REGULATORY INTELLIGENCE YEAR-END REPORT - 2021 Health Policy Tracking Service - Issue Briefs Healthcare Providers & Facilities Healthcare Facilities This Issue Brief was written by Tammy J. Raduege, J.D., a contributing writer and member of the Wisconsin bar. 12/20/2021 I], Background The success of hospitals should be a concern for everyone. Hospitals are vital not only to the health of our citizenry, but they also contribute greatly to the health of our national and local economies: Every dollar hospitals spend supports more than two dollars in other economic activity. [FN2I The American Hospital Association (AHA) has documented the contribution hospitals make to the economy. In 2018, the AHA released data showing that hospitals directly employ nearly 5.7 million people, but because of the 'ripple effect,' they support more than 16 million jobs. Hospitals spend over $852 billion on goods and services, and they create nearly $3 trillion in economic activity. [FNS] jy addition, hospitals never recover all of their costs, due to either uncompensated care or Medicare and Medicaid underpayments. Uncompensated care is care that a hospital gives for which it receives no pay, either because of bad debt or because it provided charity care. Medicare and Medicaid underpayments occur when the hospital receives payment that is less than the full value of the services they provided. In January 2021, the AHA released data on Medicare and Medicaid underpayments. The data show that, in 2019, Medicare underpaid hospitals by $56.8 billion and Medicaid underpaid by $19 billion. "4! These numbers are down slightly from 2018. IFN5! The total of uncompensated care came to 41.6 billion in 2019, up just slightly from 2018. [FING] Hospitals participating in the Medicare and Medicaid programs are deeply affected by state budget policies and priorities. The Kaiser Family Foundation's most recent 50-state Medicaid budget survey highlighted payment rate changes for various types of entities and facilities. As is often said of Medicaid, it is countercyclical, meaning that in lean economic times, states reduce provider payment rates as a way to contain costs in their Medicaid programs, and in better economic times, states can afford to increase rates. According to the authors, however, despite the economic downturn brought about by the pandemic, states found it less feasible to cut payments rates when providers were financially strained. IFN7] In fiscal year 2021, more states increased fee-for-service payment rates for at least one provider category than implemented payment restrictions (42 states and 27 states, respectively). For fiscal year 2022, 45 of the responding states reported plans to increase rates in at least one area, and 26 planned to implement restrictions. When states did increase fee-for-service rates, it was often in nursing facility and home- and community-based services provider categories. For fiscal year 2021, Colorado and Wyoming implemented rate reductions across most provider categories. For fiscal year 2022, California, Idaho, and North Carolina reported plans to reduce rates across most provider categories. And in Mississippi, the legislature enacted a rate freeze for all providers for fiscal years 2022 through 2024. The authors highlight fee-for-service rate increases among some common provider categories for fiscal years 2021 and 2022: Inpatient hospitals:21 states adopted increases in 2021, and 24 states have adopted them for 2022. Nursing facilities:39 states adopted increases in 2021, and 33 states have adopted them for 2022. Outpatient hospitals: 21 states adopted increases in fiscal year 2021, and 24 states have adopted them for 2022. Primary care physicians: 19 states adopted increases in fiscal year 2021, and 15 states have adopted them for 2022. Specialist physicians: 15 states adopted increases in fiscal year 2021, and 15 states have adopted them for 2022. OB/GYNs: 13 states adopted increases in fiscal year 2021, and 13 states have adopted them for 2022. In terms of decreases in provider rates in fiscal years 2021 and 2022: Inpatient hospitals:26 states adopted decreases in 2021, and 23 states have adopted them for 2022. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. Nursing facilities:8 states adopted decreases in 2021, and 10 states have adopted them for 2022. Outpatient hospitals: 4 states adopted decreases in fiscal year 2021, and 2 states have adopted them for 2022. Primary care physicians: 2 states adopted decreases in fiscal year 2021, and 3 states have adopted them for 2022. Specialist physicians: 2 states adopted decreases in fiscal year 2021, and 3 states have adopted them for 2022. OB/GYNs: 2 states adopted decreases in fiscal year 2021, and 3 states have adopted them for 2022. Of states reporting rate changes, the majority indicated the changes were made in whole or part because of the pandemic. [FING] Fee-for-service payment rates often serve as benchmarks for managed care capitation rates. Please see the Issue Brief for information about payment changes in managed care. Finally, the authors report that states continue to rely on provider taxes and fees to fund some of the state portion of Medicaid costs. ll. what is the future of the affordable care act? In March, 2010, President Obama signed two bills into law:H.B. 3590, the Patient Protection and Affordable Care Act of 2010 (P.L. 111-148) and H.B. 4872, the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152), which make comprehensive changes to Medicaid. The law aims to improve the quality of care, improve the health of the citizenry, and reduce costs. New payment and delivery models are tailored to achieve these goals. Also, the law places emphasis on decreasing fraud, abuse, and waste. Since the Affordable Care Act became law more than a decade ago, opponents have been challenging it, both congressionally and in the courts. The latest challenge was in the courts, with two individuals and governors or attorneys general from several states claiming that the act as a whole was unconstitutional since the Tax Cuts and Jobs Act of 2017 set the minimum essential coverage penalty (the penalty for not having health insurance) to $0. The Justice Department was not defending the case, and it in fact argued against the law. The case wound through the federal courts, with the lower courts generally agreeing with the plaintiffs, and it ended up in the Supreme Court. On June 17, 2021, the Supreme Court issued its 7-2 decision, holding that the plaintiffs did not have standing to bring the lawsuit. As to the individual plaintiffs, the Court held that they did not prove any injury: Their problem lies in the fact that the statutory provision, while it tells them to obtain that coverage, has no means of enforcement. With the penalty zeroed out, the IRS can no longer seek a penalty from those who fail to comply. See 26 U. S. C. ?5000A(g) (setting out IRS enforcement only of the taxpayer's failure to pay the penalty, not of the taxpayer's failure to maintain minimum essential coverage). Because of this, there is no possible Government action that is causally connected to the plaintiffs' injury-the costs of purchasing health insurance. Or to put the matter conversely, that injury is not ""fairly traceable" to any "allegedly unlawful conduct" of which the plaintiffs complain. [FNS] The state plaintiffs argued, essentially, that the mandate drove more individuals to enroll in Medicaid or Marketplace plans, causing the states to incur costs for these programs. The court held that, similar to the individual plaintiffs, the state plaintiffs could not show any harm from the unenforceable mandate: The state plaintiffs have failed to show that the challenged minimum essential coverage provision, without any prospect of penalty, will [FN10] harm them by leading more individuals to enroll in these programs. Having decided the case procedurally, the Court did not reach the merits. IFN11] The decision means that all the law's consumer protections, its Marketplace subsidies, the Medicaid expansion, and other important provisions remain in place. According to The New York Times, had the Court struck down the law, the ranks of the uninsured would have swelled by an additional 21 million people, an increase of nearly 70%. The bulk of these newly uninsured individuals would have been those who lost coverage from the Medicaid expansion. [FN12] Upon hearing of the decision, Health and Human Services (HHS) Secretary Xavier Becerra issued a statement lauding the decision and the impact it will have on people's lives: Today's decision means that all Americans continue to have a right to access affordable care, free of discrimination. More than 133 million people with pre-existing conditions, like cancer, asthma or diabetes, can have peace of mind knowing that the health protections they rely on are safe. Women who need access to birth control, life-saving maternity care and preventive care can rest easy, knowing that their care is protected and covered. Seniors and people with disabilities can breathe easy knowing their health protections will continue. Individuals who have faced discrimination can continue accessing care without fear. And people relying on Medicaid and Medicare should know these programs are stronger than ever. [FN13} The news of the decision comes on the heels of HHS' announcement earlier in June that more people than ever are receiving the benefits of the Affordable Care Act. Thirty-one million Americans are receiving coverage through one or another of the Affordable Care Act's programs, including 11.3 million in Marketplace plans, 14.8 million newly eligible individuals in the Medicaid expansion, one million in the Basic Health Plan, and nearly four million who were previously eligible for Medicaid but unenrolled until Affordable Act provisions were implemented (such as education and outreach, streamlined enrollment processes, and so forth). [FN14] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. Ill. THE SHIFT IN WAIVER POLICY FROM THE TRUMP ADMINISTRATION TO THE BIDEN ADMINISTRATION Section 1115 of the Social Security Act allows the HHS Secretary to waive Medicaid program requirements for experimental, pilot, or demonstration programs that are likely to promote the objectives of the Medicaid program. Previous administrations have interpreted this to mean that the waiver program must be designed to expand coverage. Therefore, the government had never before approved program features like work requirements, which could actually limit coverage. The Trump Administration, however, did not require such proof. According to a brief from the Kaiser Family Foundation, revised waiver criteria focus on positive health outcomes, efficiencies to ensure program sustainability, coordinated strategies to promote upward mobility and independence, incentives that promote responsible beneficiary decision-making, alignment with commercial health products, and innovative payment and delivery system reforms. [FN15] President Biden's Administration views waivers much the way that previous administrations had before the Trump Administration. We are starting to see Biden Administration's philosophy on waivers taking shape as it seeks to undo policies put in place under former President Trump. In the waning days of the Trump Administration, Texas sought a five-year extension of its Section 1115(a) demonstration titled "Texas Healthcare Transformation and Quality Improvement Program."The request included significant changes to the waiver. Texas sought approval of the extension in 2020. It was already authorized until 2022, and the state requested an extension until 2027. The state indicated that extension of the waiver without notice and comment was necessary to ensure stability for providers and the Medicaid program in the wake of the COVID-19 emergency period, and it therefore sought an exemption. In early 2021, the Centers for Medicare and Medicaid Services (CMS) approved the request, even approving features that the state had not requested, like an uncompensated care pool and an extension until 2030. Though the state sought and received an exemption from the federal notice and comment process, it did engage in some state-level notice and comment procedures, but the notice materials included details about the waiver extension as requested, not as ultimately granted. On April 16, 2021, CMS rescinded the approval, noting that the request did not meet the standard for exemption from notice and comment: We have determined that the state's exemption request did not articulate a sufficient basis for us to conclude that approving the state's emergency request for an exemption from the normal public notice process was needed to address a public health emergency or other sudden emergency threat to human lives, as required under 42 C.F.R. ? 431.416(g). The state's exemption request in its application did not establish that the request to extend the demonstration, which was already authorized through September 30, 2022, was subsiantially related to the public health emergency for COVID-19 or any other sudden emergency threat to human lives, that the circumstances surrounding the extension request constituted an emergency, or that delay sufficient to complete the public notice and comment process before approval of the extension request would have undermined or compromised the purpose of the demonstration or been contrary to the interest of beneficiaries. Rather, the erroneous initial determination to approve an exemption from the normal public notice and comment requirements was itself contrary to the interest of beneficiaries, as well as of Texas and CMS, because it deprived beneficiaries and other interested stakeholders of the opportunity to comment on, and potentially influence, the state's request to extend a complex demonstration - already authorized through September 30, 2022 - into the next decade. [FN16] Moreover, had the state truly needed to change the waiver to respond to the COVID-19 crisis, it could have used the streamlined Section 1115 template that CMS had set up for that purpose at the beginning of the emergency period, the agency wrote. It rescinded approval of the extension and invited the state to resubmit the request after following normal notice and comment processes. [FN17] At stake are billions of dollars of federal Medicaid funding, which were largely meant to address uncompensated care costs. The state has so far resisted adopting the Affordable Care Act's Medicaid expansion. [FN18] Because the state has such a high uninsured rate, [FN19} hospitals suffer significant uncompensated care costs. The Houston Chronicle writes that the state has relied on waivers as a "cheaper" alternative to expanding Medicaid. IFN20] The federal government is keen on getting the hold-out states to adopt the Medicaid expansion, and it included in the American Rescue Plan incentives for the states to do so now. According to the paper, the there is no movement in state government to do so. [FN21] According to the Houston Chronicle, health advocacy groups and some health policy experts were opposed to CMS approving the waiver without notice and comment, with one pointing out that the waiver was never meant to be a permanent fix. Several people opposed to the waiver extension argued that it is time to seriously consider the expansion as a permanent solution. On the other hand, the president of the Texas Hospital Association expressed his disappointment in the Biden Administration's decision, saying that it threatens the state's safety net and the ability of hospitals to protect patients. [FN22] Becker's Hospital Review writes that the government's decision to rescind approval of the waiver extension is ""credit negative" for state hospitals. For large urban hospitals, the waiver accounts for 10-15% of their revenue. *N7*! IV. CARE IN SPECIFIC FACILITIES THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. Community Health Centers According to the Health Resources and Services Administration (HRSA), community health centers, which serve 29 million people in more than 13,500 service sites around the country, [FN24] provide holistic care by integrating mental health services, oral health services, substance use disorder services, and primary care services. The clinicians that provide care at these centers include primary care providers, nurses, dentists, social workers, and health educators. [FN25] Health center patients are generally low-income, with 68% falling at 100% or less of the federal poverty level. About 81% of patients are either uninsured or covered by public insurance. IFN26] Increasingly, community health centers are providing crucial support to those with substance use disorder. IFN27] Recent increases in demand for health center substance abuse services are startling: Nearly seven in 10 (69%) health centers reported an increase in patients with an addiction to prescription opioids and a similar share (63%) reported an increase in patients with an addiction to nonprescription opioids such as heroin and fentanyl. The findings of the survey of community health centers are consistent with national trends and reflect a growing opioid epidemic whose impacts have been especially devastating in the medically underserved rural and urban areas where many health centers are located. [FN28] Even though community health centers fill a critical need in the health care system, they, like other safety net programs, are struggling to provide services with limited resources, and the resources they do have are under threat. According to the Commonwealth Fund, funding for federally-qualified health centers (FQHCs) comes from a variety of sources, including state and local funds, federal funds, and private donations. State and local funds are increasingly becoming inadequate as state policymakers are reticent to raise taxes. The Commonwealth Fund also noted that Medicaid funds make up about half of all revenue for FQHCs, and Medicaid funding is under threat. Further, a new Trump Administration waiver policy allows states more flexibility, and several states are seeking approval to change eligibility requirements, meaning that fewer individuals will be eligible for Medicaid. The post explores other recent changes that are affecting FQHCs and other providers that serve the poor. [FN29] Fortunately, in 2019, the HRSA awarded almost $400 million to community health centers, rural organizations, and academic institutions to allow them to establish or expand access to substance abuse and mental health services, [FN30] and HHS awarded $50 million to establish new health centers. "5"! The Coronavirus Aid, Relief and Economic Security (CARES) Act also ensured an additional $1.3 billion in funds for health centers because of the important work they are doing treating patients affected by COVID-19. IFN321 Additionally, the CARES Act extended congressional Funding for the Community Health Center Fund, which was to end in May 2020, through November. "4! In 2020, HHS announced that it had awarded more than $117 million in quality improvement awards to more than 1,300 health centers in the United States, the territories, and the District of Columbia. According to a press release, " "HRSA-funded health centers will use these funds to further strengthen quality improvement activities and expand quality primary health care service delivery."The health centers were rewarded for activities such as improving care delivery in a cost-efficient manner, improving the quality of care, reducing health disparities, and achieving patient-centered medical home recognition, among other things. [FN34] Also in 2020, HHS announced that it awarded $79 million to 165 HRSA-supported community health centers that have been affected by natural disasters in the past couple of years. The funds will be used for construction and capital support for health centers damaged by Hurricanes Florence and Michael, Typhoon Mangkut, and Super Typhoon Yutu, wildfires and earthquakes in 2018, and tornadoes and floods in 2019. HHS explains more about the funds in a press release: HRSA's Capital Assistance for Disaster Response and Recovery Efforts (CADRE) funding will help ensure access to health care services for communities impacted by disasters and increase health center capacity to respond to and recover from future emergencies. CADRE funding was made available by the Additional Supplemental Appropriations for Disaster Relief Act in 2019. [FNS] The funding recognizes the vital role that health centers play in health care for 30 million individuals in the U.S. and its territories. More recently, HHS announced that health centers in all 50 states, the District of Columbia, and the territories will share in nearly $1 billion for facility modernization. The funds, which were provided for in the American Rescue Plan (P.L. 117-2), may be used to construct new facilities and renovate existing ones as well as to purchase equipment, such as telehealth technology, mobile medical vans, and freezers to store vaccines. The award of these funds is in keeping with the Biden Administration's commitment to health equity. According to HHS Secretary Xavier Becerra, "Health centers are lifelines for many of our most vulnerable families across the country, especially amidst the pandemic... . Thanks to American Rescue Plan funds, we're modernizing facilities across the country to better meet the most pressing public health challenges associated with COVID-19. This historic investment means we get to expand access to care for COVID-19 testing, treatment and vaccination - all with an eye towards advancing equity." [FN36] As noted in the press release, individuals living in underserved communities are disproportionately affected by the COVID-19 pandemic. Please follow the links in the news release for a complete list of all of the health centers that received awards. [FNS7] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. Community health centers are key players in HIV prevention and treatment. The Department of Health and Human Services (HHS) announced that it awarded $48 million to 271 Health Resources and Services Administration-supported community health centers. The funds, which were awarded to health centers in 26 states, Puerto Rico, and the District of Columbia, will be used to expand HIV prevention and treatment services, including pre-exposure prophylaxis-related services, as well as for outreach and care coordination. [FN38] The funds serve the Ending the HIV Epidemic in the U.S. (EHE) initiative, which has the goal of reducing new HIV infections 75% by 2025 and 90% by 2030. [FN39] According to Secretary Xavier Becerra, HHS believes that community health centers are uniquely positioned to provide this care: "HHS-supported community health centers are often a key point of entry to HIV prevention and treatment services, especially for underserved populations . . . | am proud of the role they play in providing critical services to 1.2 million Americans living with HIV. Today's awards will ensure equitable access to services free from stigma and discrimination, while advancing the Biden-Harris Administration's efforts to ending the HIV/AIDS epidemic by 2025," /FN40 Community health centers already have a good track record for diagnosing and treating HIV: Last year, HRSA-funded health centers provided nearly 2.5 million HIV tests to patients. Of those who tested positive for HIV for the first time, over 81 percent were successfully linked to treatment within 30 days. Nearly 190,000 patients living with HIV receive medical care services at health centers, and over 389,000 patients received PrEP [pre-exposure prophylaxis ]-associated services. [FNAt] Community mental health centers also provide crucial services and were especially important during the pandemic. The COVID-19 pandemic has taken a toll on mental health in this country. HHS described the problem in a press release: According to data from the U.S. Centers for Disease Control and Prevention (CDC), from August 2020 through February 2021, the percentage of adults with recent symptoms of an anxiety or a depressive disorder increased from 36.4 percent to 41.5 percent, and the percentage of those reporting an unmet mental health care need increased from 9.2 percent to 11.7 percent. [FN42] Community mental health centers are community-based facilities that offer services to prevent and treat mental health conditions and to provide rehabilitation. In an effort to address the increased need for services, HHS announced that it would invest $825 million in the Community Mental Health Grant Program. This program will allow community mental health centers to address the needs of individuals who have a serious emotional disturbance or a serious mental illness as well as individuals with one of these diagnoses plus a substance use disorder. The funds derive from the Coronavirus Response and Relief Supplement Act of 2021, which was enacted as part of the Consolidated Appropriations Act of 2021 (P.L. 116-260). HHS has now announced that it made awards to 231 community mental health centers as a part of that investment. Within 60 days of receiving the award, centers must develop a behavioral health disparities impact statement. Please see the press release for the services that these centers must cover and those that they may cover. [FN43] HRSA Health Center look-alikes are community-based facilities in underserved areas that meet the requirements for HRSA Health Centers but do not receive funds from the agency. [FN44] jy 2021, the Biden Administration announced that it awarded nearly $144 million in American Rescue Plan (P.L. 117-2) funds to such facilities. HHS Secretary Xavier Becerra remarked, "Health Center Program look-alikes are key players in the Administration's efforts to address health inequities and support those disproportionately affected by COVID-19." [FN45] The new funds are meant to help these providers in their continued effort to combat the effects of the COVID-19 pandemic. In a news release, HHS explained more about how the funds will be used: These American Rescue Plan awards will support communities that rely on LALs [health center look-alikes] for access to critical health care services and are often disproportionately affected by COVID-19. Using these funds, LALs will mitigate the spread of COVID-19, strengthen vaccination efforts, and enhance health care services and infrastructure in communities across the country. In 2019, HRSA Health Center Program LALs served more than half a million patients. Currently, more than 89 percent of LAL patients live at or below 200 percent of the Federal Poverty Guidelines (a family of four making $26,500 or less per year), and more than 63 percent are racial or ethnic minorities, "N"®! According to Kaiser Health News, community health centers shouldered much of the burden for administering COVID-19 vaccinations to minority populations and those living in poverty, but many such centers have not yet been reimbursed. One of the problems is the way the federal government reimburses federally qualified health centers for Medicaid services. Vaccinations given as part of a health care appointments are usually reimbursed as a part of the appointment, but those given outside of appointments, like at a mass immunization event, are not. Centers often relied on these vaccination events as a way to vaccinate the most people without wasting doses, as the vaccination has strict storage requirements. That has left these centers trying to work out a reimbursement arrangement with the states. Some states have reimbursed clinics based on the Medicare rate for vaccinations, while others are still working with CMS to devise a reimbursement formula. In some cases, this has caused a cash flow problem for clinics. While most expect to be reimbursed in time, some are cash poor right now, leading to hiring delays and other problems. Other clinics have given up on seeking reimbursement because of the complications. Some clinics are staying afloat thanks to emergency funding, like loans from the Paycheck Protection Program and funds from the American Rescue Plan (117-2). Please see the article for more information on what particular states are doing to reimburse these clinics. IFNA7] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. Long-Term Care Facilities The Trump Administration was committed to improving the safety and quality of care in nursing homes. In April 2019, CMS announced a five-part strategy to further these goals. The parts of the strategy are: 