and correct technical errors identified in the FY 2016 and 2019 Hospice Wage Index and Payment Rate Update final rules.

6. Update Regarding the Hospice Outcomes &. Patient Evaluation (HOPE) Development As finalized in the FY 2020 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements final rule (84 FR 38484), we are developing a hospice patient assessment instrument identified as the HOPE.

This tool is intended to help hospices better understand care needs throughout the patient's dying process and contribute to the patient's plan of care. It will assess patients in real-time, based on interactions with the patient. The HOPE will support quality improvement activities and calculate outcome and other types of quality measures in a way that mitigates burden on hospice providers and patients.

Our two primary objectives for the HOPE are to provide quality data for the HQRP requirements through standardized data collection, and to provide additional clinical data that could inform future payment refinements. We anticipate that the HOPE will replace the HIS. The HIS is not a patient assessment instrument.

HIS data collection “consists of selecting responses to HIS items in conjunction with patient assessment activities or via abstraction from the patient's clinical record.” (HIS Manual v.2.01). In contrast, the HOPE is a patient assessment instrument, designed to capture patient and family care needs in real-time during patient interactions throughout the patient's hospice stay, with the flexibility to accommodate patients with varying clinical needs. The HOPE will enable CMS and hospices to understand the care needs of people through the dying process, supporting provider care planning and quality improvement efforts, and ensuring the safety and comfort of individuals enrolled in hospice nationwide.

The HOPE will include key items from the HIS along with Standardized Patient Assessment Data Elements (SPADEs), and demographics like gender and race. This approach to include key aspects of SPADES and demographics supports hospice feedback provided in the FYs 2017 and 2018 Hospice Wage Index and Payment Rate Update final rule (81 FR 52171 and 82 FR 36669) and CMS' goals for a hospice assessment instrument, as stated in the FY 2018 Hospice Wage Index and Payment Rate Update final rule. The HOPE assessment instrument would facilitate communication among providers and to measure the care of patient populations across settings.

While the standardization of measures required for adoption under the IMPACT Act of 2014 is not applicable to hospices, it makes reasonable sense to include those standardized elements and items that appropriately and feasibly apply to hospice. After all, some patients may move through the healthcare system to hospice so capturing and tracking key SPADES and social risk factor items that apply to hospice, including some of the categories of SPADES identified in the IMPACT Act of 2014, may help CMS achieve our goals for continuity of care, overall patient care and well-being, interoperability, and health equity that are also discussed in this rule. The draft HOPE has undergone cognitive and pilot testing, and will undergo field testing to establish reliability, validity and feasibility of the assessment instrument.

We anticipate proposing the HOPE in future rulemaking after testing is complete. We will continue development of the HOPE assessment in accordance with the Blueprint for the CMS Measures Management System. Development of the HOPE is grounded in extensive information gathering activities to identify and refine hospice assessment domains and candidate assessment items.

We appreciate the industry's and national associations' engagement in providing input through information sharing activities, including expert interviews, key stakeholder interviews, and focus groups to support the HOPE development. As CMS proceeds with field testing the HOPE, we will continue to engage with stakeholders through sub-regulatory channels. In particular, we will continue to host HQRP Forums to allow hospices and other interested parties to engage with us on the latest updates and ask questions on the development of the HOPE and related quality measures.

We also have a dedicated email account, HospiceAssessment@cms.hhs.gov, for comments about the HOPE. We will use field test results to create a final version of the HOPE to propose in future rulemaking for national implementation. We will continue to engage all stakeholders throughout this process.

We appreciate the support for the HOPE and reiterate our commitment to providing updates and engaging stakeholders through sub-regulatory means. Future updates and engagement opportunities regarding HOPE can be found at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​HOPE.html.

7. Update on Quality Measure Development for Future Years In the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52160), we finalized new policies and requirements related to the HQRP, including how we would provide updates related to the development of new quality measures. Information on the current HQRP quality measures can be found at.

Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​Current-Measures. In this proposed rule, we are continuing to provide updates for both HOPE-based and claims-based quality measure development. To support new measure development, our contractor, Abt Associates, convened TEP meetings in 2020 to provide feedback on several measure concepts.

In 2020, the TEP explored potential quality measure constructs that could be derived from the HOPE and their specifications. Specifically, for HOPE-based measure development, the TEP focused on pain and other symptom outcome measure concepts that could be calculated from the HOPE. Input from initial TEP workgroups held in spring 2020 informed follow-up information-gathering activities related to pain in general and neuropathic pain in particular.

The 2020 Information Start Printed Page 19742Gathering Summary report is available at https://www.cms.gov/​files/​document/​12042020-information-gathering-oy1508.pdf. During fall 2020, the TEP reviewed measure concepts focusing on pain and symptom outcomes that could be calculated from HOPE items. The TEP supported further exploration and development of these measures.

As described in the 2020 TEP Summary Report, the TEP generally supports the following measure concepts that are calculated using HOPE items. Timely Reduction of Pain Impact, Reduction in Pain Severity, and Timely Reduction of Symptoms. The candidate measure Timely Reduction of Pain Impact reports the percentage of patients who experienced a reduction in the impact of moderate or severe pain.

HOPE items assessing Symptom Impact, and Patient Desired Tolerance Level for Symptoms or Patient Preferences for Symptom Management were used to calculate this measure. The candidate measure Reduction in Pain Severity reports the percentage of patients who had a reduction in reported pain severity. The primary HOPE items used to calculate this measure include Pain Screening, Pain Active Problem, and Patient Desired Tolerance Level for Symptoms or Patient Preferences for Symptom Management.

The last candidate measure discussed by the TEP was Timely Reduction of Symptoms which measures the percentage of patients who experience a reduction in the impact of symptoms other than pain. The HOPE items assessing Symptom Impact, and Patient Desired Tolerance Level for Symptoms or Patient Preferences for Symptom Management were used to calculate this measure. The HOPE items for all three measure are collected at multiple time points across a patient's stay, including at Admission, Symptom Reassessment, Level of Care Change, and Recertification.

Overall, the TEP supported each candidate measure and agreed that they were viable for distinguishing hospice quality. We continue to develop all three candidate quality measures. We are interested in exploring patient preferences for symptom management, addressing patient spiritual and psychosocial needs, and medication management in outcomes of care in development of quality measures.

We seek public comment, methods, instruments, or brief summaries on hospice quality initiatives related to goal attainment, patient preferences, spiritual needs, psychosocial needs, and medication management. Information about the TEP feedback on these quality measures concepts and future measure concepts can be obtained via. Https://www.cms.gov/​files/​document/​2020-hqrp-tep-summary-report.pdf.

Related to the outcome measures and in order to have HOPE pain and symptom measures in the program as soon as possible, we plan to develop process measures, including on pain and symptom management. These process measures may support or complement the outcome measures. We solicit comments on current HOPE-based quality measure development and recommendations for future process and outcome measure constructs.

In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484) and as discussed below, we are interested in claims-based quality measures in order to leverage the multiple data sources currently available to support quality measure development. Specifically, we intend to develop additional claims-based measures that may enable beneficiaries and their family caregivers to make more informed choices about hospice care and to hold hospices more accountable for the care they provide. As discussed in this section, the HVLDL and HCI claims-based measures support the Meaningful Measures initiative and address gaps in HQRP.

Additional claim-based measure concepts we are considering for development include hospice services on weekends, transitions after hospice live discharge, Medicare expenditures per beneficiary (including the share of non-hospice spending during hospice election, and the share for hospice care prior to the last year of life), and post-mortem visits as measures of hospice quality. We intend to submit additional claims-based measures for future consideration and solicit public comment. We solicit public comment on the aforementioned HOPE- and claims-based quality measures to distinguish between high- and low-quality hospices, support healthcare providers in quality improvement efforts, and provide support to hospice consumers in helping to select a hospice provider.

We solicit public comment on how the candidate measures may achieve those goals. We are also considering developing hybrid quality measures that would be calculated using claims, assessment (HOPE), or other data sources. Hybrid quality measures allow for a more comprehensive set of information about care processes and outcomes than can be calculated using claims data alone.

Assessment data can be used to support risk-adjustment. We seek public comment on quality measure concepts and considerations for developing hybrid measures based on a combination of data sources. 8.

CAHPS Hospice Survey Participation Requirements for the FY 2023 APU and Subsequent Years a. Background and Description of the CAHPS Hospice Survey The CAHPS Hospice Survey is a component of the CMS HQRP which is used to collect data on the experiences of hospice patients and the primary caregivers listed in their hospice records. Readers who want more information about the development of the survey, originally called the Hospice Experience of Care Survey, may refer to 79 FR 50452 and 78 FR 48261.

National implementation of the CAHPS Hospice Survey commenced January 1, 2015 as stated in the FY 2015 Hospice Wage Index and Payment Rate Update final rule (79 FR 50452). B. Overview of the “CAHPS Hospice Survey Measures” The CAHPS Hospice Survey measures was re-endorsed by NQF on November 20, 2020.

The re-endorsement can be found on the NQF website at. Https://www.qualityforum.org/​Measures_​Reports_​Tools.aspx. Use the QPS tool and search for NQF number 2651.

The survey received its initial NQF endorsement on October 26, 2016 (NQF #2651). We adopted 8 survey based measures for the CY 2018 data collection period and for subsequent years. These eight measures are publicly reported on a designated CMS website, Care Compare, https://www.medicare.gov/​care-compare/​.

c. Data Sources We previously finalized the participation requirements for the CAHPS Hospice Survey, (84 FR 38484). We propose no changes to these requirements going forward.

D. Public Reporting of CAHPS Hospice Survey Results We began public reporting of the results of the CAHPS Hospice Survey on Hospice Compare as of February 2018. Prior to the skin care products public health emergency (PHE), we reported the most recent 8 quarters of data on the basis of a rolling average, with the most recent quarter of data being added and the oldest quarter of data removed from the averages for each data refresh.

Given the exemptions provided due to skin care products PHE in the March 27, 2020 Guidance Memorandum,[] public reporting will Start Printed Page 19743continue to be the most recent 8 quarters of data, excluding the exempted quarters. Quarter 1 and Quarter 2 of CY 2020. More information about this is detailed in the section entitled.

Proposal for Public Reporting CAHPS-based measures with Fewer than Standard Numbers of Quarters Due to PHE Exemptions. E. Volume-Based Exemption for CAHPS Hospice Survey Data Collection and Reporting Requirements We previously finalized a volume-based exemption for CAHPS Hospice Survey Data Collection and Reporting requirements for FY 2021 and every year thereafter (84 FR 38526).

We propose no changes to this exemption. The exemption request form is available on the official CAHPS Hospice Survey website. Http://www.hospiceCAHPSsurvey.org.

Hospices that intend to claim the size exemption are required to submit to CMS their completed exemption request form by December 31, of the data collection year. Hospices that served a total of fewer than 50 survey-eligible decedent/caregiver pairs in the year prior to the data collection year are eligible to apply for the size exemption. Hospices may apply for a size exemption by submitting the size exemption request form as outlined above.

The size exemption is only valid for the year on the size exemption request form. If the hospice remains eligible for the size exemption, the hospice must complete the size exemption request form for every applicable FY APU period, as shown in table 19. f.

Newness Exemption for CAHPS Hospice Survey Data Collection and Public Reporting Requirements We previously finalized a one-time newness exemption for hospices that meet the criteria as stated in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52181). In the FY 2019 Hospice Wage Index and Payment Rate Update final rule (83 FR 38642), we continued the newness exemption for FY 2023, and all subsequent years. We encourage hospices to keep the letter they receive providing them with their CMS Certification Number (CCN).

The letter can be used to show when you received your number. G. Survey Participation Requirements We previously finalized survey participation requirements for FY 2022 through FY 2025 as stated in the FY 2018 and FY 2019 Hospice Wage Index and Payment Rate Update final rules (82 FR 36670 and 83 FR 38642 through 38643).

We also continued those requirements in all subsequent years (84 FR 38526). Table 20 restates the data submission dates for FY 2023 through FY 2025. Start Printed Page 19744 For further information about the CAHPS Hospice Survey, we encourage hospices and other entities to visit.

Https://www.hospiceCAHPSsurvey.org. For direct questions, contact the CAHPS Hospice Survey Team at hospiceCAHPSsurvey@HCQIS.org or call 1-(844) 472-4621. H.

Proposal To Add CAHPS Hospice Survey Star Ratings to Public Reporting CMS currently publishes CAHPS star ratings for several of its public reporting programs including Home Health CAHPS and Hospital CAHPS. The intention in doing so is to provide a simple, easy to understand, method for summarizing CAHPS scores. Star ratings benefit the public in that they can be easier for some to understand than absolute measure scores, and they make comparisons between hospices more straightforward.

