YEAR-END REPORT - 2019 Published 23-Dec-2019 HPTS Issue Brief 12-23-19.7 Health Policy Tracking Service - Issue Briefs Healthcare Providers & Facilities Healthcare Facilities Authored by Tammy J. Raduege, J.D., a contributing writer and member of the Wisconsin bar. 12/23/2019 I. Background The success of hospitals should be a concern for everyone. Hospitals are vital not only to the health of our citizenry, but they also contribute greatly to the health of our national and local economies: Every dollar hospitals spend supports more than two dollars [FN1] in other economic activity. The American Hospital Association (AHA) has documented the contribution hospitals make to the economy. In 2018, the AHA released “Economic Contribution of Hospitals,” reporting that hospitals directly employ nearly 5.9 million people, but because of the “ripple effect,” they support more than 16 million jobs. Hospitals spend over $857 billion on goods and [FN2] services, and they create nearly $3 trillion in economic activity. In addition, hospitals never recover all of their costs, due to either uncompensated care or Medicare and Medicaid underpayments. Uncompensated care is care that a hospital gives for which it receives no pay, either because of bad debt or because it provided charity care. Medicare and Medicaid underpayments occur when the hospital receives payment that is less than the full value of the services they provided. In January 2019, the AHA released data on Medicare and Medicaid underpayments. The data show that, in 2017, Medicare underpaid hospitals by $53.9 billion and Medicaid underpaid by [FN3] $22.9 billion. The total of uncompensated care came to 38.4 billion in 2017. For comparison, in 2016, total uncompensated hospital [FN4] [FN5] care was $38.3 billion. Total underpayments came to $68.8 billion -- $48.8 billion for Medicare and $20 billion for Medicaid. II. what is the future of the affordable care act? In March 2010, President Obama signed two bills into law: H.B. 3590, the Patient Protection and Affordable Care Act of 2010 (P.L. 111-148) and H.B. 4872, the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152), which make comprehensive changes to Medicaid. The law aims to improve the quality of care, improve the health of the citizenry, and reduce costs. New payment and delivery models are tailored to achieve these goals. Also, the law places emphasis on decreasing fraud, abuse, and waste. While many hailed the law for its potential to insure tens of thousands more people and make health care less expensive, others decried the law as unconstitutional – an overreach of government power. Lawsuits in several states wended their way through the court system, resulting in inconsistent decisions in different jurisdictions. Everyone understood that disputes about the law would end only when the United States Supreme Court had the last word on it, and everyone anxiously awaited the decision. [FN6] In June 2012, the U.S. Supreme Court issued its decision. The provision always seen as the most vulnerable was what has come to be called the individual mandate, which requires nearly all individuals to be insured or pay a penalty (which the Supreme Court decided was a tax). Under the law, individuals with incomes between 100% and 400% of the federal poverty level qualify for some type of federal assistance if they are not eligible for Medicaid. The Supreme Court held that, while the individual mandate is unconstitutional under the Commerce Clause, it is within Congress' taxing authority. Somewhat surprisingly, however, the provision requiring a Medicaid expansion in 2014 was not left unscathed. Under that provision, states would have been required to expand their state Medicaid programs to include most persons making up to 133% of the federal poverty level; states refusing to do so would have run the risk of losing all federal Medicaid money. The Court found that provision to be unduly coercive, saying that it does not give states a meaningful choice. Therefore, while the government can go ahead with the expansion, it cannot pull all federal Medicaid funding for states that do not go along with it. In other words, states can “opt out” of the expansion. The Affordable Care Act was a major issue in the 2016 presidential election, and many candidates, including then-candidate Donald Trump (R) promised to repeal and replace it. Congressional Republicans worked tirelessly in the spring and summer of 2017 to create a plan that would garner enough Republican support to pass. On the second try, the House passed a repeal and replace bill, the © 2020 Thomson Reuters. No claim to original U.S. Government Works. -1- American Health Care Act, that went to the Senate. The Senate indicated that it would not consider the House's bill but would write one of its own. The Senate's bill, the Better Care Reconciliation Act, ultimately failed, and subsequent attempts to pass a “straight repeal” and a “skinny repeal” act both failed. Both bills would have called for an eventual end to the Medicaid expansion. All of the maneuvering made for high drama, but the end came with no deal and no good prospects in sight. The latest challenge to the Affordable Care Act comes not from Congress but from the courts. Nearly twenty attorneys general in Republican-led states filed a lawsuit alleging that the Affordable Care Act is unconstitutional now that the individual mandate has been [FN7] eliminated. The trial court agreed. The Trump Administration is not defending the law; it is now being defended by Democratic attorneys general and the House of Representatives, and they appealed. The Fifth Circuit Court of Appeals heard oral arguments in the case on July 9, 2019. News outlets reported that two of the judges on the three-judge panel appeared to more readily accept the plaintiffs' arguments. Writing for the Commonwealth Fund, Timothy Jost indicated that many of the judges' questions focused on the standing of the respective parties to bring the action or appeal the decision. On the merits, the two judges seems to side with the plaintiffs on whether the individual mandate was constitutional now that the tax has been set back to zero by the recent tax bill. However, according to Jost, the judges expressed some uncertainty about whether the law in its entirety must fail without the individual mandate: The court seemed a bit more uncertain, however, on the consequences of holding the mandate unconstitutional on the rest of the ACA. The Republican AGs argued that the findings section of the ACA created an “inseverability clause' by declaring that the mandate was “essential' to — and thus not severable from — other sections of the ACA. The Democratic AGs and House disagreed, arguing that [FN8] when Congress adopted the 2017 tax bill it clearly intended to affect no other provisions of the ACA. If the act is eventually declared to be unconstitutional in its entirety, it would upend the Medicaid expansion and popular consumer protections like the pre-existing conditions provision. If that happens, it could be a major issue in the upcoming presidential election and [FN9] would put the onus back on Congress to fashion a new health care plan. III. EMERGING ISSUES IN HEALTH CARE THAT AFFECT HEALTH CARE FACILITIES • The Changing Nature of Medicaid Waivers and How they Affect Hospitals Hospitals are deeply affected by changes in Medicaid policy for obvious reasons: When patients have insurance, hospitals get paid for the services they render. Waivers affect Medicaid coverage in several ways. Some waivers dictate income eligibility for Medicaid, like waivers that some states used to develop Medicaid expansions instead of simply adopting the Affordable Care Act Medicaid expansion. Other waivers affect eligibility more indirectly. For example, waivers that require program participants to report certain information (like work requirements) are likely to cause a drop in coverage, and waivers that impose premiums may have the same effect. The most controversial recent development in the area of Medicaid waivers is the Trump Administration's approval of work requirements. Section 1115 of the Social Security Act allows the HHS Secretary to waive Medicaid program requirements for experimental, pilot, or demonstration programs that are likely to promote the objectives of the Medicaid program. Previous administrations have interpreted this to mean that the waiver program must be designed to expand coverage. Therefore, the government had never before approved program features like work requirements, which could actually limit coverage. The Trump Administration, however, no longer requires such proof. According to a brief from the Kaiser Family Foundation, revised waiver criteria focus on positive health outcomes, efficiencies to ensure program sustainability, coordinated strategies to promote upward mobility and independence, incentives that promote responsible beneficiary decision-making, alignment with [FN10] commercial health products, and innovative payment and delivery system reforms. The Trump Administration's shift in waiver policy is apparent in the way it has treated waiver requests to approve work requirements in Medicaid. Seeing the writing on the wall, ten states, Arizona, Arkansas, Indiana, Kansas, Kentucky, Maine, New Hampshire, North Carolina, Utah and Wisconsin, had submitted proposals seeking to impose work requirements before the Centers for Medicare and Medicaid Services (CMS) formally issued guidance on the matter. In January 2018, CMS issued guidance specifically approving such [FN11] approaches and setting out guidelines for including them in state Medicaid programs. CMS firmly believes that education, higher income, and employment are all social determinants of health, so allowing states to impose work/community engagement requirements are all in keeping with sound Medicaid policy. However, states will not be allowed to impose such requirements on the elderly, the disabled, or pregnant women. CMS explained the types of activities it would consider “community engagement,” and it explained that demonstrations should test whether requiring these activities leads to sustained involvement in work or community engagement and whether they lead to improved health outcomes: Today, CMS is committing to support state demonstrations that require eligible adult beneficiaries to engage in work or community engagement activities (e.g., skills training, education, job search, caregiving, volunteer service) in order to determine whether those requirements assist beneficiaries in obtaining sustainable employment or other productive community engagement and whether sustained employment or other productive community engagement leads to improved health outcomes. This is a shift from prior agency policy regarding work and other community engagement as a condition of Medicaid eligibility or coverage,12 but it is anchored in [FN12] historic CMS principles that emphasize work to promote health and well-being. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -2- The agency indicated that it would approve demonstrations that align work or community engagement requirements with SNAP (Supplemental Nutrition Assistance Program) or TANF (Temporary Aid for Needy Families). However, states need to be flexible in their approach and work within the confines of other federal statutes: CMS recognizes that adults who are eligible for Medicaid on a basis other than disability (i.e. classified for Medicaid purposes as “non- disabled”) will be subject to the work/community engagement requirements as described in this guidance. These individuals, however, may have an illness or disability as defined by other federal statutes that may interfere with their ability to meet the requirements. States must comply with federal civil rights laws, ensure that individuals with disabilities are not denied Medicaid for inability to meet these requirements, and have mechanisms in place to ensure that reasonable modifications are provided to people who need them. States must also create exemptions for individuals determined by the state to be medically frail and should also exempt from the requirements any individuals with acute medical conditions validated by a medical professional that would prevent them from complying with the [FN13] requirements. Additionally, states need to take into account the needs and limitations of those suffering from addiction and make appropriate modifications for these people, including counting time in treatment toward the work or community engagement requirement or [FN14] exempting these individuals from the requirements altogether. Please see the letter for a full explanation of CMS' intent. States that have approved waivers for work requirements include Arizona, Indiana, Michigan, Ohio, Utah, and Wisconsin. Some states (Kentucky, Arkansas, and New Hampshire) had approved waivers, but courts have set aside their work requirements. (New Hampshire had earlier voluntarily suspended its program because so many people were on track to lose coverage.) Waivers are [FN15] pending in Alabama, Mississippi, Montana, Oklahoma, South Carolina, South Dakota, Tennessee, and Virginia. We discuss work requirements more thoroughly in our Medicaid Restructuring brief. Work requirements can lead to significant coverage losses. So far, Arkansas is the only state to have actually disenrolled participants from Medicaid for failing to comply with the requirements. In that state, more than 18,000 participants lost coverage in the first seven [FN16] months for failing to comply; that number represents about 25% of all participants subject to the requirements. New Hampshire imposed work requirements for the Medicaid expansion population in 2019. Beginning in June, the state was to begin removing [FN17] participants from the Medicaid rolls if they failed to report the required number of hours for two or more months. However, in June, when officials discovered that 17,000 individuals had not complied with the reporting requirements despite the state's outreach efforts, [FN18] the state decided to delay the penalty through September. Judges have now halted the work requirements in both Arkansas [FN19] [FN20] and New Hampshire. Perhaps because of the coverage losses in Arkansas and the potential losses in New Hampshire, several states are rethinking their work requirements. According to CBPP, Arizona has suspended its program, and the governor in Maine has withdrawn a waiver that would have permitted the state to disenroll low-income parents for non-compliance. Michigan's work requirements are to take effect in 2020, but the governor has expressed concern about the potential losses. She is urging the legislature to consider legislation suspending the program if appears that the coverage losses will be too great. CMS has not yet approved Virginia's waiver to impose work requirements, but the state is already having second thoughts. It is worried that without [FN21] federal funds for workforce supports, it may not be able to implement them. • Emergency Care Freestanding emergency departments (EDs) are those that are not physically connected to a hospital. While some are actually owned by hospitals, others are independent facilities. They are meant to treat less serious, often non-emergency cases: [U]nlike hospital-based EDs, [free-standing emergency departments often do not provide services for critical conditions such as trauma, stroke, and heart attacks; most do not receive ambulances or have an operating room on site; [FN22] and they are more likely to be located in affluent areas. According to a study by United Health Group, freestanding EDs are making it easy for people to seek emergency care where a less expensive setting (like a doctor's office or an urgent care facility) would be more appropriate. These facilities are proliferating, having increased in number by 42% since 2015 and 155% since 2008. Of the 566 freestanding EDs in the country, 266 are located in Texas, the overwhelming majority of which are independent and not associated with a hospital. Because of the unusually high presence of these facilities in Texas, the study focused its analysis on that state. Despite the convenience of such facilities, United Health Group's study found that, in Texas, visits to freestanding EDs cost 22 times more than the same services performed in a doctor's office and 19 times more than in an urgent care center. Also, the centers tend to be in more affluent areas where alternative, less costly options for [FN23] care exist. Across the country, freestanding EDs are often located in urban areas in close proximity to a hospital and in areas with [FN24] a well-insured population, and about 30% of them are not clinically affiliated with a hospital. The Medicare Payment Advisory Commission (MedPac), which advises Congress on Medicare matters, voted unanimously to propose [FN25] a cut in Medicare payments for certain freestanding EDs. The facilities that are not associated with hospitals do not qualify for the [FN26] Medicare program and would not be affected by this cut, if it were to occur. However, for the others, MedPac is recommending a 30% cut in payments for certain services at freestanding EDs located within six miles of a hospital ED. Currently, these freestanding © 2020 Thomson Reuters. No claim to original U.S. Government Works. -3- EDs receive the same payments as hospital EDs, even though their costs are lower and they often treat patients with less serious problems. Though these facilities are on the rise, some question what they really add to the Medicare program. A representative of MedPac expressed this concern: ”There has been a growth in free-standing emergency departments in urban areas that does not seem to be addressing any particular access need for emergency care,” said James Mathews, executive director of MedPAC. The convenience of a neighborhood [FN27] emergency department may even induce demand, he said, calling it an “if you build it, they will come' effect.” However, emergency care is an expensive proposition, whether at a freestanding ED or at a hospital, much more so than a physician's [FN28] office or an urgent care center, and MedPac would like to ensure that Medicare does not provide incentives for greater ED use. According to Modern Healthcare, though MedPac voted unanimously for the cut, it was not without reservation. Some members question whether the commission is making a recommendation without sufficient data as to whether these types of facilities are a [FN29] bad bargain for Medicare, suggesting that the decision may be premature. Some hospitals are also concerned about the move, [FN30] expressing fear that the cuts would cause some facilities to close, eliminating a viable source of care in vulnerable communities. The vice-president of payment policy for the American Hospital Association also voiced concern: “The recommendation is not based on any analysis of Medicare beneficiaries, Medicare costs or Medicare payments, and would make Medicare's record underpayment of outpatient departments and hospitals even worse . . . Even more troubling to us is that (the recommendation) has the potential to reduce patient access to care, particularly in vulnerable communities, following a year in which [FN31] hospital EDs responded to record-setting natural disasters and flu infections.” As to the effect of the cuts on vulnerable populations, recent research in five large markets revealed that 75% of freestanding EDs are [FN32] located within six miles of a hospital ED, about a 10-minute drive away. Certainly in some instances, the extra drive time could be [FN33] crucial. Freestanding EDs are controversial on another front: According to Modern Healthcare, some of these facilities are not required by federal law to accept all patients for emergency screening and stabilization regardless of their ability to pay. Freestanding EDs associated with hospitals are required to comply with the Emergency Medical Treatment and Labor Act (EMTALA); however, independently-operated EDs are not so bound. Some states have laws similar to EMTALA, but it is unclear whether they are as [FN34] aggressively enforced as the federal law. • Community Health Centers According to the Health Resources and Services Administration (HRSA), community health centers, which serve 27 million people in 11,000 service sites around the country, 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, [FN35] nurses, dentists, social workers, and health educators. Health center patients are generally poor. According to the Kaiser Family Foundation, In 2016, health centers served 25.9 million patients at over 10,400 urban and rural locations. Just under half (49%) of health center patients were covered by Medicaid and nearly a quarter (23%) were uninsured. Nationally, one in six Medicaid enrollees received care at a health center. .... [FN36] Medicaid is the largest source of funding for health centers, accounting for 43% of total health center revenue. Increasingly, community health centers are providing crucial support to those with substance use disorder. According to HRSA, “The number of health center clinicians providing [medication-assisted treatment] increased by 75 percent, from 1,700 in 2016 to nearly [FN37] 3,000 in 2017. Additionally, 90 percent of health centers provide mental health services.” Recent increases in demand for health center substance abuse services are startling: Nearly seven in 10 (69%) health centers reported an increase in patients with an addiction to prescription opioids and a similar share (63%) reported an increase in patients with an addiction to nonprescription opioids such as heroin and fentanyl. The findings of the survey of community health centers are consistent with national trends and reflect a growing opioid epidemic whose impacts have been [FN38] especially devastating in the medically underserved rural and urban areas where many health centers are located. Even though community health centers fill a critical need in the health care system, they, like other safety net programs, are struggling to provide services with limited resources, and the resources they do have are under threat. According to the Commonwealth Fund, funding for federally-qualified health centers (FQHCs) comes from a variety of sources, including state and local funds, federal funds, and private donations. State and local funds are increasingly becoming inadequate as state policymakers are reticent to raise taxes. The Commonwealth Fund also noted that Medicaid funds make up about half of all revenue for FQHCs, and Medicaid funding is under threat. Further, a new Trump Administration waiver policy allows states more flexibility, and several states are seeking approval to © 2020 Thomson Reuters. No claim to original U.S. Government Works. -4- change eligibility requirements, meaning that fewer individuals will be eligible for Medicaid. The post explores other recent changes that [FN39] are affecting FQHCs and other providers that serve the poor. Fortunately, in 2019, the Health Resources and Services Administration awarded almost $400 million to community health centers, rural organizations, and academic institutions to allow them to establish or expand access to substance abuse and mental health services, [FN40] [FN41] and HHS awarded $50 million to establish new health centers. However, Congressional Funding for the Community Health [FN42] Center Fund is in peril of expiring unless Congress acts soon to extend it. The Trump Administration is also trying to increase health center capacity for oral health. In 2018, community health centers funded by the Health Resources and Services Administration (HRSA) provided dental services to about 6.4 million patients during 16.5 million [FN43] visits. This is a 13% increase over 2016. The Department of Health and Human Services (HHS) now announces that, through the HRSA, it has awarded more than $85 million to 298 community health centers to increase oral health service capacity. HHS Secretary Alex Azar explains why oral health is worth the investment: “Health centers play a key role in providing access to a comprehensive range of services Americans need to stay healthy, and that includes high-quality oral health care . . . . Early detection of oral diseases can prevent much more costly health challenges and improve Americans' health, which is the ultimate goal of President Trump's vision for our healthcare system. These are the first awards HRSA has ever made solely for health centers' oral healthcare infrastructure, and they will support better access to oral health services [FN44] in communities across the country, including underserved urban and rural areas.” [FN45] The amounts of the awards vary, but HHS indicates that the top award is $300,000. HRSA community health centers serve a [FN46] large proportion of Medicaid participants. • Nursing Home Care The Trump Administration is committing to improving the safety and quality of care in nursing homes. In April 2019, CMS announced a five-part strategy to further these goals. The parts of the strategy are: 1. Strengthen Oversight 2. Enhance Enforcement 3. Increase Transparency 4. Improve Quality [FN47] 5. Put Patients over Paperwork In its continuing effort to keep nursing home residents safe, CMS announced that it is changing the State Performance Standards System, which is the system it uses to hold nursing home inspectors accountable. CMS explains that nursing homes are inspected by State Survey Agencies, who ensure that nursing homes are complying with federal guidelines. There have been concerns that inspections have not always been done in a timely and consistent fashion. CMS describes the changes in a press release: Under the changes announced in a memo to states today, CMS will, through the updated [State Performance Standards System] assessment tools, more rigorously and rapidly analyze [State Survey Agencies] performance to ensure inspections are timely and accurate. This includes new performance measures and stricter monitoring to ensure inspections are done in a fair, accurate, and timely manner, ensuring patient safety, and ensuring that enforcement actions – like civil money penalties – are applied consistently. This action is the latest example of CMS delivering on its five-part plan to ensure safety and quality in the nation's nursing homes – [FN48] specifically strengthening oversight. Please see the press release for a more detailed description of the changes. This action furthers the government's five-part strategy to [FN49] improve nursing home care. CMS has also taken action to increase transparency in nursing homes, a part of its five-part strategy. CMS is adding a new feature to its Nursing Home Compare site. Beginning on October 23, 2019, users of Nursing Home Compare will see an icon if the nursing home in question has been cited for abuse, neglect, or exploitation. CMS Administrator Seema Verma writes that nursing homes will be given the icon on Nursing Home Compare when they have been cited on an inspection report for one or both of the following: “1) abuse that led to harm of a resident within the past year; and 2) abuse that could have potentially led to harm of a resident in each of the last two [FN50] years.” The icon will be updated monthly, when the inspection reports are updated. E. The Opioid Crisis In October 2018, the President signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment [FN51] (SUPPORT) for Patients and Communities Act. CMS has now released two Informational Bulletins to give the states guidance as they implement the act. Specifically, one bulletin relates to Section 1007 of the act (“Caring Recovery for Infants and Babies”) and one addresses Section 1012 (“Help for Moms and Babies”). © 2020 Thomson Reuters. No claim to original U.S. Government Works. -5- Section 1007 of the act gave states the option of adding a provider type – the “residential pediatric recovery center” - for treating infants with Neonatal Abstinence Syndrome (NAS). Infants with NAS suffer from withdrawal of opioids and certain other drugs that the baby was exposed to in utero. According to CMS, NAS is not, in itself, considered an addiction or substance use disorder, but rather a physiologic response to the drugs and to the withdrawal of the drugs. CMS defines the new optional provider type as, a center or facility that furnishes items and services for which medical assistance is available under the state plan to infants with the [FN52] diagnosis of neonatal abstinence syndrome without any other significant medical risk factors. Such a provider may also offer counseling and other services to mothers, family members, and caretakers if the services are otherwise covered under the State Plan or a waiver. The purpose for creating the new optional provider type is to provide an alternative to an inpatient hospital stay. The residential pediatric recovery centers would be a place for infants who are relatively stable but not ready to go home or for infants with less severe [FN53] cases of NAS. The second Informational Bulletin deals with Section 1012 of the SUPPORT for Patients and Communities Act. This section creates a limited exception to the Institution for Mental Diseases (IMD) exclusion for some pregnant and post-partum women. Generally, Medicaid will not pay for treatment for a person under the age of 65 in an institution of mental diseases if the facility has more than 16 beds; this includes services provided both inside the facility and outside the facility. Stakeholders, policy makers, and advocates have long complained that this exclusion takes away an important tool in treating people with a substance use disorder. CMS has, in the past, made limited exceptions to the rule. The SUPPORT Act for Patients and Communities makes an additional one: Section 1012 of the SUPPORT for Patients and Communities Act creates a new limited exception to the IMD exclusion. Specifically, section 1012(a) states that for a woman who is eligible on the basis of being pregnant (and up to 60-days postpartum), who is a patient in an IMD for purposes of receiving treatment for a substance use disorder (SUD), who is either enrolled under the state plan immediately before becoming a patient in the IMD, or who becomes eligible to enroll while a patient in an IMD, the IMD exclusion shall not be construed to prohibit federal financial participation for medical assistance for items and services provided outside of the IMD to [FN54] such women. IV. prioritizing safety, quality, and transparency A. Avoidable Incidents – Health Care-Acquired Conditions, Unnecessary Admissions, and Avoidable Readmissions In compliance with the Affordable Care Act, CMS is actively working on ways to decrease the incidence of health care-acquired conditions. CMS believes that it can improve care and reduce costs by providing incentives to hospitals for safer care or by adjusting payments for health care-acquired conditions that could have been prevented by following evidence-based guidelines. HHS announced new targets for acute-care hospitals as they continue to work toward reducing health care-acquired infections. The targets are geared toward meeting the goals set out in the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination, [FN55] published in 2013. The new target measures for 2020 are these: • 50% reduction in central line-associated bloodstream infections between 2015 and 2020 • 25% reduction in catheter-associated urinary tract infections between 2015 and 2020 • 50% reduction in invasive methicillin-resistant Staphylococcus aureus, commonly known as MRSA, between 2015 and 2020 • 50% reduction in facility-onset MRSA between 2015 and 2020 • 30% reduction in Clostridium difficile infections between 2015 and 2020 • 30% reduction in Clostridium difficile hospitalizations between 2015 and 2020 [FN56] • 30% reduction in surgical site infections between 2015 and 2020 An entry on the Office of Disease Prevention and Health Promotion's health.gov web site includes a table showing the original targets for 2013 and the progress made on those targets by 2016. Another table sets out the 2020 targets, which use the year 2015 as a [FN57] baseline. The Office of Disease Prevention and Health Promotion along with the Steering Committee for the Prevention of Health Care- Associated Infections announced that they have developed Phase Four of the National Action Plan to Prevent Health Care-Associated Infections: Roadmap to Elimination. This phase of the plan, which is titled “Coordination among Federal Partners to Leverage HAI [Health Care-Associated Infection] Prevention and Antibiotic Stewardship,” focuses on responsible use of antibiotics as a way to prevent infections. The new phase aligns with other federal initiatives and authorities similarly seeking to avoid such events, and it [FN58] highlights strategies to coordinate efforts with other federal partners. The fourth phase is informed by research indicating that better prescribing practices, such as limiting prescriptions for the most powerful antibiotics and avoiding unnecessary prescribing, can [FN59] help reduce the problem with antibiotic resistant infections. Phase One of the plan focused on reducing infections in acute care hospitals; phase two looked at ways to reduce infection in ambulatory care facilities and end-stage renal disease facilities as well as © 2020 Thomson Reuters. No claim to original U.S. Government Works. -6- ways to encourage health care personnel to get flu vaccinations; and phase three concentrated on reducing infections in long-term care [FN60] facilities. One of HHS' initiatives, called Partnership for Patients (PfP), aims to save lives by improving patient safety in hospitals. The additional care required to treat for these events is needlessly expensive for the federal health programs. The goals of PfP are twofold: to make care safer and to reduce avoidable readmissions. CMS lays out the goals of the initiative the PfP web site: A 20% reduction in all-cause patient harm (to 97 Hospital-Acquired Conditions [HACs]:/1,000 discharges) from 2014 interim baseline (of 121 HACs/1,000 patient discharges); and a 12% reduction in 30-day readmissions as a population-based measure (readmissions per [FN61] 1,000 people). Hospital Improvement and Innovation Networks (HIINs), one of the PfP initiatives, work actively on hospital safety. In May 2016, CMS announced a funding opportunity for organizations wishing to become HIINs. This program is a part of the Quality Improvement Organization Initiative. (See below for a fuller discussion of the Quality Improvement Organization program.) CMS explains that HIINs will: continue the good work started by the Hospital Engagement Networks (HENs) under the Partnership for Patients initiative. These organizations will tap into the deep experience, capabilities and impact of QIOs, hospital associations, hospital systems, and national hospital affinity organizations with extensive experience in hospital quality improvement. The HIINs will engage and support the nation's [FN62] hospitals, patients, and their caregivers in work to implement and spread well-tested, evidence-based best practices. Through 2019, the new HIINs will work to achieve a 20% decrease in patient harm and a 12% reduction in unnecessary 30-day hospital [FN63] readmissions, and their work will serve to shore up the impact of both the Quality Improvement Organization program and PfP. CMS has now awarded $347 million to 16 HIINs, consisting of national, regional, or state hospital associations, Quality Improvement Organizations, and health system organizations. CMS has begun to accelerate its efforts to improve hospital safety, as their progress in the last four years has been sound. Hospitals appear to be on board with the program. The President of the American Hospital Association said: “America's hospitals embrace the ambitious new goals CMS has proposed . . . . The vast majority of the nation's 5,000 hospitals were involved in the successful pursuit of the initial Partnership for Patients aims. Our goal is to get to zero incidents. AHA and our members intend to keep an unrelenting focus on providing better, safer care to our patients -- working in close partnership with the federal [FN64] government and with each other.” HIINs will be required to address these areas: • Adverse drug events (to focus on at least the following three medication categories: opioids, anticoagulants, and hypoglycemic agents) • Central line-associated blood stream infections (in all hospital settings) • Catheter-associated urinary tract infections (in all hospital settings) • Clostridium difficile infection (including antibiotic stewardship) • Injury from falls and immobility • Pressure Ulcers • Sepsis and Septic Shock • Surgical Site Infections (for multiple classes of surgeries) • Venous thromboembolism (at a minimum in all surgical settings) • Ventilator-Associated Events [FN65] • Readmissions [FN66] Additionally, HIINs are expected to consider all other forms of preventable harm to patients for Medicare beneficiaries. Other PfP [FN67] programs include the Community-Based Care Transitions Program and patient and family engagement. Government initiatives like PfP and others 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- [FN68] Acquired Conditions Reduction Program, the government will withhold 1% of Medicare payments for hospitals that score in the [FN69] bottom quartile on specified measures. For fiscal year 2020, CMS will publish information on Hospital Compare about hospitals' performance in these measures: • CMS Recalibrated Patient Safety Indicator (PSI) 90 (CMS PSI 90) © 2020 Thomson Reuters. No claim to original U.S. Government Works. -7- • Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) healthcare- associated infection (HAI) measures: o Central Line-Associated Bloodstream Infection (CLABSI) o Catheter-Associated Urinary Tract Infection (CAUTI) o Surgical Site Infection (SSI) – colon and hysterectomy o Methicillin-resistant Staphylococcus aureus (MRSA) bacteremia [FN70] o Clostridium difficile Infection (CDI) [FN71] [FN72] CMS penalized 751 hospitals in fiscal year 2018, and 800 in fiscal year 2019. According to Kaiser Health News, the number [FN73] of hospitals penalized in 2019 is the highest it has ever been in the five-year history of the program. Similarly, the government's Hospital Readmissions Reduction Program penalizes hospitals with a greater than expected 30-day [FN74] readmission rate for a predetermined set of conditions. For fiscal year 2019, 2599 hospitals (or 82% of hospitals) were penalized, [FN75] which is virtually unchanged from the previous year. The Medicare payment adjustment varies by hospital, with some being [FN76] penalized upwards of 3%; the average penalty is about .73%. Safety net hospitals have complained that they have been unfairly penalized because they have poorer patients who may not be well-connected to primary care or who are less able to pay for needed medications. Beginning in October 2018, in figuring penalties CMS began comparing how hospitals did in relation to other comparable [FN77] hospitals (i.e., by the percentage of “dual eligible” patients the hospital treats). In the 2019 Inpatient Hospital Prospective Payment System final rule, CMS codified previously adopted terms relating to these dual eligibles (those who qualify for Medicare and full- benefits Medicaid): 3. Summary of Policies for the Hospital Readmissions Reduction Program In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20403 through 20407), we proposed to: (1) Establish the applicable period for FY 2019, FY 2020 and FY 2021; (2) codify the previously adopted definition of “dual-eligible”; (3) codify the previously adopted [FN78] definition of “proportion of dual-eligibles”; and (4) codify the previously adopted definition of “applicable period for dual-eligibility.” CMS also posted the fiscal year 2019 adjustments in the Value-Based Purchasing Program, in which it adjusts Medicare hospital payments based on the quality of the care hospitals provide. Hospitals were scored in these areas: • Clinical Care (25 percent) • Safety (25 percent) • Person and Community Engagement (25 percent) [FN79] • Efficiency and Cost Reduction (25 percent) In this latest year of the now seven-year-old program, about 1,550 hospitals (or about 55%) are receiving an upward adjustment –- more than the number receiving a downward adjustment. About 60% of hospitals will see just a slight adjustment one way or the other. However, the highest performing hospital will receive a net increase in payments of about 3.67%, and the lowest performing hospital [FN80] will receive a net decrease of 1.59%. Details are available from CMS. Policies for all three of these programs were updated in the 2020 Hospital Inpatient Prospective Payment System for acute care hospitals and long-term care hospitals final rule. The rule is published at 84 F.R. 42044 (Aug. 16, 2019). The government's work to prevent hospital-acquired conditions and unnecessary readmissions appears to be having an effect. In early 2019, HHS' Agency for Healthcare Resources and Quality (AHRC) reported that between 2014 and 2017, reductions in health care- acquired conditions helped to prevent 20,500 hospital deaths and saved $7.7 billion in health care costs. AHRQ estimates that hospital- [FN81] acquired conditions dropped 13%, cutting the incidence of these events by over 900,000. Modern Healthcare reports that MedPac (the Medicare Payment Advisory Commission) is working on a proposal that would eliminate the Hospital-Acquired Condition Reduction Program and combine two other programs -- the Hospital Readmissions Reduction Program and the Hospital Value-Based Purchasing Program -- into one new program. The new program would be called the Hospital Value Incentive Program. According to the article, a policy analyst for MedPac believes that these programs are duplicative and that hospitals payments should be adjusted under a single program. The new program would judge hospitals based on readmissions, mortality, spending, and patient experience. The government would withhold 2% of Medicare payments; well-performing hospitals would receive a bonus in excess of the amount withheld while poorer-performing hospitals would receive back an amount less than the withheld amount. The new program would not financially penalize hospitals for infections that patients develop while hospitalized. MedPac worries that this practices penalizes hospitals for developing better ways to detect infection. Others argue that hospitals will not work on [FN82] improving the rate of infections unless they are financially accountable for infections developed during a stay. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -8- B. Paying for Quality The Obama Administration was committed to shifting the way that the government pays for health care; instead of paying for the quantity of the services rendered, the government wants to pay for the quality of the services rendered. Quality is measured by outcomes and cost. The Trump Administration remains committed to the idea of paying for quality. However, CMS has indicated that it does not intend to maintain the Obama Administration's specific goals and timelines. A CMS spokesperson explained, “”The Trump administration's focus has not been on a specific targeted number by the previous administration, but rather on evaluating [FN83] the impact of new payment models on patients and providers[.]”' Many quality initiatives are evaluated by how they align with the CMS Quality Strategy. The CMS Quality Strategy includes these goals: • Make care safer by reducing harm caused in the delivery of care. • Ensure that each person and family are engaged as partners in their care. • Promote effective communication and coordination of care. • Promote the most effective prevention and treatment practices for the leading causes of mortality, starting with cardiovascular disease. • Work with communities to promote wide use of successful interventions to enable healthy living. • Make quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care [FN84] delivery models. In late 2015, CMS announced the 2016 update to the CMS Quality Strategy. In a blog post, CMS indicates that the update: incorporates this progress made in shifting Medicare payments from volume to value, since the last time we shared the CMS Quality Strategy in 2014. In addition, the updated 2016 version updates progress made on the payment reform initiatives as well as new requirements from the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) and the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) legislation. The implementation of MACRA is a major opportunity to put a broad range of health care providers on the path to value through the new Merit-Based Incentive Payment System (MIPS) and incentive payments for [FN85] participation in certain Alternative Payment Models (APMs). The government is making quality information more visible to the public. CMS believes that consumers are better able to choose their providers if they have information on the quality of care that the providers render and that making this information public encourages [FN86] providers to render better quality care. To better inform consumers, CMS maintains “Compare” web sites, like Hospital Compare, Physician Compare, and Nursing Home Compare, among others. Some Compare sites include star ratings, including Nursing Home Compare, Home Health Compare, and Dialysis Facility Compare, for example. In 2016, Kaiser Health News reported that CMS had agreed to delay the launch of a new “overall hospital quality” star rating for hospitals that was to appear on the Hospital Compare web site. This star rating was meant to be a unified rating encompassing 62 hospital measures, which was supposed to make it easier for consumers to understand the separate ratings, which are often technical and confusing. Hospitals officials had been complaining that they needed more time to gather the data necessary to replicate the ratings to make sure that the methodology was accurate and fair. They said that some of the measures may not be accurate for people seeking a certain kind of service. For example, according to Kaiser Health News, “a hospital's death rate for Medicare patients might be irrelevant for a woman trying to decide where to give birth.” Moreover, some hospitals feared being rated poorly if they tended to have a large population of lower-income patients who lacked needed support at home. After 60 senators and 255 members of Congress [FN87] contacted CMS, the agency agreed to delay the release of the new rating until at least July 2016 and maybe later. The government released the ratings on July 28, 2016, and hospitals continued to have the same complaints. According to Kaiser Health News, while the star ratings take into account the different types of patients and ailments that a hospital treats, it did not take [FN88] patient income into account. CMS contends that the ratings are fair and that, according to its analysis, hospitals of all types are capable of achieving the higher ratings. However, Kaiser Health News wrote this about the government's analysis and its own analysis: Medicare did not consider the relative wealth of patients. Its analysis showed hospitals serving large swaths of low-income people tended to receive lower star ratings. An analysis by Kaiser Health News of the hospitals that CMS rates shows 22 percent of safety- net hospitals were rated above average — four or five stars — compared with 30 percent of hospitals overall. Twenty-nine percent of safety-net hospitals were rated as below average, with just one or two stars, while 22 percent of other hospitals received those lower [FN89] ratings. [FN90] CMS reports that critical access hospitals had an overall average rating that was slightly higher than non-critical access hospitals, but safety net hospitals did not fare as well as others. These figures are based on data that was released in advance of the star ratings. [FN91] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -9- In its blog post announcing the release of the new star ratings, CMS indicated that, during the period that it was delaying release, it conducted outreach and educational activities for the hospital industry, including two phone meetings in which the agency reached 4,000 hospital representatives and private meetings with hospital associations and individual hospitals to explain their data and answer any questions. CMS also released an evaluation of the national distributions of the star ratings based on hospital characteristics showing that “all types of hospitals have both high performing and low performing hospitals.” Finally, CMS indicates that it subjected the measures used for the star ratings to “rigorous scientific review and testing.” In response to hospitals' concern about taking the socioeconomic status of patients into account, CMS writes: We continue to work closely with the National Quality Forum and the Assistant Secretary for Planning and Evaluation (ASPE), who is required by the IMPACT Act to study the effect of socioeconomic status on quality measures and payment programs based on measures. We will work with ASPE and determine what next steps, if any, should be taken to adjust our measures based on the [FN92] recommendations in the report. In December 2017, CMS announced that it updated the Overall Hospital Star Rating. In a press release announcing the update, CMS expressed its desire to respond to stakeholder feedback as it continues to refine this feature. CMS explains in the press release: For this update, CMS will respond to stakeholder concerns by updating several existing measures and the Overall Star Rating. The Overall Star Rating has been revised to use an enhanced methodology to assign ratings to hospitals, based on Technical Expert Panel recommendations and public input “We continue to refine the Star Ratings and look forward to an ongoing dialogue with hospitals and [FN93] patients and their families on how we can provide beneficiaries useful information,' [CMS Administrator Seema] Verma said. CMS indicated that it intended to update the Overall Hospitals Star Rating twice annually, in July and December, seeking stakeholder [FN94] input as it does so. In July 2018, however, CMS announced that it did not plan to update the Overall Hospitals Star Ratings, explaining, ”CMS has decided to postpone the July star ratings update to give time for additional analysis of the impact of changes to some of the measures on the star ratings and to address stakeholder concerns . . . . When changes are made to the underlying measures it is vital to take the time needed to understand the impact of those changes and ensure we are giving consumers the most useful information.“ [FN95] [FN96] CMS did finally update the Overall Hospital Star Ratings in early 2019, but the agency sought public input about the methodology. In August 2019, CMS announced that it intends to update the quality measurement methodology for the five-star hospital rating for 2021. The update to the methodology will be informed by the public comments CMS received after the last star ratings were released. CMS will publish a proposed rule in 2020 that will hopefully be finalized before the overall star ratings are released in 2021. In the [FN97] meantime, CMS will refresh the ratings in early 2020 using the current methodology. C. Health and Payment Delivery Initiatives that Focus on Quality or that Reward Outcomes Several recent government initiatives focus on quality or reward improved outcomes. We discuss a few of those below. Many of the initiatives and models were designed by and are administered by the Center for Medicare and Medicaid Innovation (the Innovation Center), which was created by the Affordable Care Act. The Comprehensive ESRD Care Model The Comprehensive ESRD Care (CEC) Model is a new ACO-type model to care for patients with end-stage renal disease (ESRD). In a press release, CMS explains why good care for this population of Medicare participants is so important: More than 600,000 Americans have end-stage renal disease (ESRD), also known as kidney failure, and require life sustaining dialysis treatments several times per week. These individuals typically have many health problems, are at higher risk of hospital readmissions, and suffer from fragmented care. In 2012, ESRD beneficiaries comprised 1.1% of the Medicare population and accounted for an [FN98] estimated 5.6% of total Medicare spending. In the new model, dialysis facilities, nephrologists, and other providers will form ESRD Seamless Care Organizations (ESCOs) that will coordinate care for participants with ESRD. Some of the ESCOs will be financially accountable for the quality of care they provide to Medicare participants and the costs they incur in Medicare Parts A and B. According to CMS, ESCOs participating with dialysis facilities owned by a large dialysis organization (one that owns 200 or more dialysis facilities) will share in both the savings and the losses, and ESCOs participating with dialysis facilities owned by a small dialysis organization (one that owns fewer than 200 dialysis facilities) [FN99] will share in the savings only. The Medicare and Medicaid Innovation Center is facilitating the new model. In early 2017, CMS announced that it had selected the participants for the second performance year. Performance year one evaluation results have been [FN100] posted. Thirty-three participants are involved with the program. Bundled Payments for Care Improvement Advanced On January 9, 2017, CMS announced a new, voluntary payment model called Bundled Payments for Care Improvement Advanced (or BPCI Advanced). The initiative encourages providers and practitioners to coordinate care in order to keep Medicare spending below © 2020 Thomson Reuters. No claim to original U.S. Government Works. -10- a specified threshold. Participants who do so may quality for additional payment. CMS is including in the initiative 32 clinical episodes that are both inpatient and outpatient services. While the initiative is a payment model, it will require delivery system reforms in order to achieve the goals of the program: quality care that does not exceed a given budget for the particular episode. CMS explains: In BPCI Advanced, participants will be expected to redesign care delivery to keep Medicare expenditures within a defined budget while maintaining or improving performance on specific quality measures. Participant bear financial risk, have payments under the model tied [FN101] to quality performance, and are required to use Certified Electronic Health Record Technology. 