REGULATORY INTELLIGENCE YEAR-END REPORT - 2022 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. 12/19/2022 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 that 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. According to the Kaiser Family Foundation, while charity care represented just 1.4% or less of operating expenses at half of all hospitals in 2020, the figure varied widely among hospitals. For 9% of hospitals, charity care represented 7% of operating expenses. IFN4] Wedicare and Medicaid underpayments occur when the hospital receives payment that is less than the full value of the services they provided. In February 2022, the AHA released data on Medicare and Medicaid underpayments. The data show that, in 2020, Medicare underpaid hospitals by $75.6 billion and Medicaid underpaid by $24.8 billion. The combined amount of Medicare and Medicaid underpayment is up significantly from 2019: In 2019, the combined figure was $75.8 billion, and in 2020, it was more than $100 billion. !FN® Il. MEDICAID PAYMENTS TO HEALTH FACILITIES In October 2022, the Kaiser Family Foundation published its annual state Medicaid budget survey, this one for the 2022 and 2023 fiscal years. As of September 2022, 49 states (including the District of Columbia), responded to the survey, but not all states responded fully to all questions. This year's survey highlighted how the pandemic affected state health policy. Hospitals participating in the Medicaid program are deeply affected by state budget policies and priorities. The authors of the study note that states have fairly broad discretion in setting fee-for-service provider payments and fees, within limits. IFNE] State budget shortfalls are often reflected in provider payments. To some extent, however, Congress and the administration acted to ameliorate the financial strain on hospitals and other providers during the pandemic. For example, the Coronavirus Aid, Relief, and Economic Security (CARES) Act" (Pub. L. 116-136) established the Provider Relief Fund, and the Families First Coronavirus Response Act (Pub. L. 116-127) increased state FMAPs IFN7] for the duration of the public health emergency for states that adhered to maintenance-of-effort requirements. According to the survey, in fiscal years 2022 and 2023 more states implemented or planned to implement rate increases than those that decreased or planned to decrease rates: For fiscal year 2022, all of the responding states (49) increased rates in at least one provider category, and all but one responding state planned to do so for 2023. With regard to health facilities specifically: * Thirty-one states in 2022 and 26 states in 2023 increased inpatient hospital payments. ¢ Forty-four states in fiscal year 2022 and 41 in fiscal year 2023 increased nursing facility payments. [FN8] * Twenty-eight states in fiscal year 2022 and 26 states in 2023 increased outpatient hospital payments. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Additionally, while most states have provider taxes in place, few have plans to increase them: The most common Medicaid provider taxes in place in FY 2022 were taxes on nursing facilities (46 states), followed by taxes on hospitals (44 states), intermediate care facilities for individuals with intellectual disabilities (33 states), and MCOs7 (18 states). Only three states reported plans to add new taxes in FY 2023: Alabama, Mississippi, and Wyoming reported new ambulance taxes. [FNS] Please see the report for further details. The Office of the Actuary in the Centers for Medicare and Medicaid Services (CMS) released its annual projection of national health care expenditures and enrollment, this one for the period 2021-2030. According to the report, while health care expenditures soared during the pandemic, they have now started to slow. CMS explained in a press release, The report notably shows that despite the increased demand for patient care in 2021, the growth in national health spending is estimated to have slowed to 4.2%, from 9.7% in 2020, as supplemental funding for public health activity and other federal programs, specifically those associated with the COVID-19 pandemic, declined significantly. IFN10] Going forward, health care expenditures are expected to grow an average of 5.1% annually from now until 2030, the same rate as the projected rise in the Gross Domestic Product. Supplemental federal funding in response to the pandemic is expected to decrease in the next three years, bringing the federal share of health care spending down from an all-time high of 51% in 2020 to 46% in 2024. IFN11] Hospital expenditures are expected to follow the same general trends, as federal pandemic-related supplemental payments decrease. However, as the pandemic wanes, utilization is expected to rise, resulting in an acceleration in spending in 2022 before it normalizes: Hospital spending growth is projected to average 5.7% for 2021-2030. In 2021, hospital spending growth is expected to be 5.7%, a deceleration from 6.4% in 2020, largely due to declining federal supplemental payments. However, growth in hospital spending for Medicare, Medicaid, and private health insurance are expected to have grown faster compared to 2020 due to a partial rebound in utilization. Demand for care is expected to remain elevated in 2022, along with a projected acceleration in price growth; as a result, hospital spending growth is likewise expected to accelerate to 6.9% in 2022. Over 2023 and 2024, growth is expected to normalize (5.6% per year) and transition away from pandemic-related impacts on utilization, federal program funding, and changes in insurance enrollment, and remain similar on average through 2030 (5.5% per year). [FN12] A link to the report is available in CMS' press release. 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, 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. [FN13} 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. [FN14] 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. [FN15] Because the state has such a high uninsured rate, [FN'16] hospitals suffer significant uncompensated care costs. The Houston Chronicle writes that the state has relied on waivers THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. as a "cheaper" alternative to expanding Medicaid. IFN17] 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. [FN18] 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. [FN19] 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. "N° Ill. ISSUES AFFECTING SPECIFIC FACILITIES « 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, [FN21] 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. [FN22] 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. IFN23} In 2021, 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." [FN24] 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. [FN25] In 2022, HHS announced that it awarded nearly $55 million to community health centers to increase virtual access to care, including telehealth, remote patient monitoring, digital patient tools, and health IT platforms. The awards went to 29 health centers funded by the Health Resources and Services Administration (HRSA). For these health centers, telehealth was a silver bullet for delivering care during the pandemic. An HHS news release cites the dramatic statistics: In response to the COVID-19 pandemic, health centers have quickly expanded their use of virtual care to maintain access to essential primary care services. They reported significant growth in the number of virtual visits from 478,333 in 2019 to 28,550,608 in 2020, a remarkable 6,000 percent increase. In total, the number of health centers offering virtual visits grew from 592 in 2019 to 1,362 in 2022, an increase of 130 percent. These new awards will enable health centers to sustain an expanded level of virtual care and identify and implement new digital strategies. IFN26] The roughly 1,400 HRSA-funded community health centers in this country are workhorses in the care delivery system for underserved communities. As HHS explained, these centers, serve as a national source of primary care for our at-risk communities. They are community-based and patient-directed organizations that deliver affordable, accessible, and high-quality medical, dental, and behavioral health services to nearly 29 million patients each year. As of late January, overall health centers have delivered over 19.2 million vaccine doses, with 68 percent going to racial or ethnic minority patients. More than 90 percent of health center patients are individuals or families living at or below 200 percent of the Federal Poverty Guidelines (about $55,000 per year for a family of four in most states) and approximately 62 percent are racial/ethnic minorities. N27] Later in 2022, HHS, through its Health Resources and Services Administration (HRSA), announced that it awarded nearly $90 million to the nation's 1,400 health centers to help them further health equity through improved data collection and reporting. The funds are provided through the American Rescue Plan, and they are focused, in part, on ensuring an equitable response to the COVID-19 pandemic. In a press release, HHS explained what it hopes to achieve in awarding these funds: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Funding supports a data modernization effort aimed at better identifying and responding to the specific needs of patients and communities through improved data quality; advancing COVID-19 response, mitigation, and recovery efforts; and helping prepare for future public health emergencies. HRSA's initiative is designed to enable health centers to have better data on both patient health status and social determinants of health. With better information, programs can tailor their efforts to improve health outcomes and advance health equity by more precisely targeting the needs of specific communities or patients, particularly as part of the public health emergency response. [FN26] 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. [FN29] 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. [FN3O] 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." IFN31] 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. [FN32] 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. [FN33] 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. [FN34] 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. [FNS] jp, 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." IFN36] 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 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. 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. [FN38] Community health centers are also playing an important role during the pandemic in meeting social needs and providing supportive services, according to a new brief from the Kaiser Family Foundation. The foundation conducted a survey examining how the pandemic has affected community health centers and their patients. The foundation's new brief discusses those findings, and it offers some thoughts about challenges that the centers and their patients continue to experience. Notably, the centers have been called upon during the pandemic to deliver a host of social supports: 71% of centers reported offering health literacy services, 63% reported offering on- site transportation services, and more than 40% reported offering food-related support services. [FNS9] The survey also found that community health centers delivered more services through telehealth; at its peak, about 50% of visits were conducted through telehealth. Telehealth visits have now decreased substantially, by they are still higher than pre-pandemic days. Despite the increase in the use of telehealth, the centers faced challenges in delivering these services. Ninety-seven percent of centers reported that one of their biggest challenges is that their patients did not have internet access, for example. Additionally, about 70% of community health centers reported inadequate reimbursement for certain telehealth modalities. And while government policies during the pandemic have allowed health centers to increase their use of telehealth, these incentives could end when the public health emergency ends, causing a decrease in this delivery method. [FN40] Other findings include these: (1) due to the increased demand for mental health and substance use disorder services, community health centers reporting adding new services to try to meet the demand; and (2) more community health centers used Medication- Assisted Therapy to treat substance use disorders during pandemic. [FN41] The foundation also reported on challenges that community health centers may experience in the future. These centers continue to be beset by financial challenges and problems recruiting and retaining staff, and these problems were made worse by the pandemic. Also, when the public health emergency ends, the facilities will lose the benefit of the increased federal medical assistance percentage (FMAP) that the government offered in exchange for complying with certain maintenance-of-effort requirements, like continuous Medicaid enrollment. N42! Nearly one-half of all community health center patients are insured by Medicaid. [FN43] Blease see the Issue Brief for a fuller discussion of all of these matters. Finally, HHS announced that it will award $90 million in American Rescue Plan funds to support data-driven efforts that will enable HRSA "Nl health centers and look-alikes to identify and reduce health disparities. [FN45] « Long-Term Care Facilities In his State of the Union Address, President Joseph Biden (D) expressed concern with the quality of care in nursing homes as more are being bought by private equity firms. Biden said, Folks and as Wall Street firms take over more nursing homes, quality in those homes has gone down and costs have gone up. That ends on my watch. Medicare is going to set higher standards for nursing homes and make sure your loved ones get the care they deserve and that they expect, and they will look at that closely. IFN46] A day earlier, the White House released a Fact Sheet detailing the President's plan to improve care in the nation's Medicare- and Medicaid-certified nursing homes. In it, the President expressed concern about the number of people who died in nursing homes during the pandemic - roughly 200,000 residents and staff, or about one-quarter of all the COVID deaths in the country. He also cited studies indicating that the quality of care in nursing homes owned by private equity firms were worse than in other facilities not owned by private equity firms, including higher rates of preventable emergency department visits and preventable hospitalizations, increased mortality, increased use of antipsychotic medications, lower staffing, higher infections, and increased Medicare costs, for example. IFN47] +4 combat these problems, the President laid out a list of reforms on which his administration will focus: ¢ Ensuring Taxpayer Dollars Support Nursing Homes That Provide Safe, Adequate, and Dignified Care ¢ Enhancing Accountability and Oversight ¢ Increasing Transparency * Creating Pathways to Good-paying Jobs with the Free and Fair Choice to Join a Union ¢ Ensuring Pandemic and Emergency Preparedness in Nursing Homes [FN48] Please see the Fact Sheet for more details about each of these reforms. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Then in October 2022, to further the administration's commitment to improving nursing home care, the administration announced an overhaul of the Special Focus Facility Program, an improvement program for poorly-performing facilities, by strengthening requirements to complete the program, increasing enforcement actions, and possibly terminating federal funding for the worst performing facilities. A press release sums up the changes to the program: ¢ Making requirements tougher: CMS is strengthening the criteria for successful completion of the SFF Program by adding a threshold that prevents a facility from exiting based on the total number of deficiencies cited-no more " "graduating" from the program's enhanced scrutiny without demonstrating systemic improvements in quality. * Terminating federal funding for facilities that don't improve: CMS is considering all facilities cited with Immediate Jeopardy deficiencies on any two surveys while in the SFF Program for discretionary termination from the Medicare and/or Medicaid programs. ¢ Increasing enforcement actions: CMS is imposing more severe, escalating enforcement remedies for SFF Program facilities that have continued noncompliance and little or no demonstrated effort to improve performance. ¢ Incentivizing sustainable improvements: CMS is extending the monitoring period and maintaining readiness to impose progressively severe enforcement actions against nursing homes whose performance declines after graduation from the SFF Program. [FN49}] Additionally, the Biden Administration is encouraging State Survey Agencies to consider staffing levels and compliance history when deciding which facilities should be placed into the program. For more information on other steps the administration is taking to improve nursing home care, please see the administration's Fact Sheet. [FNSO] To increase transparency, the administration has been releasing new data on nursing home and hospital ownership. According to a press release, the data is important in helping stakeholders and the public understand the impact of consolidation, mergers, acquisitions, and changes of ownership on the quality of care in hospitals and nursing homes that participate in Medicare. [FNS1] The data is also meant to encourage competition in facility ownership, which furthers the president's executive order on promoting competition. [FNS2] According to the press release, consolidation leads to inadequate or expensive care in underserved communities. Briefly, the data show the following: ¢ Changes of ownership have been much more common in nursing homes than hospitals over the past six years. « There is also wide ownership variation by state. For instance, 19% of hospitals (14 out of 73) in South Carolina were sold during this period, while most states had fewer than 4% of hospitals change ownership. ¢ A majority (62.3%) of Skilled Nursing Facilities (SNFs)that were purchased have a single organizational owner, 6.9% have multiple organizations owners, while 18.2% have only individual owners and 12.7% have both types of owners. [FNS3] Later, in September 2022, CMS released additional information about Medicare-certified nursing home ownership. The decision increases transparency, and in doing so, it serves the Biden Administration's commitment to improving care in nursing homes. IFN54] The move also furthers President Biden's Executive Order on Competition, [FNSS] Which could also play a role in improving quality in nursing homes. In a press release announcing the newly public data, CMS explained how the data can help improve the quality of care: This data will, for the first time, give state licensing officials, state and federal law enforcement, researchers, and the public an enhanced ability to identify common owners of nursing homes across nursing home locations. This information can be linked to other data sources to identify the performance of facilities under common ownership, such as owners affiliated with multiple nursing homes with a record of poor performance. [FNS6] CMS indicated that the data will be uploaded to data.cms.gov, and it will be updated monthly. While the data will be most useful for researchers and government agencies, it will be accessible to the public through Medicare.gov, and CMS is interested in hearing feedback about how to present the data so that it is useful to consumers. [FNS7] Nursing homes were uniquely affected by the pandemic, due to various factors such as close living arrangements and pre-existing health conditions. 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. [FNS8] 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. IFN59] « Fact Sheet for the guidance is available. [FN6O] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. CMS advised that it updated its nursing home visitation FAQs amid the surge of the Omicron variant of the COVID-19 virus. CMS does not recommend limiting visitation in facilities; instead, it provides information on safe visitation practices. CMS explains why visitation is important: While CMS is concerned about the rise of COVID-19 cases due to the Omicron variant, we're also concerned about the effects of isolation and separation of residents from their loved ones. Earlier in the pandemic we issued guidance for certain limits to visitation, but we've learned a few key things since then. Isolation and limited visitation can be traumatic for residents, resulting in physical and psychosocial decline. So, we know it can lead to worse outcomes for people in nursing homes. Furthermore, we know visitation can occur in a manner that doesn't place other residents at increased risk for COVID-19 by adhering to the practices for infection prevention, such as physical distancing, masking, and frequent hand hygiene. There are also a variety of ways that visitation can be structured to reduce the risk of COVID-19 spreading. So, CMS believes it is critical for residents to receive visits from their friends, family, and loved ones in a manner that does not impose on the rights of another resident. Lastly, as indicated above, facilities should consult with their state or local public health officials, and questions about visitation should be addressed on a case by case basis. [FN61] CMS also prepared an infographic illustrating safe visitation practices. [FN62] CMS advised that it will be adding nursing home staff turn-over rates and weekend staffing levels to its Care Compare web site. The move aligns with the government's commitment to increasing transparency so that patients and families can make the most informed choices about nursing home care. CMS explained in a press release, Staffing in nursing homes has a substantial impact on the quality of care and outcomes residents experience. Having access to this information helps consumers understand more about each nursing home facility's staffing environment and choose a facility that provides the highest quality of care that best meets the healthcare needs of their loved one. [FN63} Staff turnover is defined as the number of nursing staff and administrators that quit working at a nursing home in a 12-month period. Nursing staff includes all types of licensed nurses as well as nurse aides who work under the nursing staff and provide day-to-day personal care services. Weekend staffing level is defined as the level of nurse and registered nurse staffing on weekends over the course of a quarter. This information will also be included in the Nursing Home Five Star Quality Rating System beginning in July 2022. CMS indicated that it has seen a correlation between decreased turnover and higher star ratings. Including this new information on Care Compare and using it to calculate the star rating will not result in additional reporting for nursing homes, as nursing homes are already reporting such information in the Payroll-Based Journal Program. IFN64] CMS also published guidance on this matter. [FN65] In July 2022, CMS did indeed enhance its Five-Star Quality Rating System for nursing homes by including data on weekend staffing rates for nurses and on nurse and administrator turnover. The star ratings are found on CMS' Medicare Care Compare site. IFNE6] tn a press release, the agency indicated that these changes will increase transparency, and they are aimed at improving the quality of care in the nation's nursing homes. According to CMS' press release announcing the changes, higher nurse turnover is empirically linked with poorer outcomes: CMS research shows that higher nurse turnover is associated with lower quality of care. Nurses