REGULATORY INTELLIGENCE YEAR-END REPORT - 2023 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. 12/18/2023 |. 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. (FN3] | 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. (FN4] Medicare 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! In January 2023, the Centers for Medicare and Medicaid Services (CMS) listed its 2022 achievements, using its six strategic pillars as a framework. Those pillars are: advancing equity, expanding access to affordable care and coverage, engaging partners, driving innovation, protecting the sustainability of programs, and fostering excellence. [FN6] 5ome of the accomplishments that affect health facilities include these: Equity: CMS created a birthing friendly designation for hospitals, which denotes the hospitals' commitment to maternal health. Additionally, the agency published a final rule establishing Rural Emergency Hospitals as a new Medicare provider type. PNl cms developed new payment policies and quality measures and created the conditions of participation for this provider type, all in an effort [FN8] to address the growing concerns about rural hospital closures. « Increasing access: CMS published rules to implement the No Surprises Act, (FNST \which protects patients from surprise billing. It also published rules to improve the prior authorization process, including the Advancing Interoperability and Improving Prior Authorization [FN10] Processes proposed rule, which aims to improve the processes for Medicare, Medicaid, CHIP, and other plans. * Engaging Partners: Among other things, CMS has been meeting with dozens of stakeholder groups seeking input and feedback on implementation of the Inflation Reduction Act (Pub. L. 117-169), which contains several health-related provisions. « Driving Innovation: CMS released an update on its Innovation Center Strategy Refresh. (FN1I About 900,000 Medicaid enrollees and 4.7 million Medicare enrollees receive care from a program or plan that participates in an Innovation Center model. CMS also give examples of how it is moving toward its goal of enrolling all traditional Medicare enrollees in accountable care. Finally, CMS also noted that it developed the new Enhancing Oncology Model to improve cancer care. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. « Protecting Programs: CMS took many steps to improve the transparency and quality of care in nursing homes. Additionally, CMS reports that it launched fraud investigations targeting schemes meant to exploit, among other things, the COVID-19 pandemic, telemedicine, substance abuse treatment facilities, and opioid distribution. « Fostering Excellence: CMS has taken several steps to make employees more engaged and to increase diversity, inclusion, and accessibility in its offices. T4 Please see CMS' report for more details and a much fuller discussion. The Office of the Actuary in CMS has published its annual 10-year projection of national health expenditures and insurance enroliment, this one covering the years 2022 through 2031. As for overall health expenditures, CMS predicts that between 2022 and 2031, the average annual growth in national health care expenditures - 5.4% - will outpace the average annual growth in the gross domestic product - 4.6% - meaning that health care expenditures will account for a greater proportion of the gross national product. In 2022, that proportion was 18.3%, and in 2031, it is projected to be 19.6%. Medicaid expenditures are projected to grow 5% during the years 2022 to 2031. N3 with regard to hospital spending specifically, CMS projects an average annual growth of 5.8% between 2022 and 2031, but the full picture is more nuanced: Over 2022-2031, hospital spending growth is expected to average 5.8% annually. In 2022, hospital spending is projected to have increased 0.8%, reflecting declines in PHI and out-of-pocket spending and low growth for Medicare, as growth in the use of hospital services slowed from higher rates in 2021. In 2023, faster growth in hospital utilization rates and accelerating growth in hospital prices (related to economywide inflation and rising labor costs) are expected to lead to faster hospital spending growth of 9.3%. For 2025-2031, hospital spending trends are expected to normalize (with projected average annual growth of 6.1%) as there is a transition away from pandemic public health emergency funding impacts on spending. (FN14] Please see the report for more details. [FN19] Il. MEDICAID PAYMENTS TO HEALTH FACILITIES In November 2023, the Kaiser Family Foundation published its annual state Medicaid budget survey, this one for the 2023 and 2024 fiscal years. Forty-eight states (including the District of Columbia), responded to the survey, but not all states responded fully to all questions. This year's survey focused on the Medicaid landscape while states unwind from the COVID-19 public health emergency. [FN16] Hospitals participating in the Medicaid program are deeply affected by state budget policies and priorities, as state budget shortfalls are often reflected in provider payments. According to the authors, states have wide latitude in deciding on fee-for-service provider rates, as long as they satisfy federal requirements, namely that they are consistent with, efficiency, economy, and quality of care; safeguard against unnecessary utilization; and are sufficient to enlist enough providers to ensure that Medicaid enrollees have access to care that is equal to the level of access enjoyed by the general population in the same geographic area. [FN17] For fiscal years 2023 and 2024, more states increased fee-for-service provider rates or had plans to do so than those implementing or planning rate cuts. In fiscal year 2023, for example, 48 of the responding states reported at least once increase in provider rates, while only 21 states reported at least one decrease. Projections are very similar for 2024, with 47 states reporting plans to increase at least one provider rate and 19 reporting plans for at least one decrease. The most common categories for increases were nursing facilities and home- and community-based services. Of the increases in home- and community-based services and nursing facility rates, the authors wrote: In some cases, state officials reported that nursing facility and HCBS rate increases included, at least in part, the continuation of pandemic-related payments or represent temporary rate increases or supplemental payments to HCBS providers using American Rescue Plan Act (ARPA) funds. Some states reported enhanced rates associated with the PHE will be discontinued, while other states noted that these rate increases were made permanent. Reflecting the ongoing staffing-related challenges impacting nursing facility and HCBS services, several states reported more significant nursing facility or HCBS rate increases. [FN18] Another popular increase in fee-for-service rates include primary care physician rates: For fiscal year 2023, 23 states had implemented increases in primary care physician rates, and 30 states had plans to do so for 2024. The Medicaid expansion also significantly affects hospitals. The Affordable Care Act provided for a Medicaid expansion covering all non-elderly, non-pregnant individuals with income up to 138% of the federal poverty level. All but 10 states have adopted the expansion. IFN19] Some have adopted the expansion as the Affordable Care Act originally contemplated it, some have done so through waivers, and others have done so through ballot initiatives when state legislatures were unwilling to act. Among other things, the intent of the expansion was to decrease the uninsured rate and thereby decrease uncompensated care costs for providers. The federal government covers 90% of the cost of the newly eligible and states cover 10% of the costs. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. The Kaiser Family Foundation's most recent literature review on the economic impacts of the expansion summarizes 24 studies conducted between April 2021 and December 2022. The foundation's previous literature reviews in 2020 and 2021 covered more than 600 studies. The newest findings are consistent with past findings. Briefly, the findings include these: « The Medicaid expansion generally improves the payer mix, resulting in an increase in Medicaid-insured individuals and a decrease in uninsured individuals. » The expansion decreases uncompensated care costs for hospitals and other providers. * Hospitals enjoyed higher reimbursements, and the reimbursements unreimbursed Medicaid costs. ¢ Federally-qualified health centers and community health centers experienced higher revenues. [FN20] Please see the report for a fuller and more nuanced discussion of the findings. lil. ISSUES AFFECTING SPECIFIC FACILITIES « Community Health Centers According to the Health Resources and Services Administration (HRSA), community health centers, which serve 30 million people in more than 14,000 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] ealth center patients are generally low-income, with 68% falling at 100% or less of the federal poverty level. About 79% of patients are either uninsured or covered by public insurance. [FN23] The roughly 1,400 Health Resource and Services Administration-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. [MN24 For these reasons, the federal government continues to invest community health centers. 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. [ \2! Later in 2022, the Department of Health and Human Services (HHS), through 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: 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] Finally, HHS announced that it will award $90 million in American Rescue Plan funds to support data-driven efforts that will enable HRSA N2l health centers and look-alikes to identify and reduce health disparities. [FN28] Community health centers played an important role during the pandemic in meeting social needs and providing supportive services, according to a brief from the Kaiser Family Foundation. The Kaiser Family 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 THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. 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. [FN29] 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. [FN30] 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. [FN31] 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 enroliment. (N2 Nearly one-half of all community health center patients are insured by Medicaid. [FN33] pjease see the Issue Brief for a fuller discussion of all of these matters. * 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. [FN34] 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. [FN35] T 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 [FN36] Please see the Fact Sheet for more details about each of these reforms. 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. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. ¢ 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. [FN37] 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. [FN38] 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. [FN39] The data is also meant to encourage competition in facility ownership, which furthers the president's executive order on promoting competition. [FN40] 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. [FN41] 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. [FN42] The move also furthers President Biden's Executive Order on Competition, [FN43] \vhich 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. [FN44] 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. [FN45] CMS also finalized a rule requiring more transparency about the ownership and management of Medicare- and Medicaid-certified nursing homes. The administration has been concerned about private equity ownership of nursing homes, citing research of poorer outcomes and less-than-ideal conditions in nursing homes owned and managed this way: One working paper examining 18,000 nursing home facilities over a 17-year period found that private equity ownership was associated with increased excess mortality for residents by 10%, increased prescription of antipsychotic drugs for residents by 50%, decreased hours of frontline nursing staffing by 3%, and increased taxpayer spending per resident by 11%. Another study found that private equity-backed nursing homes had a COVID-19 infection rate and death rate that were 30% and 40% above statewide averages, respectively. Recent research has found that resident outcomes are significantly worse at private equity-owned nursing homes. A recent study found that residents in nursing homes acquired by private equity were 11.1% more likely to have a preventable emergency department visit and 8.7% more likely to experience a preventable hospitalization, when compared to residents of for-profit nursing homes not associated with private equity. [FN46] The administration believes that requiring more transparency about how nursing homes are held and managed will increase accountability and put consumers in a better position to make informed choices about nursing home care. Please see the Fact Sheet for more detailed information about how this information is to be reported. (FN47] The rule is published at 88 F.R. 80141-01 (Nov. 17, 2023). 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. [FN48] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. 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 was 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. [FN43l cMS also published guidance on this matter. [FNS0] 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. NS 1na 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. %2 The ratings are updated quarterly. A Fact Sheet on the changes to Care Compare is available. [FNS3] A Technical Guide is also available. ™N% These changes support the Biden Administration's focus on improving care and outcomes in nursing homes. In September 2023, CMS proposed a rule setting out minimum staffing requirements in Medicare- and Medicaid-certified nursing homes. As HHS Secretary Xavier Becerra noted, inadequate staffing can have detrimental effects on residents and on the staff: "When facilities are understaffed, residents suffer. They might be unable to use the bathroom, shower, maintain hygiene, change clothes, get out of bed, or have someone respond to their call for assistance. Comprehensive staffing reforms can improve working conditions, leading to higher wages and better retention for this dedicated workforce." [FN52] CMS proposes to calculate staffing levels using hours-per-resident-day (HPRD). For registered nurses (RNs), the requirement would be .55 hours, and for nurse's aides (NAs), the requirement would be 2.45 hours. Additionally, CMS proposes a requirement that an RN be on site 24 hour per day, seven days per week. The rule also proposes enhanced facilities assessment requirements. Facilities are already required to use a facilities assessment, but CMS would update the assessment by: Clarifying that facilities must use evidence-based methods when care planning for their residents, including consideration for those residents with behavioral health needs; Requiring that facilities use the facility assessment to assess the specific needs of each resident in the facility and to adjust as necessary based on any significant changes in the resident population; Requiring that facilities include the input of facility staff, including, but not limited to, nursing home leadership, management, direct care staff (i.e., nurse staff), representatives of direct care staff, and staff who provide other services; and, Requiring facilities to develop a staffing plan to maximize recruitment and retention of staff consistent with what was described in the President's April Executive Order on Increasing Access to Higher Quality Care and Supporting Caregivers. [FNS] According to the Kaiser Family Foundation, if the rule went into effect today, about 80% of all nursing facilities would not be in compliance with the staffing requirement. [FNS7] Apparently in recognition of that fact, CMS would stagger implementation of the rule. For non-rural facilities, the requirements would be phased in as follows: Phase 1 would require facilities located in urban areas to comply with the facility assessment requirements 60 days after the publication date of the final rule; Phase 2 would require facilities located in urban areas to comply with the requirement for an RN onsite 24 hours and seven days/week two years after the publication date of the final rule and Phase 3 would require facilities located in urban areas to comply with the minimum staffing requirements of 0.55 and 2.45 hours per resident day for RNs and NAs, respectively, three years after the publication date of the final rule. [FNSE] Compliance for rural facilities would be phased in as follows: Phase 1 would require facilities to comply with the facility assessment requirements 60 days after the publication date of the final rule; Phase 2 would require facilities to comply with the requirement for an RN onsite 24 hours and seven days/week three years after the publication date of the final rule and THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. Phase 3 would require facilities to comply with the minimum staffing requirement of 0.55 and 2.45 HPRD for RNs and NAs, respectively, five years after the publication date of the final rule. [FN°%! Finally, the rule proposes Medicaid Institutional Payment transparency. According to CMS, many children and adults use Medicaid long-term care services because they have disabilities, chronic illnesses, or the like. While most of these individuals are served in the community, about 1.5 million are receiving institutional care. The proposed rule would require transparency in how those payments are used: The Medicaid institutional payment transparency reporting provisions, if adopted as proposed, would build on proposals in the Ensuring Access to Medicaid Services proposed rule in which CMS proposed to require, among other things, that states report to CMS and publicly on the percentage of Medicaid payments for certain home and community-based services that are spent on compensation for direct care workers. [ltalics omitted. [FNeo] CMS also proposes that this information be publicly shared. The proposed rule is published at 88 F.R. 61352 (Sept. 6, 2023). In the Civil Monetary Penalty Reinvestment Program, CMS collects the funds from civil monetary penalties that Medicaid- and Medicare-certified nursing homes pay when they are non-compliant with federal requirements, and it re-invests those funds to improve the quality of care and quality of life for nursing home residents. CMS has discovered that the projects for which the funds are used are becoming larger in cost and scope, thereby making access to the funds inconsistent and inequitable. To level the playing field, CMS is making revising the structure of the program by: Providing a detailed listing of allowable uses of CMP funding, so all applicants have a clear understanding of what types of projects will be approved; Funding projects to benefit residents that can be implemented in all nursing homes by a variety of different organizations (i.e., not only available through a limited number of sources that may not be accessible to all nursing homes); and Striv[ing] to enable all nursing homes have access to the similar, basic capabilities, reflective of those typically found in a traditional household (e.g., wireless internet access). [FN61] 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 iliness, 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. [FN6Z] 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. The Biden Administration is taking action to discover and prevent inaccurate diagnoses of schizophrenia in nursing home patients. Such erroneous diagnoses often lead to treatment with antipsychotic medications, which can be dangerous and even life-threatening in nursing home patients. Beginning in January 2023, CMS will begin to conduct targeted off-site audits of nursing homes to determine whether the facilities are accurately and appropriately diagnosing and coding schizophrenia. CMS already monitors the use of antipsychotic medications in nursing homes and downgrades facilities' star rating for inappropriate use of them, but the use of these drugs is not scrutinized when there is an accompanying diagnosis of schizophrenia. CMS explains in a press release how inappropriate coding will be penalized: The use of antipsychotic medications among nursing home residents is an indicator of nursing home quality and used in a nursing home's Five-Star rating, however it excludes residents with schizophrenia. If an audit identifies that a facility has a pattern of inaccurately coding residents as having schizophrenia, the facility's Five-Star Quality Measure Rating on the Care Compare site will be negatively impacted. For audits that reveal inaccurate coding, CMS will downgrade the facility's Quality Measure ratings to one star, which would drop their Overall Star Rating as well. [FN63] These new steps further the administration's commitment to improving the accuracy of quality information that is publicly reported. Separately, CMS announced that it will begin to publicly post nursing home citations that are under dispute. Previously, the citations were not publicly posted on Care Compare until the dispute was resolved. However, resolution of the dispute can take 60 days or more, and some of these citations are Immediate Jeopardy citations that can put patients at risk. Disputed citations that are publicly displayed will not, however, be used the Five-Star quality rating score. [FN64] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. In June 2023, CMS announced new publicly available data. The agency is now publishing ownership information, including names of affiliated owners, on the nursing home tab of Care Compare. New data is also being published on data.cms.gov, including aggregate data on the safety, staffing, and quality for groups of nursing homes that share operators or owners. [FN6S] In related news, the Kaiser Family Foundation also published an issue brief examining the ways states are addressing nursing home staff shortages. [FN68] * Hospitals and Other Facilities The federal government is actively working on ways to improve maternal health, and hospitals play a part in the overall strategy. In the 2023 final rule making changes to the Hospital Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System, [FN67] cMS established a ""birthing-friendly" hospital designation. According to the rule, the designation will be granted to hospitals that respond "yes" to both questions in the Maternal Morbidity Structural Measure, namely, whether they are (1) participating in a structured state or national Perinatal Quality Improvement Collaborative, and (2) whether they are implementing patient safety practices or bundles as part of these quality improvement initiatives. [FN68] 5MS has now added this designation to the Care Compare online tool. In a press release, HHS Secretary Xavier Becerra explained why this designation matters: Eighty percent of pregnancy-related deaths are preventable, and Black, American Indian and Alaska Native, and Native Hawaiian and Pacific Islander people have the highest rates of pregnancy-related death. Pregnant and postpartum people from some racial and ethnic minority groups are also more likely to have negative health care experiences during pregnancy and delivery that impact the quality of care they receive and health outcomes. The "Birthing-Friendly' designation is a step towards ensuring that all pregnant and post-partum people can find high-quality maternity care. [FN6S] In keeping with its focus on transparency in health care, CMS has been working to improve hospital price transparency. In 2019, the agency published a rule requiring hospitals to be transparent about their costs; that rule became effective on January 1, 2021. [FN701 1y an article in Health Affairs, CMS officials highlight the progress the agency has made in increasing price transparency since the rule took effect. The rule requires hospitals to publicly post their standard charges in two ways, through: 1) a consumer-friendly display comprising at least 300 shoppable services, which can be satisfied through the release of a shoppable services file or by offering a price estimator tool, and 2) a comprehensive, machine-readable file. (FN71] After the rule was published but before it took effect, CMS provided hospitals ""significant" education and technical assistance. In January and February of 2021, the agency reviewed the websites of 235 randomly sampled hospital to assess their implementation of the rule and to identify hospitals for initial enforcement actions. That review revealed that 66% of hospitals met the consumer-friendly display requirement, 30% met the machine-readable file requirement, and 27% met both. CMS referred non-compliant hospitals for a comprehensive compliance review, which CMS described as follows: That process frequently involves direct hospital engagement and discourse, which can be time consuming. Should deficiencies be found, a warning letter is sent, and should those deficiencies not be remedied, CMS requests a corrective action plan. Throughout this process, CMS responds to requests for technical assistance on issues, for example, about data completeness or presentation questions, that sometimes cannot be easily determined from simply looking at a hospital's posted data. [FN72] Also in 2021, CMS published a final rule that significantly increased fines for hospitals that do not comply with the price transparency rule. IFN73] CMS imposed fines on two non-compliant hospitals in 2022. Between September and November of 2022, CMS again conducted a review of about 600 randomly selected hospitals. Hospitals that CMS deemed non-compliant were referred for comprehensive compliance review. At the time of that review, about 82% of the hospitals had consumer-friendly display, 82% posted a machine- readable file, and 70% did both. To CMS, this represents a significant improvement in compliance, but 30% of hospitals must still do more work to come into full compliance with the rule. CMS reported that as of January 2023, it has issued almost 500 warning notices and over 230 requests for corrective action plans, and nearly 300 hospitals became compliant as a result. [FN74] On the consumer side, CMS reports that consumers have accessed the posted price information to shop for their care. Some of the noted benefits of the price transparency rule include these: Consumers have accessed prices to shop for care and save money; researchers and industry experts have uncovered potential savings by analyzing variation in negotiated charges and discounted cash prices for the same items and services within and across hospitals; employers have used the data to negotiate more competitive rates; and innovators have identified and aggregated the hospital price data for consumers to make more meaningful comparisons. [FN73] Despite this success, CMS believes there is still work to do, given that about 30% of hospitals have not fully complied with the rule. The agency is looking at ways to ensure that hospitals fully comply with the rule. For example, it is seeking feedback from stakeholders on the best strategies for the future, and it is listening to consumer groups' ideas about the most valuable ways to display price information for consumers. Please see the article for more information on what CMS is doing to ensure that more hospitals become compliant. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. In April 2023, CMS advised that it changed some aspects of its compliance enforcement that do not require rulemaking. The changes are these: CMS currently requires non-complying hospitals to submit a corrective action plan (CAP) within 45 days of CMS' request to do so. CMS will now require hospitals to be in full compliance within 90 days of CMS' CAP request, instead of allowing hospitals to propose a completion date. CMS does not impose automatic civil monetary penalties (CMPs) for failing to timely submit a requested CAP or for failing to come into compliance within 90 days of a CAP request. CMS will now automatically impose a CMP on hospitals that do not submit a CAP within 45 days of CMS' request. However, before imposing the CMP, CMS will re-review the hospital's files to determine if any of the violations continue, and if violations are found, CMS will impose a CMP. For hospitals that submit a CAP by the deadline but do not comply with its terms within 90 days, CMS will re-review the hospital's files to determine the violations continue, and if so, CMS will impose an automatic CMP. For hospitals that make no attempt to satisfy the requirements (that is, they have not posted any machine-readable file or shoppable services list/price estimator tool), CMS will no longer issue a warning notice but will instead immediately request a CAP. [FN7€] IV. prioritizing safety and quality A. Avoidable Incidents - Health Care-Acquired Conditions 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. (FN77] 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, [FN78] the government will withhold 1% of Medicare payments for hospitals that score in the bottom quartile on specified measures. IFN7S] Eor fiscal year 2024, CMS will publish information on Hospital Compare about hospitals' performance on these measures: Claims-based composite measure of patient safety: - CMS PSI 90 (Patient Safety and Adverse Events Composite) Centers for Disease Control and Prevention National Healthcare Safety Network (CDC NHSN) HAI measures: - CLABSI (Central Line-Associated Bloodstream Infection) - CAUTI (Catheter-Associated Urinary Tract Infection) - 88l (Surgical Site Infection for Abdominal Hysterectomy and Colon Procedures) - MRSA (Methicillin-resistant Staphylococcus aureus) bacteremia - CDI (Clostridium difficile Infection) [FN&¥ Though CMS has penalized around 700 hospitals in each of the past several years, it did not impose penalties for fiscal year 2023, a policy finalized in the 2023 rule for the Hospital Inpatient Prospective Payment System. IFN&11 |1y the Fact Sheet for that rule, CMS explained that it is, [plausing the Patient Safety and Adverse Events measure (CMS PSI 90 measure) and the five CDC NHSN Healthcare-Associated Infection (HAI) measures from the calculation of measure scores and the Total HAC Score, thereby not penalizing any hospital under the HAC Reduction Program FY 2023 program year[. ["\¢4 According to CMS, it made its decision to not penalize hospitals for 2023 due to the pandemic. [FN83] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. The government's work to prevent hospital-acquired conditions has 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. (FN&4] 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. [FN83] Similarly, the government's Hospital Readmissions Reduction Program, a value-based purchasing program, penalizes hospitals with a greater than expected 30-day readmission rate for a predetermined set of conditions. [FN88] Fines can be as much as 3% of a hospital's Medicare payments for the year. (FN87] £ o 2023, CMS included 30-day risk-standardized unplanned readmission measures for the following: Acute myocardial infarction (AMI) Chronic obstructive pulmonary disease (COPD) Heart failure (HF) Pneumonia (suppressed from payment reduction calculations in FY 2023) Coronary artery bypass graft (CABG) surgery Elective primary total hip and/or total knee arthroplasty replacement (THA/TKA) [FNBS] As CMS explained in a Fact Sheet, it made several changes to the program in the 2023 final rule for the Hospital Inpatient Prospective Payment System. For 2023, CMS: « [Resumed] the Hospital 30-Day, All-Cause, Risk-Standardized Readmission Rate following Pneumonia Hospitalization measure beginning with the FY 2024 program year following the pause of this measure which was previously finalized for FY 2023; « [Modified] the Hospital 30-Day, All-Cause, Risk-Standardized Readmission Rate following Pneumonia Hospitalization measure to exclude patients with COVID-19 diagnosis present on admission from the measure numerators (outcomes) and denominators (cohorts), beginning with the FY 2024 program year (confidential hospital feedback reports for this measure will include this modification for the FY 2023 program year; although the measure has been paused from being used for payment calculation for the FY 2023 program year, CMS will still be calculating and publicly reporting this measure); « [Modified] all six condition/procedure specific readmissions measures to include a risk adjustment for history of COVID-19 within 12 months prior to the index admission, beginning with the FY 2024 program yearf. [FN89] All of these policies remain in effect, as CMS did not propose or finalize any changes to the program for 2024. [FNSO] 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. (FNS1 To further this effort, in 2011, HHS developed the first National Quality Strategy. [FN92] 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." [FNS3] 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 [FNS4] 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: THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -10- 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. [FNS5] Please see the blog post for more information. CMS has a number of programs that reward or penalize providers based on the quality they provide. They include, for example: « 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) [FNSe] The Accountable Care Organization programs, which we discuss below, also reward and sometimes penalize providers based on both the cost and quality of the care they provide. 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 the Bundled Payments for Care Improvement Advanced (or BPCI Advanced), a voluntary payment model. The initiative encourages providers and practitioners to coordinate care in order to keep Medicare spending below a specified threshold and to improve the quality of care. 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. 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. [FN97] 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. [FNS8] The model qualifies as an Advanced Alternative Payment Model under the Quality Payment Program. [FNSS] 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. For Model Year 6 (which began in 2023), CMS added Major Joint Replacement of the Upper Extremity as a multi-setting clinical episode category; therefore, Model Year 6 has 29 inpatient episode categories, three outpatient categories, and two multi-setting clinical episode categories. [FN100] The model currently has 280 participants. It was set to end on December 31, 2023, but it has been extended for two years; it will now end on December 31, 2025. The model will enter Model Year 7 on January 1, 2024, and CMS has opened applications for providers who wish to participate in the program for 2024. Medicare-enrolled providers, suppliers, and ACOs are invited to apply. Applications were due May 31, 2023. (FN101] More information about the program, including measures and pricing methodology, is available on the model's web page. [FN102] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -11- 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. [FN103] 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. [FN104] 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 7. 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. [FN105] In September 2023, CMS announced a new model that will enable states to redesign care delivery to test their ability to improve the overall health care management for its citizens. The model, called the States Advancing All-Payer Health Equity Approaches and Development Model (the AHEAD Model) aims to improve overall health, reduce health care disparities, improve health equity, improve quality, and keep costs in check. [FN198] The model is a total-cost-of-care model. CMS explained how such models work: As its name suggests, when a state partners with CMS by taking on accountability for the total cost of care, the state uses its authority to assume responsibility for managing the health care costs across all payers, including Medicare, Medicaid, and private coverage. States also assume responsibility for ensuring health providers in their state deliver high quality care, improve population health, offer greater care coordination, and advance health equity by supporting underserved patients. [FN107] Participating states may use the model statewide or in a certain region, (FN108] 3 they may opt to join in one of three cohorts, each of which has different timelines and varying lengths of pre-implementation periods. The different cohorts are designed to account for states' differing levels of readiness to implement such a model. [FN109] Eligible states and territories are those with at least 10,000 Medicare fee-for-service Part A and Part B enrollees in the state or selected region, but only eight states or territories will be selected to participate. (FN110] Hospitals and primary care practices (including federally-qualified health centers, rural health centers, and other safety-net providers) in the selected state or region will be invited to participate. (FN111] CMS identifies three main components of the model: Cooperative Agreement Funding: The cooperative agreement funding provided by CMS can support initial investments for states to begin planning activities during the Model's pre-implementation period and the initial performance years of the model. This period will be critical to the model's success and will require significant effort from the state and its partners, particularly in implementing the Medicaid components of the Model and recruiting hospitals and primary care practices to participate. Hospital Global Budgets: Global budgets provide hospitals with a fixed amount of revenue for the upcoming year for a specific patient population or program, such as Medicare fee-for-service beneficiaries. A global budget encourages hospitals to eliminate avoidable hospitalizations and improve care coordination between hospitals, primary care providers, and specialists. Increased investments in primary care under the Model can be offset over time by statewide savings generated by hospital global budgets. Primary Care AHEAD: Primary care practices located in a participating state or sub-state region will have the option to participate in Primary Care AHEAD, the primary care program component of the model. Primary Care AHEAD will align with ongoing Medicaid transformation efforts within each participating state and aims to increase Medicare investment in primary care. (FN112] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -12- One of the priorities in the model is to improve health equity. States participating in the model will be directed to develop a Statewide Health Equity Plan, which will guide model activities to reduce disparities and improve population health. Also, the payment methodology will adjust payments based on the insureds' social risks. (FN113] The model will run for 11 years, starting in 2024 and ending in 2035. CMS anticipates posting the initial notice of funding opportunity in late fall 2023 and posting a second notice of funding opportunity in spring 2024. [FN114] V. 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." N1 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. [FN118] Bacause 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, which is currently running. (FN'7] The Pioneer ACO Model, the Advance Payment ACO Model, the ACO Investment Model, the Comprehensive ESRD (end stage renal disease) Model, and the Next Generation ACO Model are no longer active. Below we discuss the Shared Savings Program and the newest ACO Model, the REACH Model. Over a period of time, CMS published toolkits to inform the public about how ACOs work. They include the Beneficiary Engagement Toolkit, [FN118] {he Care Coordination Toolkit, [FN119] 4he Provider Engagement Toolkit, [FN120] e Care Transformation Toolkit, [FN121] and the Operational Elements Toolkit, [FN122) \uhich is the final toolkit in the series. On January 17, 2023, CMS published an update on ACO participation. CMS' 2023 update includes the Shared Savings Program, the REACH ACO model, and the Kidney Care Choices Model. (FN123] c\MS summed up the 2023 participation rates for these programs: Today, the Centers for Medicare & Medicaid Services (CMS) announced that three innovative accountable care initiatives will grow and provide higher quality care to more than 13.2 million people with Medicare in 2023. More than 700,000 health care providers and organizations will participate in at least one of the three initiatives - the Medicare Shared Savings Program and two CMS Innovation Center accountable care model tests. This growth furthers achieving the CMS' goal of having all people with Traditional Medicare in an accountable care relationship with their health care provider by 2030. [FN124] The Medicare Shared Savings Program is an original ACO program; it is still running today and remains the largest of all of the ACO programs. According to CMS, enrollment actually dropped for 2023, but CMS expects that changes finalized in the 2023 Physician Fee Schedule [FN12% will attract more participants for 2024. CMS summarized some of the changes in a Fact Sheet for the rule: Based on feedback from health care providers treating rural and underserved populations that they require upfront capital to make the necessary investments to succeed in accountable care and may also need additional time under a one-sided model before transitioning to performance-based risk, we are finalizing policies to advance shared savings payments (referred to as advance investment payments) to low revenue ACOs, inexperienced with performance-based risk Medicare ACO initiatives, that are new to the Shared Savings Program (that is, not a renewing ACO or a re-entering ACO), and that serve underserved populations. These advance investment payments will increase when more beneficiaries who are enrolled in the Medicare Part D low-income subsidy (LIS), are dually eligible for Medicare and Medicaid, live in areas with high deprivation (measured by the area deprivation index (ADI)), or a combination of those, are assigned to the ACO, and these funds will be available to address the social and other needs of people with Medicare. We are also finalizing other modifications to certain existing policies under the Shared Savings Program to support organizations new to accountable care by providing greater flexibility in the progression to performance-based risk, allowing these organizations more time to redesign their care processes to be successful under risk arrangements. [FN126] For 2023, 456 ACOs are participating in the Shared Savings Program, and they will serve 10.9 million Medicare enrollees. Among other things, the REACH ACO model seeks to increase ACO participation in underserved communities. In 2023, 132 ACOs are participating, and they will serve 2.1 million Medicare enrollees. Importantly, of the 131,772 providers participating in REACH ACOs, 824 of them are Federally Qualified Health Centers, Rural Health Centers, and Critical Access Hospitals - more than twice the number that participated last year. [FN1%7] Finally, in the Kidney Care Choices Model, ACOs coordinate care for Medicare enrollees with stages 4 and 5 chronic kidney disease and end-stage renal disease. One-hundred thirty ACOs comprised of 8,398 providers will participate for 2023, and they will serve nearly THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -13- 250,000 enrollees. Those numbers represent an 87% increase in providers and organizations and a 62% increase in the number of enrollees from 2022. [FN128] Please see the press release for links to Fact Sheets for each program. CMS also provided an update on how ACOs are using the SNF waiver. Generally, enrollees in traditional Medicare must have had a three-day hospital stay before being discharged to a skilled nursing facility (SNF). However, under the authority of Section 1899(f) of the Social Security Act, CMS created a waiver of this rule for certain accountable care organizations (ACOs). (FN129] ynder a waiver, the ACOs may discharge a patient to a SNF after less than a three-day stay or directly from the community, with no hospital stay. CMS recently published an analysis of how eligible ACOs used that waiver during the 2014-2019 time period. The key takeaways from the analysis are these: « Very few SNF stays were SNF waiver stays. « Direct waiver admissions were most common, particularly for beneficiaries who need rehabilitation following an injury but not hospitalization. « Beneficiaries under the waiver had shorter SNF length of stay and were more likely to be discharged home. « Beneficiaries had lower or similar adverse outcome rates relative to beneficiaries not under the waiver. [FN130 For more information about the waiver in general, please see CMS' May 2022 guidance. (FN131] * 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). [FN132] 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. [FN133] However, the government''s arrangement with most (82%) of the Shared Savings ACOs was one-sided, and ACOs were not leaping to make the change to a two-sided arrangement. [FN134] 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. (FN138] opmg 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. ™"**! The American Hospital Association released a brief statement in support of the model, FN1¥7] During the Trump Administration, CMS Administrator Seema 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." [FN138] To help correct the problems with the program, in 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. [FN139] Briefly, the major changes to the Medicare Shared Savings Program include these: ¢ Accountability: The program reduces the time that ACOs can spend in a non-risk agreement. « Quality: The program expands the use of high-quality telehealth services. « Beneficiary engagement: Pathways to Success allows ACOs to offer incentives to their beneficiaries for healthy behaviors, such as establishing a primary care relationship and following up on health services. * Program integrity: The program establishes rigorous and accurate benchmarks for evaluating ACO performance. [FN140] Pathways to Success offers 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: THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -14- (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 Altemative 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. [FN141] 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 is 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. [FN142] A Fact Sheet lays out the details of the program. The final rule is published at 83 F.R. 67816 (Dec. 31, 2018). In March 2023, CMS published the participation options for ACOs in performance year 2024. [FN143] CMS is proposing 2024 changes to the program in the Medicare Physician Fee Schedule. CMS described some of the changes in a Fact Sheet: We propose changes to continue to move ACOs toward a digital measurement of quality by establishing a new Medicare Clinical Quality Measure (CQM) collection type for ACOs under the Alternative Payment Model (APM) Performance Pathway (APP). We are also proposing additional refinements to the financial benchmarking methodology for ACOs in agreement periods beginning on January 1, 2024, and in subsequent years to apply a symmetrical cap to risk score growth in an ACO's regional service area, similar to the cap applied on an ACO's risk score growth, apply the same CMS-Hierarchical Condition Categories (CMS-HCC) risk adjustment methodology to both the benchmark and performance years, and further mitigate the impact of the negative regional adjustment on the benchmark to encourage participation by ACOs caring for medically complex, high-cost beneficiaries. [FN144] CMS is also proposing changes to the step-wise beneficiary assignment methodology and updates to the definition of primary care services for the purposes of beneficiary assignment. Finally, CMS seeks public input on the future of the program, including the possibility of adding another track to the Shared Savings Program that would offer a higher level of risk and the potential for a higher level of reward. [FN145] Please see the Fact Sheet for a description of the other ACO proposals. CMS hopes that these proposals, if finalized, will result in a 10%-20% increase in participation in the Shared Savings Program. [FN148] The proposed rule is published at 88 F.R. 52262-01 (Aug. 7, 2023). In August 2023, CMS reported on ACO performance in 2022. ACOs in the program saved Medicare $1.8 billion in 2022 while delivering quality care, marking the sixth consecutive year that Shared Savings ACOs have achieved this. CMS highlighted the savings to ACO providers: Approximately 63% of participating ACOs earned payments for their performance in 2022. ACOs that earned more shared savings tended to be low revenue. Low-revenue ACOs are usually ACOs that are mainly made up of physicians and may include a small hospital or serve rural areas. With $228 per capita in net savings, low-revenue ACOs led high-revenue ACOs, who had $140 per capita net savings, and low-revenue ACOs comprised of 75% primary care clinicians or more saw $294 per capita in net savings, more than twice as much. 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. [FN147] 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, (FN148] and in doing so, it aligns with the agency's new vision for the Innovation Center. TN |t will serve individuals in the traditional Medicare program. [FN150] 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 THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -15- « Promote Provider Leadership and Goverance * Protect Beneficiaries and the Model with More Participant Vetting, Monitoring, and Transparency [FN151] 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 was to continue until December 31, 2022, and was to 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. [FN152] please see the Fact Sheet for more information. In January 2023, CMS announced that it had selected 132 participants for the program. [FN153] Medicaid ACOs Since the Affordable Care Act was enacted, many Medicare providers have enrolled in accountable care organizations (ACOs), and the programs have largely been successful. In 2022, CMS announced that 99% of all ACOs met quality standards and were eligible to share in some of the savings they created for the Medicare program. [FN154] According to the National Association of ACOs, since 2012, ACOs have saved Medicare $13.3 billion; after making shared savings payments to providers, ACOs have saved $4.7 billion for Medicare. ™N5% state Medicaid programs may use ACOs, but few do. According to a brief from the Commonwealth Fund, only 14 states use such models. State ACO initiatives vary widely among the states. Some states implement ACO programs through direct contracting with providers, some allow or require their managed care organizations to develop ACO programs, and some take a hybrid approach. Payment models also differ among the states. [FN158] The Commonwealth Fund published an issue brief examining the potential for Medicaid ACOs. The authors synthesized findings from 30 empirical studies and conducted 16 interviews with state Medicaid officials and safety-net providers in eight states - four with and four without Medicaid ACOs. Their key findings include these: Medicaid ACOs have achieved improvements in health care quality, costs, and, to a lesser degree, equity. Barriers to their adoption include competing policy priorities and local stakeholder resistance. CMS could encourage broader adoption of ACOs in Medicaid by offering greater flexibility to meet local needs and provider capabilities while streamlining the process through which states can introduce new payment models. [FN157] Please see the brief for a fuller discussion of their findings. V1. RURAL HEALTH CARE After a deliberative and collaborative process, CMS created 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. [FN158] (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 [FN159] 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 THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -16- 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. [FN160] HHS also released a new plan, the Rural Action Plan, which grew out of its Rural Task Force. In a press release, announcing the plan, HHS explained, This action plan provides a roadmap for HHS to strengthen departmental coordination to better serve the millions of Americans who live in rural communities across the United States. Eighteen HHS agencies and offices took part in developing the plan, which includes 71 new or expanded activities for FY 2020 and beyond. Efforts that will be undertaken in FY 2020 include nine new rural-focused administrative or regulatory actions, three new rural-focused technical assistance efforts, 14 new rural research efforts, and five new rural program efforts. These efforts build on 94 new rural-focused projects the HHS Rural Task Force identified as having launched over the past three years. [FN161] Concemned 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 [FN162] taking the first step toward implementing that provision. The proposed rule sets out Conditions of Participation for the new Rural Emergency Hospitals (REHSs) 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. [FN163] 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. FN64 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 enroliment, and the Physician Self-Referral Law as it relates to REHs. A Fact Sheet on REH provisions in the final rule is available. [FN165] VIl. 