1. Strengthen Oversight 2. Enhance Enforcement 3. Increase Transparency 4. Improve Quality 5. Put Patients over Paperwork [FNAB] The work of CMS continues to be informed by these goals. Early in the pandemic, nursing home residents and staff were particularly affected by the effects of the pandemic. According to the Kaiser Family Foundation, as of June 30, 2021, deaths in long-term care facilities accounted for 31% of all deaths nationwide. When the vaccine became available, the government prioritized vaccinations in these facilities, and the death rate dropped to its lowest point since the onset of the pandemic. When the Delta variant began to spread, however, the death rate in long-term care facilities began to rise. According to the foundation, in August 2021, nearly 1,800 residents or staff members of these facilities died. This was the highest one-month total since February 2021. The rise in numbers was swift: Just a month earlier, in July 2021, 350 people in these facilities died of COVID. Fortunately, the numbers have not exceeded the numbers seen in December 2020, when 22,000 people in these facilities died. Still, the rise is higher than in the community at large. Please see the foundation's analysis for more details. [FNA8] CMS placed stringent restrictions on visitation in nursing homes before vaccines were available. Once more than three million residents had been vaccinated, CMS updated its guidance on nursing home visitation. The new guidance indicates that '"responsible" indoor visitation should be allowed at all times for all residents and visitors, regardless of their vaccination status. Visitation would be limited, however, under certain circumstances for certain residents: Unvaccinated residents, if the COVID-19 county positivity rate is greater than 10 percent and less than 70 percent of residents in the facility are fully vaccinated; Residents with confirmed COVID-19 infection, whether vaccinated or unvaccinated, until they have met the criteria to discontinue transmission-based precautions; or Residents in quarantine, whether vaccinated or unvaccinated, until they have met criteria for release from quarantine. [FNSO] A Fact Sheet for the new guidance is available. [FNS1] Hospitals and other Facilities On December 7, 2020, CMS penned a letter to Governors pointing them to the agency's comprehensive strategy to enhance hospital capacity amid the recent COVID-19 surge. IFNS2] The strategy was announced on November 25, 2020. [FN53] ih the letter, CMS sums up the strategy: Building on CMS's successful Hospital Without Walls initiative, this strategy includes the use of unprecedented regulatory flexibility to allow hospitals to provide safe inpatient care for eligible Medicare patients in their homes as well to more fully leverage ambulatory surgical centers (ASCs) as a critical relief valve to continue life-saving care, like cancer surgeries, as hospitals resources are directed to the care of COVID-19 patients. [FNS4] As CMS indicated, the strategy builds on actions that CMS previously took earlier in the pandemic to increase hospital capacity. For example, CMS is expanding its Hospitals without Walls initiative by launching the Acute Hospital Care at Home program, which gives hospitals even greater regulatory flexibility to treat patients in their homes. Similarly, CMS had previously granted flexibility for ambulatory care facilities to become certified as hospitals to provide hospital services. CMS is expanding that option as well: Today, CMS is announcing an update to that regulatory flexibility, clarifying that participating ASCs need only provide 24-hour nursing services when there is actually one or more patient receiving care onsite. The program change provides ASCs enrolled as hospitals the ability to flex up their staffing when needed and provide an important relief valve in communities experiencing hospital capacity constraints, while not mandating nurses be present when no patients are in the ASC. The flexibility is available to any of the 5732 ASCs throughout the country seeking to participate and will be immediately effective for the 85 ASCs currently participating in the Hospital Without Walls initiative, N°) CMS also pointed to the flexibility it has already granted for telehealth services and notes the part that telehealth plays in reducing the stress on hospitals by reducing the spread of the illness. Amid the surge of the Delta variant, hospital capacity is again an issue. National Public Radio reports that hospitals in Oregon are so overwhelmed by COVID care that they are postponing elective surgeries. According to the CEO of the Oregon Association of Hospitals THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. and Health Systems, there was not an excess of beds even before the pandemic: "If you look at the number of hospital beds per capita, Oregon has 1.7 hospital beds per thousand population. That's the lowest in the country."In other words, any unnecessary stress on hospital capacity was bound to require difficult choices. Unfortunately, however, many so-called elective surgeries, such as delayed cancer surgery, are very consequential for a patient's prognosis. Other types of procedures being delayed include heart surgeries and procedures, bone marrow transplants, and lung surgeries. A study investigated the effectiveness of postponing elective surgeries in Veteran's Administration hospitals earlier in the pandemic (in spring 2020) as a way to free up hospital space. The study found that the decision was largely effective, allowing the hospitals to delay about 91% of surgeries. However, the study did not look at the long-term health effects of delaying these surgeries. One of the lead authors of the study commented, 'We clearly, even in hindsight, made the right decision of curtailing elective surgery . . .. But we as a society have not really emphatically asked the question 'At what price in the long term?" [FNS6] Additional long-term research is needed to determine how the health of patients was affected by delayed surgery. According to the Oregon Health Authority, the vast majority of people taking up hospital beds right now are unvaccinated against COVID:Those who have not had the vaccine are five times more likely to end up in the hospital than those who are vaccinated. For a gentleman with cancer who had to forego his bone marrow transplant, it is hard not to be angry, he says. [FNS7] Similar scenarios are being played out in many other areas of the country, including Florida, [FNS8) Georgia, [FNS9] and other areas in the South, FN&l Finally, CMS published an emergency regulation requiring that staff at health care facilities participating in the Medicare or Medicaid programs be vaccinated against COVID-19. CMS Administrator Chiquita Brooks-LaSure explained why the agency believes the rule is necessary: "Ensuring patient safety and protection from COVID-19 has been the focus of our efforts in combatting the pandemic and the constantly evolving challenges we're seeing . . . . Today's action addresses the risk of unvaccinated health care staff to patient safety and provides stability and uniformity across the nation's health care system to strengthen the health of people and the providers who care for them." [FN61] The regulation applies to ambulatory surgical centers, hospices, Programs of All-Inclusive Care for the Elderly, hospitals, long term care facilities, psychiatric residential treatment facilities, intermediate care facilities for individuals with intellectual disabilities, home health agencies, comprehensive outpatient rehabilitation facilities, critical access hospitals, specified clinics, community mental health centers, home infusion therapy suppliers, rural health clinics/Federally Qualified Health Centers, and end-stage renal disease facilities. [FN€2] A|| workers at these facilities must receive the first dose of a two-dose vaccine or one dose of the Johnson & Johnson vaccine by December 5, 2021, and before providing any care or treatment to patients. All workers must be fully vaccinated by January 4, 2022. Exceptions will be allowed for recognized medical conditions or religious beliefs, observances, or practices. The regulation takes effect on November 5, 2021. IFN63] A list of FAQs is available. "N™! tn late November, a federal district court issued a preliminary injunction halting implementation of the rule. [FN65] V. prioritizing safety and quality A. Avoidable Incidents - Health Care-Acquired Conditions, Unnecessary Admissions, and Avoidable Readmissions In compliance with the Affordable Care Act, CMS is actively working on ways to decrease the incidence of health care-acquired conditions. CMS believes that it can improve care and reduce costs by providing incentives to hospitals for safer care or by adjusting payments for health care-acquired conditions that could have been prevented by following evidence-based guidelines. One of CMS' major initiatives to improve safety in hospitals was the Partnership for Patients (PfP), which was an umbrella for other initiatives, like Hospital Engagement Networks (HENs), Hospital Improvement Innovation Networks (HIINs), and the Community-Based Care Transitions Program, among others. PfP has now ended. On its web site, CMS summarized the success of the program: According to the Agency for Healthcare Research and Quality (AHRQ), data showed successful reductions in hospital-acquired conditions such as adverse drug events and healthcare-associated infections helped prevent 20,500 hospital deaths and save $7.7 billion in health care costs from 2014 to 2017. AHRQ's preliminary analysis estimates that hospital-acquired conditions were reduced by 910,000 from 2014 to 2017. The estimated rate of hospital-acquired conditions dropped 13 percent; from 99 per 1,000 acute care discharges to 86 per 1,000 during the same time frame. IFNG6] Government initiatives promoting hospital safety are overlaid on Affordable Care Act provisions that allow HHS to adjust Medicare payments for high rates of readmissions, quality of care, and high rates of particular types of health-care acquired conditions. In one, the Hospital-Acquired Conditions Reduction Program, IFN67] the government will withhold 1% of Medicare payments for hospitals that score in the bottom quartile on specified measures. IFN68] For fiscal year 2021, CMS will publish information on Hospital Compare about hospitals' performance in these measures: CMS PSI 90 (Patient Safety and Adverse Events Composite) CDC NHSN (Centers for Disease Control and Prevention National Healthcare Safety Network) health care associated infection measures: THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. - CLABSI (Central Line-Associated Bloodstream Infection) - CAUTI (Catheter-Associated Urinary Tract Infection) - SSI (Surgical Site Infection for Abdominal Hysterectomy and Colon Procedures) - MRSA (Methicillin-resistant Staphylococcus aureus) bacteremia - CDI (Clostridium difficile Infection) FN®*! CMS penalized 751 hospitals in fiscal year 2018, [FN70] 800 in fiscal year 2019, [FN71] 786 in fiscal year 2020, [FN72] and 774 in fiscal year 2021, N71 Similarly, the government's Hospital Readmissions Reduction Program penalizes hospitals with a greater than expected 30-day readmission rate for a predetermined set of conditions. [FN74 th the latest round, a total of 2,499 hospitals will be penalized. According to Kaiser Health News, of all the hospitals that CMS evaluated (some are exempt), 82% were penalized, which amounts to nearly one-half of all of the hospitals in the country. The Medicare payment adjustment varies by hospital; the average penalty is .64%. IFN79] Last year, the penalties were controversial because they were imposed during the pandemic, although they were calculated based on discharges before the pandemic began. At the time, CMS indicated that it was considering suspending the penalties for this year if the chaos of the pandemic made it too difficult to evaluate hospital performance. IFN76] While the agency did not suspend the penalties, Kaiser Health News reported that the latest round of penalties were calculated somewhat differently. While CMS usually calculates penalties based on three years of discharge data, this year, the agency disregarded the final six months of data (ending the evaluation period on December 1, 2019), due to the unusual circumstances hospitals are facing during the pandemic. Changes to both the Hospital-Acquired Conditions Reduction Program and the Hospital Readmissions Reduction Program were made in the 2022 Hospital Inpatient Prospective Payment System final rule. The final rule is published at 86 F.R. 44774-01 (Aug. 13, 2021).A Fact Sheet is available. """" Corrections are published at 86 F.R. 58019 (Oct. 20, 2021). Safety net hospitals have complained that they have been unfairly penalized because they have poorer patients who may not be well-connected to primary care or who are less able to pay for needed medications. IFN78] The 24st Century Cures Act (P.L. 114-255) mandated that, beginning in 2019, hospitals be compared to how they performed relative to other hospitals that serve a similar proportion of dually eligible individuals (i.e., those who are eligible for both Medicaid and Medicare). [FN79] In the 2019 Inpatient Hospital Prospective Payment System final rule, CMS codified previously adopted terms relating to these dual eligibles (those who qualify for Medicare and full-benefits Medicaid): 3. Summary of Policies for the Hospital Readmissions Reduction Program In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20403 through 20407), we proposed to: (1) Establish the applicable period for FY 2019, FY 2020 and FY 2021; (2) codify the previously adopted definition of ""dual-eligible"; (3) codify the previously adopted definition of "proportion of dual-eligibles"; and (4) codify the previously adopted definition of "applicable period for dual-eligibility." [FN80] Kaiser Health News published a tool that allows the user to see how each of the nation's hospitals fared under both the hospital- acquired conditions and the readmissions penalties from fiscal years 2015 to 2021. [FN81] The government's work to prevent hospital-acquired conditions appears to be having an effect. In early 2019, HHS' Agency for Healthcare Resources and Quality (AHRC) reported that between 2014 and 2017, reductions in health care-acquired conditions helped to prevent 20,500 hospital deaths and saved $7.7 billion in health care costs. AHRQ estimates that hospital-acquired conditions dropped 13%, cutting the incidence of these events by over 900,000. [FN82] In 2019, MedPAC formally recommended to Congress that CMS reorganize the hospital quality programs by eliminating the Hospital Inpatient Quality Reporting Program and rolling the Hospital Readmissions Reduction Program, the Hospital-Acquired Condition Reduction Program, and the Hospital Value-Based Purchasing Program into a single program. The new program would be called the Hospital Value Incentive Program, which MedPAC believes would better motivate hospitals to improve their performance. MedPAC listed it concerns with the current programs: 1. The same quality measures are used in multiple programs (e.g., hospital-acquired infection measures are used in both the HACRP and VBP Program) (CMS 2018). Overlapping hospital quality payment and reporting programs create unneeded complexity for hospitals and the Medicare program, and may unduly double-count hospitals' performance on certain measures when determining penalties or rewards (MedPAC 2016a, MedPAC 2016b). THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. 2. The IQRP, HRRP, and VBP Program score only certain condition-specific (e.g., acute myocardial infarction readmissions) measures, while ignoring performance for patients with other conditions. The Commission believes that all-condition mortality and readmissions measures are more appropriate to measure and pay for hospital performance. Using all-condition outcome measures encourages hospitals to focus on the outcomes of all their patients and offers hospitals flexibility to improve care relevant to their patient populations. Moreover, all-condition outcome measures increase the number of observations measured and reduces the random variation that single-condition readmission rates face under current policy (MedPAC 2013). 3. The IQRP includes process measures that are not tied to outcomes and are burdensome to report. For fiscal years 2020 and 2021, CMS removed some process measures from the I|QRP because the data collection and reporting costs outweigh the clinical benefit of their continued use (CMS 2018). We have supported CMS' efforts, and the Commission's redesigned program would go further in focusing on outcome measures. 4. The HRRP, VBP Program, and HACRP score hospitals using "tournament models" (i.e., providers are scored relative to one another}-not on clear, absolute, and prospectively set performance targets. For example, the HACRP's statutory design penalizes 25 percent of hospitals every year, even if all hospitals significantly reduce their rates of hospital-acquired conditions. [FN83] B. Focusing on Quality Since the Obama Administration, the government has been committed to shifting the way that it pays for health care; instead of paying for the quantity of the services rendered, the Administration was working toward paying for the quality of the services rendered. Quality is measured by outcomes and cost. The Trump Administration was also committed to the idea of paying for quality. However, during the Trump Administration, CMS indicated that it did not intend to maintain the Obama Administration's specific goals and timelines. A CMS spokesperson explained, ""The Trump administration's focus has not been on a specific targeted number by the previous administration, but rather on evaluating the impact of new payment models on patients and providers[.]" [FN84] CMS has a number of programs that reward or penalize providers based on the quality they provide. They include: - End-Stage Renal Disease Quality Incentive Program (ESRD QIP) - Hospital Value-Based Purchasing (VBP) Program - Hospital Readmission Reduction Program (HRRP) - Value Modifier (VM) Program (also called the Physician Value-Based Modifier or PVBM) - Hospital Acquired Conditions (HAC) Reduction Program - Skilled Nursing Facility Value-Based Program (SNFVBP) - Home Health Value Based Program (HHVBP) [FN85] We discussed some of these programs above, and we discuss others below. Several government initiatives focus on quality or reward improved outcomes. Many of the initiatives and models were designed by and are administered by the Center for Medicare and Medicaid Innovation (the Innovation Center), which was created by the Affordable Care Act. The Comprehensive ESRD Care (CEC) Model is an ACO-type model to care for patients with end-stage renal disease (ESRD). Ina press release, CMS explained why good care for this population of Medicare participants is so important: More than 600,000 Americans have end-stage renal disease (ESRD), also known as kidney failure, and require life sustaining dialysis treatments several times per week. These individuals typically have many health problems, are at higher risk of hospital readmissions, and suffer from fragmented care. In 2012, ESRD beneficiaries comprised 1.1% of the Medicare population and accounted for an estimated 5.6% of total Medicare spending. IFN86] In this model, dialysis facilities, nephrologists, and other providers formed ESRD Seamless Care Organizations (ESCOs) that coordinated care for participants with ESRD. Some of the ESCOs are financially accountable for the quality of care they provided to Medicare participants and the costs they incurred in Medicare Parts A and B. According to CMS, ESCOs participating with dialysis facilities owned by a large dialysis organization (one that owns 200 or more dialysis facilities) share in both the savings and the losses, and ESCOs participating with dialysis facilities owned by a small dialysis organization (one that owns fewer than 200 dialysis facilities) share in the savings only. The Medicare and Medicaid Innovation Center facilitated the model; the last performance period ends on December 31, 2021. [FN87] Evaluation reports for performance year four have now been posted. [FN88] Data plays an important role in evaluating any program. In an email update, [FN8®] CMS announced that it added Research Identifiable Files (RIFs) containing data for the CEC Model. One file, the CEC Beneficiary RIF, includes enrollment data for beneficiaries in the model, and another file, the CEC Provider RIF, contains information about the providers participating in the model. The files have been made available through ResDAC (the Research Data Assistance Center) and CCW (the Chronic Conditions Data Warehouse). THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. On January 9, 2017, CMS announced a new, voluntary payment model called Bundled Payments for Care Improvement Advanced (or BPCI Advanced). The initiative encourages providers and practitioners to coordinate care in order to keep Medicare spending below a specified threshold. Participants who do so may qualify for additional payment. Initially, CMS included in the initiative 32 clinical episodes that were both inpatient and outpatient services. While the initiative is a payment model, it will require delivery system reforms in order to achieve the goals of the program: quality care that does not exceed a given budget for the particular episode. CMS explains: In BPCI Advanced, participants will be expected to redesign care delivery to keep Medicare expenditures within a defined budget while maintaining or improving performance on specific quality measures. Participants bear financial risk, have payments under the model tied to quality performance, and are required to use Certified Electronic Health Record Technology. [FN90] CMS is interested in working with participants that are committed to these practices: continuously redesigning and improving care, decreasing costs by eliminating care that is unnecessary or provides little benefit to patients, encouraging care coordination, and fostering quality improvement, participating in a payment model that tests extended financial accountability for the outcomes of improved quality and reduced spending, creating environments that stimulate rapid development of new evidence-based knowledge, and increasing the likelihood of better health at lower cost through patient engagement, education, and on-going communication between doctors and patients. [FN91] The model qualifies as an Advanced Alternative Payment Model under the Quality Payment Program. [FN92] Model Year 4 began in January 2021. A major change from previous years is that clinical episodes are now arranged in eight clinical episode "lines" with specific episodes in each line. The lines are cardiac care, cardiac procedures, gastrointestinal surgery, gastrointestinal care, neurological care, medical and critical care, spinal procedures, and orthopedics. There are 30 inpatient episodes, three outpatient episodes, and one multi-setting episode. The model currently has more than 1,700 participants. More information about the program, including measures and pricing methodology, is available on the model's web page. IFN®3] The model is to run through December 2023. The Comprehensive Care for Joint Replacement (CJR) model tests whether patients receive better and more efficient care for knee and hip replacement surgeries when the providers are compensated with bundled payments. CMS explains more about the design on the model's web page: The CJR model holds participant hospitals financially accountable for the quality and cost of a CJR episode of care and incentivizes increased coordination of care among hospitals, physicians, and post-acute care providers. The episode of care begins with an admission to a participant hospital of a beneficiary who is ultimately discharged under MS-DRG 469 (Major joint replacement or reattachment of lower extremity with major complications or comorbidities) or 470 (Major joint replacement or reattachment of lower extremity without major complications or comorbidities) and ends 90 days post-discharge in order to cover the complete period of recovery for beneficiaries. The episode includes all related items and services paid under Medicare Part A and Part B for all Medicare fee-for-service beneficiaries, with the exception of certain exclusions. [FN94] Year 1 of the program began in 2016, and the model was to run for five years (through fiscal year 2021). However, in 2021, CMS finalized a rule making changes to the program and extending it for another three years, until December 30, 2024. [FN95] Initially, the program was mandatory for providers paid through the inpatient prospective payment system in the specified 67 metropolitan statistical areas. For year 3, participation became voluntary. The Commonwealth Fund posted about a research study examining how hospitals have responded to these incentives and how the savings in hospital costs generated by the program decreased after the second year. The research points to a few possible causes. In the third year of the program, CMS began making Medicare payment for outpatient knee replacement; however, these episodes are excluded from bundled payments in CJR. According to the research, this led some hospitals to select inpatient surgery for lower risk patients when outpatient surgery would have been less expensive. Moreover, after Year 2, when participation in CJR was made voluntary for hospitals, some of the hospitals that treated the highest-cost patients dropped out of the program. It was these hospitals that accounted for the bulk of the savings. The Commonwealth Fund summed up the findings: Despite the intention of bundled payment programs like CJR, hospitals may be able to take advantage of the incentive structures through patient selection and choosing more costly sites of care. Particularly in CJR, inadequate risk adjustment for patient complexity and the exclusion of outpatient joint replacement reinforces this problem. To promote the success of bundled payments and deliver more efficient care, the authors suggest that new alternative payment models should be designed with caution. [FN96] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -10- Vi. ACCOUNTABLE CARE ORGANIZATIONS CMS explains that an accountable care organization (ACO) is a 'group of providers and suppliers of services (e.g., hospitals, physicians, and others involved in patient care) that will work together to coordinate care for the Medicare fee-for service patients they serve.' [FNS7] This coordinated care should take place across care settings, including physicians' offices, hospitals, and long-term care centers. Coordination of care for the elderly is especially important because they often suffer from multiple medical conditions. According to the federal government, over one-half of Medicare patients are suffering with five or more chronic health conditions. IFNS8] Because these patients suffer from such a number and variety of illnesses, care is often fragmented, which can lead to a lack of communication among the different providers. When that happens, there is a risk that tests or procedures may be unnecessarily repeated or that crucial information may not get passed on from one physician to another. By coordinating care, ACOs should increase the efficiency and safety of medical care for the elderly and decrease the cost. Generally, if ACOs help save money for Medicare, they may share in some of the savings, but some also agree to share in the losses is the costs are too high. CMS launched several ACO programs after the Affordable Care Act was implemented. The largest is the Medicare Shared Savings Program (with 477 participants). [FN®9] Others include the Next Generation ACO Model (with 35 participants) IFN100] ond the Comprehensive ESRD (early stage renal disease) Model (with 33 participants). [FN101] The Pioneer ACO Model, the Advance Payment ACO Model, and the ACO Investment Model are no longer active. The programs differ on a number of features, including the level of risk the ACOs agree to take on and the areas where they work. CMS has been publishing toolkits to inform the public about how ACOs work. Previously, CMS released three toolkits: the Beneficiary Engagement Toolkit, IFN102] the Care Coordination Toolkit, [FN103] and the Provider Engagement Toolkit. [FN104] jf, January 2021, CMS released the Care Transformation