YEAR-END REPORT - 2019 Published 23-Dec-2019 HPTS Issue Brief 12-23-19.15 Health Policy Tracking Service - Issue Briefs Healthcare Reform Delivery Reform Authored by Tammy J. Raduege, J.D., a contributing writer and member of the Wisconsin bar. 12/23/2019 I. Introduction The rights to health care and necessary social services were recognized under the Universal Declaration of Human Rights, [FN1] unanimously adopted by the General Assembly of the United Nations in 1948. Few would argue about the inherent value in universal health care. We cannot agree, however, on how to achieve this. On March 23, 2010, President Barack Obama signed the Patient Protection and Affordable Care Act (the Affordable Care Act) (P.L. 111-148). The goal of the law is to provide quality care at an affordable cost. To realize this goal, the law focuses on innovative ways to deliver care that are both efficient and effective. In fact, a provision in the law directed the United States Department of Health and Human Services (HHS) to create the Center for Medicare and Medicaid Innovation to develop demonstration projects to evaluate new health delivery methods in the Medicare and Medicaid programs. In attempting to make health care delivery safer and more efficient, the law places a great deal of emphasis on electronic health records and the exchange of health information among providers. The law also directs the HHS Secretary to issue regulations to govern accountable care organizations -- formal organizations of providers that work together to provide coordinated services to their patient populations. Because it provides for a Medicaid expansion, the law contains provisions aimed at strengthening the primary care workforce to provide better access to care, and it directs the HHS Secretary to provide funding to create new community health centers or to support existing ones. In keeping with its emphasis on wellness and preventive medicine, the law requires that most preventive services be provided without patient cost-sharing. Finally, the law requires that most private insurance plans a set of “essential benefits.” The act is still mostly intact, but the Trump Administration has made some changes on how it administers the law. II. TRENDS IN HEALTH DELIVERY REFORM As it does each fall, the Kaiser Family Foundation released its 50-state Medicaid budget and policy survey in which it identifies trends and priorities in all aspects of Medicaid, including, for example, eligibility and enrollment, benefits, delivery and payment reforms, premiums and cost-sharing, and provider payments. The latest report is for fiscal years 2019 and 2020. As it relates to delivery reform, the survey identifies these trends and priorities: • Managed care • Social determinants of health [FN2] • Criminal justice-involved populations Managed care continues to be a major delivery model for Medicaid. All states except four (Alaska, Connecticut, Vermont, and Wyoming) use some sort of managed care for Medicaid. More states (40, up from 39 last year) contract with comprehensive risk-based managed care organizations (MCOs) to provide at least some of the Medicaid services they provide, fewer states (12) use a primary care case management model, and some states use a combination of both models. Of the 40 states that contract with MCOs, 33 of them indicate that 75% or more of their Medicaid participants are enrolled. North Carolina plans to implement an MCO model for its Medicaid program in fiscal year 2020, and Arkansas was the one additional state that did so in fiscal year 2019. These are some of the trends that are evident in the states that used managed care in their Medicaid programs: • Children and adults (and particularly newly eligible adults in the Medicaid expansion) are the populations most likely to be enrolled in managed care. The elderly and those who are disabled are less likely to be enrolled in managed care. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -1- • Pregnant women are most likely to be enrolled in managed care on a mandatory basis, and people with intellectual and developmental disabilities were the least likely to be enrolled on a mandatory basis. • In fiscal year 2019, six states that use MCOs made policy changes to increase the number of participants enrolled, and eight states planned to do so for fiscal year 2020. • More than one-half of the 40 states that use MCOs carve-in specific behavioral health services to their contracts. Eight states in fiscal year 2019 reporting making policy changes to their carve-in rules for behavioral health, and nine states reported plans to do so in fiscal year 2020. • For fiscal year 2019, 36 of the 40 states that use an MCO model use at least one Medicaid quality initiative; an additional two states reported plans to do so for fiscal year 2020. Most commonly, these initiatives focus on chronic disease management, perinatal/birth [FN3] outcomes, mental health, eliminating preventable events, and substance use disorder. Increasingly, states and the federal government are recognizing the effects of the social determinants of health, such as food and [FN4] housing insecurity, education, employment, transportation, and personal safety. At the federal level, the Centers for Medicare and Medicaid Services (CMS) launched the Accountable Health Communities Act in 2017 to address social determinants of health. It [FN5] is ongoing, although CMS has cancelled one of the three tracks for lack of interest. At the state level, Kaiser reports that several states are using their MCO contracts to implement strategies that pay heed to the social determinants of health. As of fiscal year 2020, 35 states will be using at least one strategy to do so, including screening for social needs, providing referrals to social services, or partnering with community-based organizations. Approximately 20 states will require MCOs to employ non-traditional health workers, [FN6] like community health workers, and some will require states to track the outcomes of the social service referrals. The issue brief gives examples of how Colorado, Michigan, and West Virginia are using MCO contracts to address social determinants of health: • Colorado is working with its MCOs to develop a reporting mechanism to track referrals to social services, with the goal of establishing a future performance metric that could be tied to payment. • Michigan establishes a minimum ratio of CHWs to members and requires MCOs to provide or arrange for CHW services as part of the state's comprehensive population health management strategy. • West Virginia's enrollment broker collects social determinants of health data for beneficiaries enrolling in managed care and shares this data with MCOs. The MCOs use the data to identify and engage members in need of non-medical supports and refer those [FN7] members to community services. The brief also highlights North Carolina's planned MCO program that focuses on social determinants of health. States have begun to realize that recognizing the health needs of incarcerated individuals before they are released may improve health outcomes once they are released. States seem to be particularly concerned with substance abuse and mental health services during the transition from incarceration to release. As the Kaiser Family Foundation indicated in its 50-state survey, Improving continuity of care for individuals released from correctional facilities into the community is important to ensure that individuals with complex or chronic health conditions, including behavioral health needs, have an effective transition to treatment in the community. [FN8] It can also help address the opioid epidemic by mitigating the risk of overdose in the period following incarceration. According to Kaiser, a total of 13 states in fiscal year 2019 have programs to provide care coordination services to prisoners prior to release, and six more had plans to do so in fiscal year 2020. In fiscal year 2019, five states (Arizona, Colorado, Louisiana, Ohio, and Washington) were leveraging MCO contracts for this purpose, and eight (California, Colorado, Connecticut, Kansas, Michigan, Pennsylvania, Rhode Island, and South Carolina) were offering the services through a fee-for-service plan. For fiscal year 2020, three states (Delaware, Hawaii, and Virginia) had plans to use their MCO contracts to provide care coordination services, and three [FN9] (District of Columbia, Delaware, and Virginia) had plans to use a fee-for-service initiative. Please see the brief for highlights of initiatives in Louisiana, Ohio, and Washington. Finally, the states were asked whether they had implemented or planned to implement delivery or payment reforms such as patient- centered medical homes, accountable care organizations, Affordable Care Act health homes, DSRIP (Delivery System Reform Incentive Payment) programs, or an episode-of-care payment system. Forty-four states had at least one such reform in place in fiscal year 2019, and 14 more planned on implementing or expanding such reforms for fiscal year 2020. The most popular reform is the patient-centered medical home: 30 states in fiscal year 2019 had implemented this reform and another four planned to do so for 2020. [FN10] III. THE AFFORDABLE CARE ACT AND THE “REPEAL AND REPLACE” EFFORTS 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 the health care system. The law aims to improve the quality of care, improve the health of the citizenry, and reduce costs. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -2- 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. [FN11] 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 not a perfect plan; probably everyone would agree on that. Some argue that it is worth keeping and improving. Others insist that it is a disaster – a behemoth that is going to collapse of its own weight. Still, the law has had successes, and it may be fair to say that the Affordable Care Act did a good job of getting people covered. Roughly 14 million gained coverage [FN12] through Medicaid. Still, the Affordable Care Act was a major issue in the 2016 national election, and many Republicans, including then-candidate Donald Trump, ran on the promise to repeal and replace the law. While Congressional Republicans worked tirelessly in the spring and summer of 2017 to create a plan that would garner enough Republican support to pass, all plans put forward failed to pass. 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 [FN13] 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 [FN14] 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 [FN15] would put the onus back on Congress to fashion a new health care plan. IV. 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 [FN16] they 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. [FN17] 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 [FN18] [FN19] Program (with over 500 participants). Others include the ACO Investment Model (with 45 participants), the Next Generation [FN20] [FN21] ACOs (with 41 participants), and the Comprehensive ESRD (early stage renal disease) Model (with 37 participants). The © 2020 Thomson Reuters. No claim to original U.S. Government Works. -3- 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 [FN22] savings. ACOs were allowed to stay in Track 1 for two agreement cycles (or six years). ACOs could also choose to participate [FN23] 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 [FN24] change to a two-sided arrangement. The Obama Administration recognized the need to encourage more ACOs to transition into [FN25] 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 [FN26] an APM, allowing participating clinicians to qualify for incentive payments. The American Hospital Association released a brief [FN27] 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 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 [FN28] 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 [FN29] 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 [FN30] 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, [FN31] [FN32] 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 [FN33] the current Shared Savings Program quality measure on the percentage of eligible clinicians using CEHRT. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -4- 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 [FN34] 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. [FN35] • Program integrity: The program establishes rigorous and accurate benchmarks for evaluating ACO performance. 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 [FN36] 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 [FN37] 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 [FN38] improve quality for patients. [FN39] 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 [FN40] 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: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -5- • 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 [FN41] 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 [FN42] [FN43] 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 Pioneer Program. ACOs in this program also have the opportunity to share in a greater portion of the savings. The program is meant for [FN44] 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 [FN45] preferences. The program, which got underway in 2015 as anticipated, premiered with 21 ACOs in January 2016. The program now has 41 participants. V. 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 [FN46] 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 [FN47] care, and have a better understanding of their health. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -6- 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 [FN48] 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 [FN49] of the Administrator's remarks. [FN50] On a related note, HHS announced the release of a new guide from the Office of the National Coordinator for Health Information [FN51] 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 [FN52] efforts to increase patient engagement, improve health outcomes, and advance person-centered health. 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), 96% of [FN53] 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. [FN54] [FN55] 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 [FN56] 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 [FN57] 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 [FN58] [FN59] 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 [FN60] 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). VI. Health Reform and Innovation The ultimate goal of a better delivery system is achieving the triple aim: better care, lower cost, and healthier people. Delivery reforms are a key component for reaching that goal. Below, we discuss some of the innovative programs the federal and state governments are using as they work toward achieving the triple aim. A. Initiatives from CMS, the Center for Medicare and Medicaid Innovation, and the Medicare-Medicaid Coordination Office © 2020 Thomson Reuters. No claim to original U.S. Government Works. -7- The Innovation Center opened in January 2011. It is responsible for identifying waste in Medicaid and Medicare and “testing ‘innovative payment and service delivery models to reduce program expenditures . . . while preserving or enhancing the quality of care more effective therapies that target chronic diseases, medical errors and safety concerns”’ for participants in Medicare, Medicaid, and CHIP. [FN61] (Alterations in original.) Additionally, the Office of Medicare-Medicaid Coordination was created by the Affordable Care Act to [FN62] coordinate care for “dual eligibles,” those who are eligible for both Medicare and Medicaid. The act requires the Innovation Center to report to Congress at least every other year on the Innovation Center's activities. The center has released its fourth report to Congress in which it highlights some of its important programs and discusses the progress the center [FN63] has made toward fulfilling its mission. The fourth report covers the period from October 1, 2016 to September 30, 2018, and it also features some of the other important programs that were announced between September 30, 2018 and December 31, 2018. During the period of time covered by the report, the Innovation Center launched 36 new payment and delivery models involving Medicare, Medicaid, and private payers. The report highlights some of the successes that the office achieved with its initiatives and models: Evaluations of CMS Innovation Center models and initiatives have indicated that a number of them have had sufficient impact on expenditures and/or quality to justify further testing. These results are described in detail in Section Three of this Report to Congress. In addition, two CMS Innovation Center models have met the statutory criteria to be eligible for expansion by reducing program spending while preserving or enhancing quality—the Pioneer Accountable Care Organization (ACO) Model (as tested in its first two years) and the Health Care Innovation Award's Diabetes Prevention Program model (DPP). The Pioneer ACO Model generated more than $384 million in savings to Medicare over its first two years—an average of approximately $300 per participating beneficiary per year with no adverse effects on quality of care or patient experience. The DPP model test saved Medicare an estimated $278 per beneficiary per quarter, which covered program costs and helped [FN64] participants lose an average of 5 percent of their body weight to significantly reduce their risk of developing diabetes. Below we discuss some of the initiatives launched by the Innovation Center and the Medicare-Medicaid Coordination Office as those offices current exist. The Care Choices Model Hospice care is a benefit covered by both Medicare and Medicaid. However, when a participant chooses to receive hospice care, he or she is no longer eligible to receive curative care. According to a recent report, less than one-half of Medicare and Medicaid participants choose the hospice benefit, and when they do, they receive hospice services for just a short time. A new program, the Medicare Care Choices Model is testing whether participants who receive both hospice and curative services simultaneously can have a better quality of life and whether offering both services improves patient and family satisfaction. It is also evaluating whether participants will select hospice services when they know that they can still receive curative care. CMS explains that the curative services that would be offered in the program include: physical or occupational therapy, speech language pathology services, drugs for the management of pain or other symptoms from the terminal illness or related conditions, medical equipment and supplies, any other service that is specified in the patient's plan of care for which payment may otherwise be made under Medicare (for example, ambulance transports), short-term inpatient care for pain or symptom management that cannot be managed in the home environment, and physician services. Medicare participants who qualify for the Medicare hospice benefit and dually eligible beneficiaries who qualify for the Medicaid hospice benefit who meet all other program requirements are qualified to participate. CMS received a greater-than-expected response to its invitation to participate in the program. Instead of granting awards to approximately 30 Medicare-certified hospices to serve up to 30,000 participants as originally anticipated, CMS granted awards to over 140 Medicare-certified hospices to serve up to 150,000 participants. (Currently, 85 hospice providers are participating.) It also enlarged the time-frame of the program from three years to five [FN65] years. Current eligibility requirements are these: • Having Medicare Part A and Part B as their primary health insurance for 12 months prior to enrollment in MCCM [Medicare Care Choices Model] • Being diagnosed with: 1) advanced cancers; 2) chronic obstructive pulmonary disease; 3) congestive heart failure or 4) human immunodeficiency virus/acquired immune deficiency syndrome • Having at least one hospital-based encounter in the last 12 months (emergency department visit, observation stay or admission) • Having at least three office visits (with a Medicare-certified provider for any reason) • Being eligible for the Medicare or Medicaid hospice benefit; • Not having elected the Medicare or Medicaid hospice benefit within the last 30 days prior to enrolling in the MCCM [FN66] • Living in a traditional home for at least 30 days prior