REGULATORY INTELLIGENCE YEAR-END REPORT - 2022 Health Policy Tracking Service - Issue Briefs Healthcare Reform Delivery Reform This Issue Brief was written by Tammy J. Raduege, J.D., a contributing writer and member of the Wisconsin bar. 12/19/2022 |. Introduction The rights to health care and necessary social services were recognized under the Universal Declaration of Human Rights, unanimously adopted by the General Assembly of the United Nations in 1948. IFN2] 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 made some changes on how it administers the law. Il. STATE TRENDS IN HEALTH DELIVERY REFORM As it does each fall, the Kaiser Family Foundation published its annual state Medicaid budget survey, this one for the 2022-2023 fiscal year. As of September 2022, 49 states (including the District of Columbia), responded to the survey, but not all states responded fully to all questions. This year's survey highlighted how the pandemic has affected state health policy. As it relates to delivery reform, some of the major findings of the report include these: * Medicaid managed care has been and continues to be the predominant choice for care delivery. Managed care enrollment grew during the pandemic, as overall Medicaid enrollment grew as well. When the pandemic ends and the unwinding process begins, managed care organizations may be well-suited to assist states in reaching out to and supporting their enrollees during the redetermination process. In 2021, North Carolina implemented its first managed care program, and five states, California, Missouri, Nevada, New Jersey, and New York, have expanded or plan to expand mandatory managed care enrollment for certain populations. Other states carved services into managed care or carved them out of managed care. In 2022, Missouri and Ohio developed specialized managed care programs for children with complex medical needs. ¢ The pandemic wrought uncertainty in care delivery, owing to inconsistent utilization patterns, labor shortages, provider capacity, and so forth. These challenges have affected states' implementation of delivery and payment reform systems, including, for example, patient-centered medical homes, health homes, accountable care organizations, and episode-based payment models. As of July 2022, forty-one states have at least one delivery or payment reform initiative that focuses on Medicaid cost and quality, and 24 states have multiple initiatives in place. Specifically: « Twenty-six states have patient-centered medical homes. * Twenty states have Affordable Care health homes. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ Eighteen states have an all-payer claims database. ¢ Eleven states have accountable care organization programs. ¢ Nine states use episodes of care for payment. [FNS] The pandemic also brought forth changes in telehealth policy. Even before the pandemic, Medicaid coverage of telehealth was fairly common. According to the Kaiser Family Foundation, states have wide berth in providing telehealth coverage without federal approval. However, policies on allowable services, providers, payment, and other requirements varied widely by state. Telehealth became an invaluable delivery method during the pandemic. During the pandemic, all states plus the District of Columbia expanded coverage of and access to telehealth. The foundation sums up some of the pandemic-related changes to telehealth policy: For example, states expanded the range of services that can be delivered via telehealth; established payment parity with face-to-face visits; expanded permitted telehealth modalities; and broadened the provider types that may be reimbursed for telehealth services. As of July 2021, most states reported covering a range of services delivered via audio-visual and audio-only telehealth in their Medicaid fee-for-service (FFS) and managed care programs. [FINA] Still, access to telehealth was not a great equalizer during the pandemic as one would have hoped. According to the survey's findings, telehealth may not have been equally accessible among different racial and ethnic groups. Usage of video telehealth was lowest among people of color, possibly due to technology barriers. Researchers believe that "policy efforts to ensure equitable access to telehealth, in particular video-enabled telehealth, are needed to ensure that disparities that emerged during the pandemic do not become permanent." And while telehealth has the potential to increase access to services in rural and underserved areas, the populations in those areas had telehealth utilization rates lower than their urban counterparts, likely owing to technology barriers. Some of the survey's findings about telehealth include these: * Forty-seven states reported expanding coverage to audio-only telehealth, with 28 states newly allowing coverage of this modality and 19 states expanding coverage of this modality. ¢ Enrollees' use of telehealth soared during the pandemic but has decreased as of late. Still usage remains much higher than in pre- pandemic times. ¢ In fiscal year 2022, telehealth behavioral health services were the most commonly-used services, followed by evaluation and management services and office/outpatient services generally. Some states also reported higher usage for services rendered by federally-qualified health centers, for therapy services, and for services to treat COVID-19. ¢ States reported increased telehealth utilization among all population groups, but many states reported that the Affordable Care Act Medicaid expansion group had among the highest utilization rates, followed by children and those with disabilities. Because telehealth usage has increased, three-quarters of the states reported a concern with the quality of telehealth services, and many states questioned the effectiveness of audio-only services. And, as mentioned above, states expressed concerns about the inequities extant in telehealth and how those inequities may impact the quality of care and outcomes. States such as Arizona, Maine, Maryland, Massachusetts, North Carolina, and South Carolina report implementing or having plans to implement measures to assess the quality of telehealth services. [FNS] Please see the report for a fuller discussion of how the pandemic has affected delivery reform. Ill. ACCOUNTABLE CARE ORGANIZATIONS The Centers for Medicare and Medicaid Services (CMS) explains that an accountable care organization (ACO) is a 'group of providers and suppliers of services (e.g., hospitals, physicians, and others involved in patient care) that will work together to coordinate care for the Medicare fee-for service patients they serve.' IFN6] 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. '""7! Because these patients suffer from such a number and variety of illnesses, care is often fragmented, which can lead to a lack of communication among the different providers. When that happens, there is a risk that tests or procedures may be unnecessarily repeated or that crucial information may not get passed on from one physician to another. By coordinating care, ACOs should increase the efficiency and safety of medical care for the elderly and decrease the cost. Generally, if ACOs help save money for Medicare, they may share in some of the savings, but some also agree to share in the losses is the costs are too high. CMS launched several ACO programs after the Affordable Care Act was implemented. The largest was the Medicare Shared Savings Program (with 483 participants in 2022), which is currently running. [FNS] The Pioneer ACO Model, the Advance Payment ACO Model, the ACO Investment Model, Comprehensive ESRD (end stage renal disease) Model, and the Next Generation ACO Model are no longer active. We discuss a new ACO Model, the REACH Model, below. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. CMS has been publishing toolkits to inform the public about how ACOs work. They include the Beneficiary Engagement Toolkit, [FNS] the Care Coordination Toolkit, [FN10] ond the Provider Engagement Toolkit, [FN"1] the Care Transformation Toolkit, [FN12] and the Operational Elements Toolkit, [FN13] which will the final toolkit in the series. A.The Medicare Shared Savings Program As the program was originally designed, ACOs in the Medicare Shared Savings Program could opt to enter the program in Track 1 in which they entered into a one-sided arrangement with the government. In a one-sided (or 'upside only") arrangement, an ACO that meets quality benchmarks and keeps costs down can share in the cost savings it achieved but accepts no risk for failing to achieve savings. ACOs were allowed to stay in Track 1 for two agreement cycles (or six years). IFN14] ACOs could also choose to participate in other tracks where they entered into a two-sided agreement and shared in both the savings and the losses. [FN15] However, the government's arrangement with most (82%) of the Shared Savings ACOs was one-sided, and ACOs were not leaping to make the change to a two-sided arrangement. IFN16] The Obama Administration recognized the need to encourage more ACOs to transition into risk-bearing arrangements, and in late 2016 it introduced the ACO Track 1+ model. IFN17] cus explained that the new model would 'test a payment model that incorporates more limited downside risk than is currently present in Tracks 2 or 3 of the Medicare Shared Savings Program in order to encourage more rapid progression to performance-based risk.' The new, time-limited model qualified as an APM, allowing participating clinicians to qualify for incentive payments. IFN18] The American Hospital Association released a brief statement in support of the model. *"*! In remarks before the American Hospital Association in 2018, then-CMS Administrator Seema Verma lamented the state of the Medicare Shared Savings Program. Verma expressed her concern that most ACOs in the program were still in one-sided agreements. ACOs in these 'upside-only" arrangements are actually costing the Medicare program money, she said, while ACOs participating in two- sided tracks are saving money. She also said she believes that the one-sided arrangements 'may be encouraging consolidation in the market place, reducing competition and choice for our beneficiaries." [FN20] Verma's remarks were portentous. On August 17, 2018, CMS proposed a rule overhauling the Medicare Shared Savings Program, calling the overhaul the Pathways to Success Program. CMS explained the purpose of the rule in the summary: The policies included in this proposed rule would provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These proposed policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free- market principles. The proposed rule also would provide new tools to support coordination of care across settings and strengthen beneficiary engagement; ensure rigorous benchmarking; promote interoperable electronic health record technology among ACO providers/suppliers; and improve information sharing on opioid use to combat opioid addiction. [FN21] At the time the proposed rule was announced, some experts and industry representatives expressed fear that the changes would drive ACOs to quit the program, and a survey by the National Association of ACOs (NAACOS) found that 70% of ACOs would rather quit the program than take on the kind of risk being proposed. The CEO of NAACOS predicted unfortunate consequences from the new rule, saying that the "likely outcome will be that many ACOs quit the program, divest their care coordination resources and return to payment models that emphasize volume over value." A representative from the American Hospital Association, who was concerned with the proposed changes, noted the immense cost, time, and effort it takes to get an ACO to the point of being ready to take on risk. IFN22] On the other hand, Farzad Mostashari, formerly an HHS official under President Obama, said that he agrees that more needs to be done to move ACOs into risk-bearing agreements. However, Mostashari indicated that, ideally, two-sided risk would be made less risky and more predictable. [FN23] CMS estimates a net loss of 100 ACOs by 2027. [FN24] 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. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ Reducing the Shared Savings Program core quality measure set by eight measures; and promoting interoperability among ACO providers and suppliers by adding a new CEHRT threshold criterion to determine ACOs' eligibility for program participation and retiring the current Shared Savings Program quality measure on the percentage of eligible clinicians using CEHRT. [FN25] The rule is published at 83 F.R. 59452-01 (Nov. 23, 2018). (Corrections are published at 84 F.R. 539 (Jan. 31, 2019)). CMS later finalized the other provisions of the proposed rule. Former CMS Administrator Seema Verma explained why the time has come to redesign the Medicare Shared Savings Program as it currently exists: 'Pathways to Success is a bold step towards quality healthcare at a lower cost through competition and beneficiary engagement... . The rule strikes a balance between encouraging participation in the ACO program and advancing the transition to value, ultimately protecting taxpayers and patients. Medicare can no longer afford to support programs with weak incentives that do not deliver value. As we structure new payment arrangements, the impact on the overall market will be top of mind." [FN26] Briefly, the major changes to the Medicare Shared Savings Program include these: * Accountability: The program reduces the time that ACOs can spend in a non-risk agreement. * Quality: The program expands the use of high-quality telehealth services. ¢ Beneficiary engagement: Pathways to Success allows ACOs to offer incentives to their beneficiaries for healthy behaviors, such as establishing a primary care relationship and following up on health services. ¢ Program integrity: The program establishes rigorous and accurate benchmarks for evaluating ACO performance. [FN27] Applications for the new program were accepted on a special one-time start date of July 1, 2019; annual application cycles were to resume in January 2020. Pathways to Success will offer ACOs two tracks in which to participate: the Basic Track and the Enhanced Track. ACOs must participate in their chosen track for no less than five years. CMS summarized the two tracks in a Fact Sheet: (1) BASIC track, which would allow eligible ACOs to begin under a one-sided model and incrementally phase-in higher levels of risk that, at the highest level, would qualify as an Advanced Alternative Payment Model (APM) under the Quality Payment Program, and (2) ENHANCED track, based on the program's existing Track 3, which provides additional tools and flexibility for ACOs that take on the highest level of risk and potential reward. IFN28] In the BASIC track's glide path, ACOs will be eligible for a higher shared savings reward based on quality performance. Time in a one- sided track will be time-limited: The glide path includes 5 levels: a one-sided model available only for the first two years to most eligible ACOs (ACOs identified as having previously participated in the program under Track 1 would be restricted to a single year under a one-sided model, but new, low revenue ACOs that are not identified as re-entering ACOs would be allowed up to three years under a one-sided model); and three levels of progressively higher risk in years 3 through 5 of the agreement period. Under Levels A and B of the glide path, an ACO's maximum shared savings rate under a one-sided model will be 40 percent based on quality performance, applicable to first dollar shared savings after the ACO meets the minimum savings rate. Under Levels C, D, and E of the glide path, an ACO can earn up to a maximum 50 percent sharing rate under a two-sided model, based on quality performance. The glide path concludes with a maximum level of risk that qualifies as an Advanced APM for purposes of the Quality Payment Program. [FN29] The Fact Sheet lays out the details of the program. The final rule is published at 83 F.R. 67816 (Dec. 31, 2018). In April 2021, CMS published the participation options for ACOs in performance year 2022. [FN3O] When the July 1, 2019 application cycle ended, former Administrator Verma took the opportunity to provide updates on the new applications and the selections that ACOs made. She reported that more ACOs are now moving into risk-bearing arrangements: | am especially encouraged to see that an increasing fraction of ACOs are taking on real accountability. Forty-eight percent of ACOs starting on July 1, 2019 are taking on risk for spending increases above their cost target; If they exceed this target, they will be on the hook to pay back to CMS up to at least 2 percent of their revenue or 1 percent of their cost target, and as noted below most of these ACOs will put at risk significantly greater amounts. These ACOs are willing to face consequences if costs increase, in exchange for higher levels of shared savings and greater regulatory flexibility. As of July 1, 2019, 29 percent of Shared Savings Program ACOs are taking on risk for spending increases, which is a 10 percentage point increase in the number of risk-based ACOs in the program. This is projected to lead to more savings for beneficiaries and taxpayers, and provide stronger incentives for ACOs to coordinate care and improve quality for patients. [FNS1] In an update the following year, Verma reported that Pathways to Success ACOs continue to generate a net savings to Medicare - $1.2 billion in 2019, or $169 per beneficiary. "N21! THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. As of January 1, 2022, over 11 million patients receive care in a Shared Savings Program ACO, up slightly from the previous year. Four-hundred eighty-three ACOs were expected to participate for 2022, which includes 66 new ACOs. [FN33) Jy August 2022, CMS reported on ACO performance in 2021. ACOs in the program saved Medicare $1.66 billion in 2021 while delivering quality care, marking the fifth consecutive year that Shared Savings ACOs have achieved this. Ninety-nine percent of ACOs reported on and met quality measures in 2021, and approximately 58% of ACOs earned payments for their performance. A CMS press release explains which ACOs tended to generate more savings: Approximately 58% of participating ACOs earned payments for their performance in 2021. The type of ACOs that saw more net savings tended to be low-revenue, meaning they were mainly made up of physicians, included a small hospital, or served rural areas. With $237 per capita in net savings, low-revenue ACOs lead high-revenue ACOs, who had $124 per capita net savings. Those ACOs comprised of 75% primary care clinicians or more, saw $281 per capita in net savings compared to $149 per capita in net savings for ACOs with fewer primary care clinicians. These results underscore how important primary care is to the success of the Shared Savings Program and demonstrate how the program supports primary care providers. [FN34] CMS made changes to the program in the Physician Fee Schedule rule for 2023 that promotes promote participation in rural and underserved communities. Please see our discussion of the final rule below, in the