Toolkit. fN'95! Among other things, the latest toolkit explores how ACOs develop and implement specific programs that: use telehealth to expand access to services and increase efficiency of care delivery; use home visits to support high risk members; and provide timely access to skilled nursing care. [FN106] CMS has granted some flexibilities for ACOs due to the COVID-19 pandemic. Please see The Government's Response to the COVID-19 Pandemic, below. A. The Medicare Shared Savings Program As the program was originally designed, ACOs in the Medicare Shared Savings Program could opt to enter the program in Track 1 in which they entered into a one-sided arrangement with the government. In a one-sided (or "upside only") arrangement, an ACO that meets quality benchmarks and keeps costs down can share in the cost savings it achieved but accepts no risk for failing to achieve savings. ACOs were allowed to stay in Track 1 for two agreement cycles (or six years). IFN107] ACOs could also choose to participate in other tracks where they entered into a two-sided agreement and shared in both the savings and the losses. [FN106] However, the government's arrangement with most (82%) of the Shared Savings ACOs was one-sided, and ACOs were not leaping to make the change to a two-sided arrangement. IFN109] The Obama Administration recognized the need to encourage more ACOs to transition into risk-bearing arrangements, and in late 2016 it introduced the ACO Track 1+ model. IFN110] ous explained that the new model would 'test a payment model that incorporates more limited downside risk than is currently present in Tracks 2 or 3 of the Medicare Shared Savings Program in order to encourage more rapid progression to performance-based risk.'The new, time-limited model qualified as an APM, allowing participating clinicians to qualify for incentive payments. IFN] The American Hospital Association released a brief statement in support of the model. [FN112] In remarks before the American Hospital Association in 2018, then-CMS Administrator Seema Verma lamented the state of the Medicare Shared Savings Program. Verma expressed her concern that most ACOs in the program were still in one-sided agreements. ACOs in these ""upside-only" arrangements are actually costing the Medicare program money, she said, while ACOs participating in two-sided tracks are saving money. She also said she believes that the one-sided arrangements "may be encouraging consolidation in the market place, reducing competition and choice for our beneficiaries." [FN113] Verma's remarks were portentous. On August 17, 2018, CMS proposed a rule overhauling the Medicare Shared Savings Program, calling the overhaul the Pathways to Success Program. CMS explained the purpose of the rule in the summary: The policies included in this proposed rule would provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These proposed policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free- market principles. The proposed rule also would provide new tools to support coordination of care across settings and strengthen THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -11- beneficiary engagement; ensure rigorous benchmarking; promote interoperable electronic health record technology among ACO providers/suppliers; and improve information sharing on opioid use to combat opioid addiction. [FN114] At the time the proposed rule was announced, some experts and industry representatives expressed fear that the changes would drive ACOs to quit the program, and a survey by the National Association of ACOs (NAACOS) found that 70% of ACOs would rather quit the program than take on the kind of risk being proposed. The CEO of NAACOS predicted unfortunate consequences from the new rule, saying that the "likely outcome will be that many ACOs quit the program, divest their care coordination resources and return to payment models that emphasize volume over value."'A representative from the American Hospital Association, who was concerned with the proposed changes, noted the immense cost, time, and effort it takes to get an ACO to the point of being ready to take on risk. IFN115] On the other hand, Farzad Mostashari, formerly an HHS official under President Obama, said that he agrees that more needs to be done to move ACOs into risk-bearing agreements. However, Mostashari indicated that, ideally, two-sided risk would be made less risky and more predictable. IFN116] CMS estimates a net loss of 100 ACOs by 2027. [FN117] In a final rule addressing payment policies under the Physician Fee Schedule, the Medicare Shared Savings Program, and the Medicaid Promoting Interoperability Program, CMS finalized some new policies for the Medicare Shared Savings Program, but did not finalize everything set out in the proposed rule. In a fact sheet, CMS explained which policies it finalized: [Granting a] voluntary 6-month extension for existing ACOs whose participation agreements expire on December 31, 2018, and the methodology for determining financial and quality performance for this 6-month performance year from January 1, 2019, through June 30, 2019. Allowing beneficiaries who voluntarily align to a Nurse Practitioner, Physician Assistant, Certified Nurse Specialist, or a physician with a specialty not used in assignment to be prospectively assigned to an ACO if the clinician they align with is participating in an ACO, as provided for in the Bipartisan Budget Act of 2018. Revising the definition of primary care services used in beneficiary assignment. Providing relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in 2018 and subsequent years. Reducing the Shared Savings Program core quality measure set by eight measures; and promoting interoperability among ACO providers and suppliers by adding a new CEHRT threshold criterion to determine ACOs' eligibility for program participation and retiring the current Shared Savings Program quality measure on the percentage of eligible clinicians using CEHRT. [FN116] The rule is published at 83 F.R. 59452-01 (Nov. 23, 2018). (Corrections are published at 84 F.R. 539 (Jan. 31, 2019)). CMS later finalized the other provisions of the proposed rule. Former CMS Administrator Seema Verma explained why the time has come to redesign the Medicare Shared Savings Program as it currently exists: ™Pathways to Success is a bold step towards quality healthcare at a lower cost through competition and beneficiary engagement... . The rule strikes a balance between encouraging participation in the ACO program and advancing the transition to value, ultimately protecting taxpayers and patients. Medicare can no longer afford to support programs with weak incentives that do not deliver value. As we structure new payment arrangements, the impact on the overall market will be top of mind." [FN119] Briefly, the major changes to the Medicare Shared Savings Program include these: Accountability: The program reduces the time that ACOs can spend in a non-risk agreement. Quality: The program expands the use of high-quality telehealth services. Beneficiary engagement: Pathways to Success allows ACOs to offer incentives to their beneficiaries for healthy behaviors, such as establishing a primary care relationship and following up on health services. Program integrity: The program establishes rigorous and accurate benchmarks for evaluating ACO performance. [FN120] Applications for the new program were accepted on a special one-time start date of July 1, 2019; annual application cycles were to resume in January 2020. Pathways to Success will offer ACOs two tracks in which to participate:the Basic Track and the Enhanced Track. ACOs must participate in their chosen track for no less than five years. CMS summarizes the two tracks in a Fact Sheet: (1) BASIC track, which would allow eligible ACOs to begin under a one-sided model and incrementally phase-in higher levels of risk that, at the highest level, would qualify as an Advanced Alternative Payment Model (APM) under the Quality Payment Program, and (2) ENHANCED track, based on the program's existing Track 3, which provides additional tools and flexibility for ACOs that take on the highest level of risk and potential reward. [FN121] In the BASIC track's glide path, ACOs will be eligible for a higher shared savings reward based on quality performance. Time in a one- sided track will be time-limited: The glide path includes 5 levels:a one-sided model available only for the first two years to most eligible ACOs (ACOs identified as having previously participated in the program under Track 1 would be restricted to a single year under a one-sided model, but new, low THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -12- revenue ACOs that are not identified as re-entering ACOs would be allowed up to three years under a one-sided model); and three levels of progressively higher risk in years 3 through 5 of the agreement period. Under Levels A and B of the glide path, an ACO's maximum shared savings rate under a one-sided model will be 40 percent based on quality performance, applicable to first dollar shared savings after the ACO meets the minimum savings rate. Under Levels C, D, and E of the glide path, an ACO can earn up to a maximum 50 percent sharing rate under a two-sided model, based on quality performance. The glide path concludes with a maximum level of risk that qualifies as an Advanced APM for purposes of the Quality Payment Program. [FN122] The Fact Sheet lays out the details of the program. The final rule is published at 83 F.R. 67816 (Dec. 31, 2018). In April 2021, CMS published the participation options for ACOs in performance year 2022. [FN123] When the July 1, 2019 application cycle ended, former Administrator Verma took the opportunity to provide updates on the new applications and the selections that ACOs made. She reported that more ACOs are now moving into risk-bearing arrangements: | am especially encouraged to see that an increasing fraction of ACOs are taking on real accountability. Forty-eight percent of ACOs starting on July 1, 2019 are taking on risk for spending increases above their cost target; If they exceed this target, they will be on the hook to pay back to CMS up to at least 2 percent of their revenue or 1 percent of their cost target, and as noted below most of these ACOs will put at risk significantly greater amounts. These ACOs are willing to face consequences if costs increase, in exchange for higher levels of shared savings and greater regulatory flexibility. As of July 1, 2019, 29 percent of Shared Savings Program ACOs are taking on risk for spending increases, which is a 10 percentage point increase in the number of risk-based ACOs in the program. This is projected to lead to more savings for beneficiaries and taxpayers, and provide stronger incentives for ACOs to coordinate care and improve quality for patients. [FN124] In an update the following year, Verma reported that Pathways to Success ACOs continue to generate a net savings to Medicare - $1.2 billion in 2019, or $169 per beneficiary. "N25! In August 2021, CMS announced that Medicare Shared Savings Programs had a successful year in 2020, the fourth successful year in a row. ACOs shared in $2.3 billion in savings, and the program saved the Medicare program $1.9 billion. It total, 67% of ACOs in the program earned the shared savings, but those in a two-sided arrangement were more successful:88% of those ACOs earned the payments, while 55% in a one-sided arrangement earned them. Announcing the results, CMS Administrator Chiquita Brooks-LaSure remarked: "Accountable Care Organizations are an Affordable Care Act success story . . . . The 2020 Shared Savings Program results continue to demonstrate the impact ACOs have in improving quality and lowering health care costs. The Biden-Harris Administration is committed to a health care system that delivers high quality, affordable, equitable, and person-centered care. CMS is similarly committed to moving health care providers to value-based payment and looks forward to partnering with the ACO community in a continued effort to advance these goals and promote affordability and sustainability." [FN126] Four-hundred seventy seven Shared Savings ACOs serve 10.7 million Medicare participants. [FN127] Changes were made to the program in the 2022 Physician Fee Schedule final rule. [FN128] B. Next Generation ACOs HHS announced the Next Generation program in March 2015. This program builds on the now inactive Pioneer ACO program in that it is designed for ACOs willing to take on more risk than is available to ACOs in the Shared Savings Program and even in the Pioneer Program. ACOs in this program also have the opportunity to share in a greater portion of the savings. The program is meant for experienced ACOs who are well-positioned to accept more risk. [FN129] HHS indicated that ACOs in this program will have several tools available to them to help manage their populations efficiently: ACOs will have a number of tools available to enhance the management of care for their beneficiaries. These tools include rewards to beneficiaries for receiving their care from physicians and professionals participating in their ACOs, coverage of skilled nursing care without prior hospitalization, and modifications to expand the coverage of telehealth and post-discharge home services to support coordinated care at home. The Next Generation ACO Model also supports patient-centered care by providing the opportunity for beneficiaries to confirm a care relationship with ACO providers and to communicate directly with their providers about their care preferences. [FN130] The program, which got underway in 2015 as anticipated, premiered with 21 ACOs in January 2016. The program now has 35 participants. [FN131] Vill. RURAL HEALTH CARE THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -13- After a deliberative and collaborative process, CMS put together a rural health strategy to improve care for those who live in rural areas. Millions of Medicaid and Medicare participants live in rural areas, and they have unique needs when compared to urban dwellers: Compared to their urban counterparts, rural Americans are more likely to be living in poverty, unhealthy, older, uninsured or underinsured, and medically underserved. Additional challenges facing rural America include a fragmented health care delivery system, stretched and diminishing rural health workforce, affordability of insurance, and lack of access to specialty services and providers. [FN132] (Citations omitted.) The strategy, which was developed as a part of the Rethinking Rural Health Initiative, has five objectives: 1. Apply a rural lens to CMS programs and policies 2. Improve access to care through provider engagement and support 3. Advance telehealth and telemedicine 4. Empower patients in rural communities to make decisions about their health care 5. Leverage partnerships to achieve the goals of the CMS Rural Health Strategy [FN133] CMS prepared a report outlining the steps it took in fiscal year 2021 to advance the Rural Health Strategy. The report highlighted, for example, the actions CMS took during the COVID-19 public health emergency to improve rural health, such as launching the Acute Hospital Care at Home Program, expanding telehealth, and promoting COVID-19 vaccinations. It also outlined how the agency adopted policies aimed at sustaining rural providers and how it addressed practitioner shortages. Additionally, the report highlighted some of the models and demonstrations meant to improve care in rural areas, such as the CHART Model (which we discuss below) and the Frontier Community Health Integration Project Demonstration. Please see the report for more information. IFN134] HHS has also released a new plan - the Rural Action Plan, which grew out of its Rural Task Force. In a press release, announcing the plan, HHS explained, This action plan provides a roadmap for HHS to strengthen departmental coordination to better serve the millions of Americans who live in rural communities across the United States. Eighteen HHS agencies and offices took part in developing the plan, which includes 71 new or expanded activities for FY 2020 and beyond. Efforts that will be undertaken in FY 2020 include nine new rural-focused administrative or regulatory actions, three new rural-focused technical assistance efforts, 14 new rural research efforts, and five new rural program efforts. These efforts build on 94 new rural-focused projects the HHS Rural Task Force identified as having launched over the past three years. [FN135] Rural hospitals have been closing at a rate that is concerning to many, with some calling the trend "alarming" [FN136] oy characterizing itas a" "crisis." "\197] since 2010, 136 rural hospitals have closed, most of them in the South, including 21 in Texas alone and 16 in Tennessee. These closures hit a record high in 2020, according to Becker's Hospital Review, with 29 closures. [FN138] tn states like Texas, which have not adopted the Affordable Care Act's Medicaid expansion, rural hospitals suffer as they deal with increasingly older and poorer patients who may not have Medicaid coverage. When these hospitals do receive Medicaid reimbursement, they often result in" "underpayments" - payments that do not match the cost of the services rendered. Kaiser Health News reports that rural advocates in Texas are pushing the legislature to find some way to support and save the remaining 161 rural hospitals in the state by, for example, securing Medicaid payments that fairly cover the services rendered. They are also pushing for legislation in Congress that would allow a rural hospital to close its inpatient beds while maintaining other services such as an emergency department and primary care. Ina Texas hospital that reopened after closing, the hospital is offering emergency and primary care services, but it is now offering only limited inpatient beds for more routine care. Unfortunately, it could not resume maternity services. Many other rural hospitals in Texas are vulnerable. The executive director of the A&M Rural and Community Health Institute at Texas A&M Health Science Center said that rural communities are going to need to get creative about providing for the health care needs of their citizens; they could form partnerships with other communities, for example, or expand services through telemedicine. [FN139] The Commonwealth Fund notes that pregnant women in particular are affected by the crisis in rural health. When hospitals close, so do their obstetric units; at this point, fewer than half of all rural counties have obstetric units, and fewer than half have access to good prenatal care. Postpartum care is scarce in rural counties as well. Many women face long journeys to a hospital where they can give birth, and they are giving birth in less than ideal situations: These hospital and OB unit closures mean rural women in labor increasingly face lengthy journeys to the hospital, sometimes even hours long. They also have contributed to increases in births outside hospitals, births in hospitals without OB care, and in preterm births - all of which carry greater risks for mom and baby. Experts believe these closures also contribute to early elective deliveries using induction and cesarean section - procedures that increase the risk of complications - because women do not want to risk going into labor when they are hours from the nearest hospital. [FN140] The Commonwealth Fund sets out multiple ways to ameliorate the effects of rural hospital closures: THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -14- Growing the maternity workforce (OB/GYN practitioners, family practice practitioners, and midwives) by offering incentives to providers to work in rural areas; Expanding the scope of practice for nurses and midwives; Coverage, particularly Medicaid coverage, for doulas; Soliciting health care systems, hospitals, and universities to provide training to a wide range of practitioners, particularly those who practice maternity and pediatric care; Offering higher Medicaid reimbursements to rural hospitals to stem the number of closures. According to the Commonwealth Fund's article, evidence suggests that the Medicaid expansion has improved the fate of rural hospitals, and Medicaid policies that reduce coverage worsen it. IFN141] Recognizing the scarcity of maternity care in rural areas, HHS announced $9 million in funds to establish the Rural Maternity and Obstetrics Management Strategies (RMOMS) program. Awardees in three states, Missouri, New Mexico, and Texas, will use the funds to plan, test, and implement models to improve access to maternity care in rural areas. The program will involve several stakeholders, including rural hospitals, health centers, state Medicaid offices, Healthy Start programs, and home visiting programs. IFN142] The program, which aligns with the Rural Action Plan, will run until August 2023. FN143] In August 2020, CMS announced a new model, the Community Health Access and Rural Transformation (CHART) Model, to test innovative solutions to the rural health crisis. "\'! The goals of the model are these: Increase financial stability for rural providers through the use of new ways of reimbursing providers that provide up-front investments and predictable, capitated payments that pay for quality and patient outcomes; Remove regulatory burden by providing waivers that increase operational and regulatory flexibility for rural providers; and Enhance beneficiaries' access to health care services by ensuring rural providers remain financially sustainable for years to come and can offer additional services such as those that address social determinants of health including food and housing. [FN145] The model consists of two tracks, the Community Transformation Track and the Accountable Care Organization (ACO) Transformation Track. In the Community Transformation Track, CMS will select up to 15 Lead Organizations, each of which will represent a discrete rural community. CMS gives these examples of entities that could be lead organizations: state Medicaid agencies, State Offices of Rural Health, local public health departments, Independent Practice Associations, and Academic Medical Centers, among others. These lead organizations will work with model participants (including, for example, participant hospitals or a state Medicaid agency) to develop and implement Transformation Plans. CMS explains the role of Lead Organizations: The 15 Community Lead Organizations are critical to the success of the Model because they will coordinate efforts across the community to ensure that access to care is maintained and that the needs of various stakeholders are understood and accounted for in the transformation plan. Lead Organizations are responsible for managing cooperative agreement funding, recruiting Participant Hospitals, engaging the state Medicaid agency, establishing relationships with other aligned payers, convening the Advisory Council, and ensuring compliance with Model requirements. Ultimately, the Lead Organization will oversee the execution and coordination of a Transformation Plan that outlines the health care delivery redesign strategy for the Community. [FN146] In the ACO Transformation Track, CMS will select up to 20 ACOs with a rural focus that will receive advanced shared payments through the Medicare Shared Savings Program; the ACOs can use these payments to implement value-based payment models to improve the quality of care and health outcomes in rural communities. [FN147] The application deadline for the Community Transformation Track was extended twice due to the pandemic. However, in September 2021, CMS announced that it awarded funds to four entities to serve as Lead Organizations in that track. The four entities are the University of Alabama Birmingham, the South Dakota Department of Social Services, the Texas Health and Human Services Commission, and Washington State Healthcare Authority. These entities will serve, respectively, in the states of Alabama, South Dakota, Texas, and Washington and they will be responsible to developing and implementing a health care redesign strategy for communities in which they serve. IFN148] The request for applications for the ACO Transformation Track was to be issued in the spring of 2021, IFN149] However, CMS later announced that it is postponing the RFA release until spring 2022. [FN150] In 2021, HHS announced that it awarded $389 million in American Rescue Plan funds to over 1,500 small rural hospitals through HRSA's Small Rural Hospital Improvement Program. A small rural hospital is a critical access hospital or a hospital with fewer than 50 beds. HHS indicates that these facilities are important in the effort to close the equity gap and to get rural Americans proper COVID-19 care. According to HHS, "Hospitals will use the funds to maintain or increase COVID-19 testing, expand access to testing for rural residents, and tailor mitigation efforts to reflect the needs of local communities." [FN151] Biease see the News Release for information on how much each state received in funds and how many rural hospitals in each state will benefit from the funds. IX. selected Federal Activity THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -15- The first piece of COVID-related legislation that Congress passed was The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123). The act allocated funds for health-related programs and for testing and vaccines. [FN152] President Donald Trump (R) signed that bill on March 6, 2020. The second piece of legislation that Congress passed was The Families First Coronavirus Response Act (P.L. 116-127), which the president signed on March 18, 2020. Among other things, the bill provides for Medicaid coverage without cost sharing for COVID-19 testing and testing related services. It also includes a 6.2% increase in states' federal medical assistance percentage (FMAP). FN153] The increase applies retroactively from January 1, 2020, and continues until the time that the public health emergency ends. However, states must meet certain requirements to claim the increase, and the increase does not apply to all expenditures. The government released an FAQ document !FN""4] to clarify the requirements for receiving the enhanced FMAP. Importantly, the increase does not apply to the already higher FMAP for newly eligible adults in the Medicaid expansion, nor does it apply in other situations in which a special FMAP is already in place. Additionally, administrative expenses do not qualify for the enhanced FMAP. Notably, in order to qualify for the increase, states must refrain from disenrolling program participants during the emergency period. The full list of requirements is set out on Medicaid.gov: To qualify for the temporary FMAP increase, states must, through the end of the month when the public health emergency ends: a. Maintain eligibility standards, methodologies, or procedures that are no more restrictive than what the state had in place as of January 1, 2020 (maintenance of effort requirement). b. Not charge premiums that exceed those that were in place as of January 1, 2020[.] c. Cover, without impositions of any cost sharing, testing, services and treatments- including vaccines, specialized equipment, and therapies-related to COVID-19. d. Not terminate individuals from Medicaid if such individuals were enrolled in the program as of the date of the beginning of the emergency period, or becomes enrolled during the emergency period, unless the individual voluntarily terminates eligibility or is no longer a resident of the state (continuous coverage requirement). These requirements became effective on March 18, 2020. [FN155] The third major piece of legislation was the Coronavirus Aid, Relief and Economic Security (CARES) Act (P.L. 116-136). The Kaiser Family Foundation has provided an extensive summary of all of the bill's provisions. Those affecting health facilities include these, among others: ¢ It appropriates funds for fiscal years 2021 through 2025 for the Telehealth Network Grant Program [FN156] from four to five years. and extends the grant period « It temporarily allows federally-qualified health centers and rural health centers to render telehealth services to Medicare participants. * The act allows hospice physicians or nurse practitioners to use telehealth for hospice face-to-face visits for the purpose of recertifying Medicare hospice eligibility. ¢ The act generally grants protects volunteer health care professionals from liability when they are treating COVID-19 patients during