to MCCM enrollment In late 2017, CMS provided this update on the model: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -8- Selected hospices were randomly assigned to one of two cohorts. Cohort 1 began furnishing MCCM services on January 1, 2016. Cohort 2 will begin to furnish services January 1, 2018. Both cohorts will end December 31, 2020. As Cohort 1 approaches the end of the Model's second year, 1,325 beneficiaries have been enrolled and have been offered more than 21,149 encounters. Ten percent of beneficiaries approached about the Model have elected hospice immediately and nearly 80 percent [FN67] of those who enroll in MCCM elect hospice when they leave the Model. Comprehensive Primary Care Plus Model [FN68] CMS calls the Comprehensive Primary Care Plus (CPC+) model the “largest-ever initiative to improve primary care in America.” CMS describes the five-year program, which began in January 2017: CPC+ is an opportunity for practices of diverse sizes, structures, and ownership who are interested in qualifying for the incentive payment for Advanced Alternative Payment Models through the proposed Quality Payment Program. CMS estimates that up to 5,000 primary care practices serving an estimated 3.5 million beneficiaries could participate in the model. . . . By aligning Medicare, Medicaid, and private insurance, CPC+ moves the health care system away from one-size-fits-all, fee-for-service to a model that supports [FN69] clinicians delivering the care that best meets the needs of their patients and improves health outcomes. The initiative is a multi-payer program (including Medicare, Medicaid, and private insurance companies), and CMS chose regions of the country to participate, based on payer interest and coverage. In the first round of the initiative, CMS selected 14 regions to participate: 1. Arkansas: Statewide 2. Colorado: Statewide 3. Hawaii: Statewide 4. Kansas and Missouri: Greater Kansas City Region 5. Michigan: Statewide 6. Montana: Statewide 7. New Jersey: Statewide 8. New York: North Hudson-Capital Region 9. Ohio: Statewide and Northern Kentucky Region 10. Oklahoma: Statewide 11. Oregon: Statewide 12. Pennsylvania: Greater Philadelphia Region 13. Rhode Island: Statewide [FN70] 14. Tennessee: Statewide Once the regions were announced, CMS invited eligible practice to apply. CMS is interested in working with practices that would: Support patients with serious or chronic diseases achieve their health goals Give patients 24-hour access to care and health information Deliver preventive care Engage patients and their families in their own care [FN71] Work together with hospitals and other clinicians, including specialists, to provide better-coordinated care [FN72] The practices selected for Round 1 were announced in January 2017; 2,866 practices were participating from Round 1. CMS has now announced funding for Round 2 of CPC+. The regions selected for Round 2 include: 1. Louisiana: Statewide 2. Nebraska: Statewide 3. North Dakota: Statewide 4. New York: Greater Buffalo Region (Erie and Niagara Counties) CMS invited practices in those regions to apply. In early 2018, CMS announced that 165 new primary care practices have entered the [FN73] program. Currently, 2,851 practices are participating in the program. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -9- The first annual report for the program was posted in April 2019, and a 2018 Year in Review document was posted on May 14, 2019. The latest update for the program, the quality and utilization performance results, was posted in September 2019. For more information [FN74] about CPC+, please see the initiative's web site. Oncology Care Model HHS announced that the Innovation Center will be administering a new care coordination program for oncology services called the Oncology Care Model that will reward the value of care provided. It will offer opportunities for innovation in both payment for and delivery of health services. According to a press release, “The initiative will include 24-hour access to practitioners for beneficiaries undergoing treatment and an emphasis on coordinated, person-centered care, aimed at rewarding value of care, rather than volume.” The model will focus on Medicare, as the majority of the more than 1.6 million people diagnosed with cancer each year are over age 65 and participating in Medicare. Currently enrolled physician group practices and sole practitioners that provide chemotherapy for cancer patients are qualified to participate. The initiative will use episode-based, performance-based payments that make it financially attractive to provide high-quality, coordinated care, which should ultimately cost less. Participating practices will also receive monthly care management payments for each fee-for-service Medicare participant beneficiary during an episode of care to support oncology practice transformation. While the initiative focuses on Medicare, other payers, including commercial insurers, Medicare Advantage [FN75] plans, state programs, and Medicaid managed care plans may also apply to take part in the initiative. According to the Request for Applications Notice published in the Federal Register, participating practices must be able and willing to: • Use treatment therapies that are consistent with nationally recognized clinical guidelines. • Provide 24/7 access to an appropriate practitioner who has real-time access to the practice's medical records. • Use electronic health record technology certified by the Office of the National Coordinator for Health Information Technology (ONC), as described in the Federal Register Notice. • Use data to continually improve the quality of care. • Provide core functions of patient navigation. [FN76] • Implement a care plan containing the 13 components in the Institute of Medicine Care Management Plan. Program participants must commit to the program for the five year duration. The Oncology Care Model page of the Innovation Center's web site contains a number of resources, including a Fact Sheet, an FAQ document, the Request for Applications, letters of intent, and [FN77] [FN78] application templates. One-hundred seventy-five physician group practices and 10 payers participate in the program. CMS posted a new evaluation report on the initiative's web page. The program is ongoing. Million Hearts®: Cardiovascular Disease (CVD) Risk Reduction Model Million Hearts®: Cardiovascular Disease (CVD) Risk Reduction Model is an initiative focusing on heart disease. Health care professionals that participate will design models to reduce the 10-year risk of atherosclerotic cardiovascular disease and prevent heart attacks and strokes in Medicare patients. To be eligible, CMS indicated that practices would have to meet the following criteria: • Practice must have at least 1 provider. Providers are defined as Medical Doctors, Doctors of Osteopathic Medicine, Physician Assistants, and Nurse Practitioners. • Practices must be using an Office of the National Coordinator (ONC) certified Electronic Health Record system • Participating physician providers or professionals within the practice must have met the criteria for the EHR Incentive Programs Stage 1, also known as “meaningful use,” of a certified electronic health record. Participants are expected to incorporate the following care delivery elements into the models they design: • Risk Stratified Care • Population Health Management • Shared Decision Making • Individual Risk Modification Planning • Team-Based Care • Quality and Clinical Data Reporting [FN79] Currently, there are 319 participants. Please see the initiative web page for the key dates and for more details about the model. This model is ongoing. The Comprehensive ESRD Care (CEC) 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: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -10- 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 [FN80] 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) will share in the savings only. CMS explains that this model fits with its stated intention of tying Medicare payments to quality by paying 30% of traditional Medicare payments through alternative payment models by the end of 2016 and 50% by the end of 2018. [FN81] The Medicare and Medicaid Innovation Center is facilitating the new model. In early 2017, CMS announced that it had selected [FN82] the participants for the second performance year. Performance year one evaluation results have been posted. Thirty-three participants are involved with the program. Accountable Health Communities Model and Other Social Supports In 2017, CMS has launched an initiative called the Accountable Health Communities Model that will fund organizations that can act as bridges joining the world of medical care with the world of social services. In a blog post, CMS gives this example: Here's a hypothetical example of how the bridge might help: a mother comes in to a participating community health center for her child with asthma. During a complete social screening, the center learns the mother has been living in a moldy trailer after fleeing a violent home life. They refer the family to a local safe housing program and legal aid to protect her. The center also connects her with these services with the aid of a community health navigator. By helping the family find safe permanent housing, we reduce the frequency of [FN83] the child's visits to the ER for asthma attacks. The five year initiative is targeted toward both Medicaid and Medicare participants. HHS will provide funding of up to $157 million to [FN84] bridge organizations. The model will consist of three tracks. CMS explains the purpose of each track: Track 1 Awareness – Increase beneficiary awareness of available community services through information dissemination and referral Track 2 Assistance – Provide community service navigation services to assist high-risk beneficiaries with accessing services Track 3 Alignment – Encourage partner alignment to ensure that community services are available and responsive to the needs of the [FN85] beneficiaries In April 2017, CMS announced funding for 32 participants in the Assistance and Alignment Tracks. (There are currently 30 participants.) [FN86] CMS stresses that funding may not be used directly or indirectly for community services such as housing, food, transportation, [FN87] and so forth. Unfortunately, CMS withdrew a funding opportunity for the Awareness Track in August 2017, indicating that it did not receive enough qualified applicants to justify moving forward with this track. The agency does not anticipate opening up a new funding [FN88] opportunity at this time. Please visit the program's web page a list of the 30 participants and for other updates. CMS is willing to approve state waiver requests to address social needs. In 2018, CMS approved North Carolina's Section 1115 waiver for its pilot program. The waiver allows the state to provide case management and other services to address social determinants of health, such as “socioeconomic status, education, neighborhood and physical environment, employment, nutrition/food security, and [FN89] social support networks, as well as access to health care.” To be eligible, a person must be enrolled in managed care and must exhibit at least one physical or behavioral health risk factor and at least one social risk factor. The program, which has not yet begun, will be implemented in two to four regions of the state, and officials estimate that 25,000 to 50,000 Medicaid participants will benefit from the program. A Kaiser Family Foundation brief describes some of the services that the pilot will offer: Pilot services will include evidence-based enhanced case management and other services designed to address enrollee needs related to: housing, food, transportation, and interpersonal safety. For example, pilot services may include housing modifications (e.g., carpet replacement, air conditioner repair) to improve a child's asthma control, travel vouchers to a community- based food pantry or a medically-targeted healthy food box for an adult with diabetes living in a rural food desert, or assistance securing safe housing for a pregnant woman experiencing interpersonal violence. The care manager will recommend pilot services at the lowest intensity level that can be reasonably expected to meet an individual's needs. Pilot transportation services include non-emergency health-related transportation including transportation to social services or to access pilot services. (Transportation services under the pilot are in addition to the non-emergency medical transportation (NEMT) benefit states are required to provide which helps ensure [FN90] Medicaid beneficiaries have transportation to and from medical providers.) © 2020 Thomson Reuters. No claim to original U.S. Government Works. -11- The authors point out that this waiver differs a bit from the types of waivers that CMS has typically approved in the last couple of years. CMS' new direction in waiver approval has been favoring work and community engagement requirements and reporting requirements, while North Carolina's pilot is aimed at ameliorating the causes of health disparities and poor health. The authors write of CMS' new waiver policies, which favor work requirements and reporting, In its approval of these demonstrations, the administration asserts such policies are designed to address health determinants (like employment) and to ultimately improve health outcomes. These new waivers run counter to many other efforts to address social determinants of health that focus on identifying social needs and facilitating links to services rather than making individuals' health [FN91] coverage dependent on meeting certain requirements – like reporting minimum monthly work hours. Please see the brief for a fuller discussion of the program. In many respects, social needs are related to medical needs. People have to prioritize their concerns, and if they have no home, they are unlikely to follow a medication regimen, for example. Some make a distinction between social needs and social determinants of health, arguing that addressing someone's social needs is helpful only to that particular person's health, while addressing social [FN92] determinants of health means making systemic changes to improve way people live. Authors in a Health Affairs Blog post argue that conflating the two may impede efforts to actually make a difference on social determinants of health: [The referenced articles on social determinants of health] aren't about improving the underlying social and economic conditions in communities to foster improved health for all – they're about mediating patients' individual social needs. If this is what addressing the social determinants of health has come to mean, not only has the definition changed, but it has changed in ways that may impede [FN93] efforts to address those conditions that impact the overall health of our country. The authors' observations are well-taken and thoughtful; however, policymakers, writers, and advocates have not widely made a distinction. For purposes of this discussion, we will use the terms that our sources use. Citing the World Health Organization, the Kaiser Family Foundation sets out these factors as social determinants of health: • Economic stability (employment, income, debt, bills, etc.) • Neighborhood and physical environment (safety, housing, transportation, recreation, walkability, etc.) • Education (literacy, language, level of education) • Food (hunger and access to decent food) • Community and social context (social integration, support, involvement in the community, discrimination, etc.) [FN94] Health care system (coverage, access to providers, the level of the provider's cultural competence, etc.) Experts see a need to rebalance spending on clinical needs and social needs. According to some experts, the United States spends more of its GDP on medical needs than most other developed countries but does not experience better health outcomes (and sometimes experiences worse outcomes). On the other hand, our spending on other social services is considerably less than other [FN95] developed countries. The question is how to effectively add health-related social supports to programs like Medicaid. The Commonwealth Fund has released a brief describing various ways that states can enable Medicaid managed care organizations and their providers to offer health-related social supports. The organization offers six strategies, and it discusses at length the pros and cons of each: We identify the following options: 1) classify certain social services as covered benefits under the state's Medicaid plan; 2) explore the additional flexibility afforded states through Section 1115 waivers; 3) use value-based payments to support provider investment in social interventions; 4) use incentives and withholds to encourage plan investment in social interventions; 5) integrate efforts to address social issues into quality improvement activities; and 6) reward plans through higher rates for effective investments in social interventions. [FN96] The brief also includes brief descriptions of strategies used in Arizona and Oregon. The Commonwealth Fund has worked with other health policy leaders to release “The Evolving Roadmap to Address Social Determinants of Health,” which is an extensive library of tools, resources, guidance, and best practices. Many of the resources focus on Medicaid's potential for addressing social problems, lessons learned from Medicaid initiatives, and so forth. The roadmap focuses on six areas that are deemed to be “drivers” for successfully addressing social needs in clinical settings. These drivers are: • patient identification and screening; • navigation and resource connections; • social health team and workflow; • data and evaluation • community partnerships; © 2020 Thomson Reuters. No claim to original U.S. Government Works. -12- [FN97] • leadership and change management 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 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 [FN98] to quality performance, and are required to use Certified Electronic Health Record Technology. CMS indicated that it was 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 [FN99] doctors and patients. [FN100] The model qualifies as an Advanced Alternative Payment Model under the Quality Payment Program. It is currently in Model Year 2. In early 2019, CMS announced that it planned to accept 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 [FN101] participants. CMS indicated that it does not at this time anticipate opening up applications for Model Year 4 or 5. The agency has [FN102] now published the clinical episodes for Model Year 3. The Medicare Diabetes Prevention Program Expanded Model According to CMS, about one-quarter of adults aged 65 or older have diabetes, and the incidence of the disease is expected to grow dramatically for all adults if the trend continues. The high rate of diabetes in Medicare patients costs the program billions of dollars that it would not have to spend if the disease could be prevented. The good news is that Type 2 diabetes can often be prevented or delayed with appropriate health behavior changes. To help prevent the disease, CMS has launched the Medicare Diabetes Prevention Program (MDPP) Expanded Model, which builds on Diabetes Prevention Program (DPP) model test. DPP was tested through Health [FN103] Care Innovations Awards. CMS explains how the model works: The Medicare Diabetes Prevention Program expanded model is a structured intervention with the goal of preventing type 2 diabetes in individuals with an indication of prediabetes. The clinical intervention consists of a minimum of 16 intensive “core” sessions of a Centers for Disease Control and Prevention (CDC) approved curriculum furnished over six months in a group-based, classroom-style setting that provides practical training in long-term dietary change, increased physical activity, and behavior change strategies for weight control. After the completing the core sessions, less intensive follow-up meetings furnished monthly help ensure that the participants maintain healthy behaviors. The primary goal of the expanded model is at least 5 percent weight loss by participants. The National DPP is based on the results of the Diabetes Prevention Program (DPP) study funded by the National Institutes of Health (NIH). The study found that lifestyle changes resulting in modest weight loss sharply reduced the development of type 2 diabetes in people at high risk [FN104] for the disease. CMS Administrator Seema Verma stated in a blog post