section titled, 'Selected Federal Activity." B. The REACH Model CMS announced that it is redesigning the Global and Professional Direct Contracting (GPDC) Model and transitioning it into the new ACO Realizing Equity, Access, and Community Health (REACH) Model. The agency is also cancelling the Geographic Direct Contracting Model. These acts align with the Administration's priorities for the health care system, which include creating equitable outcomes through quality, affordable, person-centered care, and they respond to stakeholder feedback. The REACH model will focus on health care equity and closing health care disparities, [FNS] and in doing so, it aligns with the agency's new vision for the Innovation Center. '-N%4 |t will serve individuals in the traditional Medicare program. [FNS7] The REACH Model makes changes to the GPDC in three important ways. It will: ¢ Advance Health Equity to Bring the Benefits of Accountable Care to Underserved Communities ¢ Promote Provider Leadership and Governance ¢ Protect Beneficiaries and the Model with More Participant Vetting, Monitoring, and Transparency [FNS8] A Fact Sheet explains the program's options: The ACO REACH Model will offer two voluntary risk sharing options: (1) Professional Option ("Professional'), a lower-risk option with 50 percent Shared Savings/Shared Losses and Primary Care Capitation Payment; and (2) Global Option ("Global'), a full risk option with 100 percent Shared Savings/Shared Losses and either Primary Care Capitation Payment or Total Care Capitation Payment. The ACO REACH Model will also allow participation by three different participant types: (1) Standard ACOs for organizations with substantial experience serving people with Traditional Medicare; (2) New Entrant ACOs for organizations with less experience serving the Traditional Medicare population; and (3) High Needs Population ACOs, for organizations that serve small Traditional Medicare populations with complex health care needs. The GPDC will continue until December 31, 2022, and will transition to the REACH Model on January 1, 2023. GPDC participants will need to agree to the REACH Model requirements before they can transition to the new model. IFN3®] Please see the Fact Sheet for more information. IV. ELECTRONIC HEALTH RECORDS The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted in 2009 as a part of the American Reinvestment & Recovery Act, spurred adoption and meaningful use of electronic health records as a way to modernize the health infrastructure. Programs like the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs supported and encouraged these efforts. Initially, the programs focused on getting providers to adopt certified EHRs systems and to use them for at least some functions (like electronic prescribing, for example). IFN40] AS more and more providers got on board with EHRs and began using them for sophisticated functions, the government's focus turned to interoperability ? the ability to exchange health information among different technology systems and applications and to use that information. [FN41] To reflect this refined focus, the EHR Incentive Programs were renamed Promoting Interoperability. To ensure that health information can be freely exchanged, both statutory [FN42] and regulatory [FN43] provisions define and prohibit what is known as information blocking. In 2021, the Office of the National Coordinator for Health Information Technology (ONC) released a data brief summarizing how acute care non-federal hospitals use and exchange health information. The brief used data from the 2019 American Hospital Association IT Supplement, and ONC sets out the highlights of the findings in the opening page of the brief: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ About 70 percent of hospitals reported integrating data into their EHR ? a nearly 15 percent increase from 2018. ¢ A majority of hospitals used a mix of electronic and non-electronic methods to exchange summary of care records, however use of electronic third party methods Health Information Service Providers (HISPs), HIEs, and vendor networks increased in 2019. ¢ The proportion of hospitals that used a national network to find (or query) patient health information increased by nearly 40 percent between 2018 and 2019, FN"4l Notably, about 90% of all of the hospitals surveyed had adopted a 2015 Edition EHR system; more than one-half of all hospitals surveyed performed all four domains of interoperability (sending information, receiving information, finding information, and integrating information) from outside their health system; and three-quarters report electronically finding information from outside their health systems. [FN45] In calendar year 2022, to attest as a meaningful user of certified electronic health record technology (CEHRT), providers were required to be using either the 2015 Edition certification criteria, the 2015 Edition Cures Update criteria, or a combination of the two. IFN46] cus announced that for calendar year 2023, the CEHRT requirements will require program participants to use the 2015 Cures Update criteria only. In an email update, CMS set out the 2023 CEHRT requirements: The CY 2023 CEHRT requirements for the Medicare Promoting Interoperability Program are as follows: ¢ 2015 Edition Cures Update functionality must be used as needed for a measure action to count in the numerator during the EHR reporting period chosen by the eligible hospital or CAH (a minimum of any continuous 90 days in 2023). ¢ In some situations, the product may be deployed during the EHR reporting period but pending certification. In such cases, the product must be updated to the 2015 Edition Cures Update criteria by the last day of the EHR reporting period. * Eligible hospitals and CAHs must provide their EHR's CMS Identification code from the Certified Health IT Product List (CHPL), available on HealthIT.gov, when submitting their data. IFNA7] CMS finalized changes to the Medicare Promoting Interoperability Program for hospitals and critical access hospitals in the 2023 Hospital Inpatient Prospective Payment System proposed rule. [FN48] In calendar year 2022, hospitals and critical access hospitals were required to report on four objectives: 1. Electronic Prescribing 2. Health Information Exchange 3. Provider to Patient Exchange 4. Public Health and Clinical Data Exchange "49! For 2023, CMS did not make changes to these objectives, but it changed the points awarded for each of them and the associated measures under them. In a Fact Sheet, CMS laid out the changes in the final rule for 2023: ¢ Make mandatory the Electronic Prescribing Objective's Query of Prescription Drug Monitoring Program (PDMP) measure, adding a third exclusion to the two that we proposed; expand the measure to include not only Schedule II opioids, but also Schedule III and IV drugs, and maintain the associated points at 10 points; ¢ Add a new Enabling Exchange under the Trusted Exchange Framework and Common Agreement (TEFCA) measure under the Health Information Exchange (HIE) Objective as a yes/no attestation measure, beginning with the EHR reporting period in CY 2023, as an optional alternative to the three existing measures under the HIE Objective; ¢ Add a new Antimicrobial Use and Resistance (AUR) Surveillance measure and require its reporting under the Public Health and Clinical Data Exchange Objective, beginning with the CY 2024 EHR reporting period; * Beginning with the CY 2023 EHR reporting period, reduce the active engagement options for the Public Health and Clinical Data Exchange Objective from three to two options; * Beginning with the CY 2023 EHR reporting period, require submission of the level of active engagement, in addition to submitting the measures for the Public Health and Clinical Data Exchange Objective; ¢ Beginning with the CY 2024 EHR reporting period, require eligible hospitals and CAHs to limit the duration of their time on level of active engagement option one to a single EHR reporting period. ¢ Institute public reporting of certain Medicare Promoting Interoperability Program data beginning with the CY 2023 EHR reporting period; * Beginning with CY 2023 EHR reporting period, we will increase the Public Health and Clinical Data Exchange Objective from 10 to 25 points, increase the points associated with the Electronic Prescribing Objective from 10 to 20, reduce the points associated with the Health Information Exchange Objective from the current 40 points to 30 points, and reduce the points associated with the Provide Patients Electronic Access to Their Health Information from the current 40 to 25 points; THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. ¢ Adopt two new eCQMs to the Medicare Promoting Interoperability Program's eCQM measure set beginning with the CY 2023 reporting period, and two new eCQMs beginning with the CY 2024 reporting period, in alignment with the Hospital IQR Program; * Modify the eCQM reporting and submission requirements to increase eCQM reporting from four eCQMs (one mandatory and three self-selected) to six eCQMs (three mandatory and three self-selected) beginning with the CY 2024 reporting period in alignment with the Hospital IQR Program. [FN50] CMS and ONC have both released final rules to improve interoperability. CMS' rule aims 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 includes changes to health care delivery that support the MyHealthE Data Initiative. IFN51] To this end, the rule, among other things, requires that 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 that engage in 'information blocking" that impedes the free flow of information. It also requires payers regulated by CMS to be able to share with other payers, on a patient's request, certain clinical data so that the information is available as patients move between payers. CMS is also changing the Conditions of Participation for hospitals to require sharing of certain health information: CMS is modifying Conditions of Participation (CoPs) to require hospitals, including psychiatric hospitals and CAHs, to send electronic patient event notifications of a patient's admission, discharge, and/or transfer to another healthcare facility or to another community provider or practitioner. This will improve care coordination by allowing a receiving provider, facility, or practitioner to reach out to the patient and deliver appropriate follow-up care in a timely manner. [FNS2] The rule is published at 85 F.R. 25510-0171 (May 1, 2020). CMS' rule applies to many types of entities and organizations, including Medicaid managed care organizations and state Medicaid agencies. In an email update, IFNS3] cms explained, The Interoperability and Patient Access final rule (CMS-9115-F), published May 1, 2020, included revisions to the hospital Conditions of Participation (CoPs) at 42 CFR 482.24(d) (and at 42 CFR 482.61(f) for psychiatric hospitals and at 42 CFR 485.638(d) for critical access hospitals (CAHs). These revisions require hospitals, including psychiatric hospitals, and CAHSs that utilize an electronic medical records system or other electronic administrative system, which is conformant with the content exchange standard at 45 CFR 170.205(d)(2), to send electronic patient event notifications of a patient's admission, discharge, and/or transfer to applicable post-acute care services providers and suppliers or any practitioner(s) a patient considers primarily responsible for his or her care. Today, The Centers for Clinical Standards and Quality released guidance for providers and state surveyors outlining the new requirements for admission, discharge, and transfer electronic patient event notifications for surveyors assessing compliance with the revised CoPs, [FN The guidance is in the form of a memo IFNSS] and an FAQ sheet. /FNS6! ONC's rule includes provisions meant to comply with the 21st Century Cures Act (P.L. 114-255). Among other things, the rule includes language setting out necessary activities that do not constitute 'information blocking." That rule also makes changes to the 2015 edition health IT certification criteria in order to advance interoperability. More information is available on the government's health IT page. [FNS7] The rule is published at 85 F.R. 25642-01 (May 1, 2020). V. innovation in health care delivery 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 HHS, CMS, the Center for Medicare and Medicaid Innovation, and the Medicare-Medicaid Coordination Office The Center for Medicare and Medicaid Innovation (the Innovation Center) was a creature of the Affordable Care Act. At the time, CMS described the center as having a triple aim of improving patient experience, managing costs, and improving population health in the Medicare and Medicaid programs and CHIP. IFN58] innovation Center initiatives have often focused on payment and delivery reforms to achieve the triple aim. After more than ten years of experience, CMS believes that it is time to consider a 'refresh' of the center, and it has published a white paper outlining a new vision for it. Since its inception, the Innovation Center has launched more than 50 test models, and in the period of 2018-2020, nearly 28 million patients and more than 528,000 health care providers and plans have participated in them. Of the models, CMS explained, These models have generated important lessons about how to transition the U.S. health system to value-based care. Models have been launched in advanced primary care, episode-based care, accountable care, state-based transformation efforts, and for specific THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. populations, such as Medicare beneficiaries with end-stage renal disease (ESRD), diabetes, heart disease, and in Medicaid for maternal opioid-use disorders, and populations that experience higher risk for premature births. [FNS9] Leaning on the lessons it has learned after ten years of experience with Innovation Center models, CMS is outlining a new strategy for the center which will be guided by five objectives: ¢ driving accountable care; * advancing health equity; * supporting innovation; ¢ addressing affordability; and * partnering to achieve system transformation. [FN6O] The white paper articulates the lessons learned, the issues and challenges of each of those lessons, and the next steps for applying those lessons and addressing the issues and challenges involved in doing so. CMS identifies the lessons from past experience as these: ¢ Health equity should be embedded in each Innovation Center model. ¢ The Innovation Center should pare down its portfolio of models to reduce complexity and overlap. * The Innovation Center must recognize the tools that providers need to assume financial risk. ¢ Models should be designed to ensure broader provider participation. ¢ The effectiveness of models may have been hampered by the complexity in financial benchmarks. * Models should encourage lasting delivery transformation after the model ends. [FN61] Please see the white paper for a fuller discussion of all of these issues. A year later, CMS provided an update on the progress toward achieving the objectives set out in the strategy. In that report, CMS sets out each objective and the activities the agency has undertaken to realize the objective. For example, under the 'driving accountable care" objective, CMS pointed to the new Enhancing Oncology model and the redesigned REACH ACO model, among other things. Under the 'improving access to care" objective, it pointed to the Part D Senior Savings Model, which makes insulin more affordable, among other things. The report also includes an implementation timeline through 2029, and it lays out the metrics it will use to measure success for each objective. Please see the report for more details. IFN62] On a related note, the Innovation Center published its 2020 Report to Congress. (It is required to file a report least every other year.) The latest report details the activities of the center from October 1, 2018, to September 30, 2020. [FN63] Below we discuss some of the initiatives launched by the Innovation Center and the Medicare-Medicaid Coordination Office as those offices currently exist. Enhancing Oncology Model When he was the vice-president, now-President Joe Biden (D) spearheaded the Cancer Moonshot Initiative, which was designed to speed up the progress in the nation's fight against cancer. President Biden has now 'reignited' that initiative, announcing the goal to decrease cancer deaths by 50% over the next 25 years. IFN64] Taking a step in that direction, the Biden Administration announced a new model to improve the quality of care for cancer patients while also lowering health care costs. Called The Enhancing Oncology Model, the model will test strategies for improving cancer care delivery by making it more patient-centered: CMS' Center for Medicare and Medicaid Innovation (Innovation Center) designed the Enhancing Oncology Model (EOM) to test how to improve health care providers' ability to deliver care centered around patients, consider patients' unique needs, and deliver cancer care in a way that will generate the best possible patient outcomes. The model will focus on supporting and learning from cancer patients, caregivers, and cancer survivors, while addressing inequities and providing patients with treatments that address their unique needs. [FN65] According to CMS' press release announcing the model, participating providers should expect to deliver patient-focused 'Enhanced Services," such as 24/7 access to care providers, patient navigation services, a detailed care plan, and screening for unmet health- related social needs. Screening for unmet social needs furthers the administration's focus on equity. Other equity-related program features include: * Offering an additional payment to participating oncology practices that provide Enhanced Services to patients who qualify for both Medicare and Medicaid, ¢ Requiring participating providers to report patient demographic data (e.g., race, ethnicity, language, gender identity), and ¢ Requiring participating providers to develop plans showing how they will address health equity gaps in their patient population. [FN66] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. The model, which builds on the now-defunct Oncology Care Model, will run for five years, from July 2023 to July 2028. [FNG71 it will include two risk-based payment options, both of which the administration expects to include as MIPS [FN68] A Iterative Payments Models in the Quality Payment Program. IFN69] ~ Fact Sheet is available, "N70 222? 