the course of the emergency period, with some requirements and exceptions. ¢ It authorizes funding for health care professional workforce development in rural and underserved areas. ¢ The act authorizes funding for geriatric workforce enhancement programs. * lt authorizes funding for nursing workforce education, training, retention, and diversity. ¢ The act expands the types of hospitals eligible for the Medicare Hospital Accelerated Payment Program during the public health emergency; the act added hospitals whose inpatients are predominantly children, certain hospitals working extensively in on cancer research or treatment, and critical access hospitals. ¢ The act clarifies that home- and community-based Medicaid services may be provided in an acute care hospital if they are identified in the patient's service plan, meet needs that the hospital does not satisfy, do not substitute for services that the hospital is required to render, and are designed to ease the transition from acute care to home- and community-based services. [FN157] Please see the brief for more details. Following the CARES Act, on April 24, 2020, former President Donald Trump (R) signed 2019 FD H.B. 266 (NS), "N18 which enacted the Paycheck Protection Program and Health Care Enhancement Act (the Paycheck Protection Act). The Paycheck Protection Program was established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136). The Paycheck Protection Act makes changes to the CARES Act to afford enhanced relief to businesses affected by the COVID-19 pandemic. The Paycheck Protection Act also contains health provisions that funnel additional funds to HHS. The funds are to be used to ameliorate losses that "eligible health care providers" have suffered due to the pandemic and to support them as they continue to fight the effects of the pandemic. Medicare and Medicaid providers and suppliers are included in the definition of ""other eligible providers. "Additionally, the THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -16- act ensures funding to advance research and testing for the virus. The Kaiser Family Foundation has published a summary of the act's health-related provisions. [FN159] The Medicare Learning Network has released a memorandum describing how theCoronavirus Aid, Relief, and Economic Security (CARES) Act affects Medicare billing for various types of health facilities that bill Medicare Administrative Contractors (MACs). N16! The first one explains how Section 3710 of the CARES Act affects Inpatient Prospective Payment System hospitals. Briefly, Section 3710 directs the HHS Secretary (the Secretary) to increase the weighting factor of the assigned Diagnosis-Related Group by 20% for an individual who was diagnosed with COVID-19 and was discharged during the public health emergency period. That memo also discusses how Section 3711 of the act affects claims by inpatient rehabilitation facilities (the Secretary is waiving the requirement that patients receive 15 hours of therapy per week) and long-term care hospitals (the Secretary is waiving the site neutral payment rate provisions). [FN161] A second memo from the Medicare Learning Network discusses Medicare billing for telehealth services in federally qualified health centers rural health centers. The CARES Act allowed these facilities to render distant site telehealth services during the COVID-19 public health emergency. The memo explains how these services should be billed. [FN162] On December 27, 2020, the president signed 2019 FD H.B. 133 (NS), the 2021 Consolidated Appropriations Act, another Coronavirus stimulus bill. The bill contains many health-related provisions, including new funding for vaccines, testing, contract tracing, and mental health and substance abuse services, and a ban on surprise Medicaid bills, among other things. As it relates to health facilities, the bill allocates an additional $3 billion for the provider relief fund, provides for a one-time increase in reimbursement rates to physicians and other professionals in 2021 to ameliorate the effects of the reduction in rates from the 2021 Physician Fee Schedule, and extends the delay on cuts to the Medicaid disproportionate share hospital payments, among other things. The latest stimulus bill, the American Rescue Plan Act of 2021 (2021 FD H.B. 1319 (NS)), was signed into law by President Joseph Biden (D) on March 11, 2021. IFN163] The American Hospital Association summed up the main provisions that affect health facilities. Among other things, the bill: ¢ provides additional financial relief for rural providers; ¢ allocates funds to increase testing and vaccine capacity, which includes " "medical supplies and equipment related to combatting the COVID-19 pandemic, including diagnostic products, PPE, drugs, medical devices and biological products[,]; * provides a financial incentive for the remaining states to adopt the Medicaid expansion; * temporarily expands Marketplace subsidies; ¢ maintains disproportionate share hospital payments during the public health emergency; * allocates funds for behavioral health; * allocates additional funds to help skilled nursing facilities combat the COVID-19 pandemic; and ¢ includes funds to bolster the public health workforce. [FN164] On June 3, 2021, CMS published guidance on some of these provisions. As it relates to health facilities, the guidance covered these provisions: * mandatory coverage of COVID-19 vaccines, vaccine administration, testing, and treatment; « the enhanced, temporary FMAP for states that implement the Medicaid expansion; the recalculation of the disproportionate share hospital allotments for states that claim the enhanced FMAP provided for the in the Families First Coronavirus Response Act (P.L. 116-127); and ¢ the extension of 100% to Urban Indian Health Organizations and Native Hawaiian Health Care Systems. [FN 165] CMS published a proposed rule affecting the Preadmission Screening and Resident Review. States must have a system to conduct this type of review for individuals with mental illness or intellectual disability who are residing in or applying to reside in a Medicaid nursing facility. The review is done to ensure that such individuals are properly place. The purpose of the rule, which is published at 85 F.R. 9990 (Feb. 20, 2020) is stated in the summary: This proposed rule would modernize the requirements for Preadmission Screening and Resident Review (PASRR), currently referred to in regulation as Preadmission Screening and Annual Resident Review, by incorporating statutory changes, reflecting updates to diagnostic criteria for mental illness and intellectual disability, reducing duplicative requirements and other administrative burdens on State PASRR programs, and making the process more streamlined and person-centered. The Medicare Care Choices Model was designed to test whether the quality of life for terminally ill Medicare participants would improve if they were allowed to receive care for their terminal illness as well as hospice supportive services. Under current Medicare rules, patients who receive services under the hospice benefit may not also receive care related to their terminal illness. Eighty-two hospice THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -17- organizations currently participate in the model, which is administered by CMS' Innovation Center. The model was to end after 2020, but CMS has announced that it will extend it, and it will now run through 2021, 'FN"66] Representatives Jan Schakowsky (D-lIll.) and Mark Takano (D-Calif.) are sponsoring 2021 FD H.B. 598 (NS), which seeks to improve nursing home care during the COVID-19 pandemic. The bill would enact the Quality Care for Nursing Home Residents and Workers during COVID-19 and Beyond Act. In a News Release, Representative Schakowsky explains what the bill would accomplish: This legislation protects the health and well-being of those living and working in nursing homes by increasing infection control and prevention, testing, and personal protective equipment; surging funding for strike teams to the hardest hit nursing homes; mandating transparency and reporting of COVID-19 cases and fatalities; and, requiring the Centers for Medicare & Medicaid Services (CMS) to conduct better oversight, including inspections and guidance. [FN167] Representative Jamaal Bowman (D-N.Y.) and Senator Elizabeth Warren (D-Mass.) introduced a resolution calling for a nationwide commitment to strengthen all aspects of the care economy, including, for example, child care, health care, and adult care. The House bill is 2021 FD H.R. 180 (NS) and the Senate Bill is 2021 FD S.R. 85 (NS). The lengthy findings supplied with the bill note, among other things, that: ¢ nearly 20 million adults have long-term care needs stemming from age or disability; * the average cost of a private room in a nursing facility exceeds $100,000 a year; * Medicaid covers long-term care but with strict income and resource limitations; ¢ Medicaid mandates coverage of institutional long-term care while home- and community-based care services are optional and more limited; ¢ Medicare does not generally cover long-term care; * only 7% of Americans have private long-term care insurance because of the expense; * nearly 30,000,000 Americans are uninsured, many of them people of color; ¢ the COVID-19 pandemic has highlighted the essential nature of care work, including health care and child care; ¢ 135 rural hospitals have closed since 2010, and the rate of closure is accelerating; and * adults in institutional long-term care represent just 1% of the population but have accounted for nearly one-third of the nation's COVID-19 deaths. The resolution asserts that the federal government has the duty to dramatically strengthen the care economy, and this duty can only be met by the government redressing the wrongs of history and acknowledging the oppression and exclusion of care workers, particularly immigrants and those of color. In a press release, Representative Bowman sums up why the bill is important: Just as our physical infrastructure is crumbling, the United States today suffers from a lack of care infrastructure. Millions are struggling to access child care, health care, long-term supports and services, and paid family and medical leave. Growing numbers of care workers, disproportionately women of color and immigrants, face poverty wages and exploitation; along with education, social assistance, and other essential workers, they are on the frontlines of multiple crises in our society. Investing in care work and programs can boost the economy, meet people's fundamental needs, and help us face the challenges of the 21st century and beyond. The resolution calls for far-reaching public investments to guarantee the care people need at all stages of life, and to ensure caregivers and care workers are treated with the dignity they deserve. That must include raising pay, benefits, protections, and standards for all care workers, ensuring pathways to unionization, and creating millions of new care jobs over the next decade. [FN 166] Senate Bill 274 (2021 FD S.B. 274 (NS)) would enact the Stronger Medicaid Response to the COVID-19 Pandemic Act. That act would allow states, at their option, to provide Medicaid coverage for COVID-19 vaccines and treatment for uninsured individuals. Senator Michael Bennet (D-Colo.), one of the bill's sponsors, explains what the bill would do: The Stronger Medicaid Response to the COVID-19 Pandemic Act increases support for expanding health care needs resulting from the current public health crisis. The legislation would allow Medicaid programs to pay for treatment and prevention, hospitalization, drugs, vaccines, and other related services for individuals with COVID-19 who are uninsured. This builds on the Families First Coronavirus Response Act which provided Medicaid coverage for COVID-19 testing for uninsured individuals. [FN 169] CMS gave final notice of its decision to approve The Joint Commission for continued recognition as an accrediting organization for hospices that wish to participate in Medicare and Medicaid. The notice is published at 86 F.R. 16373 (Mar. 29, 2021). CMS announced that it approved an exception to the prohibition on the expansion of facility capacity under the Hospital Ownership and Rural Provider exceptions to the physician self-referral prohibition. The exception was made for Solutions Medical Consulting, LLC d/b/ a Serenity Springs Hospital in Louisiana. The notice is published at 86 F.R. 13901 (Mar. 11, 2021). During the COVID-19 emergency period, CMS began making accelerated and advanced payments to Medicare Part A providers and Part B suppliers, respectively. CMS explained that these payments were, THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -18- intended to provide necessary funds to Part A providers and Part B suppliers, respectively, when there is a disruption in claims submission and/or claims processing. CMS can also offer these payments in circumstances such as national emergencies, or natural disasters in order to accelerate cash flow to the impacted health care providers and suppliers. [FN170] The Continuing Appropriations Act, 2021 and Other Extensions Act (P.L. 116-159) provided that recipients of these payments would begin to repay them one year after receiving them. IFN171] OMS began recouping these payments from the first recipients on March 30, 2021. A post from the Medicare Learning Network explained how the funds will be recouped over time: « Repayment begins 1 year starting from the date we issued your first CAAP. ¢ Beginning 1 year from the date we issued the CAAP and continuing for 11 months, we'll recover the CAAP from Medicare payments due to providers and suppliers at a rate of 25%. ¢ After the end of this 11 month period, we'll continue to recover remaining CAAP from Medicare payments due to providers and suppliers at a rate of 50% for 6 months. « After the end of the 6 month period, your Medicare Administrative Contractor (MAC) will issue you a demand letter for full repayment of any remaining balance of the CAAP. If we don't receive payment within 30 days, interest will accrue at the rate of 4% from the date your MAC issues you the demand letter. After that, we'll assess interest for each full 30-day period that you fail to repay the balance. [FN172] CMS published an FAQ document for the hospice benefit component of the Value-Based Insurance Design Model. IFN173] On the web page for the model, CMS explained how the hospice benefit component works: Currently, when an enrollee in an MA plan elects hospice, Fee-for-Service (FFS) Medicare becomes financially responsible for most services, while the MAO retains responsibility for certain services (e.g., supplemental benefits). Under the Hospice Benefit Component of the VBID Model, participating MAOs retain responsibility for all Original Medicare services, including hospice care. The Hospice Benefit Component of the Model implements a set of changes recommended by the Medicare Payment Advisory Commission (MedPAC), the Health and Human Services (HHS) Office of Inspector General (OIG), and other stakeholders. [FN174] Senate Bill 620 (2021 FD S.B. 620 (NS)) would direct the Secretary of the Department of Health and Human Services, in consultation with the CMS Administrator, to prepare a report for Congress setting out the changes that HHS has made during the COVID-19 emergency period to expand access to telehealth in Medicare, Medicaid, and CHIP (the Children's Health Insurance Program). The bill, which would enact the Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2021, was reintroduced for this session by Senator Deb Fischer (R-Neb.) and Jackie Rosen (D-Nev.). In a press release, Senator Fischer said of the bill, ™Millions of Americans, including many Nebraskans, have benefited from telehealth services during this pandemic. This bipartisan legislation will provide us with valuable information on how to improve and expand this technology to save more lives... ." IFN179] The overriding goal of 2021 FD S.B. 926 (NS) is to increase access to medical forensic exams following a sexual assault. As it relates to health facilities, the bill would require hospitals that receive federal funds to annually report to the government on a number of factors relating to such exams, including, for example, the number of sexual assault survivors who report for such an exam, the number of trained personnel the hospital employs to conduct such an exam, the number of exams performed, and so on. Senators John Barrasso (R-Wyo.) and Tom Cotton (R-Ark.) are sponsoring 2021 FD S.B. 918 NS), which calls for a supplemental appropriation of $12 billion to the Provider Relief Fund. The funds would be available for, building or construction of temporary structures, leasing of properties, medical supplies and equipment including personal protective equipment and testing supplies, increased workforce and trainings, emergency operation centers, retrofitting facilities, and surge capacity. Those entities eligible for funds include, public entities, Medicare or Medicaid enrolled suppliers and providers, and such for-profit entities and not-for-profit entities not otherwise described in this paragraph as the Secretary may specify, within the United States (including territories), that provide diagnoses, testing, or care for individuals with possible or actual cases of COVID-19. House Bill 1205 (2021 FD H.B. 1205 (NS)) has passed the House. The bill would enact the Improving Mental Health Access from the Emergency Department Act of 2021. That act would authorize the Substance Abuse and Mental Health Services Administration to award grants to selected health care providers to implement innovative strategies for ensuring that patients who present at the emergency department with an acute mental health episode receive appropriate follow-up care. In the House, 2021 FD H.B. 2114 (NS) would enact the Essential Caregivers Act of 2021. That act would require Medicare and Medicaid skilled nursing facilities, nursing facilities, and intermediate care facilities for the intellectually disabled to allow certain essential caregiver visitors to visit a resident during a public health emergency. Essential caregivers are those who agree to follow specified safety protocols and who: (i) furnished care to such resident prior to the first day of the emergency period described in section 1135(g)(1)(B); THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -19- (ii) will provide activities of daily living (as determined appropriate by the facility) or emotional support to such resident, in accordance with the care plan of such resident; (iii) the facility approves to furnish such activities or support[,.] CMS published a final rule making changes to and extending the Comprehensive Care for Joint Replacement (CJR) Model. Because the model has been successful, it will be extended three years, until December 30, 2024. The rule also makes some changes to the program, as indicated in the summary: [This final rule revises certain aspects of the CJR model including the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements, and the appeals process. In addition, for PY 6 through 8, this final rule eliminates the 50 percent cap on gainsharing payments, distribution payments, and downstream distribution payments for certain recipients. This final rule extends the additional flexibilities provided to participant hospitals related to certain Medicare program rules consistent with the revised episode of care definition. [FN176] Additionally, the rule finalizes provisions in an interim final rule with comment period (IFC): Specifically, the IFC titled, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, implemented a 3 month extension to CJR PY 5 such that the model would end on March 31, 2021, rather than ending on December 31, 2020, and provided an adjustment to the extreme and uncontrollable circumstances policy to account for the COVID-19 pandemic. The second IFC titled, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, further extended PY 5 through September 30, 2021, created an episode-based extreme and uncontrollable circumstances COVID-19 policy, provided two reconciliation periods for PY 5, and added Medicare Severity-Diagnostic Related Groupings (MS-DRGs) 521 and 522 for hip and knee procedures. IFN177] Corrections are published at 86 F.R. 36229-01 (July 9, 2021). Representative Jan Schakowsky (D-Ill.) and others are sponsoring 2021 FD H.B. 3165 (NS), which would require a minimum registered nurse-to-patient staffing requirement in hospitals. The findings supplied with the bill note that patient outcomes are directly tied to patient-to-nurse staffing. In the midst of a nursing shortage, a minimum staffing requirement would aid in recruitment and retention of nurses who may be leaving the field due to inadequate staffing. Generally, the bill would require one registered nurse to care for: (A) One patient in trauma emergency units. (B) One patient in operating room units, provided that a minimum of 1 additional person serves as a scrub assistant in such unit. (C) Two patients in critical care units, including neonatal intensive care units, emergency critical care and intensive care units, labor and delivery units, coronary care units, acute respiratory care units, postanesthesia units, and burn units. (D) Three patients in emergency room units, pediatrics units, stepdown units, telemetry units, antepartum units, and combined labor, deliver, and postpartum units. (E) Four patients in medical-surgical units, intermediate care nursery units, acute care psychiatric units, and other specialty care units. (F) Five patients in rehabilitation units and skilled nursing units. (G) Six patients in postpartum (3 couplets) units and well-baby nursery units. In the Senate, 2021 FD S.B. 1524 (NS) would enact the Health Care Prices Revealed and Information to Consumers Explained Transparency Act (the Health Care PRICE Transparency Act). The bill would require price transparency for hospitals and insurers. Senator Mike Braun (R-Ind.), one of the bill's sponsors, explains how the bill would affect hospitals: The Health Care PRICE Transparency Act would codify two U.S. Department of Health and Human Services (HHS) final rules, Hospital Price Transparency and Transparency in Coverage. The Hospital Price Transparency rule would require hospitals to disclose standard charges, the cost of an item or service set by the hospital, for a total of 300 shoppable services. In order for a hospital to participate in Medicare, it must establish and maintain an internet-based price estimator, free of charge and without subscription. This tool would allow health care consumers to receive an estimate of the costs they will be responsible for paying to a hospital for a shoppable service. Under this legislation, hospitals that fail to comply with price transparency requirements will be penalized $300 per day, until the violation is resolved, '*N178] Its companion in the House is 2021 FD H.B. 3029 (NS). House Bill 3069 (2021 FD H.B. 3069 (NS)) would enact the Access for Rural Communities (ARC) Act. The title of Section 2 indicates that the bill is meant to provide relief for small rural hospitals from inaccurate instructions provided by Medicare Administrative Contractors. The bill provides for a recalculation of any volume decrease adjustment: (a) Application of Revised Volume Decrease Adjustment Methodology. Subject to subsection (b), in the case of a sole community hospital or a Medicare-dependent, small rural hospital with respect to which a Medicare administrative contractor determined a volume decrease adjustment applies for any specified cost reporting period, at the election of the hospital, the Secretary of Health and Human Services shall recalculate the amount of the volume decrease adjustment determined by the Medicare administrative contractor for THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -20- such hospital and specified cost reporting period using the revised volume decrease adjustment payment methodology for any specified cost reporting period requested by the hospital in its election. Representative Claudia Tenney (R-N.Y.) and others are sponsoring 2021 FD H.B. 3733 (NS), which would enact the Essential Caregivers Act of 2021. That act would require skilled nursing facilities, nursing facilities, intermediate care facilities for the intellectually disabled, and inpatient rehabilitation facilities that participate in Medicaid or Medicare to permit residents access to two self-designated essential caregivers during any public health emergency declared by the Department of Health and Human Services (HHS). Senator Marco Rubio (R-Fla.) introduced the State Accountability, Flexibility, and Equity for Hospitals Act of 2021 (the SAFE for Hospitals Act) on June 10, 2021. The bill would reform how states' allotments for Medicaid disproportionate share hospital payments are calculated. In a press release, Senator Rubio explained what the bill (2021 FD S.B. 2021 (NS)) would do: ¢ Gradually change the DSH allocation formula so states' allocations are based on the number of low-income earners living in the state, as a percentage of the total U.S. population earning less than 100 percent of the Federal Poverty Level (FPL). ¢ Prioritize DSH funding to hospitals providing the most care to vulnerable patients, while providing states with the necessary flexibility to address the unique needs of hospitals in each state. ¢ Expand the definition of uncompensated care to include costs incurred by hospitals to provide certain outpatient physician and clinical services, which is a change recommended by MACPAC. * Allow states to reserve some of their DSH funding allocations to be used in future years in order to give hospitals more certainty or consistency in the amount of DSH funding they can expect when planning for the future. IFN179] In the House, 2021 FD H.B. 3337 (NS) would enact the Birth Access Benefiting Improved Essential Facility Services (BABIES) Act. That act would require HHS to create a Medicaid demonstration program testing innovative payment models for freestanding birth center services for women with a low-risk pregnancy. The bill aims to increase access to these services and to improve the quality and scope of such services. Congresswoman Stacey Plaskett (D-V.I.) and others are sponsoring 2021 FD H.B. 3434 (NS), which seeks to improve the way the territories are treated under the Medicaid and Medicare programs. As it relates to Medicaid, the bill would eliminate the general Medicaid funding caps, eliminate the specific FMAPs for territories, and permit Medicaid disproportionate share hospital payments for the territories. "18! jn Medicare, the bill would increase hospital reimbursements and extend disproportionate share hospital payments. According to Congresswoman Plaskett, the territories are treated unfairly when it comes to Medicare and Medicaid funding: "People in the territories should have just as much access to health care as anyone else. With federal attention focused on how health care disparities have contributed to the financial crisis in the territories, we believe that this is an opportune time to press the issue of Medicaid and Medicare. The inequities in federal funding provided to the territories for Medicaid and Medicare has placed a significant financial burden on local governments, including in the U.S. Virgin Islands, and has further exacerbated their respective financial situations. It has also put access to affordable health care out of reach for too many Virgin Islanders, making our hospitals' emergency rooms the primary health care provider for the one-third of our population without health insurance, which contributes to unmanageable costs in uncompensated care[.]' 