The public's familiarity with a 1 through 5 star rating system, given its use by other programs, is also a benefit to using this system. We propose to introduce Star Ratings for public reporting of CAHPS Hospice Survey results on the Care Compare or successor websites no sooner than FY 2022. We propose that the calculation and display of the CAHPS Hospice Survey Star Ratings be similar to that of other CAHPS Star Ratings programs such as Hospital CAHPS and Home Health CAHPS.

The stars would range from one star (worst) to five stars (best). We propose that the stars be calculated based on “top-box” scores for each of the eight CAHPS Hospice Survey measures. Specifically, individual-level responses to survey items would be scored such that the most favorable response is scored as 100 and all other responses are scored as 0.

A hospice-level score for a given survey item would then be calculated as the average of the individual-level responses, with adjustment for differences in case mix and mode of survey administration. For a measure composed of multiple items, the hospice-level measure score is the average of the hospice-level scores for each item within the measure. Similar to other CAHPS programs, we propose that the cut-points used to determine the stars be constructed using statistical clustering procedures that minimize the score differences within a star category and maximize the differences across star categories.

We propose to use a two-stage approach to calculate these cut-points. In the first stage, we would determine initial cut-points by calculating the clustering algorithm among hospices with 30 or more completed surveys over 2 quarters (that is, 6 months). Restricting these calculations to hospices that meet a minimum sample size promotes stability of cut-points.

Depending on whether hospices that meet this minimum sample size have different score patterns than smaller hospices, the initial cut-points may be too high or too low. To ensure that cut-points reflect the full distribution of measure performance, in the second stage, we would compare mean measure scores for the bigger hospices used in the first stage to all other hospices, and update cut-points by adjusting the initial cut-points to reflect the normalized difference between bigger and smaller hospices. This two-stage approach allows for calculation of stable cut-points that reflect the full range of hospice performance.

We propose that hospice star ratings for each measure be assigned based on where the hospice-level measure score falls within these cut-points. We further propose to calculate a summary or overall CAHPS Hospice Survey Star Rating by averaging the Star Ratings across the 8 measures, with a weight of 1/2 for Rating of the Hospice, a weight of 1/2 for Willingness to Recommend the Hospice, and a weight of 1 for each of the other measures, and then rounding to a whole number. We propose that only the overall Star Rating be publicly reported and that hospices must have a minimum of 75 completed surveys in order to be assigned a Star Rating.

We propose to publish the details of the Star Ratings methodology on the CAHPS Hospice Survey website, www.hospicecahpssurvey.org. CMS requires no additional resources to create and display CAHPS star ratings. We solicit comments on these proposals for CAHPS Star Ratings and included in public reporting no sooner than FY 2022.Start Printed Page 19745 9.

Form, Manner, and Timing of Quality Data Submission a. Background Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. Such data must be submitted in a form and manner, and at a time specified by the Secretary.

Section 1814(i)(5)(A)(i) of the Act was amended by the CAA 2021 and the payment reduction for failing to meet hospice quality reporting requirements is increased from 2 percent to 4 percent beginning with FY 2024. The Act requires that, beginning with FY 2014 through FY 2023, the Secretary shall reduce the market basket update by 2 percentage points and then beginning in FY 2024 and for each subsequent year, the Secretary shall reduce the market basket update by 4 percentage points for any hospice that does not comply with the quality data submission requirements for that FY. B.

Compliance HQRP Compliance requires understanding three timeframes for both HIS and CAHPS. (1) The relevant Reporting Year, payment FY and the Reference Year. The “Reporting Year” (HIS)/“Data Collection Year” (CAHPS).

This timeframe is based on the CY. It is the same CY for both HIS and CAHPS. If the CAHPS Data Collection year is CY 2022, then the HIS reporting year is also CY 2022.

(2) The APU is subsequently applied to FY payments based on compliance in the corresponding Reporting Year/Data Collection Year. (3) For the CAHPS Hospice Survey, the Reference Year is the CY prior to the Data Collection Year. The Reference Year applies to hospices submitting a size exemption from the CAHPS survey (there is no similar exemption for HIS).

For example, for the CY 2022 data collection year, the Reference Year, is CY 2021. This means providers seeking a size exemption for CAHPS in CY 2022 would base it on their hospice size in CY 2021. Submission requirements are codified in § 418.312.

For every CY, all Medicare-certified hospices are required to submit HIS and CAHPS data according to the requirements in § 418.312. Table 21 summarizes the three timeframes described above. It illustrates how the CY interacts with the FY payments, covering the CY 2020 through CY 2023 data collection periods and the corresponding APU application from FY 2022 through FY 2025.

As illustrated in Table 21, CY 2020 data submissions compliance impacts the FY 2022 APU. CY 2021 data submissions compliance impacts the FY 2023 APU. CY 2022 data submissions compliance impacts FY 2024 APU.

This CY data submission impacting FY APU pattern follows for subsequent years. C. Submission Data and Requirements As finalized in the FY 2016 Hospice Wage Index and Payment Rate Update final rule (80 FR 47192), hospices' compliance with HIS requirements beginning with the FY 2020 APU determination (that is, based on HIS-Admission and Discharge records submitted in CY 2018) are based on a timeliness threshold of 90 percent.

This means CMS requires that hospices submit 90 percent of all required HIS records within 30-days of the event (that is, patient's admission or discharge). The 90-percent threshold is hereafter referred to as the timeliness compliance threshold. Ninety percent of all required HIS records must be submitted and accepted within the 30-day submission deadline to avoid the statutorily-mandated payment penalty.

To comply with CMS' quality reporting requirements for CAHPS, hospices are required to collect data monthly using the CAHPS Hospice Survey. Hospices comply by utilizing a CMS-approved third-party vendor. Approved Hospice CAHPS vendors must successfully submit data on the hospice's behalf to the CAHPS Hospice Survey Data Center.

A list of the approved vendors can be found on the CAHPS Hospice Survey website. Www.hospicecahpssurvey.org. Table 22.

HQRP Compliance Checklist illustrates the APU and timeliness threshold requirements. Start Printed Page 19746 Most hospices that fail to meet HQRP requirements do so because they miss the 90 percent threshold. We offer many training and education opportunities through our website, which are available 24/7, 365 days per year, to enable hospice staff to learn at the pace and time of their choice.

We want hospices to be successful with meeting the HQRP requirements. We encourage hospices to use this website at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​Hospice-Quality-Reporting-Training-Training-and-Education-Library.

For more information about HQRP Requirements, please visit the frequently-updated HQRP website and especially the Best Practice, Education and Training Library, and Help Desk web pages at. Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting. We also encourage members of the public to go to the HQRP web page and sign-up for the Hospice Quality ListServ to stay informed about HQRP.

D. Update on Transition to iQIES In the FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484), we finalized the proposal to migrate our systems for submitting and processing assessment data. Hospices are currently required to submit HIS data to CMS using the Quality Improvement and Evaluation System (QIES) Assessment and the Submission Processing (ASAP) system.

The FY 2020 Hospice Wage Index and Payment Rate Update final rule (84 FR 38484) finalized the proposal to migrate to a new internet Quality Improvement and Evaluation System (iQIES) that will enable us to make real-time upgrades. We are designating that system as the data submission system for the Hospice QRP. We will notify the public about any system migration updates using subregulatory mechanisms such as web page postings, listserv messaging, and webinars.

10. Public Display of “Quality Measures” and Other Hospice Data for the HQRP a. Background Under section 1814(i)(5)(E) of the Act, the Secretary is required to establish procedures for making any quality data submitted by hospices available to the public.

These procedures shall ensure that individual hospices have the opportunity to review their data prior to these data being made public on our designated public website. To meet the Act's requirement for making quality measure data public, we launched Hospice Compare in August 2017. This website allows consumers, providers, and other stakeholders to search for all Medicare-certified hospice providers and view their information and quality measure scores.

In September 2020, CMS transitioned Hospice Compare to the Care Compare website. Hospice Compare was discontinued in December 2020. Care Compare supports all Medicare settings and fulfills the Act's requirements for the HQRP.

For more information about Care Compare, please see the Update on the Hospice Quality Reporting Requirements for FY 2022 in section D. Since 2017, we have increased and improved available information about the care hospices provide for consumers. To indicate the quality of care hospices provide, we first posted the seven HIS Measures (NQF #1641, NQF #1647, NQF #1634, NQF #1637, NQF #1639, NQF #1638, and NQF #1617) in 2017, and then added the CAHPS Hospice Survey measure (NQF #2651) and the HIS Comprehensive Assessment at Admission (NQF #3235) in 2018.

In 2019, we added the Hospice Visits When Death is Imminent (Measure 1) to the website. As discussed above, we propose to remove the seven HIS Measures from public reporting on Care Compare no earlier than May 2022. The Hospice Item Set V3.00 PRA Submission replaced the HVWDII measure with a more robust version.

The claims-based measure HVLDL. We propose to publicly report the HVLDL no earlier than May 2022. We are also proposing to publicly report the HCI, another claims-based measure no earlier than May 2022.

In addition to the publicly-reported quality measure data, in 2019 we added to public reporting, information about the hospices' characteristics, taking raw data available from the Medicare Public Use File and other publicly-available government data sources and making them more consumer friendly and accessible for people seeking hospice care for themselves or family members, (83 FR 38649). This publicly reported information currently includes diagnoses, location of care, and levels of care provided.Start Printed Page 19747 b. Proposal Regarding Data Collection and Reporting During a Public Health Emergency (1).

Background. skin care products Public Health Emergency Temporary Exemption and Its Impact on the Public Reporting Schedule Under authority of section 319 of the Public Health Service (PHS) Act, the Secretary declared a Public Health Emergency (PHE) effective as of January 27, 2020. On March 13, 2020, the President declared a national state of emergency under the Stafford Act, effective March 1, 2020, allowing the Secretary to invoke section 1135(b) of the Act (42 U.S.C.

1320b-5) to waive or modify the requirements of titles XVIII, XIX, and XXI of the Act and regulations to the extent necessary to address the skin care products PHE. Many waivers and modifications were made effective as of March 1, 2020 [] in accordance with the president's declaration. On March 27, 2020, we sent a guidance memorandum under the subject title, “Exceptions and Extensions for Quality Reporting Requirements for Acute Care Hospitals, PPS-Exempt Cancer Hospitals, Inpatient Psychiatric Facilities, Skilled Nursing Facilities, Home Health Agencies, Hospices, Inpatient Rehabilitation Facilities, Long-Term Care Hospitals, Ambulatory Surgical Centers, Renal Dialysis Facilities, and MIPS Eligible Clinicians Affected by skin care products” [] to the Medicare Learning Network (MLN) Connects Newsletter and Other Program-Specific Listserv Recipients,[] hereafter referred to as the March 27, 2020 CMS Guidance Memorandum.

In that memo, which applies to HIS and CAHPS Hospice Survey, CMS granted an exemption to the HQRP reporting requirements for Quarter 4 (Q4) 2019 (October 1, 2019 through December 31, 2019), Quarter 1 (Q1) 2020 (January 1, 2020 through March 30, 2020), and Quarter 2 (Q2) 2020 (April 1, 2020 through June 30, 2020). We discuss the impact to the HIS here, and the impact to the CAHPS Hospice Survey further below. For HIS, the quarters are defined based on submission of HIS admission or discharge assessments.

The exemption has impacted the public reporting schedule. Since launching Hospice Compare in 2017, HIS-measures have been reported using 4 quarters of data. The 4 quarters included are the most recent data that have gone through Review and Correct processes, have been issued in a provider preview report, and have time allotted for addressing requests for data suppression before being publicly reported.

As discussed in the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52183), CMS requires at least 4 quarters of data to establish the scientific acceptability for our HIS-based quality measures. For CAHPS-based measures, we have reported CAHPS measures using eight rolling quarters of data on Hospice Compare since 2018. In the FY 2017 Hospice Wage Index and Payment Rate Update final rule (81 FR 52143), we stated that we would continue CAHPS reporting with eight rolling quarters on an ongoing basis.

This original public reporting schedule included the exempted quarters of Q4 2019 and Q1 and Q2 2020 in six refreshes for HIS and 11 refreshes for CAHPS. Table 23 displays the original schedule for public reporting prior to the skin care products PHE. Start Printed Page 19748 During the spring and summer of 2020, we conducted testing to inform decisions about publicly reporting data for those refreshes which include exempt data.

The testing helped us develop a plan for posting data as early as possible, for as many hospices as possible, and with scientific acceptability similar to standard threshold for public reporting. The following sections provide the results of our testing and explain how we used the results to develop a plan that we believe allows us to achieve these objectives as best as possible. (2).