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 launched the Medicare Diabetes Prevention Program (MDPP) Expanded Model, which builds on Diabetes Prevention Program (DPP) model test. DPP was tested through Health Care Innovations Awards. *N7"l cms explained 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 for the disease. N71 Former 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 recognition from the CDC. IFN73] Nine hundred forty-seven participants have now been named. New resources for the program were posted in 2020, and an evaluation report was posted in 2021. [FN74] Changes to the program were made in the 2022 Physician Fee Schedule final rule. N75 ?7???The CHART Model Rural health has long been a concern for the government, as those living in rural communities have poorer health outcomes and higher rates of preventable disease than their urban counterparts, [FN76] ond many rural hospitals have closed or are on the brink of closing. [FN77] Willions of Medicare and Medicaid participants live in rural areas. To respond to the crisis in a thoughtful and organized fashion, CMS adopted a Rural Health Strategy [FN78] and has taken several steps to further the strategy. In August 2020, CMS announced a new model, the Community Health Access and Rural Transformation (CHART) Model, to test innovative solutions to the rural health crisis. "879! The goals of the model are these: Increase financial stability for rural providers through the use of new ways of reimbursing providers that provide up-front investments and predictable, capitated payments that pay for quality and patient outcomes; Remove regulatory burden by providing waivers that increase operational and regulatory flexibility for rural providers; and Enhance beneficiaries' access to health care services by ensuring rural providers remain financially sustainable for years to come and can offer additional services such as those that address social determinants of health including food and housing. [FN80] As originally designed, the model consisted of two tracks, the Community Transformation Track and the Accountable Care Organization (ACO) Transformation Track. In the Community Transformation Track, CMS announced that it would select up to 15 Lead Organizations, each of which would represent a discrete rural community. CMS gave these examples of entities that could be lead organizations: state Medicaid agencies, State Offices of Rural Health, local public health departments, Independent Practice Associations, and Academic Medical Centers, among others. These lead organizations will work with model participants (including, for example, participant hospitals or a state Medicaid agency) to develop and implement Transformation Plans. CMS explained the role of Lead Organizations: The 15 Community Lead Organizations are critical to the success of the Model because they will coordinate efforts across the community to ensure that access to care is maintained and that the needs of various stakeholders are understood and accounted for in the transformation plan. Lead Organizations are responsible for managing cooperative agreement funding, recruiting Participant Hospitals, engaging the state Medicaid agency, establishing relationships with other aligned payers, convening the Advisory Council, and ensuring compliance with Model requirements. Ultimately, the Lead Organization will oversee the execution and coordination of a Transformation Plan that outlines the health care delivery redesign strategy for the Community. [FN81] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. In the ACO Transformation Track, CMS was to select up to 20 ACOs with a rural focus that will receive advanced shared payments through the Medicare Shared Savings Program; the ACOs could use these payments to implement value-based payment models to improve the quality of care and health outcomes in rural communities. [FN82] The application deadline for the Community Transformation Track was extended twice due to the pandemic. However, in September 2021, CMS announced that it awarded funds to four entities to serve as Lead Organizations in that track. The four entities are the University of Alabama Birmingham, the South Dakota Department of Social Services, the Texas Health and Human Services Commission, and Washington State Healthcare Authority. These entities will serve, respectively, in the states of Alabama, South Dakota, Texas, and Washington and they will be responsible to developing and implementing a health care redesign strategy for communities in which they serve. IFN83] The request for applications for the ACO Transformation Track was to be issued in the spring of 2021, IFNS4] However, CMS later announced that it is postponing the RFA release until spring 2022. [FN85] |, 2022, CMS announced that it removed the ACO Transformation Track from the model. In an email update, IFN86] CMS explained that it remains committed to increasing ACO adoption in rural areas, but it will not be doing so in this model. The agency explained that it is examining lessons from the ACO Investment Model as it settles on a way to do this. B.Opportunities to Address Social Determinants of Health 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 determinants of health means making systemic changes to improve way people live. [FN87] 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 efforts to address those conditions that impact the overall health of our country. [FN88] 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.) ¢ Health care system (coverage, access to providers, the level of the provider's cultural competence, etc.) [FN89) In a State Health Official Letter, CMS gave guidance to the states about existing opportunities to address social determinants of health through Medicaid services. The letter had three areas of focus: (1) describing general principles to which states must adhere when offering services and supports addressing social determinants of health, (2) commonly-offered Medicaid services and supports that address social determinants of health, and (3) federal authorities that states can use to offer such services and supports. [FNSO] One of the overarching principles that states must keep in mind is that these types of services and supports must be offered based on individual needs and not on a 'one-size-fits-all' basis. Services that can be covered under Medicaid include: ¢ Housing services and supports ¢ Non-medical transportation * Home-delivered meals « Educational services ¢ Employment services * Community Integration and social support services ¢ Case management services [FN91] CMS also outlined some of the authorities on which states can rely in offering services, including State Plan authority, home- and community-based services options under Section 1915, demonstration authority under Section 1115, Section 1945 health homes, managed care, and PACE (Programs of All-Inclusive Care for the Elderly), among others. Please see the letter for more details on all of these options. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -10- The Accountable Health Communities Model was CMS' first ever model that addressed health-related social needs. The five-year model, open to both Medicare and Medicaid enrollees, launched in 2017 and ended in 2022. As originally designed, the model consisted of three tracks: the assistance track, which provided community navigation to help high-risk beneficiaries access services that address health-related social needs; the alignment track, which built the infrastructure to ensure that community services were available and responsive to enrollees' needs; and the awareness track, which was meant to improve awareness of community resources. CMS ended the awareness track when it determined that it did not have enough qualified applicants to continue with the track. [FN82] Twenty- eight bridge organizations in 21 states implemented the program, which included, among other things, screening for health needs such as food insecurity, housing instability, transportation problems, utility difficulties, and interpersonal violence. [FNS3] The model has now ended and CMS is in the midst of evaluating what was gained from the model. In a CMS Blog post in Health Affairs, CMS reviewed some of the results: * Bridge organizations screened more than one million individuals, and 35% of those screened identified at least one health-related social need. Those individuals qualified for referral to community services. ¢ Those who had one health-related social need and who self-reported two or more emergency department visits in the last 12 months were eligible for navigation services. More than 137,000 ? about 80% of those eligible - accepted the navigation services. Over 92,000 health-related social needs were resolved through the model. Please see the blog post for a more detailed description of the findings. The authors of the post report that communities are taking advantage of the infrastructure built during the model to scale and spread the interventions that were tested. And CMS will continue to build on the lessons learned from the model. For example, the authors note that the newest ACO model, the Realizing Equity, Access, and Community Health (REACH) Model, builds on the Accountable Health Communities Model: First, REACH ACOs are required to identify underserved communities within their aligned beneficiary populations and implement initiatives to measure and reduce health disparities through required Health Equity Plans; these are similar to the Health Resource Equity Plans required within the AHC Model. Additionally, the ACO REACH Model builds on the AHC Model's investment in the infrastructure necessary to support whole-person care. That is why, to mitigate historical disincentives, the ACO REACH Model includes a financial benchmark adjustment for participating REACH ACOs serving a disproportionate number of underserved beneficiaries. It also moves REACH ACOs towards collecting and reporting HRSN [health-related social needs] data on their aligned beneficiaries alongside demographic data critical to supporting Health Equity initiatives. [FN94] Moreover, the 2023 Physician Fee Schedule proposed rule would allow certain Medicare ACOs to use advance payments to identify and address health-related social needs. ""*! Please see the blog post for a fuller discussion of how CMS is building on lessons learned during the Accountable Health Communities Model. On September 28, 2022, HHS announced that it, through CMS, approved Section 1115 demonstrations in Massachusetts and Oregon that will allow those states to tests strategies to improve coverage, access to care, and quality of care. Notably, the demonstrations will also allow those states to test strategies to address social determinants of health. HHS described these new authorities in a press release: The initiatives also take steps to address unmet health-related social needs, such as by giving Massachusetts and Oregon new authority to test coverage for evidenced-based nutritional assistance and medically tailored meals, clinically-tailored housing supports, and other interventions for certain beneficiaries where there is a clinical need. These efforts coincide with the White House Conference on Hunger, Nutrition, and Health, where the Biden-Harris Administration released its national strategy to end hunger, improve nutrition and physical activity, and reduce diet-related diseases and disparities ? all goals supported by the initiatives approved today. [FN96] Additionally, the initiatives will focus on improving enrollment and continuity of coverage. Oregon will keep children enrolled in Medicaid until age six. These approvals further several of the Biden Administrations priorities: to address hunger, to improve health equity, and to strengthen Medicaid and the Affordable Care Act. [FN97] CMS has now approved such a waiver in Arizona as well. The program in Arizona will focus on housing insecurity. In a press release, HHS explains how Arizona will advance solutions to housing insecurity: CMS has authorized the state to advance solutions to a key health-related social need: housing insecurity. Through the 'Housing and Health Opportunities" program, Arizona will provide: ¢ Services to help more people become and remain stably housed; ¢ Support for community and transitional housing for those with unique clinical needs or transitioning out of institutional care; and ¢ Rent and temporary housing for up to six months for individuals transitioning out of places such as congregate settings, homeless shelters, the child welfare system, and a range of other options to transition more people out of homelessness. [FN98] In addition to testing housing-related interventions, the state will offer case management, outreach, and education to advance those services, 'FN®9l THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -11- Arkansas is the latest state to receive approval for such a waiver, and CMS Administrator Chiquita Brooks-LaSure applauded the state's efforts: 'With this demonstration, Arkansas has taken a significant step toward advancing whole-person care for people with health-related social needs . . . . We are glad to partner with the state to advance services and supports that can expand access to high-quality, affordable care targeting a person's comprehensive health needs." [FN100] The amendment to the state's Arkansas Health and Opportunity for Me (ARHOME) Medicaid demonstration waiver will allow the state to provide targeted support for health-related social needs. Specifically, the state will cover care coordination and other person-centered supports provided by 'Life360 HOMEs," which will connect the targeted groups to health services and community supports while also engaging these enrollees in their own health and well-being. HHS explains that the state will collaborate with hospitals and community partners to support three types of Life360 HOMEs: ¢ Rural Life360 HOMEs will support individuals with serious mental illness and/or substance use diagnoses who live in rural areas; ¢ Maternal Life360 HOMEs will support individuals with high-risk pregnancies up to two years postpartum; and ¢ Success Life360 HOMEs will support young adults (ages 19-24) at high-risk for long-term poverty and poor health outcomes due to prior incarceration, involvement with the foster care system, or involvement with the juvenile justice system, as well as veterans ages 19-30 who are at high risk of homelessness. [FN101] The state will also be authorized to provide or increase coverage of other related services for Life360 HOMEs participants, including nutritional services, case management, outreach, and education. [FN102] C. 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; allowing private health plans to provide coverage through a PCMH plan; and requiring insurers to report if they cover PCMHs. [FN103] According to the National Academy on State Health Policy, as of 2015, 46 states and the District of Columbia have policies and programs in place to encourage PCMHs in their Medicaid and/or CHIP programs. IFN104] 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 resources as needed. !FN1051 The Agency for Health Care Research and Quality list five basic principles of patient-centered medical homes: * Comprehensive care geared toward the whole person and addressing the patient's physical and mental needs, whether acute, chronic, or preventive. ¢ A patient-centered approach to care that honors the patient's needs, values, culture, and preferences. ¢ Care that is coordinated through the patient-centered medical home, whether the care is rendered in a hospital, from a specialist (including mental and behavioral health specialists), or through a home- or community-based setting. ¢ Service that is accessible at all hours through a variety of modes, including urgent care, by telephone, or through technology. « Acommitment to quality and safety through quality improvement, performance improvement, patient satisfaction, and so forth. [FN106] Three major programs offer recognition for patient-centered medical homes. [FN107] 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 having a BMI of over 25. 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 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -12- ¢ Health promotion ¢ Comprehensive transitional care/follow-up ¢ Patient & family support ¢ Referral to community & social support services [FN 108] CMS lists the states that currently have approved State Plan Amendments for health homes. For each such state, the table also lists the model type, the target populations, the health home providers, the enrollment requirements (i.e., opt-in or opt-out), the payment model, and the geographic area in which the health home operates. The following states have these health home models: Connecticut (severe mental illness), Delaware (severe mental illness and intellectual and developmental disabilities), the District of Columbia (severe mental illness and chronic conditions), lowa (chronic conditions and severe mental illness), Kansas (chronic conditions and severe mental illness), Maine (chronic conditions, severe mental illness, and substance use disorder), Maryland (severe mental illness and substance use disorder), Michigan (severe mental illness, chronic conditions, and substance use disorder), Minnesota (severe mental illness/serious mental disorder), Missouri (chronic conditions and severe mental illness), New Jersey (severe mental illness in adults and serious emotional disturbance in children), New Mexico (severe mental illness/serious emotional disturbance), New York (severe mental illness and chronic conditions, and chronic conditions only), Rhode Island (chronic conditions and severe mental illness, severe mental illness, and opioid dependency), South Dakota (chronic conditions and severe mental illness), Tennessee (severe mental illness), Vermont (opioid dependency), Washington (chronic conditions), West Virginia (severe mental illness and chronic conditions), and Wisconsin (AIDS/HIV and opioid dependency). [FN109] On August 1, 2022, CMS published a State Medicaid Director Letter giving states guidance on implementing Section 1945A of the Social Security Act. That section allows states to offer a health home State Plan benefit for Medicaid-eligible children with complex medical conditions. This benefit affords care coordination, care management, patient and family support, and other services that would support a family-centered system of care in the hopes of improving health outcomes for these children. The option was added as an amendment to the Affordable Care Act in the Medicaid Services Investment and Accountability Act of 2019 (Pub. L. 116-16), and it becomes available on October 1, 2022. To be eligible as a child with a medically complex condition, the child must have: * One or more chronic conditions that cumulatively affect three or more organ systems and severely reduces cognitive or physical functioning (such as the ability to eat, drink, or breathe independently) and that also requires the use of medication, durable medical equipment, therapy, surgery, or other treatments; or ¢ One life-limiting illness or rare pediatric disease (as defined in Section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(a)(3)). N19) Chronic conditions include things such as cystic fibrosis, AIDS/HIV, cerebral palsy, and severe autism spectrum disorder, among others, [FN1111 In a press release announcing the guidance, CMS explained how this benefit could be a game changer for families: Children with medically complex conditions - including serious health concerns like cerebral palsy, cystic fibrosis, blood diseases, and mental health conditions that can severely impact a child's ability to function - often require tremendous care coordination and highly specialized treatment. Finding needed services often requires traveling well beyond a family's home, and often care is only available for these children out-of-state. The new health home services are expected to give these children and their families help in coordinating and managing care. [FN112] On September 30, 2022, CMS announced that it issued a notice of funding opportunity for planning grants for states interested in pursuing this option. Up to $5 million will be awarded; each state approved for the funding may receive up to 100,000. [FN113] In related news, CMS released a State Plan Amendment template and implementation guide for states interested in taking up this ; [FN114] option. CMS has published resources providing guidance on the Health Home Medicaid State Plan Option. Please visit the Health Home Resource Center, !FN115] In 2013, CMS released a Health Home Core Set of quality measures to ensure that people with chronic conditions receiving care ina health home are getting high quality care with positive outcomes. CMS reviews the set annually. In February 2022, CMS advised that it made a 2022 update to the set, in which it added these two new measures: Follow-Up After Emergency Department (ED) Visit for Mental Illness (FUM), NQF #3489 which measures the percentage of ED visits for beneficiaries age six and older with a principal diagnosis of mental illness or intentional self-harm and who had a follow-up visit for mental illness. Two rates are reported for this measure: (1) the percentage of ED visits for mental illness for which the beneficiary received follow-up within 30 days of the ED visit; and (2) the percentage of ED visits for mental illness for which the beneficiary received follow-up within 7 days of the ED visit. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -13- Colorectal Cancer Screening (COL), NQF# 0034 which measures the percentage of patients 50 to 75 years of age who had appropriate screening for colorectal cancer. N""8l D. Home- and Community-Based Services The goal of home- and community-based services (HCBS) is to allow those with physical or cognitive limitations to remain at home instead of moving into institutional care. The term includes a wide range of services to meet medical needs (such as home health, durable medical equipment, personal care, etc.) and social needs (such as adult daycare, home-delivered meals, home assessments, and so forth). IFN117] For the most part, HCBS are optional benefits in Medicaid, [FN118) though home health services are mandatory. [FN118] States offer optional benefits either through the State Plan or through Section 1915 or Section 1115 waivers. IFN120] Migst people receive HCBS through optional authorities. [FN121] The Affordable Care Act emphasizes HCBS for Medicaid participants, including the elderly and persons with physical or cognitive disabilities or mental illness. In 2013, the government reached the point where it is now spending more on HCBS than on institutional care. IFN122] 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 were employing one or more strategies to increase the number of Medicaid participants served in a home or community setting. [FN123] CMS has now created its first ever quality measure set for HCBS. As CMS explained in the State Medicaid Director Letter, while HCBS are optional in Medicaid, the use of such services has increased dramatically in the last couple of decades. However, until now, there was not a consensus on how to define quality for HCBS. In 2020, CMS issued a Request for Information seeking comment on a draft set of quality measures. CMS has now created a measure set, and future guidance will advise states on how they can use the measures as a part of their HCBS quality measurement, reporting, and improvement activities. For now, states may voluntarily choose to report on the measures, but in time the measures will be built into the reporting requirements for various programs and HCBS authorities. In the guidance, CMS described the purpose of the measures and how they may actually reduce burdens on states: The HCBS Quality Measure Set is intended to promote more common and consistent use, within and across states, of nationally standardized quality measures in HCBS programs, and to create opportunities for CMS and states to have comparative quality data on HCBS programs. In doing so, it is expected to support states with improving the quality and outcomes of HCBS. It is also intended to reduce some of the burden that states and others may experience in identifying and using HCBS quality measures. By providing states and other entities with a set of nationally standardized measures to assess HCBS quality and outcomes and by facilitating access to information on those measures, CMS may be able to reduce the time and resources expended on identifying, assessing, and implementing measures for use in HCBS programs. 174] The guidance also explained how the measures can be used to advance equity, a key priority for the Biden Administration. [FN125] According to CMS, data stratification can be used to identify disparities: Stratification of data is necessary to use the HCBS Quality Measure Set effectively to identify health disparities experienced by Medicaid beneficiaries receiving HCBS, and to identify effectively where targeted interventions are needed to reduce inequities. We strongly recommend and encourage states that implement the measure set to stratify a subset of measures within two years of implementing the HCBS Quality Measure Set, and to increase meaningfully the number of measures that they stratify over time. Further, we strongly recommend and encourage states to oversample sufficiently to be able to stratify their data on key demographic and other beneficiary characteristics, such as race and ethnicity, sex, age, rural/urban, disability, and language. CMS recognizes that oversampling may be associated with increased cost of implementation and recommends that states consider using part of the enhanced FFP noted above for system improvements that will enhance their ability to collect the demographic and other data necessary for stratification. [FN126] The measure set is included as an appendix to the guidance. To be eligible for reimbursement under Sections 1915(c), 1915(i), and 1915(k), HCBS must be offered in a community-based, non- institutional setting. In 2014, CMS released its HCBS Settings rule, which set out the requirements for appropriate HCBS settings. Such settings include these features, generally: ¢ The setting is integrated in and supports full access to the greater community; * Is selected by the individual from among setting options; ¢ Ensures individual rights of privacy, dignity and respect, and freedom from coercion and restraint; ¢ Optimizes autonomy and independence in making life choices; and * Facilitates choice regarding services and who provides them. [FN127] The final rule 128! 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 an Informational Bulletin, CMS announced that it would extend the THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -14- deadline for another three years, until March 16, 2022. IFN129] GMS then realized that, due to the COVID-19 pandemic, states may need additional time to fully implement the rule. In a State Medicaid Director Letter, CMS spelled out some of the problems states may be experiencing during the pandemic: As states are responding to the Coronavirus Disease 2019 public health emergency (COVID-19 PHE), CMS recognizes that its impact has necessitated changes to states' ongoing efforts to comply with the HCBS settings criteria. States' stay-at-home and/or safer-at- home orders and the process of social distancing have made it difficult, if not impossible, for states to accurately evaluate how an individual is experiencing community integration in current HCBS settings. These necessary directives have seriously impacted not only the measurement of community integration for individuals, but the intent of the Settings Rule to ensure that individuals with disabilities and older adults have the opportunity to be active participants in their communities. Lastly, older adults and individuals with disabilities who receive Medicaid HCBS often have underlying conditions that increase risks to health and welfare associated with COVID-19 that can further delay a return to integrated activities as they existed prior to the global pandemic. [FN130] Because of these difficulties, CMS indicated that it will give states an additional year, until March 2023, to fully comply with the rule. On May 24, 2022, CMS announced a strategy to get states into compliance with the rule in a timely fashion. CMS indicates that the implementation approach includes these components: ¢ States must receive final Statewide Transition Plan approval by March 17, 2023. ¢ States and providers must be in compliance with all settings criteria not directly impacted by PHE [public health emergency] disruptions, including PHE-related workforce challenges, by March 17, 2023. * Time-limited corrective action plans (CAPs) will be available to states to authorize additional time to achieve full compliance with settings criteria that are directly impacted by PHE disruptions, when states document the efforts to meet these requirements to the fullest extent possible, and are in compliance with all other settings criteria. [FN131] CMS also indicated that it will be holding multiple meetings with stakeholders to review this information. The agency directs stakeholders to Medicaid.gov for more information. [FN132] The American Rescue Plan (P.L. 117-2) provided for a temporary ten-percentage point increase in the federal medical assistance percentage (FMAP) for certain HCBS during the COVID-19 emergency period. CMS provided guidance for states on implementing that provision. The bulk of the guidance, which takes the form of a State Medicaid Director Letter, focuses on how to qualify for and claim the additional federal funds. It addresses these areas: * eligible services; * program requirements; ¢ ways to enhance, expand, or strengthen HCBS; * how to report on activities that enhance, expand, or strengthen HCBS; and * how to claim the increased funding. Please see the guidance for further details about this new opportunity. IFN133] On June 3, 2022, CMS announced that states will have an additional year, through March 31, 2025, to use these increased funds: As a result of the ARP increase in the federal matching rate on activities, states originally had a three-year period - from April 1, 2021 through March 31, 2024 - to use the available state funds, attributable to the ARP's increased FMAP, on activities to enhance, expand, or strengthen HCBS in Medicaid. The extended timeframe, of an additional year, will help to facilitate high-quality, cost- effective, person-centered services for people with Medicaid. This will allow Medicaid beneficiaries to remain in the setting of their choice-whebther it is their home or another setting-and remain a valued part of their communities. [FN134] Children with special needs rely on home- and community-based services and Medicaid is the largest payer for these services. According to the authors of an Issue Brief from the Kaiser Family Foundation, the pandemic is disproportionately affecting individuals with disabilities, including children with special needs. The purpose of the brief is to provide context for continuing discussions about the need to invest in and support HCBS. In short, the brief concludes that, though children with Medicaid have high needs, Medicaid HCBS, when available, do a good job of serving those needs. Among the key findings are these: ¢ While families of Medicaid/CHIP-only children with special health care needs are more likely to face financial difficulty, they find their health care more affordable than those with private insurance only due to Medicaid's cost-sharing protections. ¢ Even though children with special health care needs covered by Medicaid/CHIP-only have greater health care needs, they are more likely than those with private insurance alone to report that their benefits are always adequate to meet their needs, allow them to see needed providers, and meet their behavioral health needs, reflecting Medicaid's robust benefit package. [FN135] These are important considerations when discussing the need to strengthen and support the long-term care system. As indicated, the American Rescue Plan provided a temporary ten percentage point increase in the federal medical assistance percentage (FMAP) THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -15- for HCBS. Whether states can continue with these services and supports when the temporary increased FMAP ends is unclear. Additionally, many states took emergency action to support long-term care during the COVID-19 public health emergency, but again, it is unclear whether states can afford to make these changes permanent once the public health emergency ends. [FN136] There seems to be widespread agreement that the long-term care system needs to be strengthened, but no clear federal commitment has been made yet for the required funding. The authors of a Kaiser Family Foundation brief note, Although President Biden earlier this year proposed a $400 billion federal investment over 10 years to expand access to Medicaid HCBS and strengthen the direct care workforce, it is unclear how much of that funding increase will be approved by Congress as it considers competing priorities in the budget package and calls among some to reduce the overall spending level. The reconciliation bill being considered by the House includes $190 billion for HCBS. Increased federal funding for Medicaid HCBS beyond the current 1-year could enable states to support the HCBS provider workforce, offer new or expanded HCBS benefits, and/or serve more HCBS enrollees, all of which can benefit children with special health care needs. [FN137] Please see the brief for a much more detailed explanation of the matter and some thoughts for the future. [FN 138] 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 services and supports to those who would otherwise be institutionalized. [FN139] 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 community from an institution, may also be covered. [FN140] Currently, only five states have an approved State Plan Amendment for a CFC program. [FN141] 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 optional Medicaid benefit, and not every state offers it. [FN142] 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 sole source of Medicaid and Medicare benefits for PACE participants. [FN143] The Money Follows the Person demonstration is a Medicaid home- and community-based program that supports people moving out of institutions and back into their homes or the community. According to a CMS press release, HHS has already awarded over $4 billion to support people in these moves. HHS has now issued a funding opportunity offering awards of up to $5 million to each of the 20 states and territories that are not yet participating in the demonstration. The funds are meant for the planning process to allow states to get these programs up and running. They can be used, for example, for: ¢ Establishing partnerships with community stakeholders, including those representing diverse and underserved populations, Tribal entities and governments, key state and local agencies (such as state and local public housing authorities), and community-based organizations; ¢ Conducting system assessments to better understand how HCBS support local residents; * Developing programs for the types of community transitions MFP supports; * Establishing or enhancing Medicaid HCBS quality improvement programs; ¢ Recruiting HCBS providers as well as expert providers for transition coordination and technical assistance; and ¢ Conducting a range of planning activities deemed necessary by the award recipients and approved by CMS. IFN144] Additionally, for states that already participate in Money Follows the Person, HHS will provide additional funding for 'supplemental services": For states already participating in MFP, CMS also announced that the agency is increasing the reimbursement rate for MFP 'supplemental services." These services will now be 100% federally funded with no state share. Further, CMS is expanding the definition of supplemental services to include additional services that can support an individual's transition from an institution to the community, including short-term housing and food assistance. These changes will help further address critical barriers to community THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -16- living for eligible individuals, as well as increase community transition rates and the effectiveness of the MFP demonstration overall. [FN145] E. State Innovation On September 28, 2022, the Department of Health and Human Services (HHS) announced that it, through CMS, approved Section 1115 demonstrations in Massachusetts and Oregon that will allow those states to tests strategies to improve coverage, access to care, and quality of care. Notably, the demonstrations will also allow those states to test strategies to address social determinants of health. HHS described these new authorities in a press release: The initiatives also take steps to address unmet health-related social needs, such as by giving Massachusetts and Oregon new authority to test coverage for evidenced-based nutritional assistance and medically tailored meals, clinically-tailored housing supports, and other interventions for certain beneficiaries where there is a clinical need. These efforts coincide with the White House Conference on Hunger, Nutrition, and Health, where the Biden-Harris Administration released its national strategy to end hunger, improve nutrition and physical activity, and reduce diet-related diseases and disparities ? all goals supported by the initiatives approved today. [FN146] Additionally, the initiatives will focus on improving enrollment and continuity of coverage. Oregon will keep children enrolled in Medicaid until age six. These approvals further several of the Biden Administrations priorities: to address hunger, to improve health equity, and to strengthen Medicaid and the Affordable Care Act. [FN147] F. The CMS National Quality Strategy The United States government has been concerned with the quality of care for decades, but modern efforts at prioritizing quality and paying for the quality of care over the quantity of care arose from the Affordable Care Act. [FN148] [9 further this effort, in 2011, HHS developed the first National Quality Strategy. [FN149] In 2022, CMS unveiled the new CMS National Quality Strategy. In announcing the new strategy, CMS noted that it had developed previous quality strategies, but they and other efforts have not been sustained or have not acknowledged the importance of equity in a robust quality strategy. According to CMS, 'true quality cannot exist without equity." [FN150] Notably, the strategy builds on lessons learned during the pandemic. It has eight goals: ¢ Goal 1: Embed Quality into the Care Journey * Goal 2: Advance Health Equity ¢ Goal 3: Promote Safety ¢ Goal 4: Foster Engagement ¢ Goal 5: Strengthen Resiliency ¢ Goal 6: Embrace the Digital Age ¢ Goal 7: Incentivize Innovation and Technology Adoption to Drive Care Improvements * Goal 8: Increasing Alignment IFN151] The strategy is meant to be a person-oriented approach across the continuum of care during a person's lifetime, and it applies to all payer types, including Medicaid: The CMS National Quality Strategy focuses on a person-centric approach from birth to death as individuals journey across the continuum of care, from home or community-based settings to hospital to post-acute care, and across payer types, including Traditional Medicare, Medicare Advantage, Medicaid and Children's Health Insurance Program coverage, and Marketplace plans. It builds on our previous efforts to improve quality across the health care system, incorporates lessons learned from the COVID-19 Public Health Emergency (PHE), and endeavors to foster and promote the expanded levers used during the pandemic such as interoperability and data sharing, data collection specific to social determinants of health and social risk factors, telenealth, emergency preparedness, leadership, and organizational governance among others. [FN152] Please see the blog post for more information. VI. telehealth Telehealth is a term covering a broad range of services, including telemedicine. Telemedicine refers to virtual clinical services, while telehealth includes clinical services as well as non-clinical services, such as offering education, sending reminders about the patient's health conditions, allowing patients to upload health information for the clinic to review, and so forth. Telehealth can also include telemonitoring, where a health team can keep track of a patient's health through information that is wirelessly transmitted from the patient to the clinic, such as blood pressure readings, heart rate, and sleep patterns, to name a few. IFN153] fs brief from the Kaiser Family Foundation revealed that from March to August 2021, telehealth accounted for 8% of all outpatient visits. This is down from THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -17- 13% earlier in the pandemic, but up from pre-pandemic days, when telehealth accounted for 1% of outpatient visits. According to the foundation, telehealth may permanently take on an increased role in health care delivery, but the future of telehealth depends on regulations, clinical guidelines, and coverage policies in both the private market and in the federal health programs. [FN154] HHS announced that it awarded nearly $55 million to community health centers to increase virtual access to care, including telehealth, remote patient monitoring, digital patient tools, and health IT platforms. The awards went to 29 health centers funded by the Health Resources and Services Administration (HRSA). For these health centers, telehealth was a silver bullet for delivering care during the pandemic. An HHS news release cites the dramatic statistics: In response to the COVID-19 pandemic, health centers have quickly expanded their use of virtual care to maintain access to essential primary care services. They reported significant growth in the number of virtual visits from 478,333 in 2019 to 28,550,608 in 2020, a remarkable 6,000 percent increase. In total, the number of health centers offering virtual visits grew from 592 in 2019 to 1,362 in 2022, an increase of 130 percent. These new awards will enable health centers to sustain an expanded level of virtual care and identify and implement new digital strategies. *N19°! The roughly 1,400 HRSA-funded community health centers in this country are workhorses in the care delivery system for underserved communities. As HHS explains, these centers, serve as a national source of primary care for our at-risk communities. They are community-based and patient-directed organizations that deliver affordable, accessible, and high-quality medical, dental, and behavioral health services to nearly 29 million patients each year. As of late January, overall health centers have delivered over 19.2 million vaccine doses, with 68 percent going to racial or ethnic minority patients. More than 90 percent of health center patients are individuals or families living at or below 200 percent of the Federal Poverty Guidelines (about $55,000 per year for a family of four in most states) and approximately 62 percent are racial/ethnic minorities. FN15¢! The abortion debate is raging in this country, with tensions rising even higher since the U.S. Supreme Court published its decision in Dobbs v. Jackson Women's Health Organization. [FN187] The Court held in that case that there was no federal constitutional right to an abortion. For years, some states have been chipping away at abortion rights by adding new requirements. In contrast, a recent decision by the Food and Drug Administration (FDA) actually expands access to abortion by loosening rules on medication abortions. (A medication abortion is a series of two medications that end a pregnancy. It may be used in the first 10 weeks of pregnancy.) Previously, the prescribing clinician was required to dispense the first drug, mifepristone, in person. That requirement was reversed in December 2021 when the FDA changed a Risk Evaluation and Mitigation Strategy (REMS) and eliminated that requirement. Once the change becomes effective, the medicine may be dispensed by a certified prescribing clinician or a certified pharmacist, and it may be done in a health care setting, at a pharmacy, or through the mail. The new rules open up the possibility of medication abortions by telehealth. [FN158] As telehealth has become a more widely-used delivery method, many states have begun to place restrictions on telehealth abortions. According to a brief from the Kaiser Family Foundation, these can take the form of banning the practice outright, requiring the medication to be dispensed in person, requiring an ultrasound before the medication is dispensed, requiring a waiting period, or requiring in-person counseling. [FN159] Some of these restrictions run afoul of the new federal REMS, and it is unclear whether the REMS would preempt state law. [FN160] This sets up a debate that may have to be resolved in court. Already, plaintiffs in Ohio and Montana are challenging state laws that ban mail-order abortion medications; the laws in those states are currently blocked by courts. A handful of other states have also enacted such bans. And litigation is ongoing in South Dakota where an executive order bans telehealth abortions and requires four in-person visits for a medication abortion. IFN161] Before the Dobbs decision was released, the Kaiser Family Foundation summed up how telehealth could feature in the abortion landscape: Later this year, the Supreme Court will issue its decision in Dobbs v. Jackson Women's Health Organization, that could dramatically alter the landscape of abortion law in states across the country. It is clear that the FDA's decision to remove the in-person requirements for dispensing mifepristone will greatly expand access to abortion care through telehealth, particularly for people living far from clinics in states that will continue to allow abortions regardless of the Supreme Court's decision in Dobbs. What is less clear, however, will be the impact of existing and forthcoming state policies limiting abortions on the availability of medication abortion for the people who reside in those states. Regardless of the outcome of the Mississippi law being challenged at the Supreme Court, access to medication abortion -either over state lines by mail or when traveling from a state that bans abortion to one that permits it-could play an increasingly important role for those seeking abortion care. [FN162] Please see the brief for a fuller discussion and for state-level data on these restrictions. HHS announced that it awarded over $16 million in American Rescue Plan "18 funds to 31 grantees to allow them to increase telehealth capacity for Title X family planning services. As HHS points out in a press release, over the last two years, providers have dramatically increased their use of telehealth, and Title X family planning providers are no exception. The Biden Administration sees these grants as a way to ensure that patients receive needed sexual and reproductive services, as those services seem to be in jeopardy as of late. Secretary Xavier Bercerra remarked, THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -18- 'Expanding telehealth at our nation's Title X family planning clinics will help ensure all women and families have equitable access to this essential care . . .. Across the nation we are seeing attacks on sexual and reproductive health care services, and through these funds and other HHS efforts we can ensure that we're able to provide this care that so many across the country need." [FN164] Title X family planning services are delivered through a variety of providers, including state and local health departments, federally- qualified health centers, hospital-based clinics, and other private nonprofit and community-based health centers. The services benefit low-income and uninsured patients, allowing them to access a wide range of services such as breast and cervical cancer screening, contraceptive counseling and care, and testing for sexually transmitted diseases, including HIV. The funds will be used for a 12-month project. [FN165] Vil. selected Federal Activity ¢ In the House, 2021 FD H.B. 379 (NS) would enact the Improving Social Determinants of Health Act of 2021. That act would authorize the Director of the Centers for Disease Control and Prevention (CDC) to implement a Social Determinants of Health Program. The findings supplied with the bill note the many ways various agencies have stressed the importance of tackling social determinants of health: The CDC has created the Healthy People 2030 initiative; CMS has expressly noted the importance of considering social determinants of health; the Department of Health and Human Services' Health 3.0 initiative recognizes the public health system's role in addressing social determinants of health; and the CDC's Health Impact in 5 Years initiative has documented how nonclinical, community-wide approaches have positively affected health. However, according to the findings, health departments and the CDC have not been funded for 'cross-cutting work." Therefore, the bill would direct the CDC to establish a social determinants of health program: (a) Program. To the extent and in the amounts made available in advance in appropriations Acts, the Director of the Centers for Disease Control and Prevention (in this Act referred to as the 'Director') shall carry out a program, to be known as the Social Determinants of Health Program (in this Act referred to as the 'Program'), to achieve the following goals: (1) Improve health outcomes and reduce health inequities by coordinating social determinants of health activities across the Centers for Disease Control and Prevention. (2) Improve the capacity of public health agencies and community organizations to address social determinants of health in communities. The bill is sponsored by Representative Nanette Diaz Barragan (D-Calif.) and many others. Representative Barragan noted in a press release that the COVID-19 pandemic has exposed health disparities: low-income and minority communities have suffered from the virus more than other communities. She explained how her bill would address that problem: The legislation would create a new Social Determinants of Health (SDOH) program at the U.S. Centers for Disease Control and Prevention (CDC). Through grants and guidance, this program would empower public health departments and community organizations to lead efforts to build integrated systems that research and address the social factors that negatively impact health in their regions. The SDOH program would: Coordinate across CDC to ensure programs consider and incorporate SDOH in grants and activities. Award grants to state, local, territorial, and Tribal health agencies and organizations to address SDOHSs in target communities. Award grants to nonprofit organizations and institutions of higher education to conduct research on SDOH best practices; provide technical assistance, training and evaluation assistance to target community grantees; and disseminate best practices. Coordinate, support, and align SDOH activities of other agencies, such as CMS and others. Collect and analyze data related to SDOH activities. [FN166] * Representative Mike Thompson (D-Calif.) and others are sponsoring 2021 FD H.B. 366 (NS), which would enact the Protecting Access to Post-COVID-19 Telehealth Act of 2021. That act would direct the HHS Secretary to waive or modify Medicare telehealth requirements during any declared emergency period. In a press release, Representative Thompson explained why this bill is important to him: 'Telehealth has been a game changer during the Coronavirus pandemic, ensuring that patients can continue to get care while reducing the spread of the virus during routine medical visits. However, patients could face an abrupt end to the practice once the pandemic is over, even though it's long been a proven and cost-effective way to get care... . That's why | am proud to join with my colleagues to reintroduce the Protecting Access to Post-COVID-19 Telehealth Act. This bill ensures the expansion of telehealth can stay in place and be used for continuous care during future disasters and emergencies. | will continue working to get this bill passed and to expand the use of telehealth both during and after the pandemic." [FN167] ¢ Senate Bill 408 (2021 FD S.B. 408 (NS)) would direct the HHS Secretary to publish guidance for states setting out strategies that Medicaid maternal care providers can use to reduce maternal mortality and morbidity. The bill provides, in pertinent part, THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -19- Subject to the availability of appropriations, not later than 36 months after the date of enactment of this Act, the Secretary shall publish on a public website of the Centers for Medicare & Medicaid Services guidance for States on resources and strategies for hospitals, freestanding birth centers (as defined in section 1905(I)(3)(B) of the Social Security Act (42 U.S.C. 1396d(I)(3)(B))), and other maternal care providers as determined by the Secretary for reducing maternal mortality and severe morbidity in individuals who are eligible for and receiving medical assistance under Medicaid or CHIP. Senator Pat Toomey (R-Pa.), one of the bill's sponsors, explained in a press release why this bill is important to him: 'Hundreds of women in the United States die each year as a result of complications from pregnancy and childbirth, but as many as two-thirds of these deaths are believed to be preventable . . . . By bolstering information and resources to better monitor and treat at-risk pregnancies, this legislation will help improve health outcomes for pregnant women and mothers enrolled in Medicaid. | am glad Senator Brown and | are continuing this important effort, and am hopeful our colleagues on both sides of the aisle will join us in reducing maternal deaths." [FN168] «¢ Introduced by Senator Cory Booker (D-NJ) and others, 2021 FD S.B. 346 (NS) would enact the Black Maternal Health Momnibus Act of 2021. This multifocal bill aims to end preventable maternal mortality and severe morbidity and address racial disparities in maternal outcomes. The bill would, among other things: ¢ call for a task force to address social determinants of health in maternal care. The report of that task force would include recommendations for expanding social service coverage to address social determinants of maternal health under Medicaid managed care organizations and State Medicaid programs; * require HHS to report on maternal health data collection processes and quality measures, including the strengths and weaknesses of maternal care quality measures in Medicaid; * require a report from MACPAC on the implications of pregnant and postpartum incarcerated individuals being ineligible for Medicaid under a State plan; ¢ call for a demonstration project, to be known as the Perinatal Care Alternative Payment Model Demonstration Project, to test payment models for maternity care under Medicaid State Plans. ¢ Senate Bill 620 (2021 FD S.B. 620 (NS)) would direct the HHS Secretary, in consultation with the CMS Administrator, to prepare a report for Congress setting out the changes that HHS has made during the COVID-19 emergency period to expand access to telehealth in Medicare, Medicaid, and CHIP (the Children's Health Insurance Program). The bill, which would enact the Knowing the Efficiency and Efficacy of Permanent (KEEP) Telehealth Options Act of 2021, was reintroduced for this session by Senator Deb Fischer (R-Neb.) and Jackie Rosen (D-Nev.). In a press release, Senator Fischer said of the bill, 'Millions of Americans, including many Nebraskans, have benefited from telehealth services during this pandemic. This bipartisan legislation will provide us with valuable information on how to improve and expand this technology to save more lives... ." IFN169] « In the Senate, Senator Bob Casey (D-Pa.) is sponsoring 2021 FD S.B. 1162 (NS), which would enact the Program of All-Inclusive Care for the Elderly Plus Act (or the PACE Plus Act). According to a press release from the Senate Special Committee on Aging, the act would strengthen and expand the PACE program in these ways: ¢ Increase the number of PACE programs nationally by making it easier for states to adopt PACE as a model of care and provide grants to organizations to start PACE centers or expand existing PACE centers; ¢ Expand the number of seniors and people with disabilities eligible to receive PACE services by ensuring individuals with a high level of care need are eligible for PACE and incentivize states to grow their PACE programs; and * Reduce the administrative burden on PACE programs through improved technical assistance and streamlined application processes. [FN170] ¢ In the House, 2021 FD H.B. 1677 (NS) would direct the HHS Secretary, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission to conduct studies and prepare a report to Congress on the actions taken to expand access to telehealth services under the Medicare and Medicaid programs and CHIP (the Children's Health Insurance Program) during the COVID-19 emergency period. ¢ House Bill 1205 (2021 FD H.B. 1205 (NS)) passed the House on May 12, 2021. The bill would enact the Improving Mental Health Access from the Emergency Department Act of 2021. That act would authorize the Substance Abuse and Mental Health Services Administration to award grants to selected health care providers to implement innovative strategies for ensuring that patients who present at the emergency department with an acute mental health episode receive appropriate follow-up care. « Among other things, 2021 FD S.B. 1234 (NS) would award grants to states to create Pregnancy Medical Home Demonstration Projects. The findings supplied with the bill note the high incidence of maternal mortality and morbidity in the United States relative to other developed countries, and they note that many of these