that suppliers eligible to participate include not only traditional health care providers but community-based organizations, which can participate in Medicare to provide these preventive services after receiving [FN105] [FN106] recognition from the CDC. One hundred fifty-seven participants have now been named. Integrated Care for Kids Model The federal government is in high gear enacting legislation, implementing policy, and introducing new models to combat the opioid problem in the United States. The Center for Medicare and Medicaid Innovation (the Innovation Center) has now launched a new [FN107] accountable payment and delivery model to improve Medicaid and CHIP behavioral health services for children (individuals [FN108] under age 21). Included under the category of behavioral health is misuse of opioids and other substances. A crucial aim of the model is early identification in a wide variety of settings in addition to a clinical setting. Personnel in schools, the child welfare system, © 2020 Thomson Reuters. No claim to original U.S. Government Works. -13- [FN109] and the foster care system may be the first to see risk factors. The goals of the program are to improve child health (including preventing substance abuse problems); reducing avoidable in-patient stays and out-of-home placements; and developing sustainable [FN110] alternative payment models (APMs). The Innovation Center believes that these goals can be met through these interventions: Early identification and treatment of children with multiple physical, behavioral, or other health-related needs and risk factors through population-level engagement in assessment and risk stratification. Integrated care coordination and case management across physical health, behavioral health, and other local service providers for children with health needs impacting their functioning in their schools, communities, and homes. Development of state-specific APMs [alternative payment models] to align payment with care quality and supporting accountability [FN111] for improved child health outcomes and long-term health system sustainability. (Emphasis in original.) Two types of participants will be involved in the model: state Medicaid agencies, which will provide the infrastructure for information sharing, provide data, and develop the APM, among other things; and Lead Organizations. The Innovation Center describes the duties of the Lead Organizations: Lead Organizations will convene community partners to integrate coordination and management of the InCK Model's core child services for the attributed population. The Lead Organization will be accountable for improving population-level care quality and outcomes and developing service integration protocols and processes. HIPAA-covered entities, including state Medicaid agencies, will be eligible to serve as Lead Organizations. (Emphasis in original.) [FN112] The Innovation Center announced the model in July 2018 and has just posted materials from the overview webinar. The program [FN113] will begin after a two-year pre-implementation period, and once it begins, it will last five years. Applications are currently under [FN114] review. B. Patient-Centered Medical Homes and Health Homes The Affordable Care Act spurred renewed interest in patient-centered medical homes (PCMHs). The Robert Wood Johnson Foundation points out the various ways that the Affordable Care Act encourages PCMH model-care: relying on the model in accountable care organizations; testing the PCMH model with demonstrations run by the Innovation Center; covering PCMH care through Medicaid; [FN115] allowing private health plans to provide coverage through a PCMH plan; and requiring insurers to report if they cover PCMHs. According to the National Academy on State Health Policy, as of 2015, 46 states and the District of Columbia have policies and [FN116] programs in place to encourage PCMHs in their Medicaid and/or CHIP programs. The Primary Care Collaborative describes the work of a patient-centered medical home: The patient-centered medical home (PCMH) is a model of care in which patients are engaged in a direct relationship with a chosen provider who coordinates a cooperative team of healthcare professionals, takes collective responsibility for the comprehensive integrated care provided to the patient, and advocates and arranges appropriate care with other qualified providers and community [FN117] resources as needed. In 2007, the American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American Osteopathic Association, jointly developed seven principles for medical homes. Briefly, they are: • Personal physician – each patient has an ongoing relationship with his or her own physician who is the point of first contact and who delivers “continuous and comprehensive care” • Physician directed medical practice – the personal physician leads a team that collectively cares for the patient • Whole person orientation – the personal physician either provides or arranges for others to provide care through all stages of life, including acute and chronic care, preventive care, and end-of-life care • Care is coordinated and/or integrated – care is coordinated across various practice settings (including, for example, subspecialty care, hospital care, home health care, and nursing home care) and within the patient's community (family and public and private community-based settings); coordinated care is accomplished through the use of registries and health IT (including the exchange of health IT) to ensure that patients get the care they need, when and where they need it, and in a culturally appropriate manner. • Quality and safety are paramount – patients are active participants in their care; care is given through the use of evidence-based practices; communication with the patient is important, as is patient education; and practices voluntarily submit to a recognition process, among other things • Enhanced access – patients should have greater access to care through expanded office hours, open scheduling, and alternative means of communication among patients and the medical staff [FN118] • Payment – recognizes the “added value” to the patient from a patient-centered medical home © 2020 Thomson Reuters. No claim to original U.S. Government Works. -14- Related to PCMHs are “health homes.” Section 2703 of the Affordable Care Act created a state option in Section 1945 of the Social Security Act for Medicaid Health Homes to coordinate care for Medicaid participants who: • Have 2 or more chronic conditions • Have one chronic condition and are at risk for a second • Have one serious and persistent mental health condition The chronic conditions listed in the Act include mental health, substance abuse, asthma, diabetes, heart disease and being overweight. States may request CMS approval to amend their State Plans to include other conditions, like HIV/AIDS. States will receive a 90-10 match rate for health home services for the first two years. Health home services include: • Comprehensive care management • Care coordination • Health promotion • Comprehensive transitional care/follow-up • Patient & family support [FN119] • Referral to community & social support services CMS lists the states that currently have approved State Plan Amendments for health homes: California, Connecticut, Delaware, the District of Columbia, Iowa, Maine, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Oklahoma, Rhode Island, South Dakota, Tennessee, Vermont, Washington, West Virginia, and Wisconsin. Some states have more than one [FN120] amendment or have amendments for specified purposes. CMS has published resources providing guidance on the Health Home Medicaid State Plan Option. First, CMS has provided an FAQ document covering various definitions; enrollment and certification standards; the provider delivery system; quality measurement and [FN121] evaluation; and payment. Other documents added to the Health Home Resource Center include a health home map; a Fact Sheet; a health home State Plan Amendment Overview by state; and an FAQ sheet with a list of chronic conditions that states have [FN122] been approved to target. C . Home- and Community-Based Services The Affordable Care Act emphasizes home- and community-based services (HCBS) for Medicaid participants, including the elderly and persons with physical or cognitive disabilities or mental illness. The idea is to care for seniors and the disabled close to where they live – in a community setting instead of an institutional setting. In 2013, the government reached the point where it is now spending more [FN123] on HCBS than on institutional care. The preference for home- and community-based services is also evident in the increasing number of states that are expanding the number of people they serve in the community. According to the Kaiser Family Foundation's annual budget survey for fiscal years 2019 and 2020, 48 states in 2019 and 47 in 2020 are employing one or more strategies to [FN124] increase the number of Medicaid participants served in a home or community setting. Most are using a HCBS waiver and/or a state plan option under Section 1915 of the Social Security Act. [FN125] The final rule for HCBS required states to submit a transition plan to CMS demonstrating that they brought existing HCBS settings into compliance with the final rule. CMS recognized at that time that the transition would be complex, so it gave states five years to do so. The original due date was March 17, 2019. In a new Informational Bulletin, CMS announced that it is extending the [FN126] deadline for another three years, until March 16, 2022. HCBS cannot be offered in an institution-like setting. Certain settings are presumptively institutional. They include: • Settings that are located in a building that is also a publicly or privately operated facility that provides inpatient institutional treatment; • Settings that are in a building located on the grounds of, or immediately adjacent to, a public institution; and • Any other settings that have the effect of isolating individuals receiving Medicaid home and community-based services (HCBS) from [FN127] the broader community of individuals not receiving Medicaid HCBS. Settings that are presumptively institutional must undergo a heightened scrutiny process to overcome the presumption. In 2019, CMS published guidance in the form on an FAQ document that addresses the heightened scrutiny process for HCBS settings. CMS explains, The FAQs discuss settings identified by the regulation as being presumed to have the qualities of an institution, unless CMS determines through a heightened scrutiny review that the settings do not have the qualities of an institution and that the settings do have the qualities of home and community based settings. The FAQs focus on settings that have “the effect of isolating individuals receiving Medicaid [Home and Community-Based Services] HCBS from the broader community of individuals not receiving Medicaid HCBS.” [FN128] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -15- The guidance also addresses these two issues: whether an individual's private residence should be assessed for compliance with the settings criteria, and whether an individual should [FN129] reside in a compliant setting in order to receive Medicaid reimbursement for non-residential HCBS. Parts of the guidance replace or supplement previous HCBS guidance; CMS indicates where this is the case. CMS also issued guidance in 2019 specifically addressing the heightened scrutiny process for newly constructed settings or those under development. CMS addressed this matter in earlier guidance published in 2016 and explained that CMS could only determine whether a setting overcame its institutional presumption after the facility was in use and occupied by Medicaid participants who were receiving services there: We explained that our determination would consider factors beyond the physical structure of the setting itself to include considerations of how individuals residing or receiving services in the setting actually experience the setting in a manner that promotes independence and community integration. CMS cannot properly consider the factors that go beyond physical structure until the facility is operational [FN130] and services are actually being provided to individuals. In August 2019, CMS issued new guidance revising the earlier guidance to allow states to submit a new setting to CMS for heightened [FN131] scrutiny review while only non-Medicaid individuals are receiving services there. The new guidance sets out the specific revisions to the earlier guidance, including a timeline for Medicaid approval under the new process. Safety in HCBS settings is vital. In 2018, CMS released a report making recommendations to ensure safety in certain HCBS environments. In January 2018, three agencies within HHS - Administration for Community Living, Office for Civil Rights, and Office of Inspector General – released a report titled, “Ensuring Beneficiary Health and Safety in Group Homes through State Implementation of Comprehensive Compliance Oversight.” The report was compiled after the Office of the Inspector General conducted audits in four states to determine how they were ensuring the health and welfare of those with developmental disabilities living in group homes. The report made three recommendations for doing so. The recent guidance from the Center for Medicaid and CHIP Services (CMCS) focuses on one of those suggestions: “[E]ncourage states to implement compliance oversight programs for group homes, such as the Model Practices, and regularly report to CMS.” CMCS' guidance touches on model practices in four areas: incident management and [FN132] investigation, incident management audits, mortality reviews, and quality assurance. CMS explains why it is committed to this cause: At the outset, CMS acknowledges that ensuring high quality HCBS [home-and community-based services] to Medicaid beneficiaries is a shared goal among our state partners, provider communities, beneficiaries and their families and caregivers, and other stakeholders. [FN133] Medicaid-funded HCBS play a critical role in facilitating beneficiary independence and community participation. The guidance does not rescind or supplant any previous guidance on home- and community-based services. CMCS encourages state Medicaid programs and providers to become familiar with the report's model practices. The guidance notes the potential for enhanced [FN134] matching funds for states that will work to implement these model practices. This is the first in a series of guidance documents that will address health and safety. CMS has offered states the opportunity to implement some federally-developed HCBS programs. One such program is the Community First Choice Option (CFC), which can be approved as a Section 1915 waiver. Under the Affordable Care Act, states choosing this option receive a 6% bump in their Medicaid federal matching funds to design programs that provide community-based attendant [FN135] services and supports to those who would otherwise be institutionalized. Services that fall under the CFC program include such things as attendant services to help with daily living activities (e.g., eating, toileting, grooming, dressing, and bathing), instrumental activities of daily living (e.g., meal preparation, managing finances, and transportation); and health-related tasks, (e.g., catheterization, range of motion exercises, and medication administration). Other personal services, plus the cost of moving patients back into the [FN136] community from an institution, may also be covered. Currently, only five states have an approved State Plan Amendment for a [FN137] CFC program. CMS has provided guidance in the form of a State Medicaid Director Letter for states wishing to implement the CFC Option for providing home- and community-based services. CMS explains in the guidance: The purpose of the CFC option is to provide individuals meeting an institutional level of care the opportunity to receive necessary personal attendant services (PAS) and supports in a home and community-based setting. The CFC option expands Medicaid opportunities for the provision of home and community-based long-term services and supports (LTSS) and is an additional tool that states can use to facilitate community integration while receiving enhanced Federal match of six (6) additional percentage points for [FN138] CFC services and supports. [FN139] The guidance includes a link to a State Plan Amendment template and a technical guide for Community First Choice. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -16- PACE is both a Medicare and Medicaid program. To be eligible, one must be 55 or older, live in the service area of a PACE organization, be eligible for nursing home care, and be able to live safely in the community instead of in a nursing facility. PACE is an [FN140] optional Medicaid benefit, and not every state offers it. According to Medicaid.gov, PACE, provides comprehensive medical and social services to certain frail, community-dwelling elderly individuals, most of whom are dually eligible for Medicare and Medicaid benefits . An interdisciplinary team of health professionals provides PACE participants with coordinated care. For most participants, the comprehensive service package enables them to remain in the community rather than receive care in a nursing home. Financing for the program is capped, which allows providers to deliver all services participants need rather than only those reimbursable under Medicare and Medicaid fee-for-service plans. PACE is a program under Medicare, and states can elect to provide PACE services to Medicaid beneficiaries as an optional Medicaid benefit. The PACE program becomes the [FN141] sole source of Medicaid and Medicare benefits for PACE participants. CMS published a final rule in 2019 that updates PACE. According to CMS, the final rule updates the program by: • Strengthening protections and improving care for PACE participants; and [FN142] • Providing administrative flexibility and regulatory relief for PACE organizations The final rule is published at 84 F.R. 25610-01 (June 3, 2019). Finally, the Money Follows the Person program helps people transition from institutions to home- and community-based settings. [FN143] Funding for the program ended in 2016, but any funds authorized in 2016 may be used until 2020. House Bill 259 (2017 FD H.B. 259 (NS)), the Medicaid Extenders Act, extends the demonstration until September 30, 2021. However, the act contains a special rule for 2019: The extended funding will only apply to states that had an approved program as of December 31, 2018. D. Care for High-Cost, High-Need Patients The government is keen on integrating care and aligning incentives and payments for the so-called dual eligibles – those who are eligible for both Medicare and Medicaid. CMS explains that some of these people qualify first for Medicare based on their age or disability and then additionally qualify for Medicaid based on their income. The opposite may be true as well. Of all dual eligibles, only 10% are receiving care in a program that integrates services between Medicare and Medicaid. Others must navigate the murky waters between two programs that have different benefits, services, and payment structures. CMS believes that better aligning the two [FN144] programs could improve care for this population and save federal health care dollars. The estimates vary, but approximately ten [FN145] to twelve million individuals fit in this category. CMS has always been concerned about this population because they tend to be sicker and suffer from multiple chronic illnesses: Forty-one percent of dually eligible individuals have at least one mental health diagnosis, 49 percent receive long-term care services [FN146] and supports (LTSS), and 60 percent have multiple chronic conditions. Because of their poor health, dual eligible have historically been disproportionate users of federal health care funds. According to CMS: In 2012, Medicare-Medicaid enrollees accounted for 20 percent of Medicare enrollees, yet 34 percent of Medicare spending. The same [FN147] individuals comprised only 15 percent of Medicaid enrollees but represented 33 percent of Medicaid spending. CMS is hoping to provide better, less costly care to these individuals through several initiatives, including the Medicare-Medicaid Financial Alignment Initiative. In this program, the federal government partners with states to integrate care for these patients and align Medicare and Medicaid payments and incentives. The initiative