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. [FN186] 14g 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. [FN167] 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. [FN168] |£ these services were rendered by a 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. [FN189] 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. [FN170] And HHS indicates that about 70% of air transports are furnished out of network, services that can exceed $30,000. [FN171] 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. [FN172] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -17- 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 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. [FN173] 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. [FN174] | 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. [FN175] Some lawmakers contend that the Biden Administration was not true to congressional intent when crafting regulations relating to arbitration. [FN176] 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. [FN177] 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. [FN178] 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. (M7 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. [FN180] The interim final rule is published at 86 F.R. 36870-01 (July 13, 2021). Fact Sheets are available. N'8"] 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. [FN182] A later rule, an interim final rule with comment period, (FN183]jncludes 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. [FN184] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -18- Most recently, HHS announced a proposed rule to improve federal independent dispute resolution (IDR) of disputed billing. (The rule is the work of HHS, the Department of Labor, the Department of the Treasury, and the Office of Personnel Management). According to HHS, if finalized the rule would, facilitate improved communications between payers, providers, and certified IDR entities; adjust specific timelines and steps of the Federal IDR process; establish new batching provisions; create more efficiencies; and change the administrative fee structure to improve accessibility of the process. [FN185] In brief, the rule would accomplish the following, if finalized: It would improve early communications between payers and providers by requiring payers to provide additional information at the time of its initial payment or denial in order to help the parties determine whether the claim may be eligible for federal IDR. It would improve the open negotiation process by requiring that a party to the dispute file an open negotiation notice to the other party and to the government to initiate the open negotiation period, and it would require the other party to file a response. It would allow for more flexibility in ""batching" disputes of individual items and services into one batched dispute. It would require IDR entities to more quickly determine whether a dispute is eligible for IDR, and it would require the parties to more quickly respond to an IDR entity's request for information. It would streamline collection of the administrative fees for IDR. It would amend existing provisions on the extenuating circumstances that warrant extensions of time. It would establish an IDR registry for payers to make it easier for parties to acquire needed information. [FN188] Please see the Fact Sheet for more information. The proposed rule is published at 88 F.R. 88 F.R. 75744 (Nov. 3, 2023). CMS recently published resources to help consumers understand their rights under the law. The resources explain a consumer's rights as an insured, and it addresses rights that uninsured consumers have as well. The resources include an interactive tool where consumers can describe their billing questions and get an action plan. [FN187] VIIl. 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 [FN188] 45 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. (FN1891 |, the 2018 and 2019 Outpatient 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. [N 1%0] 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. (FN191] 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. [FN192] 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." [FN193] In a final rule published at 88 F.R. 77150-01 (Nov. 8, 2023) CMS explained how it corrected the problem: THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -19- In the CY 2023 OPPS/ASC final rule with comment period (87 FR 71970), we finalized a policy reversing the 340B Payment Policy. To do so, we first provided that drugs acquired through the 340B Program would be paid at the default rate (generally ASP plus 6 percent) for CY 2023. Second, to ensure budget neutrality for CY 2023 OPPS payment rates as required by statute, we finalized a reduction of 3.09 percent to the 2023 OPPS conversion factor. This 3.09 percent reduction for CY 2023 offsets the prior increase of 3.19 percent that was applied to the conversion factor by the 340B Payment Policy in CY 2018. This is because a downward adjustment involves a smaller percentage reduction from a larger number to get the same dollar amount as the original upward adjustment from a smaller number. More specifically, in order to achieve the original budget neutrality adjustment for CY 2018, we had to multiply the conversion factor by 1.0319. In order to offset this prior increase for the CY 2023 rule, we had to make a downward adjustment to the conversion factor, which involved dividing 1 by 1.0319, which equals 0.9691. And 1 minus 0.9691 equals 0.0309, which is where we derived the 3.09 percent reduction to the conversion factor for CY 2023. As we explained in the CY 2023 OPPS/ASC final rule, we decreased the OPPS conversion factor to offset the increase in the OPPS conversion factor in CY 2018, which originally implemented the 340B policy in a budget neutral manner. We stated: "This adjustment to the conversion factor is appropriate in these circumstances, including because it removes the effect of the 340B policy as originally adopted in CY 2018, which was recently invalidated by the Supreme Court as explained above, from the CY 2023 conversion factor and ensures it is equivalent to the conversion factor that would be in place if the 340B Payment Policy had never been implemented" (87 FR 71975). Additionally, we explained that we agreed with commenters, including the American Hospital Association, that under these specific circumstances it was appropriate to decrease payments for non-drug items and services by a percentage that would offset the percentage by which they were increased by the 340B Payment Policy in CY 2018 (87 FR 71975). 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. [FN194] 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. [FN195] 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: (1) 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]. [FN196] 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? [FN197] 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. [FN198] 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. IX. HEALTH FACILITIES AND THE END OF THE COVID-19 EMERGENCY PERIOD During the COVID-19 public health emergency, the federal government granted many flexibilities and extended extra funding to health care providers, including hospitals, community health centers, and other health care facilities, to help them manage the crisis. The emergency period ended on May 11, 2023. We discuss below some of the ways that the end of the emergency period is affecting health care facilities. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -20- Telehealth became a lifeline during the pandemic. Initially, Medicare telehealth flexibilities were to end when the public health emergency ended, but the Consolidated Appropriations Act, 2023, (Pub. L. 117-328) extended most of them to the end of 2024. For hospitals, these extensions include hospital-at-home programs. [FN199T Here are some of the temporary extensions in Medicare: FQHCs [federally qualified health centers] and RHCs [rural health centers] can serve as a distant site provider for non-behavioral/ mental telehealth services Medicare patients can receive telehealth services in their home There are no geographic restrictions for originating site for non-behavioral/mental telehealth services Some non-behavioral/mental telehealth services can be delivered using audio-only communication platforms An in-person visit within six months of an initial behavioral/mental telehealth service, and annually thereafter, is not required Telehealth services can be provided by all eligible Medicare providers [FN200] Some Medicare telehealth flexibilities became permanent. They include these: Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) can serve as a distant site provider for behavioral/mental telehealth services Medicare patients can receive telehealth services for behavioral/mental health care in their home There are no geographic restrictions for originating site for behavioral/mental telehealth services Behavioral/mental telehealth services can be delivered using audio-only communication platforms Rural Emergency Hospitals (REHSs) are eligible originating sites for telehealth [FN201] Moreover, the Drug Enforcement Administration has extended telehealth provisions relating to remote prescribing of controlled substances to continue into November of this year. [FN202] According to the Commonwealth Fund, during the pandemic, health care delivery through telehealth skyrocketed in community health centers. Before the pandemic, community health centers' ability to use telehealth was limited; these centers rely heavily on Medicaid payments, and reimbursements for telehealth was often insufficient. Moreover, the cost of telehealth infrastructure limited the ability of many health centers to offer these services. At the start of the public health emergency, only 43% of these centers used telehealth; that number jumped to 99% during the public health emergency. Community health centers were aided by additional federal funds and better reimbursements. Providers in these centers reported being happy with telehealth, and they found the technology easy to work with. However, community health centers continue to report concerns about reimbursements and about having the money to maintain the equipment. [FN203] Funding is also a concern for health facilities now that the public health emergency has ended. Hospitals received extra funding - a 20% add-on - for caring for Medicare patients with COVID. That funding ended with the public health emergency. To be sure, COVID hospitalizations are way down, but hospitals still care for COVID patients, and the costs are high. According to Chief Healthcare Executive, hospitals are hoping that CMS will adjust reimbursement rates for caring for COVID patients, who require longer hospitalizations. [FN204] Community health centers were aided during the pandemic by an increase in federal funding. They also benefited from the continuous enroliment provision of the Families First Coronavirus Response Act (Pub. L. 116-127). Those funds will gradually decrease during the course of the year. Still, the extra funds were not enough to ameliorate losses in community health centers during the pandemic. According to The Commonwealth Fund, 33% of health center physicians reporting lost revenues during the pandemic, and only 13% reported a gain in revenue. Funding concerns are expected to continue now that the public health emergency has ended. [FN205] Moreover, the Community Health Center Fund, which funds nearly 70% of community health center expenses, is set to expire at the end of the 2023 fiscal year. [FN206] Hopefully, it will be renewed. Please see the article in the Chief Health Care Executive for more information on how the end of the public health emergency will affect rural health centers and nursing homes. [FN207] Health facilities are deeply affected by Medicaid payments. As HPTS has previously reported, states that accepted an increase in their FMAP during the pandemic had to comply with certain maintenance-of-effort requirements. One of those requirements was continuous enrollment. N2%8! States have now begun the process of redetermining eligibility and disenrolling individuals no longer eligible. However, many are being disenrolled not because they earn too much but for procedural reasons, like not responding to a state's request for information. National Public Radio reports that in Florida, for example, 250,000 people were disenrolled in April, and 82% of them were for procedural reasons. [FN209] 1y Arkansas, 140,000 have lost coverage since April - about 70% for procedural or administrative reasons. [FN210] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -21- The Biden Administration has taken notice. CMS officials were in Arkansas to speak with patient advocates recently, and the agency expects to have similar meeting in other states. Daniel Tsai, the deputy administrator of CMS and director of the Center for Medicaid and CHIP Services, remarked, ""People should be concerned. This is not a good way to run a system. | say that across the country and for any state . . . . Should we create a system that's complicated and difficult to follow? No. That should be an uncaveated answer." [FN211] HHS Secretary Xavier Becerra sent a letter to all governors urging them to take the full 12 months for the process to avoid backlogs and mistakes. He offered strategies for states and urged them to work with stakeholders to ensure integrity in the process: | urge you to work with local governments, community-based organizations, schools, faith-based organizations and leaders, grocery stores, pharmacies, and anyone else in your communities who can help people understand the Medicaid and CHIP renewal process. We have innovative examples of this engagement across the country. For example, in lllinois, Chicago Public Schools provide direct assistance to families renewing their Medicaid and CHIP coverage, including by sending information home with students and holding community and outreach events. | am asking that we redouble efforts, expand what is working and reach out even further to ensure that no eligible beneficiary experiences a loss in coverage that could have been avoided. [FN212] CMS also announced additional flexibilities for states to help them avoid unnecessary disenroliments for procedural reasons. CMS listed them in a press release: Allowing managed care plans to assist people with Medicaid with completing their renewal forms, including completing certain parts of the renewal forms on their behalf. Allowing states to delay an administrative termination for one month while the state conducts additional targeted outreach. This will give people more time to be reminded to fill out and return their renewal forms. Allowing pharmacies and community-based organizations to facilitate reinstatement of coverage for those who were recently disenrolled for procedural reasons based on presumptive eligibility criteria. [FN213] The Kaiser Family Foundation is tracking disenrollments. As of December 1, 2023, over eleven million people have been disenrolled, about 71% for procedural reasons. [FN214] Not everyone who is disenrolled from Medicaid is left uninsured. According to Politico, state health officials believe that it is misleading and ultimately unhelpful to remark only on the number of disenrollments without also talking about those who get alternative coverage. For example, in Idaho, 30% who were disenrolled secured insurance in the Marketplace. In Massachusetts, that number is 25%. Still others may have gained employer-sponsored coverage. [FN215] X. selected Federal Activity « CMS gave notice that approved an application from the Joint Commission for continuing recognition as an accrediting organization for psychiatric hospitals that participate in Medicaid and Medicare. Please see 88 F.R. 88 FR 12363-01 (Feb. 27, 2023). « 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). * 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. [FN216] oS has published a Fact Sheet for the final rule, (FN217] ond it published a separate Fact Sheet on the Rural Emergency Hospital portion of the rule. [FN218] The final rule is published at 87 F.R. 71748-01 (Nov. 23, 2022). Corrections are published at 88 F.R. 297-01 (Jan. 4, 2023). « In a rule published at 87 F.R. 76238 (Dec. 13, 2022), CMS proposed to implement new requirements on various federal health care payers, including Medicare Advantage organizations, to improve the electronic exchange of health care data and to streamline the prior authorization process. Because CMS wants to encourage providers to use electronic prior authorization processes, the proposed rule would also add a new measure for eligible hospitals and critical access hospitals in the Medicare Promoting Interoperability Program, and for Merit-based Incentive Payment System (MIPS) eligible clinicians in the Promoting Interoperability performance category of MIPS. If finalized, this rule would also formally withdraw a 2020 proposed rule aiming to improve prior authorizations processes. That proposed rule is published at 85 F.R. 82586-01 (Dec. 18, 2020). CMS has published a Fact Sheet setting out the major provisions in the December 2022 proposed rule. [FN218] * In the House, 2023 FD H.B. 410 (NS) would enact the Health Care Prices Revealed and Information to Consumers Explained (PRICE) Transparency Act. That act would require hospitals and insurers to publish certain information about prices in addition to its list of standard charges. The bill sets out the list of information that would have to be published. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -29. « House Resolution 122 (2023 FD H.R. 122 (NS)) would express support for states to adopt the Medicaid expansion in order to close the coverage gap. According to the findings supplied in the bill, closing the coverage gap in the remaining 11 states that have not expanded Medicaid would reduce the national uninsured rate by nearly 10%, and it expresses the sentiment that it is unreasonable to expect that those making less than $13,000 can afford health coverage. The consequences of an individual falling into the coverage gap can be deadly: According to the findings, every day one person in the coverage gap dies because they do not have access to lifesaving care. And persons of color are disproportionately affected by the coverage gap. The findings also note the benefit of the expansion on providers: [Cllosing the Medicaid coverage gap will prevent hospital closures, particularly in rural areas that have seen more than 150 hospital closures in the last decade; [H]ospitals were 6 times less likely to close in States that expanded Medicaid between 2008 and 2016; [Flinancial margins for hospitals improved by 33 percent because uncompensated care spending dropped following Medicaid expansion in the first 36 States to adopt it[.] The resolution would urge the remaining 11 states to adopt the expansion and would express support for 2023 FD H.B. 31 (NS) (the COVER Now Act), [FN220] among other things. The sponsors of the bill also relaunched the State Medicaid Expansion Caucus, which would build support for expanding Medicaid in the 11 states that have not yet done so. Those states are Alabama, Florida, Georgia, Kansas, Mississippi, North Carolina, [FN221] South Carolina, Tennessee, Texas, Wisconsin, and Wyoming. In those states, nearly 2.2 million individuals fall into the coverage [FN222] gap. « CMS is proposing to amend rules relating to Medicaid disproportionate share hospital (DSH) payments to incorporate changes made in the Consolidated Appropriations Act, 2021 (Pub. L. 116-260). Specifically, the rule would clarify DSH hospital-specific limits when third-party payment is involved. The summary of the rule provides, in part, The purpose of this proposed rule is to update the regulatory requirements of the disproportionate share hospital (DSH) program in response to the Consolidated Appropriations Act, 2021 (herein, referred to as the CAA) . . . and to further improve upon the program. More specifically, the proposed provisions seek to implement the DSH-related provisions of the CAA concerning the treatment of third- party payments for purposes of calculating Medicaid hospital-specific DSH limits. We note that the CAA also created new supplemental payment reporting requirements through the addition of section 1903(bb) of the Act; however, DSH payments were specifically excluded from these requirements, and we have issued guidance on those requirements. This proposed rule also seeks to clarify regulatory payment and financing definitions and other regulatory language that could be subject to misinterpretation, refine administrative procedures used by States to comply with Federal regulations, and remove regulatory requirements that have been difficult to administer and do not further the program's objectives. [FN223] * CMS finalized a rule addressing Medicare DSH payments. The rule amends existing regulations governing the counting of days for the Medicaid fraction for individuals eligible for certain benefits provided by Section 1115 Medicaid demonstrations. The rule was finalized in the 2024 Hospital Inpatient Prospective Payment System rule, which is published at 88 F.R. 58640-01 (Aug. 28, 2023). « CMS gave notice that it approved the application from Accreditation Commission for Health Care, Inc. for continued recognition as a national accrediting organization for end-stage renal disease facilities that participate in Medicare or Medicaid. The notice is published at 88 F.R. 16981-02 (Mar. 21, 2023). « Corrections were made to CMS' final rule titled, ""CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs to Provide Refunds with Respect to Discarded Amounts; and COVID-19 Interim Final Rules." The final rule was published at 87 F.R. 69404 (Nov. 18, 2022), and corrections were published at 88 F.R. 15918 (Mar. 15, 2023). HHS and the Office of the National Coordinator for Health Information Technology (ONC) announced a proposed rule designed to improve interoperability of electronic health records and increase transparency, access, exchange, and use of electronic health information. The rule would also implement certain provisions of the 21st Century Cures Act (Pub. L. 114-255). HHS summarized the major provisions of the proposed rule in a press release: Proposals include: Implementing the Electronic Health Record Reporting Program as a new Condition of Certification for developers of certified health information technology (health IT) under the Program. Modifying and expanding exceptions in the information blocking regulations to support information sharing. Revising several Certification Program certification criteria, including existing criteria for clinical decision support (CDS), patient demographics and observations, electronic case reporting, and application programming interfaces for patient and population services. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -23- Adopting the United States Core Data for Interoperability (USCDI) Version 3 as a standard within the Certification Program and establishing an expiration date for USCDI Version 1 as an adopted standard within the Certification Program. Updating standards and implementation specifications adopted under the Certification Program to advance interoperability, support enhanced health IT functionality, and reduce burden and costs. [FN224] The rule is published at 88 F.R. 23746-01 (Apr. 18, 2023). CMS finalized a rule with 2024 updates to the Medicare Inpatient Psychiatric Facility Prospective Payment System and the Quality Reporting Program for these facilities. The rule is published at 88 F.R. 51054-01 (Aug. 2, 2023). Corrections are published at 88 F.R. 68491-01 (Oct. 4, 2023). CMS also finalized fiscal year 2024 updates to the Rehabilitation Facility Prospective Payment System. The rule is published at 88 F.R. 50956-01 (Aug. 2, 2023). Corrections are published at 88 F.R. 68494-01 (Oct. 4, 2023). CMS published a final rule with fiscal year 2024 updates to the Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities as well as updates to the Quality Reporting Program and Value-Based Purchasing Program. The proposed rule is published at 88 F.R. 53200-01 (Aug. 7, 2023). Corrections are published at 88 F.R. 68486-01 (Oct. 4, 2023). In the Senate, 2023 FD S.B. 1113 (NS) would enact the Nurse Staffing Standards for Hospital Patient Safety and Quality Care Act of 2023. That act would establish direct care registered nurse-to-patient staffing requirements in hospitals. The findings supplied with the bill note, among other things, that nurse-patient staffing ratios are directly related to patient outcomes, and inadequate staffing is contributing to the nursing shortage. Senator Sherrod Brown (D-Ohio), one of the bill's sponsors, highlights the problems that the bill addresses: Workers are the first line of defense keeping Ohioans safe, including in our hospitals . . . . Nurses work long hours doing vital work in our health care system, but too often they're stretched too thin, caring for too many patients with too little support. We can empower nurses to protect Ohio patients by ensuring nurses are adequately staffed and can advocate for their patients without fearing potential retaliation. [FN22%! Its companion in the House is 2023 FD H.B. 2530 (NS). Also in the Senate, the bipartisan-sponsored 2023 FD S.B. 1110 (NS) would enact the Rural Hospital Support Act to protect rural hospitals. A Senate summary of the bill explains what the bill seeks to accomplish. The bill would: Make permanent the enhanced low-volume Medicare adjustment for small rural prospective payment system hospitals. The low- volume Medicare adjustment helps to level the playing field for hospitals in small and isolated communities whose operating costs often outpace their revenue; Update the year on which sole community hospitals and Medicare-dependent hospitals can base their operating costs from FY2012 to FY2016. This would ensure these hospitals can tie reimbursement estimates to more recent trends in costs under Medicare's inpatient prospective payment system; and Make permanent the Medicare-Dependent Hospital program which ensures that eligible rural hospitals are reimbursed for their costs. [FN226] Representative Jodey Arrington (R-Tex.) and others are sponsoring 2023 FD H.B. 1694 (NS), which would permanently allow Medicare and Medicaid to pay for services rendered at freestanding emergency centers. CMS allowed for payment of these services for the duration of the public health emergency, which ends on May 11, 2023. In a press release, Representative Arrington explained why he thinks it is important to cover these services: 'Over the past three years since Medicare began recognizing Freestanding Emergency Centers, millions of seniors in Texas have benefitted from increased access to emergency care. Unfortunately, the care these facilities provide - often at a lower cost to the Medicare program than most hospital-based ERs - will disappear for thousands of seniors if something isn't done prior to the Public Health Emergency ending on May 11. The Emergency Care Improvement Act will allow seniors to continue utilizing low-cost, high- quality FECs, spurring much-needed competition in our healthcare system . . . ."" [FN227] CMS published a notice setting out the final Medicaid federal share disproportionate share hospital (DSH) allotments for fiscal years 2020 and 2021 and the preliminary federal share DSH allotments for fiscal years 2022 and 2023. This notice also set out the final limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities for fiscal years 2020 and 2021 and the preliminary limitations for fiscal years 2022 and 2023. The notice is published at 88 F.R. 23049 (Apr. 14, 2023). If passed, 2023 FD S.B. 1355 (NS) would enact the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2023, which seeks solutions to antibiotic resistance. According to the press release announcing the bill, the CDC estimates that more than 2.8 million antibiotic-resistant infections occur in this country each year, and at least 35,000 people die as a result of these infections. A National Action Plan was developed in 2015 to address this problem, but was not entirely successful. The press release THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -24- explained that, "[b]ecause of severe market failures in the health care system, many of the innovative antibiotic companies doing this work have filed for bankruptcy and stopped producing their critical drugs completely." It also explained how this bill would help: The PASTEUR Act would address this market failure and increase public health preparedness by keeping novel antibiotics on the market and improving appropriate use across the health care system. While current contracts between the government and drug makers base payment on volume, the PASTEUR Act would establish a subscription-style model which would offer antibiotic developers an upfront payment in exchange for access to their antibiotics, encouraging innovation and ensuring our health care system is prepared to treat resistant infections. (228! The bill has bipartisan support. The companion bill in the House is 2023 FD H.B. 2940 (NS). CMS approved an application from the Center for Improvement in Healthcare Quality for its Critical Access Hospital Accreditation Program for critical access hospitals wishing to participate in Medicaid and Medicare. The notice is published at 88 F.R. 32770 (May 22, 2023). In the House, 2023 FD H.B. 3561 (NS) would enact the Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023. The act aims to expand hospital price transparency requirements and increase penalties for non- compliance. JD Supra summarized the bill's major provisions. The bill would: 1. Increase maximum potential penalties for hospitals with more than 550 beds as of January 1, 2024, by an additional $10 per bed per day. The maximum penalty for large hospitals in noncompliance for more than one year would be increased from just over $2 million to no less than $5 million. 