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 [FN102] doctors and patients. [FN103] The model qualifies as an Advanced Alternative Payment Model under the Quality Payment Program. In 2018, CMS announced that nearly 1,300 participants had joined the model, including acute care hospitals and physician group practices. The participants are located in 49 states plus the District of Columbia and Puerto Rico. The initiative involves provider accountability: Under the traditional fee-for-service payment system, Medicare pays providers and suppliers for each individual service they perform. However, under this new episode payment model, participants can earn an additional payment if all expenditures for a beneficiary's episode of care are less than a spending target, which factors in measures of quality. Conversely, if the expenditures exceed the target [FN104] price, the participant must repay money to Medicare. According to CMS Administrator Seema Verma, in order to realize value-based transformation of our health care system, CMS must introduce a variety of payment reforms such as the Bundled Payments for Care Improvement – Advanced Initiative so that providers [FN105] can choose the one that works the best for them. In spring of 2019, CMS announced that it was accepting applications to participate in Model Year 3 of the initiative. The application period has now closed and CMS is reviewing the applications. Participants selected for Model Year 3 will begin the program on January 1, 2020. Acute care hospitals and physician practice groups may participate as either convener or non-convener participants. CMS [FN106] indicated that it does not at this time anticipate opening up applications for Model Year 4 or 5. The agency has now published the [FN107] clinical episodes for Model Year 3. Emergency Triage, Treat, and Transportation Model According CMS, Medicare primarily pays for emergency ground transportation when the patient is taken to a hospital. This arrangement creates an incentive to always bring patients to the emergency department, even when another setting might be appropriate. A new Medicare Fee-for-Service model called the Emergency Triage, Treat and Transport model (ET3) is designed to give the emergency transport suppliers and patients more options for destination sites and the type of treatment patients receive. The goal is to transport patients to an appropriate site best suited for their needs. In a news release, CMS explains how it envisions the program: The new model, the Emergency Triage, Treat and Transport (ET3) model, will make it possible for participating ambulance suppliers and providers to partner with qualified health care practitioners to deliver treatment in place (either on-the-scene or through telehealth) and with alternative destination sites (such as primary care doctors' offices or urgent-care clinics) to provide care for Medicare beneficiaries following a medical emergency for which they have accessed 911 services. In doing so, the model seeks to engage health care providers across the care continuum to more appropriately and effectively meet beneficiaries' needs. Additionally, the model will encourage development of medical triage lines for low-acuity 911 calls in regions where participating ambulance suppliers and [FN108] providers operate. ET3 is a payment reform model that will eventually allow ambulance service suppliers and providers to earn up to a 5% payment adjustment if they perform well on certain quality measures. CMS anticipates sent out a request for applications on May 22, 2019, and it [FN109] [FN110] anticipates starting the program in early 2020. The model is to last five years. CMS has set up a web page for the model, [FN111] and a Fact Sheet is available. D. Requiring Transparency © 2020 Thomson Reuters. No claim to original U.S. Government Works. -11- President Donald Trump (R) signed an executive order on June 24, 2019, requiring hospitals to disclose their prices for their services. [FN112] [FN113] According to news sources, the order also requires hospitals to tell patients what their out-of-pockets costs will be. The Administration believes that patients will have more choice if they know the cost of the procedures they are getting, and they believe that revealing prices will stimulate competition. Hospitals and insurance companies are wary of the move, as they are reluctant to publicly post their prices. The president of the American Hospital Association (AHA) said, ”The AHA appreciates the Administration's efforts to promote health care transparency on price and quality, and looks forward to more details as proposals are put forth . . . . While details are being developed, it's important to note that hospitals already provide consumers with information on pricing, but publicly posting privately negotiated rates could, in fact, undermine the competitive forces of private market dynamics, and result in increased prices…. We look forward to working with the agencies as they develop specific plans with [FN114] the ultimate goal of helping consumers better navigate their care.“ A representative of American's Health Insurance Plans made the same argument, saying, “Publicly disclosing competitively negotiated [FN115] proprietary rates will reduce competition and push prices higher — not lower — for consumers, patients, and taxpayers[.]” [FN116] The order directs the Department of Health and Human Services to undertake the rulemaking process. In November 2019, CMS announced a final rule and a proposed rule relating to price transparency. The final rule, which is published at 84 F.R. 65524-01 (Nov. 27, 2019), sets out requirements for price transparency for hospitals. The proposed rule, which is issued with the Internal Revenue Service, the Department of the Treasury, the Employee Benefits Security Administration, and the Department of Labor, requires group health plans and health insurance issuers in both the individual and group markets to be transparent about cost- sharing policies. That rule is published at 84 F.R. 65464-01 (Nov. 27, 2019). CMS provides more information about the rules in a press [FN117] release. 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 [FN118] serve.” 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. [FN119] Because these patients suffer from such a number and variety of illnesses, care is often fragmented, which can lead to a lack of communication among the different providers. When that happens, there is a risk that tests or procedures may be unnecessarily repeated or that crucial information may not get passed on from one physician to another. By coordinating care, ACOs should increase the efficiency and safety of medical care for the elderly and decrease the cost. Generally, if ACOs help save money for Medicare, they may share in some of the savings, but some also agree to share in the losses is the costs are too high. CMS launched several ACO programs after the Affordable Care Act was implemented. The largest is the Medicare Shared Savings [FN120] [FN121] Program (with over 500 participants). Others include the ACO Investment Model (with 45 participants), the Next [FN122] Generation ACOs (with 41 participants), and the Comprehensive ESRD (early stage renal disease) Model (with 37 participants). [FN123] The Pioneer ACO program is no longer active. The programs differ on a number of features, including the level of risk the ACOs agree to take on and the areas where they work. A. The Medicare Shared Savings Program As the program was originally designed, ACOs in the Medicare Shared Savings Program could opt to enter the program in Track 1 in which they entered into a one-sided arrangement with the government. In a one-sided (or “upside only”) arrangement, an ACO that meets quality benchmarks and keeps costs down can share in the cost savings it achieved but accepts no risk for failing to achieve [FN124] savings. ACOs were allowed to stay in Track 1 for two agreement cycles (or six years). ACOs could also choose to participate [FN125] in other tracks where they entered into a two-sided agreement and shared in both the savings and the losses. However, the government's arrangement with most (82%) of the Shared Savings ACOs was one-sided, and ACOs were not leaping to make the [FN126] change to a two-sided arrangement. The Obama Administration recognized the need to encourage more ACOs to transition into [FN127] risk-bearing arrangements, and in late 2016 it introduced the ACO Track 1+ model. CMS explained that the new model would “test a payment model that incorporates more limited downside risk than is currently present in Tracks 2 or 3 of the Medicare Shared Savings Program in order to encourage more rapid progression to performance-based risk.” The new, time-limited model qualified as [FN128] an APM, allowing participating clinicians to qualify for incentive payments. The American Hospital Association released a brief [FN129] statement in support of the model. In remarks before the American Hospital Association in 2018, CMS Administrator Seema Verma lamented the state of the Medicare Shared Savings Program. Verma expressed her concern that most ACOs in the program were still in one-sided agreements. ACOs in © 2020 Thomson Reuters. No claim to original U.S. Government Works. -12- 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 [FN130] place, reducing competition and choice for our beneficiaries.” Verma's remarks were portentous. On August 17, 2018, CMS proposed a rule overhauling the Medicare Shared Savings Program, calling the overhaul the Pathways to Success Program. CMS explained the purpose of the rule in the summary: The policies included in this proposed rule would provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These proposed policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free- market principles. The proposed rule also would provide new tools to support coordination of care across settings and strengthen beneficiary engagement; ensure rigorous benchmarking; promote interoperable electronic health record technology among ACO [FN131] providers/suppliers; and improve information sharing on opioid use to combat opioid addiction. At the time the proposed rule was announced, some experts and industry representatives expressed fear that the changes would drive ACOs to quit the program, and a survey by the National Association of ACOs (NAACOS) found that 70% of ACOs would rather quit the program than take on the kind of risk being proposed. The CEO of NAACOS predicted unfortunate consequences from the new rule, saying that the “‘likely outcome will be that many ACOs quit the program, divest their care coordination resources and return to payment models that emphasize volume over value.”’ A representative from the American Hospital Association, who was concerned with the [FN132] proposed changes, noted the immense cost, time, and effort it takes to get an ACO to the point of being ready to take on risk. On the other hand, Farzad Mostashari, formerly an official in the Department of Health and Human Services under President Obama, said that he agrees that more needs to be done to move ACOs into risk-bearing agreements. However, Mostashari indicated that, ideally, [FN133] [FN134] two-sided risk would be made less risky and more predictable. CMS estimates a net loss of 100 ACOs by 2027. In a final rule addressing payment policies under the Physician Fee Schedule, the Medicare Shared Savings Program, and the Medicaid Promoting Interoperability Program, CMS finalized some new policies for the Medicare Shared Savings Program, but did not finalize everything set out in the proposed rule. In a fact sheet, CMS explained which policies it finalized: • [Granting a] voluntary 6-month extension for existing ACOs whose participation agreements expire on December 31, 2018, and the methodology for determining financial and quality performance for this 6-month performance year from January 1, 2019, through June 30, 2019. • Allowing beneficiaries who voluntarily align to a Nurse Practitioner, Physician Assistant, Certified Nurse Specialist, or a physician with a specialty not used in assignment to be prospectively assigned to an ACO if the clinician they align with is participating in an ACO, as provided for in the Bipartisan Budget Act of 2018. • Revising the definition of primary care services used in beneficiary assignment. • Providing relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in 2018 and subsequent years. • Reducing the Shared Savings Program core quality measure set by eight measures; and promoting interoperability among ACO providers and suppliers by adding a new CEHRT threshold criterion to determine ACOs' eligibility for program participation and retiring [FN135] the current Shared Savings Program quality measure on the percentage of eligible clinicians using CEHRT. The rule is published at 83 F.R. 59452-01 (Nov. 23, 2018). (Corrections are published at 84 F.R. 539 (Jan. 31, 2019)). CMS has now finalized the other provisions of the proposed rule. CMS Administrator Seema Verma explained why the time has come to redesign the Medicare Shared Savings Program as it currently exists: ”Pathways to Success is a bold step towards quality healthcare at a lower cost through competition and beneficiary engagement . . . . The rule strikes a balance between encouraging participation in the ACO program and advancing the transition to value, ultimately protecting taxpayers and patients. Medicare can no longer afford to support programs with weak incentives that do not deliver value. As [FN136] we structure new payment arrangements, the impact on the overall market will be top of mind.“ 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. [FN137] • Program integrity: The program establishes rigorous and accurate benchmarks for evaluating ACO performance. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -13- Applications for the new program were accepted on a special one-time start date of July 1, 2019; annual application cycles will resume in January 2020. Pathways to Success will offer ACOs two tracks in which to participate: the Basic Track and the Enhanced Track. ACOs must participate in their chosen track for no less than five years. CMS summarizes the two tracks in a Fact Sheet: (1) BASIC track, which would allow eligible ACOs to begin under a one-sided model and incrementally phase-in higher levels of risk that, at the highest level, would qualify as an Advanced Alternative Payment Model (APM) under the Quality Payment Program, and (2) ENHANCED track, based on the program's existing Track 3, which provides additional tools and flexibility for ACOs that take on the [FN138] highest level of risk and potential reward. In the BASIC track's glide path, ACOs will be eligible for a higher shared savings reward based on quality performance. Time in a one- sided track will be time-limited: The glide path includes 5 levels: a one-sided model available only for the first two years to most eligible ACOs (ACOs identified as having previously participated in the program under Track 1 would be restricted to a single year under a one-sided model, but new, low revenue ACOs that are not identified as re-entering ACOs would be allowed up to three years under a one-sided model); and three levels of progressively higher risk in years 3 through 5 of the agreement period. Under Levels A and B of the glide path, an ACO's maximum shared savings rate under a one-sided model will be 40 percent based on quality performance, applicable to first dollar shared savings after the ACO meets the minimum savings rate. Under Levels C, D, and E of the glide path, an ACO can earn up to a maximum 50 percent sharing rate under a two-sided model, based on quality performance. The glide path concludes with a maximum level of risk that qualifies as an Advanced APM for purposes of the Quality [FN139] Payment Program. The Fact Sheet lays out the details of the program. The final rule is published at 83 F.R. 67816 (Dec. 31, 2018). The July 1 application cycle has now ended. Administrator Verma took the opportunity to provide updates on the new applications and the selections that ACOs made. She reports that more ACOs are now moving into risk-bearing arrangements: I am especially encouraged to see that an increasing fraction of ACOs are taking on real accountability. Forty-eight percent of ACOs starting on July 1, 2019 are taking on risk for spending increases above their cost target; If they exceed this target, they will be on the hook to pay back to CMS up to at least 2 percent of their revenue or 1 percent of their cost target, and as noted below most of these ACOs will put at risk significantly greater amounts. These ACOs are willing to face consequences if costs increase, in exchange for higher levels of shared savings and greater regulatory flexibility. As of July 1, 2019, 29 percent of Shared Savings Program ACOs are taking on risk for spending increases, which is a 10 percentage point increase in the number of risk-based ACOs in the program. This is projected to lead to more savings for beneficiaries and taxpayers, and provide stronger incentives for ACOs to coordinate care and [FN140] improve quality for patients. [FN141] For a list of the ACOs that applied for the July 1, 2019, application cycle, please see the CMS web site. B. ACO Investment Model The ACO Investment Model is open to certain new and existing ACOs in the Medicare Shared Savings Program. The defining feature of the ACO Investment Model is that it pre-pays a part of the shared savings so that new and existing ACOs have the capital to invest in the necessary infrastructure to properly provide population care management. However, CMS wants new ACOs in the ACO Investment [FN142] Model Initiative to provide service in rural and underserved areas –areas that have not previously been well-served by ACOs. The following ACOs were invited to participate: • New Shared Savings Program ACOs joining in 2015 and 2016 - The ACO Investment Model seeks to encourage uptake of coordinated, accountable care in rural geographies and areas where there has been little ACO activity, by offering pre-payment of shared savings in both upfront and ongoing per beneficiary per month payments. • ACOs that joined Shared Savings Program starting in 2012, 2013 and 2014 - The ACO Investment Model will help ACOs succeed in the shared savings program and encourage progression to higher levels of financial risk, ultimately improving care for beneficiaries and [FN143] generating Medicare savings. The newer ACOs (that joined in 2015 and 2016) will receive three types of payments: an upfront, fixed payment; an upfront, variable payment, based on the number of prospectively-assigned patients; and a monthly payment that will vary depending on the size of the ACO. ACOs that joined the Medicare Shared Savings Program before 2015 will receive just the upfront variable payment depending on the number of prospectively-assigned patients and the monthly payment depending on the size of the ACO. Application times will be staggered, depending on when the ACO joined the Shared Savings Program. CMS provides more details about the requirements for [FN144] [FN145] the program on its web site, and a Fact Sheet is available. The program has 45 participants. C. Next Generation ACOs HHS announced the Next Generation program in March 2015. This program builds on the now inactive Pioneer ACO program in that it is designed for ACOs willing to take on more risk than is available to ACOs in the Shared Savings Program and even in the © 2020 Thomson Reuters. No claim to original U.S. Government Works. -14- Pioneer Program. ACOs in this program also have the opportunity to share in a greater portion of the savings. The program is meant for [FN146] experienced ACOs who are well-positioned to accept more risk. HHS indicated that ACOs in this program will have several tools available to them to help manage their populations efficiently: ACOs will have a number of tools available to enhance the management of care for their beneficiaries. These tools include rewards to beneficiaries for receiving their care from physicians and professionals participating in their ACOs, coverage of skilled nursing care without prior hospitalization, and modifications to expand the coverage of telehealth and post-discharge home services to support coordinated care at home. The Next Generation ACO Model also supports patient-centered care by providing the opportunity for beneficiaries to confirm a care relationship with ACO providers and to communicate directly with their providers about their care [FN147] preferences. The program, which got underway in 2015 as anticipated, premiered with 21 ACOs in January 2016. The program now has 41 participants. VI. Electronic Health Records and The MyHealthEData Initiative Seema Verma, the CMS Administrator, introduced an audience at the Healthcare Information and Management Systems Society's 2018 (HIMSS18) to the government's new MyHealthEData Initiative. The pith of her remarks was about the limits of electronic health records (EHRs), including the limited extent to which they are interoperable and easily accessed by patients. She acknowledged that EHR adoption is high, particularly within hospitals, but she said that electronic records are not easily shared outside of the health system from which they originate. Verma explains: In most cases there is not yet a business case for doing that – it's in the financial interest of the provider systems to hold on to the data for their patients. . . . So in many ways, EHRs have merely replaced paper silos with electronic ones, while providers, and the patients they serve, still have difficulty obtaining health records. For the fortunate few who do ultimately obtain their records, the information is often incomplete, and not always digital or understandable. You might be able to get some information in your provider's portal but if [FN148] you are seeing different providers, you might be checking a bunch of portals. You have all been there before, and so have I. When health information cannot be easily shared among providers, it makes care coordination inefficient or impossible. Additionally, many patients have trouble accessing their own health records. Information is often still shared via fax, the administrator said. Verma used a recent experience in her own life to illustrate the problems with patients accessing their own EHRs: She related that her husband collapsed at an airport and was treated at a hospital in a city far from where they live. When he was released from the hospital a week later, she requested his records so she could share them with their doctor back home. After some amount of time and trouble, the provider gave her a few sheets of paper that were basically the discharge summary as well as a CD-ROM. After searching for a place to read the CD, she found that it did not contain all of the test results. Verma believes that patients ought to be able to easily view and share their own records. As a step toward achieving greater patient control over their records, Verma introduced the crowd to the administration's HealthEData Initiative: MyHealthEData is a government-wide initiative that will break down the barriers that contribute to preventing patients from being able to access and control their medical records. MyHealthEData makes it clear that patients should have access and control to share their data with whomever they want, making the patient the center of our health care system. Patients need to be able to control their information and know that it's secure and private. Having access to their medical information will help them make decisions about their [FN149] care, and have a better understanding of their health. Verma envisions a time when patients have ready access to their EHRs and can share it with a click of a button. She also announced a new version of Blue Button, called Blue Button 2.0, which would have many benefits: The possibilities for better care through Blue Button 2.0 data are exciting, and may include enabling the creation of health dashboards for Medicare beneficiaries to view their health information in a single portal, or allowing beneficiaries to share complete medication lists [FN150] with their doctor to prevent dangerous drug interactions. Finally, Verma mentioned that the agency is working on a complete overhaul of the EHR Incentive Program for hospitals and the Advancing Care Information category of the Quality Payment Program for physicians. Please see the press release for a full transcript [FN151] of the Administrator's remarks. [FN152] On a related note, HHS announced the release of a new guide from the Office of the National Coordinator for Health Information [FN153] Technology (ONC) titled “ONC Guide to Getting and Using your Health Records.” HHS explains why patient access is so important: Individuals' ability to access and use their health information electronically is a measure of interoperability and a cornerstone of ONC's [FN154] efforts to increase patient engagement, improve health outcomes, and advance person-centered health. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -15- For the past several years, CMS had been running Electronic Health Record (HER) Incentive Programs for Medicaid and Medicare. Under the programs, providers were paid incentive payments for adopting and meaningfully using certified electronic health records. Adoption of EHRs is high. According to the Office of the National Coordinator for Health Information Technology (ONC), [FN155] 96% of hospitals and 80% of office-based physicians have adopted a certified EHR system. CMS is now focusing more on interoperability of EHRs. To that end, CMS changed the Medicaid and Medicare EHR Incentive Programs to the Promoting Interoperability Programs. Changes to the programs were finalized in an August 2018 rule published at 83 F.R. 41144-01 (Aug. 17, 2018). The goal is to increase flexibility, decrease administrative burdens, and promote interoperability. CMS summarized the changes in the rule: In this final rule, we are finalizing several changes to reduce burden, increase interoperability and improve patient electronic access to their health information under the Medicare and Medicaid Promoting Interoperability Programs (previously referred to as Medicare and Medicaid EHR Incentive Programs). Specifically, we are finalizing: (1) An EHR reporting period of a minimum of any continuous 90 days in CYs 2019 and 2020 for new and returning participants attesting to CMS or their State Medicaid agency; (2) modifications to our proposed performance-based scoring methodology, which consists of a smaller set of objectives as well as a smaller set of new and modified measures; (3) the removal of certain CQMs beginning with the reporting period in CY 2020 as well as the CY 2019 reporting requirements we proposed to align the CQM reporting requirements for the Promoting Interoperability Programs with the Hospital IQR Program; (4) the codification of policies for subsection (d) Puerto Rico hospitals; (5) amendments to the prior approval policy applicable in the Medicaid Promoting Interoperability Program to align with the prior approval policy for MMIS and ADP systems and to minimize burden on States; and (6) deadlines for funding availability for States to conclude the Medicaid Promoting Interoperability Program. [FN156] [FN157] CMS continues to update the Promoting Interoperability Program, and it finalized changes for 2020. Finally, CMS and the Office of the National Coordinator for Health Information Technology (ONC) have both proposed rules to improve interoperability. CMS released a proposed rule to improve interoperability of health care records and to ensure that patients have access to their records at all times, including when they move between providers and health plans. The rule proposes changes to [FN158] health care delivery that support the MyHealthEData Initiative. To this end, the proposed rule, among other things, requires that by 2020, Medicaid, the Children's Health Insurance Program (CHIP), Medicare Advantage plans, and plans on the Marketplace must be able to provide participants with immediate electronic access to their health information, and it proposes public reporting of providers [FN159] that engage in “information blocking” that impedes the free flow of information. Also included are two Requests for Information soliciting feedback from stakeholders on interoperability and adoption of health information technology in post-acute centers, among [FN160] [FN161] other things. A summary of the provisions of the proposed rule is provided in a Fact Sheet. The rule is published at (March 4, 2019). st ONC's proposed rule includes provisions meant to comply with the 21 Century Cures Act (P.L. 114-255): Among other things, the rule proposes language setting out necessary activities that do not constitute “information blocking.” That proposed rule also makes [FN162] changes to the 2015 edition health IT certification criteria in order to advance interoperability. A Fact Sheet is available. The rule is published at 84 F.R. 7424-01 (March 4, 2019). VII. RURAL HEALTH CARE [FN163] Rural hospitals have been closing at a rate that is concerning to many, with some calling the trend “alarming” or characterizing it [FN164] [FN165] as a “crisis.” Since 2010, 102 rural hospitals have closed, most of them in the South, including 17 in Texas alone. Kaiser Health News now reports that a Texas rural hospital that closed a little more than a year ago has since reopened. This is good news for area residents who, since the closure, have had to travel 35 miles to the nearest hospital when a medical emergency arose. There are several reasons why rural hospitals are closing, one being that smaller rural hospitals have very little leverage when it comes to negotiating Medicare and Medicaid reimbursements. In states like Texas, which have not adopted the Affordable Care Act's Medicaid expansion, rural hospitals suffer as they deal with increasingly older and poorer patients who may not have Medicaid coverage. When these hospitals do receive Medicaid reimbursement, they often result in “underpayments” – payments that do not match the cost of the services rendered. Kaiser Health News reports that rural advocates in Texas are pushing the legislature to find some way to support and save the remaining 161 rural hospitals in the state by, for example, securing Medicaid payments that fairly cover the services rendered. They are also pushing for legislation in Congress that would allow a rural hospital to close its inpatient beds while maintaining other services such as an emergency department and primary care clinics. In the newly reopened Texas hospital, for example, the hospital is offering emergency and primary care services, but it is now offering only limited inpatient beds for more routine care. Unfortunately, it could not resume maternity services. Many other rural hospitals in Texas are vulnerable. The executive director of the A&M Rural and Community Health Institute at Texas A&M Health Science Center said that rural communities are going to need to get creative about providing for the health care needs of their citizens; they could form partnerships with other communities, for example, or [FN166] expand services through telemedicine. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -16- The Commonwealth Fund notes that pregnant women in particular are affected by the crisis in rural health. When hospitals close, so do their obstetric units; at this point, fewer than half of all rural counties have obstetric units, and fewer than half have access to good prenatal care. Postpartum care is scarce in rural counties as well. Many women face long journeys to a hospital where they can give birth, and they are giving birth in less than ideal situations: These hospital and OB unit closures mean rural women in labor increasingly face lengthy journeys to the hospital, sometimes even hours long. They also have contributed to increases in births outside hospitals, births in hospitals without OB care, and in preterm births — all of which carry greater risks for mom and baby. Experts believe these closures also contribute to early elective deliveries using induction and cesarean section — procedures that increase the risk of complications — because women do not want to risk going into labor when they are hours from the nearest hospital. [FN167] The Commonwealth Fund sets out multiple ways to ameliorate the effects of rural hospital closures: • Growing the maternity workforce (OB/GYN practitioners, family practice practitioners, and midwives) by offering incentives to providers to work in rural areas; • Expanding the scope of practice for nurses and midwives; • Coverage, particularly Medicaid coverage, for doulas; • Soliciting health care systems, hospitals, and universities to provide training to a wide range of practitioners, particularly those who practice maternity and pediatric care; • Offering higher Medicaid reimbursements to rural hospitals to stem the number of closures. According to the Commonwealth Fund's article, evidence suggests that the Medicaid expansion has improved the fate of rural hospitals, [FN168] and Medicaid policies that reduce coverage worsen it. Recognizing the scarcity of maternity care in rural areas, HHS announced $9 million in funds to establish the Rural Maternity and Obstetrics Management Strategies (RMOMS) program. Awardees in three states, Missouri, New Mexico, and Texas, will use the funds to plan, test, and implement models to improve access to maternity care in rural areas. The program will involve several stakeholders, including rural hospitals, health centers, state Medicaid offices, Healthy Start programs, and home visiting programs. [FN169] After a deliberative and collaborative process, CMS put together a rural health strategy to improve care for those who live in rural areas. Millions of Medicaid and Medicare participants live in rural areas, and they have unique needs when compared to urban dwellers: Compared to their urban counterparts, rural Americans are more likely to be living in poverty, unhealthy, older, uninsured or underinsured, and medically underserved. Additional challenges facing rural America include a fragmented health care delivery system, stretched and diminishing rural health workforce, affordability of insurance, and lack of access to specialty services and providers. [FN170] (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 [FN171] 5. Leverage partnerships to achieve the goals of the CMS Rural Health Strategy CMS Administrator Seema Verma recently blogged about the steps that CMS is taking to meaningfully improve rural health. She highlighted these changes, among others: • Expanded access to telehealth to provide greater access to service in rural areas. For example, Medicare now pays for virtual check- ins with physicians, remote evaluations of videos or images, and stand-alone phone consultations with clinicians at Rural Health and Federally Qualified Health Centers. The agency also expanded the list of services that will be covered when provided by telehealth, “such as wellness visits that require additional time for complex patients and care for patients experiencing a stroke or with End Stage Renal Disease (ESRD).” CMS has also included expanded telehealth opportunities in its overhaul of the Medicare Shared Savings Program, known as Pathways to Success. • CMS recently introduced its CMS Primary Cares initiative, which is a set of payment reforms for primary care. In the direct contracting option, organizations can agree to take on financial risk in a defined region, which could be a way to innovate in rural areas. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -17- • The agency will also be introducing another innovative model specifically for rural health care. The model will “offer a pathway for stakeholder coalitions comprised of providers, purchasers, and payers to invest collectively in increasing access and improving rural [FN172] healthcare delivery.” In late 2019, Verma blogged again, this time highlighting some of the gains the administration has made in its effort to improve rural health. Among other things, she noted that, through the Patients over Paperwork initiative, the government has reduced the administrative burden on rural providers. She estimates that the savings from these efforts will be around $100 million dollars and 950,000 hours between 2018 and 2021. Recognizing the alarming rate at which rural hospitals are closing, she also pointed out that the government has changed the way it reimburses hospitals by increasing the wage-index for certain low-wage index hospitals. Verma also mentioned how CMS is taking into account the unique needs of rural providers as it introduces new innovative payment models. Please see the blog post for other ways the government is working to improve health needs in rural communities and what it plans for [FN173] the future. VIII. selected Federal Activity • CMS gave notice that it approved a request for an exception to the Prohibition on Expansion of Facility Capacity under the Hospital Ownership and Rural Provider exceptions to the Physician Self-Referral prohibition. The approval was granted to St. James Behavioral Health Hospital Inc. in Louisiana. The notice is published at 84 F.R. 3185 (Feb. 11, 2019). • CMS gave notice that it has published the final 2017 and preliminary 2019 disproportionate share hospital allotments. It has also published the final 2017 and preliminary 2019 disproportionate share allotments for Institutions of Mental Diseases. The notice is published at 84 F.R. 3169 (Feb. 11, 2019). • CMS has approved an application from the National Dialysis Accreditation Commission to serve as an accrediting body for End Stage Renal Disease facilities participating in the Medicare and Medicaid programs. The notice is published at 84 F.R. 1737 (Feb. 11, 2019). • CMS gave final notice that it has approved an application from the Joint Commission for continued recognition as an accrediting body for psychiatric hospitals that participate in Medicare and Medicaid. The notice is published at 84 F.R. 4818 (Feb. 19, 2019). • Introduced in the House of Representatives on February 27, 2019, 2019 FD H.B. 1354 (NS) seeks to improve the way the territories are regarded for purposes of Medicaid. Among other things, the bill would eliminate certain funding caps, eliminate specific federal medical assistance percentages, allow the application waiver authority for the territories, and allow disproportionate share hospital payments. The bill has bipartisan sponsors. • CMS and the Department of Health and Human Services' Office of the Inspector General have published a final rule making changes to state Medicaid Fraud Control Unit rules. Medicaid Fraud Control Units are charged with investigating provider fraud and patient abuse or neglect in health care facilities. CMS explains the rule's purpose in the summary of the rule, which is published at 84 F.R. 10700 (March 22, 2019) explains: This final rule amends the regulation governing State Medicaid Fraud Control Units (MFCUs or Units). The rule incorporates statutory changes affecting the Units as well as policy and practice changes that have occurred since the regulation was initially issued in 1978. These changes include a recognition of OIG's delegated authority; Unit authority, functions, and responsibilities; disallowances; and issues related to organization, prosecutorial authority, staffing, recertification, and the Units' relationship with Medicaid agencies. The rule is designed to assist the MFCUs in understanding their authorities and responsibilities under the grant program, clarify the flexibilities the MFCUs have to operate their programs, and reduce administrative burden, where appropriate, by eliminating duplicative and unnecessary reporting requirements. • CMS gave notice that it approved the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program as an accrediting body for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988. The notice is published at 84 F.R. 11980-01 (March 27, 2019). • House Bill 1897 (2019 FD H.B. 1897 (NS)) and Senate Bill 3776 (2019 FD S.B. 1376 (NS)) would enact the Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act. The bills seek to improve the maternal mortality rate. One of the House bill's [FN174] sponsors, Robin Kelly (D-Ill.), notes that the rate of maternal mortality is rising and claims 700 lives per year. Senator Dick Durbin (R-Ill.), a sponsor of the Senate bill, said, ”No nation as rich and advanced as the United States should have new moms and infants—especially women and babies of color— dying at the rates we are currently seeing. It is a national tragedy . . . . Many of these deaths could have been prevented with the right interventions and health care. That's why Congresswoman Kelly, Senator Duckworth, and I are introducing the MOMMA's Act to help [FN175] provide more comprehensive and culturally competent maternal and postpartum health care for all women and babies.” A press release on Representative Kelly's web site indicates, The shocking statistics cut across geography, education level, income and socio-economic status. However, women of color die at [FN176] much higher rates than white mothers. Nationally, African American mothers die at 3-4 times the rate of white mothers. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -18- Other sponsors of the Senate bill include Senators Tammy Duckworth (D-Ill.), Richard Blumenthal (D-Conn.), Chris Van Hollen (D-Md.), Jeff Merkley (D-Ore.), Sherrod Brown (D-Ohio), Bernie Sanders (I-Vt.), Tina Smith (D-Minn.) and Angus King (I-Maine). The bills propose several steps to improve maternal mortality rates, including enhancing Medicaid and CHIP coverage for pregnant and post-partum women. The bills also propose changes in hospital procedures, noting that there are no standard emergency obstetrical protocols that apply before, during, and after delivery in hospitals. The bills would direct the Director of the Centers for Disease Control and Prevention, in consultation with the Administrator of the Health Resources and Services Administration, to issue best practices to hospitals and other groups on how best to prevent maternal mortality. The bills would also direct the Health and Human Services Secretary to establish the Alliance for Innovation on Maternal Health Grant Program, under which funds would be awarded for the purposes set out in the bills. Among other things, the funds could be used to develop and implement maternal safety bundles to help states and health care systems align national, state, and hospital-level quality improvement efforts. Please see the bill for other hospital-related proposals. • Introduced in the House on April 8, 2019, 2019 FD H.B. 2113 (NS) would require drug manufacturers to be transparent in drug pricing and would require, in certain circumstances, drug manufacturers to report on samples they give to health care providers. The bill contains a section that would require the Secretary of the Department of Health and Human Services to conduct an analysis and report on inpatient hospital drug prices. The analysis would be one that: (1) focuses on drugs that are furnished in the inpatient setting; (2) includes data on inpatient hospital drug costs, Medicare spending, volume, and spending per admission; (3) considers trends in inpatient hospital drug costs, such as trends by hospital size, classification of urban or rural, whether the hospital is a teaching hospital, or other categorization; and (4) examines the impact of drug shortages on services that are furnished in an inpatient hospital setting. • CMS gave notice that it approved an application from the Accreditation Commission for Health Care, Inc. to serve as a national accrediting organization for End Stage Renal Disease Facilities that wish to participate in the Medicare and Medicaid programs. The notice is published at 84 F.R. 14381-01 (Apr. 10, 2019). • CMS published a proposed rule with fiscal year 2020 updates for the Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting. The proposed rule is published at 84 F.R. 16948-01 (Apr. 23, 2019). The rule was finalized, and the final rule is published at 84 F.R. 38424-01 (Aug. 6, 2019). • CMS proposed fiscal year 2020 updates to the Medicare Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting requirements. The proposed rule is published at 84 F.R. 17570 (Apr. 25, 2019). A final rule was published at 84 F.R. 38484-01 (Aug. 6, 2019). • CMS also published proposed fiscal year 2020 updates to the Medicare Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities, the Quality Reporting Program, and the Value-Based Purchasing Program. The proposed rule is published at 84 F.R. 17620 (Apr. 25, 2019). A final rule is published at 84 F.R. 38728-01 (Aug. 7, 2019). • In Congress, 2019 FD H.B. 1955 (NS), the Understanding Appropriate Alzheimer's Care Act of 2019) would call for a study of anti- psychotic drug prescribing practices in non-nursing home setting in the Medicare program. The study would have to address: (A) whether antipsychotic prescribing practices in such nonnursing home settings are appropriate or inappropriate; (B) whether individuals who have been prescribed antipsychotic medications in such nonnursing home settings have had improved health outcomes, taking into account the duration of any such prescription; (C) whether physicians- (i) are aware of the health risks of antipsychotic medications for individuals with Alzheimer's disease; and (ii) attempt to use nonpharmacological interventions before prescribing such medications for such individuals; and (D) whether individuals who have been prescribed antipsychotic medications in such nonnursing home settings, and the families of such individuals, are aware of the health risks of such medications[.] • CMS has published its quarterly list of program issuances for the quarter beginning in January 2019 and ending in March. Please see 84 F.R. 18040-01 (Apr. 29, 2019). • If passed, 2019 FD S.B. 1343 (NS) would enact the Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services (MOMMIES) Act. Sponsored by Senators Cory Booker (D-N.J.), Tammy Baldwin (D-Wis.), Elizabeth Warren (D-Mass.), Kamala Harris (D.-Calif.), Kirsten Gillibrand (D-N.Y.), Richard Blumenthal (D-Conn.), and Mazie Hirono (D-Haw.) and introduced on May 7, 2019, the act would enhance Medicaid and CHIP coverage for low-income pregnant and post-partum women. On his web site, Senator Booker cites the unacceptably high rate of pregnancy-related deaths in the United States, and he summarizes what the act would do: The Maximizing Outcomes for Moms through Medicaid Improvement and Enhancement of Services (MOMMIES) Act would expand coverage for pregnant women covered by Medicaid -- which covers nearly half of all births in the U.S. -- by dramatically extending © 2020 Thomson Reuters. No claim to original U.S. Government Works. -19- coverage for new moms from two months to a full year after childbirth; ensuring that all pregnant and postpartum women have full Medicaid coverage, rather than coverage that can be limited to pregnancy-related services; and increasing access to primary care [FN177] providers and women's health providers. A related bill in the House would enact the Healthy Mommies Act. That bill, 2019 FD H.B. 2602 (NS), is sponsored by Representative Ayanna Pressley (D-Mass.) and others. • CMS announced a delay in finalizing the proposed rule titled, “Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care.” The agency is required to give such notice when a final rule is not going to be published within three years of the proposed rule. The original rule was published on June 16, 2016, and CMS gave notice about the delayed final rule at 84 F.R. 27069 (June 11, 2019). CMS' new deadline for the final rule is June 16, 2020. • Senators Kevin Cramer (R-N.D.), Jodi Ernst (R-Iowa), Marsha Blackburn (R-Tenn.), Steve Daines (R-Mont.), and Cindy Hyde-Smith (R-Miss.) are sponsoring 2019 FD S.B. 1993 (NS), which seeks to enact the Patient Rights Act. The act would restrict federal funding for entities that do not respect all human life. The bill includes several categories of life it intends to protect, including the unborn, the newly born, the prematurely born, pregnant women, the elderly, the disabled, the terminally ill, those in a persistent vegetative state, those who are comatose, and others incapable of advocating for themselves. In a press release on Senator Cramer's website, [FN178] however, he explains that the purpose of the bill is “to halt the use of taxpayer dollars to fund abortion services.” Senator Cramer elaborated on the purpose of the bill in Senator Blackburn's press release: “Abortion providers do not deserve taxpayer subsidies . . . . While current law prohibits federal funds from being used for abortions, companies like Planned Parenthood still receive millions of taxpayer dollars each year. Because federal funds pay for other parts of an organization's operations, more money is available to fund abortion services, thus turning these taxpayer dollars into de-facto subsidy for abortion. This bill closes that loophole by prohibiting federal funds not just from being used to pay for abortions, but also from going [FN179] to any entity that performs abortions.” • Representative Anthony Brindisi (D-N.Y.) and others are sponsoring 2019 FD H.B. 3672 (NS), which was introduced on July 10, 2019. The bill would enact the Access for Rural Communities Act (or ARC Act), which would allow for a recalculation for small rural hospitals when a Medicare administrative contractor determines that a volume decrease adjustment applies. The bill provides, [s]ubject to subsection (b), in the case of a sole community hospital or a Medicare-dependent, small rural hospital with respect to which a Medicare administrative contractor determined a volume decrease adjustment applies for any specified cost reporting period, at the election of the hospital, the Secretary of Health and Human Services shall recalculate the amount of the volume decrease adjustment determined by the Medicare administrative contractor for such hospital and specified cost reporting period using the revised volume decrease adjustment payment methodology for any specified cost reporting period requested by the hospital in its election. • CMS is proposing a rule to reduce administrative burdens on long-term care facilities. CMS explains in a Fact Sheet that the proposed rule is a part of CMS' five-part approach for improving the long-term care facility program in Medicare and Medicaid. The five-part approach “focuses on strengthening requirements for such facilities, working with states to enforce statutory and regulatory [FN180] requirements, increasing transparency of facility performance, and promoting improved health outcomes for facility residents.” CMS explains the purpose of the proposed rule in the fact sheet: This proposed rule would increase facilities' ability to devote their resources to improving resident care. This would be achieved by the elimination or reduction in the hours and resources that clinicians and providers spend on obsolete and redundant requirements that could impede or divert resources away from the provision of high-quality resident care. Many of the proposed provisions would simplify and/or streamline the Medicare health and safety standards long-term care facilities must meet in order to serve their residents. [FN181] Importantly, in identifying opportunities for reducing burden, CMS would maintain resident health and safety standards. CMS sets out the provisions in more detail in the fact sheet. The rule is published at 84 F.R. 34737 (July 18, 2019). • CMS also published a final rule amending requirements for long-term care facilities that provide services in Medicare and Medicaid. The rule, which is published at 84 F.R. 34718 (July 18, 2019), removes the prohibition on use of pre-dispute, binding arbitration agreements, and it also seeks to strengthen transparency of arbitration agreements and arbitration for long-term care facilities. In a fact sheet, CMS describes what the rule does: This final rule repeals the prohibition on LTC facilities entering into pre-dispute, binding arbitration agreements with their residents, as proposed. However, this final rule includes protections of residents‘’ rights by prohibiting LTC facilities from requiring residents to sign binding arbitration agreements as a condition of admission to, or as a requirement to continue to receive care at, that facility. It strengthens the transparency of arbitration agreements and the arbitration process with specific requirements for the LTC facility, such as the requirement that LTC facilities that resolve a dispute with a resident through arbitration retain copies of the signed arbitration agreement and the final arbitrator's decision for five years and make such documents available for review by CMS or its designee. It also protects residents' rights to make informed choices about their health care by ensuring that residents or their representatives have [FN182] the right to understand what the arbitration agreement says and the consequences of signing the agreement. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -20- • House Bill 3253 (2019 FD HB 3253 (NS) has become law under the title “The Sustaining Excellence in Medicaid Act of 2019.” Among other things, the act extends the Money Follows the Person program, the Community Mental Health Services Demonstration for certified community behavioral health clinics, and spousal impoverishment protections for participants receiving home- and community- based services. The president signed the bill on August 6, 2019. • CMS gave notice that it received an application from the Accreditation Association of Hospitals/Health Systems--Healthcare Facilities Accreditation Program for continued recognition as an accrediting body for critical access hospitals that participate in the Medicare and Medicaid programs, and it is seeking comment on the application. The notice is published at 84 F.R. 37302-01 (July 31, 2019). • CMS has finalized a Medicare rule titled, “Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2020,” which is published at 84 F.R. 38728-01 (Aug. 7, 2019). • CMS made updates to the fiscal year 2020 Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System. A Fact Sheet is available for the final rule, which is titled, “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements [FN183] for Eligible Hospitals and Critical Access Hospitals.” The rule includes payment updates for a variety of programs, including the Hospital-Acquired Conditions Program, the Hospital Readmissions Reduction Program, the Hospital Inpatient Reporting Program, and the Hospital Value-Based Purchasing Program. It also addresses antimicrobial resistance, rural health, the Promoting Interoperability Programs, and eCQM reporting, among other things. th The provisions on rural health will increase the wage index for hospitals with a wage index value less than the 25 percentile. In a press release announcing the proposed rule, CMS explained that the rule would advance two CMS priorities: “Rethinking Rural Health” and “Unleashing Innovation.” Administrator Seema Verma explained why her agency is concerned about strengthening rural health care: “One in five Americans are living in rural areas and the hospitals that serve them are the backbone of our nation's healthcare system . . . Rural Americans face many obstacles as the result of our fragmented healthcare system, including living in communities with disproportionally higher poverty rates, more chronic conditions, and more uninsured or underinsured individuals. The Trump administration is committed to addressing inequities in health care, which is why we are proposing historic Medicare payment changes [FN184] that will help bring stability to rural hospitals and improve patients' access to quality healthcare.” The final rule is published at 84 F.R. 42044 (Aug. 16, 2019). Corrections are published at 84 F.R. 53603 (Oct. 8, 2019). The proposed rule was published at 84 F.R. 19158 (May 3, 2019). • CMS has released final rules updating several Medicare payment systems. One updates payment and quality reporting for inpatient [FN185] psychiatric facilities. Another makes payment and policy changes and updates quality reporting for Medicare Inpatient [FN186] [FN187] Rehabilitation Facilities. Hospice payment rates have also been updated, and payments and policies for Medicare skilled [FN188] nursing facilities have been updated as well. [FN189] • In 2017, CMS published a proposed rule setting out a methodology for calculating DSH payment reductions. The rule has now been finalized. It employs the five statutorily set factors, including the uninsured percentage factor, the high volume of Medicaid inpatients factor, the high level of uncompensated care factor, the low DSH adjustment factor, and the budget neutrality factor. The aggregate amount of the reductions will be $4 billion in 2020 and $8 billion in each of the years from 2021 to 2025, inclusive. The final rule is published at 84 F.R. 50308-01 (Sept. 25, 2019). House Bill 4378 (2019 FD H.B. 4378 (NS)), which was signed into law on September 27, 2019, will delay the reductions. • CMS has released its final rule on discharge planning. The purpose of the rule is to engage patients and their families in the process of transitioning from acute care into a non-acute setting and to consider a patient's goal and treatment preferences in the discharge planning. The rule applies to long-term care hospitals, critical access hospitals, psychiatric hospitals, children's hospitals, and cancer hospitals as well as inpatient rehabilitation facilities and home health agencies that participate in Medicare or Medicaid. Among other things, the rule requires facilities to assist patients and their families in choosing a post-acute setting by providing data on quality measures and resource use measures. The rule also seeks to ease transitions by requiring that certain health information be [FN190] transmitted at the time of discharge from acute care. The final rule is The final rule is published at 84 F.R. 51836-01 (Sept. 30, 2019). • CMS announced on September 26, 2019, that it finalized a rule meant to reduce administrative burdens for hospitals and other providers. CMS explains in a Fact Sheet, On September 26, 2019, the Centers for Medicare & Medicaid Services (CMS) took action at President Trump's direction to “cut the red tape,” by reducing unnecessary burden for American's healthcare providers allowing them to focus on their priority – patients. The Omnibus Burden Reduction (Conditions of Participation) Final Rule removes Medicare regulations identified as unnecessary, obsolete, or excessively burdensome on hospitals and other healthcare providers to reduce inefficiencies and moves the nation closer to a healthcare system that delivers value, high quality care and better outcomes for patients at the lowest possible cost. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -21- This rule advances CMS's Patients over Paperwork initiative by saving providers an estimated 4.4 million hours of time previously spent [FN191] on paperwork with an overall total projected savings to providers of $800 million annually. The rule actually finalized three proposed rules: • Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (“Omnibus Burden reduction”), published September 20, 2018; • Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, published June 16, 2016; and [FN192] • Fire Safety Requirements for Certain Dialysis Facilities, published November 4, 2016. The Fact Sheet details how the final rule affects the following facilities and providers: hospitals, hospital swing-bed providers, critical access hospitals, rural health centers, federally qualified health centers, ambulatory surgical centers, transplant centers, home health; hospice, comprehensive outpatient rehabilitation facilities, community mental health centers, portable x-ray services, and religious nonmedical health care institutions. Some of the areas addressed are infection prevention, emergency preparedness, and fire safety. [FN193] The final rule is published at 84 F.R. 51732-01 (Sept. 30, 2019). • CMS is proposing to update and clarify the Physician Self-Referral Law (also called the Stark Law). The proposed rule includes new exceptions. Briefly, the law prohibits physicians from referring Medicare patients for services at entities in which the referring physician [FN194] (or an immediate family member) have a financial interest. According to CMS' Fact Sheet for the proposed rule, the Physician Self-Referral Law was promulgated in 1989, when the health system worked on a fee-for-service basis, and the law has not kept up with changes in value-based health delivery and payment reforms: Since [1989, when the rule was promulgated], Medicare and the private market have implemented many value-based healthcare delivery and payment systems to address unsustainable cost growth in the current volume-based system. A value-based system pays based on the quality of patient care rather than the volume of services provided. The Stark Law has not evolved to keep pace with this transition. In its current form, the Stark Law may prohibit some arrangements that are designed to enhance care coordination, improve quality, and reduce waste. Although the regulations that interpret the Stark Law have been updated several times, all previous changes left in place a framework that is tailored to a fee-for-service environment. . . . Under this proposed rule, for the first time, the regulations [FN195] would support the necessary evolution of the American healthcare delivery and payment system. The proposed rule is published at 84 F.R. 55766-01 (Oct. 17, 2019). • In the House, 2019 FD H.B. 4468 (NS) would amend provisions relating to nursing home in-house educational programs to train individuals as certified nursing aides. The bill would apply in both the Medicare and Medicaid programs, and would, among other things, add provisions relating to disapproval of such a program and rescission of a previous disapproval of a program. One of the primary sponsors, Representative Dwight Evans (D-Penn.) indicates that the bill, which would enact the Nursing Home Workforce Quality Act, is meant to address a shortage of certified nursing assistants in nursing homes. Current law sets out when the government may suspend in-house programs, and it allows a program to be suspended for a single deficiency that may not pose a threat of harm to a patient or [FN196] that may not reflect a systematic problem. According to Representative Evans' web site, The Nursing Home Workforce Quality Act would allow suspensions on in-house CNA education to be rescinded once deficiencies are [FN197] assessed and found to be remedied, while allowing for additional oversight of facilities not exceeding the original two years. • Introduced in the Senate on September 26, 2019, 2019 FD S.B. 2574 (NS) would amend existing statutory language to improve the ability of Medicare and Medicaid providers to use the National Practitioner Data Bank to conduct employee background checks. The bill is sponsored by Senator Cory Gardner (R-Colo.). • CMS released a State Medicaid Director Letter offering guidance to states that wish to implement a new State Plan option created by the SUPPORT for Patients and Communities Act (P.L. 115-271). Section 5052 enacted a new section of the Social Security Act, Section 1915(l), which creates an additional exception to the general prohibition on Medicaid payment for adult patients residing in an “institution for mental disease,” or IMD. An IMD is defined in Section 1905(i) of the Social Security Act as any “hospital, nursing facility, or other institution of more than 16 beds, that is primarily engaged in providing diagnosis, treatment, or care of persons with mental [FN198] diseases, including medical attention, nursing care, and related services.” The new exception will allow states, at their option, to cover IMD services from October 1, 2019 to September 30, 2023, for individuals aged 19-64 with at least one substance use disorder [FN199] diagnosis. Among other things, the letter specifically defines which individuals and IMDs are eligible under the exception. • In November 2018, CMS announced an opportunity for states to participate in a new demonstration program for adults with a serious mental illness (SMI) or children with a serious emotional disturbance (SED). The demonstration was meant to test a limited exception to the general prohibition on payment for adult Medicaid patients residing in “institutions for mental disease” (IMDs). CMS described the opportunity is a State Medicaid Director Letter: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -22- This SMI/SED demonstration opportunity will allow states, upon CMS approval of their demonstrations, to receive [federal financial participation] for services furnished to Medicaid beneficiaries during short term stays for acute care in psychiatric hospitals or residential treatment settings that qualify as IMDs if those states are also taking action, through these demonstrations, to ensure good quality of care in IMDs and to improve access to community-based services as described below. This SMI/SED demonstration opportunity is comparable to the recent section 1115(a) demonstration opportunity to improve treatment for [substance use disorders], including opioid use disorder (OUD). However, through these demonstrations, states will focus on demonstrating improved care for individuals with serious mental health conditions in inpatient or residential settings that qualify as IMDs as well as through improvements to [FN200] community-based mental health care. CMS has now announced that it approved a demonstration program submitted by the District of Columbia. At the same time, CMS approved the district's plan to implement a similar demonstration for individuals diagnosed with a substance use disorder. According to CMS's press release, the district has been particularly affected by the opioid crisis and has experienced a 236% increase in fatal drug overdoses from 2014 to 2017. Often, individuals with a substance use disorder also suffer from a serious mental illness, so CMS and [FN201] the district see the potential for saving thousands of lives. • CMS announced that it finalized calendar year 2020 changes to the Physician Fee Schedule, including changes to the Quality Payment Program, among other things. CMS explains the changes in the rule's summary: This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program quality reporting requirements; Medicaid Promoting Interoperability Program requirements for eligible professionals; the establishment of an ambulance data collection system; updates to the Quality Payment Program; Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm; and amendments to Physician Self-Referral Law advisory opinion regulations. In addition, we are issuing an interim final rule with comment period (IFC) to establish coding and payment for evaluation and management, observation and the provision of self- [FN202] administered Esketamine to facilitate beneficiary access to care for treatment-resistant depression as efficiently as possible. According to a press release, the changes are meant to simplify reporting and ameliorate undue burdens on clinicians, freeing them up to concentrate more on patients. Alex Azar, Secretary of the Department of Health and Human Services, writes, “Historic simplifications to billing requirements mean that clinicians will be able to focus on recording the information that's most important to keeping a patient healthy. As we move toward a system that pays more and more providers for outcomes rather than [FN203] procedures, we look forward to freeing clinicians from even more of these burdens.” Similarly, the rule simplifies participation in the Quality Payment Program: In addition, the final rule improves the Quality Payment Program by streamlining requirements with the goal of reducing clinician burden by including a new, simple way for clinicians to participate in CMS's pay-for-performance program, the Merit-based Incentive Payment System (MIPS). This new framework, the MIPS Value Pathways (MVPs), will be developed in collaboration with stakeholders such as medical professional societies and will begin in the 2021 performance period. It moves MIPS from its current state, which requires clinicians to report on many measures and activities across the multiple performance categories, which consist of Quality, Cost, Promoting Interoperability, and Improvement Activities, to a program that allows clinicians to pick which clinically-related, specialty- specific measurement sets to report on that are more relevant to their scope of practice. Under this framework, patients will be able to compare clinician performance on these measures, as well as on a standard set of claims-based population measures (readmissions, for example) and interoperability measures. In this way, clinicians will be held accountable for fewer but more meaningful measures. [FN204] CMS has provided resources for understanding the changes to the quality payment program, including a Fact Sheet titled, “2020 Quality Payment Program Final Rule Overview Fact Sheet,” an Executive Summary titled, “K. CY 2020 Updates to the Quality Payment Program,” and a list of frequently asked questions titled, “2020 Quality Payment Program Final Rule FAQs,” all of which are available [FN205] for download on the internet. Please also see the Fact Sheet for the Physician Fee Schedule final rule. • CMS also finalized calendar year 2020 changes to the Hospital Outpatient Prospective Payment System and the Ambulatory Surgical Center Prospective Payment System. The rule, titled, “Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity to Apply for Available Slots,” is published at 84 F.R. 61142-01 (Nov. 12, 2019). A Fact Sheet is [FN206] available. IX. Selected State Activity In Arkansas: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -23- • House Bill 1074 (2019 AR H.B. 1074 (NS)) will mandate newborn screening of spinal muscular atrophy and require certain health benefit plans, including Medicaid, to cover the screening. Governor Asa Hutchinson (R) signed the bill on February 4, 2019. In California: • Assembly Bill 1128 (2019 CA A.B. 1128 (NS)), which was adopted on October 12, 2019, relates to licensing for PACE organizations. [FN207] PACE organizations operate clinics, adult day health centers, and, sometimes, home health agencies. Their licensing and approvals have been provided through both the Department of Public Health and the Department of Health Care Services. According to the bill, the lengthy dual process hinders the speed at which new PACE organizations can begin work. Therefore, this bill will shift responsibility for PACE licensing from the Department of Public Health to the Department of Health Care Services in order to increase efficiency and expedite approval of new or expanding PACE programs. • Governor Gavin Newsom (D) signed 2019 CA S.B. 104 (NS) on July 9, 2019. The bill affects health care in important ways. Among other things, the bill extends full Medicaid coverage to immigrants aged 19-25 regardless of their immigration status if they otherwise qualify for Medicaid. • Assembly Bill 774 (2019 CA A.B. 774 (NS)) would have changed certain reporting requirements for hospitals. Specifically, the last version of the bill would have required the Hospital Discharge Abstract Data Record to note, if the admission is to an emergency department, the service date and time and the date and time of release from emergency care. It would have also required the Emergency Care Data Record to include the date and time of service and the date and time of release from emergency care. While the bill passed both houses, the governor vetoed it on October 12, 2019. His veto message read, in part: This new regulatory burden increases healthcare costs and needs to be considered as a part of a more comprehensive plan to address healthcare costs and providing care in the appropriate setting. My administration is committed to working with stakeholders to lower [FN208] healthcare costs and improving patient outcomes. • Assembly Bill 201 (2019 CA A.B. 204 (NS)) amends existing statutory provisions relating to community benefit plans that not-for-profit hospitals must annually complete and file to demonstrate that it provides a community benefit. Among other things, the definition of “community benefit” is amended to clarify that the term does not include “activities or programs that are provided primarily for marketing purposes or are more beneficial to the organization than to the community.” The bill requires disclosure of more financial information and requires hospitals to post their plans to their web sites. The bill was adopted on October 7, 2019. • Also adopted, 2019 CA S.B. 464 (NS) enacts the Dignity in Pregnancy and Childbirth Act. Among other things, the bill requires that, when giving patients' notice about their rights in the hospital, hospitals must also notify the patient of his or her right to be free from discrimination on the basis of “race, color, religion, ancestry, national origin, disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, sexual orientation, citizenship, primary language, or immigration status,” and the patient's right to file a complaint against the hospital. The act also requires hospitals, alternative birth centers, or primary care clinics that provide perinatal care to implement an evidence-based implicit bias program. In Colorado: • Governor Jared Polis (D) signed 2019 CO H.B. 1176 (NS) on May 31, 2019. The bill directs the state to establish a task force to study all aspects of the state's health care financing structure. The task force will be directed to seek and contract with an appropriately qualified analyst to conduct a study, and the analyst will be required to consult with various stakeholders to determine the methodology of the study. At a minimum, the analyst will be required to examine these health care systems: • the current system, in which individuals receive coverage from private or public insurance remain uninsured; • a public option; and • a multi-payer universal health care system • Senate Bill 201 (2019 CO S.B. 201 (NS)) establishes the Colorado Candor Act, which provides a process for providers and health care facilities to have an open discussion with a patient when an adverse health care incident occurs. The discussion would be confidential and privileged and inadmissible in a subsequent court proceeding arising out of the incident. Further, the discussions are not be subject to subpoena or discovery and may not be compelled under any other means. The discussion could include a description of what the provider intends to do to ensure that the adverse incident does not occur again and also include an offer of compensation. Governor Polis signed the bill on May 6, 2019. In Connecticut: • Introduced on January 23, 2019, 2019 CT H.B. 5894 (NS) would have required health facilities that purchased diagnostic medical equipment to ensure that the equipment met certain guidelines for accessibility. The bill did not pass before adjournment. • Senate Bill 371 (2019 CT S.B. 371 (NS)) would have allowed the state to seek a waiver from complying with the Medicare inpatient and outpatient prospective payment systems so that it could have established an all-payer hospital regulation system and rational hospital pricing. The bill was introduced on January 23, 2019; it did not pass this session. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -24- • Introduced on January 23, 2019, 2019 CT H.B. 5917 (NS) would have required hospitals to offer the influenza vaccine to senior citizens before a hospital discharge. The bill did not pass before adjournment. • Senate Bill 204 (2019 CT S.B. 204 (NS)) sought to repeal the hospitals tax. The bill was introduced on January 23, 2019; it did not advance. • Senate Bill 381 (2019 CT S.B. 381 (NS)) sought to improve physician communication with family members or legal representatives about a patient's Alzheimer's diagnosis and treatment. It would have also required hospitals, within three years, to have a plan for identifying and managing patients with dementia. The bill was introduced on January 23, 2019, but it did not pass before adjournment.. • Introduced on January 23, 2019, 2019 CT S.B. 329 (NS) would have required that covered services performed by out-of-network providers at in-network hospitals be covered at an in-network level (including cost-sharing). The bill did not pass this session. • Senate Bill 920 (2019 CT S.B. 920 (NS)) was adopted on July 9, 2019. The bill establishes a school-based health center advisory committee to advise the Public Health Commissioner on matters related to school-based health centers. Specifically, the act requires the committee to advise on these matters: (1) statutory and regulatory changes to improve health care through access to school-based health centers and expanded school health sites, (2) minimum standards for the provision of services in school-based health centers and expanded school health sites to ensure that high quality health care services are provided in school-based health centers and expanded school health sites, as such terms are defined in section 19a–6r, and (3) other topics of relevance to the school-based health centers and expanded school sites, as requested by the commissioner. The act also sets out how the committee should be constituted. Of the two appointments to be made to the committee by the Governor, one is to be a representative of a school-based health center that is sponsored by a hospital. In the District of Columbia: • The Public Welfare Department adopted rules to allow the Director of the Department of Health Care Finance to make quarterly supplemental payments for one fiscal year to physician groups with 500 physicians that contract with a public, general hospital in underserved areas of the District to deliver at least two of the following services to Medicaid participants: (1) inpatient services, (2) emergency department services, and (3) intensive care physician services. The notice is published at 2019 DC REG TEXT 499229 (NS) (Oct. 4, 2019). In Florida: • Filed on January 23, 2019, 2019 FL S.B. 448 (NS) was indefinitely postponed and eventually withdrawn. The bill would have defined “advanced birth center” and would have created licensing provisions for such facilities. An advanced birth center would have been defined as, a birth center that may perform trial of labor after cesarean deliveries for screened patients who qualify, planned low-risk cesarean deliveries, and anticipated vaginal deliveries for laboring patients from the beginning of the 37th week of gestation through the end of the 41st week of gestation. • Senate Bill 434 (2019 FL S.B. 434 (NS)) died in committee. The bill would have amended the definition of “ambulatory surgical center” and would have required rules to ensure that practitioners and facilities were delivering safe and effective surgical care to children in ambulatory surgical centers. The bill would have also added a new provision about the length of stay for children in such centers: Ambulatory surgical centers may provide operative procedures that require a length of stay past midnight on the day of surgery for children younger than 18 years of age only if the agency authorizes the performance of such procedures by rule. • Governor Ron DeSantis (R) signed 2019 FL H.B. 843 (NS) on June 25, 2019. The bill establishes a Dental Student Loan Repayment Program, and it also contains provisions relating to patient safety. The bill will require hospitals to provide written information to patients on the hospital's rate of hospital-acquired infections, the hospital's overall rating on the Hospital Consumer Assessment of Healthcare Providers and Systems survey, and the hospital's rate of 15-day readmissions. In addition to patients, the hospital will be required to provide this information to any person requesting it in writing. Other provisions of the bill require hospitals to notify a patient's primary care physician of the patient's admission within 24 hours, notify a patient that he or she may request the hospital's treating physician to consult with the patient's primary care or specialist provider when developing the patient's plan of care, and notify the patient's primary care physician within 24 hours of the patient's discharge. In Hawaii: • Introduced on January 24, 2019, 2019 HI S.B. 1228 (NS) would have continued funding for the Hospital Sustainability Program through 2021. The bill did not pass before adjournment. In Illinois: • Governor J.B. Pritzker (D) signed 2019 IL H.B. 3 (NS) on August 23, 2019. The bill will add to the list of information that hospitals must report for the Hospital Report Card Act. The following information will be added the list: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -25- (5) Each instance of preterm birth and infant mortality within the reporting period, including the racial and ethnic information of the mothers of those infants. (6) Each instance of maternal mortality within the reporting period, including the racial and ethnic information of those mothers. In Indiana: • Had it passed this session, 2019 IN S.B. 343 (NS) would have changed the way advance practice registered nurses are allowed to practice. Senate Bill 343, which was introduced on January 8, 2019, would have allowed such individuals with prescriptive authority to practice without a practice agreement with a licensed practitioner if: (1) The advanced practice registered nurse has practiced under a practice agreement with a practitioner for the full time equivalent of one (1) year. (2) The practitioner described in subdivision (1) has been licensed in Indiana for a minimum of five (5) years with the practitioner's respective governing board. (3) The practitioner has reviewed at least five percent (5%) of the advanced practice registered nurse's prescriptive charts during the previous one (1) year practice agreement period. (4) The advanced practice registered nurse has submitted an attestation to the board to the completion of the required one (1) year practice agreement. • Indiana House Bill 1671 (2019 IN H.B. 1671 (NS)) would have added conditions for tax exemption for hospital property not used for inpatient services. Such property would have only been exempt from taxation if it was in the same county as the hospital's inpatient facility and the hospital satisfied the charitable purpose requirements. House Bill 1671 was introduced on January 24, 2019. It did not pass before adjournment. In Iowa: • The Department of Aging is proposing a new rule relating to ombudsmen services in the Medicaid program. Specifically, the proposed rule adds new provisions specifying that the Office of the Long-Term Care Ombudsman may provide advocacy and assistance to qualified participants of Medicaid long-term services and supports who are receiving services in a long-term care facility or under a home- and community-based services waiver, and it sets up a process for doing so. Please see 2019 IA REG TEXT 528986 (NS) (July 17, 2019). In Kansas: • Had it passed, House Bill 2102 (2019 KS H.B. 2102 (NS)) would have established KanCare Bridge to a Healthy Kansas, a Medicaid expansion program. While the bill did not contain work requirements, unemployed individuals or those working less than 20 hours per week would have been referred to existing job training programs and resources. The Kansas Hospital Association had been advocating [FN209] for expansion and approved of this plan, and the plan was expected to help boost rural hospitals. Senate Bill 54 (2019 KS S.B. 54 (NS)) was a related bill in the Senate that likewise did not pass this session. In Kentucky: • Governor Matt Bevin (R) signed 2019 KY H.B. 320 (NS) on March 26, 2019, which seeks to improve Medicaid inpatient payments to hospitals in both the managed care and fee-for-service programs. The bill provides for hospital assessments to be used as matching funds for federal dollars and supplemental payments to hospitals. In Louisiana: • The Department of Health, Bureau of Health Services Financing has published an emergency rule in order to continue a July 2018 emergency rule addressing nursing home reimbursement in a specific situation. The agency explains in the rule's summary, As a result of a budgetary shortfall in state fiscal year 2018-2019, the department promulgated an Emergency Rule which amended the provisions governing the reimbursement methodology for nursing facilities in order to adopt provisions governing the transition of a private nursing facility to a state-owned or operated nursing facility through a change of ownership (Louisiana Register, Volume 44, Number 7). This Emergency Rule is being promulgated in order to continue the provisions of the July 5, 2018 Emergency Rule. This action is being taken to avoid a budget deficit in the Medical Assistance Program. The emergency rule is published at 2018 LA REG TEXT 498641 (NS) (Oct. 20, 2018). A permanent rule was filed on February 20, 2019. • House Bill 108 (2019 LA H.B. 108 (NS)) passed the House on May 20, 2019, but it did not pass the Senate before adjournment. The bill would have added a significant number of new statutory provisions to the existing provisions on the Safe Haven law, which allows new parents to safely relinquish newborns at designated emergency care facilities. The new language would have allowed babies to be relinquished in a newborn safety device at designated emergency facilities, and it set out the requirements for such a device. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -26- • The Department of Public Health is proposing to give a one-time supplemental payment for Medicaid-certified intermediate care facilities for persons with intellectual disabilities. The proposed rule, which is published at 2019 LA REG TEXT 537231 (NS) (Oct. 20, 2019), sets out the methodology for calculating the payments. In Maryland: • If passed, 2019 MD S.B. 976 (NS) would have directed the Secretary of Health to convene a workgroup to develop implementation plans to improve efficiency, accountability, and outcomes of behavioral health services as a part of the state's ongoing plan to provide a combined specialty behavioral health delivery system for behavioral health and substance use disorder services. In addition to setting out the composition of the workgroup, the bill set out its goals: (c) The workgroup shall develop implementation plans for uniform and system-wide adoption of measurement-based care standards for mental health and substance use disorder services delivered: (1) to recipients in the specialty community behavioral health system; (2) by Medicaid managed care organizations to their members in primary care settings; and (3) in State-run psychiatric facilities and any publicly funded behavioral health service settings not included in items (1) and (2) of this subsection. Senate Bill 976 did not advance and was withdrawn. In Michigan: • House Bill 5064 (2019 MI H.B. 5064 (NS)) and Senate Bill 554 (2019 MI S.B. 554 (NS)) aim to increase payments for Medicaid services provided by critical access hospitals. The bill provides: DEPARTMENT OF HEALTH AND HUMAN SERVICES Sec. 301. The department shall provide an additional $5,099,100.00 in general fund/general purpose revenue and any associated federal match and restricted dollars to further increase outpatient Medicaid rates for services performed at critical access hospitals. • Introduced on October 8, 2019, 2019 MI H.B. 5063 (NS) and 2019 MI S.B. 550 (NS) would appropriate money and direct that the Department of Health and Human Services to award a certain amount of funds toward rural hospital payments: Sec. 301. From the funds appropriated in part 1 for hospital services and therapy, $13,904,800.00 in general fund/general purpose revenue and any associated federal match shall be awarded as rural access payments to noncritical access hospitals that meet criteria established by the department for services to low-income rural residents. One of the reimbursement components of the distribution formula shall be assistance with labor and delivery services. In Minnesota: • Introduced on February 27, 2019, 2019 MN S.F. 1778 (NS) would have added a provision to existing statutory language relating to Medicaid disproportionate share hospital payments. The new provision would have provided for a payment adjustment for hospitals that administer a high level of high-cost drugs to participants in the Medicaid fee-for-service program. The bill did not advance, and the legislature has now adjourned. • House Bill 2916 (2019 MN H.F. 2916 (NS)) did not pass before adjournment. The bill, which was introduced on May 19, 2019, sought to require hospitals to establish a protocol for informing patients of air ambulance charges. Specifically, the bill provided that, before transporting a hospital patient with a non-emergency condition by air ambulance, the hospital would have needed to provide written notice to the patient that he or she: (1) may have a choice of being transported by air ambulance or by medically appropriate ground transportation; (2) may be responsible for some or all of the charges for transportation via air ambulance; and (3) may request from the hospital the current rate schedule for the air ambulance service. In Missouri: • House Bill 622 (2019 MO H.B. 622 (NS)) would have deleted the provisions of MO ST §§ 197.300 to 197.366, the Certificate of Needs Law, and would have amended four other statutory provisions. The bill was introduced on January 22, 2019, but it did not pass before the legislature adjourned. In New Jersey: • Senate Bill 3378 (2018 NJ S.B. 3378 (NS)) was approved on May 8, 2019. The bill will prohibit Medicaid reimbursement for non- medically indicated early elective deliveries. The bill notes the dangers to the woman and infant when such deliveries are made. The bill notes, for example, that, b. During the last few weeks of pregnancy, critical fetal development is still occurring; © 2020 Thomson Reuters. No claim to original U.S. Government Works. -27- c. As such, studies have shown that non-medically indicated early elective deliveries provide for higher incidences of neonatal intensive care unit admissions, pneumonia, and longer hospital stays for infants than when the pregnancy is allowed to progress naturally to full term; d. Additionally, an unsuccessful induction will result in a cesarean section, which can lead to infections, bleeding, and anesthesia complications for mothers[.] Therefore, the bill provides, No provider shall be approved for reimbursement by the Division of Medical Assistance and Health Services in the Department of Human Services under Medicaid for a non-medically indicated early elective delivery performed at a hospital on a pregnant woman earlier than the 39[th] week of gestation on or after the ten month period following the effective date of this section. During the ten month period following the effective date of this section, the Division of Medical Assistance and Health Services in the Department of Human Services shall provide accessible educational materials to inform pregnant women, their support networks, and Medicaid providers about the risks of non-medically indicated early elective delivery[.] • Senate Bill 984 (2018 NJ S.B. 984 (NS)) was adopted on August 9, 2019. The bill amends existing statutory provisions relating to medical records requests. For example, the new language changes “medical records” to “medical and billing records,” and it adds provisions relating to records that are stored on microfilm, microfiche, CD, or DVD. It also changes certain provisions relating to allowable fees for requested records. In New York: • If passed, 2019 NY S.B. 2664 (NS) would provide for a special Medicaid reimbursement rate for facilities that provide services to newly-released prisoners. The bill was introduced on January 28, 2019. In North Carolina: • House Bill 884 (2019 NC H.B. 884 (NS)) would ensure Medicaid reimbursement for telemedicine, telepsychiatry, and clinical pharmacist practitioner services rendered at a federally qualified health center. House Bill 884 was introduced on April 22, 2019. • House Bill 655 (2019 NC H.B. 655 (NS)) is concerned with uninsured workers with incomes too high to qualify for Medicaid as it currently exists and too low to afford private insurance. The bill would establish the NC Health Care for Working Families program. The findings supplied with the bill cite the health costs of uninsured people: citizens ultimately pay for health care costs when uninsured people seek emergency care and it results in uncompensated care costs for hospitals. Further, uninsured individuals cannot afford preventive care and thus defer services until they are very sick and the medical costs are high. The program would be a Medicaid expansion for adults earning up to 133% of the federal poverty level, and work requirements would apply. The findings also note that the program would be paid for with a combination of participant premiums, intergovernmental transfers, current hospital assessments, gross premiums tax revenue, newly enacted hospital assessments, and federal funds, and thus would not increase taxes for other citizens. The bill was introduced on April 10, 2019, and amended on July 9. In Oklahoma: • House Bill 1013 (2019 OK H.B. 1013 (NS)), which was prefiled on January 8, 2019, would direct that funds from the Nursing Facility Quality of Care Fund be used to support additional Department of Social Services ombudsmen, and it would add a new provision setting out an additional use of those funds: actual costs incurred by the Department of Human Services' Office of the State Long-Term Care Ombudsman to implement and maintain the Oklahoma Person-centered Options Counseling for Long-term Care Program created in Section 3002.7 of this title. In Oregon: • Senate Bill 1041 (2019 OR S.B. 1041 (NS)) was adopted on June 20, 2019. It is a lengthy bill that tightens oversight of the state's [FN210] coordinated care organizations. • Citing the need for transparency and accountability in health care costs and the need to contain costs, 2019 OR S.B. 889 (NS) will establish a health care cost growth benchmark for all providers and payers. The purpose of establishing such a benchmark is to, (a) [s]upport accountability for the total cost of health care across all providers and payers, both public and private; (b) [b]uild on the state's existing efforts around health care payment reform and containment of health care costs; and (c) [e]nsure the long-term affordability and financial sustainability of the health care system in this state. The bill establishes the Health Care Cost Growth Benchmark program to develop a benchmark that would promote a predictable and sustainable growth rate, use established economic indicators, be measurable on a per capita basis, and be applicable to all providers and payers in the state. Governor Kate Brown (D) signed the bill on July 15, 2019. In Pennsylvania: • Introduced on June 24, 2019, 2019 PA H.R. 422 (NS) would urge Congress to increase Pennsylvania's FMAP (federal medical assistance percentage) for long-term care nursing services. According to the resolution, the need for these services continues to © 2020 Thomson Reuters. No claim to original U.S. Government Works. -28- increase, and reimbursements are not keeping up with the increased cost of providing them. Some long-term care facilities in the state have indicated that they may not be able to continue to offer their current services with the reimbursement rate that currently exists, according to the resolution. • Senate Bill 906 (2019 PA S.B. 906 (NS)) relates to care for those receiving mental health and intellectual disability services. The bill would put a moratorium on the closure of state facilities until all eligible individuals are authorized to begin receiving services under a home- and community-based services waiver. Once that happens, a Task Force on the Closure of State Centers will be convened to comprehensively evaluate the State facilities and provide recommendations to the Department of Human Services prior to closure of any such facilities. The bill sets out how the task force is to be comprised and what the task force is to consider. In Rhode Island: • Governor Gina Raimondo (D) signed 2019 RI S.B. 139 (NS) on June 28, 2019. The bill will amend existing statutory law regarding discharge planning. Existing law requires hospitals and freestanding, emergency-care facilities to submit a comprehensive discharge plan, and the law sets out what is to be addressed in the plan. The bill would amend language about notifying emergency contacts and certified peer recovery specialists. • House Bill 5906 (2019 RI H.B. 5906 (NS)) would have required health facilities to adopt and implement evidence-based protocols for achieving early recognition of sepsis, severe sepsis, or septic shock and appropriately treating patients for these conditions. The protocols would have needed to be updated when necessary. The bill was introduced on March 27, 2019; it was subsequently withdrawn. • Also in Rhode Island, 2019 RI H.B. 5573 (NS) was adopted on July 8, 2019. The bill revises statutory provisions in a section titled, “Abuse in Health Care Facilities.” Among other things, the bill adds physician assistants and probation officers to the list of people who must report incidents, and it adds additional information that must be reported. In Texas: • Senate Bill 1085 (2019 TX S.B. 1085 (NS)) would have amended statutory provisions on hospital licensing. Among the amendments would have been one increasing penalties. New statutory provisions would have been added relating to hospital inspections, emergency license suspensions, and trustees. The bill was introduced on February 25, 2019, but it failed to advance this session. • Senate Bill 170 (2019 TX S.B. 170 (NS)) will direct the Health and Human Services Commission to establish a prospective payment methodology to reimburse rural hospitals that provide inpatient or outpatient services in Medicaid. The bill explains, (b) To the extent allowed by federal law and subject to limitations on appropriations, the executive commissioner by rule shall adopt a prospective reimbursement methodology for the payment of rural hospitals participating in Medicaid that ensures the rural hospitals are reimbursed on an individual basis for providing inpatient and general outpatient services to Medicaid recipients by using the hospitals' most recent cost information concerning the costs incurred for providing the services. The commission shall calculate the prospective cost-based reimbursement rates once every two years. Governor Greg Abbott (R) signed Senate Bill 170 on June 4, 2019. • Governor Greg Abbott (R) approved 2019 TX S.B. 2448 (NS) on June 4, 2019. The bill will authorize the Lubbock County Hospital District to establish a health care provider participation program. The bill explains the purpose of such a program: The purpose of this chapter is to authorize the district to administer a health care provider participation program to provide additional compensation to nonpublic hospitals by collecting mandatory payments from each nonpublic hospital in the district to be used to provide the nonfederal share of a Medicaid supplemental payment program and for other purposes as authorized under this chapter. In Utah: • A resolution (2019 UT S.C.R. 1 (NS)) urges Congress to extend Medicaid coverage beyond 15 days for mental health services provided to adults with serious mental illness in an Institute for Mental Disease. The resolution was introduced on January 28, 2019, and it was adopted on March 25. • Governor Gary Herbert (R) signed 2019 UT S.B. 106 (NS) on March 22, 2019. The bill will extend Medicaid coverage to certain mental health services performed in schools. Senate Bill 106 was introduced on January 28, 2019. • The Department of Health proposes to amend a rule relating to the criteria used for utilization review of Medicaid hospital services. A portion of the existing rule provides that determinations of medical necessity and appropriateness of inpatient admissions must be made using criteria set out by a specific organization. That provision would be changed to delete the name of the organization and substitute “evidence-based criteria” in its place. The proposed rule is published at 2019 UT REG TEXT 528503 (NS) (July 15, 2019). • In a notice published at 2019 UT REG TEXT 528504 (NS) (Oct. 15, 2019), the Department of Health gave notice that it amended certain policies for Medicaid Inpatient Hospital Services. Many of the changes relate to inpatient hospital intensive physical rehabilitation, which the rule defines as “an intense program of physical rehabilitation provided in an inpatient rehabilitation hospital or an inpatient rehabilitation unit of a hospital.” New language was also added for reporting routine hospital services. The rule provides that routine services must be included in the daily service charge, and it sets out a list of services that are not reported separately. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -29- • The Department of Health gave notice of an adopted rule affecting reporting for purposes of the nursing facility assessment. The purpose of the rule is to give the department the occupancy information it needs to evaluate assessments. The rule is published at 2019 UT REG TEXT 523843 (NS). In Vermont: • Introduced on January 29, 2019, 2019 VT H.B. 108 (NS) addressed Medicaid disproportionate share hospital payments. It would have prohibited a formula that would have provided for an additional allotment based on a hospital's status as an academic medical center. The bill did not pass this session. In Virginia: • Introduced on January 9, 2019, 2018 VA H.B. 1870 (NS) will create a 30-day exemption of the certificate of need requirement for projects involving a temporary increase in the total number of beds in an existing hospital or nursing home when a natural or man-made disaster has caused the evacuation of a hospital or nursing home and a public health emergency exists due to a shortage of hospital or nursing home beds. Governor Ralph Northam (D) signed the bill on February 22, 2019. • A resolution (2018 VA H.J.R. 681 (NS)) would have required the Joint Legislative Audit and Review Commission to conduct a study to evaluate how recent changes in health care financing and delivery, including the Medicaid expansion and new facility assessments, would affect the demand for charity care and the ability of providers to meet the charity care requirements that may be imposed for certificates of public need. The resolution was introduced on January 9, 2019. It died in committee. • Governor Northam signed 2018 VA H.B. 2538 (NS) on March 18, 2019. Among other things, the bill will add requirements for elective services providers. The bill will require a provider to: inform the covered person or his legal representative (i) of the names of all provider groups providing health care services at the facility, (ii) that consultation with the covered person's managed care plan is recommended to determine if the provider groups providing health care services at the facility are in-network providers, and (iii) that the covered person may be financially responsible for health care services performed by a provider that is not an in-network provider, in addition to any cost-sharing requirements. In Washington: • Senate Bill 5648 (2019 WA S.B. 5648 (NS)) would have added physician assistants and advanced registered nurse practitioners to the current statutory provisions setting out requirements for granting hospital privileges for physicians. The bill was introduced on January 25, 2019; it did not pass before adjournment. • The Washington Health Care Authority gave notice of final rules that, among other things, specify that Medicaid pays for pharmacy services and pharmaceuticals when a psychiatric patient is being kept at a hospital for an administrative stay. The notice is published at 2019 WA REG TEXT 521575 (NS) (Sept. 18, 2019). In Wisconsin: • Planned Parenthood of Wisconsin has filed a lawsuit against the state of Wisconsin in federal district court over abortion restrictions in state law. The organization contends that the state improperly bars qualified nurses from performing abortions (thus requiring abortions to be performed by physicians), improperly requires that women who receive an abortion-inducing drug be administered the drug by the same physician on both visits, and improperly requires the physician who administered the drug to be physically present when the [FN211] patient takes the drug. According to the Wisconsin State Journal, Planned Parenthood alleges in the lawsuit that since abortion providers in the state are so limited in number, the three provisions, individually or separately, significantly restrict abortion in the state. This consequence is borne largely by poorer women. The lawsuit seeks a declaration that the restrictions are improper and a bar to [FN212] enforcement of the provisions. A representative for Wisconsin Right to Life argues that the restrictions are needed to ensure the safety of women undergoing abortion, but critics argue that the restrictions do not enhance the safety of the procedure; instead, they [FN213] make it more difficult for women to access legal abortions. In West Virginia: • If passed, 2019 WV H.B. 2531 (NS) would have added to the list of professionals eligible to provide counseling in a medication- assisted drug treatment program. The latest version of the bill would have added a “psych-mental health nurse practitioner or a psych- mental health clinical nurse specialist” and a “psychiatry CAQ-certified physician assistant” to the list. The bill was introduced on January 18, 2019, and later amended. Governor Jim Justice vetoed the bill on March 27. • Introduced on January 25, 2019, 2019 WV S.B. 434 (NS) did not pass before adjournment. The bill would have made numerous amendments to existing statutes addressing nursing home licensure. Several amendments were proposed for statutory definitions, mostly as they related to the titles of personnel. More substantive changes would have been made to provisions on license denial, suspension, limitation, or revocation. Additional language set out when these actions would have been appropriate; what nursing homes would have been required to do upon receiving notice of negative action on its license; and the process that would have to have been followed after such action, including notice and hearing. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -30- • Introduced on May 20, 2019, 2019 WV H.B. 133 (NS) was adopted on May 28. The bill amends existing statutory provisions relating to admissibility of evidence in medical professional liability lawsuits. The bill provides that, in an action alleging liability based on inadequate staffing or supervision, a health facility or provider is entitled to a rebuttable presumption that it provided adequate staffing or supervision if it met the minimum legal requirements. On the other side of the coin, if a facility or provider did not meet minimum legal requirements for staffing or supervision, the plaintiff is entitled to a rebuttable presumption that staffing or supervision was, in fact, inadequate and that these failings contributed to a patient's injuries. • Introduced on June 24, 2019, 2019 WV S.B. 1045 (NS) aimed to increase services for substance use disorder. The bill would have amended existing statutory provisions that were enacted to increase beds for inpatient services for substance use disorder; the bill would have included both inpatient and outpatient services in this provision, and it would have specified that these facilities would have needed to be licensed to provide substance use disorder services. The bill would have also allocated funds to facilities for recovery services. The facilities described in the statute would have been required to accept Medicaid as payment. The bill did not pass this session. In Wyoming: • 2019 WY S.F. 67 (NS) will require a hospital cost study. Among other things, the study will seek to identify the reasons for the high cost of hospital care in the state. The bill lists several issues the study should consider in trying to answer this question. A few of those issues include, for example: • the extent to which low population in the state affects how the health system shifts costs. • the extent to which the high cost of professional labor affects overall costs, including a consideration of whether professional costs are high because the state has difficulty recruiting health care personnel; • whether profit levels are too high; • whether hospitals are managed inefficiently; • whether uncompensated care costs affect the high cost of hospital care; and • whether statutes and regulations affect high costs. The bill was introduced on January 10, 2019, and later amended. Governor Mark Gordon (R) signed the bill on February 28, 2019. X. Conclusion CMS continues to move toward a health system that pays for the quality of care rather than the quantity of care, and the agency continues to launch new models and initiatives to make this a reality. CMS also continues to refine Obama-era programs such as the EHR Incentive Programs and the ACO programs. Hospitals are deeply affected by Medicaid because well-insured patients lead to lower uncompensated care costs and underpayments for hospitals. If the Affordable Care Act is repealed or blocked by a court, the Medicaid program would likely undergo major changes, including the possible elimination of the Medicaid expansion and a whole different Medicaid financing structure. HPTS will continue to monitor developments on the current court case seeking to have the Affordable Care Act unconstitutional. © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN1] . “Hospitals are Economic Anchors in their Communities,” American Hospital Association, https://www.aha.org/statistics/2018-03-29- hospitals-are-economic-anchors-their-communities. [FN2] . Kate Samuelson, “The Role of Hospitals in Community and Economic Development,” Penn LPS, May 4, 2017, available at: https:// www.fels.upenn.edu/recap/posts/1071. [FN3] . “AHA: Medicare, Medicaid underpaid hospitals by $76.8 billion in 2017,” American Hospital Association, Jan. 3, 2019, available at: https://www.aha.org/news/headline/2019-01-03-aha-medicare-medicaid-underpaid-hospitals-768-billion-2017. [FN4] . “Uncompensated Hospital Care Cost Fact Sheet, AHA, Dec. 2017, available at: https://www.aha.org/system/files/2018-01/2017- uncompensated-care-factsheet.pdf. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -31- [FN5] . “Underpayment by Medicare and Medicaid Fact Sheet,” AHA, Dec. 2017, available at: https://www.aha.org/system/files/2018-01/ medicaremedicaidunderpmt2#017.pdf. [FN6] . The Supreme Court's decision is published on Westlaw. Please see National Federation of Independent Business v. Sebelius, 2012 WL 2427810 (June 28, 2012). [FN7] . Decision of Judge Reed O'Connor of the District Court for the Northern District of Texas, Case No. 4:18-cv-00167-O, Dec. 14, 2018, available at: https://oag.ca.gov/system/files/attachments/press-docs/211-texas-order-granting-plaintiffs-partial-summary-judgment.pdf. [FN8] . Timothy S. Jost, “The Fifth Circuit Court Hears Arguments on the Future of the ACA,” To the Point, the Commonwealth Fund, July 11, 2019, available at: https://www.commonwealthfund.org/blog/2019/fifth-circuit-court-ruling-future-aca. [FN9] . For a fuller discussion of the potential ramifications of this case and expert opinions of the outcomes, see Amy Goldstein, “5th Circuit Decision on ACA Could Create Political Havoc for GOP,” Washington Post, July 7, 2019, available at: https:// www.washingtonpost.com/health/5th-circuit-decision-on-aca-could-create-political-havoc-for-gop/2019/07/07/9c1dd558-939e-11e9- b58a-a6a9afaa0e3e_story.html?utm_term=.44ec417bca4b. [FN10] . MaryBeth Musumeci, “Section 1115 Medicaid Demonstration Waivers: The Current Landscape of Approved and Pending Waivers,” Kaiser Family Foundation, Sept. 20, 2018, available at: https://www.kff.org/medicaid/issue-brief/section-1115-medicaid-demonstration- waivers-the-current-landscape-of-approved-and-pending-waivers/?utm_campaign=KFF-2018-The-Latest&utm_source=. [FN11] . Press Release, “CMS Announces New Policy Guidance for States to Test Community Engagement for Able-Bodied Adults,” CMS, Jan. 11, 2018, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases- items/2018-01-11.html; State Medicaid Director Letter, SMD #18-002, Jan. 11, 2018, available at: https://www.medicaid.gov/federal- policy-guidance/downloads/smd18002.pdf. [FN12] . State Medicaid Director Letter, SMD #18-002, Jan. 11, 2018, available at: https://www.medicaid.gov/federal-policy-guidance/ downloads/smd18002.pdf. [FN13] . State Medicaid Director Letter, SMD #18-002, Jan. 11, 2018, available at: https://www.medicaid.gov/federal-policy-guidance/ downloads/smd18002.pdf. [FN14] . State Medicaid Director Letter, SMD #18-002, Jan. 11, 2018, available at: https://www.medicaid.gov/federal-policy-guidance/ downloads/smd18002.pdf. [FN15] . “Medicaid Waiver Tracker: Approved and Pending Section 1115 Waivers by State,” Kaiser Family Foundation, updated Nov. 11, 2019, available at: https://www.kff.org/medicaid/issue-brief/medicaid-waiver-tracker-approved-and-pending-section-1115-waivers-by-state/. [FN16] . Jennifer Wagner and Jessica Schubel, “States' Experiences Confirming Harmful Effects of Medicaid Work Requirements,” Center on Budget and Policy Priorities, updated Oct. 22, 2019, available at: https://www.cbpp.org/health/states-experiences-confirming-harmful- effects-of-medicaid-work-requirements?utm. [FN17] . Leighton Ku and Erin Brantley, “New Hampshire's Medicaid Work Requirements Could Cause More Than 15,000 to Lose Coverage,” Commonwealth Fund, May 9, 2019, available at: https://www.commonwealthfund.org/blog/2019/new-hampshires-medicaid-work- requirements-could-cause-coverage-loss. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -32- [FN18] . Todd Bookman, “With 17,000 Facing Penalty, N.H. Delays Medicaid Work Requirement,” New Hampshire Public Radio, July 8, 2019, available at: https://www.nhpr.org/post/17000-facing-penalty-nh-delays-medicaid-work-requirement#stream/0. [FN19] . Phil Galewitz, “Federal Judge Again Blocks States' Work Requirements For Medicaid,” NPR and Kaiser Health News, March 27, 2019, available at: https://www.npr.org/sections/health-shots/2019/03/27/707401647/federal-judge-again-blocks-states-work-requirements-for- medicaid. [FN20] . Nate Raymond, “U.S. Judge blocks Medicaid Work Requirements in New Hampshire,” Reuters, July 29, 2019, available at: https:// www.reuters.com/article/us-usa-healthcare-medicaid-new-hampshire/us-judge-blocks-medicaid-work-requirements-in-new-hampshire- idUSKCN1UO21R. [FN21] . Jessica Schubel, “Arizona the Latest State to Reconsider Medicaid Work Requirements,” CBPP, Oct. 22, 2019, available at: https:// www.cbpp.org/blog/arizona-the-latest-state-to-reconsider-medicaid-work-requirements?utm. [FN22] . “Freestanding Emergency Departments[:] Treating Common Conditions at Emergency Prices,” United Health Group, available at: https://www.unitedhealthgroup.com/content/dam/UHG/PDF/2017/Freestanding-ER-Cost-Analysis.pdf. See, also, Jacqueline LaPointe, “Freestanding Emergency Departments Cost 22 Times More Than Doctor,” Revcycle Intelligence, Mar. 13, 2019, available at: https:// revcycleintelligence.com/news/freestanding-emergency-departments-cost-22-times-more-than-doctor. [FN23] . “Freestanding Emergency Departments[:] Treating Common Conditions at Emergency Prices,” United Health Group, available at: https://www.unitedhealthgroup.com/content/dam/UHG/PDF/2017/Freestanding-ER-Cost-Analysis.pdf. [FN24] . Virgil Dickson, “MedPAC Votes to Cut Payments for Free-Standing ERs,” Modern Healthcare, Apr. 5, 2018, available at: http:// www.modernhealthcare.com/article/20180405/NEWS/180409947. [FN25] . Virgil Dickson, “MedPAC Votes to Cut Payments for Free-Standing ERs,” Modern Healthcare, Apr. 5, 2018, available at: http:// www.modernhealthcare.com/article/20180405/NEWS/180409947; Michelle Andrews, “Congress Urged To Cut Medicare Payments To Many Stand-Alone ERs,” Kaiser Health News, Apr. 17, 2018, available at: https://khn.org/news/congressional-advisers-urge-medicare- payments-to-many-stand-alone-ers-be-cut/?utm. [FN26] . Michelle Andrews, “Congress Urged To Cut Medicare Payments To Many Stand-Alone ERs,” Kaiser Health News, Apr. 17, 2018, available at: https://khn.org/news/congressional-advisers- urge-medicare-payments-to-many-stand-alone-ers-be-cut/?utm_campaign=KFF-2018-The- Latest&utm_source=hs_email&utm_medium=email&utm_content=62208705&_hsenc=p2ANqtz-8mV_yoTzN7sbrsiMBkkVG2bLHRKef7EC2lYuo- yDQkZHeUgGBYFMpAKLU0gI5AZmLpCG2oWxK1dozL_tojEXqw&_hsmi=62208705. [FN27] . Michelle Andrews, “Congress Urged To Cut Medicare Payments To Many Stand-Alone ERs,” Kaiser Health News, Apr. 17, 2018, available at: https://khn.org/news/congressional-advisers- urge-medicare-payments-to-many-stand-alone-ers-be-cut/?utm_campaign=KFF-2018-The- Latest&utm_source=hs_email&utm_medium=email&utm_content=62208705&_hsenc=p2ANqtz-8mV_yoTzN7sbrsiMBkkVG2bLHRKef7EC2lYuo- yDQkZHeUgGBYFMpAKLU0gI5AZmLpCG2oWxK1dozL_tojEXqw&_hsmi=62208705. [FN28] . Virgil Dickson, “MedPAC Votes to Cut Payments for Free-Standing ERs,” Modern Healthcare, Apr. 5, 2018, available at: http:// www.modernhealthcare.com/article/20180405/NEWS/180409947. [FN29] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -33- . Virgil Dickson, “MedPAC Votes to Cut Payments for Free-Standing ERs,” Modern Healthcare, Apr. 5, 2018, available at: http:// www.modernhealthcare.com/article/20180405/NEWS/180409947. [FN30] . Michelle Andrews, “Congress Urged To Cut Medicare Payments To Many Stand-Alone ERs,” Kaiser Health News, Apr. 17, 2018, available at: https://khn.org/news/congressional-advisers- urge-medicare-payments-to-many-stand-alone-ers-be-cut/?utm_campaign=KFF-2018-The- Latest&utm_source=hs_email&utm_medium=email&utm_content=62208705&_hsenc=p2ANqtz-8mV_yoTzN7sbrsiMBkkVG2bLHRKef7EC2lYuo- yDQkZHeUgGBYFMpAKLU0gI5AZmLpCG2oWxK1dozL_tojEXqw&_hsmi=62208705. [FN31] . Virgil Dickson, “MedPAC Votes to Cut Payments for Free-Standing ERs,” Modern Healthcare, Apr. 5, 2018, available at: http:// www.modernhealthcare.com/article/20180405/NEWS/180409947 [FN32] . Virgil Dickson, “MedPAC Votes to Cut Payments for Free-Standing ERs,” Modern Healthcare, Apr. 5, 2018, available at: http://www.modernhealthcare.com/article/20180405/NEWS/180409947; Michelle Andrews, “Congress Urged To Cut Medicare Payments To Many Stand-Alone ERs,” Kaiser Health News, Apr. 17, 2018, available at: https://khn.org/news/ congressional-advisers-urge-medicare-payments-to-many-stand-alone-ers-be-cut/?utm_campaign=KFF-2018-The- Latest&utm_source=hs_email&utm_medium=email&utm_content=62208705&_hsenc=p2ANqtz-8mV_yoTzN7sbrsiMBkkVG2bLHRKef7EC2lYuo- yDQkZHeUgGBYFMpAKLU0gI5AZmLpCG2oWxK1dozL_tojEXqw&_hsmi=62208705. [FN33] . See, e.g., Michelle Andrews, “Congress Urged To Cut Medicare Payments To Many Stand- Alone ERs,” Kaiser Health News, Apr. 17, 2018, available at: https://khn.org/news/congressional- advisers-urge-medicare-payments-to-many-stand-alone-ers-be-cut/?utm_campaign=KFF-2018-The- Latest&utm_source=hs_email&utm_medium=email&utm_content=62208705&_hsenc=p2ANqtz-8mV_yoTzN7sbrsiMBkkVG2bLHRKef7EC2lYuo- yDQkZHeUgGBYFMpAKLU0gI5AZmLpCG2oWxK1dozL_tojEXqw&_hsmi=62208705. [FN34] . Harris Meyer, “Boom in Free-Standing Emergency Centers Raises Questions about Regulation,” Modern Healthcare, Oct. 4, 2016, available at: http://www.modernhealthcare.com/article/20161004/NEWS/161009975. See also, Kenneth Yood and Rachel Landauer, “The Opportunities and Challenges of Freestanding Emergency Departments,” ShepardMullin Healthcare Blog, May 24, 2018, available at: https://www.sheppardhealthlaw.com/2017/05/articles/healthcare/fsed/. [FN35] . 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. [FN36] . Sara Rosenbaum, et al., “Community Health Centers: Growing Importance in a Changing Health Care System,” Kaiser Family Foundation, March 9, 2018, available at: https://www.kff.org/medicaid/issue-brief/community-health-centers-growing-importance-in-a- changing-health-care-system/. [FN37] . 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. [FN38] . “Community Health Centers Have Seen an Increase in the Share of Patients with Opioid Addiction,” Kaiser Family Foundation, July 30, 2018, available at: https://www.kff.org/medicaid/press-release/community-health- centers-have-seen-an-increase-in-the-share-of-patients-with-opioid-addiction/?utm_campaign=KFF-2018- The-Latest&utm_source=hs_email&utm_medium=email&utm_content=64962238&_hsenc=p2ANqtz-- tuJDBkEzisOFGtrAp4VRnITwa6wUkKHrGItxEGKT&_hsmi=64962238. [FN39] . Katherine Swartz, “Trying to Survive: Community Responses to Uncertainties about Federal Funding for Medicaid and Public Health Programs,” Commonwealth Fund, Aug. 17, 2018, available at: https://www.commonwealthfund.org/blog/2018/community-responses- federal-funding?omnicid=EALERT1457501&mid=. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -34- [FN40] . News Release, “Trump Administration Announces $1.8 Billion in Funding to States to Continue Combating Opioid Crisis,” HHS, Sept. 4, 2019, available at: https://www.hhs.gov/about/news/2019/09/04/trump-administration-announces-1-8-billion-funding-states- combating-opioid.html. [FN41] . News Release, “HHS Awards More than $50 Million to Establish New Health Center Sites,” HHS, Sept. 11, 2019, available at: https:// www.hhs.gov/about/news/2019/09/11/hhs-awards-more-than-50-million-establish-new-health-center-sites.html. [FN42] . “Community Health Centers Prepare for Funding Uncertainty,” Kaiser Family Foundation, Sept. 4, 2019, available at: https:// www.kff.org/medicaid/issue-brief/community-health-centers-prepare-for-funding-uncertainty/. [FN43] . News Release, “HHS Awards over $85 Million to Help Health Centers Expand Access to Oral Health Care,” HHS, Sept. 18, 2019, available at: https://www.hhs.gov/about/news/2019/09/18/hhs-awards-over-85-million-help-health-centers-expand-access-oral- healthcare.html. [FN44] . News Release, “HHS Awards over $85 Million to Help Health Centers Expand Access to Oral Health Care,” HHS, Sept. 18, 2019, available at: https://www.hhs.gov/about/news/2019/09/18/hhs-awards-over-85-million-help-health-centers-expand-access-oral- healthcare.html. [FN45] . News Release, “HHS Awards over $85 Million to Help Health Centers Expand Access to Oral Health Care,” HHS, Sept. 18, 2019, available at: https://www.hhs.gov/about/news/2019/09/18/hhs-awards-over-85-million-help-health-centers-expand-access-oral- healthcare.html. For a list of awardees and the amounts awarded, please see “FY19 Oral Health Infrastructure Awards,” HRSA, available at: https://bphc.hrsa.gov/program-opportunities/funding-opportunities/oral-health/fy19awards. [FN46] . See, e.g., Sara Rosenbaum, et al., “Community Health Centers: Recent Growth and the Role of the ACA,” Kaiser Family Foundation, Jan. 18, 2017, available at: https://www.kff.org/report-section/community-health-centers-recent-growth-and-the-role-of-the-aca-issue- brief/. [FN47] . Seema Verma, “Ensuring Safety and Quality in Nursing Homes: Five Part Strategy Deep Dive,” CMS Blog, Aug. 28, 2018, available at: https://www.cms.gov/blog/ensuring-safety-and-quality-nursing-homes-five-part-strategy-deep-dive. [FN48] . Press Release, “Trump Administration Strengthens Oversight of Nursing Home Inspections to Keep Patients and Residents Safe,” CMS, Oct. 17, 2019, available at: https://www.cms.gov/newsroom/press-releases/trump-administration-strengthens-oversight-nursing- home-inspections-keep-patients-and-residents-safe. [FN49] . Seema Verma, “Ensuring Safety and Quality in Nursing Homes: Five Part Strategy Deep Dive,” CMS Blog, Aug. 28, 2019, available at: https://www.cms.gov/blog/ensuring-safety-and-quality-nursing-homes-five-part-strategy-deep-dive. [FN50] . Press Release, “Trump Administration Empowers Nursing Home Patients, Residents, Families, and Caregivers by Enhancing Transparency about Abuse and Neglect,” CMS, Oct. 7. 2019, available at: https://www.cms.gov/newsroom/press-releases/trump- administration-empowers-nursing-home-patients-residents-families-and-caregivers-enhancing. [FN51] . P.L. 115-271. [FN52] . CMCS Informational Bulletin, “State Guidance for Implementation of the Treatment for Infants with Neonatal Abstinence Syndrome in Residential Pediatric Recovery Centers Provisions of Section 1007 of Pub. L. 115-271, the Substance Use-Disorder Prevention that © 2020 Thomson Reuters. No claim to original U.S. Government Works. -35- Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act[,]” CMS, July 26, 2019, available at: https:// www.medicaid.gov/federal-policy-guidance/downloads/cib072619-1007.pdf. [FN53] . CMCS Informational Bulletin, “State Guidance for Implementation of the Treatment for Infants with Neonatal Abstinence Syndrome in Residential Pediatric Recovery Centers Provisions of Section 1007 of Pub. L. 115-271, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act[,]” CMS, July 26, 2019, available at: https:// www.medicaid.gov/federal-policy-guidance/downloads/cib072619-1007.pdf. [FN54] . CMCS Informational Bulletin, “State Guidance for the New Limited Exception to the IMD Exclusion for Certain Pregnant and Postpartum Women Included in Section 1012 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (Pub. L. 115-271), Entitled Help for Moms and Babies,” CMS, July 26, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/ cib072619-1012.pdf. [FN55] . “National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination,” HHS, 2013, available at: https:// health.gov/hcq/pdfs/hai-action-plan-cover-toc.pdf. [FN56] . Don Wright, “Improving Quality by Reducing Health Care-Associated Infections,” health.gov, Oct. 18, 2016, available at: https:// health.gov/news/blog/2016/10/improving-quality-by-reducing-health-care-associated-infections/. [FN57] . National Targets and Metrics, health.gov, available at: https://health.gov/hcq/prevent-hai-measures.asp. [FN58] . “Proposed Phase Four of the National Action Plan to Prevent Health Care-Associated Infections,” health.gov, Dec. 19, 2017, available at: https://health.gov/news/announcements/2017/12/proposed-phase-four-national-action-plan-prevent-health-care-associated- infections/?source=govdelivery&utm_medium=email&utm_source=govdelivery; “National Action Plan to Prevent Health Care- Associated Infections: Roadmap to Elimination Phase Four: Coordination among Federal Partners to Leverage HAI Prevention and Antibiotic Stewardship,” (Draft), Nov. 9, 2017, available at: https://health.gov/news/wp-content/uploads/2017/12/508-Compliant-Tab-B- Phase-IV-Draft-with-edits-v3.0.pdf. [FN59] . “National Action Plan to Prevent Health Care-Associated Infections: Roadmap to Elimination Phase Four: Coordination among Federal Partners to Leverage HAI Prevention and Antibiotic Stewardship,” (Draft), Nov. 9, 2017, available at: https://health.gov/news/wp- content/uploads/2017/12/508-Compliant-Tab-B-Phase-IV-Draft-with-edits-v3.0.pdf. [FN60] . “National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination,” health.gov, available at: https:// health.gov/hcq/prevent-hai-action-plan.asp. [FN61] . “Partnership for Patients,” CMS, available at: https://partnershipforpatients.cms.gov/. [FN62] . Patrick Conway, “CMS Continues Progress toward a Safer Health Care System through Integrated Efforts to Improve Patient Safety and Reduce Hospital Readmissions,” CMS Blog, May 25, 2016, available at: https://blog.cms.gov/2016/05/25/cms-continues-progress- toward-a-safer-health-care-system-through-integrated-efforts-to-improve-patient-safety-and-reduce-hospital-readmissions/. [FN63] . Patrick Conway, “CMS Continues Progress toward a Safer Health Care System through Integrated Efforts to Improve Patient Safety and Reduce Hospital Readmissions,” CMS Blog, May 25, 2016, available at: https://blog.cms.gov/2016/05/25/cms-continues-progress- toward-a-safer-health-care-system-through-integrated-efforts-to-improve-patient-safety-and-reduce-hospital-readmissions/. [FN64] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -36- . Press Release, “CMS Awards $347 Million to Continue Progress Toward a Safer Health Care System,” CMS, Sept. 29, 2016, available at: https://www.cms.gov/newsroom/press-releases/cms-awards-347-million-continue-progress-toward-safer-health-care- system. [FN65] . Press Release, “CMS Awards $347 Million to Continue Progress Toward a Safer Health Care System,” CMS, Sept. 29, 2016, available at: https://www.cms.gov/newsroom/press-releases/cms-awards-347-million-continue-progress-toward-safer-health-care- system. [FN66] . “About the Partnership,” CMS, available at: https://partnershipforpatients.cms.gov/about-the-partnership/what-is-the-partnership-about/ lpwhat-the-partnership-is-about.html. [FN67] . “About the Partnership for Patients,” CMS, available at: https://partnershipforpatients.cms.gov/about-the-partnership/ aboutthepartnershipforpatients.html. [FN68] . 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. [FN69] . “Hospital-Acquired Condition Reduction Program,” CMS, updated July 20, 2017, available at: https://www.cms.gov/Medicare/ Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/HAC-Reduction-Program.html. [FN70] . “Hospital-Acquired Condition Reduction Program,” CMS, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/AcuteInpatientPPS/HAC-Reduction-Program.html. [FN71] . Jordan Rau, “Medicare Penalizes Group Of 751 Hospitals For Patient Injuries,” Kaiser Health News, Dec. 21, 2017, available at: https://khn.org/news/medicare-penalizes-group-of-751-hospitals-for-patient-injuries/. [FN72] . Jordan Rao, “Medicare Trims Payments To 800 Hospitals, Citing Patient Safety Incidents,” Kaiser Health News, March 1, 2019, available at: https://khn.org/news/medicare-trims-payments-to-800-hospitals-citing-patient-safety-incidents/. [FN73] . Jordan Rao, “Medicare Trims Payments To 800 Hospitals, Citing Patient Safety Incidents,” Kaiser Health News, March 1, 2019, available at: https://khn.org/news/medicare-trims-payments-to-800-hospitals-citing-patient-safety-incidents/. [FN74] . For more information, please the program's web page, available at: https://www.cms.gov/medicare/medicare-fee-for-service-payment/ acuteinpatientpps/readmissions-reduction-program.html. [FN75] . “Map: See the 2,599 hospitals that will face readmissions penalties this year,” Advisory Board, Sept. 27, 2018, available at: https:// www.advisory.com/daily-briefing/2018/09/27/readmissions. [FN76] . “2,573 Hospitals will Face Readmission Penalties this Year. Is yours one of Them?” Advisory Board, Aug. 7, 2017, available at: https:// www.advisory.com/daily-briefing/2017/08/07/hospital-penalties. [FN77] . Jordan Rau, “Under Trump, Hospitals Face Same Penalties Embraced By Obama,” Kaiser Health News, Aug. 3, 2017, available at: http://khn.org/news/under-trump-hospitals-face-same-penalties-embraced-by-obama/? utm_campaign=KFF-2017-The-Latest&utm_medium=email&_hsenc=p2ANqtz-8W3blMAa5jvt7xQoIdrM7rDf7IJcgkKsPTn43Xuj- blXdysYqAiCn1dY0KGRWY1KX0DsVHU2- © 2020 Thomson Reuters. No claim to original U.S. Government Works. -37- T5fzUHQxbA&_hsmi=54983441&utm_content=54983441&utm_source=hs_email&hsCtaTracking=0502294f-15f4-4880- bdb9-997c6964e2c3@635b5198-58a8-46c8-bf1c-b4f9d4bf7750. [FN78] . 83 F.R. 41144-01 (Aug. 17, 2018). [FN79] . Fact Sheet, “CMS Hospital Value-Based Purchasing Program Results for Fiscal Year 2019,” CMS, Dec. 3, 2018, available at: https:// www.cms.gov/newsroom/fact-sheets/cms-hospital-value-based-purchasing-program-results-fiscal-year-2019. [FN80] . Fact Sheet, “CMS Hospital Value-Based Purchasing Program Results for Fiscal Year 2019,” CMS, Dec. 3, 2018, available at: https:// www.cms.gov/newsroom/fact-sheets/cms-hospital-value-based-purchasing-program-results-fiscal-year-2019. [FN81] . Press Release, “AHRQ Analysis Finds Hospital-Acquired Conditions Declined By Nearly 1 Million from 2014-2017,” Jan. 29, 2019, available at: https://www.ahrq.gov/news/newsroom/press-releases/hac-rates-declined.html. [FN82] . Virgil Dickson, “MedPAC Seeks to Junk Two Hospital Quality Programs, Merge Others,” Modern Healthcare, Oct. 6, 2017, available at: http://www.modernhealthcare.com/article/20171006/NEWS/171009937. [FN83] . “HHS not Adhering to Obama Admin's 2018 Value-Based Payment Goals,” Advisory Board, Feb. 21, 2018, available at: https:// www.advisory.com/daily-briefing/2018/02/21/hhs-medicare-payments. [FN84] . Overview of the CMS Quality Strategy, CMS, available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment- Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy-Overview.pdf. [FN85] . Patrick Conway, “CMS Updates its Quality Strategy to Build a Better, Smarter, and Healthier Health Care Delivery System,” CMS Blog, Nov. 25, 2015, available at: http://blog.cms.gov/2015/11/25/cms-updates-its-quality-strategy-to-build-a-better-smarter-and- healthier-health-care-delivery-system/. The 2016 updated CMS Quality Strategy can be found at: https://www.cms.gov/Medicare/ Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf. [FN86] . Patrick Conway, “CMS Releases Data on Quality to Help Patients Choose Providers,” CMS Blog, Dec. 18, 2014, available at: http:// blog.cms.gov/2014/12/18/cms-releases-data-on-quality-to-help-patients-choose-providers/. [FN87] . Jordan Rau, “Medicare Delays Plans For New Star Ratings On Hospitals After Congressional Pressure,” Kaiser Health News, Apr. 20, 2016, available at: http://khn.org/news/medicare-delays- plans-for-new-star-ratings-on-hospitals-after-congressional-pressure/?utm_campaign=KFF-2016-The- Latest&utm_source=hs_email&utm_medium=email&utm_content=28689252&_hsenc=p2ANqtz-9xvdEkcWnpZdM_dBfI_55QTf70wlivp8iy6lkfGlj4p _A&_hsmi=28689252. [FN88] . Jordan Rau, “Medicare Prepares To Go Forward With New Hospital Quality Ratings,” Kaiser Health News, July 22, 2016, available at: http://khn.org/news/medicare-prepares-to-go-forward-with-new-hospital-quality-ratings/? utm_campaign=KFF-2016-The-Latest&utm_source=hs_email&utm_medium=email&utm_content=31998321&_hsenc=p2ANqtz- _FzjnLTQZdYj1GowpmwW5gzQk1hMotgAD-D6w1Bbqb0ms9lFRkTEJg0HqwRLBjOHHoAgQgdmW6_e51fNFGg&_hsmi=31998321. [FN89] . Jordan Rau, “Medicare Prepares To Go Forward With New Hospital Quality Ratings,” Kaiser Health News, July 22, 2016, available at: http://khn.org/news/medicare-prepares-to-go-forward-with-new-hospital-quality-ratings/? utm_campaign=KFF-2016-The-Latest&utm_source=hs_email&utm_medium=email&utm_content=31998321&_hsenc=p2ANqtz- _FzjnLTQZdYj1GowpmwW5gzQk1hMotgAD-D6w1Bbqb0ms9lFRkTEJg0HqwRLBjOHHoAgQgdmW6_e51fNFGg&_hsmi=31998321. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -38- [FN90] . Critical care hospitals are generally smaller rurally-located hospitals with short stay times. “Critical Access Hospitals,” HHS, available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/CritAccessHospfctsht.pdf. [FN91] . “Data Brief: Evaluation of National Distributions of Overall Hospital Quality Star Ratings,” CMS, July 21, 2016, available at: https:// www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-07-21-2.html. [FN92] . Kate Goodrich, “Helping Consumers Make Care Choices through Hospital Compare,” CMS Blog, July 27, 2016, available at: https:// blog.cms.gov/2016/07/27/helping-consumers-make-care-choices-through-hospital-compare/. [FN93] . Press Release, “CMS updates website to compare hospital quality,” CMS, Dec. 21, 2017, available at: https://www.cms.gov/ Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-12-21-2.html. [FN94] . Press Release, “CMS updates website to compare hospital quality,” CMS, Dec. 21, 2017, available at: https://www.cms.gov/ Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-12-21-2.html. [FN95] . “CMS Will Not Update Overall Hospital Star Ratings in July,” American Hospital Association, June 12, 2018, available at: https:// www.aha.org/news/headline/2018-06-12-cms-will-not-update-overall-hospital-star-ratings-july. [FN96] . “CMS Updates Overall Hospital Star Ratings, Proposes Future Changes,” American Hospital Association, Feb. 28, 2019, available at: https://www.aha.org/news/headline/2019-02-28-cms-updates-overall-hospital-star-ratings-proposes-future-changes. [FN97] . Press Release, “CMS Announces Upcoming Enhancement of Overall Hospital Quality Star Ratings,” CMS, Aug. 19, 2019, available at: https://www.cms.gov/newsroom/press-releases/cms-announces-upcoming-enhancement-overall-hospital-quality-star-ratings. [FN98] . Press Release, “CMS Launches New ACO Dialysis Model,” CMS, Oct. 7, 2015, available at: https://www.cms.gov/Newsroom/ MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-10-07.html. [FN99] . Press Release, “CMS Launches New ACO Dialysis Model,” CMS, Oct. 7, 2015, available at: https://www.cms.gov/Newsroom/ MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-10-07.html. [FN100] . “Comprehensive ESRD Care Model,” CMS, available at: https://innovation.cms.gov/initiatives/comprehensive-esrd-care/. [FN101] . 