uses two models: • Capitated Model: A State, CMS, and a health plan enter into a three-way contract, and the plan receives a prospective blended payment to provide comprehensive, coordinated care. • Managed Fee-for-Service Model: A State and CMS enter into an agreement by which the State would be eligible to benefit from [FN148] savings resulting from initiatives designed to improve quality and reduce costs for both Medicare and Medicaid. [FN149] Thirteen states are participating. CMS has released multiple reports from various states. Please see the initiative's web page for more information. In 2018, CMS issued a State Medicaid Director Letter that outlines ten opportunities for states to better care for dual eligibles, none of which, according to CMS, requires complex demonstrations or waivers. These include: • State contracting with D-SNPs [dual eligible special needs plans] • Default enrollment into a D-SNP • Passive enrollment to preserve continuity of integrated care • Integrating care through PACE [Programs for All-inclusive Care for the Elderly] • Reducing the administrative burden in accessing Medicare data for use in care coordination © 2020 Thomson Reuters. No claim to original U.S. Government Works. -17- • Program integrity opportunities • MMA [Medicare Prescription Drug, Improvement and Modernization Act] file timing • State buy-in file data exchange • Improving Medicare Part A buy-in [FN150] • Opportunities to simplify eligibility and enrollment CMS explains more fully about each opportunity in the State Medicaid Director Letter. In a 2019 State Medicaid Director Letter, CMS informs states about new and existing opportunities to improve care for dual eligibles [FN151] by better aligning the two programs and integrating care. Two of these models already exist. They are the capitated financial alignment model and the managed fee-for-service model, both of which are a part of the Medicare-Medicaid Financial Alignment Initiative, but CMS is willing to make revisions to the program to better suit both existing and new participants. Some of the revisions are based on experience with the initiative to date. CMS also offers a third opportunity, which would allow states to design their own models. The agency gives some guidance on what it would like to see in these new designs: States could consider approaches broadly applicable to all dually eligible individuals or focus on certain segments of the population, such as people using LTSS, younger people with disabilities, and/or people living in rural areas. These approaches could build off elements from the FAI [Financial Alignment Initiative] demonstrations or other types of delivery system reforms including alternative payment methodologies, value-based purchasing, or episode-based bundled payments. An important priority for the Innovation Center [FN152] and across CMS is addressing social determinants of health. The new State Medicaid Director Letter complements CMS' December 2018 letter, which reminded states about existing opportunities [FN153] for better caring for dual eligibles. E. The Fight Against Addiction CMS is committed to addressing the problems with all drug abuse, including opioid abuse. The health care costs of these problems are [FN154] staggering, and Medicaid is one of the largest payers for treatment in the country. In addition to actual health care costs, drug abuse problems have high societal costs as they inevitably lead to higher criminal justice involvement and lower workplace productivity. [FN155] In a State Medicaid Director letter, CMS cited statistics demonstrating the gravity of the problem with substance use disorder (SUD), particularly with opioid misuse and addiction. After a grim discussion of the increase in overdose deaths, CMS indicates that only about 20% of those with an opioid use disorder (OUD) actually receive treatment, despite the availability of effective evidence- based treatments. CMS recites this statistic about Medicaid participants in particular: Medicaid beneficiaries tend to have higher rates of OUD than the general population, comprising about 25 percent of adults with OUD [FN156] in 2015. However, only about 32 percent of Medicaid beneficiaries with OUD received treatment in 2015. To address these problems, CMS announced in the letter a new policy for addressing the opioid problem that it describes as a “more flexible, streamlined approach to accelerate states' ability to respond to the national opioid crisis while enhancing states' monitoring and reporting of the impact of any changes implemented through these demonstrations.” The new policy replaces the previous SUD Section [FN157] 1115 demonstration initiative announced in a State Medicaid Director Letter on July 27, 2015. In a Press Release announcing the new policy, CMS explained: Previously, states had been required to build out their entire delivery system for SUD treatment while also meeting rigid CMS standards before Medicaid demonstration approvals could be granted. The new policy will allow states to provide greater treatment options while [FN158] improving their continuum of care over time. Under the new policy, CMS is encouraging states to develop Section 1115 waiver demonstrations that over a five-year period significantly contribute to improvement on six goals and six milestones. The goals are: 1. Increased rates of identification, initiation, and engagement in treatment; 2. Increased adherence to and retention in treatment; 3. Reductions in overdose deaths, particularly those due to opioids; 4. Reduced utilization of emergency departments and inpatient hospital settings for treatment where the utilization is preventable or medically inappropriate through improved access to other continuum of care services; 5. Fewer readmissions to the same or higher level of care where the readmission is preventable or medically inappropriate; and 6. Improved access to care for physical health conditions among beneficiaries. The milestones are: 1. Access to critical levels of care for OUD and other SUDs; © 2020 Thomson Reuters. No claim to original U.S. Government Works. -18- 2. Widespread use of evidence-based, SUD-specific patient placement criteria; 3. Use of nationally recognized, evidence-based SUD program standards to set residential treatment provider qualifications; 4. Sufficient provider capacity at each level of care; 5. Implementation of comprehensive treatment and prevention strategies to address opioid abuse and OUD; and [FN159] 6. Improved care coordination and transitions between levels of care. The letter suggests a timeframe for reaching each milestone, and it lists performance measures for each goal. As with the policy announced in the July 2015 State Medicaid Director Letter, CMS indicates in this letter that it will waive the IMD (institutions for mental disease) exclusion when treatment in such facilities supplements and coordinates with community-based care in a state-implemented [FN160] continuum of care system. When CMS announced the new policy in a press release, it also announced that it had approved demonstrations under the new policy in New Jersey and Utah. CMS described the New Jersey demonstration in the press release: Under the new CMS demonstration policy, New Jersey will provide a comprehensive and coordinated SUD benefit to adults and children while also allowing for the continuum of SUD services provided to Medicaid beneficiaries who reside in residential treatment facilities. The services covered as part of the SUD benefit will include residential treatment, withdrawal management, medication- [FN161] assisted treatment, peer supports and targeted case management. The Utah demonstration ties in SUD services with a continuum of care that addresses social needs as well. The program is a part of a broader reform effort that includes efforts to reach and help those with chronic homelessness and those involved in the criminal justice [FN162] system. The new policy responds to the President's urging for new policy when he declared the opioid crisis a national public health emergency. According to CMS, previous policy ignored the pressing nature of the opioid problem and put onerous requirements on states that prevented people from getting treatment. CMS also believes that the new policy significantly improves its ability to evaluate whether [FN163] demonstrations are having the intended effect. As mentioned, the Trump Administration's new policy evinces a willingness to waive the Medicaid IMD exclusion, and Congress has acted to do so as well. In 2019, 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 of the act enacted a new section of the Social Security Act, Section 1915(l), which created an exception to 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 diagnosis. Among [FN164] other things, the letter specifically defines which individuals and IMDs are eligible under the exception. Administratively, 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); this demonstration also tests a limited exception to the IMD exclusion. CMS described the opportunity in a State Medicaid Director Letter: 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 [FN165] community-based mental health care. CMS has now announced that it approved such 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 opioid-related overdoses from 2014 to 2017. Often, individuals with a substance use disorder also suffer from a serious mental [FN166] illness, so CMS and the district see the potential for saving thousands of lives. Enhanced federal funding may be available for health homes that treat individuals with a Substance Use Disorder. The SUPPORT [FN167] for Patients and Communities Act extended the 90% FMAP (Federal Medical Assistance Percentage, or match rate) for certain [FN168] health homes for individuals suffering with a Substance Use Disorder. A new CMCS Informational Bulletin advises states on how they can request this extended enhanced funding. CMCS also explains the circumstances under which the funds are available: The extension of the enhanced FMAP period is available only for expenditures for the provision of health home services to “SUD- eligible individuals” under a “SUD-focused state plan amendment” (both terms are defined by the statute) that was approved by the Secretary on or after October 1, 2018. States whose health homes meet those criteria may request that the Secretary extend the © 2020 Thomson Reuters. No claim to original U.S. Government Works. -19- enhanced FMAP period beyond the first 8 fiscal year quarters, for the subsequent 2 fiscal year quarters, for a total of 10 fiscal year quarters from the effective date of the state plan amendment. States interested in this opportunity should submit a proposal for a new SUD-focused health home state plan amendment along with a letter of request for an extension of the period of enhanced FMAP. [FN169] New reporting requirements accompany the extended enhanced funds. The Informational Bulletin also includes FAQs. In late 2019, CMS added two new reporting measures for these health homes. They are: (1) Use of Pharmacotherapy for Opioid Use Disorder [FN170] (2) Follow-Up After Emergency Department Visit for Alcohol and Other Drug Abuse or Dependence (FUA-AD). However, CMS advises that, unless and until CMS makes specific measures mandatory through rulemaking, states are not required to use any of the CMS-provided health home measures, although states with an extension of the enhanced FMAP period for a SUD focused health home SPA must [FN171] submit the statutorily required reports. VIi. selected legislative Activity • President Donald Trump (R) signed the Medicaid Extenders Act (2019 FD H.B. 259 (NS)) on January 24, 2019. Section 2 of the bill extends funding for the Money Follows the Person program until September 30, 2021. In 2019, the funds only extend to states that had an approved program in place on December 31, 2018. Section 3 extends protections against spousal impoverishment for Medicaid participants receiving home- and community-based services, and Section 4 reduces the federal medical assistance percentage (FMAP) after 2020 for states that do not have an asset verification program in place. Finally, Section 5 makes changes to appropriations for the Medicaid Improvement Fund. • Introduced in the Senate on February 4, 2019, Senate Bill 317 (2019 FD S.B. 317 (NS)), the Advancing Care for Exceptional Kids Act of 2019 (the ACE Kids Act) would amend the Social Security Act to allow states the option to provide coordinated care in a health home for children with complex medical conditions. The opening paragraph of the bill explains the thrust of the act: [A] State, at its option as a State plan amendment, may provide for medical assistance under this title to children with medically complex conditions who choose to enroll in a health home under this section by selecting a designated provider, a team of health care professionals operating with such a provider, or a health team as the child's health home for purposes of providing the child with health home services. The primary sponsor of the bill is Senator Chuck Grassley (R-Iowa). • In Congress, 2019 FD H.B. 555 (NS) would prohibit discrimination against disabled individuals needing long-term services and supports. Essentially, the act seeks to ensure that people with disabilities are not denied the best environment for their needs. Two of the act's goals are: (3) to ensure that States provide long-term services and supports to individuals with disabilities in a manner that allows individuals with disabilities to live in the most integrated setting, including the individual's own home, have maximum control over their services and supports, and ensure that long-term services and supports are provided in a manner that allows individuals with disabilities to lead an independent life; (4) to establish a comprehensive State planning requirement that includes enforceable, measurable objectives that are designed to transition individuals with all types of disabilities at all ages out of institutions and into the most integrated setting[.] States would be required to create plans to carry out the act's directives. For ten years, the federal government would annually evaluate [FN172] whether states or other public entities are complying with the act. If they are, they may be eligible for a bump in their FMAPs for the costs of providing home-and community-based services under either the State Plan or a waiver. The bill has a long list of bipartisan sponsors. Senate Bill 117 (2019 FD S.B. 117 (NS)) is a related bill. • In Congress, 2019 FD H.B. 1839 (NS) will enact the Medicaid Services Investment and Accountability Act of 2019, which makes several changes in Medicaid policy. Among other things, the bill extends spousal impoverishment protections for patients receiving home- and community-based services by amending the newly-enacted Medicaid Extenders Act of 2019. It also establishes an option for states to provide coordinated care through a health home for children with medically complex conditions; adds funding for the Money Follows the Person Demonstration; adds provisions to prevent drug misclassification in the Medicaid Drug Rebate Program; and denies federal funding for vacuum erection systems and penile prosthetic implants under certain circumstances. The primary sponsor of the bill, which was introduced on March 21, 2019, is Raul Ruiz (D-Cal.). The President signed the bill on April 18, 2019. • In the Senate, 2019 FD S.B. 824 (NS), the Excellence in Mental Health and Addiction Treatment Expansion Act, would increase the number of states that may participate in the Community Mental Health Demonstration Program. The program, which is administered by the Substance Abuse and Mental Health Services Administration (SAMHSA), was originally limited to eight states. If this bill passes, 11 [FN173] more states would be selected to participate in a two-year demonstration. Senate Bill 824 was introduced on March 14, 2019. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -20- • Senate Bill 1323 (2019 FD S.B. 1323 (NS)), which was introduced on May 6, 2019, would develop a system to collect information about social determinants of health that might affect outcomes in the Medicare, Medicaid, and CHIP programs. In Medicaid, the bill would require the Health and Human Services Secretary to make available to states a model uniform reporting field that states could use to report information on social determinants of health through the Transformed Medicaid Statistical Information System. The bill lists a non-exhaustive list of what the reporting must cover, including for example, lower education levels and low literacy, unemployment, lack of secure housing, problems with social environment, and involvement with the criminal justice system. The bill explains what the government would do with the information collected: Not later than 5 years after the date of the enactment of this subparagraph, the Secretary shall submit to Congress a report that includes aggregate findings and trends across respective beneficiary populations for improving the identification of health care disparities for beneficiaries under this title and beneficiaries under title XXI based on analyses of the data collected . . . . The primary sponsor of the bill, which would enact the Utilizing National Data, Effectively Reforming Standards and Tools, to Address Negative Determinates of Health (UNDERSTAND) Act, is Senator Rob Portman (R-Ohio). Senator Portman explains the purpose of the bill on his web site: The correlation between socio-economic status and health outcomes has been known for years, and the UNDERSTAND Act seeks to further this understanding by collecting information related to these disparities for Medicare and Medicaid beneficiaries, who represent the nation's most vulnerable. By identifying the needs of these groups, the UNDERSTAND Act will provide Congress with information [FN174] and national data necessary to better inform future legislation. • House Bill 1856 (2019 FD H.B. 1856 (NS)) aims to end homelessness. A provision in the bill would direct the federal government, in using the funds to be allocated under the bill, to strive to: (1) help states and localities align and integrate funding for Medicaid, behavioral health providers, and housing providers; and (2) engage State Medicaid directors, governors, state housing and homelessness agencies, and other relevant state offices and local government entities to help States increase use of their Medicaid programs to finance supportive services for homeless people. • 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, and spousal impoverishment protections for participants receiving home- and community-based services. The president signed the bill on August 6, 2019. • House Bill 3910 (2019 FD H.B. 3910 (NS)) would enact the Equality in Medicare and Medicaid Treatment Act of 2019. The bill seeks to improve access to care for Medicare and Medicaid participants through models tested by the Center for Medicare and Medicaid Innovation that address health disparities and social determinants of health. The bill states that before model selection, the Health and Human Services Secretary must consult with CMS' Office of Minority Health, the Federal Office of Rural Health Policy, and the Office on Women's Health. The bill was introduced on July 23, 2019. • Senator Marsha Blackburn (R-Tenn.) is sponsoring 2019 FD S.B. 2408 (NS), which would enact the Telehealth Across State Lines Act of 2019. The act seeks to establish the National Telehealth Program to develop uniform best practices with the ultimate objective of providing quality telehealth services in rural areas across the country in five years. The program would also include grants in fiscal years 2020 to 2024 to expand telehealth in rural areas. Finally, the bill calls for a Center for Medicare and Medicaid Innovation model to provide incentives to encourage telehealth in rural areas. The bill, which was introduced on July 31, 2019, is co-sponsored by Senator Kevin Cramer (R-N.D.). • In Congress, 2019 FD H.B. 4004 (NS) would direct the Secretary of the Department of Health and Human Services to establish an interagency council to be called the Social Determinants Accelerator Interagency Council. The findings supplied with the bill explain the need for such an entity: (1) There is a significant body of evidence showing that economic and social conditions have a powerful impact on individual and population health outcomes and well-being, as well as medical costs. (2) State, local, and Tribal governments and the service delivery partners of such governments face significant challenges in coordinating benefits and services delivered through the Medicaid program and other social services programs because of the fragmented and complex nature of Federal and State funding and administrative requirements. (3) The Federal Government should prioritize and proactively assist State and local governments to strengthen the capacity of State and local governments to improve health and social outcomes for individuals, thereby improving cost-effectiveness and return on investment. Representative Cheri Bustos (D-Ill.) is the primary sponsor of the bill, which has bipartisan co-sponsors. A press release on Busto's web site explains why the congresswoman thinks the bill is important: This legislation would create a federal grant program to empower states and local governments to tackle persistent economic and social conditions — like limited access to health care providers, stable housing, reliable transportation and healthy foods — that often [FN175] hinder health outcomes. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -21- • Senate Bill 1880 (2019 FD SB 1880 (NS)) and House Bill 3649 (2019 FD H.B. 3649 (NS)) would direct the HHS Secretary to issue guidance to states on treatment family care services. The bills define these services as, structured daily services and interventions provided in a home-based setting for children who have not attained age 21, and who, as a result of mental illness, other emotional or behavioral disorders, medically fragile conditions, or developmental disabilities, need the level of care provided in a psychiatric residential treatment or congregate care facility the cost of which could be reimbursed under the State Medicaid program or the title IV-E program but who can receive services in a family-based setting. The required guidance would advise states on existing opportunities and flexibilities for providing these services in Medicaid and Part E of Title IV of the Social Security Act and on ways to employ and coordinate funding in these programs to support states in providing these services. Senator Tammy Baldwin (D-Wis.) and others are sponsoring the Senate bill, which was introduced on June 19, 2019, and Representative Peter Welch (D-VT) and others are sponsoring the House bill. • Introduced on September 18, 2019, and sponsored by Representative Eric Swalwell (D-Calif.) and others, House Bill 4393 (2019 FD H.B. 4393 (NS)) would provide a state option for covering genetic and genomic testing for children to improve treatment and outcomes. st st Representative Swalwell explains in a press release that the bill would allow the health care system to find “21 century cures with 21 century technology,” and he explains specifically what the bill would do: The Advancing Access to Precision Medicine Act would pilot-test whether Medicaid coverage of a variety of types of genetic and genomic sequencing for children can help settle their diagnostic challenges, improve clinical outcomes, and ultimately reduce program expenditures. It also would direct the Department of Health and Human Services to work with the National Academy of Medicine to study, utilizing the information gained from the Medicaid pilot-testing, how genetic and genomic testing may improve health outcomes [FN176] and how the federal government may reduce barriers to use of genetic and genomic testing. • Increasingly, the federal government and the states are recognizing that health outcomes are tied to social determinants. Representatives Lisa Blunt Rochester (D-De.) and Gus Bilirakis (R-De.) are sponsoring 2019 FD H.B. 4621 (NS), which would require the federal government to give guidance to the states in addressing social determinants of health in their Medicaid and CHIP programs. On her web site, Representative Blunt Rochester explains what the Collecting and Analyzing Resources Integral and Necessary for Guidance (CARING) for Social Determinants Act of 2019 would do, if enacted: The Blunt Rochester-Bilirakis legislation will provide guidance to State Medicaid programs regarding how to implement research-proven strategies to optimize social determinants of health under existing Medicaid authority or waivers, especially for pediatric populations. This legislation builds upon the success that some state Medicaid programs have already had since testing innovative delivery and [FN177] payment models designed to improve health outcomes while reducing costs. The bill would require the federal government to advise states about strategies for addressing social determinants of health, to advise states on how to encourage and offer incentives to managed care organizations to consider social determinants of health, and to offer [FN178] examples of how states are already addressing social determinants of health. • House Bill 4460 (2019 FD H.B. 4460 (NS)), which was introduced on September 24, 2019, would appropriate funds to carry out [FN179] various provisions of the SUPPORT for Patients and Communities Act. The SUPPORT Act was enacted to address the opioid crisis on several fronts. Among other things, House Bill 4460, sponsored by Ann McLane Custer (D-N.H.), would extend certain Medicaid delivery reform and incentive payment waivers to December 31, 2025 (or an earlier date selected by the state). The bill describes the waivers that would be eligible for extension: (b) Medicaid Section 1115 Waiver Described. The Medicaid section 1115 waiver described in this subsection is a waiver approved under section 1115 of the Social Security Act (42 U.S.C. 1315) relating to delivery system reform incentive payments that- (1) as of the date of enactment of this Act, is to terminate on or before December 31, 2020; (2) is in effect on the date of enactment of this Act; and (3) was approved for any State that ranks in the top quintile of all States in terms of the highest mean drug overdose death rate per 100,000 residents for the most recent 3-year period preceding the date of enactment of this Act for which data is available. • In the Senate, 2019 FD S.B. 2613 (NS) seeks to end homelessness through a variety of means. Section 6 of the bill is titled, “Technical Assistance Funds to Help States and Local Organizations Align Health and Housing Systems,” and it calls for the Secretary of Housing and Urban Development to use appropriated funds to help states align policies and funding among state Medicaid programs, behavioral health providers, and housing providers in order to create support for housing opportunities. Section 6 also calls for the Secretary to, engage State Medicaid program directors, Governors, State housing and homelessness agencies, any other relevant State offices, and any relevant local government entities, to assist States in increasing use of their Medicaid programs to finance supportive services for homeless individuals. Senate Bill 2613 was introduced on October 16, 2019, and it has Democratic sponsorship. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -22- • House Bill 4932 (2019 FD H.B. 4932 (NS)) would enact the Creating Opportunities Now for Necessary and Effective Care Technologies (or CONNECT) for Health Act of 2019. The purpose of the bill is to expand access to telehealth. In a press release, Representative Bill Thompson (R-Calif.), one of the bill's sponsors, discussed the need to increase access to telehealth, particularly in rural areas. According to the press release, studies have shown that telehealth is an effective and efficient way to deliver health care, especially in locales where there is a provider shortage, like in rural areas. Representative Thompson said, “Telehealth is a proven method of effectively and efficiently delivering health care to patients who need it, particularly in rural areas and regions with health care workforce shortages. I am proud to join my fellow Congressional Telehealth Caucus Co-Chairs to introduce the CONNECT Act . . . . This bipartisan bill introduced in both the House and Senate will help bring access to telehealth to more areas across our nation by expanding use to services like mental health and emergency care, improving the implementation process, including new sites that can provide telehealth care like Federally-qualified health centers, and helping providers better monitor [FN180] patients.” The bill has 15 sections, including sections on expanding the use of telehealth for mental health services; using telehealth for emergency services; using telehealth in rural clinics, federally-qualified health clinics, and Native American health facilities; and waiving telehealth restrictions during national emergencies, among others. Its companion in the Senate is 2019 FD S.B. 2741 (NS). • If passed in California, 2019 CA S.B. 207 (NS) would provide for Medicaid coverage of asthma prevention services. The findings supplied by the bill note that low-income individuals are more likely to suffer with asthma and the disease poses a significant public health problem. The services would include asthma education and services such as trigger assessments and remediation. The bill passed the Senate on May 22, 2019, and it was amended in the Assembly, most recently on August 15. • California Assembly Bill 1058 (2019 CA A.B. 1058 (NS)) was amended in the Senate on June 24, 2019. The bill calls for a stakeholder process for integrating mental health and substance abuse treatment. It requires a stakeholder group to be established, and it sets out how the group is to be composed. The stakeholder group would be directed to investigate the impediments to integrating mental health and substance use disorder services and to set forth recommendations. • In California, Governor Gavin Newsom (D) vetoed 2019 CA A.B. 166 (NS) on October 13, 2019. The bill called for a violence intervention pilot program that was hospital-based or hospital-linked, which would have been run in at least nine sites in the counties specified. As a part of the program, the state would have provided Medi-Cal violence prevention services to participants who met two conditions: (1) The beneficiary has received medical treatment for a violent injury, including, but not limited to, a gunshot wound, stabbing injury, or any other form of violent injury. (2) A licensed health care provider has determined that the beneficiary is at elevated risk of violent reinjury or retaliation and has referred the beneficiary to participate in a violence preventive services program. The Governor's veto message says, in part, The 2019 Budget Act provided $30 million in the General Fund for the California Violence Intervention and Prevention (CalVIP) Program, the largest investment in the program's history. I also signed AB 1603 (Wicks) which codifies the CalVIP in statute and increases the grant amount that can be distributed. Hospital-based violence intervention programs are eligible for grant funding through CalVIP. While I appreciate the legislature's intent to secure additional funding for these programs, these changes should be considered in the [FN181] annual budget process where we can have a comprehensive conversation about spending priorities for the Medi-Cal program. • Assembly Bill 744 (2019 CA A.B. 744 (NS)) has been adopted in California. The bill amends existing statutory provisions on Medi-Cal coverage of telehealth services. New language provides that face-to-face contact is not required for any telehealth services provided by asynchronous store-and-forward. Governor Gavin Newsom (D) signed the bill on October 13, 2019. • Also in California, 2019 CA S.B. 289 (NS) will allow a dependent or a spouse of active duty military personnel to remain on a waiting list for specified home- and community-based waiver services while the spouse or dependent is living in another state due to the military member's orders. Governor Newsomn signed the bill on October 12, 2019. • California Assembly Bill 1128 (2019 CA A.B. 1128 (NS)), which was adopted on October 12, 2019, relates to licensing for PACE [FN182] organizations. 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. • Colorado Senate Bill 222 (2019 CO S.B. 222 (NS)) has been adopted. The bill will allow the Medicaid program to provide incentives to behavioral health providers to accept patients with severe behavioral health disorders who are at risk of institutionalization in the criminal justice system. The current version of the bill provides, in pertinent part: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -23- (2) On or before July 1, 2021, the state department shall work collaboratively with managed care entities to create incentives for behavioral health providers to accept Medicaid recipients with severe behavioral health disorders. The incentives may include, but need not be limited to, higher reimbursement rates, quality payments to regional accountable entities for adequate networks, establishing performance measures and performance improvement plans related to network expansion, transportation solutions to incentivize Medicaid recipients to attend health care appointments, and incentivizing providers to conduct outreach to Medicaid recipients to ensure that they are engaged in needed behavioral health services, including technical assistance with billing procedures. The state department may seek any federal authorization necessary to create the incentives described in this subsection (2). The legislative finding included with the bill note the high rate of incarceration for people with several behavioral health disorders. Governor Jared Polis (D) signed the bill on May 20, 2019. • Connecticut House Bill 6681 (2019 CT H.B. 6681 (NS)) would have enacted statutory provisions allowing the Department of Social Services to establish a Medicaid pilot program to provide telemedicine services in a rural, underserved county where access to health care is impeded by transportation challenges. The bill was introduced on January 29, 2019. It failed to advance this session. • Florida Senate Bill 778 (2019 FL S.B. 778 (NS)) sought to set up a process for the Agency for Health Care Administration, in consultation with the Department of Elderly Affairs, to review and approve applications from entities seeking to deliver PACE (Program of All-Inclusive Care for the Elderly) services. The bill was introduced on March 5, 2019. It died in committee. • Citing the shortage of professionals and paraprofessionals available to provide mental health services, Florida Senate Bill 528 (2019 FL S.B. 528 (NS)) sought to create a framework for peer specialists to provide services for others suffering from addiction. In addition to defining “peer specialist,” the bill specified how peer specialists were to be screened, what kind of qualifications a peer specialist was required to have, and how peer specialists were to be reimbursed. The bill explained why peer specialists can provide important services to those struggling with addiction: 3. Peer specialists provide effective support services because they share common life experiences with the persons they assist. 4. Peer specialists promote a sense of community among those in recovery. 5. Research has shown that peer support facilitates recovery and reduces health care costs. Senate Bill 528 died in committee. • In Hawaii, 2019 HI S.B. 720 (NS), which was introduced on January 18, 2019, failed to pass. It would have expanded access to home- and community-based services for individuals who: (A) Require home care services more than twice weekly; (B) Do not have ready access to reliable transportation; and (C) Live thirty miles or more from the nearest hospital[.] • In Illinois, 2019 IL S.B. 27 (NS) would rewrite current statutory provisions and add new ones on insurance and Medicaid coverage of telehealth services. The new material would add definitions, set out the requirements for telehealth services, set out recordkeeping requirements, set out prohibitions on telehealth services, and address payment for such services. Senate Bill 27 was introduced on January 10, 2019. • Introduced in Indiana on January 14, 2019, 2019 IN S.B. 498 (NS) has been adopted. The bill will allow for the creation of a mobile integrated healthcare program. The program will allow reimbursement for mobile integrated health care, which the bill defines as: community based health care in which paramedics and emergency medical technicians employed by an emergency medical services provider agency function outside of customary emergency response and transport to do the following: (1) Facilitate more appropriate use of emergency care services. (2) Enhance access to: (A) primary care for medically underserved populations; or (B) underutilized and appropriate health care services. • Introduced in Iowa on March 4, 2019, 2019 IA S.F. 468 (NS) would have directed the Department of Human Services to issue requests for proposals from and enter into contracts with entities to implement a Medicaid managed fee-for-service value-based delivery model using an administrative services organization to coordinate physical and behavioral health services in the Medicaid program. The model would have replaced Medicaid managed care. It did not pass. • In Kansas, 2019 KS S.B. 208 (NS) would have made an appropriation to the Department for Aging and Disability Services and specified that some of the appropriated funds would have had to be used to increase Medicaid payments for providers of home- and community-based waiver services. The bill was introduced on February 20, 2019; it did not pass before adjournment. • In Maine, 2019 ME H.R. 1019 (NS) would direct the state Department of Health and Human Services to apply to CMS for a waiver to provide direct support services to individuals experiencing homelessness. The bill was introduced on March 26, 2019, and passed both houses. It has been carried over. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -24- • If passed in Maryland, 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 Minnesota, 2019 MN S.F. 1834 (NS) would have amended existing statutory language on Medicaid health homes and added new language setting out requirements for behavioral health home providers. New language would have also set out the requirements for discharging a patient from a behavioral health home. The bill was introduced on February 27, 2019. It did not pass this session. • Montana Governor Steve Bullock (D) signed 2019 MT H.B. 529 (NS) on April 18, 2019. The bill revises existing provisions related to waiting list for waiver services by adding this paragraph: (14) The [Department of Public Health and Human Services] shall establish by rule the procedures for moving a person from a waiting list for services provided through a Medicaid home and community-based services waiver into the waiver services, including the process and priorities to be used in making determinations related to the waiting list. The department may not modify the policies established in rule by adopting supplemental policies or procedures not subject to the administrative rulemaking process. • Nebraska Governor Pete Ricketts (R) signed 2019 NE L.B. 468 (NS) on May 31, 2019. The bill will prohibit adding long-term care services and supports to the Medicaid managed care program, including services of a skilled nursing facility, a nursing facility, an assisted-living facility, and home and community-based services, until July 1, 2020. The bill will also require that the Department of Health and Human Services notify the legislature before seeking a Section 1115 demonstration waiver, and it will require the Department of Insurance to notify the legislature before seeking a Section 1332 waiver. • In New Hampshire, 2019 NH S.B. 258 (NS) was adopted on August 12, 2019. The version of the bill that passed clarifies that covered telemedicine services are to include remote patient monitoring and store and forward. • In New Jersey, 2018 NJ S.B. 3365 (NS) was approved on May 8, 2019. The bill will establish a Medicaid perinatal episode of care pilot program. • Introduced in New Jersey on May 23, 2019, 2018 NJ A.B. 5458 (NS) would establish a pilot program to implement an integrated system of care for those with opioid use disorder. The bill provides, in part, The Division of Mental Health and Addiction Services in the Department of Human Services shall establish a pilot program creating an integrated system of care for the treatment of opioid use disorders. The integrated system of care shall comprise a centralized opioid treatment program, which shall be primarily responsible for the initial intake and stabilization of patients participating in the integrated system of care, and a system of office-based opioid treatment providers which shall be responsible for the ongoing treatment of patients participating in the integrated system of care upon referral by the centralized opioid treatment program. • In New Jersey, Assembly Bill 5021 (2018 NJ A.B. 5021 (NS)) was adopted on August 9, 2019. The bill calls for coverage of group prenatal services using the CenteringPregnancy model. According to the findings supplied with the bill, this evidence-based model improves birth outcomes for both mother and child in a number of ways: The model improves birth weight, improves breastfeeding rates, reduces premature births, and reduces the risk of gestational diabetes. The model appears to have a special impact on certain high-risk populations, and it can be an effective tool for reducing health disparities based on race, ethnicity, and socio-economic standing. The findings indicate that, due to the success of the model, health care costs can be reduced by minimizing high-cost medical interventions. For these reasons, the bill will add group prenatal services to the Medicaid program when rendered at certain sites. The bill sets out the limits of the coverage. • Introduced in New Mexico on January 17, 2019, 2019 NM S.B. 250 (NS) sought to enact the Rural Wraparound Services Act, which would have directed the Behavioral Health Services Division of the Department of Human Services to design and implement a comprehensive community-based mental health system in rural areas. This system would have provided wraparound services to achieve any one of these goals: A. to prevent or reduce the likelihood of relapse following discharge from inpatient care or recidivism following release from detention or incarceration; B. to correct, reduce or ameliorate the physical, mental, cognitive or developmental effects of serious mental illness or serious emotional disturbance; © 2020 Thomson Reuters. No claim to original U.S. Government Works. -25- C. to reduce or ameliorate the pain or suffering caused by serious mental illness or serious emotional disturbance; D. to assist the person to achieve or maintain maximum functional capacity in performing the activities of daily living; or E. to assist the person with life skills needed to live independently in the community. The bill did not advance, and the legislature has adjourned. • North Carolina intends to transform its program by shifting to Medicaid managed care. The state indicates that it is the most [FN183] significant change to the program in 40 years. Several bills have been introduced to realize this goal. Among others, Senate Bill 548 (2019 NC S.B. 548 (NS)) proposes several statutory changes needed to implement the plan, Senate Bill 549 (2019 NC S.B. 549 (NS)) would establish a child welfare and behavioral health pilot program to improve access to comprehensive health services for children in foster care. Senate Bill 537 (2019 NC S.B. 537 (NS)) seeks to change payment methodologies for adult care homes. The version of the bill that was adopted calls for a working group to study various reimbursement methods for adult care homes. Governor Roy Cooper (D) signed the bill on November 6, 2019. • In North Carolina, 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. • In North Carolina, 2019 NC H.B. 721 (NS) passed the House on May 6, 2019. The bill would ensure access to and Medicaid coverage for telehealth. It also sets out what may and may not be required to receive reimbursement for telehealth services. Finally, the bill ensures that health benefit plans cover telehealth services. • In North Dakota, 2019 ND S.B. 2031 (NS) would have expanded the types of providers recognized as providers of Medicaid targeted case management for both individuals with a serious emotional disturbance and individuals with a serious emotional illness. An appropriation was included in the bill. Senate Bill 2031 failed to pass this session. • Oklahoma House Bill 1013 (2019 OK H.B. 1013 (NS)), which was introduced on February 4, 2019, would direct that funds from the Nursing Facility Quality of Care Fund be used to support additional Department of Social Services ombudsmen, and 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, Governor Kate Brown (D) signed House Bill 2267 (2019 OR H.B. 2267 (NS)) on July 15, 2019. The bill relates to coordinated care organizations. It will require coordinated care organizations to collaborate with local public health authorities and hospitals to conduct a community health assessment and to adopt a community health improvement plan. The bill explains the purpose of such a plan: A coordinated care organization shall collaborate with local public health authorities and hospitals located in areas served by the coordinated care organization to conduct a community health assessment and adopt a community health improvement plan, shared with and endorsed by the coordinated care organization, local public health authorities and hospitals, to serve as a strategic population health and health care services plan for the residents of the areas served by the coordinated care organization, local public health authorities and hospitals. The health improvement plan must include strategies for achieving shared priorities. The bill requires the Oregon Health Authority to work with CMS in establishing a reinsurance program that complies with federal law in order to receive federal financial participation for the costs of the community health improvement plan. • 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 [FN184] state's coordinated care organizations. • Pennsylvania Senate Bill 314 (2019 PA S.B. 314 (NS)) would establish the Pennsylvania Rural Health Redesign Center Authority and the Pennsylvania Rural Health Redesign Center Fund to “protect and promote access by the residents of this Commonwealth to high-quality health care in rural communities by encouraging innovation in health care delivery.” The bill sets out the make-up of the board as well as its powers and duties. It passed both houses, and it was sent to the governor on November 22, 2019. • Introduced in Pennsylvania on September 19, 2019, 2019 PA S.B. 857 (NS) would provide for regulation of and coverage for telemedicine. In Medicaid, reimbursement for telemedicine services would not be permitted if: (1) the telemedicine-enabling device, technology or service fails to comply with applicable law and regulatory guidance regarding the secure transmission and maintenance of patient information; or (2) the provision of the service using telemedicine would be inconsistent with the standard of care. • Introduced in Pennsylvania 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 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. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -26- • In Pennsylvania, 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. • As introduced in Texas, 2019 TX H.B. 2062 (NS) would have amended existing statutory language on Medicaid coverage of home telemonitoring services. New language would have extended such coverage for pediatric services for children with complex or chronic health issues when the requirements of the bill were met. The bill would have also specified how reimbursement for telemonitoring was to be made in the event of an unsuccessful data transmission. A different version of House Bill 2062 passed the House on May 9, 2019, but it did not pass the Senate before adjournment. • In Virginia, 2018 VA S.B. 1221 (NS) calls for coverage of medically necessary health care services provided through telemedicine to be added to the Medicaid State Plan. It also amends statutory provisions relating to private insurance coverage of telemedicine services. Senate Bill 1221 was adopted on March 5, 2019. House Bill 1970 (2018 VA H.B. 1970 (NS)) is a similar but not identical bill. It also passed. • Adopted in Virginia on March 5, 2019, 2018 VA H.B. 1970 (NS) will provide medical assistance payments for telemedicine services, including remote monitoring services. “Remote patient monitoring” is defined as, the delivery of home health services using telecommunications technology to enhance the delivery of home health care, including monitoring of clinical patient data such as weight, blood pressure, pulse, pulse oximetry, blood glucose, and other condition-specific data; medication adherence monitoring; and interactive video conferencing with or without digital image upload. • House Bill 257 (2019 WY H.B. 257 (NS)) has been adopted Wyoming. The bill will ensure Medicaid coverage of clubhouse rehabilitation services. A clubhouse is defined as, a community-based psychosocial rehabilitation program that: (i) Has members of the program, with staff assistance, engaged in operating all aspects of the clubhouse, including food service, clerical, reception, janitorial and other member services such as employment training, housing assistance and educational support; and (ii) Is designed to alleviate a member's emotional or behavior problems with the goal of transitioning the member to a less restrictive level of care, reintegrating the member into the community and increasing social connectedness beyond a clinical or employment setting. • In Washington, 2019 WA H.B. 1087 (NS) was adopted on May 13, 2019. The bill will establish a long-term services and supports trust program to provide a long-term care benefit for Washingtonians. A person will be eligible for the benefit if the person, is age eighteen or older, residing in the state of Washington, was not disabled before the age of eighteen, has been determined to meet the minimum level of assistance with activities of daily living necessary to receive benefits through the trust program, as established in this chapter, and who has not exhausted the lifetime limit of benefit units. Among other things, the bill will set up the Long-Term Services and Supports Trust Commission, which will be directed to study and make specified recommendations by January 1, 2021. The program is expected to begin paying benefits by January 1, 2025. The purpose of the program is to help citizens pay for a service that few can afford and to save money for the Medicaid program at the same time. VIII. selected Administrative Activity [FN185] • In May 2016, CMS issued a final rule making significant changes to Medicaid managed care. CMS is once again proposing major changes to Medicaid managed care in order to promote flexibility, strengthen accountability, and promote program integrity. CMS writes that it developed the proposed rules after working with state Medicaid directors and the National Association of Medicaid Directors. According to CMS, it learned from its discussions with stakeholders that they thought that some provisions of 2016 final rule created unnecessary administrative burden and cost without leading to improved outcomes. CMS indicates that the new proposed rule is meant to “relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and [FN186] innovation in care delivery.” Briefly, some of the changes are these: • Promoting flexibility – giving states more flexibility to establish a rate range; making it easier to transition more services and populations into managed care; allowing states more flexibility to create their own network adequacy standards; and removing outdated and overly burdensome rules about how plans communicate with their members. • Strengthening accountability – requiring CMS to be accountable by providing states more guidance, and maintaining the requirement for states to develop a quality rating system but allowing states more flexibility to create an alternate system. [FN187] • Promoting program integrity - strengthening requirements to protect federal taxpayers from cost shifting. CMS also indicated in its press release that stakeholders expressed concern about the limited exception to the IMD exclusion in the [FN188] 2016 final rule, but the agency is making no changes at this time: © 2020 Thomson Reuters. No claim to original U.S. Government Works. -27- [S]tates expressed their concerns with how the 2016 final rule's limitation of 15 days on lengths of stay for managed care beneficiaries in an institution for mental disease (IMD) created difficult administrative challenges for states. CMS is not proposing any changes to this requirement at this time; however, it is asking for comment from states for data that could support revisions to this policy. Meanwhile, CMS continues to support state flexibility through section 1115 demonstrations, having approved a total of 15 waivers of the IMD exclusion for states to treat patients with substance use disorder (SUD), to expand access to treatment, and is exploring further options [FN189] remove barriers to important treatment options. The proposed rule is published at 83 F.R. 57264-01 (Nov. 14, 2018). CMS has also provided a summary of the rule's major provisions. [FN190] • 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 (Apr. 29, 2019). [FN191] • CMS published a CMCS Informational Bulletin announcing that some of the Spousal Impoverishment Standards had been updated. These standards are used to calculate certain Medicaid income and resource standards. Some are updated in January of each year and some in July. The July impoverishment standards include the community spouse's minimum monthly maintenance needs allowance and the community spouse's monthly housing allowance. The Informational Bulletin explains the standards in more [FN192] detail, and it includes a link to the standards themselves. • 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. • CMS issued a decision approving ambulatory blood pressure monitoring for Medicare participants with “white coat” hypertension and masked hypertension, as defined in the decision. To be covered, ambulatory blood pressure monitoring devices must be: • capable of producing standardized plots of blood pressure measurements for 24 hours with daytime and night-time windows and normal blood pressure bands demarcated; • provided to patients with oral and written instructions and a test run in the physician's office must be performed; and [FN193] • interpreted by the treating physician or treating non-physician practitioner. • CMS proposed to provide acupuncture in the Medicare program for participants with chronic low back pain who are in clinical trials [FN194] supported by the National Institutes of Health or in CMS-approved studies. The move is meant to gather evidence to inform [FN195] future Medicare policy on the subject. Currently, the proposal is undergoing a national coverage analysis, which will determine [FN196] whether covering acupuncture for chronic low back pain is “reasonable and necessary” for the Medicare program. CMS' interest in providing this coverage stems from the opioid crisis: CMS is eager to find treatment for chronic low back pain that does not involve [FN197] opioid drugs. According to CMS, chronic low back pain is one of the leading reasons for prescribing these drugs. Health and Human Services Secretary Alex Azar commented on the reason for the proposed decision: “Today's proposal represents the Trump Administration's commitment to providing Americans with access to a wide array of options to support their health . . . . Defeating our country's epidemic of opioid addiction requires identifying all possible ways to treat the very real problem of chronic pain, and this proposal would provide patients with new options while expanding our scientific understanding of [FN198] alternative approaches to pain”. [FN199] • In a proposed rule affecting many aspects of home care, CMS proposes to add a new, permanent Medicare benefit for home infusions for 2021. In 2019 and 2020, the benefit has been paid through a temporary transitional payment rate. The new rule proposes to update the transitional rate for 2020 and to establish policies for the new permanent home infusion benefit. Those policies affect [FN200] payment and eligibility. • CMS proposed 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 [FN201] 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. [FN202] Importantly, in identifying opportunities for reducing burden, CMS would maintain resident health and safety standards. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -28- CMS sets out the provisions in more detail in the fact sheet. The proposed rule is published at 84 F.R. 34737 (July 18, 2019). It was later finalized, and the final rule is published at 84 F.R. 60478-01 Nov. 8, 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 [FN203] the right to understand what the arbitration agreement says and the consequences of signing the agreement. • CMS 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 [FN204] transmitted at the time of discharge from acute care. The final rule is published at 84 F.R. 51836-01 (Sept. 30, 2019). • CMS is proposing to update and clarify the Stark Law (also called the Physician Self-Referral 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 [FN205] (or immediate family) have a financial interest. According to CMS' Fact Sheet for the proposed rule, the Physician Self-Referral Law was promulgated 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 [FN206] would support the necessary evolution of the American healthcare delivery and payment system. The proposed rule is published at 84 F.R. 55766 (Oct.7, 2019). • The Indiana Office of the Secretary of Family and Social Services gave notice that it will be seeking an amendment to its Family Supports waiver. The waiver provides services in a variety of home- and community-based settings to individuals with a developmental disability, intellectual disability, or autism. The amendment would provide priority status for children of an individual who is an active member or veteran of the U.S. Armed Forces or the National Guard. The notice is published at 2019 IN REG TEXT 523232 (NS) (May 8, 2019). • The Iowa Department of Aging proposed 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). • The New York Department of Mental Hygiene announced proposed rules to provide provider standards for providers wishing to become licensed as part of the Children's Mental Health Rehabilitation Program. This program grew out of a Medicaid redesign, and it provides these services for children with mental health needs as a part of the Medicaid State Plan. The proposed rule, which is published at 2019 NY REG TEXT 517286 (NS) (Feb. 20, 2019), sets out the purposes of the program: The goal of the CMHRS program is to assist children and their families with significant mental health and behavioral needs function successfully within their homes and community, ameliorate mental health symptoms, and prevent the progression of mental health conditions by providing a coordinated array of clinical treatment, rehabilitative and support services. The CMHRS program is delivered by a team of varied specialists who works with the child and family to create an individualized treatment plan to meet the unique needs of the child and their family. CMHRS can be offered individually or as a comprehensive array of services provided in an integrated and coordinated manner. Services are intended to be provided in nontraditional settings, including in the home or community settings, to children and their families for whom a flexible approach to service provision is needed to facilitate engagement or therapeutic benefit. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -29- On July 17, the agency announced that the rule was finalized and is published at the same citation noted above. • The Texas Health and Human Services Commission gave notice that it intends to file a request with CMS for an amendment to the state's Section 1915(c) home-and community services waiver. In the notice, the agency explains that the amendment would, “[c]hange the rate methodology to temporarily increase the direct care portion of the supervised living and residential support services rates.” Please see 2019 TX REG TEXT 536581 (NS) (Oct. 11, 2019). • On July 23, 2018, the Virginia Department of Health gave noticed of proposed rulemaking to establish certification for peer recovery specialists. Services from properly certified peer recovery specialists are reimbursable through Medicaid. The proposed rule is published at 2018 VA REG TEXT 458394 (NS). It was adopted on February 4, 2019. • The Virginia Department of Health gave notice that it finalized a rule to set up a care coordination model for providing residential services for children with intellectual and environmental disabilities. The regulation, which replaces emergency regulations on the subject, is published at 2019 VA REG TEXT 450458 (NS) (Aug. 22, 2019). • The Washington Department of Social and Health Services gave of notice of permanent rules adding two new services in the Community Options Program Entry Systems (COPES). Whether the individual is living at home or in a facility, the new sections will offer community support services and community choice guiding services. Additionally, the department amended existing regulatory language in these two sections. Please see 2019 WA REG TEXT 518588 (NS) (Aug. 7, 2019). COPES is a Medicaid waiver program. [FN207] IX. ADDITIONAL RESOURCES The Kaiser Family Foundation has announced three issue briefs examining various aspects of home- and community-based services. [FN208] [FN209] One examines enrollment and spending, another looks at state policy choices about HCBS, and the third answers [FN210] questions about waiting lists for HCBS. CMS released a toolkit offering information and resources about accountable care organizations (ACOs). The agency intends to release a series of toolkits. With this one, CMS hopes to “educate the general public about strategies used by ACOs to provide value-based care while also providing actionable ideas to current and prospective ACOs to help them improve or begin operations, particularly as [FN211] they consider a shift to a two-sided risk model.” The toolkit explains different innovative strategies that Medicare ACOs employ to coordinate care for their beneficiaries, focusing on beneficiaries who: • receive emergency care in an emergency department; • receive care in a skilled nursing facility; • have been recently discharged from a hospital or emergency department; • suffer from a chronic condition; or [FN212] • have afflictions that are impacted by social determinants of health. [FN213] At the same time, CMS published seven case studies describing innovative initiatives that seven ACOs have implemented. X. Conclusion For the past several years, practitioners and health care facilities have expended money and effort into implementing Affordable Care Act reforms. Not every reform was an unqualified success, but the shift away from fee-for-service to payments based on quality and outcomes appears to have bipartisan support. Even the latest repeal-and-replace plans proposed few changes to Medicare and left many Affordable Care Act programs and initiatives in place. It appears that payment and delivery reforms have taken hold, and hopefully any new health reform law will build on some of the Affordable Care Act successes in this area. This Issue Brief contains information on introduced and pending legislation. Subscribers to Legislation to Watch can view the full text of these bills, along with related information and actions. If you do not have access to Legislation to Watch, or for information about other HPTS products or subscribing to Westlaw, please contact 1-800-WESTLAW (1-800-937-8529). © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN1] . Universal Declaration of Human Rights, Article 25, available at: http://www.un.org/en/documents/udhr/index.shtml#a25. [FN2] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -30- . Kahtleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes,” Oct. 2019, available at: http://files.kff.org/attachment/ Report-A-View-from-the-States-Key-Medicaid-Policy-Changes. [FN3] . Kahtleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes,” Oct. 2019, available at: http://files.kff.org/attachment/ Report-A-View-from-the-States-Key-Medicaid-Policy-Changes. [FN4] . Kahtleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes,” Oct. 2019, available at: http://files.kff.org/attachment/ Report-A-View-from-the-States-Key-Medicaid-Policy-Changes. [FN5] . Accountable Health Communities Model, CMS, available at: https://innovation.cms.gov/initiatives/ahcm. [FN6] . Kahtleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes,” Oct. 2019, available at: http://files.kff.org/attachment/ Report-A-View-from-the-States-Key-Medicaid-Policy-Changes. [FN7] . Kahtleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes,” Oct. 2019, available at: http://files.kff.org/attachment/ Report-A-View-from-the-States-Key-Medicaid-Policy-Changes (footnote omitted). [FN8] . Kahtleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes,” Oct. 2019, available at: http://files.kff.org/attachment/ Report-A-View-from-the-States-Key-Medicaid-Policy-Changes (footnote omitted). [FN9] . Kahtleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes,” Oct. 2019, available at: http://files.kff.org/attachment/ Report-A-View-from-the-States-Key-Medicaid-Policy-Changes. [FN10] . Kahtleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes,” Oct. 2019, available at: http://files.kff.org/attachment/ Report-A-View-from-the-States-Key-Medicaid-Policy-Changes. [FN11] . The Supreme Court's decision is published on Westlaw. Please see National Federation of Independent Business v. Sebelius, 2012 WL 2427810 (June 28, 2012). [FN12] . In total, about 14 million have gained Medicaid coverage since the Affordable Care Act was implemented, but a few million of them were already eligible by unenrolled, according to data pulled together by PolitiFact. See “Medicaid Expansion Drove Health Insurance Coverage under Health Law, Rand Paul Says,” PolitiFact, Jan. 15, 2017, available at: http://www.politifact.com/truth-o-meter/ statements/2017/jan/15/rand-paul/medicaid-expansion-drove-health-insurance-coverage/. [FN13] . 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. [FN14] . 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. [FN15] . 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. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -31- [FN16] . 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. [FN17] . 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/. [FN18] . “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. [FN19] . “ACO Investment Model,” CMS, available at: https://innovation.cms.gov/initiatives/ACO-Investment-Model/. [FN20] . “Next Generation ACO Model,” CMS, available at: https://innovation.cms.gov/initiatives/next-generation-aco-model/. [FN21] . “Comprehensive ESRD Model,” CMS, available at: https://innovation.cms.gov/initiatives/comprehensive-esrd-care/. [FN22] . 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. [FN23] . “Medicare Shared Savings Program,” CMS, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/about.html. [FN24] . 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/. [FN25] . 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. [FN26] . 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. [FN27] . 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. [FN28] . 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. [FN29] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -32- . 83 F.R. 41786 (Aug. 17, 2018). [FN30] . 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/. [FN31] . 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 [FN32] . 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. [FN33] . 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. [FN34] . 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. [FN35] . 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. [FN36] . 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. [FN37] . 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. [FN38] . 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/. [FN39] . Shared Savings Program, Program Data, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/program-data.html. [FN40] . 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. [FN41] . “ACO Investment Model,” CMS web site, available at: http://innovation.cms.gov/initiatives/ACO-Investment-Model/. [FN42] . “ACO Investment Model,” CMS web site, available at: http://innovation.cms.gov/initiatives/ACO-Investment-Model/. [FN43] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -33- . 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. [FN44] . “Next Generation ACO Model,” CMS web site, available at: http://innovation.cms.gov/initiatives/Next-Generation-ACO-Model/. [FN45] . 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. [FN46] . 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. [FN47] . 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. [FN48] . 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. [FN49] . 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. [FN50] . 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. [FN51] . “The Guide to Getting & Using Your Health Records,” ONC, available at: https://www.healthit.gov/how-to-get-your-health-record/. [FN52] . 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. [FN53] . Health IT Dashboard, available at: https://dashboard.healthit.gov/quickstats/quickstats.php. [FN54] . Corrections were published at 83 F.R. 49836-01 (Oct. 3, 2018). [FN55] . 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. [FN56] . 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. [FN57] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -34- . 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. [FN58] . 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. [FN59] . 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. [FN60] . “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. [FN61] . “About the CMS Innovation Center,” CMS, available at: https://innovation.cms.gov/about/index.html. [FN62] . “About the Medicare-Medicaid Coordination Office,” CMS web site, available at: http://www.cms.gov/Medicare-Medicaid-Coordination/ Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/index.html. [FN63] . CMS and the Innovation Center Report to Congress, 2018, available at: https://innovation.cms.gov/Files/reports/rtc-2018.pdf. [FN64] . CMS and the Innovation Center Report to Congress, 2018, available at: https://innovation.cms.gov/Files/reports/rtc-2018.pdf. [FN65] . Fact Sheet, “Medicare Care Choices Model Awards,” CMS, July 20, 2015, available at: http://www.cms.gov/Newsroom/ MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-07-20.html; see, also, News Release, “CMS Announces Medicare Care Choice Model Awards,” Department of Health and Human Services, July 20, 2015, available at: http://www.hhs.gov/ news/press/2015pres/07/20150720a.html; “Medicare Care Choices Model,” CMS, CMS Innovation Center, available at: http:// innovation.cms.gov/initiatives/Medicare-Care-Choices/. [FN66] . Fact Sheet, “Medicare Care Choices Model (MCCM): The First Two Years,” CMS, Dec. 11, 2017, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-12-11.html? DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending. [FN67] . Fact Sheet, “Medicare Care Choices Model (MCCM): The First Two Years,” CMS, Dec. 11, 2017, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-12-11.html? DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending. [FN68] . This initiative builds on the Comprehensive Primary Care initiative, which has now ended. [FN69] . News Release, “CMS Announces Next Phase in Largest-Ever Initiative to Improve Primary Care in America,” CMS, Aug. 1, 2016, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-08-01.html. [FN70] . News Release, “CMS Announces Next Phase in Largest-Ever Initiative to Improve Primary Care in America,” CMS, Aug. 1, 2016, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-08-01.html. [FN71] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -35- . News Release, “CMS Announces Next Phase in Largest-Ever Initiative to Improve Primary Care in America,” CMS, Aug. 1, 2016, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-08-01.html. [FN72] . News Release, “CMS Announces Next Phase in Largest-Ever Initiative to Improve Primary Care in America,” CMS, Aug. 1, 2016, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2016-Press-releases-items/2016-08-01.html. [FN73] . “Comprehensive Primary Care Plus,” CMS, available at: https://innovation.cms.gov/initiatives/comprehensive-primary-care-plus. [FN74] . “Comprehensive Primary Care Plus,” CMS Innovation Center, available at: https://innovation.cms.gov/initiatives/comprehensive- primary-care-plus. [FN75] . Press Release, “New Affordable Care Act Initiative to Encourage Better Oncology Care,” CMS web site, Feb. 12, 2015, available at: http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-02-12.html; see, also, “Oncology Care Model,” Innovation Center web site, available at: http://innovation.cms.gov/initiatives/Oncology-Care/. [FN76] . 80 F.R. 8323-01 (Feb. 17, 2015). [FN77] . “Oncology Care Model,” Innovation Center web site, available at: http://innovation.cms.gov/initiatives/Oncology-Care/. [FN78] . “Oncology Car e Model,” Innovation Center web site, available at: https://innovation.cms.gov/initiatives/oncology-care/. [FN79] . “Million Hearts®: Cardiovascular Disease Risk Reduction Model,” CMS, available at: http://innovation.cms.gov/initiatives/Million- Hearts-CVDRRM/. [FN80] . 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. [FN81] . 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. [FN82] . “Comprehensive ESRD Care Model,” CMS, available at: https://innovation.cms.gov/initiatives/comprehensive-esrd-care/. [FN83] . Darshak Shangavi and Patrick Conway, “ Can Helping Patients' Social Needs Also Be Good for their Health?,” CMS Blog, Jan. 11, 2016, available at: http://blog.cms.gov/2016/01/11/can-helping-patients-social-needs-also-be-good-for-their-health/. [FN84] . Darshak Shangavi and Patrick Conway, “Can Helping Patients' Social Needs Also Be Good for their Health?,” CMS Blog, Jan. 11, 2016, available at: http://blog.cms.gov/2016/01/11/can-helping-patients-social-needs-also-be-good-for-their-health/. [FN85] . “Accountable Health Communities Model,” CMS, available at: https://innovation.cms.gov/initiatives/ahcm. [FN86] . “Accountable Health Communities Model,” CMS, available at: https://innovation.cms.gov/initiatives/ahcm. [FN87] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -36- . Fact Sheet, “Accountable Health Communities (AHC) Model Track 1 –Awareness,” CMS, Sept. 8, 2016, available at: https:// www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-09-08.html. [FN88] . Accountable Health Communities Model,” CMS, available at: https://innovation.cms.gov/initiatives/AHCM. [FN89] . Elizabeth Hinton, et al., “A First Look at North Carolina's Section 1115 Medicaid Waiver's Healthy Opportunities Pilots,” Kaiser Family Foundation, May 2019, available at: http://files.kff.org/attachment/ Issue-Brief-A-First-Look-at-North-Carolinas-Section-1115-Medicaid-Waivers-Healthy-Opportunities-Pilots. [FN90] . Elizabeth Hinton, et al., “A First Look at North Carolina's Section 1115 Medicaid Waiver's Healthy Opportunities Pilots,” Kaiser Family Foundation, May 2019, available at: http://files.kff.org/attachment/ Issue-Brief-A-First-Look-at-North-Carolinas-Section-1115-Medicaid-Waivers-Healthy-Opportunities-Pilots. (Emphasis in original; citation omitted.) [FN91] . Elizabeth Hinton, et al., “A First Look at North Carolina's Section 1115 Medicaid Waiver's Healthy Opportunities Pilots,” Kaiser Family Foundation, May 2019, available at: http://files.kff.org/attachment/ Issue-Brief-A-First-Look-at-North-Carolinas-Section-1115-Medicaid-Waivers-Healthy-Opportunities-Pilots. (Citation omitted.) [FN92] . See, Brian Castrucci and John Auerbach, “Meeting Individual Social Needs Falls Short Of Addressing Social Determinants Of Health,” the Health Affairs blog, January 16, 2019, available at: https://www.healthaffairs.org/do/10.1377/hblog20190115.234942/full/; “Study Calls for Clarity on SDOH, Related Terminology,” American Academy of Family Physicians,” June 10, 2019, available at: https:// www.aafp.org/news/practice-professional-issues/20190610sdohterms.html. [FN93] . Brian Castrucci and John Auerbach, “Meeting Individual Social Needs Falls Short Of Addressing Social Determinants Of Health,” the Health Affairs blog, January 16, 2019, available at: https://www.healthaffairs.org/do/10.1377/hblog20190115.234942/full/ [FN94] . Samantha Artiga and Elizabeth Hinton, “Beyond Health Care: The Role of Social Determinants in Promoting Health and Health Equity,” Kaiser Family Foundation, May 10, 2018, available at: https://www.kff.org/disparities-policy/issue-brief/beyond-health-care-the- role-of-social-determinants-in-promoting-health-and-health-equity/. [FN95] . Stuart M. Butler, et al., “Re-balancing Medical and Social Spending to Promote Health: Increasing State Flexibility to Improve Health Through Housing,” Brookings, Feb. 15, 2017, available at: https://www.brookings.edu/blog/up-front/2017/02/15/re-balancing- medical-and-social-spending-to-promote-health-increasing-state-flexibility-to-improve-health-through-housing/; Deborah Bachrach, et al., “Medicaid Coverage of Social Interventions: A Roadmap for States,” Manatt on Medicaid, Aug. 10, 2016, available at: https:// www.manatt.com/Insights/Newsletters/Medicaid-Update/Medicaid-Coverage-of-Social-Interventions-A-Roadm. [FN96] . Deborah Bachrach, et al., “Enabling Sustainable Investment in Social Interventions: A Review of Medicaid Managed Care Rate- Setting Tools,” Commonwealth Fund, January 2018, available at: http://www.commonwealthfund.org/~/media/files/publications/fund- report/2018/jan/bachrach_investment_social_interventions_medicaid_rate_setting.pdf. [FN97] . Damon Francis, “An Evolving Roadmap to Address Social Determinants of Health,” Commonwealth Fund, Jan. 16, 2019, available at: https://www.commonwealthfund.org/blog/2019/evolving-roadmap-address-social-determinants-health? omnicid=EALERT1545961&mid=. [FN98] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -37- . 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. [FN99] . 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. [FN100] . BPCI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. [FN101] . BPCI Advanced, CMS, available at: https://innovation.cms.gov/initiatives/bpci-advanced. [FN102] . “Model Overview Fact Sheet – Model Year 3 (MY3),” CMS, available at: https://innovation.cms.gov/Files/fact-sheet/bpciadvanced- my3-modeloverviewfs.pdf. [FN103] . Medicare Diabetes Prevention Program (MDPP) Expanded Model, CMS, available at: https://innovation.cms.gov/initiatives/medicare- diabetes-prevention-program/. [FN104] . Medicare Diabetes Prevention Program (MDPP) Expanded Model, CMS, available at: https://innovation.cms.gov/initiatives/medicare- diabetes-prevention-program/. [FN105] . Seema Verma, “CMS Encourages Eligible Suppliers to Participate in Expanded Medicare Diabetes Prevention Program Model,” CMS Blog, Apr. 30, 2018, available at: https://blog.cms.gov/2018/04/30/cms-encourages-eligible-suppliers-to-participate-in-expanded- medicare-diabetes-prevention-program-model/. [FN106] . “Medicare Diabetes Prevention Program Expanded Model,” CMS, available at: https://innovation.cms.gov/initiatives/medicare- diabetes-prevention-program/. [FN107] . CHIP is the federal Children's Health Insurance Program. [FN108] . “Integrated Care for Kids (InCK) Model,” CMS, available at: https://innovation.cms.gov/initiatives/integrated-care-for-kids-model/. [FN109] . Fact Sheet, “Integrating Care for Kids (InCK) Model,” Aug. 23, 2018, available at: https://www.cms.gov/newsroom/fact-sheets/ integrated-care-kids-inck-model; see, also, See, also, Press Release, “CMS Announces New Model to Address Impact of the Opioid Crisis for Children,” CMS, Aug. 23, 2018, available at: https://www.cms.gov/newsroom/press-releases/cms-announces-new-model- address-impact-opioid-crisis-children [FN110] . Fact Sheet, “Integrating Care for Kids (InCK) Model,” Aug. 23, 2018, available at: https://www.cms.gov/newsroom/fact-sheets/ integrated-care-kids-inck-model. [FN111] . “Integrated Care for Kids (InCK) Model,” CMS, https://innovation.cms.gov/initiatives/integrated-care-for-kids-model/. [FN112] . “Integrated Care for Kids (InCK) Model,” CMS, https://innovation.cms.gov/initiatives/integrated-care-for-kids-model/. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -38- [FN113] . Fact Sheet, “Integrating Care for Kids (InCK) Model,” Aug. 23, 2018, available at: https://www.cms.gov/newsroom/fact-sheets/ integrated-care-kids-inck-model. [FN114] . “Integrated Care for Kids (InCK) Model,” CMS, available at: https://innovation.cms.gov/initiatives/integrated-care-for-kids-model/. [FN115] . Robert Wood Johnson Foundation, “Reform in Action: Can Implementing Patient-Centered Medical Homes Improve Health Care Quality?” April 2012, available at: http://www.rwjf.org/qualityequality/product.jsp?id=73739&cid=XEM_A5896. [FN116] . “Medical Homes & Patient-Centered Care Maps,” National Academy on State Health Policy, available at: https://nashp.org/medical- homes-map/. [FN117] . “Patient-Centered Medical Home: What is a Patient-Centered Medical Home (PCMH)?,” Primary Care Collaborative, Sept. 2015, available at: https://www.pcpcc.org/resource/patient-centered-medical-home-what-patient-centered-medical-home-pcmh. [FN118] . “Joint Principles of the Patient-Centered Medical Home, March 2007,” American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics, and the American Osteopathic Association,” available at: http:// www.medicalhomeinfo.org/downloads/pdfs/jointstatement.pdf. [FN119] . “Health Homes,” Medicaid.gov, available at https://www.medicaid.gov/medicaid/ltss/health-homes/index.html; “Health Homes (Section 2703) Frequently Asked Questions,” Medicaid.gov, available at: https://www.medicaid.gov/state-resource-center/medicaid-state- technical-assistance/health-homes-technical-assistance/downloads/health-homes-faq-5-3-12_2.pdf. [FN120] . “State-by-State Health Home State Plan Amendment Matrix,” CMS, updated Nov. 2019, available at: https://www.medicaid.gov/state- resource-center/medicaid-state-technical-assistance/health-home-information-resource-center/downloads/state-hh-spa-at-a-glance- matrix.pdf. [FN121] . “Health Homes (1945 of SSA/ Section 2703 of ACA) Frequently Asked Questions Series II,” CMS, available at: https:// www.medicaid.gov/state-resource-center/medicaid-state-technical-assistance/health-homes-technical-assistance/downloads/health- homes-section-2703-faq.pdf. [FN122] . Please see the Health Home Resource Center, available at: https://www.medicaid.gov/State-Resource-Center/Medicaid-State- Technical-Assistance/Health-Homes-Technical-Assistance/Health-Home-Information-Resource-Center.html. [FN123] . State Medicaid Director Letter, “Community First Choice State Plan Option,” SMD #16-011, Dec. 30, 2016, available at: https:// www.medicaid.gov/federal-policy-guidance/downloads/smd16011.pdf. [FN124] . Kathleen Gifford, et al., “A View from the States: Key Medicaid Policy Changes: Results from a 50-State Medicaid Budget Survey for State Fiscal Years 2019 and 2020,” Kaiser Family Foundation, Oct. 2019, available at: https://www.kff.org/medicaid/report/a-view-from- the-states-key-medicaid-policy-changes-results-from-a-50-state-medicaid-budget-survey-for-state-fiscal-years-2019-and-2020/. [FN125] . 79 F.R. 2948-01 (Jan. 16, 2014). [FN126] . CMCS Informational Bulletin, “Extension of Transition Period for Compliance with Home and Community-Based Settings Criteria,” May 9, 2017, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib050917.pdf. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -39- [FN127] . State Medicaid Director Letter, “Home and Community-Based Settings Regulation – Heightened Scrutiny,” SMD #19-001, March 22, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/smd19001.pdf. [FN128] . State Medicaid Director Letter SMD# 19-001, “Home and Community-Based Settings Regulation – Heightened Scrutiny,” March 22, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/smd19001.pdf. [FN129] . State Medicaid Director Letter SMD# 19-001, “Home and Community-Based Settings Regulation – Heightened Scrutiny,” March 22, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/smd19001.pdf. [FN130] . See CMCS Informational Bulletin, “Heightened Scrutiny Review of Newly Constructed Presumptively Institutional Settings,” Aug. 2, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib080219.pdf. The earlier guidance is available at: https://www.medicaid.gov/medicaid/hcbs/downloads/faq-planned-construction.pdf. [FN131] . CMCS Informational Bulletin, “Heightened Scrutiny Review of Newly Constructed Presumptively Institutional Settings,” Aug. 2, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib080219.pdf. [FN132] . CMCS Informational Bulletin, “Health and Welfare of Home and Community Based Services (HCBS) Waiver Recipients,” June 28, 2018, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib062818.pdf. [FN133] . CMCS Informational Bulletin, “Health and Welfare of Home and Community Based Services (HCBS) Waiver Recipients,” June 28, 2018, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib062818.pdf. [FN134] . CMCS Informational Bulletin, “Health and Welfare of Home and Community Based Services (HCBS) Waiver Recipients,” June 28, 2018, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib062818.pdf. [FN135] . News Release, “HHS Announces new Affordable Care Act Options for Community-Based Care,” Apr. 26, 2012, available at: http:// www.cms.gov/Newsroom/MediaReleaseDatabase/Press-Releases/2012-Press-Releases-Items/2012-04-26.html. [FN136] . Report to Congress, Community First Choice: Interim Report to Congress by HHS Secretary Kathleen Sebelius, 2014, available at: http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By-Topics/Long-Term-Services-and-Supports/Home-and-Community- Based-Services/Downloads/Community-First-Choice-Interim-Report-to-Congress.pdf. [FN137] . “Community First Choice (CFC) 1915(k),” Medicaid.gov, available at: https://www.medicaid.gov/medicaid/hcbs/downloads/community- first-choice-interim-report-to-congress.pdf. [FN138] . State Medicaid Director Letter, “Community First Choice State Plan Option,” SMD #16-011, Dec. 30, 2016, available at: https:// www.medicaid.gov/federal-policy-guidance/downloads/smd16011.pdf. [FN139] . State Medicaid Director Letter, “Community First Choice State Plan Option,” SMD #16-011, Dec. 30, 2016, available at: https:// www.medicaid.gov/federal-policy-guidance/downloads/smd16011.pdf. [FN140] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -40- . Program of All-Inclusive Care for the Elderly, CMS, available at: https://www.medicaid.gov/medicaid/ltss/pace/index.html. [FN141] . Program of All-Inclusive Care for the Elderly, CMS, available at: https://www.medicaid.gov/medicaid/ltss/pace/index.html. [FN142] . Fact Sheet, “Programs of All-Inclusive Care for the Elderly (PACE) Final Rule (CMS-4168-F),” CMS, May 28, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/programs-all-inclusive-care-elderly-pace-final-rule-cms-4168-f. [FN143] . “Money Follows the Person,” Medicaid.gov, available at: https://www.medicaid.gov/medicaid/ltss/money-follows-the-person/index.html. [FN144] . State Medicaid Director Letter, “Three New Opportunities to Test Innovative Models of Integrated Care for Individuals Dually Eligible for Medicaid and Medicare,” SMD # 19-002, Apr. 24, 2019, available at: https://www.medicaid.gov/federal- policy-guidance/downloads/smd19002.pdf. [FN145] . State Medicaid Director Letter, “Three New Opportunities to Test Innovative Models of Integrated Care for Individuals Dually Eligible for Medicaid and Medicare,” SMD # 19-002, Apr. 24, 2019, available at: https://www.medicaid.gov/federal- policy-guidance/downloads/smd19002.pdf; “People Dually Eligible for Medicare and Medicaid,” CMS, Mar. 2019, available at: https:// www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/ Downloads/MMCO_Factsheet.pdf. [FN146] . “People Dually Eligible for Medicare and Medicaid,” CMS, Mar. 2019, available at: https://www.cms.gov/Medicare-Medicaid- Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Downloads/MMCO_Factsheet.pdf. (Footnotes omitted.) [FN147] . Fact Sheet, “People Enrolled in Medicare and Medicaid,” CMS, Aug. 2017, available at: https://www.cms.gov/Medicare-Medicaid- Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Downloads/MMCO_Factsheet.pdf. (Footnote omitted.) [FN148] . “Financial Alignment Initiative for Medicare-Medicaid Enrollees,” CMS, available at: https://innovation.cms.gov/initiatives/Financial- Alignment/. [FN149] . “Financial Alignment Initiative for Medicare-Medicaid Enrollees,” CMS, available at: https://innovation.cms.gov/initiatives/Financial- Alignment/. [FN150] . State Medicaid Director Letter, SMD #18-012, “Ten Opportunities to Better Serve Individuals Dually Eligible for Medicaid and Medicare,” Dec. 19, 2018, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/smd18012.pdf. [FN151] . State Medicaid Director Letter, “Three New Opportunities to Test Innovative Models of Integrated Care for Individuals Dually Eligible for Medicaid and Medicare,” SMD # 19-002, Apr. 24, 2019, available at: https://www.medicaid.gov/federal- policy-guidance/downloads/smd19002.pdf. [FN152] . State Medicaid Director Letter, “Three New Opportunities to Test Innovative Models of Integrated Care for Individuals Dually Eligible for Medicaid and Medicare,” SMD # 19-002, Apr. 24, 2019, available at: https://www.medicaid.gov/federal- policy-guidance/downloads/smd19002.pdf (footnote omitted). [FN153] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -41- . State Medicaid Director Letter, “Ten Opportunities to Better Serve Individuals Dually Eligible for Medicaid and Medicare,” SMD # 18-012, Dec. 19, 2018, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/ smd18012.pdf. [FN154] . See, e.g., Deborah Bachrach, et al., “Medicaid: States' Most Powerful Tool to Combat the Opioid Crisis,” State Health Reform Assistance Network (Robert Wood Johnson Foundation), July 2016, available at: http://www.statenetwork.org/wp-content/ uploads/2016/07/State-Network-Manatt-Medicaid-States-Most-Powerful-Tool-to-Combat-the-Opioid-Crisis-July-2016.pdf. [FN155] . See, e.g., Howard G. Birnbaum, et al., “Societal Costs of Prescription Opioid Abuse, Dependence, and Misuse in the United States,” Pain Medicine, Volume 12, Issue 4, 1 April 2011, Pages 657–667, Apr. 15, 2011, available at: https://academic.oup.com/painmedicine/ article/12/4/657/1869828. [FN156] . State Medicaid Director Letter, SMD #17-003, CMS, Nov. 1, 2017, available at: https://www.medicaid.gov/federal-policy-guidance/ downloads/smd17003.pdf. [FN157] . State Medicaid Director Letter, SMD #15-003, July 27, 2015, available at: https://www.medicaid.gov/federal-policy-guidance/ downloads/SMD15003.pdf. [FN158] . Press Release, “CMS Announces New Medicaid Policy to Combat the Opioid Crisis by Increasing Access to Treatment Options,” CMS, Nov. 1, 2017, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases- items/2017-11-01.html. [FN159] . State Medicaid Director Letter, SMD #17-003, CMS, Nov. 1, 2017, available at: https://www.medicaid.gov/federal-policy-guidance/ downloads/smd17003.pdf. [FN160] . State Medicaid Director Letter, SMD #17-003, CMS, Nov. 1, 2017, available at: https://www.medicaid.gov/federal-policy-guidance/ downloads/smd17003.pdf. [FN161] . Press Release, “CMS Announces New Medicaid Policy to Combat the Opioid Crisis by Increasing Access to Treatment Options,” CMS, Nov. 1, 2017, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases- items/2017-11-01.html. [FN162] . Press Release, “CMS Announces New Medicaid Policy to Combat the Opioid Crisis by Increasing Access to Treatment Options,” CMS, Nov. 1, 2017, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases- items/2017-11-01.html. [FN163] . Press Release, “CMS Announces New Medicaid Policy to Combat the Opioid Crisis by Increasing Access to Treatment Options,” CMS, Nov. 1, 2017, available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases- items/2017-11-01.html. [FN164] . 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. [FN165] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -42- . 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. [FN166] . 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. [FN167] . The full name of the act is the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, P.L. 115-271. [FN168] . CMCS is CMS' Center for Medicaid and CHIP Services. [FN169] . CMCS Informational Bulletin, “Guidance for States on the Availability of an Extension of the Enhanced Federal Medical Assistance Percentage (FMAP) Period for Certain Medicaid Health Homes for Individuals with Substance Use Disorders (SUD),” May 7, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib050719.pdf. [FN170] . CMCS Informational Bulletin, “New Reporting Measures for Substance Use Disorder (SUD)-focused Health Homes,” CMS, Nov. 27, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf. [FN171] . CMCS Informational Bulletin, “New Reporting Measures for Substance Use Disorder (SUD)-focused Health Homes,” CMS, Nov. 27, 2019, available at: https://www.medicaid.gov/federal-policy-guidance/downloads/cib112719.pdf. [FN172] . FMAPs are Federal Medical Assistance Percentages. [FN173] . For more information about the program, please see “Section 223 Demonstration Program for Certified Community Behavioral Health Clinics,” SAMHSA, available at: https://www.samhsa.gov/section-223. [FN174] . Press Release, “Portman, Casey Introduce Legislation to Help Improve Health Outcomes for Vulnerable Populations,” Senator Portman's web site, May 7, 2019, available at: https://www.portman.senate.gov/newsroom/press-releases/portman-casey-introduce- legislation-help-improve-health-outcomes-vulnerable. [FN175] . “Bustos Bill to Improve Health Outcomes Gains Momentum,” web site of Representative Bustos, Aug. 12, 2019, available at: https:// bustos.house.gov/bustos-bill-to-improve-health-outcomes-gains-momentum/. [FN176] . Press Release, “Swalwell Reintroduces Bipartisan Bill Advancing Personalized Medicine,” Rep. Stalwell's web site, Sept. 19, 2019, available at: https://swalwell.house.gov/media-center/press-releases/swalwell-reintroduces-bipartisan-bill-advancing-personalized- medicine. [FN177] . Press Release, “Blunt Rochester, Bilirakis File Bill to Improve Health Outcomes for Children,” web site of Rep. Blunt Rochester, Oct. 9, 2019, available at: Blunt Rochester, Bilirakis File Bill to Improve Health Outcomes for Children. [FN178] . Press Release, “Blunt Rochester, Bilirakis File Bill to Improve Health Outcomes for Children,” web site of Rep. Blunt Rochester, Oct. 9, 2019, available at: Blunt Rochester, Bilirakis File Bill to Improve Health Outcomes for Children. © 2020 Thomson Reuters. No claim to original U.S. Government Works. -43- [FN179] . P.L. 115-271. [FN180] . Press Release, “Thompson, Welch, Johnson and Schweikert Introduce Bipartisan and Bicameral Telehealth Package,” web site of Rep. Thompson, Oct. 30, 2019, available at: https://mikethompson.house.gov/newsroom/press-releases/thompson-welch-johnson-and- schweikert-introduce-bipartisan-and-bicameral. [FN181] . Veto message for AB 166, Governor Newsom's web site, Oct. 13, 2019, available at: https://www.gov.ca.gov/wp-content/ uploads/2019/10/AB-166-Veto-Message.pdf. [FN182] . 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. [FN183] . For more information, see “North Carolina's Transformation to Medicaid Managed Care,” available at: https://www.ncdhhs.gov/ assistance/medicaid-transformation. [FN184] . 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. [FN185] . The final rule is published at 81 F.R. 27498 (May 6, 2018). [FN186] . Press Release, “CMS Proposes Changes to Streamline and Strengthen Medicaid and CHIP Managed Care Regulations,” Nov. 8, 2018, available at: https://www.cms.gov/newsroom/press-releases/cms-proposes-changes-streamline-and-strengthen-medicaid-and- chip-managed-care-regulations. [FN187] . Press Release, “CMS Proposes Changes to Streamline and Strengthen Medicaid and CHIP Managed Care Regulations,” Nov. 8, 2018, available at: https://www.cms.gov/newsroom/press-releases/cms-proposes-changes-streamline-and-strengthen-medicaid-and- chip-managed-care-regulations. [FN188] . The IMD exclusion prohibits Medicaid payments for inpatient mental health treatment in “Institutes for Mental Diseases” with more than 16 beds. [FN189] . Press Release, “CMS Proposes Changes to Streamline and Strengthen Medicaid and CHIP Managed Care Regulations,” Nov. 8, 2018, available at: https://www.cms.gov/newsroom/press-releases/cms-proposes-changes-streamline-and-strengthen-medicaid-and- chip-managed-care-regulations. [FN190] . “Fact Sheet: Notice of Proposed Rulemaking (NPRM); Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care (CMS-2408-P),” CMS, Nov. 8, 2018, available at: https://www.medicaid.gov/medicaid/managed-care/downloads/ guidance/factsheet-cms-2408-p.pdf. [FN191] . CMCS is the Center for Medicaid and CHIP Services [FN192] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -44- . CMCS Informational Bulletin, “Updated 2019 Spousal Impoverishment Standards,” May 30, 2019, available at: https:// www.medicaid.gov/federal-policy-guidance/downloads/cib053019.pdf. [FN193] . “Decision Memo for Ambulatory Blood Pressure Monitoring (ABPM) (CAG-00067R2),” CMS, available at: https://www.cms.gov/ medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=294. [FN194] . “Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N),” CMS, July 15, 2019, available at: https:// www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=295. [FN195] . Press Release, “CMS Proposes to Cover Acupuncture for Chronic Low Back Pain for Medicare Beneficiaries Enrolled in Approved studies,” CMS, July 15, 2019, available at: https://www.cms.gov/newsroom/press-releases/cms-proposes-cover-acupuncture-chronic- low-back-pain-medicare-beneficiaries-enrolled-approved. [FN196] . “National Coverage Analysis (NCA) Tracking Sheet for Acupuncture for Chronic Low Back Pain (CAG-00452N),” CMS, available at: https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=295. [FN197] . Press Release, “CMS Proposes to Cover Acupuncture for Chronic Low Back Pain for Medicare Beneficiaries Enrolled in Approved studies,” CMS, July 15, 2019, available at: https://www.cms.gov/newsroom/press-releases/cms-proposes-cover-acupuncture-chronic- low-back-pain-medicare-beneficiaries-enrolled-approved. [FN198] . Press Release, “CMS Proposes to Cover Acupuncture for Chronic Low Back Pain for Medicare Beneficiaries Enrolled in Approved studies,” CMS, July 15, 2019, available at: https://www.cms.gov/newsroom/press-releases/cms-proposes-cover-acupuncture-chronic- low-back-pain-medicare-beneficiaries-enrolled-approved [FN199] . The proposed rule is published at 84 F.R. 34598 (July 18, 2019). [FN200] . For more information, see Press Release, “Trump Administration Announces Steps to Strengthen Medicare with New Home Infusion Therapy Benefit and New Regulations that Put Patients Over Paperwork,” CMS, July 11, 2019, available at: https://www.cms.gov/ newsroom/press-releases/trump-administration-announces-steps-strengthen-medicare-new-home-infusion-therapy-benefit-and-new; Fact Sheet, “CMS Proposes Calendar Year 2020 and 2021 New Home Infusion Therapy Benefit and payment and policy changes for Home Health Agencies,” CMS, July 9, 2019, available at: https://www.cms.gov/newsroom/fact-sheets/cms-proposes-calendar- year-2020-and-2021-new-home-infusion-therapy-benefit-and-payment-and-policy; “Home Infusion Therapy Services, CMS, available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Home-Infusion-Therapy/Overview.html. [FN201] . 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. [FN202] . 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. [FN203] . 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. [FN204] © 2020 Thomson Reuters. No claim to original U.S. Government Works. -45- . 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. [FN205] . 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. [FN206] . 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. [FN207] . For more information, please see Washington COPES Medicaid Waiver Program, updated Feb. 2019, available at: https:// www.payingforseniorcare.com/medicaid-waivers/wa-copes-waiver.html. [FN208] . MaryBeth Musumeci and Priya Chidambaram, “Medicaid Home and Community-Based Services Enrollment and Spending,” Apr. 4, 2019, available at: https://www.kff.org/medicaid/issue-brief/medicaid-home-and-community-based-services-enrollment-and-spending/. [FN209] . MaryBeth Musumeci and Molly O'Malley Watts, “Key State Policy Choices About Medicaid Home and Community-Based Services,” Apr. 4, 2019, available at: https://www.kff.org/medicaid/issue-brief/key-state-policy-choices-about-medicaid-home-and-community- based-services/. [FN210] . MaryBeth Musumeci and Priya Chidambaram, “Key Questions About Medicaid Home and Community-Based Services Waiver Waiting Lists,” Apr. 4, 2019, available at: https://www.kff.org/medicaid/issue-brief/key-questions-about-medicaid-home-and-community-based- services-waiver-waiting-lists/. [FN211] . “Care Coordination Toolkit,” CMS, available at: https://innovation.cms.gov/Files/x/aco-carecoordination-toolkit.pdf. [FN212] . “Care Coordination Toolkit,” CMS, available at: https://innovation.cms.gov/Files/x/aco-carecoordination-toolkit.pdf. [FN213] . The case studies can be found on CMS' ACO General Information page at: https://innovation.cms.gov/initiatives/ACO/ Produced by Thomson Reuters Accelus Regulatory Intelligence 04-Feb-2020 © 2020 Thomson Reuters. No claim to original U.S. Government Works. -46-