2. Establish that the price estimator tool would no longer exempt hospitals from publishing a list of their charges for shoppable services as of January 1, 2025. 3. Require the Centers for Medicare & Medicaid Services (CMS) to implement a template for hospitals to provide standard charges. 4. Require CMS to establish a monitoring process through notice and comment rulemaking. 5. Require CMS to establish accessibility standards to ensure the charges and information made available by hospitals will be accessible to individuals with limited English proficiency. 6. Expedite the corrective action timeframe, to come into compliance after receiving a notice of noncompliance, from the current 90 days to 45 days. 7. Require CMS to submit annual reports to Congress on enforcement activities. In particular, the bill would require the Government Accountability Office (GAO) to submit a report on compliance and enforcement within one year, and it would have CMS release a request for information (RFI) on how hospitals may be required to publish quality data alongside standard charge information. [FN229] The bill is sponsored by Representatives Frank Pallone (D-N.J.) and Cathy McMorris Rodgers (R-Wash.). Representatives Pallone and Rodgers are also sponsoring 2023 FD H.B. 3281 (NS), which would enact the Transparent Prices Required to Inform Consumer and Employers (PRICE) Act. Speaking at a meeting of the Health Subcommittee of the Energy and Commerce Committee, Representative Pallone said this of the act: ""Our bipartisan legislation will improve the transparency of our health care system, lower costs for patients, and strengthen our health care workforce by reauthorizing important programs that make care accessible in the most high-need communities. "The Transparent Price Act does exactly that - it brings more transparency to the health care system. It requires both hospitals and insurers to make price information public for all to see and requires the information to be displayed in a standardized format so it is easier for consumers to understand. Access to accurate prices for health care services empowers both employers and consumers to compare prices so that they can save money on health care services. Bringing more transparency to the health care system also encourages competition which can also help reduce health care costs." [FN230] In the Senate, Senator Mike Braun (R-Ind.) and others are sponsoring 2023 FD S.B. 1869 (NS). That bill seeks to amend Medicare billing provisions that allow hospitals to charge hospital rates for services rendered at an off-campus outpatient clinic. Senator Braun described the problem in a press release: Due to Medicare's billing structure, even if care is received at an off-campus outpatient facility, it can be billed as though the care was provided at the main hospital campus. This means the higher hospital rate is charged. This issue has become more prevalent as more and more small physician-owned practices and off-campus facilities are acquired by larger hospital systems. In 2020, the Congressional Budget Office estimated that taxpayers will pay close to $40 billion in excess costs to Medicare due to exorbitant facility fee payments over the next decade. [FN231] The bill would end that practice. If the bill passes, savings would be used to ease the nursing shortage by creating a graduate nursing education program that would provide payments for training costs. [FN232] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -25- A House resolution, 2023 FD H.R. 550 (NS) spells out the problems that can occur when older patients' mobility is limited during hospitalization. Among other things, the findings mention hospital-acquired disabilities; discharges to skilled nursing instead of home; negative health outcomes, including potentially long-lasting muscle loss and weakness; and nursing home admissions. The resolution expresses the sentiment of the House that the federal government should develop a mobility metric to guide providers in preventing mobility loss in older hospitalized patients. Specifically, the bill calls on the government to: (1) promote the development of stakeholder consensus on a mobility assessment that is validated and clinically meaningful to providers and patients; (2) develop a mobility quality measure that incentives hospitals, staff, and providers to actively intervene to prevent mobility loss among hospitalized patients; and (3) develop a mobility quality measure that focuses on the most effective improvements in patient outcomes and takes into consideration avoiding additional onerous burdens on providers. Representative Jan Schakowsky (D-lll.) and others are sponsoring 2023 FD H.B. 3346 (NS), which would enact the Innovative Maternal Payment and Coverage to Save Moms Act (or the IMPACT to Save Moms Act). The bill is concerned with the alarmingly higher rate of maternal mortality for Black women than for White women. (Black women are three time more likely to die of pregnancy-related causes than White women.) [FN233] The act would direct the Administrator of CMS to develop a demonstration project to be called the Perinatal Care Alternative Payment Model Demonstration Project to allow states to test maternity care payment models under their State Plans. In developing the model, the administrator would be directed to consult with various stakeholders, including state Medicaid programs, hospitals, matemity care providers, community-based organizations, insurers, free-standing birth centers, and health systems, among others. The administrator would be required to consider any payment model that: (1) is designed to improve maternal health outcomes for individuals from demographic groups with elevated rates of maternal mortality, severe maternal morbidity, maternal health disparities, or other adverse perinatal or childbirth outcomes; (2) includes methods for stratifying patients by pregnancy risk level and, as appropriate, adjusting payments under such model to take into account pregnancy risk level, including consideration of the appropriate transfer of patients by pregnancy risk level; (3) establishes evidence-based quality metrics for such payments; (4) includes consideration of nonhospital birth settings such as freestanding birth centers (as so defined); (5) includes consideration of social determinants of maternal health; (6) includes diverse maternity care teams . . . or; (7) includes consideration of maternal mental health conditions and substance use disorders. On August 1, 2023, CMS announced a final rule making fiscal year 2024 changes to the Hospital Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System (LTCH PPS). It is published at 88 F.R. 58640-01 (Aug. 28, 2023). [FN234] Among other things, the rule makes changes to payment rates under both systems. For the IPPS, general acute care hospitals that successfully participate in the Hospital Inpatient Quality Reporting program and are meaningfully using electronic health records will receive a payment increase of 3.1%. Additionally, hospitals may receive other adjustments based on their performance in certain quality programs as follows: Payment reductions for excess readmissions under the Hospital Readmissions Reduction Program (HRRP). Payment reduction (1%) for the worst-performing quartile under the Hospital Acquired Condition (HAC) Reduction Program. Upward and downward adjustments under the Hospital Value-Based Purchasing (VBP) Program. [FN235] Payments in the LTCH PPS will be increasing at similar rate. In addition to the IPPS payment changes discussed above, the final rule makes many other payment and policy changes in these areas, among others: payments for COVID-19 treatment, the rural wage index, disproportionate share hospital payments, physician-owned hospitals, the hospital inpatient quality reporting program, the Medicare Promoting Interoperability Program, the Health-Acquired Condition Reduction Program, and the Hospital Value-Based Purchasing Program. [FN238] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -26- Please see the Fact Sheet for an in-depth discussion of these changes and others. Consistent with Biden Administration priorities, the rule addresses health equity and social determinants of health by changing the severity designation of certain diagnosis codes. CMS explained in the Fact Sheet, IPPS payment is made based on the use of hospital resources in the treatment of a patient's severity of illness, complexity of service, and/or consumption of resources. Generally, a higher severity level designation of a diagnosis code results in a higher payment to reflect the increased hospital resource use. After review of our data analysis of the impact on resource use generated using claims data, CMS finalized a change to the severity designation of the three ICD-10-CM diagnosis codes describing homelessness (e.g., unspecified, sheltered, and unsheltered) from non-complication or comorbidity (NonCC) to complication or comorbidity (CC), based on the higher average resource costs of cases with these diagnosis codes compared to similar cases without these codes. This action is also consistent with the Administration's goal of advancing health equity for all[. [FN237] In a press release announcing the rule, CMS also explained how the rule advances health equity by making changes to the Value- Based Purchasing Program: In this final rule, CMS is finalizing a health equity adjustment in the scoring methodology for the Hospital Value-Based Purchasing (VBP) Program that rewards hospitals that serve higher proportions of dual-eligible patients for providing excellent care. The newly finalized scoring methodology allows the opportunity for hospitals to earn up to ten bonus points depending on their performance on existing quality measures and the proportion of dually eligible patients they treat. The rule is a first step toward promoting health equity in the Hospital VBP Program and as such, CMS received public comments on additional approaches for equity adjustments in the Hospital VBP Program for future years. These suggestions include using other methods of restructuring the scoring methodology and determining the best metric to identify underserved populations, which CMS will consider for future updates. [FN238] Representative Michelle Steel (R-Calif.) is sponsoring 2023 FD H.B. 4839 (NS), which seeks to codify and improve on current hospital price transparency rules. Representative Steel explained in a press release why she believes the bill is necessary: ""While roughly one in four hospitals are following current hospital price transparency rules, only seven hospitals out of 6,000 nationwide have ever been fined for noncompliance . . . . Many of those who do publish their prices in confusing formats or file types that make it difficult for anyone to access. The Hospital and ASC Price Transparency Act puts pressure on hospitals to end this practice and ensures that price transparency data is more accessible for patients and employers. | am grateful to see this legislation included in the Health Care Price Transparency Act and pass in the Ways and Means Committee. | urge my colleagues to join me in supporting this common sense legislation to lower health care costs for all Americans." [FN238] (Italics omitted.) In the Senate, 2023 FD S.B. 2418 (NS) would enact the Improving Care and Access to Nurses (| CAN) Act, which would improve access in the Medicare and Medicaid programs to services rendered by advanced practice registered nurses. A press release from Senator Jeff Merkley, one of the bill's sponsors, explained how the bill would increase access to care and reduce costs: Advanced practice registered nurses (APRNs) are prepared at the masters or doctoral level to provide primary, acute, chronic, and specialty care to patients of all ages and backgrounds, and in all settings. APRNs include nurse practitioners, nurse anesthetists, nurse- midwives, and clinical nurse specialists, and all play a pivotal role in the future of health care. Currently, there are federal barriers and institutional rules that limit APRN practice and prevent APRNs from providing the full scope of the health care services they have been trained to provide. These laws and regulations reduce patients' access to services-particularly in underserved areas-and disrupt continuity of care, increase costs in our health system, and undermine efforts to improve the quality of health care. The | CAN Act would increase access, improve quality of care, and lower costs in the Medicare and Medicaid programs by removing barriers to practice for APRNs, consistent with National Academy of Medicine (NAM) recommendations. [FN240] Several professional organizations support the legislation. Representatives from the American Association of Nurse Anesthesiology and the Oregon Association of Nurse Anesthetists stated that Certified Registered Nurse Anesthetists are often the only anesthesia providers in rural and underserved communities. (FN241] 1tg companion in the House is 2023 FD H.B. 2713 (NS). * On July 13, 2023, CMS announced that it released a proposed rule that would make calendar year 2024 changes to the Hospital Outpatient Prospective Payment System and the Ambulatory Surgical Center Prospective Payment System. The rule proposes updates to payment rates and policy changes that advance the goals of the Biden Administration: In addition to proposing payment rates, this year's rule includes proposed policies that align with several key goals of the Administration, including promoting health equity, expanding access to behavioral health care, improving transparency in the health system, promoting safe, effective, and patient-centered care, and addressing medical product shortages. The proposed rule advances the Agency's commitment to strengthening Medicare and uses the lessons learned from the COVID-19 PHE to inform the approach to quality measurement, focusing on changes that will help address health inequities. It also seeks comment on potential payment adjustments to hospitals for the additional costs of establishing and maintaining a buffer stock of essential medicines in order to help curtail shortages of these medicines in the future. [FN242] Among other things, the rule proposes: THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -27- changes to the Community Mental Health Center conditions of participation, changes to payments for remote mental health services, new payment and program requirements for the new behavioral health benefit category called Intensive Outpatient Services, changes to payments for dental services, modifying requirements for hospital price transparency, changes in the payment methodology for Indian Health Service facilities and tribal facilities that wish to convert to the Rural Emergency Hospital designation, the adoption and codification of quality measures for rural emergency hospitals, and changes to quality reporting systems. [FN243] The rule is published at 88 F.R. 49552-01 (July 31, 2023), and corrections were filed at 88 F.R. 57029 (Aug. 22, 2023) and 88 F.R. 57901 (Aug. 24, 2023). CMS published a separate Fact Sheet focusing on the hospital transparency aspects of the rule. [FN244] CMS approved an application from the Accreditation Commission for Health Care, Inc. for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that participate in the Medicare or Medicaid programs. The notice is published at 88 F.R. 61595-01 (Sept. 7, 2023). CMS also approved an application from the Accreditation Commission for Healthcare for continued recognition as a national accrediting organization for hospitals that participate in Medicare or Medicaid. The rule is published at 88 F.R. 60949-01 (Sept. 6, 2023). CMS announced its decision to approve an application from the Center for Improvement in Healthcare Quality as a national accrediting organization for psychiatric hospitals that participate in Medicare or Medicaid. The notice is published at 88 F.R. 67755 (Oct. 2, 2023). Representatives Michelle Fischbach (R-Minn.) and Greg Pence (R-Ind.) are sponsoring 2023 FD H.B. 5796 (NS), which would enact the Protecting Rural Seniors' Access to Care Act. If passed, the bill would prohibit the Secretary of the Department of Health and Human Services (HHS) from finalizing its rule setting out minimum staffing requirements for nursing facilities. [FN248]1 |y 4 press release, Representative Fischbach expressed her concern that the rule would force more nursing home closures, as these facilities are already struggling to recruit and retain staff: 'l am deeply disappointed CMS continued to move forward with this rule given the public knows their reservations regarding its efficacy. If the one-size-fits-all staffing ratios issued by CMS are put in place, it will devastate facilities across greater Minnesota, forcing them to either decrease the number of patients they serve even further, or close their doors entirely . . . . The Protecting Rural Seniors Access to Care Act will keep CMS from implementing this rule until it can prove it will not result in the closure of skilled nursing facilities, will not harm patient access, and will not make workforce shortage issues worse in areas that are already struggling. | am proud to introduce this legislation and will continue to fight for the strength of our rural communities.' [FN246] In addition to prohibiting HHS from finalizing the rule, the bill would direct the HHS Secretary to establish an advisory panel on the nursing home workforce. Sponsored by Senators Debbie Stabenow (D-Mich.) and John Comyn (R-Tex.), 2023 FD S.B. 2993 (NS) would enact the Ensuring Excellence in Mental Health Act. That act would permanently authorize certified community behavioral health clinics in the Medicaid program as an optional Medicaid benefit and would establish a Medicaid prospective payment system for them. The Substance Abuse and Mental Health Services Administration described the work of these clinics: A Certified Community Behavioral Health Clinic model is designed to ensure access to coordinated comprehensive behavioral health care. CCBHCs are required to serve anyone who requests care for mental health or substance use, regardless of their ability to pay, place of residence, or age - including developmentally appropriate care for children and youth. . . . An important feature of the CCBHC model is that it requires crisis services that are available 24 hours a day, 7 days a week. CCBHCs are required to provide a comprehensive array of behavioral health services so that people who need care don't have to piece together the behavioral health support they need across multiple providers. In addition, CCBHCs must provide care coordination to help people navigate behavioral health care, physical health care, social services, and the other systems they are involved in. [FN247] Currently, such clinics are run as a part of a demonstration program. HHS' Office of the National Coordinator for Health Information Technology (ONC) and CMS have published a proposed rule (FN248] ) establish disincentives for providers who engage in information blocking of health information. The proposed rule is meant to conform with the 21st Century Cures Act (Pub. L. 114-255). Since the Obama Administration, the government has encouraged the use of electronic health records and has worked to ensure that health information technology is interoperable so that health information can be easily exchanged among providers and with patients. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -28- Previously rulemaking implementing the Cures Act identified three types of actors that are subject to its information blocking rules: health care providers; health information networks or health information exchanges; and health IT developers. (FN24%] The newest proposed rule addresses information blocking by providers. The rule, if finalized, would not apply to all providers, just to those in certain categories, including: eligible hospitals and critical access hospitals in the Medicare Promoting Interoperability Program; eligible clinicians in the Quality Payment Program; and providers and suppliers in accountable care organizations. [FN250] Enforcement of information blocking provisions is in effect for other actors as of September 1, 2023. (FN2511 11 the summary of the most recent rule, the government acknowledges that, to be the most effective, disincentives for information blocking would ideally apply to all health care providers included in the definition in 45 CFR 171.102. However, limiting the rule to the above-mentioned providers for now would benefit a large group of Medicare enrollees and other patients. The government is seeking comment on how it can build on these proposals to create disincentives for other providers not participating in the programs mentioned above. In a press release announcing the proposed rule, HHS summarized the disincentives in the rule: Under the Medicare Promoting Interoperability Program, an eligible hospital or critical access hospital (CAH) would not be a meaningful electronic health record (EHR) user in an applicable EHR reporting period. The impact on eligible hospitals would be the loss of 75 percent of the annual market basket increase; for CAHs, payment would be reduced to 100 percent of reasonable costs instead of 101 percent. Under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS), an eligible clinician or group would not be a meaningful user of certified EHR technology in a performance period and would therefore receive a zero score in the Promoting Interoperability performance category of MIPS, if required to report on that category. The Promoting Interoperability performance category score typically can be a quarter of a clinician or group's total MIPS score in a year. Under the Medicare Shared Savings Program, a health care provider that is an Accountable Care Organization (ACO), ACO participant, or ACO provider or supplier would be deemed ineligible to participate in the program for a period of at least one year. This may result in a health care provider being removed from an ACO or prevented from joining an ACO. [FN252] Senator Cory Booker (D-N.J.) and Representative Ayanna Pressley (D-Mass.) are sponsoring the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services (MOMMIES) Act. [FN233] The bill aims to improve maternal health and to address the disparity in outcomes between white women and women of color. Among other things, the bill would increase post-partum coverage from 60 days to one year. Currently, this extended coverage is a state option, but it is not federally mandated. The bill would also: increase Medicaid reimbursement rates for maternal and obstetric services for people in underserved areas to incentivize health care providers to participate in Medicaid, establish a matemity care home model demonstration project to establish medical care homes, birth centers, and health facilities in underserved communities, direct the Centers for Medicare and Medicaid Services (CMS) to issue guidance on community-based doula care, and study telehealth as a way to increase access to maternity care. [FN254] A bipartisan bill, 2023 FD S.B. 3098 (NS) would establish a permanent State Plan option to allow states to circumvent the Medicaid Institution for Mental Disease (IMD) exclusion. As a general rule, Medicaid does not cover mental health services in facilities with more than 16 beds. The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (Pub. L. 115-272) temporarily allowed such a State Option, but that authority expired. [FN258] Other Medicaid authorities allow waivers of this exclusion under certain circumstances. The exclusion has become a stumbling block in the treatment of mental health and substance use disorder treatment. The bill is sponsored by Senators John Thune (R.