Update on Use of Q4 2019 Data and Data Freeze for Refreshes in 2021 In the March 27, 2020 Guidance Memorandum, we stated that we should not include any post-acute care (PAC) quality data that are greatly impacted by the exemption in the quality reporting programs. Given the timing of the PHE onset, we determined that we would use any data that was submitted for Q4 2019. We conducted analyses of those data to ensure that their use was appropriate.

In the original schedule (Table 23) the November 2020 refresh includes Q4 2019 data for HIS- and CAHPS-based measures (Q1 through Q4 2019 for HIS data and Q1 2018 through Q4 2019 for CAHPS data) and is the last refresh before Q1 2020 data are included. Before proceeding with the November 2020 refresh, we conducted testing to ensure that, even though we made an exception to reporting requirements for Q4 2019 in March 2020, public reporting would still allow us to publicly report data for a similar number of hospice providers, as compared to standard reporting. Specifically, we compared submission rates in Q4 2019 to average annual rates (Q4 2018 through Q3 2019) to assess the extent to which hospices had taken advantage of the exemption, and thus the extent to which data and measure scores might be affected.

We observed that the HIS data submission rate for Q4 2019 was in fact 1.8 percent higher than the previous CY (Q4 2018). For the CAHPS Hospice Survey, 2.1 percent more hospices submitted data in Q4 2019 than in Q4 2018. We note that Q4 2019 ended before the onset of the skin care products PHE in the United States (U.S.).

Thus, we proceeded with including these data in measure calculations for the November 2020 refresh. As for Q1 and Q2 2020, we determined that we would not use HIS or CAHPS data from these quarters for public reporting given the timing of the PHE onset. All refreshes, during which we decided to hold these data constant, included more than 2 quarters of data that were affected by the CMS-issued skin care products reporting exceptions.

Thus we did not have an adequate amount of data to reliably calculate and publicly display provider measures scores. Consequently, we determined to freeze the data displayed, that is, holding data constant after the November 2020 refresh without subsequently updating the data through November 2021. This decision was communicated to the public in a Public Reporting Tip Sheet, which is located at.

Https://www.cms.gov/​Medicare/​Quality-Initiatives-Patient-Assessment-Instruments/​Hospice-Quality-Reporting/​HQRP-Requirements-and-Best-Practices. Start Printed Page 19749 (3). Proposal for Public Reporting of HIS-Based Measures With Fewer Than Standard Numbers of Quarters Due to PHE Exemption in February 2022 As noted above, we used Q4 2019 data for public reporting in November 2020 and froze that data for the February, May, August, and November 2021 refreshes.

This addressed five of the six PHE-affected quarters for HIS-based measures, and five of the 11 PHE-affected quarters of CAHPS-based measures. Because November 2020 refresh data will become increasingly out-of-date and thus less useful for consumers, we analyzed whether it would be possible to use fewer quarters of data for the last refresh affected by the exemption (February 2022) and thus more quickly resume public reporting with updated quality data. Using fewer quarters of more recent data, the first option, would require that (1) a sufficient percentage of providers would still likely have enough assessment data to report quality measures (reportability).

And (2) fewer quarters would likely produce similar measure scores for hospices, and thus not unfairly represent the quality of care hospices provide during the period reported in a given refresh (reliability). To assess these criteria, we conducted reportability and reliability analysis using 3 quarters of data in a refresh, instead of the standard 4 quarters of data for reporting HIS-based measures. Specifically, we used historical data to calculate HIS-based quality measures under two scenarios.

Standard Public Reporting (SPR) Scenario. We used data from the four quarters of CY 2019, which represent CY 2020 public reporting in the absence of the temporary exemption from the submission of PAC quality data, as the basis for comparing simulated alternatives. For HIS-based measures, we used quarters Q1 through Q4 2019.

skin care products PHE Affected Reporting (CAR) Scenario. We calculated quality measures using Q2 2019, Q3 2019, and Q4 2019 data, to simulate using only Q3 2020, Q4 2020, and Q1 2021 data for public reporting. The HIS Comprehensive Assessment Measure is based on the receipt of care processes at the time of admission.

Therefore for the skin care products Affected Reporting (CAR) Scenario, we excluded data for patient stays with admission dates in Q1 2019. For each scenario, we calculated the reportability as the percent of hospices meeting the 20-case minimum for public reporting (the public reporting threshold). To test the reliability of restricting the providers included in the Standard Public Reporting (SPR) Scenario to those included in the CAR Scenario, we performed three tests.

First, we evaluated measure correlation using the Pearson and Spearman correlation coefficients, which assess the alignment of hospices' HIS Comprehensive Assessment Measure scores between scenarios. Second, for each scenario, we conducted a split-half reliability analysis and estimated intra-class correlation (ICC) scores, where higher scores imply better internal reliability. Modest differences in ICC scores between scenarios would suggest that using fewer quarters of data does not impact the internal reliability of the results.

Third, we estimated reliability scores. A higher value in these scores indicates that HIS Comprehensive Assessment Measure values are relatively consistent for patients admitted to the same hospice and variation in the measure reflects true differences across providers. Testing results show that the CAR scenario—specifically using 3 quarters of data for the HIS Comprehensive Assessment Measure—demonstrates acceptable levels of reportability and reliability.

As displayed in Table 24, the number of providers who met the public reporting threshold for the HIS Comprehensive Assessment Measure decreases by 236 (or by 5.2 percentage points) when reporting three versus four quarters of data. In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48234) we stated that reportability of 71 percent through 90 percent is acceptable. Therefore using 3 quarters of data for the HIS Comprehensive Assessment Measure would achieve acceptable reportability shown in Table 24.

Table 24 indicates that the reliability of the HIS Comprehensive Assessment Measure scores is similar for the CAR and SPR scenarios. Testing also yielded correlation coefficients above 0.9, indicating a high degree of agreement between hospices' HIS Comprehensive Assessment Measure scores when using 3 or 4 quarters of data. The results also show that the HIS Comprehensive Assessment Measure's ICC for CAR and SPR scenarios are similar, with only a 0.02 difference.

This implies high internal reliability of the measure in both scenarios. The median reliability scores for the HIS Comprehensive Assessment Measure are also very similar in both CAR and SPR scenarios. This indicates that scores estimated using 3 quarters of data continue to capture provider-level differences and that admission-level scores remain consistent within hospices.

Start Printed Page 19750 In Table 25, we explore changes in hospices' relative rankings between the SPR and CAR scenarios. For each scenario, we divided hospices in quintiles based on their HIS Comprehensive Assessment Measure score, such that higher scores are in a higher quintile. Changes in a hospices' quintile from the SPR to CAR scenario would indicate a re-ranking of hospices when using 3 quarters compared to 4 quarters.

Over 93 percent of hospices remain in the same quintile, suggesting that the ranking of hospices is fairly stable between the SPR and CAR scenarios. We also used the results presented in Table 26 to assess the option of reporting Q4 2019, Q3 2020, Q4 2020, and Q1 2021 for the February 2022 refresh. This option maintains requirements in the FY 2017 Hospice Wage Index and Payment Update final rule for publicly reporting 4 quarters of data, but it requires using some data that are more than 2 years old.

Also, the relatively high number of hospices that meet the public reporting threshold in the CAR scenario, relative to the SPR scenario, with just 3 quarters of data justify the use of 3 quarters in the unusual circumstances of the PHE and its associated exemptions. We propose that, in the skin care products PHE, we would use 3 quarters of HIS data for the final affected refresh, the February 2022 public reporting refresh of Care Compare for the Hospice setting. Using 3 quarters of data for the February 2022 refresh would allow us to begin displaying Q3 2020, Q4 2020, and Q1 2021 data in February 2022, rather than continue displaying November 2020 data (Q1 2019 through Q4 2019).

We believe that updating the data in February 2022 by more than a year relative to the November 2020 freeze data would assist consumers by providing more relevant quality data and allow hospices to demonstrate more recent performance. Our testing results indicate we can achieve these positive impacts while maintaining high standards for reportability and reliability. Table 27 summarizes the comparison between the original schedule for public reporting with the revised schedule (that is, frozen data) and with the proposed schedule that is, using 3 quarters in the February 2022 refresh.

We seek public comment on this proposal to use 3 quarters of HIS data for the February 2022 public reporting refresh. Start Printed Page 19751 (4). Proposal for Public Reporting of “CAHPS Hospice Survey-Based Measures” Due to PHE Exemption Prior to skin care products PHE, the CAHPS Hospice Survey publicly reported the most recent eight rolling quarters of data.

We propose to continue to report the most recent 8 quarters of available data after the freeze, but not to include the data from the exempted quarters of Q1 and Q2 of 2020 as issued in the March 27, 2020 Guidance Memorandum with the effected quarters discussed above. The optional data submission for Q4 2019 results in publicly reporting of that data since the CAHPS Hospice Survey from that quarter were not impacted. The data submitted for Q4 2019 referred to deaths that occurred prior to COIVD-19.

For the CAHPS Hospice Survey, 2.1 percent more hospices submitted data in Q4 2019 than in the same quarter a year earlier. Like HIS, our goal is to report as much of the most recent CAHPS Hospice Survey data as possible, to display data for as many hospices as possible, and to maintain the reliability of the data. Similar to HIS, the CAHPS Hospice Survey reviewed the data for reportability using fewer quarters than normal.

However, we found that using fewer than 8 quarters of data would have two important negative impacts on public reporting. First, it would reduce the proportion of hospices that would have CAHPS Hospice Survey data displayed on Care Compare. An analysis of the 8 quarters of data from Q1 2018 through Q4 2019 (publicly reported in November 2020) shows there were 5,041 active hospices.

Of these hospices. 2,941 (58.3 percent) had 30+ completes for those 8 quarters, and had scores publicly reported. Fewer hospices, 2,328 (46.2 percent), would have had 30+ completes if 4 quarters of data were used to calculate scores and 1,970 (39.1 percent) would have 30+ completes if 3 quarters were used to calculate scores.

In addition, the overall reliability of the CAHPS scores would decline with fewer quarters of data. For these reasons, we determined the best course of action would be to continue to publicly report the most recent 8 quarters of data, but exempting Q1 and Q2 2020. This will allow us to maximize the number of hospices that will have CAHPS scores displayed on Care Compare, protect the reliability of the data, and report as much of the most recent data as possible.

CMS froze CAHPS data starting with the November 2020 refresh and concluding with the November 2021 refresh. We propose that starting with the February 2022 refresh, CMS will display the most recent 8 quarters of CAHPS Hospice Survey data, excluding Q1 and Q2 2020. We will resume public reporting by displaying 3 quarters of post-exemption data, plus five quarters of pre-exemption data.

(Please see Table 28.) We propose that in each refresh subsequent to February 2022, we will report one more post-exemption quarter of data and one fewer pre-exemption quarter of data until we reach eight quarters of post-exemption data in May of 2023. We further propose that as of August 2023, we will resume reporting a rolling average of the most recent 8 quarters of data. Table 28 specifies the quarters for each refresh.

This will allow us to report the maximum amount of new data, maintain reliability of the data, and permit the maximum number of hospices to receive scores. In addition, Table 28 shows the proposed CAHPS public reporting schedule during and after the data freeze. Start Printed Page 19752 We seek public comment on this proposal to publicly report the most-recently available 8 quarters of CAHPS data starting with the February 2022 refresh and going through the May 2023 refresh on Care Compare because we cannot publicly report Q1 2020 and Q2 2020 data due to the skin care products PHE.

C. Quality Measures To Be Displayed on Care Compare in FY 2022 and Beyond (1). Proposal To Remove Seven “Hospice Item Set Process Measures” From Public Reporting As discussed earlier, we are proposing to remove the seven HIS process measures from the HQRP as individual measures, and no longer applying them to the FY 2024 APU and thereafter.

We propose to remove the seven HIS process measures no earlier than May 2022 refresh from public reporting on Care Compare and from the Preview Reports but continue to have it publicly available in the data catalogue at https://data.cms.gov/​provider-data/​topics/​hospice-care. We are seeking public comment on this proposal to remove the seven HIS process measures from public reporting on Care Compare. (2).

Proposals for Calculating and Publicly Reporting “Claims-Based Measure” as Part of the HQRP In the HIS V3.00 Paperwork Reduction Act Submission (OMB control number. 0938-1153, CMS-10390), we finalized a proposal to adopt HVLDL into the HQRP for FY 2021. We are also proposing in this rule, discussed above, to adopt the HCI into the HQRP for FY2022.