who have worked at a facility longer are more likely to know residents well enough to recognize small health changes and act before they become larger issues. Similarly, administrators with longer tenures help create stable leadership which can lead to more consistent policies and protocols that are tailored to better serve residents, *N®7! The ratings are updated quarterly. A Fact Sheet on the changes to Care Compare is available. IFN68] | Technical Guide is also available. "©! These changes support the Biden Administration's focus on improving care and outcomes in nursing homes. In 2016, CMS published a final rule for the Medicare and Medicaid programs titled, *"Reform of Requirements for Long-Term Care Facilities." "N""l tn late June 2022, CMS released updated guidance on the minimum standards for long-term care facilities that participate in Medicare and Medicaid; the guidance further implements the 2016 rule. IFN71] One area of concer is staffing levels in these facilities. Earlier in 2022, CMS issued a Request for Information seeking feedback on revising staffing levels. While the rulemaking process progresses, CMS added requirements for compliance surveyors to use Payroll Based Journal staffing data in their inspections to ensure compliance with current staffing requirements. The guidance also addresses infection control, timely inspections, mental health and substance use disorder, and room crowding, among other things. IFN72] CMS made changes to Chapter 5 of the State Operations Manual to address the timeliness of state investigations as well. IFN73] The updated guidance furthers President Biden's initiative to improve health and the quality of care in nursing homes. [FN74] | Fact Sheet is available, '"N7*! At the start of the COVID-19 public health emergency (which is ongoing), CMS granted waivers and regulatory flexibilities to long-term care facilities to allow the facilities to quickly respond to the emergency nature of the pandemic. On April 7, 2022, CMS announced that it was ending some of those waivers and returning to pre-COVID policies. Because vaccination rates are high in these facilities, CMS believes that it is time for facilities to refocus on meeting certain minimum standards: With steadily increasing vaccination rates for nursing home residents and staff, and with overall improvements seen in nursing homes' abilities to respond to COVID-19 outbreaks, CMS is taking steps to phase out certain flexibilities that are generally no longer needed THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. to re-establish certain minimum standards while continuing to protect the health and safety of those residing in skilled nursing facilities/ nursing facilities (SNFs/NFs). Similarly, some of the same waivers are also being terminated for inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end-stage renal disease (ESRD) facilities. "N7® CMS reports that recent surveys of long-term care facilities have revealed a rise in conditions such as pressure ulcers, weight loss, and depression, which could be linked to insufficient staff training. CMS explained that a return to previous regulatory policy may help with these issues: By ending some of the temporary waivers, CMS is helping nursing homes to redirect efforts back to meeting the regulatory requirements aimed at ensuring each resident's physical, mental, and psychosocial needs are met. In addition, CMS expects providers to have integrated practices to address any COVID-19 outbreaks into their normal operations. [FN77] Until the public health emergency ends, CMS may still grant some flexibilities if, say, facilities experience a severe infection outbreak. In a letter to state survey agency directors, CMS set out the precise waivers and flexibilities that will be ended. Some will end 30 days after CMS' announcement, and some will end 60 days after the announcement. [FN78] HHS is hoping to improve mental and behavioral health in long-term care facilities. In May 2022, HHS announced that it will award up to $15 million for a Substance Abuse and Mental Health Services Administration (SAMHSA) program to improve behavioral health care in nursing homes and other long-term care facilities. The program will be funded by civil monetary penalty funds, which are funds collected by CMS from long-term care facilities that do not comply with CMS' Medicare and Medicaid program requirements. The program will establish the Center of Excellence for Building Capacity in Nursing Facilities to Care for Residents with Behavioral Health Conditions (the Center for Excellence). An HHS news release explains what the Center for Excellence is expected to accomplish: The Center of Excellence is expected to improve overall health care in nursing homes and other long-term care facilities by providing direct consultation to staff to increase understanding, improve awareness, reduce stigmatization, and build knowledge and skills for effective resident care. Ultimately, the Center for Excellence will strengthen and sustain effective behavioral health practices and achieve better outcomes for residents who have serious mental illness, serious emotional disturbance, substance use issues, or co-occurring mental health and substance use conditions. It will also ensure accessibility of evidence-based training and technical assistance focused on mental health disorder identification, treatment, and recovery support services. [FN79] The funds will be awarded to one grantee over a three-year period. Please see the news release for a link to the funding opportunity. In related news, the Kaiser Family Foundation also published an issue brief examining the ways states are addressing nursing home staff shortages. [FN80] ¢ Hospitals and other Facilities Concerned with safety in health facilities, 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." 'FN81] 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. [FN82] A workers at these facilities were to have received 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 were to be fully vaccinated by January 4, 2022. Exceptions are allowed for recognized medical conditions or religious beliefs, observances, or practices. The regulation, which is published at 86 F.R. 61555-01 (Nov. 5, 2021), was to take effect on November 5, 2021. A list of FAQs is available. "N®! The rule was issued without notice and comment after the Secretary determined that good cause existed to forego these requirements due to the urgent nature of the matter. Subsequently, two groups of states challenged the requirements in court, and district courts in Louisiana and Missouri each filed decisions preliminarily enjoining enforcement. Courts of Appeals denied a stay. [FN84] In its per curiam decision, the Supreme Court held, among other things, that HHS was within its statutory authority in issuing the rule, that the rule was not arbitrary or capricious, and that the HHS Secretary had good cause to forego the notice and comment procedures. [FN85] The Court's decision merely stays enforcement of the preliminary injunctions while the lower court cases wend their way up the court system. The Supreme Court's decision affects the 24 states that had joined in the two lawsuits. Enforcement in the remaining states is ongoing, on the schedule set out in the interim final rule. [FN86] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. Upon learning of the Court's decision, Chiquita Brooks-LaSure, CMS Administrator, remarked, "The Centers for Medicare & Medicaid Services (CMS) is extremely pleased the Supreme Court recognized CMS' authority to set a consistent COVID-19 vaccination standard for workers in facilities that participate in Medicare and Medicaid. CMS' vaccine rule will cover 10.4 million health care workers at 76,000 medical facilities. Giving patients assurance on the safety of their care is a critical responsibility of CMS and a key to combatting the pandemic. ™"\/accines are proven to reduce the risk of severe disease. The prevalence of the virus and its ever-evolving variants in health care settings continues to increase the risk of staff contracting and transmitting COVID-19, putting their patients, families, and our broader communities at risk. And health care staff being unable to work because of illness or exposure to COVID-19 further strains the health care system and limits patient access to safe and essential care." IFN87] Because of the litigation, different states were subject to different compliance deadlines: CMS guidance requires 100% of staff in nursing facilities to have completed their vaccinations or have a pending or approved exemption by February 28th in 25 states plus D.C.; by March 15th in 24 states; and by March 21st in the remaining state, Texas. [FN88] The Kaiser Family Foundation published a new analysis of the change in the staff vaccination rate in nursing homes since the rule went into effect. Briefly, vaccination rates increased 25% in the time period between August 2021, when CMS first announced that an emergency regulation was in the works, [FN89] and March 2022, when all states were to have been in full compliance with the regulation. The foundation writes that it cannot determine for certain whether the increase in vaccination rates is a direct result of the mandate, as other factors may be in play. Despite the increased rate, only 12% of nursing homes nationwide reported 100% compliance. Thirty-nine percent of nursing homes report vaccination rates over 90% (but less than 100%), and 49% of facilities reported rates of 90% or below. The rates varied widely by state. The government did not explicitly require staff to get booster shots; nevertheless, the foundation reported on vaccination booster rates in nursing homes as well. CMS may exercise enforcement authority for facilities that are not in full compliance with the rule. This could range from civil monetary penalties or denial of payments up to termination of participation from the Medicare and Medicaid programs, though CMS stresses that this would be a last resort. [FN&0} According to The New York Times, hospitals must now contend with the realities that accompany the Court's decision. There are a good number of states that heretofore did not have a vaccine mandate for health care workers. In states that did, hospitals lost employees that did not want to be vaccinated, exacerbating existing staff shortages. The paper cites this data about state vaccine mandates for health care workers: While 21 states and the District of Columbia have already mandated vaccines for health care workers, six - Texas, Montana, Arkansas, Indiana, Tennessee and Georgia - implemented bans that prohibited some employers from requiring vaccines. Eighteen states had no requirement for health care workers, while five, including Utah, Arizona and Michigan, exempted health care organizations from bans on vaccine requirements. [FNS1] Nursing facilities are especially concerned about losing staff at this critical point in the pandemic, and administrators at some have urged the administration to allow them to test their employees instead of requiring a vaccine. Currently, about 83% of nursing home employees are vaccinated, but with the recent Omicron surge, infections among staff and residents have risen dramatically. Administrators in those facilities fear the loss of even more staff due to the vaccine mandate. '""®! administrators at smaller hospitals have the same concern. !FN99] Despite these concerns, an analysis by the Kaiser Family Foundation suggests that the mandate did not exacerbate the shortages. As the organization pointed out, staff shortages have been an issue for some time, even before the pandemic. These shortages reached their peak in January 2022, but have actually come down since then, despite the mandate. [FN94] In related news, the Kaiser Family Foundation also published an issue brief examining the ways states are addressing nursing home staff shortages. [FNS5] The federal government is actively working on ways to improve maternal health, and hospitals play a part in the overall strategy. In a news release, CMS explained that it plans to propose a ""Birthing-Friendly" designation for hospitals that provide perinatal care, participate in a maternity care quality improvement collaborative, and employ recommended patient safety practices. The news release mentions a new structural quality measure for the Hospital Inpatient Quality Reporting Program that would lead to this designation: Beginning with discharges on October 1, 2021, CMS adopted a new structural quality measure for the Hospital Inpatient Quality Reporting Program that asks hospital to attest to whether they participate in a statewide and/or national maternal safety quality collaborative and whether they have implemented the recommended patient safety practices or bundles to improve maternal outcomes. Through this measure and others CMS intends to propose, a hospital could be considered ""Birthing-Friendly" with special designation on CMS'"™Care Compare" website. [FN96] Finally, to advance equitable, high quality maternity care, CMS is encouraging hospitals to review their policies and procedures to see if they have incorporated best practices for maternity care. CMS explains, THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. One such evidence-based practice for improving patient safety and quality of care, referred to as "maternal safety bundles," has been successful in driving improvements ̶ particularly with obstetric hemorrhage, severe hypertension in pregnancy, and non- medically indicated Cesarean deliveries. These bundles have also been associated with narrowing the racial disparity gap in certain perinatal outcomes. [FN97] For more information about maternity safety bundles, please see the American College of Obstetrics and Gynecology's web site. [FNS8] 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. IFN99] 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, IFN100] the government will withhold 1% of Medicare payments for hospitals that score in the bottom quartile on specified measures. IFN101] 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: - 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) N10] CMS penalized 751 hospitals in fiscal year 2018, '*N'°3] go0 in fiscal year 2019, "N'™! 76 in fiscal year 2020, 81°! and 774 in fiscal year 2021. [FN 106] The government's work to prevent hospital-acquired conditions had been 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 estimated that hospital-acquired conditions dropped 13%, cutting the incidence of these events by over 900,000. IFN107] The pandemic changed all of that. According to a CDC report covering acute care hospitals, inpatient rehabilitation facilities, and long-term acute care hospitals, infection rates were up for most types of infections. Surgical site infections were the exception: There were no significant changes in these infections between 2020 and 2021 for the ten types of surgeries that were tracked. [FN106] 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. [FN109] tn 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%. [FN110] 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. IFN111] While the agency did not suspend the penalties, THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -10- Kaiser Health News reported that the latest round of penalties was 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 that hospitals are facing during the pandemic. 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. IFN112] The 21st 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). N""5l jn 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." [FN114] 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. [FN115] The final rule making 2023 updates to the Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System made changes to both the Hospital-Acquired Conditions Reduction Program and the Hospital Readmissions Reduction Program. The final rule is published at 87 F.R. 48780-01 (Aug. 10, 2022). In related news, CMS published the final evaluation for the Initiative to Reduce Avoidable Hospitalizations Among Nursing Facility Residents (NFI 2). The evaluation revealed that it NFI 2, unlike NFI 1, did not reduce hospitalizations, nor did it result in savings to Medicare. NFI 2 was designed to test payments reforms, whereas NFI 1 was designed to test clinical interventions. [FN116] B. Focusing on Quality The United States government has been concerned with the quality of care for decades, but modern efforts at prioritizing quality and paying for the quality of care over the quantity of care arose from the Affordable Care Act. IFN117] To further this effort, in 2011, HHS developed the first National Quality Strategy. [FN118] In 2022, CMS unveiled the CMS National Quality Strategy. In announcing the new strategy, CMS noted that it had developed previous quality strategies, but they and other efforts have not been sustained or have not acknowledged the importance of equity in a robust quality strategy. According to CMS, ""true quality cannot exist without equity." [FN119] Notably, the strategy builds on lessons learned during the pandemic. It has eight goals: ¢ Goal 1: Embed Quality into the Care Journey * Goal 2: Advance Health Equity ¢ Goal 3: Promote Safety ¢ Goal 4: Foster Engagement ¢ Goal 5: Strengthen Resiliency ¢ Goal 6: Embrace the Digital Age ¢ Goal 7: Incentivize Innovation and Technology Adoption to Drive Care Improvements * Goal 8: Increasing Alignment N'7! The strategy is meant to be a person-oriented approach across the continuum of care during a person's lifetime, and it applies to all payer types, including Medicaid: The CMS National Quality Strategy focuses on a person-centric approach from birth to death as individuals journey across the continuum of care, from home or community-based settings to hospital to post-acute care, and across payer types, including Traditional Medicare, Medicare Advantage, Medicaid and Children's Health Insurance Program coverage, and Marketplace plans. It builds on our previous efforts to improve quality across the health care system, incorporates lessons learned from the COVID-19 Public Health Emergency (PHE), and endeavors to foster and promote the expanded levers used during the pandemic such as interoperability and data sharing, data collection specific to social determinants of health and social risk factors, telehealth, emergency preparedness, leadership, and organizational governance among others. [FN121] Please see the blog post for more information. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -11- 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[.]"" [FN122] 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) - Hospital Acquired Conditions (HAC) Reduction Program - Skilled Nursing Facility Value-Based Program (SNFVBP) - Home Health Value Based Program (HHVBP) [FN123] 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. 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. Participant bear financial risk, have payments under the model tied to quality performance, and are required to use Certified Electronic Health Record Technology. [FN124] 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. [FN125] The model qualifies as an Advanced Alternative Payment Model under the Quality Payment Program. IFN126] 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 episode categories, three outpatient episode categories, and one multi-setting episode category. For Model Year 6 (which begins in 2023), CMS is adding Major Joint Replacement of the Upper Extremity as a multi-setting clinical episode category; therefore, Model Year 6 will have 29 inpatient episode categories, three outpatient categories, and two multi-setting clinical episode categories. Model Year 5 has begun. CMS indicated that it made minimal changes to the program given the significant changes made in Model Year 4. 'FN"27] For Model Year 6 (which begins in 2023), CMS is adding Major Joint Replacement of the Upper Extremity as a multi- setting clinical episode category; therefore, Model Year 6 will have 29 inpatient episode categories, three outpatient categories, and two multi-setting clinical episode categories. [FN128] ~ Fact Sheet for Model Year 6 is available. "N'2*! The model currently has more than 700 participants. More information about the program, including measures and pricing methodology, is available on the model's web page. IFN130] The model was to run through December 2023, but CMS extended it to 2025. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -12- 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 explained 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. [FN131] 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. [FN'132] 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 model is currently in Program Year 6. 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. [FN133] 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.' FN"34l 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. [FN135] 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 was the Medicare Shared Savings Program (with 483 participants in 2022), which is currently running. [FN136] The Pioneer ACO Model, the Advance Payment ACO Model, the ACO Investment Model, Comprehensive ESRD (end stage renal disease) Model, and the Next Generation ACO Model are no longer active. We discuss a new ACO Model, the REACH Model, below. CMS has been publishing toolkits to inform the public about how ACOs work. They include the Beneficiary Engagement Toolkit, [FN137] the Care Coordination Toolkit, [FN138] ond the Provider Engagement Toolkit, [FN139] the Care Transformation Toolkit, [FN140] ond the Operational Elements Toolkit, [FN141] Which will the final toolkit in the series. 