187] Also in the House, 2021 FD H.B. 3219 (NS) would provide additional payments for ""high Medicaid providers" for services and lost revenue related to COVID-19. The following providers would be eligible for the funds ($10 billion) upon approval of an application: (1) Eligible high Medicaid health care provider. The term 'eligible high Medicaid health care provider means a provider of supplier that- (A) is enrolled with a State Medicaid plan under title XIX (or a waiver of such plan); (B) provides diagnoses, testing, or care for individuals with possible or actual cases of COVID-19; and (C) is either- (i) a disproportionate share hospitals described in Section 1923(b) of the Social Security Act; (ii) a children's hospitals described in Section 1886(d)(1)(B)(iii) of the Social Security Act and Section 340E of the Public Health Service Act; (iii) a physician or other practitioner described Section 1903(t)(2) of the Social Security Act (42 U.S.C. 1396b(t)(2)(A)); or (iv) such other providers and suppliers as the Secretary determines should be appropriately considered to be included based on high caseloads of patients eligible under title XIX of the Social Security Act. The Biden Administration released an interim final rule with comment period intended to ameliorate the devastating financial consequences of surprise medical billing and balance billing. HHS defined these terms in a press release announcing the rule: Surprise billing happens when people unknowingly get care from providers that are outside of their health plan's network and can happen for both emergency and non-emergency care. Balance billing, when a provider charges a patient the remainder of what their THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -24- insurance does not pay, is currently prohibited in both Medicare and Medicaid. This rule will extend similar protections to Americans insured through employer-sponsored and commercial health plans. [FN182] The rule is the first in a series of rules that will implement the bipartisan No Surprises Act, which was a part of the larger Consolidated Appropriations Act, 2021 (P.L. 116-260). Lawmakers and administrators alike are concerned about surprise medical bills because they can devastate families. According to the press release, two-thirds of all bankruptcies filed in the United States are the result of medical expenses. The problem often arises with hospital care:One out of six emergency department visits and inpatient hospital stays involve some out-of-network expenses. Air ambulance transportation can also result in unexpected, exorbitant billing: [A 2019 study by the Government Accountability Office] found that the median price charged by air ambulance providers ranged from $36,400 to more than $40,000, and over 70% of these transports were furnished out-of-network, meaning most or all costs fell to the insured individual alone. "N15! The press release lays out some of the rule's important provisions. Among other things, the rule: ¢ Bans surprise billing for emergency services. Emergency services, regardless of where they are provided, must be treated on an in- network basis without requirements for prior authorization. * Bans high out-of-network cost-sharing for emergency and non-emergency services. Patient cost-sharing, such as co-insurance or a deductible, cannot be higher than if such services were provided by an in-network doctor, and any coinsurance or deductible must be based on in-network provider rates. ¢ Bans out-of-network charges for ancillary care (like an anesthesiologist or assistant surgeon) at an in-network facility in all circumstances. ¢ Bans other out-of-network charges without advance notice. Health care providers and facilities must provide patients with a plain- language consumer notice explaining that patient consent is required to receive care on an out-of-network basis before that provider can bill at the higher out-of-network rate. "84! The rule is published at 86 F.R. 36870-01 (July 13, 2021). Fact Sheets are available. !FN19° Among other things, the second rule in the series, a proposed rule, set out price disclosure and reporting requirements for air ambulance services. These services are a frequent source of surprise billing. [FN186] The latest rule, an interim final rule with comment period, includes provisions for settling disputed out-of-network costs. CMS' press release explains more: This rule details a process that will take patients out of the middle of payment disputes, provides a transparent process to settle out- of-network (OON) rates between providers and payers, and outlines requirements for health care cost estimates for uninsured (or self-pay) individuals. Other consumer protections in the rule include a payment dispute resolution process for uninsured or self-pay individuals. It also adds protections in the external review process so that individuals with job-based or individual health plans can dispute denied payment for certain claims. *\"97! In the Senate, a bipartisan group of legislators are sponsoring 2021 FD S.B. 2086 (NS), which aims to identify childhood victims of trauma and provide a wide range of support for them. Senator Dick Durbin (D-lIIl.) one of the bill's sponsors, explained how the bill could help such individuals: To effectively treat the root causes of violence and addiction in our communities, we must focus on the impact that exposure to violence and traumatic experiences have on children . . .. Unaddressed trauma can harm mental and physical health, life expectancy, school success, and employment, so we must take serious action to prevent the ripple effect that trauma can have. Our bipartisan legislation invests in communities and the workforce to support children and families facing trauma to heal their emotional scars and build a brighter future for our communities." [FN188] According to Senator Durbin's press release announcing it, the bill: * Creates a new, $600 million annual HHS grant program to fund community-based coalitions that coordinate stakeholders and deliver targeted local services to address trauma; ¢ Creates a new HHS grant program to support hospital-based trauma interventions, such as for patients that suffer violent injuries, in order to address mental health needs, prevent re-injury, and improve long-term outcomes; ¢ Increases funding for the National Health Service Corps loan repayment program, in order to recruit more mental health clinicians- including from under-represented populations-to serve in schools; ¢ Enhances federal training programs at HHS, U.S. Department of Justice, and the U.S. Department of Education to provide more tools for early childhood clinicians, teachers, school leaders, first responders, and community leaders; and ¢ Establishes training and certification guidelines to enable insurance reimbursement for community figures-such as mentors, peers, and faith leaders-to address trauma. *\1®*l THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -29- Additionally, the bill would provide grants to eligible entities to deliver and evaluate programs to reduce hospital readmissions and re- injuries for individuals who have been hospitalized after overdosing, attempting suicide, or suffering a violent injury or abuse. Eligible entities would include hospitals or health systems, including health systems operated by Indian tribes or tribal organizations. In the Senate, 2021 FD S.B. 2576 (NS) would enact the Reducing Unnecessary Senior Hospitalizations (RUSH) Act of 2021, which would allow certain Medicare providers to provide care in skilled nursing facilities as a way to prevent hospitalization and emergency department usage. Senator Ben Cardin (D-Md.) casts the bill as one that would facilitate increased use of telehealth in these facilities. Senator Cardin's press release sums up the purpose of the bill: The RUSH Act would allow Medicare to enter into voluntary, value-based arrangements with medical groups to provide acute care to patients in skilled nursing facilities using a combination of telehealth and on-site staff. Working together to coordinate care, the providers can avoid a more costly patient transfer to the emergency department. If the program generates savings, they would be shared between the medical group and the skilled nursing facility. [FN190] The bill has bipartisan sponsorship. The companion bill in the House is 2021 FD H.B. 4890 (NS). In the House, 2021 FD H.B. 5015 (NS) would enact the Medicaid DSH Payment Adjustment Fairness Act of 2021. That act would expand the hospitals that are eligible for Medicaid Disproportionate Share Hospital payment adjustments. The bill is sponsored by Representatives Brian Higgins (D-N.Y.) and John Katko (R-N.Y.). Without a doubt, nursing facilities were particularly hard hit by the COVID-19 pandemic. Deaths of residents and staff in nursing facilities accounted for one-third of all COVID-19 deaths in this country, despite reporting only 5% of all COVID cases nationwide. A new Senate bill (2021 FD S.B. 2694 (NS)) seeks to make needed changes in both Medicare skilled nursing facilities and Medicaid nursing homes to ensure that these facilities are better prepared should any similar emergency arise in the future. The bill seeks to make improvements in accountability, transparency, and staffing, and it calls for a demonstration program to test building modification and investment in nursing facility staff. [FN194] CMS gave notice of its final rule making fiscal year 2022 changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System. The rule also updates payment rates and makes changes to the Medicare Promoting Interoperability, Hospital Value-Based Purchasing, Hospital Readmissions Reduction, Hospital Inpatient Quality Reporting, Hospital-Acquired Condition Reduction, the PPS-Exempt Cancer Hospital Reporting, and the Long-Term Care Hospital Quality Reporting programs. The final rule is published at 86 F.R. 44774-01 (Aug. 13, 2021). A Fact Sheet is available. [FN192] Corrections are published at 86 F.R. 58019 (Oct. 20, 2021). CMS issued a number of other final rules updating Medicare policies and payments. They include ""FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements." 86 F.R. 42528-01 (Aug. 4, 2021); "FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)," 86 F.R. 42608-01 (Aug. 4, 2021); "Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program; Payment for Complex Rehabilitative Wheelchairs and Related Accessories (Including Seating Systems) and Seat and Back Cushions Furnished in Connection With Such Wheelchairs," 86 F.R. 42362-01 (Aug. 4, 2021); and ""Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2022; and Technical Correction to Long-Term Care Facilities Physical Environment Requirements," 86 F.R. 42424-01 (Aug. 4, 2021). Companion bills in the House (2021 FD H.B. 5169 (NS)) and Senate (2021 FD S.B. 2694 (NS))} would enact the Nursing Home Improvement and Accountability Act of 2021. That act seeks to improve care in skilled nursing facilities and nursing facilities and better support the workers at those sites. A Senate press release announcing the Senate bill noted the terrible toll that the pandemic has had on these facilities and the deficiencies that currently exist in them. According to Senator Ron Wyden (D-Ore.), these failings have caused families to lose faith in the ability of nursing facilities to provide safe, high quality care. The Senate's press release sums up what the act would accomplish: The bill would require nursing homes to meet minimum staffing standards, ensure a Registered Nurse (RN) is available 24 hours a day, require a full-time infection control and prevention specialist and provide additional resources through Medicaid to support these care and staffing improvements and raise wages. The bill also takes a number of steps to increase transparency and accountability by improving data collection, providing better information to residents and their families and enhancing the effectiveness of state surveys. [FN193] As mentioned earlier, CMS is issuing staged rules to implement the No Surprises Act, which was a part of the Consolidated Appropriations Act 2021 (P.L. 116-260). The No Surprises Act aims to reduce surprise medical billing. As HPTS previously reported, the first rule, an interim final rule with comment period, set out consumer protections against surprise billing. [FN194] Among other things, the second rule, a proposed rule, set out price disclosure and reporting requirements for air ambulance services. These services are a frequent source of surprise billing. IFN195] The latest rule, an interim final rule with comment period, includes provisions for settling disputed out-of-network costs. CMS' press release explains more: THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -23- This rule details a process that will take patients out of the middle of payment disputes, provides a transparent process to settle out- of-network (OON) rates between providers and payers, and outlines requirements for health care cost estimates for uninsured (or self-pay) individuals. Other consumer protections in the rule include a payment dispute resolution process for uninsured or self-pay individuals. It also adds protections in the external review process so that individuals with job-based or individual health plans can dispute denied payment for certain claims. "1%! Representatives Gus Bilirakis (R-Fla.) and Kathy Castor (D-Fla.) are sponsoring 2021 FD H.B. 5414 (NS), which would enact the Ensuring Medicaid Continuity for Children in Foster Care Act of 2021. That act would exempt foster children in a qualified residential treatment program from the Medicaid IMD exclusion. CMS published corrections to its final Medicare rule titled, "Fiscal Year (FY) 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)," which is published at 86 F.R. 42608 (Aug. 4, 2021). The corrections are published at 86 F.R. 54631 (Oct. 4, 2021). In Congress, 2021 FD H.B. 5450 (NS) would enact the Blocking Joseph Robinette Biden's Overreaching Vaccine Mandates Act. It would prohibit any federal funds to implement a COVID-19 vaccination mandate. It would also prohibit the Department of Health and Human Services from: (1) requiring health care providers, as a condition of participation in the Medicare and Medicaid programs, to mandate that their employees be vaccinated for COVID-19; or (2) penalizing providers in any other way for failing to require this of their employees. The bill is sponsored by Representative Diana Harshbarger (R-Tenn.) and others. Representative Harshbarger explained on her web site, ™I'm all for fighting COVID and keeping Americans healthy and safe, and we should use all scientific clinical tools and protections available. But authoritarian vaccine mandates and threatening jobs based on COVID vaccine status - that could have devastating impacts to our health care and first responder workforce and other parts of our economy - are not the answer." [FN197] HHS announced that it has made an additional $25.5 billion in funds available for providers negatively affected by the COVID-19 pandemic. The funds come from two sources:$8.5 billion in American Rescue Plan funds for providers who serve rural Medicaid patients, those enrolled in CHIP (the Children's Health Insurance Program), or those enrolled in Medicare; and an additional $17 billion from the Provider Relief Fund, Phase 4, for providers who can demonstrate a revenue loss due to the pandemic. [FN198] Announcing the funds, HHS Secretary Xavier Becerra remarked, "This funding critically helps health care providers who have endured demanding workloads and significant financial strains amidst the pandemic. . . . The funding will be distributed with an eye towards equity, to ensure providers who serve our most vulnerable communities will receive the support they need." [FN 199] The Biden Administration's focus on equity is apparent in the way the Provider Relief Fund monies are being distributed. According to HHS' news release, As part of the Biden-Harris Administration's ongoing commitment to equity, and to support providers with the most need, PRF [Provider Relief Fund] Phase 4 will reimburse smaller providers-who tend to operate on thin margins and often serve vulnerable or isolated communities-for their lost revenues and COVID-19 expenses at a higher rate compared to larger providers. PRF Phase 4 will also include bonus payments for providers who serve Medicaid, CHIP, and/or Medicare patients, who tend to be lower income and have greater and more complex medical needs. HRSA will price these bonus payments at the generally higher Medicare rates to ensure equity for those serving low-income children, pregnant women, people with disabilities, and seniors. [FN200] Similarly, the American Rescue Plan funds will be focused on rural providers based on the amount of Medicaid, CHIP, or Medicare services they provide to rural patients. According to the press release, rural providers serve a disproportionate share of Medicaid and CHIP patients, who often suffer with greater and more complex medical needs, and it is these rural areas that been particularly affected by the pandemic. These funds will also generally be based on Medicare reimbursement rates. [FN201] CMS gave notice that it received an application from the American Association for Accreditation of Ambulatory Surgery Facilities for continued approval of its Rural Health Clinic Accreditation Program for the Medicare and Medicaid programs. The notice is published at 86 F.R. 57429 (Oct. 15, 2021). CMS issued two final rules affecting health facilities on November 2, 2021, and Fact Sheets are available. The final rules include these: ¢ Calendar year 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System final rule, IFN202] Which includes changes to the Radiation Oncology Model ¢ Calendar year 2022 Medicare Physician Fee Schedule final rule, [FN203] which covers changes to the Quality Payment Program HPTS will provide citations when the rules are published. CMS published notice about the calendar year 2022 provider application fee for the Medicare and Medicaid programs and CHIP. The notice is published at 86 F.R. 58917 (Oct. 25, 2021). THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -24- CMS finalized a rule making calendar year 2022 payment updates for the End-Stage Renal Disease Prospective Payment System. Additionally, the rule updates payment rates for renal dialysis services furnished by an end-stage renal disease facility to individuals with acute kidney injury. The rule is published at 86 F.R. 61874 (Nov. 8, 2021). A Fact Sheet is available. 'N2! cms is concerned about equity in kidney care. As it pointed out when it published the proposed rule, CMS pointed out that individuals who are disadvantaged because of race, ethnicity, or socioeconomic factors are more likely to suffer from ESRD and to experience hospital readmission. Conversely, they are less likely to have received pre-ESRD kidney care and to receive a transplant. These concerns are a part of CMS' overall focus on equity in health care. CMS Administrator Chiquita Brooks-LaSure remarked, "Health equity is at the center of our work here at CMS . . . . Today's proposed rule is grounded in measures to ensure people with Medicare who suffer from chronic kidney disease have easy access to quality care and convenient treatment options. When CMS encourages dialysis providers to offer more options for Medicare patients to receive dialysis treatments, it can be life changing and lead to better health outcomes, greater autonomy and better quality of life for patients with kidney disease." [FN205] X. Selected State Activity In Alabama: Governor Kay lvy (D) signed 2021 AL H.B. 210 (NS) on March 31, 2021. The bill will direct the Department of Public Health to protect, collect, and disseminate hospital patient discharge data. It also establishes the Hospital Discharge Data Advisory Council to advise the department on rulemaking, and it sets up penalties for hospitals that fail to submit the required data. In Alaska: If passed, 2021 AK S.B. 26 (NS) would repeal the certificate of need program for health facilities. The bill was introduced on January 19, 2021. In California: Governor Gavin Newsom (D) signed 2021 CA A.B. 789 (NS) on October 4, 2021. The bill provides that any patient receiving primary care services in a facility, clinic, unlicensed clinic, center, office, or other setting where primary care services are provided must be offered a hepatitis B and a hepatitis C screening test, to the extent such a test if covered by the patient's insurance, according to screening indications recommended by the United States Preventive Services Task Force. Exceptions are specified. It also requires the provider to conduct certain follow-up procedures. Also in California, the current version of 2021 CA A.B. 835 (NS) would require emergency departments that draw blood from an adult patient to offer the patient an HIV test consistent with federal guidelines if the patient has consented to such a test. The bill contains sets out a procedure to follow if the patient leaves the emergency department before the test results are available. The bill passed the Assembly on June 1, 2021. Assembly Bill 226 (2021 CA A.B. 226 (NS)) would have provided for children's crisis psychiatric residential treatment facilities, which would have served as community-based substitutes for inpatient hospitalization for mental health crises. Licensing for these facilities would have been handled by the Department of Health. An amended version of the bill was passed by both houses, but the governor vetoed it on October 8. In his veto message, the governor explained his concerns with the bill: AB 226 presents implementation challenges that cannot be overlooked or easily overcome. First, the bill would eliminate CCRPs [children's crisis residential programs], a Medicaid State Plan service the state is obligated to provide, creating a gap in the continuum of care for children and youth. Second, the bill does not appropriately identify the roles of the Department of Health Care Services, the county Mental Health Plans, and the California Department of Public Health in federally certifying the proposed CCPRTF [children's crisis psychiatric residential treatment facilities] program. Finally, should CCPRTFs be authorized as a treatment option, it is critical to develop adequate safeguards so children are not in CCPRTFs any longer than necessary. These safeguards are not included in this bill, FN208I In Colorado: Governor Jared Polis (D) signed 2021 CO S.B. 142 (NS) on May 21, 2021. The bill changes statutory provisions for the Indigent Care Program and the medical assistance program to loosen some restrictions on public funding for abortions. Public funds cannot be used for abortions except in certain limited situations and when done in certain facilities. This bill loosens the facility restriction. Under current law, such services must be performed in a licensed facility unless an exception applies. This bill removes the exceptions to the licensed facility provision and instead provides: No public funds for abortion - exception - definitions - repeal. (3) (a) Any medically necessary medical services performed pursuant to this section shall be performed only by a provider who is a licensed physician by the state and acting within the scope of the provider's license and in accordance with applicable federal regulations. House Bill 1227 (2021 CO H.B. 1227 (NS)) directs the Department of Health Care Policy and Financing to develop demonstration-of- need criteria for new Medicaid nursing facilities. The bill only applies to nursing facilities seeking certification after June 30, 2021. The department is authorized to exempt facilities with five or fewer Medicaid beds. Governor Polis signed the bill on May 27, 2021. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -25- Governor Polis signed 2021 CO S.B. 214 (NS) on May 4, 2021. The bill will temporarily provide additional payments for certain hospices that treat dually eligible patients unable to secure a bed in a nursing facility in which the patient could receive hospice services. The findings supplied with the bill describe the problem: (1) The general assembly finds and declares that as a result of the presence of the COVID-19 virus in the state and other circumstances, eligible patients in need of a nursing-facility level of care who are in their final weeks of life may not be able to find an appropriate placement in a nursing facility where they can receive hospice care. Without an available or appropriate nursing facility bed, hospice providers have made residential hospice beds available to these eligible patients despite receiving only reimbursement under the federal Medicare program for hospice services but not for expenses related to room and board. Therefore, the general assembly declares that it is appropriate to make available to these qualified hospice providers for a limited period of time a state payment that is equal to the state share of funding under the medical assistance program that would otherwise be paid to a nursing facility if the nursing facility were able to provide a residential bed for an eligible patient. House Bill 1198 (2021 CO H.B. 1198 (NS)) will require health facilities (as defined in the bill) to screen patients for eligibility for public health insurance (including programs such as Medicare and Medicaid), the Colorado Indigent Care Program, or other discounted care as described in the bill. The state will prescribe a uniform application for the screening, and reporting requirements will apply. The bill also includes an appeals process for patients deemed to be ineligible. Governor Polis signed the bill on July 6, 2021. In Florida: A Florida bill (2021 FL H.B. 1009 (NS)) would have made a number of statutory changes relating to organ donations and transplants. Among other things, bill would have added organ transplantation services (including pre-transplant, transplant, and post-discharge services) as an optional Medicaid benefit for which the agency would have been authorized to pay. It would have also prohibited a transplantation facility from charging a donor or the donor's family a fee for services related to procuring an organ. Had it passed, the bill would have also directed the Organ and Tissue Procurement and Transplantation Advisory Board to make certain recommendations relating to transplants and transplant facilities, including how facilities should be overseen and what information should be collected and reported. In the Senate, the companion bill was 2021 FL S.B. 1318 (NS). Neither bill passed before the legislature adjourned. Had it passed this session, House Bill 3965 (2021 FL H.B. 3965 (NS)) would have provided an appropriation for the MCR Health Hospital Readmission Reduction Program as follows: Section 1. MCR Health Hospital Readmission Reduction Program is an Appropriations Project as defined in The Rules of The Florida House of Representatives and is described in Appropriations Project Request 397, herein incorporated by reference. Section 2. For fiscal year 2021-2022 the nonrecurring sum of $2,000,000 from the General Revenue Fund is appropriated to the Department of Health to fund the MCR Health Hospital Readmission Reduction Program as described in Appropriations Project Request 397. House Bill 1157 (2021 FL H.B. 1157 (NS)) has been adopted. The bill will require hospital-based off campus emergency departments to clearly identify as emergency departments instead of urgent care centers. The bill requires specified signage and notification. Filed for 2022, 2022 FL S.B. 646 (NS) would delete provisions requiring a portion of punitive damages awarded in nursing home claims and assisted living facility claims to be placed into the Quality of Long-Term Care Facility Improvement Trust Fund. In Hawaii: Citing the economic damage done by the pandemic, Senate Bill 1132 (2021 HI S.B. 1132 (NS)) would have created a Medicaid Sustainability Program to draw down additional federal funds by assessing a fee on health insurers. Senate Bill 1132 passed the Senate on March 9, but it ultimately did not pass before adjournment. Similarly, 2021 HI S.B. 1130 (NS) would have continued the Hospital Sustainability Program and garner more Medicaid funding by assessing a fee on hospitals. It also failed to pass this session. As a way to draw more federal Medicaid funds for nursing facilities, 2021 HI S.B. 1131 (NS) would have continued the Nursing Facility Sustainability Program and assess a fee to nursing facilities. It also did not pass before adjournment. Also in Hawaii, 2021 HI S.B. 1285 (NS) would have required any hospital serving a community with more than 500 individuals covered by the Compact of Freely Associated States to implement certain measures to ensure diversity: Any hospital or other medical facility that serves a community including more than five hundred persons eligible for benefits pursuant to the Compact of Free Association Act of 1985, P.L. 99-239, or the Compact of Free Association between the United States and the Government of Palau, P.L. 99-658, shall: (1) Establish and implement a program of diversity and inclusion training for all staff; and (2) Hire interpreters and community healthcare workers as necessary to