In this section, we present four proposals related to calculating and reporting claims-based measures, with specific application to HVLDL and HCI. First, we propose to extract claims data to calculate claims-based measures at least 90 days after the last discharge date in the applicable period, which we will use for quality measure calculations and public reporting on Care Compare. For example, if the last discharge date in the applicable period for a measure is December 31, 2022, for data collection January 1, 2022, through December 31, 2022, we would create the data extract on approximately March 31, 2023, at the earliest.

We would use those data to calculate and publicly report the claims-based measures for the CY2022 reporting period. This proposal is similar to those finalized in other PAC settings, including the CY 2017 Home Health Prospective Payment System final rule (81 FR 76702), FY 2017 Inpatient Rehabilitation Facility Prospective Payment System final rule (81 FR 52056), and the FY 2017 Long Term Care Hospital Prospective Payment System final rule (81 FR 56762). The proposed timeframe allows us to balance providing timely information to the public with calculating the claims-based measures using as complete a data set as possible.

We recognize that the proposed approximately 90-day “run-out” period is shorter than the Medicare program's current timely claims filing policy under which providers have up to 1 year from the date of discharge to submit claims. However, several months lead-time is necessary after acquiring the data to conduct the claims-based calculations. If we were to delay our data extraction point to 12 months after the last date of the last discharge in the applicable period, we would not be able to deliver the calculations to hospices sooner than 18 to 24 months after the last discharge.

To implement this process, hospices would not be able to submit corrections to the underlying claims snapshot or add claims (for those claims-based measures) to this data set at the Start Printed Page 19753conclusion of the 90-day period following the last date of discharge used in the applicable period. Therefore, we would consider the hospice claims data to be complete for purposes of calculating the claims-based measures at this point. Thus, it is important that hospices ensure the completeness and correctness of their claims prior to the claims “snapshot.” Second, we propose that we will update the claims-based measures used for the HQRP annually.

Specifically, we will refresh claims-based measure scores on Care Compare, in preview reports, and in the confidential CASPER QM preview reports annually. This periodicity of updates aligns with most claims-based measures across PAC settings. Third, we propose that we will calculate claims-based measure scores based on one or more years of data.

We considered several factors to determine the number of years to include in measure calculations. Using only 1 year (4 quarters) of data, as is currently done for HIS-based quality measures reported on Care Compare, allows us to share with the public only the most up-to-date information and best reflects current realities. Having only the most recent data can also help incentivize hospices with lower scores to make changes and have the results of their effort be reflected in better scores.

At the same time, we want to report measures scores to the public for as many hospices as possible, including small hospices. Currently, only Medicare-certified hospices with more than 20 discharges each year have quality measure results publicly available on Care Compare. This public reporting threshold protects the privacy of patients who seek care at smaller hospices.

However, due to the threshold, at least some hospices will not achieve the minimum patient discharges within 1 year. This means that their scores will not be displayed on Care Compare, and consumers will not have information about them to inform their decisions about selecting a hospice. Using more years of data allows more of these hospices to meet this threshold.

We conducted reportability testing for HCI and HVLDL to help us consider how best to balance the need for recent data with the need for transparency in reporting the HQRP claims-based measures. Specifically, we conducted a simulation using 2 years of data. We then calculated the change in the number of hospices which achieved the minimum reporting standard.

We also compared the measure scores of the hospices that meet the reporting threshold when we use 2 years of data with hospices that meet the threshold using only 1 year of data. Results for both HCI and HVLDL indicate that using 2 years of data increases reportability. For HVLDL, combining 2 years of data (FY 2018 to FY 2019) allows an additional 326 hospices to share measure scores, or 33.8 percent of the hospices that do not meet the reporting threshold in FY 2019 alone.

For HCI, combining 2 years of data (FY 2018 to FY 2019 data) allows an additional 277 to report HCI measure scores on Care Compare, or 43.2 percent of the hospices that do not meet the reporting threshold in FY 2019 alone. Our simulations indicate that the hospices that only meet the reporting threshold when using 2 years of data have performance scores substantially lower than average. For HVLDL, where higher scores indicate better quality of care, the national average score was 65.5 percent in FY 2019, where 965 hospices did not meet the reportability threshold.

After pooling data using FY 2018 to FY 2019, 326 additional hospices met the reportability threshold, or 33.8 percent of those previously missing. Those addition 326 hospices had an average HVLDL score of just 43.3 percent, about 20 percentage points lower than the hospices meeting the reportability threshold using FY 2019 alone national average score for this HVLDL measure. The results for HCI similarly show that the hospices with reportable data when using two-pooled years of data had lower HCI scores compared to the national average when using just FY 2019 data.

Higher HCI scores indicate better performance. As Figure 7 shows, a larger numbers of hospices among the 277 hospices that only meet the reporting threshold when using 2 years of data had HCI scores between four and eight, while a larger number of hospices in the FY 2019 population had a perfect score of 10. Start Printed Page 19754 Given these findings, we propose using 2 years of data to publicly report HCI and HVLDL in 2022.

The use of 2 years or 8 quarters of quality data is already publicly reported for the quality measures related to the CAHPS Hospice Survey so hospices are familiar with this approach. We plan to consider multiple years of data, like the 2 years of data, for other claims-based measures proposed in subsequent years. We believe it is important to support consumers by sharing information on the performance of hospices that have lower scores, and to incentivize those hospices to improve.

The results demonstrate that using multiple years of data help include more hospices that have lower performance rates for HVLDL and HCI in public reporting on Care Compare. While using more years of data would allow us to report measures for even more hospices, it would involve sharing data that are no longer relevant, and display scores that do not reflect recent hospice improvement efforts. We are soliciting public comment on these proposals related to the using 2 years of data for claims-based measures and public reporting of claims measures in general and their application to HVLDL and HCI specifically.

(3). Proposal To Publicly Report the Hospice Care Index and “Hospice Visits in the Last Days of Life” Claims-Based Measures As discussed previously, we are proposing to publicly report the HCI and HVLDL using 2 years, which is 8 quarters of Medicare claims data. We propose to publicly report the HCI and HVLDL beginning no earlier than May 2022 using FY2021 Medicare hospice claims data, and to include it in the Preview Reports no sooner than the May 2022 refresh.

The publicly-reported version of HCI on Care Compare will only include the final HCI score, and not the component indicators. The Preview Reports will reflect the HCI as publicly reported. We are seeking public comment on this proposal for HCI and HVLDL public reporting on Care Compare no sooner than May 2022.

(4). Update on Publicly Reporting for the “Hospice Visits When Death is Imminent (HVWDII) Measure 1” and the “Hospice Visits in the Last Days of Life (HVLDL) Measure” As discussed earlier, the HIS V3.00 PRA Submission, CMS-10390 (OMB control number. 0938-1153), finalized the proposal to replace the HVWDII measure pair with a re-specified version called HVLDL, which is a single measure based on Medicare claims.

Relatedly, in the HIS V3.00 PRA Submission, CMS-10390 (OMB control number. 0938-1153), we finalized the proposal to remove Section O from the HIS. As stated in section 1814(i)(5)(E) of the Act, we establish procedures for making all quality data submitted by hospices under § 418.312 available to the public.

Thus, we would have continued to publicly report HVWDII Measure 1 data through the November 2021 refresh. Because of the data freeze detailed above, HVWDII Measure 1 data from the November 2020 refresh, covering HIS admissions during Q1 through Q4 2019, will be publicly displayed for all calendar year 2021 refreshes. We may retain the November 2020 refresh for HVWDII Measure 1 for one or more refreshes in 2022, when there will be no HIS Section O data, if doing so will allow us to consolidate changes and thus operate more efficiently.

D. Update on Transition From Hospice Compare to Care Compare and Provider Data Catalog In September 2020, we launched Care Compare, a streamlined redesign of eight existing CMS healthcare compare tools available on Medicare.gov, including Hospice Compare. Care Compare provides a single user-friendly interface that patients and family caregivers can use to make informed Start Printed Page 19755decisions about healthcare based on cost, quality of care, volume of services, and other data.

With just one click, patients can find information that is easy to understand about doctors, hospitals, nursing homes, and other health care services instead of searching through multiple tools. For the last six years, Medicare's Hospice Compare has served as the cornerstone for publicizing quality care information for patients, family caregivers, consumers, and the healthcare community. The new website builds on the eMedicare initiative to deliver simple tools and information to current and future Medicare beneficiaries.

Drawing on lessons learned through research and stakeholder feedback, Care Compare includes features and functionalities that appeal to Hospice Compare consumers. By offering an accessible and user-friendly interface and a simple design that is optimized for mobile and tablet use, it is easier than ever to find information that is important to patients when shopping for healthcare. Enhancements for mobile use will give practical benefits like accessing the tool using a smartphone that can initiate phone calls to providers simply by clicking on the provider's phone number.

In conjunction with the Care Compare launch, we have made additional improvements to other CMS data tools, to help Medicare beneficiaries compare costs. Specifically, the Provider Data Catalog (PDC) better serves innovators and stakeholders who are interested in detailed CMS data and use interactive and downloadable datasets like those currently available on data.Medicare.gov. The PDC now makes quality datasets available through an improved Application Programming Interface (API), allowing innovators in the field to easily access and analyze the CMS publicly-reported data and make it useful for patients.

E. Update on Additional Information on Hospices for Public Reporting In the FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements final rule (83 FR 38622), we finalized plans to publicly post information from the Medicare Provider Utilization and Payment Data. Hospice Public Use File (PUF) and other publicly-available CMS data to Hospice Compare or another CMS website.

Hospice PUF data are available for CY 2014 through CY 2016. Beginning with CY 2017 data, hospice PUF data are public as part of the Post-Acute Care and Hospice Provider Utilization and Payment PUF (hereafter PAC PUF). For more information, please visit the PAC PUF web page at.

Https://www.cms.gov/​Research-Statistics-Data-and-Systems/​Statistics-Trends-and-Reports/​Medicare-Provider-Charge-Data/​PAC2017. Both the Hospice and PAC PUFs provide information on services provided to Medicare beneficiaries by hospice providers. Specifically, they contain information on utilization, payment (Medicare payment and standard payment), submitted charges, primary diagnoses, sites of service, and beneficiary demographics organized by CCN (6-digit provider identification number) and state.

PUF data, along with clear text explaining the purpose and uses of this information and suggesting consumers discuss this information with their healthcare provider, first displayed in a consumer-friendly format on Hospice Compare in May 2019. Beginning May 2021, we will begin to display additional information from the PAC PUF on Care Compare. This additional information includes hospices' beneficiary characteristics such as the percentage of patients enrolled in Medicare Advantage.

In addition, consumers will see whether a hospice provided services to Medicare Advantage enrollees or patients who have coverage under both Medicaid and Medicare, also called dual eligible patients. The data for these additional characteristics are pulled directly from the PAC PUF file and provide potential hospice service patients and family caregivers with more detail prior to selecting a hospice. As finalized in the FY 2019 Hospice Wage Index and Payment Update final rule (83 FR 38622), we also improved access to publicly-available information about hospices' compliance with Hospice QRP requirements.

Specifically, we already post the annual Hospice APU Compliant List on the HQRP Requirements and Best Practices web page. This document displays the CCN, name, and address of every hospice that successfully met quality reporting program requirements for the fiscal year. Hospices are only considered compliant if they meet the standards for HIS and CAHPS reporting, as codified in § 418.312.

Consumers can now access the Hospice APU compliance file from Care Compare, enabling them to determine if a particular hospice is compliant with CMS' quality reporting requirements. G. Proposal for the January 2022 HH QRP Public Reporting Display Schedule With Fewer Than Standard Number of Quarters Due to skin care products Public Health Emergency Exemptions 1.

Background and Statutory Authority We include this Home Health proposal in this rule because we plan to resume public reporting for the HH QRP with the January 2022 refresh of Care Compare. In order to accommodate the exception of 2020 Q1 and Q2 data, we are proposing to resume public reporting using 3 out of 4 quarters of data for the January 2022 refresh. In order to finalize this proposal in time to release the required preview report related to the refresh, which we release 3 months prior to any given refresh (October 2021), we need the rule containing this proposal to finalize by October 2021.

The HH QRP is authorized by section 1895(b)(3)(B)(v) of the Act. Section 1895(b)(3)(B)(v)(II) of the Act requires that for 2007 and subsequent years, each HHA submit to the Secretary in a form and manner, and at a time, specified by the Secretary, such data that the Secretary determines are appropriate for the measurement of health care quality. To the extent that an HHA does not submit data in accordance with this clause, the Secretary shall reduce the home health market basket percentage increase applicable to the HHA for such year by 2 percentage points.