-S.D.), Maggie Hassan (D-N.H.), and Marsha Blackburn (R-Tenn.). In a press release, Senator Thune explained why this bill is important to the people of his state: "As the opioid epidemic and substance use disorders continue to devastate families and communities across South Dakota and the country, it is critical for patients to have access to treatment services . . . . South Dakota has relied on a state plan option in Medicaid to provide these services for the past five years, and it is critical that patients do not lose access to this life-saving care." [FN256] CMS published a final rule making calendar year 2024 payment and policy changes to the End-Stage Renal Disease (ESRD) Prospective Payment System. The rule is published at 88 F.R. 76344-01 (Nov. 4, 2023). A Fact Sheet is available. [FN2%7] XI. SELECTED FEDERAL GUIDANCE THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -29- In 2018, CMS provided guidance on the survey process for reviewing home dialysis services in nursing homes (skilled nursing facilities and nursing facilities). Based on questions, comments, and feedback from state survey agencies, the dialysis provider community, as other stakeholders, CMS updated that guidance on March 22, 2023. The updated guidance addresses those questions, comments, and feedback. [FN258] XIl. Selected State Activity In Arizona: « A Senate bill, 2023 AZ S.B. 1710 (NS}, would have established a state hospital governing board to oversee the state hospital. The bill, which set out the make-up of the board and laid out its responsibilities, passed in the Senate on February 22, 2023. The bill was eventually adopted, but it no longer has provisions relating to a govermning board. » Governor Katie Hobbs (D) signed 2023 AZ S.B. 1603 (NS) on April 12, 2023. The bill adds a statutory provision requiring hospitals to comply with 45 C.F.R. 180 (on price transparency) as a condition for licensure. It does not apply to the state hospital. « Governor Hobbs also signed 2023 AZ H.B. 2042 (NS). That bill delays the sunset of a pilot program that allows licensed hospitals to provide acute care services in a patient's home. The statute authorizing this pilot is currently set to be repealed on December 31, 2024. This bill extends the repeal date to December 31, 2026. « Pursuant to state law, the Department of Health Services gave notice of proposed rules to establish a loan repayment program for portions of qualifying educational loans for physicians, dentists, and mid-level practitioners who agree to provide primary care services in Health Professional Shortage Areas or Arizona Medically Underserved Areas in an out-patient treatment setting. The proposed rules are published at 2023 AZ REG TEXT 626097 (NS) (Sept. 15, 2023). In California: An Assembly bill, 2023 CA A.B. 48 (NS), enacts the Nursing Facility Resident Informed Consent Protection Act of 2023. That act is concerned with the use of psychotherapeutic drugs in nursing facilities. It adds to the resident's list of rights the right to receive needed information for a resident's decision on whether or not to accept or refuse psychotherapeutic drugs and the right to be free from psychotherapeutic drugs for the purpose of discipline or convenience, or for chemical restraint, except in an emergency. According to the findings supplied with the bill, 80% residents in long-stay nursing homes currently receive psychotherapeutic drugs. Governor Gavin Newsom (D) signed the bill on October 13, 2023. Previously-enacted California law established the Healthy California for All Commission which, after study, recommended a unified health care financing system that provides accessible, affordable, equitable, high quality, and universal health care. The Commission found that such a system would create opportunities to deliver health care more effectively, efficiently, and equitably and could save more than five-hundred billion dollars over the next ten years. On October 7, 2023, Governor Gavin Newsom (D) signed 2023 CA S.B. 770 (NS), which inches toward that goal. The bill directs the Secretary of the Califomia Health and Human Services Agency to research and develop a health system with a unified financing structure and to consult with the federal government on the possibility of a waiver that would implement a system with these features and objectives, among others: (a) A comprehensive package of medical, behavioral health, pharmaceutical, dental, and vision benefits, which includes primary, preventive, and wellness care services. (b) A package of long-term care supports and services, including measures to support health and well-being while Californians age. (c) Services that will not vary by age, employment status, disability status, income, immigration status, or other characteristics. (d) The identification of disparities among Medicare, Medi-Cal, employer-sponsored insurance, and individual market coverage, with the goal to eliminate those disparities to the greatest extent possible in the new system. (f) The absence of cost sharing for essential services and treatments covered under the program, including primary, preventive, and wellness care services. (h) A program to implement a just transition for members of the health industry workforce whose jobs may be disrupted. (i) Assurances that no individual will pay more than a specified percentage of their income on a progressive sliding scale for the cost of financing the health system. (i} Unified financing that delivers health care more effectively, efficiently, and equitably. The Secretary would be required to file an interim report to the legislature by January 1, 2025, a draft of a waiver framework by June 1, 2025, and a final waiver framework by November 1, 2025. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -30- While many applaud the effort at moving toward a unified financing system, others claim that the effort is not bold enough. In particular, the California Nurses Association called the bill disappointing and unnecessary. That group supported Newsom's gubernatorial campaign, as he pledged to support a single-payer system. [FN258] They say that this measure stops short of that and, they say, it needlessly duplicates work that has already been done. The president of the organization released a statement when the governor signed the bill, saying, part, "In addition to demonstrating an utter lack of political courage, S.B. 770 is a tremendous waste of taxpayer resources. It not only preserves the status quo, but also duplicates the previous work of the Healthy California for All Commission under the Newsom administration, with its final report completed as recently as spring of 2022, "It is also no surprise that the health care industry did not come out in strong opposition to S.B. 770. The unified financing system that CalHHS will recommend does not need to guarantee health care for all. Uncoincidentally, the bill maintains wide latitude for insurers and health care organizations to keep doing business as usual and perpetuate the failed health care status quo." [FN260] For his part, Governor Newsom stated in 2022, | think that the ideal system is a single-payer system . . . . |'ve been consistent with that for well over a decade. . . . . The difference here is when you are in a position of responsibility, you've gotta apply, you've gotta manifest, the ideal. This is hard work. It's one thing to say, it's another to do. And with respect, there are many different pathways to achieve the goal." [FN261] An Assembly bill, 2023 CA A.B. 1481 (NS) will extend hospital presumptive eligibility for pregnant women to all pregnant people. The bill was adopted on October 7, 2023. In Colorado: Governor Jared Polis (D) signed 2023 CO H.B. 1215 (NS) on May 30, 2023. The version of the bill that passed prohibits a health care provider or health system from charging a facility fee that is not fully covered by the patient's insurance (regardless of payer type) for outpatient preventive health care services and health services provided through telehealth. The bill also requires specified public notice about facility fees. Governor Polis also signed 2023 CO H.B. 1228 (NS) on May 30. The bill addresses supplemental Medicaid reimbursements for high- performing nursing facilities. The bill provides, in pertinent part, Beginning July 1, 2024, the payment must not be less than twelve percent of total provider fee payments and must be adjusted for fiscal years 2024-25 and 2025-26. no later than July 1, 2026, the payment must not be less than fifteen percent of total provider fee payments and must be annually adjusted thereafter. The bill also calls for adjustments in supplemental payments for facilities that serve residents with severe mental illness, severe dementia, and acquired brain injury. In Connecticut: Adopted on June 28, 2023, Department of Public Health directs the Department of Public Health, in collaboration with a hospital and the Department of Social Services, to develop a Hospice at Home pilot program. The pilot program will provide the following services: a daily telehealth visit with a physician or an advanced practice registered nurse; an in-person visit with a registered nurse at least twice weekly; a personal emergency response system; remote monitoring, if the patient and others residing with the patient consent; and telephone access to an on-call physician or advanced practice registered nurse. The bill authorizes the Department of Social Services to apply to CMS for a Section 1115 waiver to provide Medicaid reimbursement for services rendered in the pilot program. In Hawaii: * A House bill, 2023 HI H.B. 1369 (NS), will make the nursing facility sustainability program permanent and would repeal the nursing facility tax. The sustainability program imposes a provider fee as a way to draw down federal Medicaid funds. The bill was adopted on June 22, 2023. » A Senate bill, 2023 HI S.B. 404 (NS), will make changes to the hospital sustainability program, which the bill's sponsors believe has been a success. According to the findings supplied with the bill, the bill would strengthen the program by: - Amending the definition of 'private hospital'; - (2) Clarifying the uses of the hospital sustainability program special fund; - (3) Increasing the hospital sustainability fee cap for various facilities; THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -31- - (4) Requiring the department of human services to consult and negotiate with the hospital trade association in the State regarding hospital sustainability fee participation and rates; - (6) Clarifying the circumstances under which the hospital sustainability fee shall be discontinued and the distribution of remaining funds; - (6) Repealing the sunset dates of Act 217, Session Laws of Hawall 2012, and Act 123, Session Laws of Hawall 2014, thereby making the hospital sustainability program permanent and permanently exempting the hospital sustainability program from the central service and administrative expenses assessments; and - (7) Appropriating funds out of the hospital sustainability program special fund. The bill was adopted on June 22, 2023. In lllinois: * Governor J.B. Pritzker (D) signed 2023 IL H.B. 2076 (NS), a bill relating to distressed nursing homes, on June 30, 2023. House Bill 2076 amends the Nursing Home Act's provision on distressed facilities by directing the Department of Public Health to adopt criteria to identify distressed facilities and to publish a list of such facilities quarterly. It also directs the department to adopt rules to create a timeframe and a procedure for removing facilities from the list. A facility will not be listed as distressed unless it committed a violation or deficiency that has harmed a resident. Facilities will have appeal rights. » Governor Pritzker signed 2023 IL H.B. 2719 (NS), a bill relating to fair patient billing, on July 28, 2023. Among other things, the bill will require hospitals to screen uninsured patients for eligibility in public health insurance programs and the hospital's financial assistance program. If the screening revealed that the patient may be eligible for coverage, the hospital will have to inform the patient about enrolling in coverage, including referral for enroliment assistance. ¢ The Department of Public Health proposed rules to implement a newly-passed law (Pub. L. 103-0114) that increases the number of allowable licensed hospice residences in each of three geographic areas; the number would increase from five in each of the geographic areas to 16. The proposed rules are published at 2023 IL REG TEXT 652042 (NS) (Sept. 15, 2023). In Indiana: » Governor Eric Holcomb (R) signed 2023 IN S.B. 400 (NS) on May 4, 2023. It contains various health provisions. Among the provisions affecting health care facilities are these: a requirement that a hospital's quality assessment and improvement program include a process for determining and reporting the occurrence of serious reportable events, as identified by the National Quality Forum; and a requirement that each hospital with an emergency department have at least one physician on site and on duty who is responsible for the emergency department whenever it is open. In lowa: A Senate bill, 2023 IA S.F. 567 (NS), would have added new statutory provisions affecting health facilities. Among them were these: One provision would have allowed the state to impose a temporary moratorium on applications for new nursing facility construction or a permanent increase in the bed capacity of a nursing facility. The moratorium would have initially lasted for twelve months but could have been extended periodically for a period of no longer than 36 months total. The moratorium could have been waived under special circumstances. Another provision would have dictated what was to be included in a nursing facility application, including the applicant's financial ability to operate a nursing facility, complaints against the facility, disciplinary action against the facility, and so forth. On April 26, 2023, the bill was withdrawn. Also in lowa, 2023 |A H.F. 708 (NS) was adopted on June 1, 2023. The bill directs the Department of Health and Human Services to establish a Medicaid reimbursement rate add-on methodology for skilled nursing facilities or nursing facility services for individuals needing a nursing facility level of care who are registered sex offenders. Such services need to include a secure unit that is separate from other residents. The department is required to report to the governor and the legislature on the established methodology by January 1, 2024. Governor Kim Reynolds (R) signed 2023 IA S.F. 75 (NS) into law on March 28, 2023. The bill sets out licensure requirements for rural emergency hospitals, a new provider type established by CMS. The bill also provides that a certificate of need is not necessary to convert a critical access hospital or general hospital into a rural emergency hospital, but any changes in a rural emergency hospital relating to licensure, structure, or type of institutional facility would require a certificate of need. In a press release, Senator Charles Grassley (R-lowa) applauded the governor's move, and explained why the rural emergency hospital provider type is important: REH [the rural emergency hospital designation] offers a financial lifeline for providers by allowing certain rural hospitals to customize their health care infrastructure and provide services that better align with the specific needs of their patient populations. The policy creates a new, voluntary Medicare payment designation that allows either a Critical Access Hospital (CAH) or a small, rural hospital THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -32- with less than 50 beds to convert to an REH. The goal is to preserve patient access to emergency medical care in rural areas that can no longer support a fully operational inpatient hospital. [FN262] In Kansas: The Department of Health and Environment-Division of Health Care Finance gave notice that it is amending its Medicaid State Plan to comply with hospice reimbursement policies enacted in the Consolidated Appropriations Act, 2021 (Pub. L. 116-260). The agency supplied this summary of the rule: The Kansas Department of Health and Environment, Division of Health Care Finance (KDHE-DHCF) is amending the Kansas Medicaid State Plan. The Centers for Medicare and Medicaid Services (CMS) announced that Section 1814(i)(5)(A)(i) of the Act was amended by the Consolidated Appropriations Act of 2021 (CAA) to increase the market basket reduction from two (2) to four (4) percentage points for any hospice provider that does not comply with the quality data submission requirements per fiscal year. The state is updating its reimbursement methodology for hospice care services to increase the market basket reduction from 2 to 4 percentage points. The notice is published at 2023 KS REG TEXT 653465 (NS) (Oct. 5, 2023). In Louisiana: A resolution, 2023 LA H.C.R. 2 (NS), provides for a hospital stabilization formula to protect and preserve access to hospital services, protect and preserve rural hospitals, stabilize funding, minimize cost-shifting, and so forth. It was adopted on June 7, 2023. A House bill, 2023 LA H.B. 658 (NS), sought to require that hospitals comply with federal law on price transparency, and it would have tasked the Department of Health to monitor and enforce compliance with these provisions. The bill set out the enforcement process. While it passed both houses, Governor John Bel Edwards vetoed it on June 27, 2023. He said in his veto statement that price transparency is important, the bill adds additional state bureaucracy and is in fact inconsistent with federal law in some respects: There is no question that pricing transparency is an important component to ensuring affordable access to healthcare for all, which is why these requirements were included in the Affordable Care Act. While | appreciate the author's and co-authors' support for my first executive action as governor in expanding Medicaid, making affordable healthcare more accessible to Louisianan, the legislation as finally passed provides for alternate notifications, timelines, and corrective action plans required by the State that do not align with federal law. Due to the confusion and administrative burden this bill will create if enacted, in addition to increased agency costs not included in the budget for implementation, it will not become law. [FN263] The Louisiana Public Health Department published an emergency rule relating to facility need review approvals of licensed and Medicaid-certified facility beds. The agency explained, Effective June 9, 2023, the Department of Health, Bureau of Health Services Financing amends the provisions governing facility need review approvals of licensed and Medicaid certified facility beds in order to prevent the expiration of approvals for nursing facilities, intermediate care facilities for persons with developmental disabilities, and adult residential care providers with inactivated licenses as a result of an executive order or proclamation of emergency or disaster issued in accordance with [LA R.S. 29:724 LA R.S. 29:766]. The rule is published at 2023 LA REG TEXT 644600 (NS) (June 12, 2023). In Minnesota: * Introduced on February 1, 2023, 2023 MN S.F. 1081 (NS) would have repealed the gross revenues tax on hospitals and health care providers. It did not pass before the legislature recessed, but the state allows carryovers. A related bill, 2023 MN H.F. 1668 (NS), similarly did not pass before recess. In Mississippi: « Governor Tate Reeves (R) signed 2023 MS S.B. 2323 (NS) on March 30, 2023. The findings supplied with the bill note that community hospitals serve rural populations and other disparately-impacted groups. The needs of these groups are best served when these hospitals have legal, financial, and operational flexibility to respond to challenges and take full advantage of opportunities. The that end, the bill will greatly expand the powers and duties of community hospital boards of trustees. Among other things, the bill will allow such boards to acquire hospitals, health care facilities and other health care-related operations and assets; to form, establish, fund, and operate nonprofit entities, state-sponsored entities, or other similar organizations, in order to conduct activities within or outside of the community hospital's service area for the benefit of the community hospital; and to have an ownership interest in, make capital contributions to, and assume financial risk under accountable care organizations or similar organizations. In Missouri: » The Department of Social Services gave notice of a final rule establishing a calculation for Outpatient Direct Medicaid payments. The rule is published at 2022 MO REG TEXT 619365 (NS) (Dec. 1, 2022). » The Department of Social Services gave notice that it finalized a rule amending administrative provisions relating to the inpatient hospital reimbursement methodology in the MO HealthNet program. The rule is published at 2022 MO REG TEXT 619364 (NS) (Dec. 15, 2022). THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -33- In Montana: ¢ A House bill, 2023 MT H.B. 509 (NS), would have, among other things, added new statutory provisions relating to reporting requirements for non-profit hospitals; specifically, the bill would have called for a yearly charity care report and a community benefit report. It would have also required such hospitals to have a charity care and community benefit policy. It did not pass this session. « As introduced, House Bill 917 (2023 MT H.B. 917 (NS)) contained a number of provisions that would have affected hospitals. Among them are were these: The bill would have required an evaluation of the noncritical access hospital supplemental payment methodology. The bill would have established a performance-based payment account that would have consisted of penalties collected from noncritical access hospitals. Funds in the account would have had to be used to develop and test value-based payment and other similar models. It would have expressed the legislative intent on rate increases for skilled nursing facilities. Sixty-percent of the increase would have had to have been used for wage increases to the direct care workforce, except for management staff. The bill would have required nursing home facilities to have an actual occupied bed count of at least 65% of its licensed bed capacity by July 1, 2025. If a nursing home facility did not meet that requirement by July 1, 2025, it would have had to relicense for no more than 120% of its average actual occupied bed count for the last calendar year. Five days after it was introduced, the bill was amended and all provisions relating to noncritical access hospitals were removed. Also in Montana, 2023 MT H.B. 899 (NS) would have included provisions to alleviate the impact of nursing home closure. For purposes of the bill, a nursing home was defined as one that was certified by CMS to participate in the Medicare or Medicaid programs. For individuals, the bill would have provided for reimbursement up to $1000 for moving expenses if the individual or a family member was displaced by a closure. The bill would have also provided grants of up to $25,000 as an incentive to reopen closed facilities. Eligible grant recipients could have included operators of closed facilities or community-based or non-profit organizations that wished to reopen a closed facility. Grant recipients would have to have committed to reserving up to 40% of bed space for Medicaid enrollees. The bill included one-time appropriations to cover these expenses. House Bill 899 did not pass this session. Adopted on May 18, 2023, 2023 MT H.B. 312 (NS) authorizes the Department of Public Health and Human Services to designate certain hospitals as rural emergency hospitals. The bill sets out the eligibility requirements for the designation and requirements for hospitals that are granted the designation. In Nebraska: * A legislative bill, 2023 NE L.B. 434 (NS). would have directed the Department of Health and Human Services to seek a State Plan amendment or waiver to allow long-term acute care hospitals to enroll as providers in the Medicaid program. It did not pass this year, but the state allows carryovers. « Legislative Bill 451, 2023 NE L.B. 451 (NS), would have provide a one-time grant of up to $30 million to one qualifying rehabilitation hospital in the state for infrastructure and upgrades. The bill, which included an emergency clause, provided, The Department of Health and Human Services shall award a one-time grant to assist a rehabilitation hospital that has a distinct nursing facility part, that is located in Nebraska, and that has a capacity to provide post-acute long-term care to [M]edicaid patients. The grant shall include thirty million dollars for infrastructure and facilities upgrades. The grant shall be expended no later than December 31, 2026. The bill did not pass before the legislature recessed, but the state allows carryovers. Governor Jim Pillen (R) signed 2023 NE L.B. 276 (NS) on May 25, 2023. The bill enacts the Certified Community Behavioral Health Clinic Act. With this act, the legislature is aiming to, increase access to mental health and substance use treatment and expand capacity for comprehensive, holistic services, respond to local needs, incorporate evidence-based practices, and establish care coordination as a linchpin for service delivery including effective community partnerships with law enforcement, schools, hospitals, primary care providers, and public and private service organizations to improve care, reduce recidivism, and address health disparities. The certified community behavioral health clinics will be required to provide, at a minimum, the following services: (i) Outpatient mental health and substance use services; (ii) Crisis mental health services; (ii) Screening, assessment, and diagnosis, including risk assessments; (iv) Person-centered treatment planning; (v) Outpatient clinic primary care screening and monitoring of key health indicators and health risks; (vi) Targeted case management; THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -34- (vii} Psychiatric rehabilitation services; (viii) Peer support and counselor services and family supports; and (ix) Community-based mental health care for members of the armed forces and veterans consistent with minimum clinical mental health guidelines promulgated by the Veterans Health Administration[.] The bill directs the Department of Health and Human Services to establish a Medicaid prospective payment system to fund such services and apply to CMS for approval to add these services to the State Plan. In Nevada: « Assembly Bill 158 (2023 NV A.B. 158 (NS)) called for the state to ratify the Emergency Medical Services Personnel Licensure Interstate Compact. The compact is designed to: 1. Increase public access to EMS personnel; 2. Enhance the states' ability to protect the public's health and safety, especially patient safety; 3. Encourage the cooperation of member states in the areas of EMS personnel licensure and regulation; 4. Support licensing of military members who are separating from an active duty tour and their spouses; 5. Facilitate the exchange of information between member states regarding EMS personnel licensure, adverse action and significant investigatory information; 6. Promote compliance with the laws governing EMS personnel practice in each member state; and 7. Invest all member states with the authority to hold EMS personnel accountable through the mutual