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). IFN142] 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. [FN143] However, the government's arrangement with most (82%) of the Shared Savings ACOs was one-sided, and ACOs were not leaping to make the THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -13- change to a two-sided arrangement. IFN144] 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. [FN145] CMS 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. IFN146] The American Hospital Association released a brief statement in support of the model. "1471 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." [FN 148] 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 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. [FN149] 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, wno 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. IFN150] 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. IFN151] CMS estimates a net loss of 100 ACOs by 2027. [FN152] 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. [FN153] 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." [FN154] Briefly, the major changes to the Medicare Shared Savings Program include these: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -14- ¢ 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. [FN155] 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 summarized 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. [FN156] 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 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. [FN197] 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. [FN 158] 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. [FN159] 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. "N'®°! As of January 1, 2022, over 11 million patients receive care in a Shared Savings Program ACO, up slightly from the previous year. Four-hundred eighty-three ACOs were expected to participate for 2022, which includes 66 new ACOs. [FN161] 1, August 2022, CMS reported on ACO performance in 2021. ACOs in the program saved Medicare $1.66 billion in 2021 while delivering quality care, marking the fifth consecutive year that Shared Savings ACOs have achieved this. Ninety-nine percent of ACOs reported on and met quality measures in 2021, and approximately 58% of ACOs earned payments for their performance. A CMS press release explains which ACOs tended to generate more savings: Approximately 58% of participating ACOs earned payments for their performance in 2021. The type of ACOs that saw more net savings tended to be low-revenue, meaning they were mainly made up of physicians, included a small hospital, or served rural areas. With $237 per capita in net savings, low-revenue ACOs lead high-revenue ACOs, who had $124 per capita net savings. Those ACOs comprised of 75% primary care clinicians or more, saw $281 per capita in net savings compared to $149 per capita in net savings for ACOs with fewer primary care clinicians. These results underscore how important primary care is to the success of the Shared Savings Program and demonstrate how the program supports primary care providers. [FN162] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -15- CMS made changes to the program in the Physician Fee Schedule rule for 2023 that promotes promote participation in rural and underserved communities. Please see our discussion of the final rule below, in the section titled, ""Selected Federal Activity." B. The REACH Model CMS announced that it is redesigning the Global and Professional Direct Contracting (GPDC) Model and transitioning it into the new ACO Realizing Equity, Access, and Community Health (REACH) Model. The agency is also cancelling the Geographic Direct Contracting Model. These acts align with the Administration's priorities for the health care system, which include creating equitable outcomes through quality, affordable, person-centered care, and they respond to stakeholder feedback. The REACH model will focus on health care equity and closing health care disparities, [FN163] Center. "© it will serve individuals in the traditional Medicare program. The REACH Model makes changes to the GPDC in three important ways. It will: ¢ Advance Health Equity to Bring the Benefits of Accountable Care to Underserved Communities and in doing so, it aligns with the agency's new vision for the Innovation [FN165] ¢ Promote Provider Leadership and Governance ¢ Protect Beneficiaries and the Model with More Participant Vetting, Monitoring, and Transparency [FN166] A Fact Sheet explains the program's options: The ACO REACH Model will offer two voluntary risk sharing options: (1) Professional Option ("Professional'), a lower-risk option with 50 percent Shared Savings/Shared Losses and Primary Care Capitation Payment; and (2) Global Option ("Global'), a full risk option with 100 percent Shared Savings/Shared Losses and either Primary Care Capitation Payment or Total Care Capitation Payment. The ACO REACH Model will also allow participation by three different participant types: (1) Standard ACOs for organizations with substantial experience serving people with Traditional Medicare; (2) New Entrant ACOs for organizations with less experience serving the Traditional Medicare population; and (3) High Needs Population ACOs, for organizations that serve small Traditional Medicare populations with complex health care needs. The GPDC will continue until December 31, 2022, and will transition to the REACH Model on January 1, 2023. GPDC participants will need to agree to the REACH Model requirements before they can transition to the new model. IFN167] Biease see the Fact Sheet for more information. Vil. RURAL HEALTH CARE 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. [FN166] (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 [FN 169] 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. IFN170] 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 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -16- 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. [FN171] «s [FN172] Rural hospitals have been closing at a rate that is concerning to many, with some calling the trend "alarming or characterizing itas a" "crisis." "\"75] 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. [FN174] 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. In a 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. [FN175] Concerned at the alarming rate of rural hospital closures, Congress in the Consolidated Appropriations Act 2021 (Pub. L. 116-260) included a provision establishing a new Medicare provider type for rural emergency hospitals. In July 2022, CMS announced a proposed rule [FN176] taking the first step toward implementing that provision. The proposed rule sets out Conditions of Participation for the new Rural Emergency Hospitals (REHs) that participate in the Medicare and Medicaid programs. CMS explained why establishing this new provider type is important: The REH designation provides an opportunity for Critical Access Hospitals (CAHs) and certain rural hospitals to avert potential closure and continue to provide essential services for the communities they serve. Conversion to an REH allows for the provision of emergency services, observation care, and additional medical and health outpatient services, if elected by the REH, that do not exceed an annual per patient average of 24 hours. This new provider type will promote equity in health care for those living in rural communities by facilitating access to needed services. N17] CMS also explained that one-fifth of the U.S. population lives in rural areas, which is why rural hospital closures (138 since 2010) is such a concern. These closures disproportionately affect communities of color and low-income communities. As a whole, rural dwellers have a shorter life expectancy and higher mortality, yet they have access to fewer health care providers and must drive longer distances to receive care. '"N"78] The REH Conditions of Participation were finalized in the final Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rule, which is published at 87 F.R. 71748-01 (Nov. 23, 2022). That final rule also includes provisions on REH payment policies, provider enrollment, and the Physician Self-Referral Law as it relates to REHs. A Fact Sheet on REH provisions in the final rule is available. [FN179] 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. "8°! 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. [FN181] As originally designed, the model consisted of two tracks, the Community Transformation Track and the Accountable Care Organization (ACO) Transformation Track. In the Community Transformation Track, CMS announced that it would select up to 15 Lead Organizations, each of which would represent a discrete rural community. CMS gave 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 explained 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 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -17- 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. [FN182] In the ACO Transformation Track, CMS was to select up to 20 ACOs with a rural focus that will receive advanced shared payments through the Medicare Shared Savings Program; the ACOs could use these payments to implement value-based payment models to improve the quality of care and health outcomes in rural communities. [FN 183] 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. IFN184] The request for applications for the ACO Transformation Track was to be issued in the spring of 2021, IFN185] However, CMS later announced that it is postponing the RFA release until spring 2022. [FN186] |, 2022, CMS announced that it removed the ACO Transformation Track from the model. In an email update, IFN187] CMS explained that it remains committed to increasing ACO adoption in rural areas, but it will not be doing so in this model. The agency explained that it is examining lessons from the ACO Investment Model as it settles on a way to do this. Finally, 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." IFN188] 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. Vill. THE NO SURPRISES ACT The No Surprises Act, which was enacted as a part of the Consolidated Appropriations Act, 2021 (P.L. 116-260), provides consumer protections against surprise billing. Surprise billing occurs when patients unknowingly receive services from an out-of-network provider. [FN189] tg protections extend to these services: ¢ Emergency services, including those provided in a hospital emergency room, a freestanding emergency department, and an urgent care center licensed to provide emergency care. ¢ Post-emergency stabilization services in a hospital after an emergency room visit. ¢ Air ambulance services, both emergency and non-emergency. * Non-emergency services provided at an in-network facility. [FN190] According to The New York Times, about 20% of patients in the U.S. who seek emergency services end up receiving care from an out-of-network provider, such as an emergency room doctor, a laboratory, or a radiologist. IFN191] if these services were rendered bya provider not contracted with the insurer to accept discounted rates, patients may receive bills demanding full payment for the services, a practice known as balance billing. IFN192] The same can happen with non-emergency services. A patient may receive services at an in-network facility and unknowingly receive treatment from a professional who does not work for the facility and could thus be out of the insurer's network. The Kaiser Family Foundation reports that about 16% of in-network facility stays result in surprise billing. IFN193] And HHS indicates that about 70% of air transports are furnished out of network, services that can exceed $30,000. [FN194] The act does not completely eliminate surprise billing. Ground ambulance transportation is currently not covered by the act. Additionally, for purposes of non-emergency services, the regulations define ""facility" as a hospital, a hospital outpatient department, and an ambulatory surgery center, meaning that services at facilities such as birthing centers, hospices, addiction clinics, and other facilities are not covered at this time. Finally, the law does not apply if a patient chooses a non-network provider and agrees to waive the protections of the act, but such waivers are not permitted for all services. [FN195] So how does the law protect consumers? Basically, the patient cannot be charged more than the in-network charge for the services covered by the act, and the insurer and provider must work out between them what the charges will be. A reporter for Kaiser Health News aptly summed it up in an interview with National Public Radio: Well, under the law, basically, the patient is taken out of the middle of these disputes. So the patient is only going to pay the deductible and the co-payments that they would have had, had their care been in-network. Then the law says insurers and the medical providers have to work it out between themselves, what the actual amounts paid will be. So if they can't agree, the law says the two sides have THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -18- to go to an arbitrator and each of them put up their best offer. And then the arbitrator is going to pick one of those, and that's what the insurer will pay. [FN196] The law was enacted with bipartisan support, and former President Donald Trump (R) signed it shortly before leaving office. As HPTS previously reported, the Biden Administration spent 2021 enacting regulations to implement the law. IFN197] | awsuits have been filed by physicians and hospitals challenging how arbitration is to be handled when the insurer and the provider cannot agree on an appropriate charge that would most closely align with the in-network charge. IFN198] Some lawmakers contend that the Biden Administration was not true to congressional intent when crafting regulations relating to arbitration. [FN199] CMS has set up a resource page for the surprise billing law. It includes links to policies and other resources, links to educate consumers on their rights, and links related to payment disputes. [FN200] The Biden Administration has promulgated rules to implement the No Surprises Act. In a press release announcing the first of those rules, HHS defined the terms "surprise billing" and "balance billing": 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 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. IFN201] 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. !*N202] 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. [FN203] The interim final rule is published at 86 F.R. 36870-01 (July 13, 2021). Fact Sheets are available. "N20! 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. [FN205] The latest rule, an interim final rule with comment period, IFN208] 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. "207! IX. Recent u.s. supreme court cases affecting health facilities Two years after Congress created the Medicaid Drug Rebate Program to reduce drug costs for Medicaid programs, it created the 340B drug program IFN208] +5 reduce the cost of outpatient drugs for certain safety net hospitals, such as community health centers, children's hospitals, hemophilia treatment centers, critical access hospitals, sole community hospitals, rural referral centers, and public and nonprofit disproportionate share hospitals that serve low-income and indigent populations. Facilities use the savings from this program to offset the cost of the services they provide to low-income and indigent patients. [FN209] th the 2018 and 2019 Outpatient THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -19- Prospective Payment System final rules, HHS reduced Medicare reimbursements for outpatient drugs for facilities that participate in the 340B program. The American Hospital Association (AHA) and others sued. The case wended through the federal court system, eventually landing in the U.S. Supreme Court. According to the Supreme Court, the impact of this action was substantial, amounting to about $1.6 billion annually for the affected facilities. [FN210] The Supreme Court decided the case unanimously. In his opinion, Justice Brett Kavanaugh wrote that the case was straightforward: According to the Medicare statute, HHS only has two options in setting reimbursement rate for drugs: To set the reimbursement rates for the prescription drugs, HHS has two options under the statute. First, if HHS has conducted a survey of hospitals' acquisition costs for the drugs, HHS may set the reimbursement rates based on the hospitals' average acquisition costs- that is, the amount that hospitals pay to acquire the prescription drugs-and may vary the reimbursement rates for different groups of hospitals. Second and alternatively, if HHS has not conducted such a survey, HHS must instead set the reimbursement rates based on the average sales price charged by manufacturers for the drugs (with certain adjustments), and HHS may not vary the reimbursement rates for different groups of hospitals. [FN211] The Court held that HHS did vary the reimbursement rate for a certain group of hospitals -- those participating in the 340B program - without conducting the required survey. The Court therefore ruled that HHS acted unlawfully. [FN212] In a press release, the plaintiffs hailed the decision: ™We are pleased that the U.S. Supreme Court unanimously agreed with us that the Department of Health and Human Services' outpatient payment cuts to hospitals in the 340B Drug Pricing Program were unlawful. This decision is a decisive victory for vulnerable communities and the hospitals on which so many patients depend. *"340B discounts help hospitals devote more resources to services and programs for vulnerable communities and increase access to prescription drugs for low-income patients." -N2"3] The Court also ruled on a case involving Medicare hospital payments. The federal government adjusts Medicare payments for services rendered at hospitals that serve a higher-than-usual percentage of low-income patients. This payment adjustment is calculated adding together two fractions: (1) the Medicare fraction, which is the proportion of a hospital's Medicare patients who are low-income, and (2) the Medicaid fraction, which is the proportion of a hospital's total patients who are not entitled to Medicare and are low-income. [FN214] The Supreme Court boiled the two fractions down to this: Roughly speaking, the former [Medicare fraction] measures the hospital's low-income senior-citizen population, and the latter [the Medicaid fraction] the hospital's low-income non-senior population. [FN215] Empire Health Foundation sued HHS contending that HHS' interpretation of how to calculate the Medicare fraction was incorrect. The Medicare statute defines this fraction as: (I) the fraction (expressed as a percentage), the numerator of which is the number of such hospital's patient days for such period which were made up of patients who (for such days) were entitled to benefits under part A of this subchapter and were entitled to supplementary security income benefits (excluding any State supplementation) under subchapter XVI of this chapter, and the denominator of which is the number of such hospital's patient days for such fiscal year which were made up of patients who (for such days) were entitled to benefits under part A of this subchapter. [FN216] Specifically, Empire Health Foundation took issue with how HHS interprets "entitled to benefits under part A of this subchapter." As the Court explained, Medicare does not necessarily pay for all of a patient's hospital stay; this may be true where the patient has exhausted their Medicare benefits for that stay, where private insurance pays, or where a third-party is liable, for example. HHS counts those Part A patients in the Medicare fraction even though Medicare is not paying for the entire stay. Empire claimed that patients should not be counted for the periods when Medicare is not paying. The Court framed the question as this: Are patients whom Medicare insures but does not pay for on a given day " "entitled to [Medicare Part A] benefits," for purposes of computing a hospital's disproportionate-patient percentage? [FN217] The Court sided with HHS. According to the majority opinion authored by Justice Elena Kagan, Text, context, and structure all support calculating the Medicare fraction HHS's way. In that fraction, individuals "entitled to [Medicare Part A] benefits" are all those qualifying for the program, regardless of whether they are receiving Medicare payments for part or all of a hospital stay. That reading gives the "entitled" phrase the same meaning it has throughout the Medicare statute. And it best implements the statute's bifurcated framework by capturing low-income individuals in each of two distinct populations a hospital serves. [FN218] Justices Clarence Thomas, Stephen Breyer, Sonia Sotomayor, and Amy Coney Barrett joined in Justice Kagan's opinion. Justice Brett Kavanaugh wrote a dissent, in which Chief Justice John Roberts and Justices Samuel Alito and Neil Gorsuch joined. X. selected Federal Activity THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -20- « 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. [FN219] * 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. [FN220] ¢ 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. [FN221] ¢ Senate Bill 620 (2021 FD S.B. 620 (NS)) would direct the HHS Secretary, 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... ." FN222] * 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 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -24- 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)) passed the House on May 12, 2022. 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); (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[,.] House Bill 3733 (2021 FD H.B. 3733 (NS)) is a related bill. * Representative Jan Schakowsky (D-IIl.) 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, '*N225] Its companion in the House is 2021 FD H.B. 3029 (NS). THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -29- ¢ 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 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. ¢ 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. [FN224] «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. "225! 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{.]" 'N226l ¢ 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. ¢ 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: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -23- "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." [FN227] 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. /FN??61 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. ¢ Inthe 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. [FN229] 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. [FN2301 | 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. * 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. [FN231] * 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. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -24- «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 HHS 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." [FN232] * In February 2022, HHS announced that it distributed $560 million in Phase 4 general distribution funds to more than 4,000 providers across the country. After this latest round of distributions, HHS has awarded roughly $11.5 billion in Phase 4 funds to about 78,000 providers. Currently, approximately 86% of the applications for Phase 4 have been processed, and the remaining funds will be awarded throughout the year. [FN233}] According to HHS' news release, Phase 4 distributions have been awarded with an eye toward equity: Phase 4 payments have an increased focus on equity, including reimbursing a higher percentage of losses for smaller providers and incorporating bonus payments for providers who serve Medicaid, Children's Health Insurance Program (CHIP), and Medicare beneficiaries, N2541 « CMS published corrections to its final Medicare rule (now codified in the Code of Federal Regulations) titled ""Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; Changes to Medicare Graduate Medical Education Payments for Teaching Hospitals; Changes to Organ Acquisition Payment Policies." The final rule is published at 86 F.R. 73416-01 (Dec. 27, 2021), and the corrections are published at 87 F.R. 4167-01 (Jan. 27, 2022). ¢ In the Senate, 2021 FD S.B. 3500 (NS) would enact the Ensuring Accurate and Complete Abortion Data Reporting Act. That bill would require states to submit abortion data as a condition of receiving certain federal Medicaid family planning funds. Its companion in the House, 2021 FD H.B. 581 (NS) was introduced in January 2021. Reporting abortion data to the Center for Disease Control and Prevention is optional, and according to Joni Ernst (R-la.), one of the bill's sponsors, only a handful full of states record and report it ina « [FN235] in a comprehensive and verifiably accurate way. ¢ Aresolution (2021 FD S.J.R. 32 (NS)) would express disapproval of the Biden Administration's rule requiring that staff in Medicaid- and Medicare-participating facilities be vaccinated against COVID-19. The resolution, which was introduced in late 2021, passed the Senate on March 2, 2022. « In Congress, 2021 FD H.B. 7156 (NS) would enact the Medicaid Coverage for Addiction Recovery Expansion (CARE) Act. That act would give states the option to extend Medicaid coverage for adults who receive services in a residential addiction treatment facility, as long as the services are a part of a full continuum of evidence-based treatment services provided under the State plan. The bill has bipartisan sponsorship. One the bill's sponsors, Representative Bill Foster (D-Ill.) indicated in a press release that the bill would allow " "countless" Medicaid enrollees access to comprehensive intensive inpatient treatment for substance use and addiction. Representative Foster said, "An outdated Medicaid policy is preventing people from accessing much-needed substance use disorder treatment . . . . If we are serious about fighting the opioid epidemic, we need to align our policies with our present-day understanding of addiction as a treatable medical condition, not a moral failing. The Medicaid CARE Act would do just that and get comprehensive substance use disorder treatment to the patients who need it the most." [FN236] ¢ In November 2020, in response to the surge in hospitalizations from the COVID-19 pandemic, CMS instituted a waiver program called Acute Hospital Care at Home. The program granted hospitals extensive flexibilities to allow Medicare enrollees to receive some hospital level services at home. CMS described the program in a press release in November 2020: In March 2020, CMS announced the Hospitals Without Walls program, which provides broad regulatory flexibility that allowed hospitals to provide services in locations beyond their existing walls. Today, CMS is expanding on this effort by executing an innovative Acute Hospital Care At Home program, providing eligible hospitals with unprecedented regulatory flexibilities to treat eligible patients in their homes. This program was developed to support models of at-home hospital care throughout the country that have seen prior success in several leading hospital institutions and networks, and reported in academic journals, including a major study funded by a Healthcare Innovation Award from the Center for Medicare and Medicaid Innovation (CMMI). The development of this program was informed by extensive consultation with both academic and private sector industry leaders to ensure appropriate safeguards are in place to protect patients, and at no point will patient safety be compromised. CMS believes that treatment for more than 60 different acute conditions, such as asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD) care, can be treated appropriately and safely in home settings with proper monitoring and treatment protocols. [FN237] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -25- A Senate bill (2021 FD S.B. 3792 (NS)) and a House bill (2021 FD H.B. 7053 (NS)) would extend those flexibilities for two years after the end of the COVID-19 public health emergency. Senator Tom Carper (D-Del.), one of the bill's sponsors, explained in a press release why he thinks the program should be extended: *"For the past two years, hospitals have endured the brunt of the COVID-19 pandemic-and without missing a beat-nurses, doctors, and other medical professionals have continued to provide quality care to individuals affected by the virus and other personal medical conditions . . . . Overrun with patients infected by the virus, hospitals like ChristianaCare in Delaware had to quickly adapt in order to treat patients with other medical needs-such as the creation of innovative programs to provide hospital-level care to patients in their homes. I'm proud to introduce this bill with my friend Senator Scott that will modernize our health care system and ensure that investments in programs to bring hospital care to patients at home can continue to go on." [FN236] The bill has bipartisan sponsorship. ¢ In the House, 2021 FD H.B. 7233 (NS) would add requirements under Medicaid State plans for health screenings and referrals for certain eligible juveniles leaving public institutions. It would also require the HHS Secretary to issue guidance under the Medicaid program and CHIP (the Children's Health Insurance Program) to improve the delivery of health care services, including mental health services, in elementary and secondary schools and school-based health centers. The bill has bipartisan sponsorship. ¢ CMS gave notice that it approved an application from the American Association for Accreditation of Ambulatory Surgery Facilities for continued recognition as a national accrediting organization for Rural Health Clinics that participate in the Medicare or Medicaid programs. The notice is published at 87 F.R. 16003-02 (Mar. 21, 2022). * CMS also gave notice of final and preliminary Medicaid federal share disproportionate share hospital (DSH) allotments and limitations on the aggregate amounts states may make to institutions of mental disease (IMDs). The rule's summary reads as follows: This notice announces the final Federal share (FS) disproportionate share hospital (DSH) allotments for Federal fiscal year (FY) 2018 and FY 2019, and the preliminary FS DSH allotments for FY 2020 and FY 2021. This notice also announces the final FY 2018 and FY 2019 and the preliminary FY 2020 and FY 2021 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FY DSH allotments. [FN239] ¢ Representative Carolyn Maloney (D-N.Y.) is sponsoring 2021 FD H.B. 7803 (NS), which would repeal the IMD exclusion. Generally, Medicaid does not pay for mental health services rendered in an IMD (institution for mental disease) with more than 16 beds. The bill would enact the Michelle Alyissa Go Act; Representative Maloney explained in a press release that the bill is named for a woman who was killed outside a subway station by an individual suffering from mental illness who was unable to access adequate health care. Representative Maloney's press release explained the problem that this bill seeks to remedy: Under current federal law, Medicaid is prohibited from covering stays for patients between the ages of 21 and 64 who are receiving mental health or substance abuse treatment in a facility with more than 16 beds. This prohibition, also known as the Institution for Mental Disease (IMD) exclusion, has been in effect since Medicaid was created in 1965 and has resulted in people like the individual who killed Ms. Go not being able to access care, as they do not have the money to cover these services out of their own pockets. [FN240] * CMS finalized a rule to delay the start date and performance periods for the Radiation Oncology model. The new start date and performance periods will be determined in future rulemaking. The rule is published at 87 F.R. 52698-01 (Aug. 29, 2022). ¢ CMS gave notice of its final decision to approve an application from the Joint Commission for continued recognition as an accrediting organization for hospitals that participate in Medicare and Medicaid. The notice is published at 87 F.R. 25642-01 (May 2, 2022). ¢ CMS published a final Medicare rule setting out requirements for accrediting organizations that undergo a change of ownership. The summary of the rule provides as follows: This final rule adds new requirements and a specified process to address change of ownership (CHOW) for Accrediting Organizations (AOs) in regard to the transfer of the existing Centers for Medicare & Medicaid Services (CMS) approval for the AO's accreditation programs to the new AO owner. These regulations are intended to provide CMS with the ability to receive notice when an AO is undergoing or negotiating a CHOW, as well as to review the prospective new AO owner's capability to perform its tasks after a CHOW has occurred, in order to ensure the ongoing effectiveness of the transferred accreditation program(s) and to minimize risk to patient safety. [FN241] « Introduced in the Senate on June 13, 2022, 2021 FD S.B. 4381 (NS) seeks to improve nursing homes' ability to hire qualified staff. Among other things, the bill would allow nursing homes to access to the National Practitioner Data Bank, a national criminal background database, for which they are currently not allowed access, to aid them in the hiring process. It would also allow nursing homes to conduct certified nurse assistant training in situations where they are currently not allowed. A press release from one of the sponsors describes the situations in which nursing homes are not allowed to provide this training, and explains how this bill would change those restrictions: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -26- Additionally, the bipartisan legislation amends overly restrictive regulations that bar certain senior living facilities from conducting training programs for in-house Certified Nurse Assistants (CNAs) - individuals who assist patients with their daily activities - for a two- year period after a care facility is found to have deficiencies, such as poor conditions or patient safety violations. Under existing regulations by the Centers for Medicare and Medicaid Services (CMS), senior living facilities that receive a civil monetary penalty (CMP) over $10,000 are automatically prohibited from conducting CNA staff training programs for a period of two years. Specifically, the legislation would allow a senior living facility to reinstate its CNA training program if: The facility has corrected the deficiency for which the CMP was assessed; The deficiency for which the CMP was assessed did not result in an immediate risk to patient safety and is not the result of patient harm resulting from abuse or neglect; And the facility has not received a repeat deficiency related to direct patient harm in the preceding two year period[. [FN242] * CMS also gave notice that it received an application from the Center for Improvement in Healthcare Quality for continued approval as an accrediting organization for hospitals that participate in Medicare and Medicaid. CMS is inviting comments on the application. Please see 87 F.R. 43525-01 (July 21, 2022). ¢ CMS released its final rule making fiscal year 2023 changes to the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System (LTCH PPS). The rule increases payments for acute care hospitals and takes steps to advance the Biden Administration's focus on health equity. The increased payment rates for certain hospitals are higher than CMS initially proposed: For acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and are meaningful electronic health record users, the final rule will result in an increase in operating payment rates of 4.3%. This reflects a FY 2023 projected hospital market basket update of 4.1%, reduced by a statutorily required productivity adjustment of a 0.3 percentage point and plus a 0.5 percentage point adjustment required by statute. This is the highest market basket update in the last 25 years and is primarily due to higher expected growth in compensation prices for hospital workers. Under the LTCH PPS, CMS expects payments in FY 2023 to increase by approximately 2.4% or $71 million. [FN243}] The rule also seeks to advance health equity by adding three new health equity-focused measures to the Hospital Inpatient Quality Reporting Program. CMS describes these measures in a press release: The first measure assesses a hospital's commitment to establishing a culture of equity and delivering more equitable health care by capturing concrete activities across five key domains, including strategic planning, data collection, data analysis, quality improvement, and leadership engagement. The second and third measures capture screening and identification of patient-level, health-related social needs - such as food insecurity, housing instability, transportation needs, utility difficulties, and interpersonal safety. By screening for and identifying such unmet needs, hospitals will be in a better position to serve patients holistically by addressing and monitoring what are often key contributors to poor physical and mental health outcomes. [FN244] Additionally, the rule addresses maternal health outcomes. It seeks to improve maternal health by finalizing a ""birthing-friendly" designation for hospitals and adopting new quality measures in an effort to improve maternal outcomes. Hospitals can earn the new designation by demonstrating a commitment to improving maternal outcomes by implementing best practices for quality care and safety for pregnant and postpartum patients. [FN245] The final rule is published at 87 F.R. 48780-01 (Aug. 10, 2022). CMS has prepared two Fact Sheets, one pertaining to hospital payments and other matters IFN246] and one pertaining to maternal health and health equity. [FN247] ¢ In Congress, 2021 FD H.B. 8597 (NS) would permanently allow Medicare coverage for services rendered at freestanding emergency centers. These centers currently receive reimbursement under a waiver issued for the duration of the COVID-19 public health emergency. According to findings supplied in the bill, the waivers have not increased Medicare costs: (4) An actuarial study of Medicare claims data found that FECs did not increase overall utilization of emergency care services and saved the Medicare program 21.8 percent in lower emergency care payments for patients of similar acuity. ¢ CMS announced a final rule making fiscal year 2023 changes to the Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities. It also makes changes to quality reporting and the Skilled Nursing Facility Value-Based Purchasing Program. CMS described the purpose of the final rule in the rule's summary: This final rule updates payment rates; forecast error adjustments; diagnosis code mappings; the Patient Driven Payment Model (PDPM) parity adjustment; the SNF Quality Reporting Program (QRP); and the SNF Value-Based Purchasing (VBP) Program. It also establishes a permanent cap policy to smooth the impact of year-to-year changes in SNF payments related to changes in the SNF wage index. We also announce the application of a risk adjustment for the SNF Readmission Measure for COVID-19 beginning in FY 2023. We are finalizing changes to the long-term care facility fire safety provisions referencing the National Fire Protection Association (NFPA)? Life Safety Code, and Director of Food and Nutrition Services requirements. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -27- The rule is published at 87 F.R. 47502-01 (Aug. 3, 2022). A Fact Sheet is available. N28! ¢ CMS also published a final rule making fiscal year 2023 changes to the Inpatient Rehabilitation Facility Prospective Payment System and to the quality reporting system for these facilities. The rule is published at 87 F.R. 47038-01 (Aug. 1, 2022). A Fact Sheet is available. '*N249 ¢ CMS finalized 2023 changes for the Inpatient Psychiatric Facility Prospective Payment System. The rule is published at 87 F.R. 46846-01 (July 29, 2022). A Fact Sheet is available. "N25°! * CMS also finalized 2023 updates to the hospice wage index, payment rate, and quality reporting requirements. The final rule is published at 87 F.R. 45669-01 (July 29, 2022). A Fact Sheet is available. ">"! « Representatives Gerry Connolly (D-Va.) and Ron Estes (R-Kan.) are sponsoring 2021 FD H.B. 8805 (NS), which would enact the Ensuring Seniors' Access to Quality Care Act. That act aims to ameliorate the shortage of certified nurse assistants (CNAs) by allowing nursing homes to more quickly resume in-house CNA training after the nursing home has been suspended from running such programs. Generally, if a nursing home has a certain number of penalties for deficiencies, it is suspended from running in-house CNA training for two years. This bill would allow facilities to resume such training, with increased oversight, once their violations have been remedied. Representative Estes explained in a press release why he is sponsoring the bill: 'Nearly every business and industry is suffering from workforce shortages, but perhaps some of the most impactful shortages are those within facilities providing care to others . . . This bipartisan bill is critical right now to address the devastating shortages of CNAs, especially in rural areas, by allowing nursing homes to resume CNA education programs faster. The Ensuring Seniors' Access to Quality Care Act makes certain that nursing homes continue to meet high standards without losing staffing levels that are needed for quality care.' [FN252] ¢ CMS gave notice that it gave final approval to Det Norske Veritas to continue as an accrediting organization for hospitals that participate in the Medicare and Medicaid programs. The notice is published at 87 F.R. 54510 (Sept. 6, 2022). « CMS released guidance to states that are considering transitioning Medicaid nursing facility payments from the Resource Utilization Groups (RUGs) to the Patient-Driven Payment Model (PDPM) and using the PDPM as the basis for nursing facility upper payment limit demonstrations. !FN253] * Representatives Gerry Connolly (D-Va.) and Ron Estes (R-Kan.) are sponsoring 2021 FD H.B. 8805 (NS), which would enact the Ensuring Seniors' Access to Quality Care Act. That act aims to ameliorate the shortage of certified nurse assistants (CNAs) by allowing nursing homes to more quickly resume in-house CNA training after the nursing home has been suspended from running such programs. Generally, if a nursing home has a certain number of penalties for deficiencies, it is suspended from running in-house CNA training for two years. This bill would allow facilities to resume such training, with increased oversight, once their violations have been remedied. Representative Estes explained in a press release why he is sponsoring the bill: 'Nearly every business and industry is suffering from workforce shortages, but perhaps some of the most impactful shortages are those within facilities providing care to others . . . This bipartisan bill is critical right now to address the devastating shortages of CNAs, especially in rural areas, by allowing nursing homes to resume CNA education programs faster. The Ensuring Seniors' Access to Quality Care Act makes certain that nursing homes continue to meet high standards without losing staffing levels that are needed for quality care.' [FN254] ¢ In the House, 2021 FD H.B. 8879 (NS) would enact the Inpatient Psychiatric Facility Improvement Act. That act would provide for revisions to the Medicare prospective payment system for psychiatric hospitals and psychiatric units. In brief, the bill would improve the prospective payment system for these facilities through the use of additional claims data and standardized patient assessment data. ¢ CMS gave notice that it received an application from the Joint Commission for continuing recognition as an accrediting organization for psychiatric hospitals that participate in Medicaid and Medicare. The agency is soliciting comments on the application. Please see 87 F.R. 59435 (Sept. 30, 2022). ¢ CMS also gave notice that it established the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for calendar year 2023. The notice is published at 87 F.R. 59094 (Sept. 29, 2022). ¢ CMS is seeking comments on the Accreditation Commission for Health Care's application for continuing recognition as an accrediting organization for end-stage renal disease facilities that participate in Medicare and Medicaid. The notice is published at 87 F.R. 60171 (Oct. 4, 2022). ¢ CMS announced that it approved the National Dialysis Accreditation Commission's application for continuing approval as an accrediting organization for end-stage renal disease facilities that participate in Medicare and Medicaid. Please see 87 F.R. 60173 (Oct. 4, 2022). « President Joe Biden (D) signed 2021 FD S.B. 958 (NS), which enacts the Maximizing Outcomes through Better Investments in Lifesaving Equipment (MOBILE) Health Act of 2022. The bill will allow health centers funded by the Health Resources and Services Administration to establish mobile delivery units even if they do not establish a permanent site. The bill aims to increase access to THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -28- services in rural and underserved areas. Senator Jacky Rosen (D-Nev.), one of the bill's sponsors, explained in a press release why mobile units are so critical: "Too many of Nevada's rural and underserved communities lack permanent health centers and reliable health care, which make mobile health centers indispensable in reaching them... . We have to make health care more accessible, which is why I'm thrilled that my bipartisan bill to provide greater resources to expand mobile health clinics is on its way to the President's desk to become law." [FN255] Senate Bill 958 is now Pub. L. 117-204. ¢ CMS announced that it finalized the Medicare Physician Fee Schedule rule for 2023. In addition to adjusting payment rates, the rule, among other things: ¢ strengthens behavioral health and opioid use disorder services; * makes changes to the Medicare Shared Savings Program to expand and enhance accountable care; * expands coverage of and access to screenings for colon and rectal cancer; and ¢ finalizes payment policies for dental services that are integral to covered health services. [FN256] The rule also makes telehealth changes, changes to pain management and treatment services, audiology services, preventive vaccine administration services, and services rendered in rural health clinics and federally qualified health centers. IFN257] cis published a Fact Sheet relating to the rule as a whole IFN258] and others relating to various aspects of the final rule. IFN259] The final rule is published at 87 F.R. 69404-01 (Nov. 18, 2022). * CMS also issued a final rule for the Outpatient Hospital Prospective Payment System and the Ambulatory Surgical Center Payment System. Notably, the final rule allows critical access hospitals and small rural hospitals to convert to Rural Emergency Hospitals, a new Medicare provider type. [FN260] CMS has published a Fact Sheet for the final rule, IFN261] ond it published a separate Fact Sheet on the Rural Emergency Hospital portion of the rule. "N62! The final rule is published at 87 F.R. 71748-01 (Nov. 23, 2022). ¢ CMS finalized 2023 changes to the End-Stage Renal Disease Prospective Payment System. The final rule is published at 87 F.R. 67136-01 (Nov. 7, 2022). A Fact Sheet is available. N26] ¢ CMS also finalized 2023 changes to the Home Health Prospective Payment System, which are published at 87 F.R. 66790-0171 (Nov. 4, 2022). A Fact Sheet is available. F264 XI. Selected State Activity In Alaska: ¢ If passed, 2021 AK S.B. 26 (NS) would have repealed the certificate of need program for health facilities. The bill was introduced on January 19, 2021 and was amended in the Senate. It did not pass before adjournment. In Arizona: ¢ Introduced on January 24, 2022, 2022 AZ H.B. 2384 (NS) would have directed the Director of the Department of Administration, in consultation with the Arizona Health Care Cost Containment System, to administer a competitive three-year grant program to find technology solutions for hospitals, health providers, and teleconsulting initiatives. The bill provided, in part, A. The department, in consultation with the Arizona health care cost containment system, shall administer a three-year competitive grant program that will provide a technology solution to support hospitals, health care providers and teleconsulting initiatives. In order to further health care accountability and reduce health care costs, the technology solution shall provide data to update cost reports to enhance emergency triage and to treat and transport patients. The department shall award the first grants under this program not later than December 31, 2022. B. The grant program shall enable the IMPLEMENTATION of a technology solution for hospitals, health care providers and patients that wish to participate by enabling a hospital's electronic medical records system to interface with other electronic medical records systems, promoting connectivity between hospital systems and facilitating increased communication between hospital staff that use different or distinctive online platforms and information systems when treating patients. The bill did not pass this session. * House Bill 2863 (2022 AZ H.B. 2863 (NS)) has been adopted. The bill will make various changes to statutory provisions governing the Health Care Cost Containment Program. Among other things, it will establish a three-year competitive grant program to provide support for an interoperability software solution to allow rural hospitals, health care providers, and urban trauma centers to