As provided at section 1895(b)(3)(B)(vi) of the Act, depending on the market basket percentage increase applicable for a particular year, the reduction of that increase by 2 percentage points for failure to comply with the requirements of the HH QRP and further reduction of the increase by the productivity adjustment (except in 2018 and 2020) described in section 1886(b)(3)(B)(xi)(II) of the Act may result in the home health market basket percentage increase being less than 0.0 percent for a year, and may result in payment rates under the Home Health PPS for a year being less than payment rates for the preceding year. For more information on the policies we have adopted for the HH QRP, we refer readers to the following rules. 2.

Public Display of Home Health Quality Data for the HH QRP Section 1895(b)(3)(B)(v)(III) of the Act requires the Secretary to establish procedures for making HH QRP data, including data submitted under sections 1899B(c)(1) and 1899B(d)(1) of the Act, available to the public. Such public display procedures must ensure that HHAs have the opportunity to review the data that will be made public with respect to each HHA prior to such data being made public. Section 1899B(g) of the Act requires that data and information regarding PAC provider performance on quality measures and resource use or other measures be made publicly available beginning not later than 2 years after the applicable specified “application date”.

We established our HH QRP Public Display Policy in the CY 2016 HH PPS final rule (80 FR 68709 through 68710). In that final rule, we noted that the procedures for HHAs to review and correct their data on a quarterly basis is performed through CASPER along with our procedure to post the data for the public on our Care Compare website. We have communicated our public display schedule, which supports our Public Display Policy, on our websites whereby the quarters of data included are announced.

3. Proposal To Modify HH QRP Public Reporting To Address CMS' Guidance To Except Data During the skin care products PHE Beginning January 2022 Through July 2024 We are proposing to modify our public display schedule to display fewer quarters of data than what we previously finalized for certain HH QRP measures for the January 2022 refreshes. Under authority of section 319 of the PHS Act, the Secretary declared a PHE effective as of January 27, 2020.

On March 13, 2020, the President declared a national state of emergency under the Stafford Act, effective March 1, 2020, allowing the Secretary to invoke section 1135(b) of the Act (42 U.S.C. 1320b-5) to waive or modify the requirements of titles XVIII, XIX, and XXI of the Act and regulations to the extent necessary to address the skin care products PHE. Many waivers and modifications were made effective as of March 1, 2020 in accordance with the President's declaration.[] On March 27, 2020, we sent a guidance memorandum under the subject title, “Exceptions and Extensions for Quality Reporting Requirements for Acute Care Hospitals, PPS-Exempt Cancer Hospitals, Inpatient Psychiatric Facilities, Skilled Nursing Facilities, Home Health Agencies (HHAs), Hospices, Inpatient Rehabilitation Facilities, Long-Term Care Hospitals, Ambulatory Surgical Centers, Renal Dialysis Facilities, and MIPS Eligible Clinicians Affected by skin care products” to the MLN Connects Newsletter and Other Program-Specific Listserv Recipients,[] hereafter referred to as the March 27, 2020 CMS Guidance Memorandum.

In the March 27, 2020 CMS Guidance Memo, we granted an exception to the HH QRP reporting requirements under the HH QRP exceptions and extension requirements for Quarter 4 (Q4) 2019 (October 1, 2019 through December 31, 2019), Q1 2020 (January 1, 2020 through March 30, 2020), and Q2 2020 (April 1, 2020 through June 30, 2020). The HH QRP exception applied to the HH QRP Outcome and Assessment Information Set (OASIS)-based measures, claims-based measures, and HH CAHPS Survey. We discuss the impact to the OASIS and claims here, and discuss to the HH CAHPS further in section III.G.

4, Update on Use of Q4 2019 HH QRP Data and Data Freeze for Refreshes in 2021. For the OASIS, the exempted quarters are based upon admission and discharge assessments. A subset of the HH QRP measures has been publicly displayed on Home Health Compare (HH Compare) since 2003.

Under the current HH QRP public display policy, Home Health Compare uses 4 quarters of data to publicly display OASIS-based measures, and 4 or more quarters of data to publicly display claims-based measures. We use four rolling quarters of data to publicly display Home Health Care Consumer Assessment of Healthcare Providers and Systems (HHCAHPS) Survey measures on Care Compare. As of September 2020, HH QRP OASIS, claims-based, and HHCAHPS Survey measures are reported on the www.medicare.gov's Care Compare website.

As of December 2020, the data is no longer reported on the www.medicare.gov's Home Health Compare website. The exception granted under the March 27, 2020 CMS Guidance Memo impacted the HH QRP public display schedule. We will resume publicly displaying HH QRP claims-based measures in January 2022 based upon the quarters of data specified for each of the claims-based measures.

Table 30 displays the original schedule for public reporting of OASIS and HHCAHPS Survey measures prior to the Q1 and Q2 2020 data impacted by the skin care products PHE. Start Printed Page 19757 Start Printed Page 19758 During the spring and summer of 2020, we conducted testing to inform decisions about publicly displaying HH QRP data for those refreshes which include data from the exception period of October 1, 2019 through June 30, 2020 (hereafter “excepted data”). The testing helped us develop a plan for displaying HH QRP data that are as up-to-date as possible and that also meet scientifically-acceptable standards for publicly displaying those data.

We believe that the plan allows us to provide consumers with helpful information on the quality of home health care, while also making the necessary adjustments to accommodate the exception granted to HHAs. The following sections provide the results of our testing for OASIS and claims and explain how we used the results to inform a proposal for accommodating excepted data in public reporting. HH CAHPS discussion is further in section III.G.4.

4. Update on Use of Q4 2019 HH QRP Data and Data Freeze for Refreshes in 2021 In the March 27, 2020 Guidance Memorandum, we stated that we should not include any PAC quality data that are greatly impacted by the exception granted in the quality reporting programs. Given the timing of the PHE onset, we determined that we would not use HH QRP OASIS, claims, or HHCAHPS data from Q1 and Q2 of 2020 for public reporting, and that we would assess the impact of the skin care products PHE on HH QRP data from Q4 2019.

In the original schedule (Table 30), the October 2020 refresh included Q4 2019 measure based on OASIS and HHCAHPS data and is the last refresh before Q1 2020 data are included. Before proceeding with the October 2020 refresh, we conducted testing to ensure that publicly displaying Q4 2019 data would still meet our standards despite granting an exception to HH QRP reporting requirements for Q4 2019. Specifically, we compared submission rates in Q4 2019 to average rates in other quarters to assess the extent to which HHAs had taken advantage of the exemption, and thus the extent to which data and measure scores might be affected.

We observed that the quality data submission rate for Q4 2019 was in fact 0.4 percent higher than the previous calendar year (Q4 2018). We note that Q4 2019 ended before the onset of the skin care products renova in the U.S. Thus, we proceeded with including Q4 2019 data in measure calculations for the October 2020 refresh.

Because we excepted HHAs from the HH QRP reporting requirements for Q1 and Q2 2020, we did not use OASIS, claims, or HHCAHPS data from these quarters. All refreshes, during which we decided to hold this data constant, included more than 2 quarters of data that were affected by the CMS-issued skin care products reporting exceptions, thus we did not have an adequate amount of data to reliably calculate and publicly display provider measures scores. Consequently, we determined to freeze the data displayed, that is, holding data constant after the October 2020 refresh without subsequently updating the data through October 2021.

We communicated this in a Public Reporting Tip Sheet, which is located at. Https://www.cms.gov/​files/​document/​hhqrp-pr-tip-sheet081320final-cx-508.pdf. 5.

Proposal To Use the skin care products PHE Affected Reporting (CAR) Scenario To Publicly Display Certain HH QRP Measures (Beginning in January 2022 through July 2024) Due to the skin care products PHE We are also proposing to use the CAR scenario for refreshes for January 2022 for OASIS and for refreshes from January 2022 through July 2024 for some claims-based measures. There are several forthcoming HH QRP refreshes Start Printed Page 19759for which the original public reporting schedule included other quarters from the quality data submission exception. These refreshes for claims-based measures, OASIS-based measures, and for HHCAHPS Survey measures are outlined above (Table 30).

Because October 2020 refresh data will become increasingly out-of-date and thus less useful for the public, we analyzed whether it would be possible to use fewer quarters of data for one or more refreshes and thus reduce the number of refreshes that continue to display October 2020 data. Using fewer quarters of more up-to-date data requires that. (1) A sufficient percentage of HHAs would still likely have enough OASIS data to report quality measures (reportability).

And (2) using fewer quarters of data to calculate measures would likely produce similar measure scores for HHAs, and thus not unfairly represent the quality of care HHAs provided during the period reported in a given refresh (reliability). To assess these criteria, we conducted reportability and reliability analysis excluding the skin care products affected quarters of data in a refresh instead of the standard number of quarters of data for reporting for each HH QRP measure to model the impact of not using Q1 or Q2 2020. Specifically, we used historical data to calculate HH quality measures under two scenarios.

Standard Public Reporting (SPR) Scenario. We used HH QRP data from CY 2017 through 2019 to build the standard reported measures, to represent as a proxy CY 2020 public reporting in the absence of the temporary exemptions from the submission of OASIS quality data, as the basis for comparing simulated alternatives. This entails using 4 quarters of CY 2019 HH QRP data to model the OASIS based measures that are normally calculated using 4 quarters of data.

This also entailed using 4 quarters of HH QRP data from CY 2019 for the all-cause hospitalization and emergency department use claims-based measures, 8 quarters of HH QRP data from CY2018 and CY2019 for Medicare spending per beneficiary (MSPB) and discharge to community (DTC) claims-based measures. And or 12 quarters from January 2017 to December 2019 for the potentially preventable readmission claims-based measure. skin care products Affected Reporting (CAR) Scenario.

We calculated OASIS-based measures using 3 quarters of HH QRP CY 2019 data to simulate using only Q3 2020, Q4 2020, and Q1 2021 data for public reporting. We calculated claims-based measures using HH QRP CY 2017 to 2019 data, to simulate using the most recent data while excluding the same quarters (Q1 and Q2) that are relevant from the PHE exception. We used 3 quarters of HH QRP data from CY 2019 for the all-cause hospitalization and emergency department use claims-based measures and 6 quarters of data from HH QRP CY 2018 and CY 2019 were used for both the Medicare spending per beneficiary and discharge to community claims-based measures.

We used 10 quarters of HH QRP data from CY 2017 to 2019 to calculate the CAR scenario for the potentially preventable readmissions claims-based measure. For both claims and OASIS-based measures, the quarters used in our analysis were the most recently available data that exclude the same quarters (Q1 and Q2) as that are relevant from the PHE exception, and thus take seasonality into consideration. The OASIS-based measures are based on the start of care and calculated using admission dates.

Therefore, under the CAR scenario we excluded data for OASIS-based measures for HHA patient stays with admission dates in Q1 and Q2 2019. To assess performance in these scenarios, we calculated the reportability as the percent of HHAs meeting the 20-case minimum for public reporting (the public reporting threshold, or “PRT”). We evaluated measure reliability using the Pearson and Spearman correlation coefficients, which assess the alignment of HHs measure scores between scenarios.

To calculate the reliability results, we restricted the HHAs included in the SPR Scenario to those included in the CAR Scenario. Testing results showed that using the CAR scenario would achieve scientifically acceptable quality measure scores for the HH QRP. As displayed in Table 31, the percentage of HHAs that met the public display threshold for the OASIS-based measure decreases by 5.5 percentage points or less for all but one QM, the Influenza Immunization for the Current Flu Season in the CAR scenario versus SPR scenario.

CMS has traditionally used a reportability threshold of 70 percent, meaning at least 70 percent of HHAs are able to report at least 20 episodes for a given measure, as the standard to determine whether a measure should be publicly reported. By this standard, we consider a decrease of 5.5 percentage points or less scientifically acceptable. The change in reportability for the Influenza Immunization for the Current Flu Season measure is related to the seasonality of this measure, which includes cases that occur during the flu season only.

Under the CAR scenario, the January 2022 refresh data would cover Q3 and Q4 of 2020 and Q1 of 2021, which occur during the flu season. This simulation included Q2 through Q4 of 2019, which crosses the flu season. Thus, the reportability of the actual data used is likely to be better than this simulation.

Therefore, in general, using CAR scenario for the OASIS and claims-based measures would achieve acceptable reportability for the HH QRP measures. Testing also yielded correlation coefficients above 0.85, indicating a high degree of agreement between HH measure scores when using the CAR scenario or the SPR scenario. Start Printed Page 19760 Start Printed Page 19761 We are proposing to use the CAR scenario for the last of the refreshes affecting OASIS-based measures, which will occur in January 2022.