recognition of member state licenses. The bill did not pass this session. * An Assembly bill, 2023 NV A.B. 198 (NS), would have enacted the Uniform Telehealth Act. The bill would have also amended existing provisions to relax current law on provider licensing for telehealth. While it passed both houses, it was not adopted before adjournment. In New Hampshire: « House Bill 215 (2023 NH H.B. 215 (NS)) will direct the Department of Health and Human Services to adopt rules authorizing licensed nursing assistants to administer medicine in certain facilities, in accordance with the Medicaid State Plan. Governor Chris Sununu (R) signed the bill on July 12, 2023. In New Mexico: * An emergency rule, 2023 NM REG TEXT 645743 (NS) (June 16, 2023), sets out the requirements for facilities to qualify as a rural emergency hospital in the Medicare program. » The Department of Health gave notice of a public hearing on a proposed rule to adopt new regulations on licensing for Rural Emergency Hospitals. The notice is published at 2023 NM REG TEXT 654748 (NS) (Oct. 24, 2023). In New Jersey: « An Assembly Bill, 2022 NJ A.B. 4484 (NS), would revise existing reporting requirements for nursing homes upon transfer of ownership. The bill would require the prospective new owner to provide certain financial disclosures and disclosure of the ownership structure. The bill was introduced in September 2022, and it was amended in January 2023. « Senate Bill 405 (2022 NJ S.B. 405 (NS)) has been adopted. The bill updates Medicaid per diem rates for assisted living residences, comprehensive personal care homes, and assisted living programs. In addition to the rate increases, assisted living residences and comprehensive personal care homes will also receive an increased per diem rate based on the percentage of their population that is enrolled in Medicaid. * An Assembly bill, 2022 NJ A.B. 4914 (NS), will establish a state Hospital at Home program and require Medicaid and NJ Family Care to cover services provided under the program. The state program will remain in place as long as the federal Acute Hospital Care at Home program is in place. The bill was adopted on September 25, 2023. « The current version of 2022 NJ S.B. 3495 (NS) would provide for presumptive Medicaid eligibility for home- and community-based services, nursing home services, and services rendered through a PACE program (Programs of All-Inclusive Care for the Elderly). In New York: * Introduced on May 17, 2023, 2023 NY A.B. 7328 (NS) calls for a four-year demonstration program to reduce the use of temporary staffing agencies in residential health care facilities. Current law requires facilities to remit to the state a portion of excess revenue. As a part of the demonstration, amount that the facilities owe to the state would be reduced based on the facility's reduction in the use of temporary staffing agencies. The bill has now passed both houses. In North Carolina: THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -35- « A House bill, 2023 NC H.B. 107 (NS), would repeal the state's certificate of need laws. « Governor Roy Cooper (D) signed a Medicaid expansion bill into law on March 27, 2023. The bill, 2023 NC H.B. 76 (NS), enacts the Access to Healthcare Options Act. According to the governor's press release, the expansion will cover up to 600,000 individuals and will bring billions of dollars of federal funds to the state. The governor remarked, ""Medicaid expansion is a once-in-a-generation investment that will strengthen our mental health system, boost our rural hospitals, support working families and so much more . . . . This is a historic step toward a healthier North Carolina that will bring people the opportunity of better health and a better life." [FN264] Among other things, the govermnor's press release touted the benefits the expansion will have on those living in rural communities. According to the governor, those in rural areas are 40% more likely to be uninsured; furthermore, 11 rural hospitals in the state have closed since 2005, with more at risk due to the costs of uncompensated care. The governor also noted the impact that the expansion could have on the opioid and substance abuse crisis. According to the press release, about 40% of overdose patients in emergency departments are uninsured, making it less likely that they can access appropriate care. A Senate Bill, 2023 NC S.B. 206 (NS), provides that, for hospitals that CMS has approved to participate in the Acute Care at Home program, compliance with Chapter 131E of the statutes (on health care facilities), and any related rules adopted under that chapter, will be deemed to be waived to the extent that they prohibit, conflict with, or impose additional obligations on a hospital's ability to operate under the Acute Hospital Care at Home Program. The bill also provides that care provided under the program to patients in their home does not count as licensed bed capacity under Chapter 131E. Moreover, a hospital's activities as a part of the Acute Hospital Care at Home Program do not require a home care license or certificate of need as a home health agency office. All of the above also apply to any similar CMS program administers that provides for acute hospital care at home. These provisions expire on December 31, 2024. Governor Roy Cooper (D) signed the bill on May 19, 2023. In Ohio: * The Medicaid Department finalized a rule that requires nursing facilities that sell any part of their business or bed licenses from March 29, 2022, to June 30, 2023, to reimburse the state for any relief payments the nursing facility received. The rule sets out how the amount of reimbursement is to be calculated. Please see 2022 OH REG TEXT 628493 (NS) (Mar. 13, 2023). In Pennsylvania: « A Senate bill, 2023 PA S.B. 606 (NS), would establish the Medicaid Care Transition Program to improve transfers from emergency departments to appropriate post-acute settings. The findings supplied with the bill note that hospitals sometimes experience delays in transitioning patients with behavioral health care or other long-term care needs from the emergency department to an appropriate inpatient or outpatient treatment setting. This means that patients must wait in the emergency department, causing undue stress to the patient, the patient's family, and other patients needing emergency care. The Medicaid Care Transition Program would have an established system for escalating cases when a patient has not been timely discharged to another setting. « Introduced on September 12, 2023, 2023 PA H.R. 199 (NS) urges Congress to pass a law requiring the Department of Health and Human Services to promulgate rules prohibiting disproportionate electronic payment processing fees for physicians. The findings supplied with the resolution note that the federal government has encouraged electronic bill payment functionality as a part of electronic health records implementation. However, physician practices are being charged unfair payment processing fees to receive the payments from insurers and third-party vendors. These fees can add up to $1 million annually for large practices and $100,000 annually for smaller practices. In Rhode Island: The Department of Health (RIDOH) filed emergency rules addressing accountability for safety in nursing facilities and the quality of care in such facilities. In a notice published at 2023 RI REG TEXT 653050 (NS) (Oct. 2, 2023), the department offered these justifications for the emergency rules: Since August 2020, six Rhode Island nursing homes have closed and three nursing homes with a total of 472 beds are currently in receivership status, with Court-appointed receivers assuming operational responsibilities. In RIDOH's examination into facilities that have closed or are currently under receivership, it has become clear that some of these financial difficulties are a result, in part, of premature transfer of operational and financial control. RIDOH believes that issuing these amendments will clearly hold operators, licensees, and governing bodies wholly accountable for the care provided to residents. In South Dakota: The Department of Health gave notice of proposed rules on matters relating to health care facilities. The rules would clarify minimum standards for hospitals, specialized hospitals, critical access hospitals, and rural emergency hospitals to ensure the health and safety of patients receiving care in these facilities. The department gave this summary of the proposed rules, which are published at 2023 SD REG TEXT 652342 (NS) (Sept. 18, 2023): THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -36- The Department of Health intends to adopt and amend rules to update and clarify the minimum regulations related to operation, physical environment, fire protection, management and administration, physician services, nursing and related care services, dietetic services, medication control, medical record services, hospital diagnostic services, hospital complimentary services, long-term care supportive services, construction standards, additional hospital standards, and swing bed patients' rights necessary for hospitals, specialized hospitals, critical access hospitals, and rural emergency hospitals to maintain the health and safety of patients receiving services in these facilities|.] Additionally, the proposed rules would add administrative provisions relating to rural emergency hospitals, a new Medicare provider designation. In Tennessee: * Tennessee law provides for a Nursing Home Assessment Trust Fund to be used to pay for, among other things, Medicaid nursing facility payments for fiscal year 2022-2023. [FN26] The total aggregated amount of assessments for all nursing facilities is 4.75% of the net patient service revenue. [FN288] House Bill 493 (2023 TN H.B. 493 (NS)) will extend the trust fund through fiscal year 2023-2024 and increase the total aggregated amount of assessments for all nursing facilities to 6% of the net patient service revenue. Governor Bill Lee (R) signed the bill on May 11, 2023. Senate Bill 671 (2023 TN S.B. 671 (NS)) was a related bill. In Texas: - Senate Bill 905 (2023 TX S.B. 905 (NS)) would have amended the law governing what Medicaid managed care organizations should cover. The amendment would have changed the definition of behavioral health services to include intensive outpatient services and partial hospitalization services, as defined in the bill. It did not pass before adjournment. - A Senate bill, 2023 TX S.B. 1275 (NS), would have restricted health care providers from imposing a facility fee, which was defined as afee that is, (A) intended to compensate the health care provider for operational expenses; and (B) separate from a fee charged by a health care provider for professional medical services provided in a hospital-based facility. Health care providers covered by the bill included any person or entity that provided health care services in the normal course of business, including a hospital system, a hospital, a hospital-based facility, a freestanding emergency medical care facility, and an urgent care clinic. The bill would have generally prohibited providers from imposing such a fee for outpatient health care services and for other services that the Health and Human Services Commission identified by rule. Certain exceptions would have applied; for example, the prohibition would not have applied to services rendered on hospital campuses or at a freestanding emergency care facility. Senate Bill 905 did not pass before adjournment. « Also in Texas, 2023 TX S.B. 1197 (NS) would have required hospitals to report monthly on the number of reports that a hospital employee or agent made to the Department of Family and Protective Services of alleged or suspected abuse, exploitation, or neglect of a child. The bill spelled out exactly what information the hospital would have needed to report to the Commissioner of Health and Human Services, and it sets out fines for hospitals that did not comply. It did not pass this session. « A Senate bill, 2023 TX S.B. 1629 (NS), would have required the Executive Commissioner of the Department of Health and Human Services Commission to establish a direct care expense ratio for non-state-owned nursing facilities that would have required that 80% Medicaid reimbursements paid to a nursing facility that was attributable to patient care expenses be spent on reasonable and necessary direct care expenses, as defined in the bill. The state would not have made compliance a condition of participation in Medicaid; however, the bill would have allowed the state to adjust reimbursements for non-complying facilities. The bill would have also required nursing facilities participating in the STAR + PLUS Medicaid managed care program to comply with the ratio, and the compliance requirement would have been put into the managed care organization's provider contract. Finally, the bill would have required specified ownership information on nursing facility applications. While it passed the Senate on April 20, 2023, it was not adopted before adjournment. « A House bill, 2023 TX H.B. 3468 (NS), would have amended the Business and Commerce Code to make it a violation of state law for any party to engage in information blocking in violation of federal law. Generally, information blocking is defined in federal law as any practice that is likely to interfere with access, exchange, or use of electronic health information. [FN267] |t would have also established that a patient's medical records, including electronic records, are the property of the patient, and it would have set up limits on the charges a provider may imposed for copying medical records for a patient. It did not pass this session. » Governor Greg Abbott (R) signed 2023 TX H.B. 1290 (NS) on June 9, 2023. The bill will prohibit a nursing facility from misappropriating or confiscating federal payments made to a Medicaid enrollee. The bill sets an administrative penalty of $25,000 for such acts, and each day that the facility does not return the payments to the resident would be counted as a new violation. ¢ The Department of Health and Human Services adopted new rules to implement state law on Limited Services Rural Hospitals (LSRHSs). The rules adopt definitions and cover topics such as licensing; responsibilities of LSRH governing bodies; the provision of emergency services, laboratory services, and radiologic services; and medical staff, among other things. The rules are published at 2023 TX REG TEXT 644864 (NS) (Sept. 29, 2023). THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -37- In Utah: - Governor Spencer Cox (R) signed 2023 UT H.B. 315 (NS) on March, 13, 2023. The bill directs the Department of Health and Human Services to apply for a waiver or a Medicaid State Plan amendment to allow for reimbursement for recreational therapy services. Such services are defined in UT ST § 58-40-102 as ""a person-centered process that uses recreation and psychoeducational activities as intervention tools to improve the physical, cognitive, social, behavioral, emotional, or spiritual well-being of a person with an iliness or a disability." The latest version of House Bill 315 provides for reimbursement for these services when provided by a qualified practitioner in these settings: (i) general acute hospital; (i) youth residential treatment facility; (iii) behavioral health program; (iv) intermediate care facility; (v) assisted living facility; (vi) skilled nursing facility; (vii) psychiatric hospital; or (viii) mental health agency. In Virginia: * Governor Glen Youngkin (R) signed 2022 VA S.B. 1339 (NS) on March 24, 2023. The bill sets out minimum staffing requirements for nursing facilities eligible to participate in the Virginia Medicaid Nursing Facility Value-Based Purchasing program, as follows: [Regulations shall]l require each certified nursing facility eligible to participate in the Virginia Medicaid Nursing Facility Value-Based Purchasing (VBP) program, as referenced in Chapter 2 of the Acts of Assembly of 2022, Special Session I, to provide at least 3.08 hours of case mix-adjusted total nurse staffing hours per resident per day on average as determined annually by the Department of Medical Assistance Services for use in the VBP program, utilizing job codes for the calculation of total nurse staffing hours per resident per day following the Centers for Medicare and Medicaid Services (CMS) definitions as of January 1, 2022, used for similar purposes and including certified nursing assistants, licensed practical nurses, and registered nurses. No additional reporting shall be required by a certified nursing facility under this subdivision. The bill also sets out administrative sanctions for non-compliance. A related House bill, 2022 VA H.B. 1446 (NS), was also adopted. In Washington: » 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 finalized rules amending the Hospice Services Standards and Need Forecasting Method. The department indicated that the new method will more accurately measure hospice utilization. The rules are published at 2022 WA REG TEXT 544305 (NS) (Dec. 21, 2022). * Governor Jay Inslee (D) signed 2023 WA S.B. 5103 (NS) on May 4, 2023. The bill provides for Medicaid payment to hospitals for days in which an enrollee does not meet the acute inpatient criteria but cannot be discharged to an appropriate setting because a placement is not available in that setting. « House Bill 1850 (2023 WA H.B. 1850 (NS)), which was adopted on May 11, 2023, created a hospital safety net program for Medicaid payments to hospitals. The Washington State Hospital Association explained that the bill, directs the Health Care Authority to implement a directed payment program to increase funding and payment for hospitals services provided to Medicaid enrollees. The new program will significantly reduce the gap between the actual cost of care and payment for Medicaid services. Since the program is fully funded through assessments from hospitals and federal match, no state funds are required. [FN268] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -38- « In September 2023, the Health Care Authority gave notice at 2023 WA REG TEXT 652127 (NS) (Sept. 20, 2023) that it intends to file a State Plan amendment to update outpatient hospital supplemental payment amounts for the new program. The agency described the changes in the notice: The health care authority (HCA) intends to submit SPA 23-0046 to update outpatient hospital supplemental payment amounts for the new safety net program. Prospective payment system hospitals' total supplemental payment pool will be reduced to $24,800,000. SPA 23-0046 will also change 'state fiscal year' to 'calendar year.' In Wisconsin: A Senate bill, 2023 WI S.B. 257 (NS), set outs visiting policies for assisted living centers and nursing homes during a communicable disease outbreak. The latest version of the bill provides that whenever such facilities limit visitors due to a communicable disease outbreak, the facility must allow one essential visitor to visit with a resident in compassionate care situations. An essential visitor is defined as: 1. An individual to visit and provide support to a resident in an assisted living facility or nursing home who is designated by the resident or the resident's guardian or agent under an activated power of attomey for health care. 2. The guardian of an assisted living facility or nursing home resident or the agent under an activated power of attorney for health care for an assisted living facility or nursing home resident. An essential visitor would be allowed under the following circumstances: a. The resident has recently been admitted to the assisted living facility or nursing home and is experiencing difficulty in adjusting to the change in environment and lack of family presence. b. The resident is grieving the recent death of a friend or family member. c. The resident is nearing end of life. d. In the judgment of the attending health care professional, as defined in s. 154.01 (1r), the benefits of the presence of the essential visitor outweighs the potential negative impacts that the essential visitor's presence might have on other patients, visitors, and staff in the assisted living facility or nursing home. Further, an assisted living facility or nursing home would be required to allow one clergy member to visit during a communicable disease outbreak. Visitors allowed by the bill could be denied visitation if they do not comply with the facility's health and safety policies, if there is a risk that they could be contagious, or if the resident does not care to see the visitor. The bill also addresses hospital visits by essential visitors and clergy during an outbreak of a communicative disease. The version of the bill that was introduced in May 2023 was broader. The above is a description of the bill as amended in November 2023. XIll. additional resources The COVID-19 public health emergency, which was declared in January 2020, ended on May 11, 2023. In a Fact Sheet, HHS provided its justifications for ending the emergency: Over the last two years, the Biden Administration has effectively implemented the largest adult vaccination program in U.S. history, with nearly 270 million Americans receiving at least one shot of a COVID-19 vaccine. As a result of this and other efforts, since the peak of the Omicron surge at the end of January 2022: - Daily COVID-19 reported cases are down 92%, - COVID-19 deaths have declined by over 80%, and - New COVID-19 hospitalizations are down nearly 80%. [FN269] Even before it announced the end of the public health emergency, the Biden Administration had been providing guidance on unwinding to states and other stakeholders, hoping for a smooth transition to pre-pandemic times. It continues to do so. Of particular note is a recent update that contains a list of provider-specific waivers and flexibilities with links to more information about whether they have been terminated or made permanent or whether they will end at when the public health emergency ends. The update indicates how the changes will affect the Medicare and Medicaid programs. [FN2701 Apother resource is a Fact Sheet addressing how the end of the emergency will affect COVID-19 vaccines, testing, and treatments; telehealth services; health care access; and the Inpatient Hospital Care at Home program. For each of these topics, the Fact Sheet explains the changes that will take place in the Medicaid and Medicare programs and in private insurance. [FN271] XIV. Conclusion THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -39- 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 public health emergency impelled many temporary changes to health facility requirements. The emergency period ended on May 11, 2023, and we will continue to report on the transition to pre-pandemic policies. © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] 'Hospitals are Economic Anchors in their Communities," American Hospital Association, https://www.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 al., ""Hospital Charity Care: How It Works and Why It Matters," Kaiser Family Foundation, Nov. 3, 2022, available at: https://www 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-8HcBdNir7AgLVrplh3cwAzaBmo6DW6qKacu1Ecjt&utm_content=232620119: [FN5] "Fact Sheet: Uncompensated Hospital Care Cost," American Hospital Association, Feb. 2022, available at: https://www.aha.org/ system/files/media/file/2022/02/medicare-medicaid-underpayment-fact-sheet-current.pdf. [FN§] ""Strategic Plan Cross-Cutting Initiatives," CMS, available at: https://www.cms.gov/files/document/strategic-plan-overview-fact- sheet.pdf. [FN7] 87 F.R. 71748-01 (Nov. 23, 2022). [FN8] CMS recently issued guidance on this new provider type addressing the conversion process and the conditions of participation. Memo to State Survey Directors, "Guidance for Rural Emergency Hospital Provisions, Conversion Process and Conditions of Participation," CMS, Jan. 26, 2023, available at: https://www.cms.gov/files/document/qso-23-07-reh.pdf. [FN9] The No Surprises Act was enacted as a part of the Consolidated Appropriations Act, 2021, Publ. L. 116-260. [FN10] 87 F.R. 76238 (Dec. 13, 2022). [FN11] "Innovation Center Strategy Refresh," CMS, available at: [FN12] *"Centers for Medicare & Medicaid Services (CMS) Accomplishments for 2022," CMS, available at: https://www.cms.govi/files/ document/cms-accomplishments-2022.pdf. [FN13] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -40- Press Release, "CMS Office of the Actuary Releases 2022-2031 National Health Expenditure Projections," CMS, June 14, 2023, available at: https://www.cms.gov/newsroom/press-releases/cms-office-actuary-releases-2022-203 1-national-health-expenditure- projections. [FN14] Press Release, "CMS Office of the Actuary Releases 2022-2031 National Health Expenditure Projections," CMS, June 14, 2023, available at: https://www.cms.gov/newsroom/press-releases/cms-office-actuary-releases-2022-203 1-national-health-expenditure- projections. [FN15] The report is available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ NationalHealthExpendData/NationalHealthAccountsProjected. [FN16] Elizabeth Hinton, et al., "Amid Unwinding of Pandemic-Era Policies, Medicaid Programs Continue to Focus on Delivery Systems, Benefits, and Reimbursement Rates: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2023 and 2024," Kaiser Family Foundation, Nov. 14, 2023, available at: https://www kff.org/report-section/50-state-medicaid-budget-survey-fy-2023-2024- executive-summary/. [FN17] Elizabeth Hinton, et al., ""Amid Unwinding of Pandemic-Era Policies, Medicaid Programs Continue to Focus on Delivery Systems, Benefits, and Reimbursement Rates: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2023 and 2024," Kaiser Family Foundation, Nov. 14, 2023, available at: https://www.kff.org/report-section/50-state-medicaid-budget-survey-fy-2023-2024- provider-rates-and-taxes/. [FN18] Elizabeth Hinton, et al., "Amid Unwinding of Pandemic-Era Policies, Medicaid Programs Continue to Focus on Delivery Systems, Benefits, and Reimbursement Rates: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2023 and 2024," Kaiser Family Foundation, Nov. 14, 2023, available at: https://www kff.org/report-section/50-state-medicaid-budget-survey-fy-2023-2024- provider-rates-and-taxes/. [FN19] The following states have not adopted the expansion: Alabama, Florida, Georgia, Kansas, Mississippi, South Carolina, Tennessee, Texas, Wisconsin, and Wyoming. ""Status of State Action on the Medicaid Expansion Decision," Kaiser Family Foundation, updated Dec. 1, 2023, https://www.kff.org/medicaid/issue-brief/status-of-state-medicaid-expansion-decisions-interactive-map/. [FN20] Meghana Ammula and Madeline Guth, ""What Does the Recent Literature Say About Medicaid Expansion?: Economic Impacts on Providers," Kaiser Family Foundation, Jan. 18, 2023, available at: https://www.kff.org/medicaid/issue-brief/what-does-the-recent- literature-say-about-medicaid-expansion-economic-impacts-on-providers/?utm. [FN21] "Health Center Program Impact and Growth," HRSA, updated Aug. 21, 2022, available at: https://bphc.hrsa.gov/about-health-centers/ health-center-program-impact-growth. [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] *2022 Community Health Center Chart Book," National Association of Community Health Centers, available at: https://www.nachc.org/ research-and-data/research-fact-sheets-and-infographics/2021-community-health-center-chartbook/. [FN24] 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://www.hhs.gov/about/news/2022/02/14/hhs-awards-nearly-55-million-increase-virtual- health-care-access-quality-through-community-health-centers.html?utm. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -41- [FN25] 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://www.hhs.gov/about/news/2022/02/14/hhs-awards-nearly-55-million-increase-virtual- health-care-access-quality-through-community-health-centers.html?utm. [FN26] News Release, "*HHS Awards Nearly $90 Million to Community Health Centers to Advance Health Equity through Better Data," HHS, Aug. 8, 2022, available at: hitps://www.hhs.gov/about/news/2022/08/08/hhs-awards-nearly-30-million-dollars-to-community-health- centers-to-advance-health-equity-through-better-data.html. [FN27] HRSA is the Health Resources and Services Administration. [FN28] 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://www.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. [FN29] Jessica Sharac, ef 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://www.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. [FN30] 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://www 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/. [FN31] 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://www 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/. [FN32] 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: hitps://www 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/. [FN33] **Community Health Center Patients by Payer Source," Kaiser Family Foundation, Timeframe: 2020, available at: https://www.kff.org/other/state-indicator/chc-patients-by-payer-source/? dataView=1&currentTimeframe=08&selectedDistributions=medicaid&sortModel=#c#olld:#L#ocation #s#ort:#asc'#. [FN34] ""State of the Union Address," The White House, Mar. 1, 2022, available at: https://www.whitehouse.gov/state-of-the-union-2022/. [FN35] 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://www.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/. [FN36] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -42- 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://www.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;/. [FN37] Press Release, "Biden-Harris Administration Strengthens Oversight of Nation's Poorest-Performing Nursing Homes," CMS, Oct. 21, 2022, available at: https://www.cms.gov/newsroom/press-releases/biden-harris-administration-strengthens-oversight-nations-poorest- performing-nursing-homes (emphasis deleted). [FN38] Fact Sheet, ""Biden-⁠Harris Administration Announces New Steps to Improve Quality of Nursing Homes," The White House, Oct. 21, 2022, available at: https://www .whitehouse.gov/briefing-room/statements-releases/2022/10/21/fact-sheet-biden-harris- administration-announces-new-steps-to-improve-quality-of-nursing-homes/. [FN39] News Release, "HHS Releases New Data and Report on Hospital and Nursing Home Ownership," HHS, Apr. 20, 2022, available at: https://www.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. [FN40] ""Executive Order on Promoting Competition in the American Economy," The White House, July 9, 2022, available at: hitps:// www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american- economy/. [FN41] News Release, "HHS Releases New Data and Report on Hospital and Nursing Home Ownership," HHS, Apr. 20, 2022, available at: https://www.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. [FN42] 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://www.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://www.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/. [FN43] ""Executive Order on Promoting Competition in the American Economy," The White House, July 9, 2021, available at: hitps:// www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american- economy/. [FN44] 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://www.cms.gov/newsroom/ press-releases/biden-harris-administration-makes-more-medicare-nursing-home-ownership-data-publicly-available. [FN45] 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://www.cms.gov/newsroom/ press-releases/biden-harris-administration-makes-more-medicare-nursing-home-ownership-data-publicly-available. [FN46] Fact Sheet, ""Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities; Definitions of Private Equity Companies and Real Estate Investment Trusts for Medicare Providers and Suppliers," CMS, Nov. 15, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/disclosures-ownership-and-additional-disclosable-parties- information-skilled-nursing-facilities-and-0. Follow the links in the Fact Sheet to read the research. [FN47] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -43- Fact Sheet, ""Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities; Definitions of Private Equity Companies and Real Estate Investment Trusts for Medicare Providers and Suppliers," CMS, Nov. 15, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/disclosures-ownership-and-additional-disclosable-parties- information-skilled-nursing-facilities-and-0. Follow the links in the Fact Sheet to read the research. [FN48] Press Release, ""To Advance Information on Quality of Care, CMS Makes Nursing Home Staffing Data Available," CMS, Jan. 26, 2022, available at: https://www.cms.gov/newsroom/press-releases/advance-information-quality-care-cms-makes-nursing-home-staffing-data- available. [FN49] Press Release, "To Advance Information on Quality of Care, CMS Makes Nursing Home Staffing Data Available," CMS, Jan. 26, 2022, available at: https://www.cms.gov/newsroom/press-releases/advance-information-quality-care-cms-makes-nursing-home-staffing-data- available. [FN50] Letter to CMS Certified Nursing Home Operators, "*Nursing Home Staff Turnover and Weekend Staffing Levels," Ref: QS0-22-08-NH, Jan. 7, 2022, available at: https://www.cms.gov/files/document/qso-22-08-nh.pdf. [FN51] Medicare.gov, hitps://www.medicare.gov/care-compare/. [FN52] Press Release, "CMS Enhances Nursing Home Rating System with Staffing and Turnover Data," CMS, July 27, 2022, available at: https://www.cms.gov/newsroom/press-releases/cms-enhances-nursing-home-rating-system-staffing-and-turnover-data. [FN53] Fact Sheet, ""Updates to the Care Compare Website July 2022," CMS, July 27, 2022, available at: https://www.cms.gov/newsroom/ fact-sheets/updates-care-compare-website-july-2022. [FN54] *"Design for Care Compare Nursing Home Five-Star Quality Rating System: Technical Users' Guide," CMS. July 2022, available at: hitps://iwww.cms.gov/Medicare/Provider-Enroliment-and-Certification/CertificationandComplianc/downloads/usersguide.pdf. [FN55] Press Release, "HHS Proposes Minimum Staffing Standards to Enhance Safety and Quality in Nursing Homes," CMS, Sept. 1, 2023, available at: https://www.cms.gov/newsroom/press-releases/hhs-proposes-minimum-staffing-standards-enhance-safety-and-quality- nursing-homes. [FNS6] Fact Sheet, ""Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (CMS 3442-P)," CMS, Sept. 1, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/ medicare-and-medicaid-programs-minimum-staffing-standards-long-term-care-facilities-and-medicaid. [FN57] Alice Burns, et al., "What Share of Nursing Facilities Might Meet Proposed New Requirements for Nursing Staff Hours?," Kaiser Family Foundation, Sept. 18, 2023, available at: https://www.kff.org/medicaid/issue-brief/what-share-of-nursing-facilities-might-meet-proposed- new-requirements-for-nursing-staff-hours/?utm_campaign=KFF-2023-Medicaid&utm. [FN58] Fact Sheet, ""Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (CMS 3442-P)," CMS, Sept. 1, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/ medicare-and-medicaid-programs-minimum-staffing-standards-long-term-care-facilities-and-medicaid. [FN59] Fact Sheet, ""Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (CMS 3442-P)," CMS, Sept. 1, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/ medicare-and-medicaid-programs-minimum-staffing-standards-long-term-care-facilities-and-medicaid. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -44- [FN60] Fact Sheet, ""Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (CMS 3442-P)," CMS, Sept. 1, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/ medicare-and-medicaid-programs-minimum-staffing-standards-long-term-care-facilities-and-medicaid.. [FN61] Memorandum to State Survey Agency Directors, # QS0-23-23-NHs, CMS, Sept. 25, 2023, available at: https://www.cms.gov/files/ document/qso-23-23-nhs.pdf. [FN62] 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://www.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. [FN63] Press Release, "Biden-Harris Administration Takes Additional Steps to Strengthen Nursing Home Safety and Transparency," CMS, Jan. 18, 2023, available at: https://www.cms.gov/newsroom/press-releases/biden-harris-administration-takes-additional-steps- strengthen-nursing-home-safety-and-transparency. [FN84] Press Release, "Biden-Harris Administration Takes Additional Steps to Strengthen Nursing Home Safety and Transparency," CMS, Jan. 18, 2023, available at: https://www.cms.gov/newsroom/press-releases/biden-harris-administration-takes-additional-steps- strengthen-nursing-home-safety-and-transparency. [FN65] "CMS Increases Nursing Home Ownership Transparency," Medicaid.gov, June 28, 2023, available at: https://content.govdelivery.com/ accounts/USCMSMEDICAID/bulletins/36281a6. [FN66] MaryBeth Musumeci, et al., ""State Actions to Address Nursing Home Staffing During COVID-19," Kaiser Family Foundation, May 16, 2022, available at: https://www kff.org/medicaid/issue-brief/state-actions-to-address-nursing-home-staffing-during-covid-19/? utm_campaign=KFF-2022-The-Latest&utm. [FN67] This rule is published at: 87 F.R. 48780-01 (Aug. 10, 2022). [FN68] Fact Sheet, ""FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospitals (LTCH PPS) Final Rule - CMS-1771-F Maternal Health," 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. [FN69] Press Release, "Biden-Harris Administration Launches "Birthing-Friendly' Designation on Web-Based Care Compare Tool," HHS, Nov. 8, 2023, available at: https://www.hhs.gov/about/news/2023/11/08/biden-harris-administration-launches-birthing-friendly-designation- web-based-care-compare-tool.html. [FN70] 84 F.R. 65524-01 (Nov. 19, 2019). [FN71] Meena Seshamani and Douglas Jacobs, "Hospital Price Transparency: Progress and Commitment to Achieving its Potential," Health Affairs, Feb. 14, 2023, available at: https://www.healthaffairs.org/content/forefront/hospital-price-transparency-progress-and- commitment-achieving-its-potential. [FN72] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -45- Meena Seshamani and Douglas Jacobs, "Hospital Price Transparency: Progress and Commitment to Achieving its Potential," Health Affairs, Feb. 14, 2023, available at: https://www.healthaffairs.org/content/forefront/hospital-price-transparency-progress-and- commitment-achieving-its-potential. [FN73] That rule is published at 86 F.R. 63458 (Nov. 16, 2021). [FN74] Meena Seshamani and Douglas Jacobs, "Hospital Price Transparency: Progress and Commitment to Achieving its Potential," Health Affairs, Feb. 14, 2023, available at: https://www.healthaffairs.org/content/forefront/hospital-price-transparency-progress-and- commitment-achieving-its-potential. [FN75] Meena Seshamani and Douglas Jacobs, "Hospital Price Transparency: Progress and Commitment to Achieving its Potential," Health Affairs, Feb. 14, 2023, available at: https://www.healthaffairs.org/content/forefront/hospital-price-transparency-progress-and- commitment-achieving-its-potential. [FN78] Fact Sheet, ""Hospital Price Transparency Enforcement Updates," CMS, Apr. 26, 2023, available at: hitps://www.cms.gov/newsroom/ fact-sheets/hospital-price-transparency-enforcement-updates. [FN77] **Partnership for Patients," CMS, available at: https://innovation.cms.gov/innovation-models/partnership-for-patients. [FN78] For a primer on the program, please see 'Understanding the Hospital-Acquired Condition Reduction Program,'" Lake Superior Quality Innovation Network, available at: https://www.stratishealth.org/documents/HAC_fact_sheet.pdf. [FN79] 'Hospital-Acquired Condition Reduction Program,' CMS, updated July 20, 2017, available at: hitps://www.cms.gov/Medicare/Medicare- Fee-for-Service-Payment/AcutelnpatientPPS/HAC-Reduction-Program.html. [FN80] Hospital-Acquired Condition (HAC) Reduction Program Fiscal Year 2024 Fact Sheet," CMS, available at: https://www.cms.gov/files/ document/fy-2024-hac-reduction-program-fact-sheet.pdf. [FN81] 87 F.R. 48780 (Aug. 10, 2022). [FN82] 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://www.cms.gov/newsroom/fact-sheets/ fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective. [FN83] 2023 Fact Sheet, ""Hospital-Acquired Condition (HAC) Reduction Program," CMS, available at: https://www.cms.gov/files/document/ fy-2023-hac-reduction-program-fact-sheet.pdf. For more information, please see CMS' Frequently Asked Questions for the 2023 program year, available at: https://qualitynet.cms.gov/inpatient/hac/resources. [FN84] Press Release, "AHRQ Analysis Finds Hospital-Acquired Conditions Declined by Nearly 1 Million from 2014-2017," Jan. 29, 2019, available at: https://www.ahrg.gov/news/newsroom/press-releases/hac-rates-declined.html. [FN85] *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. [FN86] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -46- For more information, please the program's web page, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient- Assessment-Instruments/Value-Based-Programs/HRRP/Hospital-Readmission-Reduction-Program. [FN87] Jordan Rau, ""Medicare Fines for High Hospital Readmissions Drop, but Nearly 2,300 Facilities Are Still Penalized," Kaiser Health News, Nov. 1, 2022, available at: https://khn.org/news/article/medicare-fines-hospital-readmissions-drop-covid/. [FN88] "FY 2023 Hospital Readmissions Reduction Program: Hospital-Specific Reports and Review and Correction Period Information," CMS, available at: https://qualitynet.cms.gov/news/62ed068125af600016945262. (Footnote omitted.) [FN89] 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://www.cms.gov/newsroom/fact-sheets/ fy-2023-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective. [FNSO0] Fact Sheet, "FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule - CMS-1785-F and CMS-1788-F Fact Sheet," CMS, Aug. 1, 2023, available at: https://www.cms.gov/ newsroom/fact-sheets/fy-2024-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0. [FN91] Youssra Marjoua and Kevin J. Bozic, ""Brief History of Quality Movement in US healthcare," National Library of Medicine, Sept. 9, 2012, available at: https://www.ncbi.nim.nih.gov/pmc/articles/PMC3702754/#. [FN92] See, e.g., "Report to Congress: National Strategy for Quality Improvement in Health Care," CMS, Mar. 2011, available at: https:// www.cms.gov/CCllIO/Resources/Forms-Reports-and-Other-Resources/quality03212011a. [FN93] 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/31afec9. [FN94] 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/31afec9. [FNg5] 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/31afec9. [FN96] "What are Value-Based Programs?" CMS, updated 1/6/2020, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient- Assessment-Instruments/Value-Based-Programs/Value-Based-Programs. [FN97] 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://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018- Press-releases-items/2018-01-09.html. [FNg8] 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://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018- Press-releases-items/2018-01-09.html. [FNog] BPCI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. 47- [FN100] ""Model Overview Fact Sheet - Model Year 6 (2023)," CMS, available at: https://innovation.cms.gov/media/document/bpcia-model- overview-fact-sheet-my6. [FN101] ""BCPI Advanced," CMS, available at: https://innovation.cms.gov/innovation-models/bpci-advanced. [FN102] BPCI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. [FN103] **Comprehensive Care for Joint Replacement Model," CMS' Innovation Center, available at: https://innovation.cms.gov/innovation- models/cjr. [FN104] 86 F.R. 23496 (May 3, 2021). [FN105] Andrew D. Wilcock, ef al., "How Hospitals Respond to Incentives in Bundled Payment Models for Joint Surgery," The Commonwealth Fund, May 18, 2021, available at: https://www.commonwealthfund.org/publications/journal-article/2021/may/hospital-incentives- bundled-payment-joint-surgery?utm_source=alert&utm_medium=email&utm_campaign=Drug Costs/. [FN106] Press Release, "CMS Announces Transformative Model to Give States Incentives and Flexibilities to Redesign Health Care Delivery, Improve Equitable Access to Care," CMS, Sept. 5, 2023, available at: https://www.cms.gov/newsroom/press-releases/cms-announces- transformative-model-give-states-incentives-and-flexibilities-redesign-health-care/. [FN107] ""Total Cost of Care and Hospital Global Budgets," CMS, available at: https://www.cms.gov/priorities/innovation/key-concept/total-cost- care-and-hospital-global-budgets. [FN108] Press Release, "CMS Announces Transformative Model to Give States Incentives and Flexibilities to Redesign Health Care Delivery, Improve Equitable Access to Care," CMS, Sept. 5, 2023, available at: https://www.cms.gov/newsroom/press-releases/cms-announces- transformative-model-give-states-incentives-and-flexibilities-redesign-health-care/. [FN109] ""States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model," CMS, available at: https://www.cms.gov/ priorities/innovation/innovation-models/ahead. [FN110] Model Overview Fact Sheet, "States Advancing All-Payer Health Equity Approaches and Development (AHEAD)," CMS, available at: https://www.cms.gov/files/document/ahead-overview-fs.pdf. [FN111] ""States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model," CMS, available at: hitps://www.cms.gov/ priorities/innovation/innovation-models/ahead. [FN112] ""States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model," CMS, available at: https://www.cms.gov/ priorities/innovation/innovation-models/ahead. [FN113] ""States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model," CMS, available at: https://www.cms.gov/ priorities/innovation/innovation-models/ahead. [FN114] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -48- *"States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model," CMS, available at: hitps://www.cms.gov/ priorities/innovation/innovation-models/ahead. [FN115] Fact Sheet, 'Accountable Care Organizations: What Providers Need to Know, Oct. 20, 2011, available at: http://www.cms.gov/ Newsroom/MediaReleaseDatabase/Fact-Sheets/2011-Fact-Sheets-ltems/2011-10-207 .html. [FN116] See, e.g., Dr. Donald Berwick, 'Improving Care for People with Medicare," Medicare Blog, April 4, 2011, available at: hitp:// blog.medicare.gov/category/affordable-care-act/. [FN117] *Shared Savings Program Fast Facts - As of Jan. 1, 2022," CMS, available at: https://www.cms.gov/files/document/2022-shared- savings-program-fast-facts.pdf. [FN118] ""Beneficiary Engagement Toolkit," CMS, Nov. 2019, available at: https://innovation.cms.gov/files/x/aco-beneficiary-engagement- toolkit.pdf. [FN119] *Care Coordination Toolkit," CMS, Mar. 2019, available at: https://innovation.cms.gov/files/x/aco-carecoordination-toolkit.pdf/. [FN120] ""Provider Engagement Toolkit," CMS, July 2020, available at: https://innovation.cms.gov/media/document/2020-provider-engagement- toolkit. [FN121] ""Care Transformation Toolkit," CMS, Jan. 2021, available at: https://innovation.cms.gov/media/document/aco-caretransformation- toolkit. [FN122] Operation Elements Toolkit, CMS, May 2021, available at: https://innovation.cms.gov/media/document/aco-operational-elements-toolkit. [FN123] Press Release, "CMS Announces Increase in 2023 in Organizations and Beneficiaries Benefiting from Coordinated Care in Accountable Care Relationship," CMS, Jan. 17, 2023, available at: https://www.cms.gov/newsroom/press-releases/cms-announces- increase-2023-organizations-and-beneficiaries-benefiting-coordinated-care-accountable. [FN124] Press Release, "CMS Announces Increase in 2023 in Organizations and Beneficiaries Benefiting from Coordinated Care in Accountable Care Relationship," CMS, Jan. 17, 2023, available at: https://www.cms.gov/newsroom/press-releases/cms-announces- increase-2023-organizations-and-beneficiaries-benefiting-coordinated-care-accountable. [FN125] 87 F.R. 69404-01 (Nov. 18, 2022). [FN126] Fact Sheet, ""Calendar Year (CY) 2023 Medicare Physician Fee Schedule Final Rule - Medicare Shared Savings Program," CMS, Nov. 1, 2022, available at: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule- medicare-shared-savings-program. [FN127] Press Release, "CMS Announces Increase in 2023 in Organizations and Beneficiaries Benefiting from Coordinated Care in Accountable Care Relationship," CMS, Jan. 17, 2023, available at: https://www.cms.gov/newsroom/press-releases/cms-announces- increase-2023-organizations-and-beneficiaries-benefiting-coordinated-care-accountable. [FN128] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -49- Press Release, "CMS Announces Increase in 2023 in Organizations and Beneficiaries Benefiting from Coordinated Care in Accountable Care Relationship," CMS, Jan. 17, 2023, available at: https://www.cms.gov/newsroom/press-releases/cms-announces- increase-2023-organizations-and-beneficiaries-benefiting-coordinated-care-accountable. [FN129] ""Medicare Shared Savings Program Skilled Nursing Facility 3-Day Rule Waiver," CMS. May 2022, available at: https://www.cms.gov/ medicare/medicare-fee-for-service-payment/sharedsavingsprogram/downloads/snf-waiver-guidance.pdf. The waiver is embodied in 42 C.F.R. § 425.612. [FN130] *Skilled Nursing Facility 3-day Waiver Analysis of Use in ACOs 2014 to 2019," CMS, available at: https://innovation.cms.gov/data-and- reports/2023/snf-waiver-summary. [FN131] "*Medicare Shared Savings Program Skilled Nursing Facility 3-Day Rule Waiver," CMS. May 2022, available at: https://www.cms.gov/ medicare/medicare-fee-for-service-payment/sharedsavingsprogram/downloads/snf-waiver-guidance.pdf. [FN132] Phil Galewitz, ""Medicare to Overhaul ACOs but Critics Fear Less Participation," Kaiser Health News, Aug. 9, 2018, available at: https:// khn.org/news/medicare-to-overhaul-acos-but-critics-fear-fewer-participants/; Press Release, ""CMS Proposes ""Pathways to Success," an Overhaul of Medicare's ACO Program," CMS, Aug. 9, 2018, available at: https://www.cms.gov/newsroom/press-releases/cms- proposes-pathways-success-overhaul-medicares-aco-program. [FN133] "*Medicare Shared Savings Program," CMS, available at: hitps://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/about.html. [FN134] Rajiv Leventhal, "EXCLUSIVE: Substantial ACO Reforms Could be Forthcoming," Healthcare Informatics, May 9, 2018, available at: hitps://www.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/. [FN135] Fact Sheet, "New Accountable Care Organization Model Opportunity: Medicare ACO Track 1+ Model," updated July 2017, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/New-Accountable-Care- Organization-Model-Opportunity-Fact-Sheet.pdf. [FN136] 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://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-12-20.htmI? DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending. [FN137] Press Release, Tom Nickels, 'Statement on the New Track 1+ Accountable Care Organization Model,' available at: hitp://www.aha.org/ presscenter/pressrel/2016/162012-pr-track.shtml. [FN138] Fact Sheet, ""Speech: Remarks by CMS Administrator Seema Verma at the American Hospital Association Annual Membership Meeting," CMS, May 7, 2018, available at: https://www.cms.gov/newsroom/fact-sheets/speech-remarks-cms-administrator-seema- verma-american-hospital-association-annual-membership-meeting. [FN139] 83 F.R. 41786 (Aug. 17, 2018). [FN140] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -50- Press Release, ™CMS Finalizes "Pathways to Success,' an Overhaul of Medicare's National ACO Program," CMS, Dec. 21, 2018, available at: https://www.cms.gov/newsroom/press-releases/cms-finalizes-pathways-success-overhaul-medicares-national-aco- program. [FN141] Fact Sheet, "Final Rule Creates Pathways to Success for the Medicare Shared Savings Program," CMS, Dec. 21, 2018, available at: hitps://www.cms.gov/newsroom/fact-sheets/final-rule-creates-pathways-success-medicare-shared-savings-program. [FN142] Fact Sheet, "Final Rule Creates Pathways to Success for the Medicare Shared Savings Program," CMS, Dec. 21, 2018, available at: https://www.cms.gov/newsroom/fact-sheets/final-rule-creates-pathways-success-medicare-shared-savings-program. [FN143] *Shared Savings Program Participation Options for Performance Year 2024," CMS, Mar. 2023, available at: https://www.cms.gov/ Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/ssp-aco-participation-options.pdf. [FN144] Fact Sheet, ""Calendar Year (CY) 2024 Medicare Physician Fee Schedule Proposed Rule - Medicare Shared Savings Program Proposals," CMS, July 13, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2024-medicare-physician- fee-schedule-proposed-rule-medicare-shared-savings-program. [FN145] Fact Sheet, ""Calendar Year (CY) 2024 Medicare Physician Fee Schedule Proposed Rule - Medicare Shared Savings Program Proposals," CMS, July 13, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2024-medicare-physician- fee-schedule-proposed-rule-medicare-shared-savings-program. [FN146] Fact Sheet, ""Calendar Year (CY) 2024 Medicare Physician Fee Schedule Proposed Rule - Medicare Shared Savings Program Proposals," CMS, July 13, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2024-medicare-physician- fee-schedule-proposed-rule-medicare-shared-savings-program. [FN147] Press Release, ""Medicare Shared Savings Program Saves Medicare More Than $1.8 Billion in 2022 and Continues to Deliver High- quality Care," CMS, Aug. 24, 2023, available at: https://www.cms.gov/newsroom/press-releases/medicare-shared-savings-program- saves-medicare-more-18-billion-2022-and-continues-deliver-high. [FN148] Press Release, "CMS Redesigns Accountable Care Organization Model to Provide Better Care for People with Traditional Medicare," CMS, Feb. 24, 2022, available at: hitps://www.cms.gov/newsroom/press-releases/cms-redesigns-accountable-care-organization-model- provide-better-care-people-traditional-medicare. [FN149] See Innovation Center Design Refresh, CMS, available at: https://innovation.cms.gov/strategic-direction-whitepaper. [FN150] Press Release, "CMS Redesigns Accountable Care Organization Model to Provide Better Care for People with Traditional Medicare," CMS, Feb. 24, 2022, available at: hitps://www.cms.gov/newsroom/press-releases/cms-redesigns-accountable-care-organization-model- provide-better-care-people-traditional-medicare. [FN151] Fact Sheet, ""Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model," CMS, Feb. 24, 2022, available at: https://www.cms.gov/newsroom/fact-sheets/accountable-care-organization-aco-realizing-equity-access-and- community-health-reach-model. [FN152] Fact Sheet, ""Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model," CMS, Feb. 24, 2022, available at: https://www.cms.gov/newsroom/fact-sheets/accountable-care-organization-aco-realizing-equity-access-and- community-health-reach-model. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -51- [FN153] "ACO Reach," CMS, available at: https://innovation.cms.gov/innovation-models/aco-reach. [FN154] News Release, "*Medicare Shared Savings Program Saves Medicare More Than $1.6 Billion in 2021 and Continues to Deliver High- quality Care," HHS, Aug. 31, 2022, available at: hitps://www.hhs.gov/about/news/2022/08/30/medicare-shared-savings-program-saves- medicare-more-than-1-6-billion-in-2021-and-continues-to-deliver-high-quality-care.html. [FN155] ""ACOs and Cost Savings," NAACOS, available at: https://www.naacos.com/acos-and-cost-savings#:?:text=ACOs and Cost Savings&text=Since 2021# ACOs have saved,savings# according to CMS data. [FN156] Meredith B. Rosenthal, et al., "Realizing the Potential of Accountable Care in Medicaid," The Commonwealth Fund, Apr. 12, 2023, available at: https://www.commonwealthfund.org/publications/issue-briefs/2023/apr/realizing-potential-accountable-care-medicaid ?utm. [FN157] Meredith B. Rosenthal, ef al., ""Realizing the Potential of Accountable Care in Medicaid," The Commonwealth Fund, Apr. 12, 2023, available at: https://www.commonwealthfund.org/publications/issue-briefs/2023/apr/realizing-potential-accountable-care-medicaid ?utm. [FN158] CMS Rural Health Strategy, CMS, 2018, available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural- Strategy-2018.pdf. [FN159] CMS Rural Health Strategy, CMS, 2018, available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural- Strategy-2018.pdf. [FN160] "Improving Health in Rural Communities Fiscal Year 2021 in Review," CMS, available at: https://www.cms.gov/files/document/fy-21- improving-health-rural-communities508compliant.pdf. [FN161] News Release, "HHS Releases Rural Action Plan," HHS, Sept. 3, 2020, available at: https://www.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. [FN162] The proposed rule is published at 87 F.R. 40350-01 (July 6, 2022). [FN163] 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://www.cms.gov/newsroom/fact-sheets/conditions-participation-rural-emergency-hospitals-and- critical-access-hospital-cop-updates-cms-3419. [FN164] Press Release, "Biden-Harris Administration Takes Action to Expand Access to Emergency Care Services in Rural Communities," CMS, June 30, 2022, available at: https://www.cms.gov/newsroom/press-releases/biden-harris-isadministration-takes-action-expand- access-emergency-care-services-rural-communities. [FN165] 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. [FN166] 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. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -52- [FN167] Karen Pollitz, "No Surprises Act Implementation: What to Expect in 2022," Kaiser Family Foundation, Dec. 10, 2021, available at: https://www kff.org/health-reform/issue-brief/no-surprises-act-implementation-what-to-expect-in-2022/?utm_campaign=KFF-2021- Health-Reform&utm. [FN168] 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. [FN169] Karen Pollitz, "No Surprises Act Implementation: What to Expect in 2022," Kaiser Family Foundation, Dec. 10, 2021, available at: hitps://iwww kff.org/health-reform/issue-brief/no-surprises-act-implementation-what-to-expect-in-2022/?utm_campaign=KFF-2021- Health-Reform&utm. [FN170] Karen Pollitz, "No Surprises Act Implementation: What to Expect in 2022," Kaiser Family Foundation, Dec. 10, 2021, available at: https://www kff.org/health-reform/issue-brief/no-surprises-act-implementation-what-to-expect-in-2022/?utm_campaign=KFF-2021- Health-Reform&utm. [FN171] 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. [FN172] Karen Pollitz, "No Surprises Act Implementation: What to Expect in 2022," Kaiser Family Foundation, Dec. 10, 2021, available at: https://www kff.org/health-reform/issue-brief/no-surprises-act-implementation-what-to-expect-in-2022/?utm_campaign=KFF-2021- Health-Reform&utm. [FN173] *Law Aiming to Protect Consumers against Surprise Medical Bills takes Effect," All Things Considered, NPR, Jan. 2, 2022, available at: https://www.npr.org/2022/01/02/1069784227/no-surprises-act-begins. [FN174] 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). [FN175] 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://www.usatoday.com/story/news/health/2021/12/11/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://www.nytimes.com/2021/12/30/upshot/medical-bill-ban-biden.html; Ariel Cohen, "Lawmakers Push for Surprise Biling Changes as Law Takes Effect," Roll Call, Jan. 5, 2022, available at: https://www.rollcall.com/2022/01/05/lawmakers-push-for- surprise-billing-changes-as-law-takes-effect/. [FN176] 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://www.rollcall.com/2022/01/05/lawmakers-push-for-surprise-billing-changes-as-law-takes-effect/. [FN177] ""Ending Surprise Medical Bills," available at: https://www.cms.gov/nosurprises. [FN178] 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.htmI?utm_source=news- releases-email&utm_medium=email&utm_campaign=july-4-2021. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -53- [FN179] 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.htmI?utm_source=news- releases-email&utm_medium=email&utm_campaign=july-4-2021. [FN180] 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.htmI?utm_source=news- releases-email&utm_medium=email&utm_campaign=july-4-2021. [FN181] 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://www.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://www.cms.gov/newsroom/fact-sheets/requirements-related-surprise-billing-part-i-interim-final-rule-comment- period. [FN182] Fact Sheet, ""Air Ambulance NPRM - Fact Sheet," CMS, Sept. 10, 2021, available at: hitps://www.cms.gov/newsroom/fact-sheets/air- ambulance-nprm-fact-sheet. The proposed rule is published at 86 F.R. 51730 (Sept. 16, 2021). [FN183] The rule is published at 86 F.R. 55980-01 (Oct. 7, 2021). [FN184] 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://www.cms.gov/newsroom/press-releases/ biden-harris-administration-advances-key-protections-against-surprise-medical-bills-giving-peace. [FN185] Fact Sheet, ""No Surprises Act Independent Dispute Resolution Process Proposed Rule Fact Sheet," HHS, Oct. 27, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/no-surprises-act-independent-dispute-resolution-process-proposed-rule-fact-sheet. [FN186] Fact Sheet, ""No Surprises Act Independent Dispute Resolution Process Proposed Rule Fact Sheet," HHS, Oct. 27, 2023, available at: hitps://www.cms.gov/newsroom/fact-sheets/no-surprises-act-independent-dispute-resolution-process-proposed-rule-fact-sheet. [FN187] "The No Surprises Act Protects People from Unexpected Medical Bills," CMS, available at: https://www.cms.gov/medical-bill-rights. [FN188] 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://www.hrsa.gov/sites/default/files/opa/ programrequirements/phsactsection340b.pdf. [FN189] "Fact Sheet: The 340B Drug Pricing Program," American Hospital Association, available at: https://www.aha.org/fact- sheets/2020-01-28-fact-sheet-340b-drug-pricing-program. [FN190] American Hospital Assoc. v. Becerra, U.S. Supreme Court, Slip Op., No. 20-1114, June 15, 2022, available at: https:// www.supremecourt.gov/opinions/21pdf/20-1114_09m1.pdf. [FN191] American Hospital Assoc. v. Becerra, U.S. Supreme Court, Slip Op., No. 201114, June 15, 2022, available at: hitps:// www.supremecourt.gov/opinions/21pdf/20-1114_09m1.pdf. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -54- [FN192] American Hospital Assoc. v. Becerra, U.S. Supreme Court, Slip Op., No. 20-1114, June 15, 2022, available at: https:// www.supremecourt.gov/opinions/21pdf/20-1114_09m1.pdf. [FN193] Special Bulletin, ""Supreme Court Rules Unanimously in Favor of AHA, Others in 340B Case," AHA, June 15, 2022, available at: hitps://www.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. [FN194] Becerra v. Empire Health Foundation, U.S. Supreme Court, No. 20-1312, June 24 2022, available at: hitps://www.supremecourt.gov/ opinions/21pdf/20-1312_j42|.pdf. [FN195] Becerra v. Empire Health Foundation, U.S. Supreme Court, No. 20-1312, June 24 2022, available at: hitps://www.supremecourt.gov/ opinions/21pdf/20-1312_j42l.pdf. [FN196] 42 U.S.C. 1395ww(d)(5)(F)vi)(l). [FN197] Becerra v. Empire Health Foundation, U.S. Supreme Court, No. 20-1312, June 24 2022, available at: hitps://www.supremecourt.gov/ opinions/21pdf/20-1312_j42l.pdf. [FN198] Becerra v. Empire Health Foundation, U.S. Supreme Court, No. 20-1312, June 24 2022, available at: hitps://www.supremecourt.gov/ opinions/21pdf/20-1312_j42l.pdf. [FN199] Ron Southwick, ""The Public Health Emergency Has Ended. Hospitals will Face Some Challenges," Chief Healthcare Executive, May 11, 2023, available at: https://www.chiefhealthcareexecutive.com/view/the-public-health-emergency-ends-today-hospitals-will-face- some-challenges-. [FN200] "Telehealth Policy Changes After the COVID-19 Public Health Emergency," HHS, available at: https://telehealth.hhs.gov/providers/ telehealth-policy/policy-changes-after-the-covid-19-public-health-emergency. [FN201] "Telehealth Policy Changes After the COVID-19 Public Health Emergency," HHS, available at: https://telehealth.hhs.gov/providers/ telehealth-policy/policy-changes-after-the-covid-19-public-health-emergency. [FN202] Ron Southwick, ""The Public Health Emergency Has Ended. Hospitals will Face Some Challenges," Chief Healthcare Executive, May 11, 2023, available at: https://www.chiefhealthcareexecutive.com/view/the-public-health-emergency-ends-today-hospitals-will- face-some-challenges-; see, also, "Prescribing Controlled Substances via Telehealth," HHS, available at: hitps://telehealth.hhs.gov/ providers/telehealth-policy/prescribing-controlled-substances-via-telehealth#:?:text=November 11# 2024-, Telemedicineflexibilities regarding prescription of controlled medications as were in,clinic registered with the DEA. [FN203] Celli Horstman, ""Underfunded and Overburdened: The Toll of the COVID-19 Pandemic on Community Health Centers," The Commonwealth Fund, June 5, 2023, available at: https://www.commonwealthfund.org/blog/2023/underfunded-and-overburdened-toll- covid-19-pandemic-community-health-centers?utm. [FN204] Ron Southwick, ""The Public Health Emergency Has Ended. Hospitals will Face Some Challenges," Chief Healthcare Executive, May 11, 2023, available at: https://www.chiefhealthcareexecutive.com/view/the-public-health-emergency-ends-today-hospitals-will-face- some-challenges-. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -55- [FN205] Celli Horstman, ""Underfunded and Overburdened: The Toll of the COVID-19 Pandemic on Community Health Centers," The Commonwealth Fund, June 5, 2023, available at: https://www.commonwealthfund.org/blog/2023/underfunded-and-overburdened-toll- covid-19-pandemic-community-health-centers?utm. [FN206] Community Health Center Funding, National Association of Community Health Centers, Mar. 2023, available at: hitps:// www.hcadvocacy.org/wp-content/uploads/2023/03/HealthCenterFunding_PolicyPaper_2023.pdf. [FN207] Ron Southwick, ""The Public Health Emergency Has Ended. Hospitals will Face Some Challenges," Chief Healthcare Executive, May 11, 2023, available at: https://www.chiefhealthcareexecutive.com/view/the-public-health-emergency-ends-today-hospitals-will-face- some-challenges-. [FN208] Jennifer Tolbert and Meghana Ammula, "10 Things to Know About the Unwinding of the Medicaid Continuous Enroliment Provision," Kaiser Family Foundation, June 9, 2023, available at: https://www.kff.org/medicaid/issue-brief/10-things-to-know-about-the-unwinding- of-the-medicaid-continuous-enroliment-provision/. [FN209] Selena Simmons-Duffin, *"In Some States, Hundreds of Thousands Dropped from Medicaid," NPR, May 24, 2023, available at: https:// www.npr.org/sections/health-shots/2023/05/24/1177973604/in-some-states-hundreds-of-thousands-dropped-from-medicaid. [FN210] Megan Messerly, ""Thousands Lose Medicaid in Arkansas: Is this America's Future?" Politico, June 14, 2023, available at: https:// www.politico.com/news/2023/06/14/medicaid-insurance-coverage-arkansas-00101744. [FN211] Megan Messerly, ""Thousands Lose Medicaid in Arkansas: Is this America's Future?" Politico, June 14, 2023, available at: https:// www.politico.com/news/2023/06/14/medicaid-insurance-coverage-arkansas-00101744. [FN212] "Letter to U.S. Governors from HHS Secretary Xavier Becerra on Medicaid Redeterminations," HHS, June 12, 2023, available at: hitps://www.hhs.gov/about/news/2023/06/12/letter-us-governors-from-hhs-secretary-xavier-becerra-medicaid-redeterminations.html. [FN213] "HHS Takes Additional Action to Keep People Covered as States Resume Medicaid, CHIP Renewals," CMS, June 12, 2023, available at: https://www.cms.gov/newsroom/press-releases/hhs-takes-additional-action-keep-people-covered-states-resume-medicaid-chip- renewals. [FN214] ""Medicaid Enrollment and Unwinding Tracker," Kaiser Family Foundation, December 1, 2023, available at: https://www.kff.org/ medicaid/issue-brief/medicaid-enrollment-and-unwinding-tracker/?utm_campaign=KFF-2023-The-Latest&utm. [FN215] Ben Leonard and Chelsea Cirruzzo, *"Medicaid Narrative Misleading, Officials Say," Politico, Aug. 15, 2023, available at: https:// www.politico.com/newsletters/politico-pulse/2023/08/15/medicaid-narrative-misleading-officials-say-00111203. [FN216] 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: hitps://www.cms.gov/ newsroom/press-releases/hhs-continues-biden-harris-administration-progress-promoting-health-equity-rural-care-access-through. [FN217] 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: hitps://www.cms.gov/newsroom/fact-sheets/ cy-2023-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-2. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -56- [FN218] 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. [FN219™a] vancing Interoperability and Improving Prior Authorization Processes Proposed Rule CMS-0057-P: Fact Sheet," CMS, Dec. 6, 2022, available at: https://www.cms.gov/newsroom/fact-sheets/advancing-interoperability-and-improving-prior-authorization-processes- proposed-rule-cms-0057-p-fact. [FN220] The COVER Now Act calls for a demonstration program to allow local governments in non-expansion states to expand Medicaid. [FN221] North Carolina has since adopted the expansion. ""Status of State Action on the Medicaid Expansion Decision," Kaiser Family Foundation, updated May 8, 2023, 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'#. [FN222] Press Release, ""U.S. Representatives Davis, Cohen, & Johnson Relaunch State Medicaid Expansion Caucus," web site of Rep. Don Davis (D-S.C.), Feb. 10, 2023, available at: https://dondavis.house.gov/media/press-releases/us-representatives-davis-cohen-johnson- relaunch-state-medicaid-expansion. [FN223] The proposed rule is published at 88 F.R. 11865-01 (Feb. 24, 2023). For more information, please see ""CMS Releases Proposed Rule on Medicaid Third-Party Payments," American Association of Medical Colleges (AAMC), Feb. 24, 2023, available at: https:// www.aamc.org/advocacy-policy/washington-highlights/cms-releases-proposed-rule-medicaid-third-party-payments. [FN224] Press Release, ' HHS Proposes New Rule to Further Implement the 21st Century Cures Act,' HHS, Apr. 11, 2023, available at: https:// www.hhs.gov/about/news/2023/04/11/hhs-propose-new-rule-to-further-implement-the-21st-century-cures-act.htmi. [FN225] Press Release, ""Brown, Schakowsky Introduce Legislation to Improve Patient Care and Empower Nurses," Sen. Brown's web site, Mar. 30, 2023, available at: hitps://www.brown.senate.gov/newsroom/press/release/sherrod-brown-schakowsky-introduce-legislation- improve-patient-care-empower-nurses. [FN226] The Rural Hospital Support Act, Sen. Grassley's web site, available at: https://www.grassley.senate.gov/imo/media/doc/ rural_hospital_support_act_-_summary.pdf. [FN227] Press Release, "Reps. Arrington, Gonzalez Introduce Bipartisan Emergency Care Improvement Act," Rep. Arrington's web site, Mar. 22, 2023, available at: https://arrington.house.gov/news/documentsingle.aspx?DocumentlD=949. [FN228] Press Release, "Bipartisan, Bicameral Legislation Would Support Development of Innovative Antibiotics to Treat Resistant Infections and Improve Appropriate Antibiotic Use," web site of Sen. Michael Bennet, Apr. 27, 2023, available at: https://www.bennet.senate.gov/ public/index.cfm/2023/4/bennet-young-bipartisan-house-colleagues-reintroduce-bipartisan-pasteur-act-to-fight-antimicrobial-resistance. [FN229] Emily Jane Cook, et al., "Proposed Legislation Would Require Greater Transparency and Disclosure from Hospitals, Reduce Reimbursement to Certain Off-Campus Patient Departments," JD Supra, June 12, 2023, available at: https://www.jdsupra.com/ legalnews/proposed-legislation-would-require-9770454/. [FN230] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -57- **Pallone Opening Remarks at Health Subcommittee Markup of Bills to Increase Transparency and Lower Costs," Energy and Commerce Committee Democrats, May 17, 2023, available at: https://democrats-energycommerce.house.gov/newsroom/press- releases/pallone-opening-remarks-at-health-subcommittee-markup-of-bills-to-increase. [FN231] Press Release, "Senators Braun, Hassan, Kennedy Lead Bipartisan Bill to Fix Part of Medicare Billing Structure, Saving Billions," Sen. Braun's web site, June 12, 2023, available at: https://www.braun.senate.gov/senators-braun-hassan-kennedy-lead-bipartisan-bill-fix- part-medicare-billing-structure-saving. [FN232] Press Release, "Senators Braun, Hassan, Kennedy Lead Bipartisan Bill to Fix Part of Medicare Billing Structure, Saving Billions," Sen. Braun's web site, June 12, 2023, available at; https://www.braun.senate.gov/senators-braun-hassan-kennedy-lead-bipartisan-bill-fix- part-medicare-billing-structure-saving. [FN233] Press Release, "™Schakowsky Reintroduces Legislation to Address Black Maternal Health Disparities," Rep. Schakowsky's web site, May 15, 2023, available at: https://schakowsky.house.gov/media/press-releases/schakowsky-reintroduces-legislation-address-black- maternal-health-disparities. [FN234] Corrections are published at 88 F.R. 68482-01 (Oct. 4, 2023). [FN235] Fact Sheet, ""FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule - CMS-1785-F and CMS-1788-F Fact Sheet," CMS, Aug. 1, 2023, available at: https://www.cms.gov/ newsroom/fact-sheets/fy-2024-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0. [FN236] Fact Sheet, "™FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule - CMS-1785-F and CMS-1788-F Fact Sheet," CMS, Aug. 1, 2023, available at: https://www.cms.gov/ newsroom/fact-sheets/fy-2024-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0. [FN237] Fact Sheet, "™FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule - CMS-1785-F and CMS-1788-F Fact Sheet," CMS, Aug. 1, 2023, available at: https://www.cms.gov/ newsroom/fact-sheets/fy-2024-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0. [FN238] Press Release, "New CMS Rule Promotes High-Quality Care and Rewards Hospitals that Deliver High-Quality Care to Underserved Populations," CMS, Aug. 1, 2023, available at: https://www.cms.gov/newsroom/press-releases/new-cms-rule-promotes-high-quality- care-and-rewards-hospitals-deliver-high-quality-care-underserved. [FN239] Press Release, ""Steel Bill to Increase Hospital Price Transparency Passes Committee," Rep. Steel's web site, July 27, 2023, available at: https://steel.house.gov/media/press-releases/steel-bill-increase-hospital-price-transparency-passes-committee. [FN240] Press Release, "Merkley, Lummis Introduce Bipartisan Legislation to Increase Access to Care from Nurses, Maintain Patient Choice," Sen. Merkley's web site, July 20, 2023, available at: hitps://www.merkley.senate.gov/merkley-lummis-introduce-bipartisan-legislation-to- increase-access-to-care-from-nurses-maintain-patient-choice/. [FN241] Press Release, "Merkley, Lummis Introduce Bipartisan Legislation to Increase Access to Care from Nurses, Maintain Patient Choice," Sen. Merkley's web site, July 20, 2023, available at: hitps://www.merkley.senate.gov/merkley-lummis-introduce-bipartisan-legislation-to- increase-access-to-care-from-nurses-maintain-patient-choice/. [FN242] THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -58- Fact Sheet, ""CY 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS 1786-P)," CMS, July 13, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/cy-2024-medicare- hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center. [FN243] Fact Sheet, ""CY 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS 1786-P)," CMS, July 13, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/cy-2024-medicare- hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center. [FN244] Fact Sheet, ""CY 2024 Hospital Outpatient Prospective Payment System (OPPS) Policy Changes: Hospital Price Transparency Proposals (CMS-1786-P)," CMS, July 13, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/cy-2024-hospital-outpatient- prospective-payment-system-opps-policy-changes-hospital-price. [FN245] The proposed rule is published at 88 FR 61352-01 (Sept. 6, 2023). [FN246] Press Release, ""Rep. Fischbach Introduces the Protecting Rural Seniors Access to Care Act," Rep. Fischbach's web site, Sept. 29, 2023, available at: https://fischbach.house.gov/press-releases?|D=6C8E322A-3A00-4326-B10C-B38EF8E3AF45. [FN247] *Certified Community Behavioral Health Clinics (CCBHCs)," SAMHSA, available at: https://www.samhsa.gov/certified-community- behavioral-health-clinics. [FN248] 88 F.R. 74947-01 (Nov. 1, 2023). [FN249] 85 F.R. 25642-01 (May 1, 2020). [FN250] Micky Tripathi and Jonathon Blum, "Consequences for Information Blocking: New Proposals to Establish Disincentives for Health Care Providers," ONC, Oct. 30, 2023, available at: https://www.healthit.gov/buzz-blog/information-blocking/consequences-for-information- blocking-new-proposals-to-establish-disincentives-for-health-care-providers. [FN251] Micky Tripathi and Jonathon Blum, ""Consequences for Information Blocking: New Proposals to Establish Disincentives for Health Care Providers," ONC, Oct. 30, 2023, available at: https://www.healthit.gov/buzz-blog/information-blocking/consequences-for-information- blocking-new-proposals-to-establish-disincentives-for-health-care-providers. [FN252] News Release, "HHS Proposes Rule to Establish Disincentives for Health Care Providers that have Committed Information Blocking," HHS, Oct. 30, 2023, available at: https://www.hhs.gov/about/news/2023/10/30/hhs-proposes-rule-establish-disincentives-health-care- providers-have-committed-information-blocking.html. [FN253] The Senate bill is 2023 FD S.B. 3090 (NS); the House bill has not been numbered yet. [FN254] One page summary, ""The Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services Act (MOMMIES) Act," Rep. Pressley, available at: https://pressley.house.gov/wp-content/ uploads/2023/10/MOMMIES-Act-2023-One-Pager.pdf. [FN255] Press Release, "Thune, Hassan, Blackburn Introduce the SAVE IMD Options Act," Sen. Thune's web site, Oct. 19, 2023, available at: https://www.thune.senate.gov/public/index.cfm/press-releases?ID=FD1FF772-C2BF-4566-B3BA-72874E2DC70A. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -50- [FN256] Press Release, "Thune, Hassan, Blackburn Introduce the SAVE IMD Options Act," Sen. Thune's web site, Oct. 19, 2023, available at: https://www.thune.senate.gov/public/index.cfm/press-releases?ID=FD1FF772-C2BF-4566-B3BA-72874E2DC70A. [FN257] Fact Sheet, ""Calendar Year 2024 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Final Rule (CMS-1782- F)," CMS, Oct. 27, 2023, available at: https://www.cms.gov/newsroom/fact-sheets/calendar-year-2024-end-stage-renal-disease-esrd- prospective-payment-system-pps-final-rule-cms-1782-f#:?:text=Annual Update to the ESRD,2023 base rate of 2#65.57. [FN258] Letter to State Survey Agencies, QS0-18-24-ESRD, updated Mar. 23, 2023, available at: https://www.cms.gov/files/document/ qso-18-24-esrd-revised.pdf. [FN259] Dan Walters, ""Newsom Signs Bill that May Resurrect Pledge on Single-Payer Health Care," Cal Matters, Oct. 11, 2023, available at: https://calmatters.org/commentary/2023/10/newsom-resurrect-single-payer-health-care/#:?:text=It doesn't specify a,our patients and our communities.S%eo. [FN260] Press Release, "California Nurses Association: Gov. Newsom Betrays Nurses and Calcare Movement by Signing S.B. 770," National Nurses United, Oct. 7, 2023, available at: https://www.nationalnursesunited.org/press/gov-newsom-betrays-nurses-signing-sb-770. [FN261] Dan Walters, ""Newsom Signs Bill that may Resurrect Pledge on Single-Payer Health Care," Cal Matters, Oct. 11, 2023, available at: https://calmatters.org/commentary/2023/10/newsom-resurrect-single-payer-health-care/#:?:text=It doesn't specify a,our patients and our communities.S%e. [FN262] Press Release, "™Grassley Statement on lowa's Action to Support the Rural Emergency Hospital Program," Mar. 28, 2023, available at: https://www.grassley.senate.gov/news/news-releases/grassley-statement-on-iowas-action-to-support-the-rural-emergency-hospital- program. [FN263] Veto Message,Letter to the Louisiana Speaker of the House, June 27, 2023, available at: https://www.legis.la.gov/Legis/ ViewDocument.aspx?d=1333223. [FN264] Press Release, ™Governor Cooper Signs Medicaid Expansion into Law," Gov. Cooper's web site, Mar. 27, 2023, available at: https:// governor.nc.gov/news/press-releases/2023/03/27/governor-cooper-signs-medicaid-expansion-law. [FN265] TN ST § 71-5-1002 [FN266] TN ST § 71-5-1003. [FN267] 45 C.F.R. § 171.103. [FN268] Andrew Busz, "Great News! WSHA Safety Net and Payment for Difficult to Discharge Bills Pass Legislature," Washington State Hospital Association, Apr. 20, 2023, available at: https://www.wsha.org/articles/great-news-wsha-safety-net-and-payment-for-difficult-to- discharge-bills-pass-legislature/. [FN269] Fact Sheet, " COVID-19 Public Health Emergency Transition Roadmap," HHS, Feb. 9, 2023, available at; https://www.hhs.gov/about/ news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html. THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -60- [FN270] *Coronavirus Waivers and Flexibilities," CMS, updated Feb. 23, 2023, available at: https://www.cms.gov/coronavirus-waivers. [FN271] Fact Sheet, ""CMS Waivers, Flexibilities, and the Transition Forward from the COVID-19 Public Health Emergency," CMS, Feb. 27, 2023, available at: https://www.cms.gov/files/document/what-do-i-need-know-cms-waivers-flexibilities-and-transition-forward-covid-19- public-health.pdf. Produced by Thomson Reuters Accelus Regulatory Intelligence 17-Jan-2024 THOMSON REUTERS © 2024 Thomson Reuters. No claim to original U.S. Government Works. -61-