incidents are avoidable. Moreover, women of color are disproportionately affected by maternal mortality and morbidity. The findings also highlight a successful Pregnancy Medical Home program in North Carolina: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -20- (10) North Carolina has established a statewide Pregnancy Medical Home (PMH) program, which aims to reduce adverse maternal health outcomes and maternal deaths by incentivizing maternal health care providers to provide integral health care services to pregnant women and new mothers. According to the North Carolina Department of Health and Human Services Center for Health Statistics, the pregnancy-related mortality rate for Black women was approximately 5.1 times higher than that of White women in 2004. Almost a decade later, in 2013, the pregnancy-related mortality rates for Black women and White women were 24.3 and 24.2 deaths per 100,000 live births, respectively. The PMH program has been credited with the convergence in pregnancy-related mortality rates because the program partners each high-risk pregnant and postpartum woman that is covered under Medicaid with a pregnancy care manager. The bill would allow grants for other states to establish such demonstrations. To be eligible, a state must, among other things, commit to working with state and local Medicaid agencies, and the program must prioritize women enrolled in a Medicaid state plan or waiver program. The bill is sponsored by Senator Kristen Gillibrand (D-N.Y.). «In the Senate, 2021 FD S.B. 1675 (NS) seeks to improve the health of pregnant and perinatal women and their infants. Among other things, the bill would authorize grants for states, Indian tribes, or tribal organizations to establish innovative programs of integrated care for pregnant or post-partum women: (a) In General. The Secretary may award grants for the purpose of establishing or operating evidence-based or innovative, evidence- informed programs to deliver integrated health care services to pregnant and postpartum women to optimize the health of women and their infants, including to reduce adverse maternal health outcomes, pregnancy-related deaths, and related health disparities (including such disparities associated with racial and ethnic minority populations), and, as appropriate, by addressing issues researched under subsection (b)(2) of section 317K. To be eligible for such a grant, states, tribes, or tribal organizations must commit to working with relevant stakeholders, including state, local, or tribal agencies responsible for Medicaid and home- and community-based service providers. ¢ In the Senate, 2021 FD S.B. 1190 (NS) would provide enhanced federal Medicaid matching payments for direct support worker training programs. Such programs would include: (A) training in the core training competencies for personal or home care aides described in section 2008(b)(3)(A); and (B) opportunities for education, training, and career advancement. The bill aims to support workers such as personal or home care aides, direct support workers, home health aides, nursing assistants, and other specified direct support professionals. «In the Senate, 2021 FD S.B. 1798 (NS) would direct the Secretary of HHS to issue guidance on how to increase access to telehealth in Medicaid and CHIP. The guidance would include technical assistance and best practices on the issues specified in the bill (delivery, billing, existing strategies, examples from states, and so forth). The bill would also direct the Medicaid and CHIP Payment and Access Commission to conduct a study in at least ten states in different geographic regions of the country on how telehealth impacts 'health care access, utilization, cost, and outcomes, broken down by race, ethnicity, sex, age, disability status, and zip code[.]" ¢ Senator Tim Scott (R-S.C.) and others are sponsoring 2021 FD S.B. 2173 (NS), which would allow CDC-approved virtual suppliers of diabetes prevention programs to participate in the Medicare Diabetes Prevention Program Expanded Model. The bill aims to make diabetes care (and preventive care) more accessible to those who need it. In a press release, Senator Scott explains why the bill is important to him and his constituents: 'One quarter of South Carolina's elderly population and one in five South Carolinians living below the poverty line have diabetes... . Our bill not only expands access to life-saving health care options for those who already have the disease, but it also supports programs that can delay or prevent the full onset of diabetes. By opening the door to virtual suppliers, we can ensure all patients have access to care regardless of zip code. " *N171] The bill has bipartisan sponsorship. * Also in the Senate, a bipartisan group of legislators are sponsoring 2021 FD S.B. 2086 (NS), which aims to identify childhood victims of trauma and provide a wide range of support for them. Senator Dick Durbin (D-Ill.) one of the bill's sponsors, explained how the bill could help such individuals: 'To effectively treat the root causes of violence and addiction in our communities, we must focus on the impact that exposure to violence and traumatic experiences have on children . . .. Unaddressed trauma can harm mental and physical health, life expectancy, school success, and employment, so we must take serious action to prevent the ripple effect that trauma can have. Our bipartisan legislation invests in communities and the workforce to support children and families facing trauma to heal their emotional scars and build a brighter future for our communities." [FN172] According to Senator Durbin's press release announcing it, the bill: * Creates a new, $600 million annual HHS grant program to fund community-based coalitions that coordinate stakeholders and deliver targeted local services to address trauma; THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -24- ¢ Creates a new HHS grant program to support hospital-based trauma interventions, such as for patients that suffer violent injuries, in order to address mental health needs, prevent re-injury, and improve long-term outcomes; ¢ Increases funding for the National Health Service Corps loan repayment program, in order to recruit more mental health clinicians- including from under-represented populations-to serve in schools; ¢ Enhances federal training programs at HHS, U.S. Department of Justice, and the U.S. Department of Education to provide more tools for early childhood clinicians, teachers, school leaders, first responders, and community leaders; and ¢ Establishes training and certification guidelines to enable insurance reimbursement for community figures-such as mentors, peers, and faith leaders-to address trauma. /FN1791 Additionally, the bill would provide grants to eligible entities to deliver and evaluate programs to reduce hospital readmissions and re- injuries for individuals who have been hospitalized after overdosing, attempting suicide, or suffering a violent injury or abuse. Eligible entities would include hospitals or health systems, including health systems operated by Indian tribes or tribal organizations. ¢ Senator Tim Kaine (D-Va.) and others are sponsoring 2021 FD S.B. 2344 (NS), which would enact the Supporting Our Direct Care Workforce and Family Caregivers Act. That act would direct the Secretary of Health and Human Resources, acting through the Administrator for Community Living, to take several actions to support, train, and retain direct care workers. In a press release announcing the bill, Senator Kaine indicated that the bill supports the values in President Biden's (D) Jobs Plan, which calls for substantial investments to meet the increasing demand for home and community-based services. Senator Kaine also explained why this bill is needed right now: Currently, 4.5 million workers ? including nearly 2.3 million home care workers ? make up the direct care workforce, and this industry is expected to grow by more than a million jobs by 2028, not including the jobs that will need to be filled as existing workers leave the field or exit the labor force. Better pay and benefits, strategies to recruit and retain professionals in the field, education and training enhancements, and better career advancement opportunities are some of the investments needed to meet the demands of this workforce shortage. [FN174] ¢ In the House, 2021 FD H.B. 3894 (NS), which would enact the Collecting and Analyzing Resources Integral and Necessary for Guidance (CARING) for Social Determinants Act of 2021 passed the House on December 8, 2021. That act would direct the HHS Secretary to regularly issue guidance to states to clarify strategies for addressing social determinants of health in the Medicaid and CHIP programs. ¢ Senator Bob Casey (D-Penn.) and others are sponsoring 2021 FD S.B. 2210 (NS), which would enact the Better Care Better Jobs Act. The bill would make significant investments in home- and community-based services by increasing access to such care and ensuring a well-compensated health care workforce. Among other things, the bill calls for state planning grants to strengthen and expand home- and community-based services, make permanent the state option to provide community spouses protection against spousal impoverishment, and make the Money Follows the Person program permanent. In a news release, Senator Casey explained why this bill is important: 'For millions of families, and especially for women, home and community-based services are a bridge to work and a bridge to economic security. The Better Care Better Jobs Act would not only enable more older adults and people with disabilities to remain in their homes, stay active in their communities and lead independent lives, it would also create jobs and lead to higher wages for care workers, who are predominantly women and people of color. This legislation is critical to advancing equity, spurring economic recovery and improving quality of life for older adults and people with disabilities[.]* "N75! ¢ Senate Bill 197 (2021 FD S.B. 2197 (NS)) seeks to expand access to telehealth in rural and frontier states. The bill, which would enact the Rural and Frontier Telehealth Expansion Act, has bipartisan sponsorship. A press release explains what the bill would do: This bipartisan bill would increase federal FMAP for telehealth services, including audio-only telehealth, by 5 percentage points if the state covers telehealth services under Medicaid and is a frontier state (Nevada, Alaska, Montana, North Dakota, South Dakota, and Wyoming) or a state "where less than 90% of the total population has access to fixed terrestrial broadband service of at least has fixed 25 Megabits per second (Mbps) download and 3 Mbps upload according to the annual Broadband Deployment Report of the Federal Communications Commission.' N76 The press release stresses the importance of telehealth services in caring for individuals who do not have easy access to in-person care. Several of the sponsors noted that the pandemic highlighted how critical telehealth is to our health care system, and they indicated that they want to incentivize states to continue offering such services. « In Congress, Representatives Guy Bilirakis (R-Fla.) and Darren Soto (D-Fla.) are sponsoring 2021 FD H.B. 4036 (NS), which seeks to expand Medicaid reimbursement for telehealth mental and behavioral health services. Representative Bilirakis' press release explained why the bill is needed: There has been widespread agreement that telehealth has been successfully used throughout the pandemic to increase access to quality behavioral healthcare, adding enhanced safety and convenience. Prior to the pandemic, Medicare's coverage of telehealth services was limited to treatments associated with opioid addiction. At the end of last year, Bilirakis and Soto championed a provision THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -29- put into law that would expand access by allowing Medicare and Medicaid to reimburse for all behavioral health services for children, seniors and those on disability. However, there are some restrictions in place that limit full access. The EASE Act, co-authored by Bilirakis and Soto would permanently remove those remaining restrictions. [FN177] The findings supplied with the bill note the increasing demand for mental health services and the shrinking psychiatric workforce. The companion bill in the Senate is 2021 FD S.B. 2112 (NS), sponsored by Senator John Kennedy (R-La.). « In the Senate, 2021 FD S.B. 2576 (NS) would enact the Reducing Unnecessary Senior Hospitalizations (RUSH) Act of 2021, which would allow certain Medicare providers to provide care in skilled nursing facilities as a way to prevent hospitalization and emergency department usage. Senator Ben Cardin (D-Md.) casts the bill as one that would facilitate increased use of telehealth in these facilities. Senator Cardin's press release sums up the purpose of the bill: The RUSH Act would allow Medicare to enter into voluntary, value-based arrangements with medical groups to provide acute care to patients in skilled nursing facilities using a combination of telehealth and on-site staff. Working together to coordinate care, the providers can avoid a more costly patient transfer to the emergency department. If the program generates savings, they would be shared between the medical group and the skilled nursing facility. [FN178] The bill has bipartisan sponsorship. The companion bill in the House is 2021 FD H.B. 4890 (NS). * During the COVID-19 emergency period, states have been allowing the use of telehealth to a much greater degree. CMS allowed flexibilities for using this delivery method, and many states changed their programs in response to that and to the higher demand for safe health care delivery. House Bill 4770 (2021 FD H.B. 4770 (NS)) would require the HHS Secretary to report on the changes states made to telehealth benefits. In pertinent part, the bill provides, (1) Interim report. Not later than 1 year after the last day of the emergency period described in subsection (a), the Secretary shall submit to Congress an interim report that- (A) details any changes made to the provision or availability of telenealth benefits (such as eligibility, coverage, or payment changes) under State plans (or waivers of such plan) under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) during such emergency period[.] ¢ Inthe Senate, 2021 FD S.B. 2646 (NS) would require states to provide Medicaid coverage for survivors of a disaster or emergency, as defined in the bill. Income thresholds would apply, and the bill would allow for more lenient eligibility and enrollment requirements, like presumptive eligibility, continuous eligibility, and simplified verification. The bill would create an option for states to provide home- and community-based services under these circumstances, regardless of the level of care. ¢ In the House, 2021 FD H.B. 4670 (NS) would enact the Advanced Safe Testing at Residence Telehealth (A-START) Act of 2021, which calls for three demonstration programs (in Medicare, Medicaid, and Veteran's Affairs) to test innovative telehealth technology. The bill's sponsor, Representative David Schweikert (R-Ariz.) explained in a press release that the bill builds on the successful use of telehealth during the COVID-19 pandemic: 'This legislation is an important step in expanding patient and provider access to healthcare innovation to promote high quality, 21st century technology-based care. The COVID-19 pandemic revealed just how valuable access to health care technology can be, and | am proud to build upon its advancements. The A-START Act would accelerate the enormous achievements recently made in expanding telehealth, diagnostics, screening, wearables, and patient monitoring technology. Patients deserve access to the best information and data that modern technology can provide, to make informed decisions about their health." [FN179] ¢ The Affordable Care Act provided for the Community-Based Collaborative Care Network Program, which authorizes HHS to award grants to health care provider consortiums that provide comprehensive coordinated and integrated health care in low-income communities. 'N18° jp, Congress, 2021 FD H.B. 5218 (NS) would provide incentives for health care providers to participate in this model. The bill provides, in part, (a) Grants. The Secretary shall make grants to primary health care physicians and primary health care practices to meet the initial costs of establishing and delivering behavioral health integration services through the collaborative care model or a combined approach of the collaborative care model and primary care behavioral health integration models. One of the bill's primary sponsors, Representative Lizzie Fletcher (D-Tex.) explained in a press release that she sees the Collaborative Care Model and a way to improve mental health in the country, which has suffered in the trauma of the pandemic: It is time we make serious investments to improve how mental health is treated in our country and to ensure that mental health care is more accessible to those who need it . . . . After such a challenging time for all Americans ? a year marked by isolation, trauma, and survival ? it is clear that our mental health is as vital to our well-being as our physical health. | am glad to introduce the bipartisan Collaborative in an Orderly and Cohesive Manner Act with Congresswoman Herrera Beutler to allow primary care providers to better identify and treat mental health and substance use disorders using the Collaborative Care Model. This will help provide relief both to patients experiencing challenging times and in need of support and to the nation's mental health system that is working to meet increased demand in services. "18"! THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -23- « Representatives G.K. Butterfield (D-N.C.) and Gus Bilirakis (R-Fla.) are sponsoring 2021 FD H.B. 5377 (NS), which would enact the Cancer Patient Equity Act. The bill would ensure Medicare, Medicaid, and CHIP coverage of cancer molecular diagnostics, analysis, and testing. In a press release, Representative Butterfield explains what the act would accomplish: 'The Cancer Patient Equity Act will give patients access to cutting-edge, next-generation molecular diagnostic tests that can help identify an individual's specific type of cancer and can inform treatment protocols. Determining whether a patient's cancer is rare or whether it has traits that make it more or less responsive to available treatments can be a game-changer for patients. Too often patients do not have access to these tests unless their cancer reoccurs, at which point it may be too late. My bill will help ensure that patients and their physicians are empowered with actionable information from the beginning of their treatment[.]" [FN182] * Representative Lloyd Doggett (R-Tex.) and a bipartisan group of his colleagues on the Health subcommittee of the Committee on Ways and Means introduced 2021 FD H.B. 6202 (NS), which would enact the Telehealth Extension Act of 2021. Representative Doggett's press release explains what the bill aims to achieve: This bipartisan bill ensures permanent access to telehealth for patients across