We are also proposing to use the CAR scenario for refreshes from January 2022 through July 2024 for some claims-based measures. Our proposal of the CAR scenario for the January 2022 refresh would allow us to begin displaying recent data in January 2022, rather than continue displaying October 2020 data (Q1 2019 Start Printed Page 19762through Q4 2019). We believe that updating the data in January 2022 by more than a year relative to the October 2020 freeze data can assist the public by providing more relevant quality data and allow CMS to display more recent HHA performance.

Similarly, using fewer than standard numbers of quarters for claims-based measures that typically use eight or twelve months of data for reporting between January 2022 and July 2024 will allow us to begin providing more relevant data sooner. Our testing results indicate we can achieve these positive impacts while maintaining high standards for reportability and reliability. Table 32 and Table 33 summarize the comparison between the original schedule for public reporting with the revised schedule (that is, frozen data) and also with the proposed public display schedule under the CAR scenario (that is, using 3 quarters in the January 2022 refresh), for OASIS- and claims-based measures respectively.

Start Printed Page 19763 We are soliciting public comments on the proposal to use the CAR scenario to publicly report HH OASIS in January 2022 and claims-based measures beginning with the January 2022 through July 2024 refreshes. 6. Update to the Public Display of HHCAHPS Measures Due to the skin care products PHE Exception Since April 2012, we have publicly displayed four quarters of HHCAHPS data every quarter, in the months of January, April, July, and October.

The skin care products PHE Exception applied to Q1 and Q2 of 2020. Those excepted quarters cannot be publicly displayed and resulted in the freezing of the public display using Q1 2019 through Q4 2019 data for the refreshes that would have occurred from October 2020 through October 2021, as shown in Table 34. Beginning with January 2022, we will resume reporting four quarters of HHCAHPS data.

The data for the January 2022 refresh are Q3 2020 through Q2 2021. These are the same quarters that would have been publicly Start Printed Page 19764displayed despite the skin care products PHE. Table 34 summarizes this discussion.

IV. Requests for Information A. Fast Healthcare Interoperability Resources (FHIR) in Support of Digital Quality Measurement in Post-Acute Care Quality Reporting Programs—Request for Information 1.

Background A goal of the HQRP is to improve the quality of health care for beneficiaries through measurement, transparency, and public reporting of data. The HQRP contributes to improvements in health care, enhancing patient outcomes, and informing consumer choice. In October 2017, we launched the Meaningful Measures Framework.

This framework captures our vision to address health care quality priorities and gaps, including emphasizing digital quality measurement (dQM), reducing measurement burden, and promoting patient perspectives, while also focusing on modernization and innovation. The scope of the Meaningful Measures Framework has evolved to Meaningful Measure 2.0 to accommodate the changes in the health care environment, initially focusing on measure and burden reduction to include the promotion of innovation and modernization of all aspects of quality.[] There is a need to streamline our approach to data collection, calculation, and reporting to fully leverage clinical and patient-centered information for measurement, improvement, and learning. In alignment with the Meaningful Measure 2.0, we are seeking feedback on our future plans to define digital quality measures for the HQRP.

We also are seeking feedback on the potential use of Fast Healthcare Interoperable Resources (FHIR) for dQMs within the HQRP aligning where possible with other quality programs. FHIR is an open source standards framework (in both commercial and government settings) created by Health Level Seven International (HL7®) that establishes a common language and process for all health information technology. 2.

Definition of Digital Quality Measures We are considering adopting a standardized definition of Digital Quality Measures (dQMs) in alignment across QRPs. We are considering in the future to propose the adoption within the HQRP the following definition. Digital Quality Measures (dQMs) are quality measures that use one or more sources of health information that are captured and can be transmitted electronically via interoperable Start Printed Page 19765systems.[] A dQM includes software that processes digital data to produce a measure score or measure scores.

Data sources for dQMs may include administrative systems, electronically submitted clinical assessment data, case management systems, electronic health records (EHRs), instruments (for example, medical devices and wearable devices), patient portals or applications (for example, for collection of patient-generated health data), health information exchanges (HIEs) or registries, and other sources. As an example, the quality measures calculated from patient assessment data submitted electronically to CMS would be considered digital quality measures. 3.

Use of FHIR for Future dQMs in HQRP Over the past two years in other programs, we have focused on opportunities to streamline and modernize quality data collection and reporting processes, such as exploring HL7® FHIR® (http://hl7.org/​fhir) for quality reporting programs. One of the first areas CMS has identified relative to improving our digital strategy is through the use of FHIR-based standards to exchange clinical information through application programming interfaces (APIs), allowing clinicians to digitally submit quality information one time that can then be used in many ways. We believe that in the future proposing such a standard within the HQRP could potentially enable collaboration and information sharing, which is essential for delivering high-quality care and better outcomes at a lower cost.

We are currently evaluating the use of FHIR based APIs to access assessment data collected and maintained through the Quality Improvement and Evaluation System (QIES) and internet QIES (iQIES) health information systems and are working with healthcare standards organizations to assure that their evolving standards fully support our assessment instrument content. Further, as more hospice providers are adopting EHRs including hospices, we are evaluating using the FHIR interfaces for accessing patient data (including standard assessments) directly from hospice EHRs. Accessing data in this manner could also enable the exchange of data for purposes beyond data reporting to CMS, such as care coordination further increasing the value of EHR investments across the healthcare continuum.

Once providers map their EHR data to a FHIR API in standard FHIR formats it could be possible to send and receive the data needed for measures and other uses from their EHRs through FHIR APIs. 4. Future Alignment of Measures Across Reporting Programs, Federal and State Agencies, and the Private Sector We are committed to using policy levers and working with stakeholders to achieve interoperable data exchange and to transition to full digital quality measurement in our quality programs.

We are considering the future potential development and staged implementation of a cohesive portfolio of dQMs across our regulated programs, including HQRP, agencies, and private payers. This cohesive portfolio would require, where possible, alignment of. (1) Measure concepts and specifications including narrative statements, measure logic, and value sets, and (2) the individual data elements used to build these measure specifications and calculate the measures.

Further, the required data elements would be limited to standardized, interoperable elements to the fullest extent possible. Hence, part of the alignment strategy will be the consideration and advancement of data standards and implementation guides for key data elements. We would coordinate closely with quality measure developers, Federal and state agencies, and private payers to develop and to maintain a cohesive dQM portfolio that meets our programmatic requirements and that fully aligns across Federal and state agencies and payers to the extent possible.

We intend this coordination to be ongoing and allow for continuous refinement to ensure quality measures remain aligned with evolving healthcare practices and priorities (for example, patient reported outcomes (PROs), disparities, care coordination), and track with the transformation of data collection. This includes conformance with standards and health IT module updates, future adoption of technologies incorporated within the ONC Health IT Certification Program and may also include standards adopted by ONC (for example, standards-based APIs). The coordination would build on the principles outlined in HHS' Nation Health Quality Roadmap.[] It would focus on the quality domains of safety, timeliness, efficiency, effectiveness, equitability, and patient-centeredness.

It would leverage several existing Federal and public-private efforts including our Meaningful Measures 2.0 Framework. The Federal Electronic Health Record Modernization (DoD/VA). The Core Quality Measure Collaborative, which convenes stakeholders from America's Health Insurance Plans (AHIP), CMS, NQF, provider organizations, private payers, and consumers and develops consensus on quality measures for provider specialties.

And the NQF-convened Measure Applications Partnership (MAP), which recommends measures for use in public payment and reporting programs. We would coordinate with HL7's ongoing work to advance FHIR resources in critical areas to support patient care and measurement such as social determinants of health. Through this coordination, we would identify which existing measures could be used or evolved to be used as dQMs, in recognition of current healthcare practice and priorities.

This multi-stakeholder, joint Federal, state, and industry effort, made possible and enabled by the pending advances towards interoperability, would yield a significantly improved quality measurement enterprise. The success of the dQM portfolio would be enhanced by the degree to which the measures achieve our programmatic requirements as well as the requirements of other agencies and payers. 5.

Solicitation of Comments We seek input on the following steps that would enable transformation of CMS' quality measurement enterprise to be fully digital. A. What EHR/IT systems do you use and do you participate in a health information exchange (HIE)?.

b. How do you currently share information with other providers and are there specific industry best practices for integrating SDOH screening into EHR's?. c.

What ways could we incentivize or reward innovative uses of health information technology (IT) that could reduce burden for post-acute care settings, including but not limited to hospices?. d. What additional resources or tools would post-acute care settings, including but not limited to hospices and health IT vendors find helpful to support testing, implementation, collection, and reporting of all measures using FHIR standards via secure APIs to reinforce the sharing of patient health information between care settings?.

e. Would vendors, including those that service post-acute care settings, including but not limited to hospices, be interested in or willing to participate in pilots or models of alternative approaches to quality measurement that Start Printed Page 19766would align standards for quality measure data collection across care settings to improve care coordination, such as sharing patient data via secure FHIR API as the basis for calculating and reporting digital measures?. f.

What could be the potential use of FHIR dQMs that could be adopted across all QRPs?. We plan to continue working with other agencies and stakeholders to coordinate and to inform our transformation to dQMs leveraging health IT standards. While we will not be responding to specific comments submitted in response to this Request for Information in the FY 2022 Hospice final rule, we will actively consider all input as we develop future regulatory proposals or future sub-regulatory policy guidance.

Any updates to specific program requirements related to quality measurement and reporting provisions would be addressed through separate and future notice- and-comment rulemaking, as necessary. B. Closing the Health Equity Gap in Post-Acute Care Quality Reporting Programs—Request for Information 1.

Background Significant and persistent inequities in health outcomes exist in the United States. In recognition of persistent health disparities and the importance of closing the health equity gap, we request information on expanding several related CMS programs to make reporting of health disparities based on social risk factors and race and ethnicity more comprehensive and actionable for providers and patients. Belonging to a racial or ethnic minority group.

Living with a disability. Being a member of the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community. Or being near or below the poverty level, is often associated with worse health outcomes.[] Such disparities in health outcomes are the result of number of factors, but importantly for CMS programs, although not the sole determinant, poor access and provision of lower quality health care contribute to health disparities.

For instance, numerous studies have shown that among Medicare beneficiaries, racial and ethnic minority individuals often receive lower quality of care, report lower experiences of care, and experience more frequent hospital readmissions and operative complications.[] Readmission rates for common conditions in the Hospital Readmissions Reduction Program are higher for black Medicare beneficiaries and higher for Hispanic Medicare beneficiaries with Congestive Heart Failure and Acute Myocardial Infarction.[] Studies have also shown that African Americans are significantly more likely than white Americans to die prematurely from heart disease and stroke.[] The skin care products renova has further illustrated many of these longstanding health inequities with higher rates of , hospitalization, and mortality among black, Latino, and Indigenous and Native American persons relative to white persons.[] As noted by the Centers for Disease Control “long-standing systemic health and social inequities have put many people from racial and ethnic minority groups at increased risk of getting sick and dying from skin care products”.[] One important strategy for addressing these important inequities is by improving data collection to allow for better measurement and reporting on equity across our programs and policies. We are committed to achieving equity in health care outcomes for our beneficiaries by supporting providers in quality improvement activities to reduce health inequities, enabling beneficiaries to make more informed decisions, and promoting provider accountability for health care disparities.[] For the purposes of this rule, we are using a definition of equity established in Executive Order 13985, as “the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color. Members of religious minorities.

Lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons. Persons with disabilities. Persons who live in rural areas.

And persons otherwise adversely Start Printed Page 19767affected by persistent poverty or inequality.” [] We note that this definition was recently established by the current administration, and provides a useful, common definition for equity across different areas of government, although numerous other definitions of equity exist. Our ongoing commitment to closing the equity gap in CMS quality programs is demonstrated by a portfolio of programs aimed at making information on the quality of health care providers and services, including disparities, more transparent to consumers and providers. The CMS Equity Plan for Improving Quality in Medicare aims to support Quality Improvement Networks and Quality Improvement Organizations (QIN-QIOs).

Federal, state, local, and tribal organizations. Providers. Researchers.

Policymakers. Beneficiaries and their families. And other stakeholders in activities to achieve health equity.

The CMS Equity Plan includes three core elements. (1) Increasing understanding and awareness of disparities. (2) developing and disseminating solutions to achieve health equity.

And (3) implementing sustainable actions to achieve health equity.[] The CMS Quality Strategy and Meaningful Measures Framework [] include elimination of racial and ethnic disparities as a fundamental principle. Our ongoing commitment to closing the health equity gap in the HQRP is demonstrated by the sharing of information from the Medicare PAC PUF on Care Compare and seeking to adopt through future rulemaking aspects of the standardized patient assessment data elements (SPADEs) that apply to hospice which include several social determinants of health (SDOH). We continue to work with Federal and private partners to better collect and leverage data on social risk to improve our understanding of how these factors can be better measured in order to close the health equity gap.