effectively communicate with and provide culturally sensitive services to the community. According to the findings supplied with the bill, residents of such communities have been disproportionately affected by the pandemic. The COVID relief bill that Congress passed in December 2020 (the Consolidated Appropriations Act of 2021) restores Medicaid benefits for this group. As these individuals enter the ranks of the insured, this bill would have ensured that they did not experience THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -26- prejudice or discrimination in health care. [FN207] an amended version of Senate Bill 1285 passed the Senate on March 9, but ultimately the bill did not pass before adjournment. If passed, 2021 HI S.B. 1151 (NS) would have expanded accreditation options for hospitals seeking to be licensed in Hawaii. Previously, the state recognized accreditation or certification by The Joint Commission. This bill would have allowed hospital accreditation or certification from other organizations accepted by CMS. It did not pass this session. In Illinois: Senate Bill 1966 (2021 IL S.B. 1966 (NS)) has been adopted. The bill would enact the Interstate Contracts for Mental Health Disorder Treatment Act. That act would allow Illinois and Wisconsin residents who, by court order, are involuntarily committed for inpatient mental health or substance abuse treatment to seek care across state lines so as to receive treatment closer to where they live. In Indiana: Governor Eric Holcomb (R) signed 2021 IN H.B. 1577 (NS) on April 29, 2021. The bill adds several provisions to the statutory sections on facilities that provide abortions. Among other things, new statutory material provides that results of a facility's yearly inspections are to be considered for licensing purposes. One part of the inspection will be an examination of required paperwork. Another new section limits telemedicine in such facilities: Sec. 0.5. Telemedicine may not be used to provide any abortion, including the writing or filling of a prescription for any purpose that is intended to result in an abortion. Governor Holcomb also signed 2021 IN H.B. 1421 (NS) on April 29, 2021. The bill addresses, among other things, hospital price transparency requirements. Amendments to the existing statutory section would provide that if the federal Hospital Price Transparency rule 'FN208] j, repealed or if enforcement of the rule ceases, hospitals must post pricing information in compliance with the rule as it existed on January 1, 2021. In Kansas: Senate Bill 283 (2021 KS S.B. 283 (NS)) addressed the state's response to COVID-19. As it relates to health care, the bill would have temporarily allowed a physician to prescribe a medication, including a controlled substance, without physically examining the patient and would have allowed a physician under quarantine to practice telemedicine. It would have also allowed a hospital to admit patients in excess of the hospital's number of licensed beds or inconsistent with the licensed classification of such hospital's beds if the hospital determines that it is necessary to treat COVID-19 patients and to separate COVID-19 patients from non-COVID-19 patients. Importantly, the bill would have granted immunity from liability to health care providers for care rendered during the COVID-19 emergency. The last version of the bill provided, (a) Notwithstanding any other provision of law, except as provided in subsection (c), a healthcare provider is immune from civil liability for damages, administrative fines or penalties for acts, omissions, healthcare decisions or the rendering of or the failure to render healthcare services, including services that are altered, delayed or withheld, as a direct response to any state of disaster emergency declared pursuant to K.S.A. 48-924, and amendments thereto, related to the COVID-19 public health emergency. (b) The provisions of this section shall apply to any claims for damages or liability that arise out of or relate to acts, omissions or healthcare decisions occurring during any state of disaster emergency declared pursuant to K.S.A. 48-924, and amendments thereto, related to the COVID-19 public health emergency. (c) (1) The provisions of this section shall not apply to civil liability when it is established that the act, omission or healthcare decision constituted gross negligence or willful, wanton or reckless conduct. (2) The provisions of this section shall not apply to healthcare services not related to COVID-19 that have not been altered, delayed or withheld as a direct response to the COVID-19 public health emergency. The bill did not pass before the legislature adjourned. In Louisiana: The Department of Health gave notice of an emergency rule to temporarily allow Medicaid reimbursement for private intermediate care facility services to individuals with intellectual disabilities. The rule sets out the limitations. Please see 2021 LA REG TEXT 576091 (NS) (Feb. 1, 2021). In 2018, CMS announced a demonstration that would allow states to treat those with a serious mental illness in an inpatient setting; normally, the IMD (Institute for Mental Disease) exclusion would exclude coverage for these services when provided in a facility with more than 16 beds. §20°l A | ouisiana bill, 2021 LA H.B. 598 (NS), would have directed the Secretary of the Department of Health to seek federal approval of a Section 1115 waiver to participate in this demonsiration. It did not pass this session. In Minnesota: THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -27- Had it passed this session, 2021 MN S.F. 253 (NS) would have created an emergency medical services task force to assess medical services in the state and make recommendations for improvement. The task force would have been asked to make recommendations on these areas: (1) how to improve and modernize the provision of emergency medical services in Minnesota; (2) any needed changes to education or training requirements for ambulance service personnel or emergency medical responders that will improve the provision of emergency medical services; and (3) how to coordinate ambulance service operations with the roles, transportation needs, and other needs of hospitals within and outside service areas of ambulance services. House File 1087 (2021 MN H.F. 1087 (NS)) contained a number of provisions relating to health facilities. Among other things, it would have required various facilities to have a severe acute respiratory syndrome-related coronavirus response plan. It did not pass this session. Also in Minnesota, 2021 MN H.F. 1102 (NS) would have provided that a person receiving Medicaid home- and community-based services would not have needed to be reassessed for eligibility if the person temporarily (for 121 days or less) discontinued these services due to a stay in a specified type of health facility. In Mississippi: Senate Bill 2345 (2021 MS S.B. 2345 (NS)) would have added new language to the existing statutory provision on Medicaid reimbursement for services rendered by federally qualified health centers and community health centers. The new language would have read: (b) For telehealth services provided by federally qualified health centers and community health centers, the distant or hub site provider shall be reimbursed the applicable Medicaid fee for the telehealth services provided. (c) Telehealth services provided by federally qualified health centers and community health centers shall be considered to be billable at the same face-to-face encounter rate used for all other Medicaid reimbursements to federally qualified health centers and community health centers under the prospective payment system. The bill died in committee. In Montana: Governor Greg Gianforte (R) signed 2021 MT H.B. 231 (NS) on May 12, 2021. The bill amends provisions setting out which facilities and services are required to have a certificate of need. Specifically, it will limit the certificate of need requirement to long-term care facilities and services. In Nevada: In Nevada, 2021 NV S.B. 211 (NS) will require certain providers (including physicians, physician assistants, advanced practice registered nurses, and midwives) who provide (or supervise the provision of) emergency services in a hospital or primary care setting to consult with any patient 15 and over about whether the patient wants to be tested for sexually transmitted diseases. It will also require hospitals that provide emergency services to ensure that any such patient has been consulted about this testing and that the testing is done if the patient wishes. Certain exceptions apply. The bill contains an appropriation for Medicaid funds to pay for such tests for Medicaid participants. Governor Steve Sisolak (D) signed the bill on June 4, 2021. In New Jersey: Assembly Bill 5274 (2020 NJ A.B. 5274 (NS)) would establish, in two hospitals in each Regional Health Hub, a pilot program in which certain patients seeking emergency care would be referred to a coordinated behavioral health care treatment and support services plan. Patients that could be referred would be those with a behavioral health issue (including substance use disorder) whose symptoms do not meet the criteria for hospital admission. Assembly Bill 5270 (2020 NJ A.B. 5270 (NS)) would establish pilot programs providing 24-hour urgent care for behavioral health and 24-hour county substance use disorder crisis centers. In New Mexico: Governor Michelle Lujan Grisham signed 2021 NM S.B. 71 (NS) on April 5, 2021. The bill enacts the Patients' Debt Collection Protection Act. It requires health facilities to take certain steps before they seek payment for emergency or medically necessary care. Those steps are these: ¢ offer to verify the patient's insurance, and screen uninsured patients for public insurance, public programs, and the facility's financial assistance program; ¢ offer assistance with applications necessary for any identified source of funding; * send applicable information to any third-party provider that will be billing the patient. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -28- It also prohibits health facilities from engaging in debt collection against indigent patients; requires the state to provide guidance to health facilities about accessing available funding from federal sources, state sources, and other sources, in that order; and requires that bills be written in plain language, among other things. In New York: Assembly Bill 2557 (2021 NY A.B. 2557 (NS)) would have required a hospital to provide a consultation with the patient and a parent or guardian and provide a discharge plan before discharging a medically fragile young adult. The bill set out what the discharge plan should address. It did not pass the session. Assembly Bill 2628 (2021 NY A.B. 2628 (NS)) sought to develop a pilot program to place a specially-trained autism team in a hospital to improve the hospital experience for patients with autism. The bill was introduced on January 19, 2021; it did not pass before adjournment. The latest version of 2021 NY S.B. 2103 (NS) would have enacted statutory requirements for the use of psychotropic drugs in nursing homes and adult care homes. Among other things, it would have required informed consent from the patient or the patient's representative before a health care professional ordered or increased an order for such medication. Exceptions would have applied for certain emergencies. The Department of Health gave notice of emergency rulemaking that will prevent duplicate payments for certain ground transportation services. In short, the department will not provide non-comparable ambulance add-on payments to hospitals as well as a supplemental add-on payment for these services. The department explains, Based on the requirements of Chapter 56 of the Laws of 2020, eligible ground emergency transportation providers will be provided the ability to participate in a supplemental payment in lieu of receiving reimbursement through a hospital. Article 28 hospitals currently receive reimbursement through their acute hospital inpatient rate for ambulance services provided by the ground emergency medical transportation providers. For ground emergency transportation providers that meet the requirements of this chapter and receive the supplemental payment, the hospitals through which they were reimbursed will not be eligible to also receive the ambulance add-on in the acute hospital inpatient rate. The notice is published at 2021 NY REG TEXT 561433 (NS) (Oct. 27, 2021). The Department of Mental Hygiene gave notice of emergency rulemaking requiring staff at specialty hospitals operated or certified by the Office of People with Developmental Disabilities to be vaccinated against COVID-19. As justification for this requirement, the department explained that individuals served in these settings suffer with comorbidities that make them disproportionately affected by the virus. The notice is published at 2021 NY REG TEXT 597204 (NS) (Oct. 27, 2021). A similar emergency rule requiring vaccinations at hospitals operated or licensed by the Office of Mental Hygiene is published at 2021 NY REG TEXT 597203 (NS) (Oct. 27, 2021). In North Carolina: The Department of Health and Human Services adopted regulations amending and repealing existing regulations relating to nursing home licensing for ventilator assisted care. According to the department, the changes are necessary to comply with federal regulations on the matter. Please see 2021 NC REG TEXT 557426 (NS) (Feb. 1, 2021). Introduced on March 31, 2021, 2021 NC S.B. 391 (NS) would repeal existing statutory provisions and adopt a new Hospital Assessment Act to account for the Medicaid transformation process. Introduced on April 26, 2021, 2021 NC H.B. 660 (NS) would remove from the certificate of need requirement psychiatric facilities, chemical dependency treatment facilities, and kidney disease treatment centers and would provide a limited exemption for ocular surgical procedures. Adopted in North Carolina, 2021 NC S.B. 191 (NS) sets out guidelines for visiting policies in hospitals and other health facilities. The bill aims to strike a humane balance between infection control and the need for patients in facilities to have the support of loved ones during their stay. Generally, the bill will ensure that facilities allow patients to have visitation ""to the fullest extent permitted under any applicable rules, regulations, or guidelines adopted by either CMS or the Centers for Disease Control and Prevention or any federal law."It also sets up civil penalties for facilities that continue to violate patients' visitation rights following a warning. In North Dakota: Senate Bill 2334 (2021 ND S.B. 2334 (NS)) has been adopted. The bill enacts new statutory provisions governing the licensure of extended care centers. According to the bill, extended stay centers are centers that provide extended stay services, which are "postsurgical and postdiagnostic medical and nursing services provided to a patient recovering from a surgical procedure performed in an ambulatory surgical center." In Oklahoma: Senate Bill 434 (2021 OK S.B. 434 (NS)) passed both houses and was sent to Governor Kevin Stitt (R), who signed it on May 28, 2021. The bill creates an Indian Health Service, Tribal, and Urban Indian (I/T/U) Shared Savings Program to share in savings accruing to the Oklahoma Health Care Authority from a 100% federal match rate for certain services rendered to an American Indian, Alaskan native Medicaid patient. The bill explains, THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -29- Pursuant to guidance of the Centers for Medicare & Medicaid Services (CMS), authorized services provided by a non-I/T/U Medicaid provider to an American Indian or Alaska Native (AI/AN) Medicaid beneficiary as a result of a referral from an I/T/U facility provider may be eligible for the enhanced federal matching rate of one hundred percent (100%). C. 1. The Authority shall distribute up to fifty percent (50%) of any savings that result from the I/T/U Shared Savings Program provided for in this section to participating I/T/U facilities that have complied with the terms of this act and applicable federal law, but only after administrative costs incurred by the Authority in implementing the I/T/U Shared Savings Program have been fully satisfied. 2. Distributions to participating I/T/U facilities shall be used to increase care coordination and to support health care initiatives for AI/AN populations. In Oregon: House Bill 2360 (2021 OR H.B. 2360 (NS)) was adopted on May 26, 2021. The bill amends an existing statutory section on the required price adjustments that non-profit hospitals must include in their financial assistance policies. New material would specify that such hospitals may not require patients to apply for Medicaid before offering those adjustments or screening for them, but they may give patients information about applying for Medicaid or help in doing so. In Pennsylvania: Introduced on July 19, 2021, 2021 PA H.B. 1723 (NS) would prohibit health care providers from charging certain fees, including a COVID-19 fee and specified facility fees. In Rhode Island: Adopted on July 12, 2021, 2021 RI H.B. 6365 (NS) adds new statutory language on newborn screening requirements. The previous section directed a physician attending a newborn child to order certain newborn screening tests, and it directed the Department of Health to promulgate rules for such screening. The new language sets out in more specificity what those rules should include: Such rules and regulations shall include, at a minimum, newborn screening tests for all disorders and conditions for which there is a medical benefit to the early detection and treatment of the disorder or condition listed in the current version of the federal Recommended Uniform Screening Panel (RUSP) issued by the Secretary of the U.S. Department of Health and Human Services, and shall include newborn screening tests for all new disorders or conditions for which there is a medical benefit to the early detection and treatment of the disorder or condition added to the federal RUSP within two (2) years after the disorder or condition is added; provided, if the director of health determines in writing that it is not practicable to include a new disorder or condition within two (2) years, the time period may be extended for the shortest amount of time necessary, as determined by the director. In Tennessee: Had it passed, 2021 TN S.B. 255 (NS) would have allowed certain entities to re-establish a hospital without seeking a certificate of need. The bill was introduced on January 21, 2021. In Texas: Had it passed, 2021 TX S.B. 412 (NS) would have added several provisions relating to telehealth. Among other things, it would have required Medicaid reimbursement for telehealth services rendered by a rural health center; required reimbursement for telemedicine and telehealth services in several programs, services, and benefits, including, for example, physical, occupational, and speech therapy, targeted case management, and Section 1915(c) Medicaid waivers; and required access to home telemonitoring in Medicaid managed care. The Health and Human Services Commission gave notice of proposed rules to amend the Medicaid State Plan to establish the Hospital Augmented Reimbursement Program. That program would arrange for payments to non-state government-owned and -operated hospitals and to private hospitals. The notice, which is published at 2021 TX REG TEXT 588311 (NS) (July 16, 2021), includes this explanation for the proposed rule: [The Health and Human Services Commission] plans to create this program to continue the financial transition for providers who have historically participated in the Delivery System Reform Incentive Payment program. We continue to work on solutions to preserve the financial resources many of our hospitals depend on to provide access to quality care to Medicaid clients and the uninsured. The Hospital Augmented Reimbursement Program would be created, subject to approval by the Centers for Medicare and Medicaid Services (CMS), through the Medicaid state plan. . .. HHSC intends to submit state plan amendments to CMS to request authorization to make payments as described under new 7355.8070 to non-state government-owned and -operated hospitals and to private hospitals. State plan amendments to include various hospital ownership types may be submitted on individual timelines. . . . The program will provide additional funding to hospitals to help offset the cost hospitals incur while providing Medicaid services. The payment calculation will be based on a participating hospital's Medicare payment gap and/or Average Commercial Reimbursement (ACR) gap. The hospital's maximum payment before any reductions will be the combined Medicare payment gap and ACR gap for hospitals that submitted ACR data and the Medicare gap for those that did not submit ACR data. Payments will be capped at the total aggregate Medicare Upper Payment Limit (UPL) gap for all hospital services. The most current Medicare UPL demonstration available at the time of calculation will be used. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -30- Senate Bill 1137 (2021 TX S.B. 1137 (NS)) has been adopted. The bill codifies into state law the final CMS rule on hospital price transparency. That rule is published at 84 F.R. 65524-01 (Nov. 27, 2019). In Utah: Adopted on March 12, 2021, 2021 UT H.B. 202 (NS)) will enact the Health Care Consumer Protection Act. In short, the bill will make it a deceptive act or practice for a provider or a provider's representative to represent to an insurance enrollee that the provider is contracted with the enrollee's health insurance if it is not so enrolled. In Vermont: House Bill 121 (2021 VT H.B. 121 (NS)) would have set out licensing requirements for freestanding birth centers, and it would have required Medicaid and health insurance plans offering maternity benefits to cover services rendered at such centers. Finally, it would have excluded freestanding birth centers from the certificate of need requirement. Introduced on March 30, 2021, 2021 VT S.B. 132 (NS) would have consolidated authority for health reform innovation and added certification requirements for accountable care organizations. The introduction to the bill explained what the bill aimed to do: This bill proposes to consolidate responsibility for health care innovation under the Director of Health Care Reform in the Agency of Human Services and to add new criteria to the certification requirements for accountable care organizations. It would require accountable care organizations to collect, analyze, and report quality data to the Green Mountain Care Board to enable the Board to determine value-based payment amounts and the appropriate distribution of shared savings among the accountable care organization's participating health care providers. It would also require accountable care organizations to provide the Office of the Auditor of Accounts with access to their records to enable the Auditor to audit their financial statements, receipt and use of federal and State monies, and performance. . . . The bill would also require submission of reports to the General Assembly on health insurers' administrative expenses, inclusion of specialty care in the All-Payer ACO Model, accountable care organizations' care coordination efforts, and the likely impacts of requiring health insurance plans to offer at least two primary care visits per year without cost-sharing. The All-Payer ACO Model is a partnership program with CMS in which all major payers in the state (Medicare, Medicaid, and commercial health insurers) work together under the same payment structure with a focus on high quality care, cost, and outcomes. FFN210] The bill did not pass this session. In Virginia: Health Department gave notice of emergency rules adding and amending definitions and adding provisions setting out requirements for clinically managed, medium-intensity residential services and clinically managed, low-intensity residential services. The notice is published at 2021 VA REG TEXT 576092 (NS) (Feb. 1, 2021). Governor Ralph Northam (D) signed 2020 VA H.B. 1987 (NS) on March 24, 2021. The bill ensures Medicaid coverage for remote patient monitoring of certain high-risk individuals, including: (i) high-risk pregnant persons; (ii) medically complex infants and children; (iii) transplant patients; (iv) patients who have undergone surgery, for up to three months following the date of such surgery; and (v) patients with a chronic health condition who have had two or more hospitalizations or emergency department visits related to such chronic health condition in the previous 12 months. A related bill, 2020 VA S.B. 1338 (NS), was also adopted. Senate Bill 1356 (2020 VA S.B. 1356 (NS)) was adopted in the first special session. The bill amends existing statutory provisions relating to licensure regulations for hospitals, nursing homes and certified nursing homes; hospices; and assisted living facilities. The bill adds additional language relating to clergy visits during a public health emergency declared because of a communicable disease that threatens public health. The new language provides that these facilities must, establish a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy of any religious denomination or sect consistent with guidance from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services and subject to compliance with any executive order, order of public health, Department guidance, or any other applicable federal or state guidance having the effect of limiting visitation. Such protocol may restrict the frequency and duration of visits and may require visits to be conducted virtually using interactive audio or video technology. Such a protocol may require the visitor to comply with all reasonable requirements of the facility. Virginia adopted the Medicaid expansion in 2018. IFN211] The Department of Health, through the Fast-Track process, amended existing regulatory provisions on hospital presumptive eligibility in order to incorporate changes made in the State Plan on account of the expansion. Please see the notice at 2021 VA REG TEXT 534347 (NS) (July 19, 2021). A new state law requires nursing homes and certified nursing facilities to establish policies to allow residents to have access to and use of intelligent personal assistants. In final regulations, the Department of Health promulgated rules requiring these policies and providing a definition of "intelligent person assistant': THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -31- ™ Intelligent personal assistant" means a combination of an electronic device and a specialized software application designed to assist users with basic tasks using a combination of natural language processing and artificial intelligence, including such combinations known as digital assistants or virtual assistants. A new regulation also requires these facilities to establish protocols to ensure that residents are allowed visits from religious counselors during public health emergencies, subject to the requirements specified in the regulation. Please see 2021 VA REG TEXT 596126 (NS) (Oct. 11, 2021). In Washington: Governor Jay Inslee (D) signed 2021 WA S.B. 5236 (NS) on May 12, 2021. It will, among other things, extend for two years (through June 30, 2023) the exemption from certificate of need requirements for hospitals wishing to add psychiatric bed capacity. Governor Inslee also approved 2021 WA S.B. 5271 (NS), which will clarify the burden of proof for health-related injury claims arising during the COVID-19 pandemic. The bill seeks to give some measure of protection to health care providers and facilities which, according to the bill, have had an ""oversized burden" placed on them. The findings supplied with the bill provide, in part, (2) The legislature further finds that during the pandemic, the law should accurately reflect the realities of the challenging practice conditions. It is fair and appropriate to give special consideration to the challenges arising during the pandemic, such as evolving and sometimes conflicting direction from health officials regarding treatment for COVID-19 infected patients, supply chain shortages of personal protective equipment and testing supplies, and a proclamation on nonurgent procedures resulting in delayed or missed health screenings and diagnoses. The Health Care Authority is seeking to amend the State Plan to increase reimbursements for individual providers, agency providers, and adult family homes, and to raise the nursing facility budget dial and swing bed rates. Please see the notice published at 2021 WA REG TEXT 588691 (NS) (July 21, 2021). XI. additional resources The Commonwealth Fund has published a brief explaining how non-institutional providers that serve the Medicaid population are disadvantaged in their ability to share in distributions from the Provider Relief Fund. [FN212] CMS published updated guidance for ambulatory surgical centers that temporarily enroll as hospitals during the COVID-19 emergency . [FN213] period. CMS provided resources for hospitals interested in applying for the Acute Care at Home waiver. [FN214] CMS released a toolkit for states that explores some of the actions that states might take to mitigate the transmission of COVID-19 in nursing homes. [FN215] CMS published a one-page graphic comparing and contrasting the Medicare Promoting Interoperability Program and the Promoting Interoperability performance category for MIPS (the Merit-Based Incentive Payment System), which is a component of the Quality Payment Program. [FN216] During the COVID-19 public health emergency period, patients have foregone non-COVID-related medical care. This led to a significant decline in hospital admissions for both elective and acute procedures and a drop in utilization for preventive care. Corresponding health spending also fell. As the pandemic eased, experts expected that pent-up demand would cause utilization and spending to rebound. However, according to the Kaiser Family Foundation, as of spring 2021, non-COVID-related utilization and spending did not return to expected levels. This fact impacts the financial health of providers (for the worse) and insurance companies (for the better) and may have significant effects on patient health. The Kaiser Family Foundation's new brief examines the data and the potential implications for the future, FN217] XII. Conclusion CMS continues to move toward a health system that pays for the quality of care rather than the quantity of care, and the agency continues to launch new models and initiatives to make this a reality. CMS also continues to refine Obama-era programs such as the EHR Incentive Programs (now known as Promoting Interoperability) and the ACO programs. Hospitals are deeply affected by Medicaid because well-insured patients lead to lower uncompensated care costs and underpayments for hospitals. The latest decision from the Supreme Court ensures that the Affordable Care Act, and its Medicaid expansion, will remain in place for the foreseeable future. The COVID-19 pandemic has required many temporary changes to Medicaid policy. We will continue to report on those as they are issued, and when the emergency period ends, we will report on the transition to pre-COVID-19 policy. © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -32- [FN2] . 