the country by ending outdated geographic and site restrictions on where patients can receive approved telehealth services. Following recommendations from the nonpartisan, independent advisory group Medicare Payment Advisory Commission (MedPAC), the bill also temporarily extends emergency authorities established during the COVID-19 pandemic that authorize a wide range of providers and services via telehealth. The temporary extension of these authorities will prevent an abrupt cliff in services at the end of the Public Health Emergency (PHE) period and allow for further study of the utilization and impact of telehealth in different medical settings. Finally, to ensure Medicare program integrity, the Telehealth Extension Act implements MedPAC recommendations to prevent unnecessary spending and telehealth-related fraud. [FN183] « In the Senate, Senators Bob Casey (D-Pa.) and Tim Scott (R-N.C.) are sponsoring 2021 FD S.B. 3626 (NS), which would enact the Program of All-inclusive Care for the Elderly (PACE) Expanded Act. The bill would expand Medicare enrollee access to PACE by allowing individuals to enroll any time and providers to enroll in the program and apply for site expansion at any time. The bill also calls for a pilot program to test expanded eligibility, and it would create flexibility in establishing premiums for Medicare enrollees who are not dually eligible. Finally, the bill contains provisions on program evaluation. * Introduced on February 8, 2022, 2021 FD S.B. 3593 (NS) would, among other things, call for a study of the effects of changes to telehealth policy in Medicare and Medicaid during the COVID-19 pandemic. The bill would provide grants to states that provided telehealth services during the pandemic to study and report on changes made to the provision or availability of telehealth during this period. The bill would also extend some of the Medicare telehealth flexibilities that CMS put in place during the pandemic, with an eye toward making some of them permanent. A press release from Senator Catherine Cortez Masto (D-Nev.), one of the bill's sponsors, explains what the bill aims to do: The Telehealth Extension and Evaluation Act would allow Centers for Medicare and Medicaid Services (CMS) to extend Medicare payments for a broad range of telehealth services, including for substance abuse treatment, for an additional two years. The bill would also commission a study on the impact of the pandemic telehealth flexibilities extended in this bill in order to better inform Congress' work to make telehealth flexibilities permanent. [FN184] * Representatives Eric Swalwell (D-Cal.) and Tom Emmers (R-Minn.) are sponsoring 2021 FD H.B. 6875 (NS), which would enact the Right Drug Dose Now Act. That act would improve medication prescribing by increasing awareness of how genes affect the efficacy and dosage of prescription medication. Among other things, the bill would require electronic health records to provide pharmacogenomic information. In a press release, Representative Swalwell summarizes the major provisions of the act: The Right Drug Dose Now Act would update the Department of Health and Human Services' National Action Plan for Adverse Drug Event Prevention, create an educational campaign to prevent adverse drug events, and improve electronic health record systems to ensure that healthcare providers are alerted to interactions between medications and genes when making prescribing decisions. The bill would also allocate additional funding to the Genomic Community Resources program at the National Institute of Health to better integrate PGx testing into patient care. [FN185] ¢ If passed, 2021 FD H.B. 6823 (NS) would expand home- and community-based services for elderly and disabled veterans receiving veterans' benefits. Representative Julia Brownley (R-Cal.), one of the bill's sponsors, provides this summary: [K]ey features of this legislation include: * Expanding access to home and community-based services for veterans living in US territories and to Native veterans enrolled in IHS or tribal health program ¢ Raising the cap on how much the VA can pay for the cost of home care from 65% of the cost of nursing home care to 100%. ¢ Coordinating expanded VA home care programs with other VA programs, like the Program of Comprehensive Assistance for Family Caregivers, and other federal programs, like Medicare's PACE program. ¢ Reviewing existing service gaps in geriatric and extended care at the VA. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -24- ¢ Establishing a pilot project to address home health aide shortages ¢ Providing respite care to caregivers of veterans enrolled in home care programs ¢ Establishing a 'one stop shop" webpage to centralize information for families and veterans on programs available. ¢ Requiring VA to provide a coordinated handoff for veterans and caregivers denied or discharged from the Program of Comprehensive Assistance for Family Caregivers into any other home care program they may be eligible for. [FN 186] ¢ Representatives Debra Dingell (D-Mich.) and Earl Blumenauer (D-Ore.) are sponsoring 2021 FD H.B. 6770 (NS), which would enact the Program of All-Inclusive Care for the Elderly Plus Act (or PACE Plus Act). That act seeks to improve access to PACE by awarding grants to PACE providers to open pilot sites in rural areas or urban underserved areas. An individual grant could be up to $1 million, and up to 30 awards could be made. ¢ In Congress, 2021 FD H.B. 7156 (NS) would enact the Medicaid Coverage for Addiction Recovery Expansion (CARE) Act. That act would give states the option to extend Medicaid coverage for adults who receive services in a residential addiction treatment facility, as long as the services are a part of a full continuum of evidence-based treatment services provided under the State plan. The bill has bipartisan sponsorship. One the bill's sponsors, Representative Bill Foster (D-Ill.) indicated in a press release that the bill would allow 'countless" Medicaid enrollees access to comprehensive intensive inpatient treatment for substance use and addiction. Representative Foster said, 'An outdated Medicaid policy is preventing people from accessing much-needed substance use disorder treatment .. . . If we are serious about fighting the opioid epidemic, we need to align our policies with our present-day understanding of addiction as a treatable medical condition, not a moral failing. The Medicaid CARE Act would do just that and get comprehensive substance use disorder treatment to the patients who need it the most. " [FN187] ¢ In November 2020, in response to the surge in hospitalizations from the COVID-19 pandemic, CMS instituted a waiver program called Acute Hospital Care at Home. The program granted hospitals extensive flexibilities to allow Medicare enrollees to receive some hospital level services at home. CMS described the program in a press release in November 2020: In March 2020, CMS announced the Hospitals Without Walls program, which provides broad regulatory flexibility that allowed hospitals to provide services in locations beyond their existing walls. Today, CMS is expanding on this effort by executing an innovative Acute Hospital Care At Home program, providing eligible hospitals with unprecedented regulatory flexibilities to treat eligible patients in their homes. This program was developed to support models of at-home hospital care throughout the country that have seen prior success in several leading hospital institutions and networks, and reported in academic journals, including a major study funded by a Healthcare Innovation Award from the Center for Medicare and Medicaid Innovation (CMMI). The development of this program was informed by extensive consultation with both academic and private sector industry leaders to ensure appropriate safeguards are in place to protect patients, and at no point will patient safety be compromised. CMS believes that treatment for more than 60 different acute conditions, such as asthma, congestive heart failure, pneumonia and chronic obstructive pulmonary disease (COPD) care, can be treated appropriately and safely in home settings with proper monitoring and treatment protocols. [FN 188] A Senate bill (2021 FD S.B. 3792 (NS)) and a House bill (2021 FD H.B. 7053 (NS)) would extend those flexibilities for two years after the end of the COVID-19 public health emergency. Senator Tom Carper (D-Del.), one of the bill's sponsors, explained in a press release why he thinks the program should be extended: 'For the past two years, hospitals have endured the brunt of the COVID-19 pandemic-and without missing a beat-nurses, doctors, and other medical professionals have continued to provide quality care to individuals affected by the virus and other personal medical conditions . . . . Overrun with patients infected by the virus, hospitals like ChristianaCare in Delaware had to quickly adapt in order to treat patients with other medical needs-such as the creation of innovative programs to provide hospital-level care to patients in their homes. I'm proud to introduce this bill with my friend Senator Scott that will modernize our health care system and ensure that investments in programs to bring hospital care to patients at home can continue to go on." [FN189] ¢ Senate Bill 3791 (2021 FD S.B. 3791 (NS)) and House Bill 7051 (2021 FD H.B. 7051 (NS)) would provide for Medicaid coverage of prescription digital therapeutics. In a press release, Senator Shelley Moore Capito (R-W.V.), one of the Senate bill's sponsors, explained what prescription digital therapeutics (PDTs) are: [They] are software-based disease treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA), and prescribed by health care providers. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software. [FN190] « In the Senate, 2021 FD S.B. 4039 (NS) would enact the Medicaid Ensuring Necessary Telehealth is Available Long-term (MENTAL) Health for Kids and Underserved Act. That act would direct the HHS Secretary to provide guidance to states on reimbursement for THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -25- behavioral health services provided by telehealth in the Medicaid program and CHIP (the Children's Health Insurance Program). In a press release announcing the bill, the bipartisan group of sponsors explained what the bill would do: The MENTAL Health for Kids and Underserved Act would require CMS to provide guidance to states on how they can increase access to mental and behavioral health services and treatment via telehealth under Medicaid and CHIP. Additionally, it would request guidance on how states can furnish behavioral services and treatments in school-based settings and best practices for integration. The bill focuses on those most at risk including underserved Americans and school-aged children. IFN191] ¢ Senator Cory Booker (D-N.J.} and others are sponsoring 2021 FD S.B. 4067 (NS), which would enact the John Lewis Equality in Medicare and Medicaid Treatment (EMMT) Act of 2022. Its companion in the House is 2021 FD H.B. 7755 (NS). The EMMT Act would require the Center for Medicare and Medicaid Innovation (CMMI) to consider health equity in developing new models. A press release from Senator Booker's office explains that CMMI is currently not required to do this: Established by the Affordable Care Act, CMMI works to develop, test, and implement new value-based payment models. Under current law, however, CMMI is not required to consider social determinants of health - such as a patient's environment, education, and economic status - when implementing and testing new payment models. The current status quo incentivizes health providers to pick patients who will produce favorable clinical outcomes, which leaves women, people in rural communities, and Black and Brown people sidelined in the development of payment models. [FN192] Among other things, the bill would require CMMI to: * Consider a model's impact on access to care for people of color, women, and people in rural areas, in addition to cost and quality. * Include experts in health disparities and social determinants of health during the evaluation and review process for new payment models. * [Create] a Social Determinants of Health Model that focuses on health conditions of those dually eligible for Medicaid and Medicare, behavioral health, and maternal mortality. [FN193] ¢ Senator Lisa Blunt Rochester (D-Del.) and others are sponsoring 2021 FD H.B. 7617 (NS), which would enact the Preventive Care Awareness Act of 2022. According to a press release from Representative Blunt Rochester's office, many people chose to forego preventive care, including cancer screenings, during the pandemic. This bill would create a grant program to encourage people to seek preventive care now. The bill would achieve this by: * Creating a $50 million grant program administered by the Centers for Disease Control and Prevention (CDC) to promote preventive care services, with a focus on care that patients have delayed or forgone due to coronavirus-related concerns; ¢ Directing the Department of Health and Human Services to undertake a coordinated, focused public health education campaign to enhance access to preventive services, in consultation with the CDC, the Office of the U.S. Surgeon General, and CMS; and ¢ Establishing a task force to develop recommendations to increase use of preventive health services and to address disparities in preventive care service use, including recommendations on how to best provide preventive health care services when hospital capacity becomes limited or strained due to a public health emergency. [FN194] « Congressman Greg Pence (R-Ind.) is sponsoring 2021 FD H.B. 8169 (NS), which would enact the Rural Telehealth Access Task Force Act. That act would call for a task force to examine opportunities for and barriers to telehealth in rural areas. Specifically, the task force would be directed to: (1) Identify barriers and opportunities to telehealth service in rural areas. (2) Identify barriers to, and opportunities for, utilization of telehealth services in rural areas. (3) Identify opportunities for coordination among covered agencies and across high-cost programs to prevent duplication of effort or overbuilding of existing or planned broadband internet access service projects. (4) Evaluate the adoption and usage rates of telehealth services in rural areas. (5) Evaluate how expanded access to telehealth services can address health disparities in rural patients. (6) Determine how to expand access to broadband internet access service for telehealth services in rural areas, including- (A) rural health systems; and (B) internet service providers. (7) Develop recommendations on how to use current high-cost broadband resources to expand access to telehealth services in rural areas. House Bill 8169 was introduced on June 22, 2022. ¢ Senators Bob Casey (D-Pa.) Bill Cassidy (R-La.) and others are sponsoring a bipartisan bill to increase capacity for pediatric mental health services. Senate Bill 4472 (2021 FD S.B. 4472 (NS)) would enact the Health Care Capacity for Pediatric Mental Health Act of THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -26- 2022. That act is meant to support children and teenagers needing services for mental health and substance use disorder. In a press release, Senator Casey summed up the importance of the act: 'For many young people navigating mental health or substance use disorders, the pandemic exacerbated the everyday challenges they face. It has never been more clear-we need to fill in the many gaps in mental health care for kids. This legislation would ramp up efforts to expand the workforce that provides this crucial care while improving resources for kids who need care in their communities[.]" [FN195] The act would create grant programs to improve behavioral health integration, improve coordination of physical and mental health services as well as community-based resources, and support data collection on behavioral health care needs. It also seeks to modernize and improve mental health services through telehealth and through other care sites. [FN196] Additionally, the bill calls for workforce training grants to train workers who can offer these services. The grants would be administered through the HHS Secretary, in coordination with the Assistant Secretary for Mental Health and Substance Use and the Administrator of CMS. ¢ In the Senate, Senators Rob Portman (R-Ohio) and Bob Casey (D-Pa.) are sponsoring 2021 FD S.B. 4747 (NS), which would enact the Investing in Kids' Mental Health Now Act of 2022. That act seeks to expand access to mental, emotional, and behavioral health care for children in the wake of the pandemic. A press release from Senator Portman's office explains how the bill would achieve that: To help address the severe toll that the COVID-19 pandemic has had on children's mental health, the bill provides pediatric mental health care providers with additional resources ? a one-year Medicaid funding increase through an enhanced Federal Medical Assistance Percentages (FMAP). Pediatric mental, emotional, and behavioral health care providers serving Medicaid patients in participating states will have access to this funding. [FN197] Additionally, the bill would direct HHS to issue guidance to states on how to expand mental, emotional, and behavioral telehealth services and on best practices for supporting children in crisis or in need of intensive mental, emotional, or behavioral services. [FN 198] ¢ The American Rescue Plan (Pub. L. 117-2) authorized a State Plan option for Medicaid community-based mobile crisis intervention services. CMS announced in December 2021 that the option would become available in April 2022. The option furthers the government's intense focus on mental health. In a press release at that time, CMS explained how the option can be an important tool in the mental health crisis: Mobile crisis intervention services are essential tools to meet people in crisis where they are and rapidly provide critical services to people experiencing mental health or substance use crises by connecting then to a behavioral health specialist 24 hours per day, 365 days a year. This new option will help states integrate these services into their Medicaid programs, a critical component in establishing a sustainable and public health-focused support network. [FN199] CMS explained that some states offer these services, but the new option offers states additional federal funding for three years, plus additional tools and flexibilities, ¥N2! In September 2022, CMS approved Oregon as the first state to take up this option. CMS encourages other states to take up the option as well, FN201] ¢ Senators Jacky Rosen (D-Nev.) and John Boozman (R-Ark.) are sponsoring 2021 FD S.B. 4862 (NS), which would enact the Supporting Our Seniors Act. That act would call for the creation of the Commission on Long-Term Care, which would, on a yearly basis, provide a report with policy recommendations on the long-term care system. The report would address these things, among others: * long-term care coverage for those not eligible for Medicaid; * options for aging in place; ¢ affordability, and financing options for low- and middle-class