further care coordination. The bill provides, in part, The software shall be made available to rural hospitals, health care providers and urban trauma centers that wish to participate by enabling a hospital's electronic medical records system to interface with other electronic medical records systems and providers to THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -29- promote connectivity between hospital systems and facilitate increased communication between hospital staff and providers that use different or distinctive online platforms and information systems when treating patients. In California: ¢ An Assembly bill, 2021 CA A.B. 1502 (NS), pertaining to freestanding skilled nursing facilities, was adopted on September 27, 2022. The bill adds a new statutory section relating to licensure of these facilities. It prohibits unlawful operation of such a facility and would allow the Department of Public Health, after licensure, to impose civil penalties for violating the new provisions. ¢ Arecently-adopted Assembly bill, 2021 CA A.B. 2673 (NS), imposes a moratorium on the transfer of hospice agency licenses and limits changes in ownership in such agencies. An exception may be granted if needed for the continuity of patient care, or in the case of financial hardship, if there is demonstrated need for hospice services in the geographic area. Governor Gavin Newsom (D) approved the bill on September 29, 2022. « An Assembly bill, 2021 CA A.B. 1907 (NS), changes requirements regarding inspection of skilled nursing facilities. Adopted on September 13, 2022, Assembly Bill 1907 changes the maximum time between inspections from 24 months to 30 months. ¢ An Assembly bill, 2021 CA A.B. 1502 (NS), will establish licensing requirements for freestanding skilled nursing facilities. The licensing requirements also apply to changes of ownership or management of such facilities. Governor Gavin Newsom (D) signed the bill on September 27, 2022. In Colorado: ¢ The Department of Health Care Policy and Financing gave notice that it intends to seek approval from CMS to amend its Medicaid State Plan. The amendment would update the pricing methodology for certain drugs delivered in the outpatient hospital setting. The department provides this summary of the changes: The Department of Health Care Policy and Financing (Department) intends to submit a State Plan Amendment to the Centers for Medicare and Medicaid Services (CMS) to update the pricing methodology for hospital services utilizing certain specialty drugs delivered in the outpatient hospital setting, effective February 26, 2022. The change will allow the Department to reimburse outpatient hospitals at a rate which more closely aligns with the hospital cost expectations. This change impacts outpatient hospital providers by altering the reimbursement methodology for certain specialty drugs with the intention of maintaining access to care for Health First Colorado's Medicaid population. The notice is published at 2022 CO REG TEXT 608451 (NS) (Feb. 25, 2022). ¢ A House bill, 2022 CO S.B. 53 (NS), will set out a specific set of visiting rules for patients in hospitals, nursing homes, and assisted living facilities. The version of the bill that passed specifies that residents have the right to have at least one visitor from three categories of persons: a compassionate care visitor; a support person, for a resident with a disability; and for a child, a parent or someone in loco parentis. The bill then specifies how a facility may modify visitation in the event of a pandemic. Governor Jared Polis (D) signed the bill on June 8, 2022. * Also in Colorado, 2022 CO H.B. 1333 (NS) will, subject to available appropriations and federal funding, provide for a wage enhancement supplemental payment for nursing facilities that pay their employees at least $15 per hour. The bill was adopted on April 25, 2022. ¢ A House bill, 2022 CO H.B. 1285 (NS), will prohibit hospitals from taking collection action against a patient when the hospital is not in material compliance with federal price transparency laws. Governor Polis signed the bill on June 8, 2022. ¢ Introduced on April 26, 2022, 2022 CO H.B. 1401 (NS) will require all hospitals to establish a nurse staffing committee in accordance with rules that would be developed by the Board of Health. Among other things, the nurse staffing committee will be required to: [A]nnually develop and oversee a patient-care staffing plan for the hospital that: (A) is voted on and recommended by at least sixty percent of the nurse staffing committee; (B) includes minimum staffing requirements as established in rules promulgated by the state board of health for each inpatient unit and emergency department that are aligned with nationally recognized standards and guidelines; (C) includes strategies that promote the health, safety, and welfare of the hospital's employees and patients; (D) includes guidance and a process for reducing provider-to-patient ratios to align with the demand based on patient acuity; and (E) may include innovative staffing models[.] Governor Jared Polis (D) signed the bill on May 18, 2022. In Florida: ¢ Introduced on January 11, 2022, 2022 FL S.B. 646 (NS) would have deleted 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. The bill died in the Judiciary Committee on March 14, 2022. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -30- ¢ A Senate bill, 2022 FL S.B. 292 (NS), directs the Department of Health to adopt rules to require newborn screening for congenital cytomegalovirus before three weeks of age or discharge, whichever comes first. The rules will apply to hospitals and other state- licensed birthing facilities that provide maternity and newborn care. The requirement will be a part of a comprehensive interdisciplinary program for early detection of hearing loss in newborns. The provisions of the bill will only be implemented if funds are available for it. The initial screening and any follow-up required for diagnosis is a covered benefit under Medicaid. Governor Ron DeSantis (R) signed the bill into law on April 6, 2022. ¢ Another Senate bill, 2022 FL S.B. 804 (NS), sought to modermize requirements for nursing home staffing. Among other things, the bill would have added definitions of ""average monthly hours of direct care per resident per day," ""direct care staff," and ""non-nursing direct care staff." Additionally, it would have added language providing that direct care staffing hours would not include "time spent on nursing administration, staff development, staffing coordination, and the administrative portion of the minimum data set and care plan coordination for Medicaid." The bill also called for amendments to the statutory provisions dictating what the applicable rules should require for specific minimum staffing requirements. It did not pass before adjournment. In Georgia: ¢ Introduced on February 1, 2022, 2021 GA H.R. 647 (NS) would have urged the Department of Community Health to apply to the federal government for approval to provide reimbursement for services provided in an institution of mental disease (IMD). Services in an IMD are typically excluded in Medicaid, but CMS policy allows reimbursement in certain circumstances. The resolution was not adopted before adjournment. « House Resolution 768 (2021 GA H.R. 768 (NS)) called for the creation of the House Study Committee on Expanding Long-Term Care Options. The resolution noted the increasingly high number of individuals residing in nursing homes and the shortage of bed space. It also noted the disproportionately high death rate among nursing home residents during the pandemic, 72% of who are insured by Medicaid. The authors of the resolution pointed to the success of smaller, person-centered communities and asserted that Medicaid reimbursement rates could be used to incentivize the adoption of such models. It called for the committee to study such options. The bill was introduced on February 14, 2022; it did not pass this session. ¢ Also in Georgia, 2021 GA H.B. 1336 (NS), introduced on February 14, 2022, would have allowed assisted living centers and personal care homes to enroll as Medicaid providers. It did not pass before adjournment. * House Bill 1394 (2021 GA H.B. 1304 (NS)) enacts the Georgia Caregivers Act. That act permits a patient upon admission to a hospital to identify at least one lay caregiver. The caregiver shall then be included in discharge planning for the patient, and the hospital will be required to notify the caregiver of the patient's discharge or of a transfer to another hospital. Governor Brian Kemp (R) signed the bill on May 6, 2022. In Illinois: ¢ A House bill, 2021 IL H.B. 4573 (NS), would change an existing statutory provision on managed care organization reimbursement for nursing facilities in the Medicare-Medicaid Alignment Initiative. Current law calls for reimbursement based on quarterly facility-specific RUG-IV per diem rates, and House Bill 4573 would change that to quarterly facility-specific fee-for-service rates. The bill would also add this new language: No managed care contract shall provide for a level of reimbursement lower than the fee-for-service rate in effect for the facility at the time service is rendered. Managed care organizations are expressly prohibited, at any time and for any reason, from offering, negotiating, or entering into contracts with a nursing facility for a level of compensation less than the fee-for-service rate in effect at the time the service is rendered. * If passed, 2021 IL H.B. 5547 (NS) would create the Nursing Home Oversight Committee. The purpose of the committee would be to, oversee, assess, and provide direction to the Department of Healthcare and Family Services as it relates to long-term care services, including, but not limited to, Medicaid reimbursement, bed assessments, managed long-term care, and Medicaid long-term care eligibility. The Committee would also be called upon to oversee, assess, and provide leadership to the Department of Health and Family Services on matters related to nursing facilities, and it would evaluate policies, regulations, and State Plan amendments relating to nursing homes. Before promulgating rules or seeking a State Plan amendment, the department would be required to obtain advice and consent of the committee. ¢ Also in Illinois, 2021 IL H.B. 5593 (NS) would extend Medicaid eligibility to all women of childbearing age regardless of income, and it would direct all hospitals licensed by the state or organized under the University of Illinois Hospital Act to apply for Medicaid on behalf of any such uninsured woman who is admitted for inpatient or outpatient services. ¢ Introduced on January 31, 2022, 2021 IL H.B. 5370 (NS) would adjust the Medicaid per diem rate for certain services in Children's Specialty hospitals. If the bill passes, new statutory language would read: Sec. 5-5.05d. Rate parity for Children's Specialty Hospitals. For dates of service on and after July 1, 2022, all Illinois and out-of-state cost reporting hospitals designated as Children's Specialty Hospitals by the Department as of January 1, 2022 must be paid a base per diem rate for inpatient general acute services and rehabilitation services no less than $2,500 per day. As used in this Section, THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -31- 'base rate' means the per diem rate in effect before adding any additional rate add-ons for disproportionate share hospital adjustment payments, Medicaid percentage adjustments, or Medicaid High Volume Adjustments. ¢ Senate Bill 1405 (2021 IL S.B. 1405 (NS)) has been adopted. It amends statutory provisions relating to patients' visiting rights in health facilities. New language would spell out how visitation is to be handled during a declared disaster, an infectious disease outbreak, or an epidemic. In part, new language would provide as follows: (a-5) Notwithstanding subsection (a), during a period for which the Governor has issued a proclamation under Section 7 of the Illinois Emergency Management Agency Act declaring that a disaster exists or in the event of an outbreak or epidemic of a communicable disease in the community in which the health care facility is located, a health care facility shall ensure an opportunity for at least one visitor to visit a resident or patient of the health care facility. A health care facility shall not count a clergy member toward any limit on the number of visitors permitted to visit a resident or patient at one time and shall permit a clergy member to visit with a resident or patient in addition to the permitted number of visitors. Visitation shall be subject to the guidelines, conditions, and limitations of the health care facility's visitation policy and any rules or guidelines established by the U.S. Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention. A skilled nursing home, extended care facility, or intermediate care facility would be allowed to prohibit a visitor if specific facts demonstrate that the individual would endanger his or her physical health or safety or the safety or health of a resident, patient, or health care worker of the facility. Governor J.B. Pritzker (D) signed the bill on May 27, 2022. ¢ The Department of Public Health gave notice of a proposed rule adding new administrative provisions to the section on birth center licensing. The new material would require birth centers to have a policy on continuing education and to provide continuing education to its staff members that provide care for pregnant and post-partum women. It would also require birth centers to incorporate best practices for timely identification and assessment of common pregnancy or postpartum complications. Finally, the new language would require these facilities to make reasonable efforts to activate closed captioning on televisions in the facility. The proposed rule is published at 2022 IL REG TEXT 603533 (NS) (July 1, 2022). In Indiana: ¢ A House bill, 2022 IN H.B. 1108 (NS), would have directed the Secretary of Family and Social Services to apply to CMS for waiver to allow the expansion of physician-owned hospitals in Indiana. The purpose of the waiver would have been to demonstrate that physician owned hospitals could be used to reduce Medicaid program costs, provide Medicaid participants with access to quality health care, and serve as an effective part of the state's delivery system. It did not pass this session. In lowa: ¢ House File 2546 (2021 IA H.F. 2546 (NS) was adopted on June 14, 2022. The bill, which relates to a reimbursement methodology for psychiatric intensive inpatient services, provides, Section 1. PSYCHIATRIC INTENSIVE INPATIENT CARE REIMBURSEMENT -- MEDICAID. No later than January 1, 2023, the department of human services shall implement a tiered rate reimbursement methodology for psychiatric intensive inpatient care under the Medicaid program based on the level of patient acuity and other factors as recommended in the inpatient bed tracking study committee report submitted to the governor and the general assembly on December 1, 2021. In Louisiana: ¢ Aresolution, 2022 LA H.C.R. 4 (NS) amends an administrative rule to change the Medicaid reimbursement rate for leave-of-absence days at non-state intermediate care facilities. Currently, the rule provides for a reimbursement that is 75% of the normal per diem rate; this bill amends that rule to provide for an 85% reimbursement for such days. The resolution has been adopted. ¢ A House bill (2022 LA H.B. 286 (NS)) that addresses credentialing in the Medicaid managed care program was adopted on May 25, 2022. The bill provide exemptions from the credentialing rules as follows: F. All of the following providers shall be considered to have satisfied, and shall otherwise be exempt from having to satisfy, any credentialing requirements of a managed care organization: (1) Any provider who maintains hospital privileges or is a member of a hospital medical staff with a hospital licensed in accordance with the Hospital Licensing Law, R.S. 40:2100 et seq. (2) Any provider who is a member of the medical staff of a rural health clinic licensed in accordance with R.S. 40:2197 et seq. (3) Any provider who is a member of the medical staff of a federally qualified health center as defined in R.S. 40:1185.3. ¢ Governor John Bel Edwards (D) signed 2022 LA H.B. 784 (NS) on May 25, 2022. The bill seeks to improve maternal mental health. The bill would, among other things: * require all hospitals and birthing centers that provide labor and delivery services to, prior to discharge following pregnancy, provide pregnant women and their families information about perinatal mood and anxiety disorders, including symptoms, treatment, and available resources; THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -32- ¢ require the Department of Health to provide the above information to hospitals and birthing centers and to provide such information on the department's web site; ¢ require health care providers who provide up to 12 months of postnatal care to women to screen for the signs and symptoms of postpartum depression and other related mental health disorders if in the medical professional's judgement such screening would be in the patient's best interest; * require health care providers who provide providing pediatric care to an infant to screen caregivers, upon the caregiver's consent, for postpartum depression or related mental health disorders; and * require the Department of Health to work with work with Medicaid managed care organizations to identify providers who specialize in pregnancy-related and postpartum depression or substance use disorders and related mental health disorders and to develop network adequacy standards for the treatment of pregnant and postpartum women with such disorders. « An amended version of 2022 LA H.B. 933 (NS) has become law. The latest version of the bill calls for nursing homes in specified parishes to have an emergency preparedness plan that covers the following: (a) A primary evacuation site and a secondary evacuation site, verified by one or more contracts or other written agreements, as well as any other alternative evacuation sites that the nursing home may have. (b) Proof of transportation or a contract with a transportation company, verified by a written transportation agreement or contract. (c) Staffing patterns for evacuation, including contact information for facility staff. (d) Detailed provisions which address supply of emergency electrical power in instances when primary electrical power in the nursing home is lost but evacuation from the nursing home is not required. (e) Any data, other information, documentation, or other content required by administrative rules of the department. In Maine: ¢ Senate Paper 625 (2021 ME S.P. 625 (NS)) became law on May 8, 2022, without the governor's signature. The bill aims to reform MaineCare payments to federally-qualified health centers, which the bill's authors claim are outdated and inequitable, when compared to payments for other primary care services. The bill specifies how the new payments are to be determined. In Massachusetts: ¢ House Bill 5034 (2021 MA H.B. 5034 (NS)) is a bill that appropriates funds received from the federal government for COVID-19 response. Among other things, the bill would appropriate money for a nursing home supplemental Medicaid payment for certain costs, including those relating COVID-19. The bill was introduced on July 15, 2022. 2021 MA H.B. 5007 (NS) is a related bill introduced on the same day. In Michigan: ¢ A House bill, 2021 MI H.B. 6364 (NS), would enact new statutory language governing supplemental nursing services agencies. Such agencies are defined in the bill as follows: (5) 'Supplemental nursing services agency' means a person that is engaged for hire in the business of providing or procuring temporary employment in a health facility or agency for a nurse, nursing assistant, nurse aide, or orderly. Supplemental nursing services agency does not include either of the following: (a) A person that provides staff to a home health agency as that term is defined in section 20173a. (b) An individual if the individual is a nurse, nursing assistant, nurse aide, or orderly and provides the individual's services as a nurse, nursing assistant, nurse aide, or orderly on a temporary basis to a health facility or agency. New statutory language would govern assessments on such agencies and licensing of such agencies, among other things. The bill was introduced on September 7, 2022. ¢ Also in Michigan, 2021 MI H.B. 6380 (NS) would allow hospitals designated as rural emergency hospitals to temporarily delicense 100% of its beds for no more than five years. ¢ A Senate Bill, 2021 MI S.B. 1202 (NS), would add new statutory provisions governing freestanding birth centers. Among other things, the bill addresses licensure, required policies and procedures, services that the center may and may not offer, and requirements for staff vaccination. The bill was introduced on October 13, 2022. In Minnesota: ¢ Senate File 3560 (2021 MN S.F. 3560 (NS)) would have added an additional exception to the general rule prohibiting Medicaid reimbursement for swing bed services. A new exception would have allowed such reimbursement if the swing bed was in a facility that was, (iii) a hospital that the Centers for Medicare and Medicaid Services has both certified as a critical access hospital and approved to provide post-hospital extended care services[.] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -33- The bill did not pass this session. In Mississippi: ¢ A House bill, 2022 MS H.B. 593 (NS), would have dramatically re-written existing provisions relating to certificates of need. Among many other things, it would have removed the statutory language requiring a certificate of need to perform listed health care services; it would have removed other provisions requiring a certificate of need for activities such as a change of ownership, acquisition of major medical equipment, and relocation of health care services; and it would have removed end-stage renal disease facilities and ambulatory surgical centers from the list of facilities that would require a certificate of need. It died in committee. * If passed, 2022 MS S.B. 2664 (NS) would have ensured Medicaid reimbursement for services rendered in a licensed birthing center, in accordance with federal law. The Division of Medicaid would have been directed to seek any necessary waivers or State Plan amendments. The bill died in committee. « Also in Mississippi, 2022 MS S.B. 2820 (NS) will direct the Department of Health to establish and administer the COVID-19 Hospital Expanded Capacity Program for hospitals that increased treatment capacity in response to the pandemic. Grants under the program will be made as reimbursement for expenses incurred from March 3, 2021, through December 31, 2023. The first priority for the funds would be to reimburse expenses for the creation of new ICU beds. The next priority would be to reimburse expenses for the creation negative pressure beds. Governor Tate Reeves (R) signed the bill on April 25, 2022. In Missouri: ¢ The Department of Social Services gave notice of a proposed rule establishing a calculation for Outpatient Direct Medicaid payments. Existing administrative provisions setting out a calculation of Inpatient Direct Medicaid payments would be eliminated. The proposed rule is published at 2022 MO REG TEXT 619365 (NS) (July 15, 2022). In addition to the rule proposing these changes, the department issued an emergency rule as well. Please see 2022 MO REG TEXT 619347 (NS) (July 15, 2022). ¢ The Department of Social Services gave notice of proposed rulemaking that would amend administrative provisions relating to the inpatient hospital reimbursement methodology in the MO HealthNet program. The proposed rule is published at 2022 MO REG TEXT 619364 (NS) (July 15, 2022). An emergency rule was also filed. Please see 2022 MO REG TEXT 619346 (NS) (July 15, 2022). In Nebraska: ¢ Aresolution, 2021 NE L.R. 390 (NS), called for a study on the current Medicaid reimbursement model and processes for critical access hospitals to determine if the state is adequately paying those hospitals. The study would have included, at a minimum: (1) Reviewing medicaid inpatient per diem rates and outpatient cost-to-charges ratio rates, when such rates were last updated, and if such rates accurately reflect hospital costs; (2) Reviewing how much time the medical assistance program takes to settle cost reports and how significant delays impact the ability of critical access hospitals to fund hospital operations; and (3) Reviewing how critical access hospitals financially sustain other important rural health initiatives, including community wellness outreach and long-term care services. The resolution was not adopted. In New Jersey: * A Senate bill, 2022 NJ S.B. 1456 (NS), would set a minimum base Medicaid reimbursement rate of $950 per day for pediatric skilled care nursing facilities. The bill, which was introduced on February 10, 2022, also provides for an appropriation to carry out this provision. ¢ An Assembly bill, 2022 NJ A.B. 4091 (NS) will make the County Option Hospital Fee Program permanent. The program had been a pilot. The stated purpose of the program is as follows: (1) to increase financial resources through the Medicaid program to support local hospitals and to ensure that they continue to provide necessary services to low-income citizens; and (2) to provide participating counties with new fiscal resources. [FN265] The bill, which was adopted on July 5, 2022, also allows more counties to participate in the program. ¢ Introduced on September 15, 2022, 2022 NJ A.B. 4484 (NS) would amend existing statutory provisions on transfer of nursing home ownership and management. For example, it would change requirements for the transfer application, change requirements for public notice of the transfer application, and change requirements for the transfer of substantial management control, among other things. ¢ Introduced on the same day, 2022 NJ A.B. 4466 (NS) would change certain Medicaid eligibility rules. For example, it would increase to 60 months the look-back period for those seeking long-term care services who disposed of income below the fair market value. It would also add language clarifying that an applicant would not be subject to a period of ineligibility as a result of transfers the applicant made that amount to less than $500 in a calendar month. Additionally, the bill would add language detailing how a county welfare agency is to handle incomplete Medicaid applications. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -34- ¢ Senate Bill 2892 (2022 NJ S.B. 2892 (NS)) addresses actions against low-performing nursing homes. It would direct the Department of Human Services' Division of Medical Assistance and Health Services to issue a warning to a nursing home that receives a one-star rating from the CMS when the nursing home received two stars or higher in the preceding quarter. The warning would: (1) urg[e] the nursing home to improve the quality of care provided to residents; (2) advis[e] the nursing home that a second or subsequent one-star rating may result in the division requiring the nursing home to take specific steps to improve the quality of care; and (3) advis[e] the nursing home that the failure to improve quality of care at the nursing home may result in the division imposing sanctions against the nursing home. If a nursing home receives a one-star rating for two consecutive quarters, the department would be directed to evaluate whether sanctions are in order. Those sanctions could include, for example, prohibiting the nursing home from admitting new Medicaid patients or limiting the number of such patients the facility could admit, or reducing payments to the facility under the federal government's quality incentive payment program. If a nursing home receives a one-star rating for three consecutive quarters, the Department would be directed to evaluate whether it should impose more severe sanction, including, for example, prohibiting the nursing home from admitting new residents; removing current residents who are Medicaid enrollees from the nursing home; stopping all payments to the nursing home under the Department of Human Services' quality incentive payment program; declining to approve or revoking the approval of the owner or operator of the nursing home to participate in Medicaid; and, in consultation with the Department of Health, prohibiting the owner or operator of the nursing home from obtaining an interest in, or contracting with, any other nursing home in the State. The bill was introduced in June 2022, and it underwent amendments in October. * Introduced on October 27, 2022, 2022 NJ S.B. 3238 (NS) would require certain nursing homes to engage the services of a monitor. In short, if a nursing home is in substantial violation of the standards of health, safety, and resident care established under federal or state law, or if the nursing home has a pattern and practice of habitual violations, the Department of Health may provide at the nursing home's expense a monitor or other vendor for management support services and resources, consultative services, staffing services, or any other support for the nursing home. Instead of providing a monitor for such facilities, the state could require the facilities to contract for these services. Such a monitor would assist the nursing home to: (1) remedy the violations or deficient conditions; (2) transition the nursing home to new ownership; (3) facilitate the safe and orderly closure of the nursing home if ordered by the department; or (4) avoid the cessation of operations of the nursing home. In New York: ¢ Senate Bill 8285 (2021 NY S.B. 8285 (NS)) would direct the Commissioner of Health to investigate the Department of Health's performance during the COVID-19 pandemic in nursing homes, adult care facilities, and assisted living facilities. The bill reads, in part, The commissioner shall conduct an investigation of the department with respect to such agency's performance, as well as compliance and enforcement of applicable state laws, rules, regulations, and directives or executive orders issued by the governor pursuant to section 29-a of the executive law, including any guidance or advisory issued by the department with respect to its compliance with United States centers for Medicaid and Medicare services and centers for disease control and prevention guidance and recommendations, with respect to mitigating the impact of COVID-19 in nursing homes, adult care facilities, and assisted living residences during the time period beginning March 1, 2020, and ending August 24, 2021. The investigation would consider funding for these facilities, including the adequacy of Medicaid payments; enforcement of infection prevention and conirol policies; and resident health outcomes, among other things. ¢ Introduced on May 6, 2022, 2021 NY A.B. 10211 (NS) would add new statutory language permitting certain named treatment centers for mentally disabled persons to provide mental health and health care services to those admitted for substance use disorder. Such services would be reimbursable by Medicaid and private insurance. ¢ Assembly Bill 5499 (2021 NY A.B. 5499 (NS)) was adopted on June 13, 2022. The bill authorizes the Commissioner of Health to conduct a study of the unmet needs of pregnant women in the state and the impact of limited services pregnancy centers on women's ability to receive accurate and non-coercive health care information and access to a comprehensive range of reproductive and sexual health care services. A limited services pregnancy center is defined in the bill as one that: 1. (a) is not a health care facility licensed by the state of New York under article 28 of the public health law or articles 31 and 32 of the mental hygiene law; or (b) is not providing services under the direction of a health care provider licensed under title 8 of the education law who is acting within his or her scope of practice; and THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -35- 2. fails to provide or refer for the full range of comprehensive reproductive and sexual health care services reimbursed under the state's Medicaid program including, but not limited to contraception, testing and treatment of sexually transmitted infections, abortion care, and prenatal care. In Ohio: * A House bill, 2021 OH H.B. 120 (NS), will require long-term care facilities to allow residents to have compassionate care visits in a compassionate care situation, which would include the following situations: (a) The resident's end of life; (b) The resident was recently admitted to the facility and is struggling with the change in environment and lack of physical family support; (c) The resident is grieving after a friend or family member has recently passed away; (d) The resident is experiencing weight loss or dehydration and needs cueing and encouragement when eating or drinking; (e) The resident is experiencing emotional distress from isolation as demonstrated by behavioral changes such as rarely speaking or crying more frequently; (f) The resident is in transmission-based precautions for a disease or illness. If the facility is regulated by CMS, the visitor will need to comply with all CMS regulations and guidance. If the facility is not regulated by CMS, the visitor will need to comply with the facility's visitor policy. The bill sets out what that policy should include. Governor Mike DeWine (R) signed the bill on April 21, 2022. In Oklahoma: * Senate Bill 1661 (2021 OK S.B. 1661 (NS)) provides a definition of " "nonstate government owned" for purposes of the federal Medicaid supplemental payment program for nonstate government owned nursing facilities and hospitals. New statutory language would read as follows: For the purposes of a federal Medicaid supplemental payment program for non-state government-owned nursing facilities and hospitals, 'non-state government-owned' means owned by a government other than the state including but not limited to: 1. A board of control created by and charged by a board of county commissioners with the management and control of a county hospital as provided by Section 789 of Title 19 of the Oklahoma Statutes; 2. A public trust or other organization that is created by a county under Section 176 of Title 60 of the Oklahoma Statutes and is under lease with a board of county commissioners for the operation of a county hospital as provided by Section 789 of Title 19 of the Oklahoma Statutes; 3. A municipal governing body that has established and maintains a municipal hospital as provided by Section 30-101 of Title 11 of the Oklahoma Statutes; 4. A board of control created by and charged by a municipal governing body with the management and control of a municipal hospital as provided by Section 30-102 of Title 11 of the Oklahoma Statutes; and 5. Any municipal or governmental body other than the state authorized to operate a health care facility including a hospital or nursing facility. Governor Kevin Stitt (R) signed the bill on May 20, 2022. In Oregon: ¢ The Health Authority gave notice of temporary rules governing visitation in the Oregon State Hospital in order to comply with the CMS' rule and guidance on visitation. The agency explained, OSH [Oregon State Hospital] is modifying its rules concerning patient visitation to comply with Center for Medicaid and Medicare Services (CMS) rules and guidelines and to ensure the safety and security of Oregon State Hospital, patients and staff with rules that ensure visitation processes are safe, and that contraband is not introduced into the hospital, and if found, processed and eliminated accordingly. These rules set out processes that allow for safe visits, and that mitigate against the presence of contraband that could pose a health and safety risk to patients and staff. The notice is published at 2022 OR REG TEXT 618673 (NS) (July 5, 2022). In Pennsylvania: ¢ If passed, 2021 PA H.B. 1644 (NS) would establish the Medicaid Care Transition Program. The findings supplied in the bill note that, while hospital emergency departments are effective at identifying patients in need of behavioral health services or other long-term care services, there is often a delay in getting patients to those settings. The delay often means that patients are waiting for lengthy periods in the emergency department. That can cause undue stress for patients and their families and delay appropriate treatment that could avert an inpatient stay. Further, such delays tax already-strained resources, leading to crowded emergency departments and delay THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -36- in treating other patients. The Medicaid Care Transition Program would facilitate quicker transfers for appropriate treatment. The bill passed the House on May 25, 2022. ¢ House Bill 1693 (2021 PA H.B. 1693 (NS)) would require long-term care nursing facility operators to provide notice to residents upon admission that they have to the option to seek legal counsel to help them apply for Medicaid long-term care services. The notice would also warn that nonlegal entities cannot provide legal advice and may not be able to represent the residents' best interests. It would refer residents to the bar association or Legal Aid to determine if they are entitled to free legal services. The bill was introduced in June 2021, and it has been amended. In Texas: ¢ The Department of Health and Human Services gave notice of an emergency rule IFN266] to address the COVID-19 pandemic. The summary of the rule, which can only be in effect for 120 days with a possible 60-day extension, provides, in part: The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) adopts on an emergency basis in Title 26, Texas Administrative Code, Chapter 554, Nursing Facility Requirements for Licensure and Medicaid Certification, new s.554.2802. This emergency rule is adopted in response to COVID-19 and requires nursing facilities to take certain actions to reduce the risk of spreading COVID-19. The emergency rule also permits nursing facilities to request temporary increases in capacity and Medicaid bed allocations to aid in preventing the transmission of COVID-19 or caring for residents with COVID-19. In Virginia: * Anew 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": ™"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). * A Senate bill, 2022 VA S.B. 40 (NS), adds statutory provisions requiring that regulations relating to admissions to and discharges from assisted living facilities specifically address involuntary discharges. The statute spells out what the rules should cover, including the conditions under which an individual can be involuntarily discharged, the notice required before such discharge, procedures for appeals, relocation assistance, and so forth. The bill was passed after both houses concurred in the governor's recommendations. In Washington: ¢ Introduced on January 4, 2022, 2021 WA H.B. 1739 (NS) directs hospitals to adopt a policy to prevent and control the transmission of pathogens of epidemiological concern. According to the findings supplied with the bill, hospitals' concentration on preventing methicillin- resistant staphylococcus aureus does not square with the reality that there are many other pathogens of epidemiological concern. The findings read as follows: The legislature finds that a singular focus on methicillin-resistant staphylococcus aureus does not reflect the reality that there are many more pathogens of epidemiological concern. Modernization of state law is needed. Hospitals must prepare and respond effectively to pathogens of epidemiological concern within their facilities through a broad facility risk assessment that identifies pathogens of epidemiological concern that pose risks to patients, health care workers, and visitors. Department of health oversight and surveys will ensure risk assessments are appropriate and current. Lab identified pathogens must be reported to the national healthcare safety network of the United States centers for disease control and prevention pursuant to requirements from the centers for medicare and medicaid services. Governor Jay Inslee (D) signed the bill on March 30, 2022. * House Bill 1688 (2021 WA H.B. 1688 (NS)) amends existing state statutes to align with the federal No Surprise Act (P.L. 116-260). Governor Inslee signed the bill on March 31, 2022. ¢ The Health Care Authority gave notice of an adopted rule relating to Medicaid hospital administrative day rates for post-partum women who no longer need acute care but who stay in the hospital because their newborn needs monitoring. New language provides for the administrative day rate under these circumstances: (ii) The postpartum parent's newborn remains on an inpatient claim for monitoring post-in utero exposure to substances that may lead to physiologic dependence and continuous care by the postpartum parent is the appropriate first-line treatment (newborn administrative day). 'Postpartum parent' means the client who delivered the baby(ies). THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -37- Up to five administrative days would be allowed, though more may be permitted using an expedited prior authorization process. The mother would be required to room with the newborn during the administrative days. The rule is published at 2022 WA REG TEXT 587367 (NS) (July 6, 2022). ¢ The Department of Social and Health Services filed emergency rules extending prior emergency rules to ensure that nursing homes are not ""significantly impeded" from admitting and caring for residents during the COVID-19 pandemic. The department provided this summary of its actions: This rule making extends emergency rules filed consecutively since April 13, 2020, to maintain compliance with blanket waivers issued by the Centers for Medicare and Medicaid Services (CMS). The amendments will continue to align state nursing home rules with federal rules that are suspended or amended to help facilitate care during the COVID-19 pandemic until such time as CMS reinstates their rules. The federal rules were amended to delay the requirement by 30 days to complete preadmission screening and resident review (PASRR) screening prior to admission to a nursing home under WAC 388-97-1915 and 388-97-1975. The rules are published at 2022 WA REG TEXT 563902 (NS) (Oct. 5, 2022). ¢ The Health Department proposed rules to amend the Hospice Services Standards and Need Forecasting Method. The department indicated that the proposed method will more accurately measure hospice utilization. The proposed rules are published at 2022 WA REG TEXT 544305 (NS) (Oct. 19, 2022). In West Virginia: * House Bill 4351 (2022 WV H.B. 4351 (NS)) called for an acuity-based patient classification system for nursing homes. The bill defined such a system as, a set of criteria based on scientific data that acts as a measurement instrument which predicts registered nursing care requirements for individual patients based on severity of patient illness, need for specialized equipment and technology, intensity of nursing interventions required, and the complexity of clinical nursing judgment needed to design, implement and evaluate the patient's nursing care plan consistent with professional standards of care. The acuity system criteria shall take into consideration the patient care services provided by registered nurses, licensed practical nurses and other health care personnel. If passed, the bill would have called on facilities to develop an acuity-based patient classification system. The bill did not pass before adjournment. 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 Biden Administration's commitment to the vitality of the Medicaid program should benefit health facilities, and we will continue to report on these efforts. The COVID-19 pandemic has required many temporary changes to Medicaid policy. HPTS 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 [FN2] 'Hospitals are Economic Anchors in their Communities,' American Hospital Association, https:/Avww.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/2018-03-29-hospitals-are-economic-anchors-their-communities. [FN4] Zachary Levinson, ef a/., "Hospital Charity Care: How It Works and Why It Matters," Kaiser Family Foundation, Nov. 3, 2022, available at: https:/Avww.kff.org/health-costs/issue-brief/hospital-charity-care-how-it-works-and-why-it-matters/?utm_campaign=KFF-2022-The- Latest&utm_medium=email&_hsmi=232620119&_hsenc=p2ANqtz-8HcBdNir7AqLVrplh3cwAzaBmo6DWé6qKacu1 Ecjt&utm_content=2326201 1% [FN5] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -38- "Fact Sheet: Uncompensated Hospital Care Cost," American Hospital Association, Feb. 2022, available at: https://Awww.aha.org/ system/files/media/file/2022/02/medicare-medicaid-underpayment-fact-sheet-current. pdf. [FN6] Elizabeth Hinton, ef al., **How the Pandemic Continues to Shape Medicaid Priorities: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2022 and 2023," Kaiser Family Foundation, Oct. 25, 2022, available at: https:/Avww.kff.org/report-section/ medicaid-budget-survey-for-state-fiscal-years-2022-and-2023-provider-rates-and-taxes/. [FN7] The FMAP is the federal medical assistance percentage, or match rate. [FN8] Elizabeth Hinton, et al., "How the Pandemic Continues to Shape Medicaid Priorities: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2022 and 2023," Kaiser Family Foundation, Oct. 25, 2022, available at: https:/Awww.kff.org/report-section/ medicaid-budget-survey-for-state-fiscal-years-2022-and-2023-provider-rates-and-taxes/. [FN9] Elizabeth Hinton, et al., "How the Pandemic Continues to Shape Medicaid Priorities: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2022 and 2023," Kaiser Family Foundation, Oct. 25, 2022, available at: https:/Avww.kff.org/report-section/ medicaid-budget-survey-for-state-fiscal-years-2022-and-2023-provider-rates-and-taxes/. [FN10] Press Release, "CMS Office of the Actuary Releases 2021-2030 Projections of National Health Expenditures," CMS, Mar. 28, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-office-actuary-releases-202 1-2030-projections-national-health- expenditures. [FN11] Press Release, "CMS Office of the Actuary Releases 2021-2030 Projections of National Health Expenditures," CMS, Mar. 28, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-office-actuary-releases-202 1-2030-projections-national-health- expenditures. [FN12] Press Release, "CMS Office of the Actuary Releases 2021-2030 Projections of National Health Expenditures," CMS, Mar. 28, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-office-actuary-releases-202 1-2030-projections-national-health- expenditures. [FN13] Letter from HHS to Texas Medicaid Director, Apr. 16, 2021, available at: https:/Avww.medicaid.gov/medicaid/section-1 115- demonstrations/downloads/tx-healthcare-transformation-ca.pdf. [FN14] Letter from HHS to Texas Medicaid Director, Apr. 16, 2021, available at: https:/Awww.medicaid.gov/medicaid/section-1 115- demonstrations/downloads/tx-healthcare-transformation-ca. pdf. [FN15] Texas is one of just 11 states that have not adopted the Medicaid expansion. See "Status of State Action on the Medicaid Expansion Decision," Kaiser Family Foundation, updated Nov. 9, 2022, 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'#. [FN16] 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. [FN17] Jeremy Blackman, "Biden Administration Rescinds Billions in Medicaid Funding for Texas," Houston Chronicle, Apr. 16, 2021, available at: https:/Avwww.houstonchronicle.com/politics/texas/article/Biden-administration-rescinds-billions-in-16107275.php. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -39- [FN18] 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. [FN19] 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. [FN20] Morgan Haefner, '"Revoked Texas Medicaid Waiver Credit Negative for Hospitals," Becker's Hospital Review, Apr. 27, 2021, available at: https:/Awww.beckershospitalreview.com/finance/revoked-texas-medicaid-waiver-credit-negative-for-hospitals.html. [FN21] "Health Center Program Impact and Growth," HRSA, updated Aug. 21, 2021, available at: https://ophc.hrsa.gov/about/ healthcenterprogram/index.html. [FN22] 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. [FN23] *"2021 Community Health Center Chart Book," National Association of Community Health Centers, available at: https:/Awww.nachc.org/ research-and-data/research-fact-sheets-and-infographics/2021-community-health-center-chartbook/. [FN24] 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-modernize-health-centers.html. [FN25] 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-modermize-health-centers.html. [FN26] News Release, "*HHS Awards Nearly $55 Million to Increase Virtual Health Care Access and Quality Through Community Health Centers," HHS, Feb. 14, 2022, available at: https:/Awww.hhs.gov/about/news/2022/02/14/hhs-awards-nearly-55-million-increase-virtual- health-care-access-quality-through-community-health-centers.html?utm. [FN27] News Release, "HHS Awards Nearly $55 Million to Increase Virtual Health Care Access and Quality Through Community Health Centers," HHS, Feb. 14, 2022, available at: https:/Avww.hhs.gov/about/news/2022/02/1 4/hhs-awards-nearly-55-million-increase-virtual- health-care-access-quality-through-community-health-centers.html?utm. [FN28] News Release, ""HHS Awards Nearly $90 Million to Community Health Centers to Advance Health Equity through Better Data," HHS, Aug. 8, 2022, available at: https:/Avww.hhs.gov/about/news/2022/08/08/hhs-awards-nearly-90-million-dollars-to-community-health- centers-to-advance-health-equity-through-better-data.html. [FN29] 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. [FN30] "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 © 2023 Thomson Reuters. No claim to original U.S. Government Works. -40- [FN31] 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. [FN32] 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. [FN33] 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. [FN34] 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. [FN35] 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. [FN36] 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. [FN37] 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. [FN38] 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. [FN39] Jessica Sharac, et al., "How Community Health Centers Are Serving Low-Income Communities During the COVID-19 Pandemic Amid New and Continuing Challenges," Kaiser Family Foundation, June 3, 2022, available at: https:/Avww.kff.org/medicaid/issue-brief/how- community-health-centers-are-serving-low-income-communities-during-the-covid-19-pandemic-amid-new-and-continuing-challenges. Follow the link from this Executive Summary to the Issue Brief for more detailed information. [FN40] Jessica Sharac, ef al., "How Community Health Centers Are Serving Low-Income Communities During the COVID-19 Pandemic Amid New and Continuing Challenges," Issue Brief, Kaiser Family Foundation, June 3, 2022, available at: https:/Avww.kff.org/report- section/how-community-health-centers-are-serving-low-income-communities-during-the-covid-1 9-pandemic-amid-new-and-continuing- challenges-issue-brief/. [FN41] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -41- How Community Health Centers Are Serving Low-Income Communities During the COVID-19 Pandemic Amid New and Continuing Challenges," Issue Brief, Kaiser Family Foundation, June 3, 2022, available at: https:/Awww.kff.org/report-section/how-community- health-centers-are-serving-low-income-communities-during-the-covid-19-pandemic-amid-new-and-continuing-challenges-issue-brief/. [FN42] Jessica Sharac, et al., "How Community Health Centers Are Serving Low-Income Communities During the COVID-19 Pandemic Amid New and Continuing Challenges," Issue Brief, Kaiser Family Foundation, June 3, 2022, available at: https:/Avww.kff.org/report- section/how-community-health-centers-are-serving-low-income-communities-during-the-covid-1 9-pandemic-amid-new-and-continuing- challenges-issue-brief/. [FN43] "Community Health Center Patients by Payer Source," Kaiser Family Foundation, Timeframe: 2020, available at: https:/Avww.kff.org/other/state-indicator/chc-patients-by-payer-source/? dataView=1 &currentTimeframe=0&selectedDistributions=medicaid&sortModel=#c#olld:#L#ocation, #s#ort:#asc'#. [FN44] HRSA is the Health Resources and Services Administration. [FN45] News Release, ""HHS Announces $90 Million to Support New Data-Driven Approaches for Health Centers to Identify and Reduce Health Disparities," HHS, Apr. 21, 2022, available at: https:/Awww.hhs.gov/about/news/2022/04/21 /hhs-announces-90- million-support-new-data-driven-approaches-health-centers-identify-reduce-health-disparities.html?utm_source=news-releases- email&utm_medium=email&utm_campaign=april-24-2022. [FN46] "State of the Union Address," The White House, Mar. 1, 2022, available at: https:/Avww.whitehouse.gov/state-of-the-union-2022/. [FN47] Fact Sheet, "Protecting Seniors and People with Disabilities by Improving Safety and Quality of Care in the Nation's Nursing Homes," The White House, Feb. 28, 2022, available at: https://Awww.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet- protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/. [FN48] Fact Sheet, "Protecting Seniors and People with Disabilities by Improving Safety and Quality of Care in the Nation's Nursing Homes," The White House, Feb. 28, 2022, available at: https://Awww.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet- protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/. [FN49] Press Release, ""Biden-Harris Administration Strengthens Oversight of Nation's Poorest-Performing Nursing Homes," CMS, Oct. 21, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/biden-harris-administration-strengthens-oversight-nations-poorest- performing-nursing-homes (emphasis deleted). [FN50] Fact Sheet, '"Biden-⁠Harris Administration Announces New Steps to Improve Quality of Nursing Homes," The White House, Oct. 21, 2022, available at: https:/Avww.whitehouse.gov/briefing-room/statements-releases/2022/1 0/2 1/fact-sheet-biden-harris- administration-announces-new-steps-to-improve-quality-of-nursing-homes/. [FN51] News Release, ""HHS Releases New Data and Report on Hospital and Nursing Home Ownership," HHS, Apr. 20, 2022, available at: https:/Avww.hhs.gov/about/news/2022/04/20/hhs-releases-new-data-and-report-hospital-and-nursing-home-ownership.html? utm_source=news-releases-email&utm_medium=email&utm_campaign=april-24-2022. [FN52] "Executive Order on Promoting Competition in the American Economy," The White House, July 9, 2022, available at: https:// www.whitehouse.gov/briefing-room/presidential-actions/202 1/07/09/executive-order-on-promoting-competition-in-the-american- economy/. [FN53] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -42- News Release, "HHS Releases New Data and Report on Hospital and Nursing Home Ownership," HHS, Apr. 20, 2022, available at: https:/Avww.hhs.gov/about/news/2022/04/20/hhs-releases-new-data-and-report-hospital-and-nursing-home-ownership.html? utm_source=news-releases-email&utm_medium=email&utm_campaign=april-24-2022. [FN54] Press Release, ""Biden-Harris Administration Makes More Medicare Nursing Home Ownership Data Publicly Available, Improving Identification of Multiple Facilities Under Common Ownership," CMS, Sept. 26, 2022, available at: https:/Avww.cms.gov/newsroom/ press-releases/biden-harris-administration-makes-more-medicare-nursing-home-ownership-data-publicly-available; Fact Sheet, "Protecting Seniors by Improving Safety and Quality of Care in the Nation's Nursing Homes," The White House, Feb. 28, 2022, available at: https:/Awww.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with- disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/. [FN55] "Executive Order on Promoting Competition in the American Economy," The White House, July 9, 2021, available at: https:// www.whitehouse.gov/briefing-room/presidential-actions/202 1/07/09/executive-order-on-promoting-competition-in-the-american- economy/. [FN56] Press Release, '"Biden-Harris Administration Makes More Medicare Nursing Home Ownership Data Publicly Available, Improving Identification of Multiple Facilities Under Common Ownership," CMS, Sept. 26, 2022, available at: https:/Avww.cms.gov/newsroom/ press-releases/biden-harris-administration-makes-more-medicare-nursing-home-ownership-data-publicly-available. [FN57] Press Release, ""Biden-Harris Administration Makes More Medicare Nursing Home Ownership Data Publicly Available, Improving Identification of Multiple Facilities Under Common Ownership," CMS, Sept. 26, 2022, available at: https:/Avww.cms.gov/newsroom/ press-releases/biden-harris-administration-makes-more-medicare-nursing-home-ownership-data-publicly-available. [FN58] 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. [FN59] 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. [FN60] 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. [FN61] "Nursing Home Visitation Frequently Asked Questions (FAQs)," CMS, Jan. 6, 2022, available at: https:/Awww.cms.gov/files/document/ nursing-home-visitation-faq-1223.pdf (footnote omitted). [FN62] "How to Safely Conduct Visits to Nursing Homes," CMS, available at: https:/Awww.cms.gov/files/document/how-safely-visit-nursing- homes. pdf. [FN63] Press Release, *"To Advance Information on Quality of Care, CMS Makes Nursing Home Staffing Data Available," CMS, Jan. 26, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/advance-information-quality-care-cms-makes-nursing-home-staffing-data- available. [FN64] Press Release, *"To Advance Information on Quality of Care, CMS Makes Nursing Home Staffing Data Available," CMS, Jan. 26, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/advance-information-quality-care-cms-makes-nursing-home-staffing-data- available. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -43- [FN65] Letter to CMS Certified Nursing Home Operators, "Nursing Home Staff Turnover and Weekend Staffing Levels," Ref: QSO-22-08-NH, Jan. 7, 2022, available at: https:/Avww.cms.gov/files/document/qso-22-08-nh.pdf. [FN66] Medicare.gov, https:/Awww.medicare.gov/care-compare/. [FN67] Press Release, ""CMS Enhances Nursing Home Rating System with Staffing and Turnover Data," CMS, July 27, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/cms-enhances-nursing-home-rating-system-staffing-and-turnover-data. [FN68] Fact Sheet, ""Updates to the Care Compare Website July 2022," CMS, July 27, 2022, available at: https:/Avwww.cms.gov/newsroom/ fact-sheets/updates-care-compare-website-july-2022. [FN69] "Design for Care Compare Nursing Home Five-Star Quality Rating System: Technical Users' Guide," CMS. July 2022, available at: https:/Avww.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/downloads/usersguide.pdf. [FN70] 81 F.R. 68688-01 (Oct. 4, 2016). [FN71] Fact Sheet, '"Updated Guidance for Nursing Home Resident Health and Safety," CMS, June 29, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/updated-guidance-nursing-home-resident-health-and-safety. [FN72] Press Release, ""CMS Issues Significant Updates to Improve the Safety and Quality Care for Long-Term Care Residents and Calls for Reducing Room Crowding," CMS, June 29, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-issues-significant- updates-improve-safety-and-quality-care-long-term-care-residents-and-calls. [FN73] Fact Sheet, '"Updated Guidance for Nursing Home Resident Health and Safety," CMS, June 29, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/updated-guidance-nursing-home-resident-health-and-safety. [FN74] Fact Sheet, "Protecting Seniors by Improving Safety and Quality of Care in the Nation's Nursing Homes," The White House, Feb. 28, 2022, available at: https:/Avww.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and- people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/. [FN75] Fact Sheet, "Updated Guidance for Nursing Home Resident Health and Safety," CMS, June 29, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/updated-guidance-nursing-home-resident-health-and-safety. [FN76] Press Release, "CMS Returning to Certain Pre-COVID-19 Policies in Long-term Care and Other Facilities," CMS, Apr. 7, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-returning-certain-pre-covid-19-policies-long-term-care-and-other- facilities. [FN77] Press Release, "CMS Returning to Certain Pre-COVID-19 Policies in Long-term Care and Other Facilities," CMS, Apr. 7, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-returning-certain-pre-covid-1 9-policies-long-term-care-and-other- facilities. [FN78] Letter to State Survey Directors, "Update to COVID-19 Emergency Declaration Blanket Waivers for Specific Providers," CMS, Apr. 7, 2022, available at: https:/Awww.cms.gov/files/document/qso-22-15-nh-nltc-Isc.pdf. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -44- [FN79] News Release, "HHS Announces New Funding Opportunity to Strengthen Behavioral Health Services in Nursing Homes and Other Long-Term Care Facilities," HHS, May 16, 2022, available at: https:/Awww.hhs.gov/about/news/2022/05/16/hhs-announces-new- funding-opportunity-strengthen-behavioral-health-services-nursing-homes-other-long-term-care-facilities.html?utm_source=news- releases-email&utm. [FN80] MaryBeth Musumeci, et a/., "State Actions to Address Nursing Home Staffing During COVID-19," Kaiser Family Foundation, May 16, 2022, available at: https://Awww.kff.org/medicaid/issue-brief/state-actions-to-address-nursing-home-staffing-during-covid-19/? utm_campaign =KFF-2022-The-Latest&utm. [FN81] 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. [FN82] 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. [FN83] "CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule," CMS, available at: https:/Awww.cms.gov/files/document/ cms-omnibus-staff-vax-requirements-2021 .pdf. [FN84] Biden v. Missouri, U.S. Supreme Court, Nos. 21A240 and 21A241, Jan. 13, 2021, 2022 WL 120950. [FN85] Biden v. Missouri, U.S. Supreme Court, Nos. 21A240 and 21A241, Jan. 13, 2021, 2022 WL 120950. [FN86] Press Release, "Statement by CMS Administrator Chiquita Brooks-LaSure on the U.S. Supreme Court's Decision on Vaccine Requirements," CMS, Jan. 13, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/statement-cms-administrator- chiquita-brooks-lasure-us-supreme-courts-decision-vaccine-requirements. [FN87] Press Release, *"Statement by CMS Administrator Chiquita Brooks-LaSure on the U.S. Supreme Court's Decision on Vaccine Requirements," CMS, Jan. 13, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/statement-cms-administrator- chiquita-brooks-lasure-us-supreme-courts-decision-vaccine-requirements. [FN88] Priya Chidambaram and MaryBeth Musumeci, ""Nursing Facility Staff Vaccinations, Boosters, and Shortages After Vaccination Deadlines Passed," Kaiser Family Foundation, May 16, 2022, available at: https://www.kff.org/medicaid/issue-brief/nursing-facility-staff- vaccinations-boosters-and-shortages-after-vaccination-deadlines-passed/?utm_campaign=KFF-2022-Medicare&utm. [FN89] Press Release, ""Biden-Harris Administration Takes Additional Action to Protect America's Nursing Home Residents from COVID-19," CMS, Aug. 18, 2021, available at: https://Awww.cms.gov/newsroom/press-releases/biden-harris-administration-takes-additional-action- protect-americas-nursing-home-residents-covid-19. [FN90] Priya Chidambaram and MaryBeth Musumeci, ""Nursing Facility Staff Vaccinations, Boosters, and Shortages After Vaccination Deadlines Passed," Kaiser Family Foundation, May 16, 2022, available at: https:/Awww.kff.org/medicaid/issue-brief/nursing-facility-staff- vaccinations-boosters-and-shortages-after-vaccination-deadlines-passed/?utm_campaign=KFF-2022-Medicare&utm. [FN91] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -45- Audra D.S. Burch and Reed Abelson, ""Hospitals Confront the Fallout from Supreme Court Ruling on Vaccine Mandate," The New York Times, Jan. 15, 2022, available at: https:/Awww.nytimes.com/2022/01/15/us/healthcare-workers-vaccine-mandate.html. [FN92] Audra D.S. Burch and Reed Abelson, ""Hospitals Confront the Fallout from Supreme Court Ruling on Vaccine Mandate," The New York Times, Jan. 15, 2022, available at: https:/Avww.nytimes.com/2022/01/15/us/healthcare-workers-vaccine-mandate.html. [FN93] Audra D.S. Burch and Reed Abelson, ""Hospitals Confront the Fallout from Supreme Court Ruling on Vaccine Mandate," The New York Times, Jan. 15, 2022, available at: https:/Avww.nytimes.com/2022/01/15/us/healthcare-workers-vaccine-mandate.html. [FN94] Press Release, *"COVID-19 Vaccination Rates Among Nursing Home Staff Have Risen by 25 Percentage Points Since the Biden Administration Announced a Vaccination Mandate for Health Care Workers Last Year," Kaiser Family Foundation, May 16, 2022, available at: https:/Awww.kff.org/coronavirus-covid-19/press-release/covid-19-vaccination-rates-among-nursing-home-staff-have-risen- by-25-percentage-points-since-the-biden-administration-announced-a-vaccination-mandate-for-health-care-workers-last-year/?utm. [FN95] MaryBeth Musumeci, et a/., "State Actions to Address Nursing Home Staffing During COVID-19," Kaiser Family Foundation, May 16, 2022, available at: https://Awww.kff.org/medicaid/issue-brief/state-actions-to-address-nursing-home-staffing-during-covid-19/? utm_campaign =KFF-2022-The-Latest&utm. [FN96] News Release, ""HHS Announces Efforts to Help Expand Nationwide Access and Coverage for High-quality Maternal Health Services," HHS, Dec. 7, 2021, available at: https:/Avww.hhs.gov/about/news/2021/12/07/hhs-announces-efforts-help-expand-nationwide-access- coverage-high-quality-maternal-health-services.html. [FN97] News Release, ""HHS Encourages Hospitals to Implement Patient Safety Best Practices to Improve Maternity Care and Outcomes," HHS, Dec. 14, 2021, available at: https:/Avww.hhs.gov/about/news/2021/12/14/hhs-encourages-hospitals-implement-patient-safety- best-practices-improve-matermnity-care-and-outcomes.html?utm. [FN98] "Patient Safety Bundles," ACOG, available at: https://safehealthcareforeverywoman.org/council/patient-safety-bundles/maternal- safety-bundles/. [FN99] "Partnership for Patients," CMS, available at: https://innovation.cms.gov/innovation-models/partnership-for-patients. [FN100] 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. [FN101] 'Hospital-Acquired Condition Reduction Program,' CMS, updated July 20, 2017, available at: https:/Awww.cms.gov/Medicare/Medicare- Fee-for-Service-Payment/AcutelnpatientPPS/HAC-Reduction-Program.html. [FN102] "Fiscal Year 2022 Fact Sheet Hospital-Acquired Condition (HAC) Reduction Program," CMS, available on this page: https:// qualitynet.cms.gov/inpatient/hac/resources. [FN103] 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-75 1 -hospitals-for-patient-injuries/. [FN104] 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/. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -46- [FN105] "Map: The 786 hospitals facing HAC penalties in 2020," Advisory Board, Feb. 3, 2020, available at: https://www.advisory.com/daily- briefing/2020/02/03/hac-penalties. [FN106] 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/. [FN107] 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. [FN108] "2021 National and State Healthcare-Associated Infections Progress Report," CDC, available at: https://www.cdc.gov/hai/pdfs/ progress-report/2021 -Progress-Report-Executive-Summary-H.pdf. [FN109] For more information, please the program's web page, available at: https:/Awww.cms.gov/Medicare/Quality-Initiatives-Patient- Assessment-Instruments/Value-Based-Programs/HRRP/Hospital-Readmission-Reduction-Program. [FN110] 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/. [FN111] 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/. [FN112] 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-8W3bIMAa5djvt7xQoldrM7rDf7lJegkKsPTn43Xuj- bIXdysYqAiCn1dYOKGRWY 1KXODsVHU2- T5fZUHOQxbA&_hsmi=54983441 &utm_content=54983441&utm_source=hs_email&hsCtaTracking=0502294f-1 5f4-4880- bdb9-997c6964e2c3@635b5198-58a8-46c8-bf1 c-b4f9d4bf7750. [FN113] "Hospital Readmissions Reduction Program," CMS, available at: https:/Avww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ AcutelnpatientPPS/Readmissions-Reduction-Program. [FN114] 83 F.R. 41144-01 (Aug. 17, 2018). [FN115] 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. [FN116] "Evaluation of the Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents - Payment Reform (NFI 2) Final Report (FY 2017-FY 2019)," Innovation Center, available at: https://innovation.cms.gov/data-and-reports/2022/nfi2-final-aag-report. From this at-a-glance report, you may link to the full report. [FN117] Youssra Marjoua and Kevin J. Bozic, "Brief History of Quality Movement in US healthcare," National Library of Medicine, Sept. 9, 2012, available at: https:/Avww.ncbi.nim.nih.gov/pmc/articles/PMC3702754/#. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -47- [FN118] See, e.g., "Report to Congress: National Strategy for Quality Improvement in Health Care," CMS, Mar. 2011, available at: https:// www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/qualityO321201 1a. [FN119] Michelle Schreiber, et ai/., **The CMS National Quality Strategy: A Person-Centered Approach to Improving Quality," CMS Blog, June 6, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/3 1afec9. [FN120] Michelle Schreiber, ef al/., **The CMS National Quality Strategy: A Person-Centered Approach to Improving Quality," CMS Blog, June 6, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/3 1afec9. [FN121] Michelle Schreiber, et al., *"*The CMS National Quality Strategy: A Person-Centered Approach to Improving Quality," CMS Blog, June 6, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/3 1afec9. [FN122] "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. [FN123] "What are Value-Based Programs?" CMS, updated 1/6/2020, available at: https:/Avww.cms.gov/Medicare/Quality-Initiatives-Patient- Assessment-Instruments/Value-Based-Programs/Value-Based-Programs. [FN124] 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. [FN125] 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. [FN126] BPCI Advanced, CMS, available at: https://innovation.cms.goviinitiatives/bpci-advanced. [FN127] ™"BPCI Advanced Model Year 5 Fact Sheet," CMS, Nov. 2021, available at: https://innovation.cms.gov/media/document/bpci-advanced- model-overview-fact-sheet-my5. [FN128] BPCI Advanced, CMS, available at: https://innovation.cms.goviinitiatives/bpci-advanced. [FN129} "Model Overview Fact Sheet - Model Year 6 (2023)," CMS, available at: https://innovation.cms.gov/media/document/bpcia-model- overview-fact-sheet-my6. [FN130] BPCI Advanced, CMS, available at: https://innovation.cms.goviinitiatives/bpci-advanced. [FN131] "Comprehensive Care for Joint Replacement Model," CMS' Innovation Center, available at: https://innovation.cms.gov/innovation- models/cjr. [FN132] 86 F.R. 23496 (May 3, 2021). THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -48- [FN133] 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:/Avwww.commonwealthfund.org/publications/journal-article/2021/may/hospital-incentives- bundled-payment-joint-surgery?utm_source=alert&utm_medium=email&utm_campaign=Drug Costs/. [FN134] Fact Sheet, 'Accountable Care Organizations: What Providers Need to Know, Oct. 20, 2011, available at: http:/Avww.cms.gov/ Newsroom/MediaReleaseDatabase/Fact-Sheets/201 1-Fact-Sheets-ltems/2011-10-207.html. [FN135] 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/. [FN136] "Shared Savings Program Fast Facts - As of Jan. 1, 2022," CMS, available at: https:/Avww.cms.gov/files/document/2022-shared- savings-program-fast-facts. pdf. [FN137] "Beneficiary Engagement Toolkit," CMS, Nov. 2019, available at: https://innovation.cms.gov/files/x/aco-beneficiary-engagement- toolkit.pdf. [FN138] "Care Coordination Toolkit," CMS, Mar. 2019, available at: https://innovation.cms.gov/files/x/aco-carecoordination-toolkit.pdf/. [FN139] "Provider Engagement Toolkit," CMS, July 2020, available at: https://innovation.cms.gov/media/document/2020-provider-engagement- toolkit. [FN140] "Care Transformation Toolkit," CMS, Jan. 2021, available at: https://innovation.cms.gov/media/document/aco-caretransformation- toolkit. [FN141] Operation Elements Toolkit, CMS, May 2021, available at: https://innovation.cms.gov/media/document/aco-operational-elements-toolkit. [FN142] 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:/Avww.cms.gov/newsroom/press-releases/cms- proposes-pathways-success-overhaul-medicares-aco-program. [FN143] "Medicare Shared Savings Program," CMS, available at: https:/Avww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/about.html. [FN144] 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/. [FN145] Fact Sheet, '""New Accountable Care Organization Model Opportunity: Medicare ACO Track 1+ Model," updated July 2017, available at: https:/Avwww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/New-Accountable-Care- Organization-Model-Opportunity-Fact-Sheet. pdf. [FN146] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -49- 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. [FN147] Press Release, Tom Nickels, 'Statement on the New Track 1+ Accountable Care Organization Model,' available at: http:/Avww.aha.org/ presscenter/pressrel/2016/162012-pr-track.shtml. [FN148] 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. [FN149] 83 F.R. 41786 (Aug. 17, 2018). [FN150] 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/. [FN151] 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 [FN152] 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:/Av ww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/about.html. [FN153] 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. [FN154] 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. [FN155] 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. [FN156] 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. [FN157] 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. [FN158] "Shared Savings Program Participation Options for Performance Year 2022," CMS, Apr. 2021, available at: https:/Awww.cms.gov/ Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/ssp-aco-participation-options. pdf. [FN159] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -50- 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/. [FN160] 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. [FN164] Press Release, "Medicare Shared Savings Program Continues to Grow and Deliver High-Quality, Person-Centered Care Through Accountable Care Organizations," Jan. 26, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/medicare-shared- savings-program-continues-grow-and-deliver-high-quality-person-centered-care-through. From that page, you may link to the data. [FN162] Press Release, "Medicare Shared Savings Program Saves Medicare More Than $1.6 Billion in 2021 and Continues to Deliver High- quality Care," CMS, Aug. 30, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/medicare-shared-savings-program- saves-medicare-more-16-billion-2021-and-continues-deliver-high. [FN163] Press Release, *"CMS Redesigns Accountable Care Organization Model to Provide Better Care for People with Traditional Medicare," CMS, Feb. 24, 2022, available at: https:/Avwww.cms.gov/newsroom/press-releases/cms-redesigns-accountable-care-organization-model- provide-better-care-people-traditional-medicare. [FN164] See Innovation Center Design Refresh, CMS, available at: https://innovation.cms.gov/strategic-direction-whitepaper. [FN165] Press Release, ""CMS Redesigns Accountable Care Organization Model to Provide Better Care for People with Traditional Medicare," CMS, Feb. 24, 2022, available at: https:/Avwww.cms.gov/newsroom/press-releases/cms-redesigns-accountable-care-organization-model- provide-better-care-people-traditional-medicare. [FN166] Fact Sheet, '"Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model," CMS, Feb. 24, 2022, available at: https:/Avww.cms.gov/newsroom/fact-sheets/accountable-care-organization-aco-realizing-equity-access-and- community-health-reach-model. [FN167] Fact Sheet, ""Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model," CMS, Feb. 24, 2022, available at: https:/Avww.cms.gov/newsroom/fact-sheets/accountable-care-organization-aco-realizing-equity-access-and- community-health-reach-model. [FN168] CMS Rural Health Strategy, CMS, 2018, available at: https:/Avww.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural- Strategy-2018.pdf. [FN169] CMS Rural Health Strategy, CMS, 2018, available at: https:/Awww.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural- Strategy-2018.pdf. [FN170] "Improving Health in Rural Communities Fiscal Year 2021 in Review," CMS, available at: https:/Avww.cms.gov/files/document/fy-21 - improving-health-rural-communities508compliant. pdf. [FN171] 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. [FN172] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -51- Shawn Radcliffe, "Rural Hospitals Closing at an Alarming Rate," Healthline, Feb. 15, 2017, available at: https:/Avww.healthline.com/ health-news/rural-hospitals-closing#1. [FN173] 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. [FN174] 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. [FN175] 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# Topic- based&utm_source=hs_email&utm_medium=email&utm_content=69092496& _hsenc=p2ANatz-9tsv7t9Gth4T2860-hnjgN2k4pR-fzM- VQ3jjHGb83-D9uu3-PTuXpIBIGaK79_3NjoVil2ZOKiwi8mcNSakFIQE1tBUw&_hsmi=69092496. [FN176] The proposed rule is published at 87 F.R. 40350-01 (July 6, 2022). [FN177] Fact Sheet, '"Conditions of Participation for Rural Emergency Hospitals and Critical Access Hospital COP Updates (CMS-3419-P)," CMS, June 30, 2022, available at: https:/Awww.cms.gov/newsroom/fact-sheets/conditions-participation-rural-emergency-hospitals-and- critical-access-hospital-cop-updates-cms-3419. [FN178] Press Release, ""Biden-Harris Administration Takes Action to Expand Access to Emergency Care Services in Rural Communities," CMS, June 30, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/biden-harris-isadministration-takes-action-expand- access-emergency-care-services-rural-communities. [FN179] Fact Sheet, "CY 2023 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS 1772-FC) Rural Emergency Hospitals - New Medicare Provider Type," CMS, Nov. 1, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical- center-1. [FN180] 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. [FN181] CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN182] CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN183] CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN184] CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN185] "Chart Model," Innovation Center web site, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN186] CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -52- [FN187] Email, "ACO Transformation Track Update," CMS, Feb. 22, 2022. [FN188] 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. [FN189] 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. [FN190] Karen Pollitz, *"No Surprises Act Implementation: What to Expect in 2022," Kaiser Family Foundation, Dec. 10, 2021, available at: https:/Avww.kff.org/health-reform/issue-brief/no-surprises-act-implementation-what-to-expect-in-2022/?utm_campaign=KFF-2021 - Health-Reform&utm. [FN191] Margot Sanger-Katz, *"A New Ban on Surprise Medical Bills Starts Today," The New York Times, Jan. 1, 2022, available at: https:// www.nytimes.com/2021/12/30/upshot/medical-bill-ban-biden.html. [FN192] Karen Pollitz, *"No Surprises Act Implementation: What to Expect in 2022," Kaiser Family Foundation, Dec. 10, 2021, available at: https:/Avww.kff.org/health-reform/issue-brief/no-surprises-act-implementation-what-to-expect-in-2022/?utm_campaign=KFF-2021 - Health-Reform&utm. [FN193] Karen Pollitz, "No Surprises Act Implementation: What to Expect in 2022," Kaiser Family Foundation, Dec. 10, 2021, available at: https:/Avww.kff.org/health-reform/issue-brief/no-surprises-act-implementation-what-to-expect-in-2022/?utm_campaign=KFF-2021- Health-Reform&utm. [FN194] 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. [FN195] Karen Pollitz, *"No Surprises Act Implementation: What to Expect in 2022," Kaiser Family Foundation, Dec. 10, 2021, available at: https:/Avww.kff.org/health-reform/issue-brief/no-surprises-act-implementation-what-to-expect-in-2022/?utm_campaign=KFF-2021 - Health-Reform&utm. [FN196] "Law Aiming to Protect Consumers against Surprise Medical Bills takes Effect," All Things Considered, NPR, Jan. 2, 2022, available at: https:/Avww.npr.org/2022/01/02/1069784227/no-surprises-act-begins. [FN197] Among the regulations are final rules published at 86 F.R. 36870-01 (July 13, 2021) and 86 F.R. 55980 (Oct. 7, 2021), and a proposed rule published at 86 F.R. 51730-01 (Sept. 16, 2021). [FN198] See, e.g., Ken Alltucker, "As Surprise Billing Ban Nears, Doctors and Hospitals Scramble to Delay Federal Law," USA Today, Dec. 11, 2021, available at: https:/Avww.usatoday.com/story/news/health/2021/12/1 1/no-surprises-act-has-doctors-pushing-delay-medical-billing- changes/6457833001/; Margot Sanger-Katz, ""A New Ban on Surprise Medical Bills Starts Today," The New York Times, Jan. 1, 2022, available at: https:/Awww.nytimes.com/2021/12/30/upshot/medical-bill-ban-biden.html; Ariel Cohen, "Lawmakers Push for Surprise Billing Changes as Law Takes Effect," Roll Call, Jan. 5, 2022, available at: https:/Awww.rollcall.com/2022/01/05/lawmakers-push-for- surprise-billing-changes-as-law-takes-effect/. [FN199] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -53- Ken Alltucker, *"As Surprise Billing Ban Nears, Doctors and Hospitals Scramble to Delay Federal Law," USA Today, Dec. 11, 2021, available at: https://(www.usatoday.com/story/news/health/2021/12/11/no-surprises-act-has-doctors-pushing-delay-medical-billing- changes/6457833001/; Ariel Cohen, "Lawmakers Push for Surprise Billing Changes as Law Takes Effect," Roll Call, Jan. 5, 2022, available at: https://Awww.rollcall.com/2022/01/05/lawmakers-push-for-surprise-billing-changes-as-law-takes-effect/. [FN200] "Ending Surprise Medical Bills," available at: https:/Avww.cms.gov/nosurprises. [FN201] 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. [FN202] 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. [FN203] 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. [FN204] 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:/Avww.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing-part-i-interim-final-rule-comment- period. [FN205] 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). [FN206] The rule is published at 86 F.R. 55980-01 (Oct. 7, 2021). [FN207] 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. [FN208] The program is so named because it was created by Section 340B of the Public Health Service Act, Pub. L. 102-585. It has been amended by later acts, such as the Affordable Care Act (Pub. L. 111-148) and the Medicare and Medicaid Extenders Act of 2010 (Pub. L. 111-309. "Section 340B Public Health Service Act," HRSA, available at: https:/Avww.hrsa.gov/sites/default/files/opa/ programrequirements/phsactsection340b.pdf. [FN209] "Fact Sheet: The 340B Drug Pricing Program," American Hospital Association, available at: https:/Avww.aha.org/fact- sheets/2020-01-28-fact-sheet-340b-drug-pricing-program. [FN210] American Hospital Assoc. v. Becerra, U.S. Supreme Court, Slip Op., No. 20-1114, June 15, 2022, available at: https:// www.supremecourt.gov/opinions/21 pdf/20-1114_09m1.pdf. [FN211] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -54- American Hospital Assoc. v. Becerra, U.S. Supreme Court, Slip Op., No. 20-1114, June 15, 2022, available at: https:// www.supremecourt.gov/opinions/21 pdf/20-1114_09m1.pdf. [FN212] American Hospital Assoc. v. Becerra, U.S. Supreme Court, Slip Op., No. 20-1114, June 15, 2022, available at: https:// www.supremecourt.gov/opinions/21 pdf/20-1114_09m1.pdf. [FN213] Special Bulletin, "Supreme Court Rules Unanimously in Favor of AHA, Others in 340B Case," AHA, June 15, 2022, available at: https:/Avww.aha.org/special-bulletin/2022-06-22-supreme-court-rules-unanimously-favor-aha-others-340b-case#:?:text=The Supreme Court of the,340B Drug Pricing Program# and. [FN214] Becerra v. Empire Health Foundation, U.S. Supreme Court, No. 20-1312, June 24 2022, available at: https:/Avwww.supremecourt.gov/ opinions/21pdf/20-1312_j42I.pdf. [FN215] Becerra v. Empire Health Foundation, U.S. Supreme Court, No. 20-1312, June 24 2022, available at: https:/Avww.supremecourt.gov/ opinions/21pdf/20-1312_j42I.pdf. [FN216] 42 U.S.C. 1395ww(d)(5)(F)(vi)(I). [FN217] Becerra v. Empire Health Foundation, U.S. Supreme Court, No. 20-1312, June 24 2022, available at: https:/Avww.supremecourt.gov/ opinions/21pdf/20-1312_j42I.pdf. [FN218] Becerra v. Empire Health Foundation, U.S. Supreme Court, No. 20-1312, June 24 2022, available at: https:/Avww.supremecourt.gov/ opinions/21pdf/20-1312_j42I.pdf. [FN219] 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. [FN220] 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. [FN221] 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.cim/2021/2/bennet- colleagues-introduce-bicameral-legislation-to-expand-medicaid-coverage-for-covid-1 9-treatment-vaccines. [FN222] 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. [FN223] 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. [FN224] Press Release, '"Rubio Reintroduces Bill to Modemize 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. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -55- [FN225] 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/2019/07/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://www.kff.org/medicaid/state-indicator/federal-matching-rate-and-multiplier/? currentTimeframe=0&sortModel=#c#olld:#L#ocation,#s#ort:#asc'#. [FN226] 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. [FN227] 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. [FN228] 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. [FN229] 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. [FN230] "The Nursing Home Improvement and Accountability Act of 2021," Senate Finance Committee, available at: https:// www.finance.senate.gov/imo/media/doc/Nursing Home Improvement and Accountability Act_One-Pager_Final.pdf. [FN231] 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. [FN232] 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://harshbarger.house.gov/media/press-releases/ congresswoman-diana-harshbarger-introduces-bill-prohibit-federal-government. [FN233] News Release, ""HHS Distributing $560 Million in Provider Relief Fund Payments to Health Care Providers Affected by the COVID-19 Pandemic," HHS, Feb. 24, 2022, available at: https:/Awww.hhs.gov/about/news/2022/02/24/hhs-distributing-560-million-provider-relief- fund-payments-health-care-providers-affected-covid-19-pandemic.html?utm. [FN234] News Release, ""HHS Distributing $560 Million in Provider Relief Fund Payments to Health Care Providers Affected by the COVID-19 Pandemic," HHS, Feb. 24, 2022, available at: https:/Awww.hhs.gov/about/news/2022/02/24/hhs-distributing-560-million-provider-relief- fund-payments-health-care-providers-affected-covid-19-pandemic.html?utm. [FN235] Press Release, "Ernst Leads Effort to Ensure Abortion Data Is Reported Accurately, Completely," web site of Sen. Joni Ernst, Jan. 21, 2022, available at: https:/Avww.ernst.senate.gov/public/index.cfm/2022/1 /ernst-leads-effort-to-ensure-abortion-data-is-reported- accurately-completely/ [FN236] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -56- Press Release, *"Foster Introduces Bipartisan Medicaid CARE Act to Expand Access to Substance Use Disorder Treatment Under Medicaid," Rep. Foster's web site, Mar. 22, 2022, available at: https://foster.house.gov/media/press-releases/foster-introduces- bipartisan-medicaid-care-act-to-expand-access-to-substance. [FN237] 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. [FN238] Press Release, *"Senators Carper, Scott Introduce Bill to Extend Hospital at Home Waiver Program," Sen. Carper''s web site, Mar. 10, 2022, available at: https:/Awww.carper.senate.gov/public/index.cfm/pressreleases?ID=E21A7F2D-856C-4D1E-819F-A8A411C2A139. [FN239] The notice is published at 87 F.R. 14858 (Mar. 16, 2022). [FN240] Press Release, "Rep. Maloney Introduces the Michelle Go Act to Improve Medicaid Coverage of Mental Health Services," Rep. Maloney's web site, May 21, 2022, available at: https://maloney.house.gov/media-center/press-releases/rep-maloney-introduces-the- michelle-go-act-to-improve-medicaid-coverage. [FN241] The rule is published at 87 F.R. 25413-01 (Apr. 29, 2022). Corrections were published at 87 F.R. 36409 (June 17, 2022). [FN242] Press Release, ""Warner, Scott Reintroduce Bipartisan Legislation to Improve Hiring of Caregivers for Seniors," web site of Sen. Mark Warner (D-Va.), June 13, 2022, available at: https:/Avww.wamer.senate.gov/public/index.cfm/pressreleases? ID=69426FAC-SEE2-43B3-A82F-2A6B7904EFFF. [FN243] Press Release, New CMS Rule Increases Payments for Acute Care Hospitals and Advances Health Equity, Maternal Health," CMS, Aug. 1, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/new-cms-rule-increases-payments-acute-care-hospitals-and- advances-health-equity-maternal-health. [FN244] Press Release, New CMS Rule Increases Payments for Acute Care Hospitals and Advances Health Equity, Maternal Health," CMS, Aug. 1, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/new-cms-rule-increases-payments-acute-care-hospitals-and- advances-health-equity-maternal-health. [FN245] Press Release, New CMS Rule Increases Payments for Acute Care Hospitals and Advances Health Equity, Maternal Health," CMS, Aug. 1, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/new-cms-rule-increases-payments-acute-care-hospitals-and- advances-health-equity-maternal-health. [FN246] Fact Sheet, ""FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule - CMS-1771-F," CMS, Aug. 1, 2022, available at: https:/Avwww.cms.gov/newsroom/fact-sheets/ fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective. [FN247] Fact Sheet, '"FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospitals (LTCH PPS) Final Rule - CMS-1771-F Maternal Health," CMS, Aug. 1, 2022, available at: https://www.cms.gov/newsroom/fact-sheets/fy-2023-hospital- inpatient-prospective-payment-system-ipps-and-long-term-care-hospitals-ltch-pps-1. [FN248] Fact Sheet, "Fiscal Year (FY) 2023 Skilled Nursing Facility Prospective Payment System Final Rule (CMS 1765-F)," CMS, July 22, 2022, available at: https:/Awww.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2023-skilled-nursing-facility-prospective-payment-system- final-rule-cms-1765-f. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -57- [FN249] Fact Sheet, ""Fiscal Year 2023 Inpatient Rehabilitation Facility Prospective Payment System Final Rule (CMS-1767-F)," CMS, Aug. 1, 2022, available at: https:/Awww.cms.gov/newsroom/fact-sheets/fiscal-year-2023-inpatient-rehabilitation-facility-prospective-payment- system-final-rule-cms-1767-f#:?:text=For FY 2023# CMS is updating the IRF PPS payment,at 3.0 #of total payments. [FN250] Fact Sheet, '"Fiscal Year 2023 Medicare Inpatient Psychiatric Facility Prospective Payment System Final Rule (CMS-1769-F)," CMS, July 27, 2022, available at: https:/Awww.cms.gov/newsroom/fact-sheets/fiscal-year-2023-medicare-inpatient-psychiatric-facility- prospective-payment-system-final-rule-cms. [FN251] Fact Sheet, '"Fiscal Year (FY) 2023 Hospice Payment Rate Update Final Rule (CMS-1773-F)," CMS, July 27, 2022, available at: https:/Avww.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2023-hospice-payment-rate-update-final-rule-cms-1773-f. [FN252] Press Release, "Reps. Estes, Connolly Introduce Seniors' Access to Quality Care Act," Rep. Estes' web site, Sept. 14, 2022, available at: https://estes.house.gov/news/documentsingle.aspx?DocumentID=3590. [FN253] State Medicaid Director Letter, #22-005, ""Guidance on Nursing Facility State Plan Payment and Upper Payment Limit Approaches in Medicaid Relying on the Medicare Patient-Driven Payment Model," CMS, Sept. 21, 2022, available at: https:/Awww.medicaid.gov/ federal-policy-guidance/downloads/smd22005.pdf. [FN254] Press Release, "Reps. Estes, Connolly Introduce Seniors' Access to Quality Care Act," Rep. Estes' web site, Sept. 14, 2022, available at: https://estes.house.gov/news/documentsingle.aspx?DocumentID=3590. [FN255] Press Release, *"Rosen, Collins, Lee, Hudson Bipartisan, Bicameral Mobile Health Care Act Heads to President's Desk," Sen. Rosen's web site, Sept. 29, 2022, available at: https://www.rosen.senate.gov/2022/09/29/rosen-collins-lee-hudson-bipartisan-bicameral-mobile- health-care-act-heads-to-presidents-desk/. [FN256] Press Release, "HHS Finalizes Physician Payment Rule Strengthening Access to Behavioral Health Services and Whole-Person Care," CMS, Nov. 1, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/hhs-finalizes-physician-payment-rule- strengthening-access-behavioral-health-services-and-whole. [FN257] Fact Sheet, '"Calendar Year (CY) 2023 Medicare Physician Fee Schedule Final Rule," CMS, Nov. 1, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule. [FN258] Fact Sheet, '"Calendar Year (CY) 2023 Medicare Physician Fee Schedule Final Rule," CMS, Nov. 1, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule. [FN259] Please see the press release for links to other resources for the final rule. Press Release, *"HHS Finalizes Physician Payment Rule Strengthening Access to Behavioral Health Services and Whole-Person Care," CMS, Nov. 1, 2022, available at: https:/Awww.cms.gov/ newsroom/press-releases/hhs-finalizes-physician-payment-rule-strengthening-access-behavioral-health-services-and-whole. [FN260] Press Release, ""HHS Continues Biden-Harris Administration Progress in Promoting Health Equity in Rural Care Access Through Outpatient Hospital and Surgical Center Payment System Final Rule," CMS, Nov. 1, 2022, available at: https:/Awww.cms.gov/ newsroom/press-releases/hhs-continues-biden-harris-administration-progress-promoting-health-equity-rural-care-access-through. [FN261] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -58- Fact Sheet, "CY 2023 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule with Comment Period (CMS 1772-FC)," CMS, Nov. 1, 2022, available at: https:/Avww.cms.gov/newsroom/fact-sheets/ cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-2. [FN262] Fact Sheet, "CY 2023 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS 1772-FC) Rural Emergency Hospitals - New Medicare Provider Type," CMS, Nov. 1, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical- center-1. [FN263] Fact Sheet, ""Calendar Year 2023 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-1768- F)," CMS, Oct. 30, 2022, available at: https:/Avww.cms.gov/newsroom/fact-sheets/calendar-year-2023-end-stage-renal-disease-esrd- prospective-payment-system-pps-final-rule-cms-1768-f. [FN264] Fact Sheet, "CY 2023 Home Health Prospective Payment System Rate Update and Home Infusion Therapy Services Requirements - Final Rule (CMS-1766-F)," CMS, Oct. 31, 2022, available at: https:/Avwww.cms.gov/newsroom/fact-sheets/cy-2023-home-health- prospective-payment-system-rate-update-and-home-infusion-therapy-services-O0. [FN265] NJ ST 30:4D-7t. [FN266] The emergency rule is published at 2022 TX REG TEXT 611683 (NS) (Mar. 28, 2022). Produced by Thomson Reuters Accelus Regulatory Intelligence 27-Jun-2023 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -59-