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. [FN102] . 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. [FN103] . BPCI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. [FN104] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -39- . Press Release, “CMS Announces Participants in New Value-Based Bundled Payment Model,” CMS, Oct. 9, 2018, available at: https:// www.cms.gov/newsroom/press-releases/cms-announces-participants-new-value-based-bundled-payment-model; see, also, BCPI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. [FN105] . Press Release, “CMS Announces Participants in New Value-Based Bundled Payment Model,” CMS, Oct. 9, 2018, available at: https:// www.cms.gov/newsroom/press-releases/cms-announces-participants-new-value-based-bundled-payment-model. [FN106] . BPCI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. [FN107] . “Model Overview Fact Sheet – Model Year 3 (MY3),” CMS, available at: https://innovation.cms.gov/Files/fact-sheet/bpciadvanced- my3-modeloverviewfs.pdf. [FN108] . Press Release, “HHS Launches Innovative Payment Model with new Treatment and Transport Options to More Appropriately And Effectively Meet Beneficiaries' Emergency Needs,” CMS, Feb. 14, 2019, available at: https://www.cms.gov/newsroom/press-releases/ hhs-launches-innovative-payment-model-new-treatment-and-transport-options-more-appropriately-and [FN109] . Press Release, “HHS Launches Innovative Payment Model with new Treatment and Transport Options to More Appropriately And Effectively Meet Beneficiaries' Emergency Needs,” CMS, Feb. 14, 2019, available at: https://www.cms.gov/newsroom/press-releases/ hhs-launches-innovative-payment-model-new-treatment-and-transport-options-more-appropriately-and [FN110] . “Emergency Triage, Treat, and Transport (ET3) Model,” CMS, available at: https://innovation.cms.gov/initiatives/et3/. [FN111] . Fact Sheet, “Emergency Triage, Treat, and Transport (ET3) Model,” CMS, Feb. 14, 2019, available at: https://www.cms.gov/ newsroom/fact-sheets/emergency-triage-treat-and-transport-et3-model. [FN112] . “Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First,” June 24, 2019, available at: https://www.whitehouse.gov/presidential-actions/executive-order-improving-price-quality-transparency-american-healthcare-put- patients-first/. [FN113] . Ricardo Alonso-Zalvidar, “Trump Signs Order Requiring Hospitals to Disclose Test and Procedure Prices,” Time, June 24, 2019, available at: https://time.com/5613157/trump-executive-order-hospital-prices/; see, also, Tamara Keith, “Trump Administration Pushes To Make Health Care Pricing More Transparent,” NPR, June 24, 2019, available at: https://www.npr.org/sections/health- shots/2019/06/24/735432387/trump-administration-pushes-to-make-health-care-pricing-more-transparent. [FN114] . “President Issues Executive Order on Price Transparency,” American Hospital Association, June 24, 2019, available at: https:// www.aha.org/news/headline/2019-06-24-president-issues-executive-order-price-transparency. [FN115] . Ricardo Alonso-Zalvidar, “Trump Signs Order Requiring Hospitals to Disclose Test and Procedure Prices,” Time, June 24, 2019, available at: https://time.com/5613157/trump-executive-order-hospital-prices/. [FN116] . See, e.g., Susannah Luthi, “Trump's Transparency Executive Order Leaves Details to HHS, CMS,” Modern Healthcare, June 24, 2019, available at: https://www.modernhealthcare.com/payment/trumps-transparency-executive-order-leaves-details-hhs-cms; Tamara Keith, “Trump Administration Pushes To Make Health Care Pricing More Transparent,” NPR, June 24, 2019, available at: https:// www.npr.org/sections/health-shots/2019/06/24/735432387/trump-administration-pushes-to-make-health-care-pricing-more-transparent. [FN117] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -40- . Press Release, “Trump Administration Announces Historic Price Transparency Requirements to Increase Competition and Lower Healthcare Costs for All Americans,” Nov. 15, 2019, available at: https://www.cms.gov/newsroom/press-releases/trump-administration- announces-historic-price-transparency-requirements-increase-competition-and. [FN118] . 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-Items/2011-10-207.html. [FN119] . See, e.g., Dr. Donald Berwick, “Improving Care for People with Medicare,” Medicare Blog, April 4, 2011, available at: http:// blog.medicare.gov/category/affordable-care-act/. [FN120] . “Shared Savings Program Fast Facts – As of July 1, 2019,” CMS, available at: https://www.cms.gov/Medicare/Medicare-Fee-for- Service-Payment/sharedsavingsprogram/Downloads/ssp-2019-fast-facts.pdf. [FN121] . “ACO Investment Model,” CMS, available at: https://innovation.cms.gov/initiatives/ACO-Investment-Model/. [FN122] . “Next Generation ACO Model,” CMS, available at: https://innovation.cms.gov/initiatives/next-generation-aco-model/. [FN123] . “Comprehensive ESRD Model,” CMS, available at: https://innovation.cms.gov/initiatives/comprehensive-esrd-care/. [FN124] . 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. [FN125] . “Medicare Shared Savings Program,” CMS, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/about.html. [FN126] . Rajiv Leventhal, “EXCLUSIVE: Substantial ACO Reforms Could be Forthcoming,” Healthcare Informatics, May 9, 2018, available at: https://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/. [FN127] . 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. [FN128] . 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.html? DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending. [FN129] . Press Release, Tom Nickels, “Statement on the New Track 1+ Accountable Care Organization Model,” available at: http:// www.aha.org/presscenter/pressrel/2016/162012-pr-track.shtml. [FN130] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -41- . 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. [FN131] . 83 F.R. 41786 (Aug. 17, 2018). [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/. [FN133] . Rajiv Leventhal, “EXCLUSIVE: Substantial ACO Reforms Could be Forthcoming,” Healthcare Informatics, May 9, 2018, available at: https://www.healthcare-informatics.com/article/payment/exclusive-substantial-aco-reforms-could-be-forthcoming [FN134] . Phil Galewitz, “Medicare to Overhaul ACOs but Critics Fear Less Participation,” Kaiser Health News, Aug. 9, 2018, available at: https://khn.org/news/medicare-to-overhaul-acos-but-critics-fear-fewer-participants/. “Medicare Shared Savings Program,” CMS, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/about.html. [FN135] . Fact Sheet, “Final Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2019,” CMS, Nov. 1, 2018, available at: https://www.cms.gov/newsroom/fact-sheets/final-policy-payment-and-quality-provisions- changes-medicare-physician-fee-schedule-calendar-year. [FN136] . 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. [FN137] . 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. [FN138] . 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. [FN139] . 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. [FN140] . Seema Verma, “More ACOs Taking Accountability Under MSSP Through “Pathways To Success',” Health Affairs, July 17, 2019, available at: https://www.healthaffairs.org/do/10.1377/hblog20190717.482997/full/. [FN141] . Shared Savings Program, Program Data, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/program-data.html. [FN142] . Press Release, “New Affordable Care Act Initiative to Support Care Coordination Nationwide,” CMS web site, Oct. 15, 2014, available at: http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2014-Press-releases-items/2014-10-15-3.html. [FN143] . “ACO Investment Model,” CMS web site, available at: http://innovation.cms.gov/initiatives/ACO-Investment-Model/. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -42- [FN144] . “ACO Investment Model,” CMS web site, available at: http://innovation.cms.gov/initiatives/ACO-Investment-Model/. [FN145] . Fact Sheets, “Accountable Care Organization (ACO) Investment Model Fact Sheet,” CMS web site, Oct. 15, 2014, available at: http:// www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2014-Fact-sheets-items/2014-10-15.html. [FN146] . “Next Generation ACO Model,” CMS web site, available at: http://innovation.cms.gov/initiatives/Next-Generation-ACO-Model/. [FN147] . News Release, “Affordable Care Act Initiative Builds on Success of ACOs,” HHS web site, March 10, 2015, available at: http:// wayback.archive-it.org/3926/20170127185549/https://www.hhs.gov/about/news/2015/03/10/affordable-care-act-initiative-builds-on- success-of-acos.html. [FN148] . Press Release, “Speech: Remarks by CMS Administrator Seema Verma at the HIMSS18 Conference,” CMS, March 6, 2018, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-03-06-2.html. [FN149] . Press Release, “Speech: Remarks by CMS Administrator Seema Verma at the HIMSS18 Conference,” CMS, March 6, 2018, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-03-06-2.html. [FN150] . Press Release, “Speech: Remarks by CMS Administrator Seema Verma at the HIMSS18 Conference,” CMS, March 6, 2018, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-03-06-2.html. [FN151] . Press Release, “Speech: Remarks by CMS Administrator Seema Verma at the HIMSS18 Conference,” CMS, March 6, 2018, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-03-06-2.html. [FN152] . News Release, “HHS Releases a New Resource to Help Individuals Access and Use Their Health Information,” HHS, Apr. 4, 2018, available at: https://www.hhs.gov/about/news/2018/04/04/hhs-releases-a-new-resource-to-help-individuals-access-and-use-their-health- information.html. [FN153] . “The Guide to Getting & Using Your Health Records,” ONC, available at: https://www.healthit.gov/how-to-get-your-health-record/. [FN154] . News Release, “HHS Releases a New Resource to Help Individuals Access and Use Their Health Information,” HHS, Apr. 4, 2018, available at: https://www.hhs.gov/about/news/2018/04/04/hhs-releases-a-new-resource-to-help-individuals-access-and-use-their-health- information.html. [FN155] . Health IT Dashboard, available at: https://dashboard.healthit.gov/quickstats/quickstats.php. [FN156] . Corrections were published at 83 F.R. 49836-01 (Oct. 3, 2018). [FN157] . Fact Sheet, “Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System (CMS-1716-F),” CMS, Aug. 2, 2019, available at: https://www.cms.gov/newsroom/fact- sheets/fiscal-year-fy-2020-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-acute-0. [FN158] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -43- . News Release, “HHS Proposes New Rules to Improve the Interoperability of Electronic Health Information,” Department of Health and Human Services, Feb. 11, 2019, available at: https://www.hhs.gov/about/news/2019/02/11/hhs-proposes-new-rules-improve- interoperability-electronic-health-information.html. [FN159] . News Release, “HHS Proposes New Rules to Improve the Interoperability of Electronic Health Information,” Department of Health and Human Services, Feb. 11, 2019, available at: https://www.hhs.gov/about/news/2019/02/11/hhs-proposes-new-rules-improve- interoperability-electronic-health-information.html. [FN160] . Fact Sheet, “CMS Advances Interoperability & Patient Access to Health Data through New Proposals,” CMS, Feb. 8, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/cms-advances-interoperability-patient-access-health-data-through-new-proposals. [FN161] . Fact Sheet, “CMS Advances Interoperability & Patient Access to Health Data through New Proposals,” CMS, Feb. 8, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/cms-advances-interoperability-patient-access-health-data-through-new-proposals. [FN162] . “Notice of Proposed Rulemaking to Improve the Interoperability of Health Information,” HealthIT.gov, available at: https:// www.healthit.gov/topic/laws-regulation-and-policy/notice-proposed-rulemaking-improve-interoperability-health. [FN163] . Shawn Radcliffe, “Rural Hospitals Closing at an Alarming Rate,” Healthline, Feb. 15, 2017, available at: https://www.healthline.com/ health-news/rural-hospitals-closing#1. [FN164] . Ayla Ellison, “The Rural Hospital Closure Crisis: 9 Things to Know,” Becker's Hospital Review, Nov. 1, 2018, available at: https:// www.beckershospitalreview.com/finance/the-rural-hospital-closure-crisis-9-things-to-know-110118.html. [FN165] . Ayla Ellison, “State-by-State Breakdown of 102 Rural Hospital Closures,” Becker's Hospital Review, Mar. 20, 2019, available at: https://www.beckershospitalreview.com/finance/state-by-state-breakdown-of-102-rural-hospital-closures.html. [FN166] . Charlotte Huff, “After Bitter Closure, Rural Texas Hospital Defies The Norm And Reopens,” Kaiser Health News, Jan. 7, 2019, available at: https://khn.org/news/after-bitter-closure-rural-texas-hospital-defies-the-norm-and-reopens/?utm_campaign=KHN#T#opic- based&utm_source=hs_email&utm_medium=email&utm_content=69092496&_hsenc=p2ANqtz-9tsv7t9Gth4T286o-hnjgN2k4pR-fzM- VQ3jjHGb83-D9uu3-PTuXplBIGaK79_3NjoVil2OKiwi8mcN9akFIQE1tBUw&_hsmi=69092496. [FN167] . Corrine Lewis, et al., “The Rural Maternity Care Crisis,” Commonwealth Fund, Aug. 15, 2019, available at: https:// www.commonwealthfund.org/blog/2019/rural-maternity-care-crisis. [FN168] . Corrine Lewis, et al., “The Rural Maternity Care Crisis,” Commonwealth Fund, Aug. 15, 2019, available at: https:// www.commonwealthfund.org/blog/2019/rural-maternity-care-crisis. [FN169] . News Release, “HHS Awards $9 Million to Develop New Models to Improve Obstetrics Care in Rural Communities,” HHS, Sept. 10, 2019, available at: https://www.hhs.gov/about/news/2019/09/10/hhs-awards-9-million-new-models-obstetrics-care-rural- communities.html. [FN170] . CMS Rural Health Strategy, CMS, 2018, available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural- Strategy-2018.pdf. [FN171] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -44- . CMS Rural Health Strategy, CMS, 2018, available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural- Strategy-2018.pdf. [FN172] . Seema Verma, “Putting our Rethinking Rural Health Strategy into Action,” CMS Blog, May 8, 2019, available at: https://www.cms.gov/ blog/putting-our-rethinking-rural-health-strategy-action. [FN173] . Seema Verma, “Rural Health at CMS: What's Been Done and What's to Come,” CMS Blog, Nov. 21, 2019, available at: https:// www.cms.gov/blog/rural-health-cms-whats-been-done-and-whats-come. [FN174] . “Illinois Health Leaders Introduce MOMMA's Act to Save Mothers' Lives,” web site of Senator Robin Kelly, Mar. 27, 2019, available at: https://robinkelly.house.gov/media-center/press-releases/illinois-health-leaders-introduce-momma-s-act-to-save-mothers-lives. [FN175] . “Illinois Health Leaders Introduce MOMMA's Act to Save Mothers' Lives,” web site of Senator Robin Kelly, Mar. 27, 2019, available at: https://robinkelly.house.gov/media-center/press-releases/illinois-health-leaders-introduce-momma-s-act-to-save-mothers-lives. [FN176] . “Illinois Health Leaders Introduce MOMMA's Act to Save Mothers' Lives,” web site of Senator Robin Kelly, Mar. 27, 2019, available at: https://robinkelly.house.gov/media-center/press-releases/illinois-health-leaders-introduce-momma-s-act-to-save-mothers-lives. [FN177] . Press Release, “Ahead of Mother's Day, Booker, Pressley, Colleagues Introduce Bill to Improve Maternal Health Outcomes,” Senator Booker's web site, May 8, 2019, available at: https://www.booker.senate.gov/?p=press_release&id=921. [FN178] . “Senator Cramer joins Senator Blackburn in introducing the Protecting Life and Taxpayers Act,” Senator Cramer's web site, June 25, 2019, available at: https://www.cramer.senate.gov/senator-cramer-joins-senator-blackburn-introducing-protecting-life-and-taxpayers- act. [FN179] . Press Release, Senator Blackburn's web site, June 25, 2019, available at: https://www.blackburn.senate.gov/blackburn-colleagues- introduce-bill-help-end-taxpayer-funding-abortions. [FN180] . Fact Sheet, “Medicare & Medicaid Programs; Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Efficiency and Transparency,” CMS, July 16, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/medicare-medicaid- programs-requirements-long-term-care-facilities-regulatory-provisions-promote. [FN181] . Fact Sheet, “Medicare & Medicaid Programs; Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Efficiency and Transparency,” CMS, July 16, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/medicare-medicaid- programs-requirements-long-term-care-facilities-regulatory-provisions-promote. [FN182] . Fact Sheet, “Medicare and Medicaid Programs; Revision of Requirements for Long-Term Care Facilities Arbitration Agreements (CMS-3342-F),” CMS, July 16, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/medicare-and-medicaid-programs- revision-requirements-long-term-care-facilities-arbitration. [FN183] . Fact Sheet, “Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System (CMS-1716-F),” CMS, Aug. 2, 2019, available at: https://www.cms.gov/newsroom/fact- sheets/fiscal-year-fy-2020-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-acute-0. [FN184] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -45- . Press Release, “CMS Advances Agenda to Re-think Rural Health and Unleash Medical Innovation,” CMS, Apr. 23, 2019, available at: https://www.cms.gov/newsroom/press-releases/cms-advances-agenda-re-think-rural-health-and-unleash-medical-innovation. The press release for the final rule is: “Trump Administration Finalizes Policies to Advance Rural Health and Medical Innovation,” CMS, Aug. 2, 2019, available at: https://www.cms.gov/newsroom/press-releases/trump-administration-finalizes-policies-advance-rural-health-and- medical-innovation. [FN185] . The rule is published at 84 F.R. 38424-01 (Aug. 6, 2019, and a Fact Sheet is available. Please see Fact Sheet, “FY 2020 Medicare Payment and Quality Reporting Updates for Inpatient Psychiatric Facilities (CMS-1712-F),” CMS, July 30, 2019, available at: https:// www.cms.gov/newsroom/fact-sheets/fy-2020-medicare-payment-and-quality-reporting-updates-inpatient-psychiatric-facilities-cms-1712- f. [FN186] . The rule is published at 84 F.R. 39054-01 (Aug. 8, 2019), and a Fact Sheet is available. Please see Fact Sheet, “Fiscal Year 2020 Payment and Policy Changes for Medicare Inpatient Rehabilitation Facilities (CMS-1710-F),” CMS, July 31, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-2020-payment-and-policy-changes-medicare-inpatient-rehabilitation-facilities- cms-1710-f. [FN187] . The rule is published at 84 F.R. 38484-01 (Aug. 6, 2019), and a Fact Sheet is available. Please see Fact Sheet, “Fiscal Year 2020 Hospice Payment Rate Update Final Rule,” CMS, July 31, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/fiscal- year-2020-hospice-payment-rate-update-final-rule. [FN188] . The rule is published at 84 F.R. 38728 (Aug. 7, 2019), and a Fact Sheet is available. Please see, Fact Sheet, “Fiscal Year 2020 Payment and Policy changes for Medicare Skilled Nursing Facilities (CMS-1718-F),” CMS, July 30, 2019, available at: https:// www.cms.gov/newsroom/fact-sheets/fiscal-year-2020-payment-and-policy-changes-medicare-skilled-nursing-facilities-cms-1718-f. [FN189] . The rule is published at 82 F.R. 35155-01 (July 28, 2017). [FN190] . Press Release, “CMS' Discharge Planning Rule Supports Interoperability and Patient Preferences,” CMS, Sept. 26, 2019, available at: https://www.cms.gov/newsroom/press-releases/cms-discharge-planning-rule-supports-interoperability-and-patient-preferences; Fact Sheet “CMS' Discharge Planning Rule Supports Interoperability and Patient Preferences,” CMS, Sept. 26, 2019, available at: https:// www.cms.gov/newsroom/fact-sheets/cms-discharge-planning-rule-supports-interoperability-and-patient-preferences. [FN191] . Fact Sheet, “Omnibus Burden Reduction (Conditions of Participation) Final Rule CMS-3346-F,” CMS, Sept. 26, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/omnibus-burden-reduction-conditions-participation-final-rule-cms-3346-f. [FN192] . Fact Sheet, “Omnibus Burden Reduction (Conditions of Participation) Final Rule CMS-3346-F,” CMS, Sept. 26, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/omnibus-burden-reduction-conditions-participation-final-rule-cms-3346-f. [FN193] . Fact Sheet, “Omnibus Burden Reduction (Conditions of Participation) Final Rule CMS-3346-F,” CMS, Sept. 26, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/omnibus-burden-reduction-conditions-participation-final-rule-cms-3346-f. [FN194] . Fact Sheet, “Modernizing and Clarifying the Physician Self-Referral Regulations Proposed Rule,” CMS, Oct.9, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-proposed-rule. [FN195] . Fact Sheet, “Modernizing and Clarifying the Physician Self-Referral Regulations Proposed Rule,” CMS, Oct.9, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-proposed-rule. [FN196] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -46- . Press Release, “Evans, Estes Introduce Bipartisan Nursing Home Workforce Quality Act to Address Critical Shortage of Certified Nursing Assistants,” Rep. Evans' web site, Sept. 29, 2019, available at: https://evans.house.gov/media-center/press-releases/evans- estes-introduce-bipartisan-nursing-home-workforce-quality-act. [FN197] . Press Release, “Evans, Estes Introduce Bipartisan Nursing Home Workforce Quality Act to Address Critical Shortage of Certified Nursing Assistants,” Rep. Evans' web site, Sept. 29, 2019, available at: https://evans.house.gov/media-center/press-releases/evans- estes-introduce-bipartisan-nursing-home-workforce-quality-act. [FN198] . See State Medicaid Director Letter, “Implementation of Section 5052 of the SUPPORT for Patients and Communities Act – State Plan Option under Section 1915(l) of the Social Security Act,” SMD #19-003, Nov. 6, 2019, available at: https://www.medicaid.gov/federal- policy-guidance/downloads/smd19003.pdf. [FN199] . State Medicaid Director Letter, “Implementation of Section 5052 of the SUPPORT for Patients and Communities Act – State Plan Option under Section 1915(l) of the Social Security Act,” SMD #19-003, Nov. 6, 2019, available at: https://www.medicaid.gov/federal- policy-guidance/downloads/smd19003.pdf. [FN200] . State Medicaid Director Letter, “Opportunities to Design Innovative Service Delivery Systems for Adults with a Serious Mental Illness or Children with a Serious Emotional Disturbance,” SMD #18-011, Nov. 13, 2018, available at: https://www.medicaid.gov/federal-policy- guidance/downloads/smd18011.pdf. [FN201] . Press Release, “CMS Announces Approval of Groundbreaking Demonstration to Expand Access to Behavioral Health Treatment,” CMS, Nov. 6, 2019, available at: https://www.cms.gov/newsroom/press-releases/cms-announces-approval-groundbreaking- demonstration-expand-access-behavioral-health-treatment. [FN202] . The final rule is scheduled for Federal Register Publication on Nov. 15, 2019. Until then, it may be viewed in its unofficial form at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-24086.pdf. [FN203] . Press Release, “Trump Administration Strengthens Medicare by Reducing Provider Burden and Valuing Time Spent with Patients,” CMS, Nov. 1, 2019, available at: https://www.cms.gov/newsroom/press-releases/trump-administration-strengthens-medicare-reducing- provider-burden-and-valuing-time-spent-patients. [FN204] . Press Release, “Trump Administration Strengthens Medicare by Reducing Provider Burden and Valuing Time Spent with Patients,” CMS, Nov. 1, 2019, available at: https://www.cms.gov/newsroom/press-releases/trump-administration-strengthens-medicare-reducing- provider-burden-and-valuing-time-spent-patients. [FN205] . Fact Sheet, “Finalized Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2020,” CMS, Nov. 1, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/finalized-policy-payment-and-quality-provisions- changes-medicare-physician-fee-schedule-calendar. [FN206] . Fact Sheet, “CY 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS-1717-FC),” CMS, Nov. 1, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/cy-2020-medicare-hospital- outpatient-prospective-payment-system-and-ambulatory-surgical-center-0. [FN207] . PACE is Programs of All-Inclusive Care for the Elderly, a federal Medicare and Medicaid program that provides health care service and social service supports to participants who are dually eligible for Medicare and Medicaid. [FN208] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -47- . Veto message for Assembly Bill 774, Governor Newsom's web site (under the Newsroom tab), Oct. 12, 2019, available at: https:// www.gov.ca.gov/wp-content/uploads/2019/10/AB-774-Veto-Message-2019.pdf. [FN209] . Jim McLean, “Kansas Gov. Kelly Goes with Medicaid Expansion Plan That Almost Worked Before,” KCUR, Jan. 29, 2019, available at: https://www.kcur.org/post/kansas-gov-kelly-goes-medicaid-expansion-plan-almost-worked#stream/0. [FN210] . For more information about the competing interests, see, e.g., Elon Glucklich, “Medicaid Insurers Looking At More State Oversight,” The Lund Report, available at: https://www.thelundreport.org/content/medicaid-insurers-looking-more-state-oversight and Jeff Manning, “Health care companies furious after Legislature moves toward surprise cut in allowable inflation rate,” The Oregonian, June 14, 2019, available at: https://www.oregonlive.com/business/2019/06/health-care-companies-furious-after-legislature-moves-toward-surprise-cut- in-allowable-inflation-rate.html. [FN211] . Ed Treleven, “Planned Parenthood Sues to Bar State Restrictions on Abortion Providers,” Wisconsin State Journal, Jan. 16, 2019, available at: https://madison.com/wsj/news/local/courts/planned-parenthood-sues-to-bar-state-restrictions-on-abortion- providers/article_51743e4a-e7c8-5c2e-81e4-864f4e6b117e.html#utm_source=madison.com&utm_campaign=®email®breaking- news®&utm_medium=email&utm_content=1DE995458449CAB889D307EAE5F3C7FDC7846BA1. [FN212] . Ed Treleven, “Planned Parenthood Sues to Bar State Restrictions on Abortion Providers,” Wisconsin State Journal, Jan. 16, 2019, available at: https://madison.com/wsj/news/local/courts/planned-parenthood-sues-to-bar-state-restrictions-on-abortion- providers/article_51743e4a-e7c8-5c2e-81e4-864f4e6b117e.html#utm_source=madison.com&utm_campaign=®email®breaking- news®&utm_medium=email&utm_content=1DE995458449CAB889D307EAE5F3C7FDC7846BA1. [FN213] . Scott Bauer, Associated Press, “Planned Parenthood Challenges Wisconsin Abortion Laws,” Washington Post, Jan. 16, 2019, available at: https://www.washingtonpost.com/national/health-science/planned-parenthood-challenges-wisconsin-abortion- laws/2019/01/16/2e8681ca-19c3-11e9-b8e6-567190c2fd08_story.html?utm_term=.a4b46e204d82. Produced by Thomson Reuters Accelus Regulatory Intelligence 04-Feb-2020 © 2020 Thomson Reuters. No claim to original U.S. Government Works. -48-