'Hospitals are Economic Anchors in their Communities,' American Hospital Association, https:/Awww.aha.org/statistics/2018-03-29- hospitals-are-economic-anchors-their-communities. [FN3] . "Hospitals are Economic Anchors in their Communities," American Hospital Association, Mar. 29, 2018, available at: https:// www.aha.org/statistics/201 8-03-29-hospitals-are-economic-anchors-their-communities. [FN4] . "Fact Sheet: Underpayment by Medicare and Medicaid," American Hospital Association, Jan. 2021, available at: https:/Avww.aha.org/ fact-sheets/2020-01-07-fact-sheet-underpayment-medicare-and-medicaid. [FN5] . "Fact Sheet: Underpayment by Medicare and Medicaid," American Hospital Association, Jan. 2020, available at: https:/Avww.aha.org/ system/files/media/file/2020/01/2020-Medicare-Medicaid-Underpayment-Fact-Sheet. pdf. [FN6] . "Fact Sheet: Uncompensated Hospital Care Cost," American Hospital Association, Jan. 2021, available at: https:/Awww.aha.org/fact- sheets/2020-01-06-fact-sheet-uncompensated-hospital-care-cost [FN7] . Kathleen Gifford, et a/., "States Respond to COVID-19 Challenges but Also Take Advantage of New Opportunities to Address Long-Standing Issues," Kaiser Family Foundation, Oct. 2021, available at: https://files.kff.org/attachment/Report-States-Respond-to- COVID-19-Challenges. pdf. [FN8] . Kathleen Gifford, et a/., "States Respond to COVID-19 Challenges but Also Take Advantage of New Opportunities to Address Long-Standing Issues," Kaiser Family Foundation, Oct. 2021, available at: https://files.kff.org/attachment/Report-States-Respond-to- COVID-19-Challenges. pdf. [FN] . Texas v. United States, Case nos. 19-840 and 19-1019, June 17, 2021, available at: https:/Awww.supremecourt.gov/ opinions/20pdf/19-840_6jfm.pdf. [FN10] . Texas v. United States, Case nos. 19-840 and 19-1019, June 17, 2021, available at: https:/Avww.supremecourt.gov/ opinions/20pdf/19-840_6jfm.pdf. [FN11] . For an excellent discussion of the major events in this case, please see ""Texas v. United States," Constitutional Accountability Center, https://www.theusconstitution.org/litigation/texas-v-united-states/. [FN12] . Adam Liptak, '"Affordable Care Act Survives Latest Supreme Court Challenge," The New York Times, June 17, 2021, available at: https:/Avww.nytimes.com/2021/06/17/us/obamacare-supreme-court.html. [FN13] . Press Release, ""Statement by HHS Secretary Xavier Becerra on U.S. Supreme Court Decision to Uphold the Affordable Care Act in California v. Texas," HHS, June 17, 2021, available at: https:/Avww.hhs.gov/about/news/202 1/06/17/statement-hhs-secretary-xavier- becerra-us-supreme-court-decision-uphold-affordable-care-act-california-texas.html. [FN14] . Press Release, ""New HHS Data Show More Americans than Ever Have Health Coverage through the Affordable Care Act," HHS, June 5, 2021, available at: https://www.hhs.gov/about/news/2021/06/05/new-hhs-data-show-more-americans-than-ever-have-health- coverage-through-affordable-care-act.html#:?:text=Today##heU.S. D#epartmentéf,AffordableC#areActS#%lartecord.&text=Tod#ate #3#7s#tatesdnd,coverddultsinder#heACA.. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -33- [FN15] . MaryBeth Musumeci, "Section 1115 Medicaid Demonstration Waivers: The Current Landscape of Approved and Pending Waivers," Kaiser Family Foundation, Sept. 20, 2018, available at: https:/Avww.kff.org/medicaid/issue-brief/section-1 115-medicaid-demonstration- waivers-the-current-landscape-of-approved-and-pending-waivers/?utm_campaign=KFF-2018-The-Latest&utm_source=. [FN16] . Letter from HHS to Texas Medicaid Director, Apr. 16, 2021, available at: https:/Awww.medicaid.gov/medicaid/section-1115- demonstrations/downloads/tx-healthcare-transformation-ca. pdf. [FN17] . Letter from HHS to Texas Medicaid Director, Apr. 16, 2021, available at: https:/Awww.medicaid.gov/medicaid/section-1115- demonstrations/downloads/tx-healthcare-transformation-ca. pdf. [FN18] . Texas is one of just 12 states that have not adopted the Medicaid expansion. See "Status of State Action on the Medicaid Expansion Decision," Kaiser Family Foundation, updated Apr. 13, 2021, available at: https:/Awww.kff.org/health-reform/state-indicator/state-activity- around-expanding-medicaid-under-the-affordable-care-act/?currentTimeframe=0&sortModel=#c#olld:#L#ocation #s#ort:#asc'#. [FN19] . Sources name Texas as the state with the highest, or one of the highest, uninsured rates in the country, at roughly 29%. See, e.g., Ayla Ellison, *"States Ranked by Uninsured Rates," Becker's Hospital Review, July 15, 2020, available at: https:// www.beckershospitalreview.com/rankings-and-ratings/states-ranked-by-uninsured-rates.html. [FN20] . Jeremy Blackman, "Biden Administration Rescinds Billions in Medicaid Funding for Texas," Houston Chronicle, Apr. 16, 2021, available at: https:/Awww.houstonchronicle.com/politics/texas/article/Biden-administration-rescinds-billions-in-16107275.php. [FN21] . Jeremy Blackman, *"Biden Administration Rescinds Billions in Medicaid Funding for Texas," Houston Chronicle, Apr. 16, 2021, available at: https://(www.houstonchronicle.com/politics/texas/article/Biden-administration-rescinds-billions-in-16107275.php. [FN22] . Jeremy Blackman, ""Biden Administration Rescinds Billions in Medicaid Funding for Texas," Houston Chronicle, Apr. 16, 2021, available at: https:/Awww.houstonchronicle.com/politics/texas/article/Biden-administration-rescinds-billions-in-16107275.php. [FN23] . Morgan Haefner, "Revoked Texas Medicaid Waiver Credit Negative for Hospitals," Becker's Hospital Review, Apr. 27, 2021, available at: https:/Avww.beckershospitalreview.com/finance/revoked-texas-medicaid-waiver-credit-negative-for-hospitals.html. [FN24] . "Health Center Program Impact and Growth," HRSA, updated Aug. 21, 2021, available at: https://ophc.hrsa.gov/about/ healthcenterprogram/index.html. [FN25] . George Sigounas, ""Celebrating America's Health Centers: Our Healthcare Heroes," HHS Blog, Aug. 13, 2018, available at: https:// www.hhs.gov/blog/2018/08/13/celebrating-americas-health-centers-our-healthcare-heroes.html. [FN26] . "2021 Community Health Center Chart Book," National Association of Community Health Centers, available at: https:// www.nachc.org/research-and-data/research-fact-sheets-and-infographics/2021-community-health-center-chartbook/. [FN27] . See, e.g., "Substance Use Disorders and the Community Based Landscape," National Association of Community Health Centers, available at: https:/Awww.nachc.org/wp-content/uploads/201 8/09/Substance-Use-Disorders-and-the-Community-Based-Landscape.pdf. [FN28] . "Community Health Centers Have Seen an Increase in the Share of Patients with Opioid Addiction," Kaiser Family Foundation, July 30, 2018, available at: https://Awww.kff.org/medicaid/press-release/community-health- THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -34- centers-have-seen-an-increase-in-the-share-of-patients-with-opioid-addiction/?utm_campaign=KFF-2018- The-Latest&utm_source=hs_email&utm_medium=email&utm_content=64962238&_hsenc=p2ANatz-- tuJDBkEzisOF GtrAp4VRnITwa6wUkKHrGitxEGKT&_hsmi=64962238. [FN29] . Katherine Swartz, "Trying to Survive: Community Responses to Uncertainties about Federal Funding for Medicaid and Public Health Programs," Commonwealth Fund, Aug. 17, 2018, available at: https:/Avww.commonwealthfund.org/blog/201 8/community-responses- federal-funding?omnicid=EALERT 1457501 &mid=. [FN30] . News Release, "Trump Administration Announces $1.8 Billion in Funding to States to Continue Combating Opioid Crisis," HHS, Sept. 4, 2019, available at: https:/Avww.hhs.gov/about/news/201 9/09/04/trump-administration-announces-1 -8-billion-funding-states- combating-opioid.html. [FN31] . News Release, "HHS Awards More than $50 Million to Establish New Health Center Sites," HHS, Sept. 11, 2019, available at: https:// www.hhs.gov/about/news/2019/09/1 1/nhhs-awards-more-than-50-million-establish-new-health-center-sites.html. [FN32] . Press Release, "HHS Awards $1.3 Billion to Health Centers in Historic U.S. Response to COVID-19," HHS, Apr. 8, 2020, available at: https:/Avww.hhs.gov/about/news/2020/04/08/hhs-awards-billion-to-health-centers-in-historic-covid19-response.html. [FN33] . Kellie Moss, et al., "The Coronavirus Aid, Relief, and Economic Security Act: Summary of Key Health Provisions," Apr. 9, 2020, available at: https://Awww.kff.org/coronavirus-covid-1 9/issue-brief/the-coronavirus-aid-relief-and-economic-security-act-summary- of-key-health-provisions/; see, also, Rebecca Shin, et al, "Keeping Community Health Centers Strong During the Coronavirus Pandemic is Essential to Public Health," Health Affairs, Apr. 10, 2020, available at: https:/Avww.healthaffairs.org/do/10.1377/ hblog20200409.175784/full/. [FN34] . Press Release, """HHS Awards $117 Million to Support Health Center Quality Improvement," HHS, Aug. 25, 2020, available at: https:// www.hhs.gov/about/news/2020/08/25/hhs-awards-1 17-million-to-support-health-center-quality-improvement.html?utm_source=news- releases-email&utm_medium=email&utm_campaign=august-30-2020. [FN35] . News Release, '*HHS Awards $79 Million to Support Health Center Response to Emergencies," HHS, Sept. 8, 2020, available at: https:/Avww.hhs.gov/about/news/2020/09/08/hhs-awards-79-million-to-support-health-center-response-to-emergencies.html? utm_source=news-releases-email&utm_medium=email&utm_campaign=september-13-2020. [FN36] . News Release, ""Biden-Harris Administration Provides Nearly $1 Billion in American Rescue Plan Funds to Modernize Health Centers and Support Underserved Communities," HHS, Sept. 28, 2021, available at: https:/Awww.hhs.gov/about/news/202 1/09/28/biden-harris- admin-providers-nearly-1-billion-in-arp-funding-to-modemize-health-centers.html. [FN37] . News Release, ""Biden-Harris Administration Provides Nearly $1 Billion in American Rescue Plan Funds to Modernize Health Centers and Support Underserved Communities," HHS, Sept. 28, 2021, available at: https:/Avww.hhs.gov/about/news/202 1/09/28/biden-harris- admin-providers-nearly-1-billion-in-arp-funding-to-modemize-health-centers.html. [FN38] . News Release, "HHS Awards Over $48 Million to Health Centers for Ending the HIV Epidemic in the U.S. Initiative," HHS, Sept. 16, 2021, available at: https:/Avww.hhs.gov/about/news/2021/09/16/hhs-awards-48-million-to-health-centers-to-end-the-hiv-epidemic.html? utm. [FN39] . "What Is Ending the HIV Epidemic in the U.S.?° hiv.gov, available at: https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/ overview. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -35- [FN40] . News Release, "HHS Awards Over $48 Million to Health Centers for Ending the HIV Epidemic in the U.S. Initiative," HHS, Sept. 16, 2021, available at: https:/Avww.hhs.gov/about/news/2021/09/16/hhs-awards-48-million-to-health-centers-to-end-the-hiv-epidemic.html? utm. [FN41] . News Release, '*HHS Awards Over $48 Million to Health Centers for Ending the HIV Epidemic in the U.S. Initiative," HHS, Sept. 16, 2021, available at: https:/Avww.hhs.gov/about/news/2021/09/16/hhs-awards-48-million-to-health-centers-to-end-the-hiv-epidemic. html? utm. [FN42] . Press Release, ""SAMHSA Awards Record-Setting $825 Million in Grants to Strengthen Community Mental Health Centers, and Support Americans Living with Serious Emotional Disturbances, Mental Illnesses," HHS, Sept. 28, 2021, available at: https:// www.hhs.gov/about/news/2021 /09/28/samhsa-awards-record-setting-825-million-grants-strengthen-community-mental-health- centers.html. [FN43] . News Release, ""SAMHSA Awards Record-Setting $825 Million in Grants to Strengthen Community Mental Health Centers, and Support Americans Living with Serious Emotional Disturbances, Mental Illnesses," HHS, Sept. 28, 2021, available at: https:// www.hhs.gov/about/news/2021/09/28/samhsa-awards-record-setting-825-million-grants-strengthen-community-mental-health- centers.html. [FN44] . For more information about these look-alike facilities, please see " "Federally Qualified Health Center Look-Alike," HRSA, available at: https:/Avww.hrsa.gov/opa/eligibility-and-registration/health-centers/fqhc-look-alikes/index.html. [FN45] . New Release, ""Biden-Harris Administration Provides Nearly $144 Million in American Rescue Plan Funds to Support COVID-19 Response Efforts in Underserved Communities," July 15, 2021, available at: https://www.hhs.gov/about/news/2021/07/1 5/biden- harris-administration-provides-nearly-144-million-american-rescue-plan-funds-support-covid-1 9-response-efforts-underserved- communities.html?utm_source=news-releases-email&utm_medium=email&utm_campaign=july-18-202. [FN46] . New Release, ""Biden-Harris Administration Provides Nearly $144 Million in American Rescue Plan Funds to Support COVID-19 Response Efforts in Underserved Communities," July 15, 2021, available at: https:/Awww.hhs.gov/about/news/2021/07/15/biden- harris-administration-provides-nearly-144-million-american-rescue-plan-funds-support-covid-1 9-response-efforts-underserved- communities.html?utm_source=news-releases-email&utm_medium=email&utm_campaign=july-18-202. [FN47] . Rachana Pradhan and Rachel Bluth, "Community Clinics Shouldered Much of the Vaccine Rollout. Many Haven't Been Paid," Kaiser Health News, Oct. 11, 2021, available at: https://khn.org/news/article/community-clinics-shouldered-much-of-the-vaccine-rollout-many- havent-been-paid/?utm_campaign=KFF-2021-The-Latest&utm. [FN48] . Seema Verma, "Ensuring Safety and Quality in Nursing Homes: Five Part Strategy Deep Dive," CMS Blog, Aug. 28, 2018, available at: https:/Avww.cms.gov/blog/ensuring-safety-and-quality-nursing-homes-five-part-strategy-deep-dive. [FN49] . Priya Chidambaram and Rachel Garfield, "Nursing Homes Experienced Steeper Increase In COVID-19 Cases and Deaths in August 2021 Than the Rest of the Country," Kaiser Family Foundation, Oct. 1, 2021, available at: https:/Awww.kff.org/coronavirus-covid-19/ issue-brief/nursing-homes-experienced-steeper-increase-in-covid-19-cases-and-deaths-in-august-2021 -than-the-rest-of-the-country/? utm. [FN50] . Press Release, "CMS Updates Nursing Home Guidance with Revised Visitation Recommendations," CMS, Mar. 10, 2021, available at: https:/Avww.cms.gov/newsroom/press-releases/cms-updates-nursing-home-guidance-revised-visitation-recommendations. The guidance itself is available from a link on that page. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -36- [FN51] . Fact Sheet, "CMS Updates Nursing Home Guidance with Revised Visitation Recommendations," CMS, Mar. 10, 2021, available at: https:/Avww.cms.gov/newsroom/fact-sheets/cms-updates-nursing-home-guidance-revised-visitation-recommendations. [FN52] . CMS Letter to Governors, Dec. 7, 2020, available at: https:/Awww.cms.gov/files/document/covid-hospital-capacity-governors-letter.pdf. [FN53] . Press Release, "CMS Announces Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge," CMS, Nov. 25, 2020, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-announces-comprehensive-strategy-enhance-hospital-capacity- amid-covid-19-surge. [FN54] . CMS Letter to Govemors, Dec. 7, 2020, available at: https:/Awww.cms.gov/files/document/covid-hospital-capacity-governors-letter.pdf. [FN55] . Press Release, "CMS Announces Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge," CMS, Nov. 25, 2020, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-announces-comprehensive-strategy-enhance-hospital-capacity- amid-covid-19-surge. [FN56] . Erik Neuman, "Overwhelmed with COVID Patients, Oregon Hospitals Postpone Surgeries And Cancer Care," NPR and Kaiser Health News, Sept. 16, 2021, available at: https:/Avww.npr.org/sections/health-shots/2021/09/16/1037621883/overwhelmed-with-covid- patients-oregon-hospitals-postpone-surgeries-and-cancer-c?utm. [FN57] . Erik Neuman, "Overwhelmed with COVID Patients, Oregon Hospitals Postpone Surgeries And Cancer Care," NPR and Kaiser Health News, Sept. 16, 2021, available at: https:/Awww.npr.org/sections/health-shots/202 1/09/16/1037621883/overwhelmed-with-covid- patients-oregon-hospitals-postpone-surgeries-and-cancer-c?utm. [FN53] . Kelli Kennedy and Philip Marcelo, ""''There are only so Many Beds': COVID-19 Surge Hits Hospitals," AP News, Aug. 5, 2021, available at: https://apnews.com/article/joe-biden-health-florida-coronavirus-pandemic-3891 7e4fd073c8142df15de2d8102a24. [FN59] . Jeff Amy, "Georgia Hospitals Swamped by COVID-19 Postpone Surgeries," AP News, Sept. 8, 2021, available at: https:// apnews.com/article/technology-business-health-georgia-coronavirus-pandemic-1fe96 1 77ea72d63f889886747 763ad72. [FN60] . Kelli Kennedy and Philip Marcelo, ""'There are only so Many Beds': COVID-19 Surge Hits Hospitals," AP News, Aug. 5, 2021, available at: https://apnews.com/article/joe-biden-health-florida-coronavirus-pandemic-3891 7e4fd073c8142df15de2d8102a24. [FN61] . Press Release, ""Biden-Harris Administration Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Workers," CMS, Nov. 4, 2021, available at: https://Awww.cms.gov/newsroom/press-releases/biden-harris-administration-issues- emergency-regulation-requiring-covid-19-vaccination-health-care. [FN62] . Press Release, ""Biden-Harris Administration Issues Emergency Regulation Requiring COVID-19 Vaccination for Health Care Workers," CMS, Nov. 4, 2021, available at: https:/Awww.cms.gov/newsroom/press-releases/biden-harris-administration-issues- emergency-regulation-requiring-covid-19-vaccination-health-care. [FN63] . As of this writing, the regulation is unpublished. However, an unofficial version of the regulation is available at: https://public- inspection.federalregister.gov/2021-23831.pdf. [FN64] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -37- . "CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule," CMS, available at: https:/Avww.cms.gov/files/document/ cms-omnibus-staff-vax-requirements-2021 pdf. [FN65] . See, e.g., Azi Paybara and Reed Abelson, A Federal Judge Blocks Biden's Vaccine Mandate for U.S. Health Workers," New York Times, Nov. 30, 2021, available at: https:/Avww.nytimes.com/202 1/1 1/30/world/vaccine-mandate-health-workers-blocked.html. [FN66] . "Partnership for Patients," CMS, available at: https://innovation.cms.gov/innovation-models/partnership-for-patients. [FN67] . For a primer on the program, please see 'Understanding the Hospital-Acquired Condition Reduction Program,' Lake Superior Quality Innovation Network, available at: https:/Avww.stratishealth.org/documents/HAC_fact_sheet.pdf. [FN68] . 'Hospital-Acquired Condition Reduction Program,' CMS, updated July 20, 2017, available at: https:/Avwww.cms.gov/Medicare/Medicare- Fee-for-Service-Payment/AcutelnpatientPPS/HAC-Reduction-Program.html. [FN69] . "Fiscal Year 2022 Fact Sheet Hospital-Acquired Condition (HAC) Reduction Program," CMS, available on this page: https:// qualitynet.cms.gov/inpatient/hac/resources. [FN70] . Jordan Rau, ""Medicare Penalizes Group of 751 Hospitals For Patient Injuries," Kaiser Health News, Dec. 21, 2017, available at: https://khn.org/news/medicare-penalizes-group-of-751 -hospitals-for-patient-injuries/. [FN71] . Jordan Rao, ""Medicare Trims Payments To 800 Hospitals, Citing Patient Safety Incidents," Kaiser Health News, March 1, 2019, available at: https://khn.org/news/medicare-trims-payments-to-800-hospitals-citing-patient-safety-incidents/. [FN72] . "Map: The 786 hospitals facing HAC penalties in 2020," Advisory Board, Feb. 3, 2020, available at: https:/Avww.advisory.com/daily- briefing/2020/02/03/hac-penalties. [FN73] . Jordan Rau, ""Medicare Cuts Payment to 774 Hospitals over Patient Complications," Kaiser Health News, Feb. 19, 2021, available at: https://khn.org/news/article/medicare-cuts-payment-to-774-hospitals-over-patient-complications/. [FN74] . For more information, please the program's web page, available at: https:/Avww.cms.gov/Medicare/Quality-Initiatives-Patient- Assessment-Instruments/Value-Based-Programs/HRRP/Hospital-Readmission-Reduction-Program. [FN75] . Jordan Rao, "Medicare Punishes 2,499 Hospitals for High Readmissions," Kaiser Health News, Oct. 28, 2021, available at: https:// khn.org/news/article/hospital-readmission-rates-medicare-penalties/. This year's penalties are similar to last year's penalties. For last year's results, see Jordan Rao, ""Medicare Fines Half of Hospitals for Readmitting Too Many Patients," Kaiser Health News, Nov. 2, 2020, available at: https://khn.org/news/medicare-fines-half-of-hospitals-for-readmitting-too-many-patients/. [FN76] . Jordan Rao, ""Medicare Fines Half of Hospitals for Readmitting Too Many Patients," Kaiser Health News, Nov. 2, 2020, available at: https://khn.org/news/medicare-fines-half-of-hospitals-for-readmitting-too-many-patients/. [FN77] . Fact Sheet, "Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Rates Final Rule (CMS-1752-F)," CMS, Aug. 2, 2021, available at: https://www.cms.gov/newsroom/fact-sheets/fiscal-year- fy-2022-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-0. [FN78] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -38- . Jordan Rau, 'Under Trump, Hospitals Face Same Penalties Embraced By Obama,' Kaiser Health News, Aug. 3, 2017, available at: http://khn.org/news/under-trump-hospitals-face-same-penalties-embraced-by-obama/? utm_campaign=KFF-2017-The-Latest&utm_medium=email&_hsenc=p2ANqtz-8W3bIMAadjvt7xQoldrM7rDf7lJcgkKsPTn43Xuj- bIXdysYqAiCn1dYOKGRWY 1KX0DsVHU2- T5fZUHQxbA&_hsmi=54983441 &utm_content=54983441&utm_source=hs_email&hsCtaTracking=0502294f-1 5f4-4880- bdb9-997c6964e2c3@635b5198-58a8-46c8-bf1 c-b4f9d4bf7750. [FN79] . "Hospital Readmissions Reduction Program," CMS, available at: https:/Avww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ AcutelnpatientPPS/Readmissions-Reduction-Program. [FN80] . 83 F.R. 41144-01 (Aug. 17, 2018). [FN81] . Jordan Rau, ""Look Up Your Hospital: Is It Being Penalized By Medicare?," Kaiser Health News, Feb. 21, 2021, available at: https:// khn.org/news/hospital-penalties/?penalty=readmission. [FN82] . Press Release, "AHRQ Analysis Finds Hospital-Acquired Conditions Declined By Nearly 1 Million from 2014-2017," Jan. 29, 2019, available at: https:/Awww.ahrq.gov/news/newsroom/press-releases/hac-rates-declined.html. [FN83] - "The Hospital Value Incentive Program: Measuring and Rewarding Meaningful Hospital Quality," The MedPAC Blog, Jan. 31, 2019, available at: http:/Avwww.medpac.gov/-blog-/the-hospital-value-incentive-program/2019/01/30/-measuring-and-rewarding-meaningful- hospital-quality. [FN84] - "HHS not Adhering to Obama Admin's 2018 Value-Based Payment Goals," Advisory Board, Feb. 21, 2018, available at: https:// www.advisory.com/daily-briefing/201 8/02/21 /hhs-medicare-payments. [FN85] . "What are Value-Based Programs?" CMS, updated 1/6/2020, available at: https://Awww.cms.gov/Medicare/Quality-Initiatives-Patient- Assessment-Instruments/Value-Based-Programs/Value-Based-Programs. [FN86] . Press Release, 'CMS Launches New ACO Dialysis Model,' CMS, Oct. 7, 2015, available at: https:/Avww.cms.gov/Newsroom/ MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-10-07.html. [FN87] . Press Release, 'CMS Launches New ACO Dialysis Model,' CMS, Oct. 7, 2015, available at: https:/Avww.cms.gov/Newsroom/ MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-10-07.html. [FN88] . 'Comprehensive ESRD Care Model,' CMS, available at: https://innovation.cms.gov/initiatives/comprehensive-esrd-care/. [FN89] . Email update, "Comprehensive ESRD Care (CEC) Model Beneficiary and Provider RIF Files Now available on ResDAC and CCW," CMS, July 14, 2021. [FNS0] . Press Release, "CMS Announces New Payment Model to Improve Quality, Coordination, and Cost-Effectiveness for Both Inpatient and Outpatient Care," CMS, Jan. 9, 2018, available at: https:/Avww.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018- Press-releases-items/2018-01-09.html. [FN91] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -39- . Press Release, ""CMS Announces New Payment Model to Improve Quality, Coordination, and Cost-Effectiveness for Both Inpatient and Outpatient Care," CMS, Jan. 9, 2018, available at: https:/Avww.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018- Press-releases-items/2018-01-09.html. [FN92] . BPCI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. [FN93] . BPCI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. [FN94] . "Comprehensive Care for Joint Replacement Model," CMS' Innovation Center, available at: https://innovation.cms.gov/innovation- models/cjr. [FN95] . 86 F.R. 23496 (May 3, 2021). [FN96] . Andrew D. Wilcock, et a/., "How Hospitals Respond to Incentives in Bundled Payment Models for Joint Surgery," The Commonwealth Fund, May 18, 2021, available at: https:/Awww.commonwealthfund.org/publications/journal-article/2021/may/hospital-incentives- bundled-payment-joint-surgery?utm_source=alert&utm_medium=email&utm_campaign=DrugC#osts/. [FN97] . Fact Sheet, 'Accountable Care Organizations: What Providers Need to Know, Oct. 20, 2011, available at: http:/Avwww.cms.gov/ Newsroom/MediaReleaseDatabase/Fact-Sheets/201 1-Fact-Sheets-ltems/2011-10-207.html. [FN98] . See, e.g., Dr. Donald Berwick, 'Improving Care for People with Medicare,' Medicare Blog, April 4, 2011, available at: http:// blog.medicare.gov/category/affordable-care-act/. [FN99] . "Shared Savings Program Fast Facts - As of Jan. 1, 2021," CMS, available at: https:/Awww.cms.gov/files/document/2021-shared- savings-program-fast-facts. pdf. [FN100] . ""Next Generation ACO Model," CMS, available at: https://innovation.cms.goviinitiatives/next-generation-aco-model/. [FN101] . "Comprehensive ESRD Model," CMS, available at: https://innovation.cms.goviinitiatives/comprehensive-esrd-care/. [FN102] . "Beneficiary Engagement Toolkit," CMS, Nov. 2019, available at: https://innovation.cms.gov/files/x/aco-beneficiary-engagement- toolkit. pdf. [FN103] . "Care Coordination Toolkit," CMS, Mar. 2019, available at: https://innovation.cms.gov/files/x/aco-carecoordination-toolkit.pdf/. [FN104] . "Provider Engagement Toolkit," CMS, July 2020, available at: https://innovation.cms.gov/media/document/2020-provider- engagement-toolkit. [FN105] . "Care Transformation Toolkit," CMS, Jan. 2021, available at: https://innovation.cms.gov/media/document/aco-caretransformation- toolkit. [FN106] . "Care Transformation Toolkit," CMS, Jan. 2021, available at: https://innovation.cms.gov/media/document/aco-caretransformation- toolkit. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -40- [FN107] . Phil Galewitz, "Medicare to Overhaul ACOs but Critics Fear Less Participation," Kaiser Health News, Aug. 9, 2018, available at: https://khn.org/news/medicare-to-overhaul-acos-but-critics-fear-fewer-participants/; Press Release, ""CMS Proposes ""Pathways to Success," an Overhaul of Medicare's ACO Program," CMS, Aug. 9, 2018, available at: https:/;www.cms.gov/newsroom/press-releases/ cms-proposes-pathways-success-overhaul-medicares-aco-program. [FN108] . "Medicare Shared Savings Program," CMS, available at: https:/Avwww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/about.html. [FN109] . Rajiv Leventhal, ""EXCLUSIVE: Substantial ACO Reforms Could be Forthcoming," Healthcare Informatics, May 9, 2018, available at: https:/Avww.healthcare-informatics.com/article/payment/exclusive-substantial-aco-reforms-could-be-forthcoming; Farzad Mostashari and Travis Broome, ""Medicare Advantage Holds the Key to Reforming the ACO Program," New England Journal of Medicine, March 20, 2018, available at: https://catalyst.nejm.org/medicare-advantage-key-aco-reform/. [FN110] . Fact Sheet, ""New Accountable Care Organization Model Opportunity: Medicare ACO Track 1+ Model," updated July 2017, available at: https:/Avww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/New-Accountable-Care- Organization-Model-Opportunity-Fact-Sheet. pdf. [FN111] . Fact Sheet, 'Advancing Care Coordination through Episode Payment Models (Cardiac and Orthopedic Bundled Payment Models) Final Rule (CMS-5519-F) and Medicare ACO Track 1+ Model,' CMS, Dec. 20, 2016, available at: https:/Avww.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-12-20.html? DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending. [FN112] . Press Release, Tom Nickels, 'Statement on the New Track 1+ Accountable Care Organization Model,' available at: http:// www.aha.org/presscenter/pressrel/2016/162012-pr-track.shtml. [FN113] . Fact Sheet, "Speech: Remarks by CMS Administrator Seema Verma at the American Hospital Association Annual Membership Meeting," CMS, May 7, 2018, available at: https:/Awww.cms.gov/newsroom/fact-sheets/speech-remarks-cms-administrator-seema- verma-american-hospital-association-annual-membership-meeting. [FN114] . 83 F.R. 41786 (Aug. 17, 2018). [FN115] . Phil Galewitz, "Medicare to Overhaul ACOs but Critics Fear Less Participation," Kaiser Health News, Aug. 9, 2018, available at: https://khn.org/news/medicare-to-overhaul-acos-but-critics-fear-fewer-participants/. [FN116] . Rajiv Leventhal, ""EXCLUSIVE: Substantial ACO Reforms Could be Forthcoming," Healthcare Informatics, May 9, 2018, available at: https:/Avww.healthcare-informatics.com/article/payment/exclusive-substantial-aco-reforms-could-be-forthcoming [FN117] . Phil Galewitz, *"Medicare to Overhaul ACOs but Critics Fear Less Participation," Kaiser Health News, Aug. 9, 2018, available at: https://khn.org/news/medicare-to-overhaul-acos-but-critics-fear-fewer-participants/. "Medicare Shared Savings Program," CMS, available at: https:/Awww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/about.html. [FN118] . Fact Sheet, ""Final Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2019," CMS, Nov. 1, 2018, available at: https:/Avww.cms.gov/newsroom/fact-sheets/final-policy-payment-and-quality-provisions- changes-medicare-physician-fee-schedule-calendar-year. [FN119] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -41- . Press Release, ""CMS Finalizes "Pathways to Success,' an Overhaul of Medicare's National ACO Program," CMS, Dec. 21, 2018, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-finalizes-pathways-success-overhaul-medicares-national-aco- program. [FN120] . Press Release, "CMS Finalizes "Pathways to Success,' an Overhaul of Medicare's National ACO Program," CMS, Dec. 21, 2018, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-finalizes-pathways-success-overhaul-medicares-national-aco- program. [FN121] . Fact Sheet, "Final Rule Creates Pathways to Success for the Medicare Shared Savings Program," CMS, Dec. 21, 2018, available at: https:/Avww.cms.gov/newsroom/fact-sheets/final-rule-creates-pathways-success-medicare-shared-savings-program. [FN122] . Fact Sheet, "Final Rule Creates Pathways to Success for the Medicare Shared Savings Program," CMS, Dec. 21, 2018, available at: https:/Avww.cms.gov/newsroom/fact-sheets/final-rule-creates-pathways-success-medicare-shared-savings-program. [FN123] . "Shared Savings Program Participation Options for Performance Year 2022," CMS, Apr. 2021, available at: https://www.cms.gov/ Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/ssp-aco-participation-options. pdf. [FN124] . Seema Verma, ""More ACOs Taking Accountability Under MSSP Through "Pathways To Success'," Health Affairs, July 17, 2019, available at: https:/Awww.healthaffairs.org/do/10.1377/hblog20190717.482997/full/. [FN125] . Tina Reed, "*CMS: ACOs Save Medicare $1.2B under 'Pathways to Success' Program," Health Affairs, Sept. 15, 202, available at: https:/Avww.fiercehealthcare.com/payer/cms-acos-save-medicare-1-2b-under-pathways-to-success-program. [FN126] . Press Release, ""Affordable Care Act's Shared Savings Program Continues to Improve Quality of Care While Saving Medicare Money During the COVID-19 Pandemic," CMS, Aug. 25, 2021, available at: https:/Avwww.cms.gov/newsroom/press-releases/affordable-care- acts-shared-savings-program-continues-improve-quality-care-while-saving-medicare. [FN127] . Shared Savings Program, CMS, updated June 2021, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/about. [FN128] . The rule is published at 86 F.R. 64996-01 (Nov. 19, 2021). The Fact Sheet is: "Calendar Year (CY) 2022 Medicare Physician Fee Schedule Final Rule," CMS, Nov. 2, 2021, available at: https:/Awww.cms.gov/newsroom/fact-sheets/calendar-year-cy-2022-medicare- physician-fee-schedule-final-rule. [FN129] . 'Next Generation ACO Model,' CMS web site, available at: http://innovation.cms.gov/initiatives/Next-Generation-ACO-Model/. [FN130] . News Release, 'Affordable Care Act Initiative Builds on Success of ACOs,' HHS web site, March 10, 2015, available at: http:// wayback.archive-it.org/3926/20170127185549/https:/Avww.hhs.gov/about/news/2015/03/10/affordable-care-act-initiative-builds-on- success-of-acos.html. [FN131] . ""Next Generation ACO Model," CMS, available at: https://innovation.cms.gov/innovation-models/next-generation-aco-model. [FN132] . CMS Rural Health Strategy, CMS, 2018, available at: https:/Avww.cms.gov/About-CMS/Agency-Information'/OMH/Downloads/Rural- Strategy-2018.pdf. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -42- [FN133] . CMS Rural Health Strategy, CMS, 2018, available at: https:/Avww.cms.gov/About-CMS/Agency-Information'/OMH/Downloads/Rural- Strategy-2018.pdf. [FN134] . "Improving Health in Rural Communities Fiscal Year 2021 in Review," CMS, available at: https:/Avww.cms.gov/files/document/ffy-21 - improving-health-rural-communities508compliant. pdf. [FN135] . News Release, ""HHS Releases Rural Action Plan," HHS, Sept. 3, 2020, available at: https:/Avww.hhs.gov/about/news/2020/09/03/ hhs-releases-rural-action-plan.html?utm_source=news-releases-email&utm_medium=email&utm_campaign=september-06-2020. [FN136] . Shawn Radcliffe, *"Rural Hospitals Closing at an Alarming Rate," Healthline, Feb. 15, 2017, available at:https:/Awww.healthline.com/ health-news/rural-hospitals-closing#1. [FN137] . Ayla Ellison, "The Rural Hospital Closure Crisis: 9 Things to Know," Becker's Hospital Review, Nov. 1, 2018, available at: https:// www.beckershospitalreview.com/finance/the-rural-hospital-closure-crisis-9-things-to-know-1 101 18.html. [FN138] . Ayla Ellison, ""Why Rural Hospital Closures Hit a Record High in 2020," Becker's Hospital Review, Mar. 16, 2021, available at: https:// www.beckershospitalreview.com/finance/why-rural-hospital-closures-hit-a-record-high-in-2020.html. [FN139] . Charlotte Huff, "After Bitter Closure, Rural Texas Hospital Defies The Norm And Reopens," Kaiser Health News, Jan. 7, 2019, available at: https://khn.org/news/after-bitter-closure-rural-texas-hospital-defies-the-norm-and-reopens/?utm_campaign=KHN#T#opic- based&utm_source=hs_email&utm_medium=email&utm_content=690924968&_hsenc=p2ANatz-9tsv7t9Gth4 T 2860-hnjgN2k4pR-fzM- VQ3jjHGb83-D9uu3-PTuXpIBIGaK79_3NjoVil20Kiwi8mcN9akFIQE 1tBUw&_hsmi=69092496. [FN140] . Corrine Lewis, ef a/., "The Rural Maternity Care Crisis," Commonwealth Fund, Aug. 15, 2019, available at: https:// www.commonwealthfund.org/blog/201 9/rural-maternity-care-crisis. [FN141] . Corrine Lewis, et al., ""The Rural Maternity Care Crisis," Commonwealth Fund, Aug. 15, 2019, available at: https:// www.commonwealthfund.org/blog/201 9/rural-maternity-care-crisis. [FN142] . News Release, "HHS Awards $9 Million to Develop New Models to Improve Obstetrics Care in Rural Communities," HHS, Sept. 10, 2019, available at: https://www.hhs.gov/about/news/201 9/09/10/hhs-awards-9-million-new-models-obstetrics-care-rural- communities.html. [FN143] . "Rural Maternity and Obstetrics Management Strategies (RMOMS) Program," HRSA, available at: https:/Avww.hrsa.gov/rural-health/ community/rmoms. [FN144] . Press Release, ""Trump Administration Announces Initiative to Transform Rural Health," CMS, Aug. 11, 2020, available at: https:// www.cms.gov/newsroom/press-releases/trump-administration-announces-initiative-transform-rural-health. [FN145] . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN146] . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN147] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -43- . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN148] . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN149] . "Chart Model," Innovation Center web site, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN150} . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN151] . News Release, '*HHS Provides $398 Million to Small Rural Hospitals for COVID-19 Testing and Mitigation," HHS, July 13, 2021, available at: https:/Awww.hhs.gov/about/news/2021/07/13/hhs-provides-398-million-to-small-rural-hospitals-for-covid-testing.html? utm_source=news-releases-email&utm_medium=email&utm_campaign=july-18-2021. [FN152] . Stephanie Oum, et a/., "*The U.S. Response to Coronavirus: Summary of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020," Kaiser Family Foundation, Mar. 11, 2020, available at: https:/Avww.kff.org/global-health-policy/issue-brief/ the-u-s-response-to-coronavirus-summary-of-the-coronavirus-preparedness-and-response-supplemental-appropriations-act-2020/. [FN153] . Kellie Moss, ef al.,"' The Families First Coronavirus Response Act: Summary of Key Provisions," Kaiser Family Foundation, Mar. 23, 2020, available at: https:/Awww.kff.org/coronavirus-covid-19/issue-brief/the-families-first-coronavirus-response-act-summary-of-key- provisions/. [FN154] . "Families First Coronavirus Response Act - Increased FMAP FAQs," available at: https://Awww.medicaid.gov/state-resource-center/ downloads/covid-19-section-6008-faqs.pdf. [FN155] . "Families First Coronavirus Response Act - Increased FMAP FAQs," available at: https://www.medicaid.gov/state-resource-center/ downloads/covid-19-section-6008-faqs. pdf. [FN156] . The Telehealth Network Grant Program, which is administered by the Health Resources and Services Administration, awards grants for demonstrations that use telehealth networks to improve access to care in underserved communities in rural, urban, and frontier settings. See *"Telehealth Programs,' HRSA, available at: https:/Avww.hrsa.gov/rural-health/telehealth. [FN157] . Kellie Moss, et al., "The Coronavirus Aid, Relief, and Economic Security Act: Summary of Key Health Provisions," Kaiser Family Foundation, Apr. 9, 2020, available at: https:/Avww.kff.org/global-health-policy/issue-brief/the-coronavirus-aid-relief-and-economic- security-act-summary-of-key-health-provisions/. The act is available on Westlaw at 2019 Cong US HR 748 (2019 FD H.B. 748 (NS)). [FN158] . P.L. 116-139. [FN159] . Kellie Moss, ""The Paycheck Protection Program and Health Care Enhancement Act: Summary of Key Health Provisions," Kaiser Family Foundation, May 1, 2020, available at: https:/Awww.kff.org/global-health-policy/issue-brief/the-paycheck-protection-program-and- health-care-enhancement-act-summary-of-key-health-provisions/?utm. [FN160] . AMAC is a private health care insurer that is under contract to processes certain Medicare claims in a specific geographic jurisdiction. These claims include Medicare Part A and Part B (A/B) or Durable Medical Equipment claims for Medicare Fee-For-Service participants. See "What is a MAC, CMS, available at: https:/Awww.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative- Contractors/What-is-a-MAC. THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -44- [FN161] . "New Waivers for Inpatient Prospective Payment System (IPPS) Hospitals, Long-Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) due to Provisions of the CARES Act," Medicare Learning Network, Apr. 15, 2020, available at: https:// www.cms.gov/files/document/se20015. pdf. [FN162] . ""New and Expanded Flexibilities for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) During the COVID-19 Public Health Emergency (PHE)," Medicare Learning Network, Apr. 17, 2020, available at: https://www.cms.gov/files/ document/se20016.pdf. [FN163] . P.L. 117-2. [FN164] . "Summary of American Rescue Plan Act of 2021 and Provisions Affecting Hospitals and Health Systems," American Hospital Association, Mar. 17, 2021, available at: https://www.aha.org/advisory/2021-03-17-summary-american-rescue-plan-act-2021-and- provisions-affecting-hospitals-and. [FN165] . CMCS Informational Bulletin, "Medicaid, Children's Health Insurance Program (CHIP), and Basic Health Program (BHP) Related Provisions in the American Rescue Plan Act of 2021," CMS, June 3, 2021, available at: https:/Avww.medicaid.gov/federal-policy- guidance/downloads/cib060321.pdf. [FN166] . Medicare Care Choices Model, CMS, available at: https://innovation.cms.gov/innovation-models/medicare-care-choices. [FN167] . Press Release, ""Schakowsky, Takano Introduce Bill to Protect Nursing Home Resident and Staff During COVID-19 Pandemic," web site of Rep. Schakowsky, Jan. 28, 2021, available at: https://schakowsky.house.gov/media/press-releases/schakowsky-takano- introduce-bill-protect-nursing-home-resident-and-staff-during. [FN168] . Press Release, "Bowman, Warren Introduce Care for All Agenda to Expand and Revitalize the Care Economy," web site of Rep. Bowman, Mar. 1, 2021, available at: https://oowman.house.gov/press-releases?|D=6F768584-ED84-4209-A7CF-5CC724DC771F. [FN169] . Press Release, "Bennet, Colleagues Introduce Bicameral Legislation to Expand Medicaid Coverage for COVID-19 Treatment, Vaccines," web site of Sen. Bennet, Feb. 8, 2021, available at: https://www.bennet.senate.gov/public/index.cfm/2021/2/bennet- colleagues-introduce-bicameral-legislation-to-expand-medicaid-coverage-for-covid-1 9-treatment-vaccines. [FN170] .""COVID-19 Accelerated and Advance Payments," CMS, available at: https:/Avww.cms.gov/medicare/covid-1 9-accelerated-and- advance-payments#:? :text=Acceleratedandadvancep#aymentsare,submissionand®orc#laimsp#rocessing. [FN171] .""COVID-19 Accelerated and Advance Payments," CMS, available at: https:/Avww.cms.gov/medicare/covid-1 9-accelerated-and- advance-payments#:? :text=Acceleratedandadvancep#aymentsare,submissionand®orc#laimsp#rocessing. [FN172] . "Repayment of COVID-19 Accelerated and Advance Payments Began on March 30, 2021," CMS and Medicare Learning Network, Apr. 1, 2021, available at: https:/Avww.cms.gov/files/document/se2 1004. pdf. [FN173] . FAQ, "Hospice Benefit Component of the Value-Based Insurance Design Model," CMS, updated Mar. 30, 2021, available at: https:// innovation.cms.gov/media/document/vbid-hospice-2021-faqs. [FN174] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -45- .""VBID Model Hospice Benefit Component Overview," CMS, available at: https://innovation.cms.gov/innovation-models/vbid-hospice- benefit-overview. [FN175] . Press Release, ""Senator Fischer Reintroduces Telehealth Legislation," Senator Fischer's web site, Mar. 9, 2021, available at: https:// www.fischer.senate.gov/public/index.cfm/news?|D=37E247B4-C1 17-4EB1-91DA-AC3F400DF20F. [FN176] . 86 F.R. 23496 (May 3, 2021). [FN177] . 86 F.R. 23496 (May 3, 2021) (footnotes omitted). [FN178] . Press Release, "Braun Reintroduces Healthcare Transparency Bills," Sen. Braun's web site, Apr. 29, 2021, available at: https:// www.braun.senate.gov/braun-reintroduces-healthcare-transparency-bills. [FN179] . Press Release, ""Rubio Reintroduces Bill to Modernize Medicaid DSH, Help Hospitals Providing Care to Low-Income Patients," Sen. Rubio's web site, June 11, 2021, available at: https://www.rubio.senate.gov/public/index.cfm/press-releases? ID=97766731-179C-44AC-8ED4-07075F88DCC7. [FN180] . For more information on federal Medicaid funding for the territories, please see Fact Sheet, "Medicaid and CHIP in the Territories," MACPAC, Feb. 2021, available at: https:/Awww.macpac.gov/wp-content/uploads/201 9/07/Medicaid-and- CHIP-in-the-Territories.pdf; "Federal Medical Assistance Percentage (FMAP) for Medicaid and Multiplier," Kaiser Family Foundation, Fiscal Year 2022, available at: https://Awww.kff.org/medicaid/state-indicator/federal-matching-rate-and-multiplier/? currentTimeframe=0&sortModel=#c#olld:#L#ocation,#s#ort:#asc'#. [FN181] . Press Release, ""Plaskett Introduces Legislation to Improve Medicaid and Medicare in U.S. Territories," web site of Rep. Plaskett, May 15, 2021, available at: https://plaskett.house.gov/news/documentsingle.aspx?DocumentID=188. [FN182] . News Release, ""HHS Announces Rule to Protect Consumers from Surprise Medical Bills," HHS, July 1, 2021, available at: https:// www.hhs.gov/about/news/2021/07/01/hhs-announces-rule-to-protect-consumers-from-surprise-medical-bills.html?utm_source=news- releases-email&utm_medium=email&utm_campaign=july-4-2021. [FN183] . News Release, ""HHS Announces Rule to Protect Consumers from Surprise Medical Bills," HHS, July 1, 2021, available at: https:// www.hhs.gov/about/news/2021/07/01/hhs-announces-rule-to-protect-consumers-from-surprise-medical-bills.html?utm_source=news- releases-email&utm_medium=email&utm_campaign=july-4-2021. [FN184] . News Release, ""HHS Announces Rule to Protect Consumers from Surprise Medical Bills," HHS, July 1, 2021, available at: https:// www.hhs.gov/about/news/2021/07/01/hhs-announces-rule-to-protect-consumers-from-surprise-medical-bills.html?utm_source=news- releases-email&utm_medium=email&utm_campaign=july-4-2021. [FN185] . Fact Sheet, ""What You Need to Know about the Biden-Harris Administration's Actions to Prevent Surprise Billing," CMS, July 1, 2021, available at: https:/Awww.cms.gov/newsroom/fact-sheets/what-you-need-know-about-biden-harris-administrations-actions-prevent- surprise-billing; Fact Sheet, "Requirements Related to Surprise Billing; Part | Interim Final Rule with Comment Period," CMS, July 1, 2021, available at: https:/Avwww.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing-part-i-interim-final-rule-comment- period. [FN186] . Fact Sheet, "Air Ambulance NPRM -- Fact Sheet," CMS, Sept. 10, 2021, available at: https:/Avww.cms.gov/newsroom/fact-sheets/air- ambulance-nprm-fact-sheet. The proposed rule is published at 86 F.R. 51730 (Sept. 16, 2021). THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -46- [FN187] . Press Release, ""Biden-Harris Administration Advances Key Protections Against Surprise Medical Bills, Giving Peace of Mind to Millions of Consumers Plagued by High Costs," CMS, Sept. 30, 2021, available at: https:/Awww.cms.gov/newsroom/press-releases/ biden-harris-administration-advances-key-protections-against-surprise-medical-bills-giving-peace. [FN188] . Press Release, "Durbin, Capito, Colleagues Introduce Bipartisan Legislation to Address Childhood Trauma," Sen. Durbin's web site, June 16, 2021, available at: https:/Avww.durbin.senate.gov/newsroom/press-releases/durbin-capito-colleagues-introduce-bipartisan- legislation-to-address-childhood-trauma. [FN189] . Press Release, "Durbin, Capito, Colleagues Introduce Bipartisan Legislation to Address Childhood Trauma," Sen. Durbin's web site, June 16, 2021, available at: https:/Avww.durbin.senate.gov/newsroom/press-releases/durbin-capito-colleagues-introduce-bipartisan- legislation-to-address-childhood-trauma. [FN190] . Press Release, ""Cardin, Thune, Kuster, Smith Reintroduce Legislation to Increase Telehealth Services in Nursing Facilities," web site of Sen. Cardin, July 30, 2021, available at: https:/Avww.cardin.senate.gov/newsroom/press/release/cardin-thune-kuster-smith- reintroduce-legislation-to-increase-telehealth-services-in-nursing-facilities. [FN194] - "The Nursing Home Improvement and Accountability Act of 2021," Senate Finance Committee, available at: https:// www. finance.senate.gov/imo/media/doc/Nursing#omeimprovementandAccountabilityA_One-Pager_Final.pdf. [FN192] . Fact Sheet, "Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Rates Final Rule (CMS-1752-F)," CMS, Aug. 2, 2021, available at: https://www.cms.gov/newsroom/fact-sheets/fiscal-year- fy-2022-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-0. [FN193] . Press Release, "Wyden, Casey Unveil Comprehensive Bill to Improve Nursing Homes for Residents and Workers," Senate Finance Committee, Aug. 10, 2021, available at: https:/Avww.finance.senate.gov/chairmans-news/wyden-casey-unveil-comprehensive-bill-to- improve-nursing-homes-for-residents-and-workers. [FN194] . 86 F.R. 36872 (July 13, 2021). [FN195] . Fact Sheet, "Air Ambulance NPRM -- Fact Sheet," CMS, Sept. 10, 2021, available at: https:/Avww.cms.gov/newsroom/fact-sheets/air- ambulance-nprm-fact-sheet. The proposed rule is published at 86 F.R. 51730 (Sept. 16, 2021). [FN196] . Press Release, ""Biden-Harris Administration Advances Key Protections Against Surprise Medical Bills, Giving Peace of Mind to Millions of Consumers Plagued by High Costs," CMS, Sept. 30, 2021, available at: https:/Avww.cms.gov/newsroom/press-releases/ biden-harris-administration-advances-key-protections-against-surprise-medical-bills-giving-peace. [FN197] . Press Release, "Congresswoman Diana Harshbarger Introduces Bill to Prohibit the Federal Government from Requiring COVID-19 Vaccines," web site of Rep. Harshbarger, Oct. 1, 2021, available at: https://narshbarger.house.gov/media/press-releases/ congresswoman-diana-harshbarger-introduces-bill-prohibit-federal-government. [FN198] . News Release, "HHS Announces the Availability of $25.5 Billion in COVID-19 Provider Funding," HHS, Sept. 10, 2021, available at: https:/Avww.hhs.gov/about/news/2021/09/10/hhs-announces-the-availability-of-25-point-5-billion-in-covid-19-provider-funding.html?utm. [FN199] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -47- . News Release, "HHS Announces the Availability of $25.5 Billion in COVID-19 Provider Funding," HHS, Sept. 10, 2021, available at: https:/Avww.hhs.gov/about/news/2021/09/10/hhs-announces-the-availability-of-25-point-5-billion-in-covid-19-provider-funding.html? utm_source=news-releases-email&utm. [FN200] . News Release, '*HHS Announces the Availability of $25.5 Billion in COVID-19 Provider Funding," HHS, Sept. 10, 2021, available at: https:/Avww.hhs.gov/about/news/2021/09/10/hhs-announces-the-availability-of-25-point-5-billion-in-covid-19-provider-funding.html? utm_source=news-releases-email&utm. [FN201] . News Release, "HHS Announces the Availability of $25.5 Billion in COVID-19 Provider Funding," HHS, Sept. 10, 2021, available at: https:/Avww.hhs.gov/about/news/2021/09/10/hhs-announces-the-availability-of-25-point-5-billion-in-covid-19-provider-funding.html? utm_source=news-releases-email&utm. [FN202] . The rule is published at 86 F.R. 63458-01 (Nov. 16, 2021). The Fact Sheet is: "*CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule," CMS, Nov. 2, 2021, available at: https:/Awww.cms.gov/ newsroom/fact-sheets/cy-2022-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0. [FN203] . The rule is published at 86 F.R. 64996-01 (Nov. 19, 2021). The Fact Sheet is: "Calendar Year (CY) 2022 Medicare Physician Fee Schedule Final Rule," CMS, Nov. 2, 2021, available at: https:/Awww.cms.gov/newsroom/fact-sheets/calendar-year-cy-2022-medicare- physician-fee-schedule-final-rule. [FN204] . Fact Sheet, "CY 2022 End Stage Renal Disease Prospective Payment System Final Rule (CMS-1749-F)," CMS, Oct. 29, 2021, available at: https://(www.cms.gov/newsroom/fact-sheets/cy-2022-end-stage-renal-disease-prospective-payment-system-final-rule- cms-1749-f. [FN205] . Press Release, "CMS Proposes Changes to Reduce Health Care Disparities Among Patients with Chronic Kidney Disease and End-Stage Renal Disease," CMS, July 1, 2021, available at: https:/Avww.cms.gov/newsroom/press-releases/cms-proposes-changes- reduce-health-care-disparities-among-patients-chronic-kidney-disease-and-end. The proposed rule is published at 86 F.R. 36322 (July 9, 2021). [FN206] . Governor Newsom's veto message for Assembly Bill 226, available at: https:/Avww.gov.ca.gov/wp-content/uploads/2021/10/ AB-226-1082021 pdf. [FN207] . For more information about Medicaid coverage for individuals covered by the Compact of Freely Associated States, please see ""FAQ: What Does COFA Medicaid Restoration Mean?" Asian and Pacific Islander American Health Forum, https:/Awww.apiahf.org/resource/ fagq-what-does-cofa-medicaid-restoration-mean/. [FN208] . 84 F.R. 65524-01 (Nov. 27, 2019). [FN209] . Press Release, "CMS Announces New Medicaid Demonstration Opportunity to Expand Mental Health Treatment Services," CMS, Nov. 13, 2018, available at: https:/Avwww.cms.gov/newsroom/press-releases/cms-announces-new-medicaid-demonstration-opportunity- expand-mental-health-treatment-services. [FN210] . "Vermont All-Payer ACO Model," CMS, available at: https://innovation.cms.gov/innovation-models/vermont-all-payer-aco-model. [FN211] THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -48- . "Status of State Action on the Medicaid Expansion Decision," updated July 9, 2021, available at: https:// www.kff.org/health-reform/state-indicator/state-activity-around-expanding-medicaid-under-the-affordable-care-act/? currentTimeframe=0&sortModel=#c#olld:#L#ocation,#s#ort:#asc'#. [FN212] . Cindy Mann and Gayle E. Hauser, "*COVID-19 Relief Needed to Keep Medicaid Community-Based Providers Afloat," Commonwealth Fund, Oct. 5, 2020, available at: https:/Awww.commonwealthfund.org/blog/2020/covid-19-relief-needed-keep-medicaid-community- based-providers-afloat?utm_source=alert&utm_medium=email&utm_campaign=Medicaid. [FN213] . Letter to State Survey Agency Directors, "Guidance for Processing Attestation Statements from Ambulatory Surgical Centers (ASCs) Temporarily Enrolling as Hospitals during the COVID-19 Public Health Emergency," Ref: QSO-20-24-ASC, updated Nov. 25, 2020, available at: https:/Awww.cms.gov/files/document/qso-20-24-asc-revised.pdf. [FN214] . "Acute Hospital Care at Home Individual Waiver Only (not a blanket waiver)," CMS, available at: https://qualitynet.cms.gov/acute- hospital-care-at-home; "Frequently Asked Questions," CMS, available at: https:/Awww.cms.gov/files/document/covid-acute-hospital- care-home-faqs.pdf. [FN215] - "Toolkit on State Actions to Mitigate COVID-19 Prevalence in Nursing Homes," CMS, May 2020, available at: https:/Awww.cms.gov/ files/document/covid-toolkit-states-mitigate-covid-19-nursing-homes.pdf. [FN216] - "The Medicare Promoting Interoperability Program vs. MIPS Promoting Interoperability Performance Category," CMS, available at: https:/Awww.cms.gov/files/document/infographic-pi-program-vs-mips-pi-perf-category.padf. [FN217] . Keiran Gallagher, e¢ a/., "Early 2021 Data Show no Rebound in Health Care Utilization," Peterson-KFF, Aug. 17, 2021, available at: https:/Avww.healthsystemtracker.org/brief/early-2021-data-show-no-rebound-in-health-care-utilization. Produced by Thomson Reuters Accelus Regulatory Intelligence 24-Jan-2022 THOMSON REUTERS © 2022 Thomson Reuters. No claim to original U.S. Government Works. -49-