Among other things, we have developed an Inventory of Resources for Standardized Demographic and Language Data Collection [] and supported collection of specialized International Classification of Disease, 10th Edition, Clinical Modification (ICD-10-CM) codes for describing the socioeconomic, cultural, and environmental determinants of health. We continue to work to improve our understanding of this important issue and to identify policy solutions that achieve the goals of attaining health equity for all patients. 2.

Solicitation of Public Comment While hospice is not included in the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 (Pub. L. 113-185), we look at measures adopted based on that Act, like SPADES and if aspects apply to hospice then we would consider including it in the HQRP.

This helps with continuity of care since patients may transition from different PAC settings to hospice and it would address a gap in hospice care. We are seeking comment on the possibility of expanding measure development, and adding aspects of SPADEs that could apply to hospice and address gaps in health equity in the HQRP. Any potential health equity data collection or measure reporting within a CMS program that might result from public comments received in response to this solicitation would be addressed through a separate notice- and-comment rulemaking in the future.

Specifically, we are inviting public comment on the following. Recommendations for quality measures, or measurement domains that address health equity, for use in the HQRP. Suggested parts of SDOH SPADEs adoption that could apply to hospice in alignment with national data collection and interoperable exchange standards.

This could include collecting information on certain SDOH, including race, ethnicity, preferred language, interpreter services, health literacy, transportation and social isolation. CMS is seeking guidance on any additional items, including SPADEs that could be used to assess health equity in the care of hospice patients, for use in the HQRP. Ways CMS can promote health equity in outcomes among hospice patients.

We are also interested in feedback regarding whether including facility-level quality measure results stratified by social risk factors and social determinants of health (for example, dual eligibility for Medicare and Medicaid, race) in confidential feedback reports could allow facilities to identify gaps in the quality of care they provide. (For example, methods similar or analogous to the CMS Disparity Methods [] which provide hospital-level confidential results stratified by dual eligibility for condition-specific readmission measures currently included in the Hospital Readmission Reduction Program (84 FR 42496 through 42500)). Methods that commenters or their organizations use in employing data to reduce disparities and improve patient outcomes, including the source(s) of data used, as appropriate.

Given the importance of structured data and health IT standards for the capture, use, and exchange of relevant health data for improving health equity, the existing challenges providers' encounter for effective capture, use, and exchange of health information, such as data on race, ethnicity, and other social determinants of health, to support care delivery and decision making. While we will not be responding to specific comments submitted in response to this Request for Information in the FY 2022 Hospice Wage Index final rule, we intend to use this input to inform future policy development. We look forward to receiving feedback on these topics, and note for readers that responses to the RFI will not directly impact payment decisions.

We also note our intention for an additional RFI or rulemaking on this topic in the future. We look forward to receiving feedback on these topics, and note for readers that responses to the RFI should focus on how they could be applied to the quality reporting program requirements. V.

Advancing Health Information Exchange The Department of Health and Human Services (HHS) has a number of initiatives designed to encourage and support the adoption of interoperable health information technology and to promote nationwide health information exchange to improve health care and patient access to their health information. To further interoperability in post-acute care settings, the Centers for Medicare &. Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) participate in the Post-Acute Care Interoperability Workgroup (PACIO) (https://pacioproject.org/​) to facilitate collaboration with industry stakeholders to develop Fast Healthcare Interoperability Resources (FHIR) Start Printed Page 19768standards.

These standards could support the exchange and reuse of patient assessment data derived from the minimum data set (MDS), inpatient rehabilitation facility patient assessment instrument (IRF-PAI), long term care hospital continuity assessment record and evaluation (LCDS), outcome and assessment information set (OASIS), and other sources, including HOPE if implemented in HQRP through future rulemaking. The PACIO Project has focused on FHIR implementation guides for functional status, cognitive status and new use cases on advance directives and speech, and language pathology. We encourage PAC provider and health IT vendor participation as these efforts advance.

The CMS Data Element Library (DEL) continues to be updated and serves as the authoritative resource for PAC assessment data elements and their associated mappings to health IT standards such as Logical Observation Identifiers Names and Codes and Systematized Nomenclature of Medicine. The DEL furthers CMS' goal of data standardization and interoperability. These interoperable data elements can reduce provider burden by allowing the use and exchange of healthcare data.

Supporting provider exchange of electronic health information for care coordination, person-centered care. And supporting real-time, data driven, clinical decision making. Standards in the Data Element Library (https://del.cms.gov/​DELWeb/​pubHome) can be referenced on the CMS website and in the ONC Interoperability Standards Advisory (ISA).

The 2021 ISA is available at https://www.healthit.gov/​isa. The 21st Century Cures Act (Cures Act) (Pub. L.

114-255, enacted December 13, 2016) requires HHS to take new steps to enable the electronic sharing of health information ensuring interoperability for providers and settings across the care continuum. The Cures Act includes a trusted exchange framework and common agreement (TEFCA) provision [] that will enable the nationwide exchange of electronic health information across health information networks and provide an important way to enable bi-directional health information exchange in the future. For more information on current developments related to TEFCA, we refer readers to https://www.healthit.gov/​topic/​interoperability/​trusted-exchange-framework-and-common-agreement and https://rce.sequoiaproject.org/​.

On May 1, 2020, ONC published a final rule in the Federal Register entitled “21st Century Cures Act. Interoperability, Information Blocking, and the ONC Health IT Certification Program” (85 FR 25642) that established policies related to information blocking as authorized under section 4004 of the 21st Century Cures Act. Information blocking is generally defined as a practice by a health IT developer of certified health IT, health information network, health information exchange, or health care provider that, except as required by law or specified by the Secretary of HHS as a reasonable and necessary activity, is likely to interfere with access, exchange, or use of electronic health information.

The definition of information blocking includes a knowledge standard, which is different for health care providers than for health IT developers of certified health IT and health information networks or health information exchanges. A healthcare provider must know that the practice is unreasonable as well as likely to interfere with access, exchange, or use of electronic health information. To deter information blocking, health IT developers of certified health IT, health information networks and health information exchanges whom the HHS Inspector General determines, following an investigation, have committed information blocking, are subject to civil monetary penalties of up to $1 million per violation.

Appropriate disincentives for health care providers are expected to be established by the Secretary through future rulemaking. Stakeholders can learn more about information blocking at https://www.healthit.gov/​curesrule/​final-rule-policy/​information-blocking. ONC has posted information resources including fact sheets (https://www.healthit.gov/​curesrule/​resources/​fact-sheets), frequently asked questions (https://www.healthit.gov/​curesrule/​resources/​information-blocking-faqs), and recorded webinars (https://www.healthit.gov/​curesrule/​resources/​webinars).

We invite providers to learn more about these important developments and how they could affect hospices. VI. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval.

In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues. The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden.

The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of these issues for the following sections of this rule that contain information collection requirements.

A. ICRs Regarding Hospice QRP The HQRP proposals would not change provider burden or costs. For the proposal to remove the 7 HIS measures from the HQRP, we do not propose any changes to the requirement to submit the HIS admission assessment since we continue to collect the data for these 7 HIS measures in order to calculate the more broadly applicable NQF # 3235, the Hospice and Palliative Care Composite Process Measure—HIS-Comprehensive Assessment Measure at Admission.

The proposal to add the HCI also would not change provider burden or costs since it is a claims-based measure that CMS calculates from the Medicare claims data. Likewise, the proposal to publicly report the claims-based HVLDL quality measure would not result in reduced provider burden and related costs. The reduction in provider burden and costs occurred when we replaced the HIS-based HVWDII quality measure via the HIS-PRA package that OMB approved on February 16, 2021 (OMB Control Number.

0938-1153, CMS-10390). Finally, the Home Health Rider proposal would not change provider burden or costs since it only affects the number of quarters used in the calculation of certain claims-based measures for the public display for certain refresh cycles. B.

ICRs Regarding Hospice CoPs We are proposing to revise the provisions at § 418.76(c)(1) that requires the hospice aide to be evaluated by observing an aide's performance of the task with a patient. This proposed revision is subject to the PRA. However, the information collection burden associated with the existing requirements at § 418.76(c)(1) are Start Printed Page 19769accounted for under the information collection request currently approved OMB control number 0938-1067.

The proposed revision's addition of the use of a “pseudo patient” allow for greater flexibility and may minimally reduce burden on the hospice. We request public comment on our determination that the time and effort necessary to comply with implementing the use of the pseudo-patient for hospice aide training at § 418.76(c)(1), may reduce burden on the provider. We are also proposing to revise the provisions at § 418.76(h)(1)(iii) to state that if an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation related to the deficient and related skill(s) in accordance with § 418.76(c).

We believe this could increase the speed with which hospices perform competency testing and could allow new aides to begin serving patients more quickly as these proposed changes will allow the hospice to focus on specific aide skills when a skill deficiency is assessed. In accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2), we believe that both the existing requirements and the proposed revisions to the requirements at § 418.76(h) are exempt from the PRA. We believe competency evaluations are a usual and customary business practice and we state as such in the information collection request associated with the Hospice Conditions of Participation (0938-1067).

Therefore, we are not proposing to seek PRA approval for any information collection or recordkeeping activities that may be conducted in connection with the proposed revisions to § 418.76(h), but we request public comment on our determination that the time and effort necessary to comply with these evaluation requirements is usual and customary, and would be incurred by hospice staff even absent this regulatory requirement. C. Submission of PRA-Related Comments We have submitted a copy of this proposed rule to OMB for its review of the rule's information collection and recordkeeping requirements.

The requirements are not effective until they have been approved by OMB. We invite public comments on these information collection requirements. If you wish to comment, please identify the rule (CMS-1754-P) and, where applicable, the preamble section, and the ICR section.

See this rule's DATES and ADDRESSES sections for the comment due date and for additional instructions and OMB control number 0938-1153 (CMS-10390) or OMB control number 0938-1067 (CMS-10277). VII. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually.

We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. VIII. Regulatory Impact Analysis A.

Statement of Need This proposed rule meets the requirements of our regulations at § 418.306(c) and (d), which require annual issuance, in the Federal Register, of the hospice wage index based on the most current available CMS hospital wage data, including any changes to the definitions of CBSAs or previously used MSAs, as well as any changes to the methodology for determining the per diem payment rates. This proposed rule would also update payment rates for each of the categories of hospice care, described in § 418.302(b), for FY 2022 as required under section 1814(i)(1)(C)(ii)(VII) of the Act. The payment rate updates are subject to changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act.

B. Overall Impacts We estimate that the aggregate impact of the payment provisions in this proposed rule would result in an estimated increase of $530 million in payments to hospices, resulting from the hospice payment update percentage of 2.3 percent for FY 2022. The impact analysis of this proposed rule represents the projected effects of the changes in hospice payments from FY 2021 to FY 2022.

Using the most recent complete data available at the time of rulemaking, in this case FY 2020 hospice claims data as of January 15, 2021, we apply the current FY 2021 wage index with the current labor shares. Using the same FY 2020 data, we apply the FY 2022 wage index and the current labor share values to simulate FY 2022 payments. We then apply a budget neutrality adjustment so that the aggregate simulated payments do not increase or decrease due to changes in the wage index.

Then, using the same FY 2020 data, we apply the FY 2022 wage index and the current labor share values to simulate FY 2022 payments and compare simulated payments using the FY 2022 wage index and the proposed revised labor shares. We then apply a budget neutrality adjustment so that the aggregate simulated payments do not increase or decrease due to changes in the labor share values. Certain events may limit the scope or accuracy of our impact analysis, because such an analysis is susceptible to forecasting errors due to other changes in the forecasted impact time period.

The nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to predict accurately the full scope of the impact upon hospices. We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L.

96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995. Pub. L.

104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule. (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”). (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency.

(3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof. Or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with Start Printed Page 19770economically significant effects ($100 million or more in any 1 year).

We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability presents the costs and benefits of the rulemaking. C.

Anticipated Effects The RFA requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The great majority of hospitals and most other health care providers and suppliers are small entities by meeting the Small Business Administration (SBA) definition of a small business (in the service sector, having revenues of less than $8.0 million to $41.5 million in any 1 year), or being nonprofit organizations. For purposes of the RFA, we consider all hospices as small entities as that term is used in the RFA.

The Department of Health and Human Services practice in interpreting the RFA is to consider effects economically “significant” only if greater than 5 percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs. The effect of the FY 2022 hospice payment update percentage results in an overall increase in estimated hospice payments of 2.3 percent, or $530 million. The distributional effects of the proposed FY 2022 hospice wage index do not result in a greater than 5 percent of hospices experiencing decreases in payments of 3 percent or more of total revenue.

Therefore, the Secretary has determined that this rule will not create a significant economic impact on a substantial number of small entities. In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA.

For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a MSA and has fewer than 100 beds. This rule will only affect hospices. Therefore, the Secretary has determined that this rule will not have a significant impact on the operations of a substantial number of small rural hospitals (see table 34).

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. The 2021 UMRA threshold is $158 million. This rule is not anticipated to have an effect on state, local, or tribal governments, in the aggregate, or on the private sector of $158 million or more.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. We have reviewed this rule under these criteria of Executive Order 13132, and have determined that it will not impose substantial direct costs on state or local governments. If regulations impose administrative costs on private entities, such as the time needed to read and interpret this proposed rule, we should estimate the cost associated with regulatory review.

Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's proposed rule will be the number of reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this proposed rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the proposed rule.

For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this proposed rule. Using the wage information from the Bureau of Labor Statistics (BLS) for medical and health service managers (Code 11-9111). We estimate that the cost of reviewing this rule is $114.24 per hour, including overhead and fringe benefits (https://www.bls.gov/​oes/​current/​oes_​nat.htm).

This proposed rule consists of approximately 55,000 words. Assuming an average reading speed of 250 words per minute, it would take approximately 1.83 hours for the staff to review half of it. For each hospice that reviews the rule, the estimated cost is $209.06 (1.83 hour × $114.24).

Therefore, we estimate that the total cost of reviewing this regulation is $11,080.18 ($209.06 × 53 reviewers). D. Detailed Economic Analysis 1.

Proposed Hospice Payment Update for FY 2022 The FY 2022 hospice payment impacts appear in Table 34. We tabulate the resulting payments according to the classifications (for example, provider type, geographic region, facility size), and compare the difference between current and future payments to determine the overall impact. The first column shows the breakdown of all hospices by provider type and control (non-profit, for-profit, government, other), facility location, facility size.

The second column shows the number of hospices in each of the categories in the first column. The third column shows the effect of using the FY 2022 updated wage index data. This represents the effect of moving from the FY 2021 hospice wage index to the FY 2022 hospice wage index.

The fourth column shows the effect of the proposed rebased labor shares. The aggregate impact of the changes in column three and four is zero percent, due to the hospice wage index standardization factor and the labor share standardization factor. However, there are distributional effects of the FY 2022 hospice wage index.

The fifth column shows the effect of the hospice payment update percentage as mandated by section 1814(i)(1)(C) of the Act, and is consistent for all providers. The 2.3 hospice payment update percentage is based on the 2.5 percent inpatient hospital market basket update, reduced by a 0.2 percentage point productivity adjustment. The sixth column shows the effect of all the proposed changes on FY 2022 hospice payments.

It is projected aggregate payments would increase by 2.3 percent. Assuming hospices do not change their billing practices. As illustrated in Table 35, the combined effects of all the proposals vary by specific types of providers and by location.

In addition, we are providing a provider-specific impact analysis file, which is available on our website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​Hospice/​Hospice-Regulations-and-Notices.html. We note that simulated payments are based on utilization in FY 2020 as seen on Medicare hospice claims (accessed from the CCW in January of 2021) and only include payments related to the level of care and do not include payments related to the service intensity add-on. As illustrated in Table 35, the combined effects of all the proposals vary by specific types of providers and by location.

Start Printed Page 19771 Start Printed Page 19772 E. Alternatives Considered For the FY 2022 Hospice Wage Index and Rate Update proposed rule, we considered alternatives to the calculations of the wage index standardization factor and the labor share standardization factor. Typically, the wage index standardization factor is calculated using the most recent, complete hospice claims data available at the time of rulemaking.

However, due to the skin care products PHE, we looked at using FY 2019 claims data to determine if there were significant differences between utilizing FY 2019 and FY 2020 claims data for the calculation of the wage index and labor share standardization factors. The wage index standardization factors and labor share standardization factors for each level of care calculated using the FY 2020 claims data that was available at the time of rulemaking did not show significant differences compared to those calculated using FY 2019 claims data. As such, the differences between using FY 2019 and FY 2020 claims data for rate-setting were minimal.

Therefore, we will continue our practice of using the most recent, complete hospice claims data to available at the time of rulemaking to set payment rates. F. Accounting Statement As required by OMB Circular A-4 (available at https://www.whitehouse.gov/​sites/​whitehouse.gov/​files/​omb/​circulars/​A4/​a-4.pdf), in Table 36, we have prepared an accounting statement showing the classification of the expenditures associated with the provisions of this proposed rule.

Table 36 provides our best estimate of the possible changes in Medicare payments under the hospice benefit as a result of the policies in this proposed rule. This estimate is based on the data for 4,957 hospices in our impact analysis file, which was constructed using FY 2020 claims available in January 2021. All Start Printed Page 19773expenditures are classified as transfers to hospices.

G. Conclusion We estimate that aggregate payments to hospices in FY 2022 will increase by $530 million as a result of the market basket update, compared to payments in FY 2021. We estimate that in FY 2022, hospices in urban areas will experience, on average, 2.2 percent increase in estimated payments compared to FY 2021.

While hospices in rural areas will experience, on average, 2.6 percent increase in estimated payments compared to FY 2021. Hospices providing services in the Outlying and South Atlantic regions would experience the largest estimated increases in payments of 4.4 percent and 2.9 percent, respectively. Hospices serving patients in areas in the New England and Middle Atlantic regions would experience, on average, the lowest estimated increase of 1.4 percent in FY 2022 payments.

In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. Start List of Subjects Health facilitiesHospice careMedicareReporting and recordkeeping requirements End List of Subjects For the reasons set forth in the preamble, the Centers for Medicare &. Medicaid Services proposes to amend 42 CFR chapter IV as set forth below.

Start Part End Part Start Amendment Part1. The authority citation for part 418 continues to read as follows. End Amendment Part Start Authority 42 U.S.C.

1302 and 1395hh. End Authority Start Amendment Part2. Section 418.3 is amended by adding definitions for “Pseudo-patient” and “Simulation” in alphabetical order to read as follows.

End Amendment Part Definitions. * * * * * Pseudo-patient means a person trained to participate in a role-play situation, or a computer-based mannequin device. A pseudo-patient must be capable of responding to and interacting with the hospice aide trainee, and must demonstrate the general characteristics of the primary patient population served by the hospice in key areas such as age, frailty, functional status, cognitive status and care goals.

* * * * * Simulation means a training and assessment technique that mimics the reality of the homecare environment, including environmental distractions and constraints that evoke or replicate substantial aspects of the real world in a fully interactive fashion, in order to teach and assess proficiency in performing skills, and to promote decision making and critical thinking. * * * * * Start Amendment Part3. Section 418.24 is amended by.

End Amendment Part Start Amendment Parta. Revising paragraphs (c) introductory text and (c)(9). End Amendment Part Start Amendment Partb.

Adding paragraph (c)(10). End Amendment Part Start Amendment Partc. Redesignating paragraphs (d) through (g) as paragraphs (e) through (h).

And End Amendment Part Start Amendment Partd. Adding a new paragraph (d). End Amendment Part The revisions and additions read as follows.

Election of hospice care. * * * * * (c) Content of hospice election statement addendum. For hospice elections beginning on or after October 1, 2020, in the event that the hospice determines there are conditions, items, services, or drugs that are unrelated to the individual's terminal illness and related conditions, the individual (or representative), non-hospice providers furnishing such items, services, or drugs, or Medicare contractors may request a written list as an addendum to the election statement.

The election statement addendum must include the following. * * * * * (9) Name and signature of the individual (or representative) and date signed, along with a statement that signing this addendum (or its updates) is only acknowledgement of receipt of the addendum (or its updates) and not the individual's (or representative's) agreement with the hospice's determinations. If a non-hospice provider or Medicare contractor requests the addendum, the non-hospice provider or Medicare contractor are not required to sign the addendum.

(10) Date the hospice furnished the addendum. (d) Timeframes for the hospice election statement addendum. (1) If the addendum is requested within the first 5 days of a hospice election (that is, in the first 5 days of the hospice election date), the hospice must provide this information, in writing, to the individual (or representative), non-hospice provider, or Medicare contractor within 5 days from the date of the request.

(2) If the addendum is requested during the course of hospice care (that is, after the first 5 days of the hospice election date), the hospice must provide this information, in writing, within 3 days of the request to the requesting individual (or representative), non-hospice provider, or Medicare contractor. (3) If there are any changes to the plan of care during the course of hospice care, the hospice must update the addendum and provide these updates, in writing, to the individual (or representative) in order to communicate these changes to the individual (or representative). (4) If the individual dies, revokes, or is discharged within the required timeframe for furnishing the addendum (as outlined in paragraphs (d)(1) and (2) Start Printed Page 19774of this section, and before the hospice has furnished the addendum, the addendum would not be required to be furnished to the individual (or representative).

The hospice must note the reason the addendum was not furnished to the patient and the addendum would become part of the patient's medical record if the hospice has completed it at the time of discharge, revocation, or death. (5) If the beneficiary dies, revokes, or is discharged prior to signing the addendum (as outlined in paragraphs (d)(1) and (2) of this section), the addendum would not be required to be furnished to the individual (or representative). The hospice must note the reason the addendum was not signed and the addendum would become part of the patient's medical record.

* * * * * Start Amendment Part4. Section 418.76 is amended by revising paragraphs (c)(1) and (h)(1)(iii) to read as follows. End Amendment Part Condition of participation.

Hospice aide and homemaker services. * * * * * (c) * * * (1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section must be evaluated by observing an aide's performance of the task with a patient or pseudo-patient.

The remaining subject areas may be evaluated through written examination, oral examination, or after observation of a hospice aide with a patient or a pseudo-patient during a simulation. * * * * * (h) * * * (1) * * * (iii) If an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete, a competency evaluation of the deficient skill and all related skill(s) in accordance with paragraph (c) of this section. * * * * * Start Amendment Part5.

Section 418.309 is amended by revising paragraphs (a)(1) and (2) to read as follows. End Amendment Part Hospice aggregate cap. * * * * * (a) * * * (1) For accounting years that end on or before September 30, 2016 and end on or after October 1, 2030, the cap amount is adjusted for inflation by using the percentage change in the medical care expenditure category of the Consumer Price Index (CPI) for urban consumers that is published by the Bureau of Labor Statistics.

This adjustment is made using the change in the CPI from March 1984 to the fifth month of the cap year. (2) For accounting years that end after September 30, 2016, and before October 1, 2030, the cap amount is the cap amount for the preceding accounting year updated by the percentage update to payment rates for hospice care for services furnished during the fiscal year beginning on the October 1 preceding the beginning of the accounting year as determined pursuant to section 1814(i)(1)(C) of the Act (including the application of any productivity or other adjustments to the hospice percentage update). * * * * * Start Amendment Part6.

Section 418.312 is amended by revising paragraph (b) to read as follows. End Amendment Part Data submission requirements under the hospice quality reporting program. * * * * * (b) Submission of Hospice Quality Reporting Program data.

(1) Standardized set of admission and discharge items Hospices are required to complete and submit an admission Hospice Item Set (HIS) and a discharge HIS for each patient to capture patient-level data, regardless of payer or patient age. The HIS is a standardized set of items intended to capture patient-level data. (2) Administrative data, such as Medicare claims data, used for hospice quality measures to capture services throughout the hospice stay, are required and automatically meet the HQRP requirements for § 418.306(b)(2).

(3) CMS may remove a quality measure from the Hospice QRP based on one or more of the following factors. (i) Measure performance among hospices is so high and unvarying that meaningful distinctions in improvements in performance can no longer be made. (ii) Performance or improvement on a measure does not result in better patient outcomes.

(iii) A measure does not align with current clinical guidelines or practice. (iv) The availability of a more broadly applicable (across settings, populations, or conditions) measure for the particular topic. (v) The availability of a measure that is more proximal in time to desired patient outcomes for the particular topic.

(vi) The availability of a measure that is more strongly associated with desired patient outcomes for the particular topic. (vii) Collection or public reporting of a measure leads to negative unintended consequences other than patient harm. (viii) The costs associated with a measure outweigh the benefit of its continued use in the program.

* * * * * Start Signature Dated. March 29, 2021. Elizabeth Richter, Acting Administrator, Centers for Medicare &.

Xavier Becerra, Secretary, Department of Health and Human Services. End Signature End Supplemental Information BILLING CODE 4120-?. ?.

-PBILLING CODE 4120-?. ?. -CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-CBILLING CODE 4120-01-PBILLING CODE 4120-01-C[FR Doc.

2021-07344 Filed 4-8-21. 4:15 pm]BILLING CODE 4120-01-P.

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