individuals; « workforce stability; * caregiver support; and ¢ reducing hospitalization costs through increased access to home-based services, including options in the Medicare and Medicaid programs. In a press release, Senator Boozman said of the bill: 'As our population ages, the need for long-term care assistance will increase . . . . Establishing a national advisory commission will help us better prepare for future challenges including coordinating services, training a workforce to meet seniors' and individuals' with disabilities needs and providing information and options to empower them and their caregivers with the resources available." [FN202] ¢ President Joe Biden (D) signed 2021 FD S.B. 958 (NS), which enacts the Maximizing Outcomes through Better Investments in Lifesaving Equipment (MOBILE) Health Act of 2022. The bill will allow health centers funded by the Health Resources and Services Administration to establish mobile delivery units even if they do not establish a permanent site. The bill aims to increase access to THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -27- services in rural and underserved areas. Senator Jacky Rosen (D-Nev.), one of the bill's sponsors, explained in a press release why mobile units are so critical: 'Too many of Nevada's rural and underserved communities lack permanent health centers and reliable health care, which make mobile health centers indispensable in reaching them... . We have to make health care more accessible, which is why I'm thrilled that my bipartisan bill to provide greater resources to expand mobile health clinics is on its way to the President's desk to become law." [FN203] Senate Bill 958 is now Pub. L. 117-204. ¢ Senator Tom Carper (D-Del.) and others are sponsoring 2021 FD S.B. 5011 (NS), a bipartisan, bicameral measure to improve coordination of physical and mental health services for children. (The House bill is 2021 FD H.B. 9037 (NS).) The bill's sponsors recognize the children's mental health crisis and acknowledge that, in 2021, the U.S. Surgeon General issued a public health advisory calling for a comprehensive and coordinated response to that crisis. IFN204] The bill calls for the federal government to develop a Medicaid Whole Child Health Care model. In a press release, Senator Carper summarizes what the bill would accomplish: Specifically, the KIDS Health Act of 2022 would: * Authorize a $125 million demonstration program to help states improve coordination between mental health and community health care providers, which will better support children's needs through a holistic approach; * Allow states to establish or enhance payment models that reward doctors for providing higher-quality care that helps children stay healthier and invest in workforce recruitment and training; ¢ Allow participating states to design and implement a delivery model in which health care providers partner with community organizations and government agencies to coordinate services across multiple sectors; ¢ Require GAO to issue a report, evaluating the individual, financial, and systems-level impacts associated with whole child health models implemented under the demonstration project; and * Require the Secretary of Health and Human Services to issue guidance on combining federal and non-federal funds to address social determinants of health in low-income populations. [FN205] ¢ In the Senate, Senator Chuck Grassley (R-lowa) is sponsoring 2021 FD S.B. 5015 (NS), which would enact the Healthy Moms and Babies Act. That act would include several varied measures to improve maternal and child health in Medicaid and CHIP [FN206] , including, among other things: * requiring state Medicaid programs to report on adult health care quality measures of maternal and perinatal health; * establishing Medicaid quality improvement measures to decrease caesarean births; * creating a state Medicaid health home option to provide coordinated maternal and post-partum care; ¢ directing the Health and Human Services Secretary (HHS) to release guidance on care coordination to improve maternal health; * calling for a MACPAC IFN207] study on doulas and community health workers; * directing CMS to study coverage of remote patient monitoring and its impact on maternal and child health outcomes; ¢ developing guidance for Medicaid maternal care providers on reducing maternal mortality and morbidity; « directing the HHS Secretary to submit a report to Congress on social determinants of health for Medicaid and CHIP enrollees; * directing the HHS Secretary to submit a report to Congress on payment methodologies for transferring pregnant individuals between facilities before, during, and after delivery; * requiring the HHS Secretary to provide guidance to states on state options for addressing social determinants of health; and ¢ directing the CMS Administrator to conduct payment error rate audits on state Medicaid agencies every two years. ¢ House Bill 9209 (2021 FD H.B. 9209 (NS)) would enact the Program of All-inclusive Care for the Elderly Expanded Act, which would facilitate enrollment into the PACE program for Medicare enrollees who are not also eligible for Medicaid. The act would add flexibility in rate setting for services not covered by Medicare, allow enrollment at any time, allow program providers to apply for the program at any time, and call for a pilot program, among other things. The bill, which was introduced on October 21, 2022, is sponsored by Representatives Debra Dingell (D-Mich.) and John Moolenaar (R-Mich.). ¢ CMS announced that it finalized the Medicare Physician Fee Schedule rule for 2023. In addition to adjusting payment rates, the rule, among other things: * strengthens behavioral health and opioid use disorder services; ¢ makes changes to the Medicare Shared Savings Program to expand and enhance accountable care; ¢ expands coverage of and access to screenings for colon and rectal cancer; and THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -28- ¢ finalizes payment policies for dental services that are integral to covered health services. [FN208] The rule also makes telehealth changes, changes to pain management and treatment services, audiology services, preventive vaccine administration services, and services rendered in rural health clinics and federally qualified health centers. IFN209] cis published a Fact Sheet relating to the rule as a whole [FN210] published in the Federa/ Register, but until it is, the rule may be viewed in its unofficial form. and others relating to various aspects of the final rule. IFN211] The final rule has not yet been [FN212] IX. SELECTED STATE ACTIVITY In Alaska: ¢ House Bill 265 (2021 AK H.B. 265 (NS)) has been adopted. The bill will ensure Medicaid reimbursement for telehealth services as outlined in the bill. ¢ A Senate bill, 2021 AK S.B. 183 (NS), would have amend existing statutory provisions on Medicaid home- and community-based services. Among other things, it would have amended a statute to allow these services to be offered under a Section 1915(c) State Plan amendment, and it would have added Medicaid personal services to the provision. It would have also amended provisions on termination of these services; specifically, it would have expanded the section to include not only termination of payment, but also a reduction in payment for services or a reduction in the level of services, and it would have changed how assessments are to be conducted. The bill did not pass before adjournment. In Arizona: * Had it passed this session, House Bill 2885 (2021 AZ H.B. 2885 (NS)) would have appropriated Medicaid funds to expand and operate the Healthy Communities Health Care Program on a state-wide basis, focusing especially on rural and underserved communities. The program would have: ¢ allowed community service providers and state and local governments to screen vulnerable persons for program eligibility; ¢ managed enrollment and insurance and provided referrals to and scheduling for primary care physicians that accept both Medicare and Medicaid; * provided telehealth for specified conditions and provided remote patient monitoring at no cost to the patient; * provided access to trained life coaches who could help with transportation and other barriers to health; ¢ developed a mobile-friendly application that program participants could have used to develop self-management skills and other good habits; * provided access to advanced medical nutritional therapy; and * coordinated and provided access to reimbursable broadband communications to facilitate telehealth. * House Bill 2863 (2022 AZ H.B. 2863 (NS)) has been adopted. The bill makes various changes to statutory provisions governing the Health Care Cost Containment Program. Among other things, it establishes a three-year competitive grant program to provide support for an interoperability software solution to allow rural hospitals, health care providers, and urban trauma centers to further care coordination. The bill provides, in part, The software shall be made available to rural hospitals, health care providers and urban trauma centers that wish to participate by enabling a hospital's electronic medical records system to interface with other electronic medical records systems and providers to promote connectivity between hospital systems and facilitate increased communication between hospital staff and providers that use different or distinctive online platforms and information systems when treating patients. The department shall award grants for an interoperability software technology solution[.] Governor Doug Ducey (R) signed the bill on June 28, 2022. In California: + Assembly Bill 2697 (2021 CA A.B. 2697 (NS)) will establish a Community Health Worker and Promotores ""2"5! benefit and require managed care organizations to provide outreach and education for these services. Governor Gavin Newsom (D) signed the bill on September 23, 2022. « Assembly Bill 32 (2021 CA A.B. 32 (NS)), which deals with Medicaid payment for telehealth services rendered by federally-qualified health centers and rural health centers, was adopted on September 25, 2022. The bill authorizes the Department of Health Care Services to allow federally-qualified health centers and rural health centers to establish a new patient relationship using an audio-only synchronous interaction if the visit is related to 'sensitive services," and it authorizes the department to allow these facilities to establish a new patient relationship using an audio-only synchronous interaction when the patient requests audio-only or attests they do not have access to video. In Colorado: THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -29- ¢ Governor Jared Polis (D) signed 2022, 2022 CO S.B. 203 (NS) on June 8, 2022. The bill will direct the Department of Health Care Policy and Financing, in conjunction with the Department of Public Health and Environment, to develop a regulatory plan to establish formal oversight for PACE (Program of All-Inclusive Care for the Elderly). ¢ Senate Bill 231 (2022 CO S.B. 231 (NS)) sought to establish a grant program to provide supportive housing services for individuals with behavioral or mental health conditions or substance use disorder. The bill would have directed the Division of Housing in the Department of Local Affairs, in collaboration with the Office of Behavioral Health and the Department of Health care Policy and Financing, to identify providers of such services who could be eligible for reimbursement in the Medicaid program and to seek federal approval for such reimbursement: (5) To support the implementation of grants under this section, expand the provision of supportive housing services, and allow individuals served by the grant program to receive supportive housing services on a long-term sustainable basis, the Division, the Office of Behavioral Health, and the Department of Health Care Policy and Financing shall collaborate on an ongoing basis to identify additional providers and services that could be eligible for reimbursement under the state medical assistance program. The department of Health Care Policy and Financing shall submit to the federal Centers for Medicare and Medicaid Services an amendment to the state medical assistance plan and shall request any necessary waivers from the Secretary of the federal Department of Health and Human services to allow such additional reimbursements as identified in accordance with this subsection (5). The bill did not pass this session. ¢ A House bill, 2022 CO H.B. 1302 (NS), will create the Primary Care and Behavioral Health Statewide Integration Grant Program to award grants to providers of both physical and behavioral health care to implement evidence-based clinical integration models. American Rescue Plan funds will be used. The findings supplied with the bill note that the Practice Transformation Program resulted in greater access to behavioral health care and fewer behavioral-health-related emergency visits, and similar efforts continue. However, too few have access to behavioral health, and fewer still have access to behavioral health in their primary care practices. The bill passed both chambers, Govemor Polis signed it on May 18, 2022. In Connecticut: ¢ A House bill, 2022 CT H.B. 5339 (NS), sought to increase access to the state-funded portion of the home care program for the elderly by decreasing co-payments and increasing the amount that enrollees may hold in assets. The bill did not pass this session. In the District of Columbia: ¢ The Department of Public Welfare gave notice of emergency and proposed regulations to continue certain behavioral health services for which CMS had granted temporary authority. The regulations would add these services to the State Plan. The department provided this summary of the regulations, which are published at 2022 DC REG TEXT 613849 (NS) (May 6, 2022): On November 6, 2019, the Centers for Medicare and Medicaid Services (CMS) granted the District temporary authority to provide community-based behavioral health services under the District's Section 1115 Behavioral Health Transformation Demonstration Program, from January 1, 2020 through December 31, 2021. Because this temporary authority expired at the end of 2021, the District is transitioning these services to permanent State Plan authority to retain authority to provide Medicaid reimbursement for these services. This rule is one of three (3) policy initiatives that DHCF intends to implement to effectuate this change. The other two (2) planned initiatives are: 1. Supported Employment Services; and 2. Mental Health Rehabilitation Services (MHRS)/Adult Substance Use Rehabilitative Services (ASURS)/Behavioral Health Stabilization. Under the District's Section 1115 Behavioral Health Transformation Demonstration Program, there has been an exclusion for treatment of autism spectrum disorder (ASD) under the behavioral health services authorized under the demonstration. Under the State Plan Amendment authority for behavioral health services, approved by CMS on September 24, 2021, with an effective January 1, 2022, there will be no similar ASD treatment exclusion. ¢ The Public Welfare Department adopted rules that make changes to the Services My Way program. That program is the district's Medicaid participant-directed program, which allows participants in the Home- and Community-Based Services, Elderly and Disabled Person waiver program to direct their own care. Most participants in the program live in private homes. The amendments relate to oversight of the program and its workers, and it changes some of the allowable goods and services: The amendments address a current gap in DHCF programmatic oversight. The amendments will require a PDW [participant-directed worker] for participant-directed services ('PDS') to have an individual National Provider Identifier, register with the National Plan and Provider Enumeration System, and complete an application for PDWs in the Provider Data Management System. The rule removes the requirement for a PDW to enter into an agreement with DHCF, and instead requires an agreement with the Vendor Fiscal/Employer Agent Financial Management Services-Support Broker. The final rulemaking also removes some allowable goods and services. The rule further removes the requirement for additional PDW workers if a Services My Way participant submits a budget for more than one hundred and twelve (112) hours or more per week of personal care aide services. The removal of these requirements corresponds to the EPD Waiver amendment approved by the Center for Medicare and Medicaid Services on October 1, 2020, which limits participants THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -30- to one hundred twelve (112) hours of participant-directed community supports per week or sixteen (16) hours per day. This change was retained in the EPD Waiver renewal, approved by CMS on February 7, 2022. The adopted rules are published at 2022 DC REG TEXT 620623 (NS) (Oct. 7, 2022). In Florida: * Had it passed, 2022 FL S.B. 330 (NS) would have allowed the state to pay for Medicaid remote patient evaluation and monitoring as optional services. New language would have read: (28) REMOTE EVALUATION AND MONITORING SERVICES.- (a) The agency may pay for remote evaluation of recorded video and images, including interpretation and followup with the recipient within 24 business hours, not originating from a related evaluation and monitoring service provided within the previous 7 days or leading to an evaluation and monitoring service or a procedure within the next 24 hours or at the soonest available appointment. (b) The agency may pay for remote patient monitoring services, including remote monitoring of physiologic parameters, supply of devices with daily recording or programmed alert transmission, and remote physiologic monitoring treatment management services requiring interactive communication with the recipient and provider. The bill died in committee. « Also in Florida, 2022 FL H.B. 1569 (NS) would have called for an estimating committee to report on certain information about Medicaid home- and community-based services. The information was specified in the bill: c) The Social Services Estimating Conference shall develop information relating to the iBudget system for the home-based and community-based Medicaid waiver services program and must include iBudget enrollment, the number of current waiver recipients, the size of the waiting list, the utilization rate of program services, and expenditure information that the conference determines is needed to plan for and project future budgets and the drawdown of federal matching funds. IFN214] The bill died in committee. ¢ The Department of Children and Families adopted rules amending existing provisions governing qualified organizations that provide waiver support coordination services. The department provided this summary of the changes, which are published at 2022 FL REG TEXT 623121 (NS) (Oct. 11, 2022): Defining the Medicaid Waiver Service Agreement ('MWSA') as a voluntary contract between the Agency for Persons with Disabilities ('Agency') and the provider, as described in section 409.907(2), F.S.; removing the incorporation of the Support Coordinator Dual Employment Medicaid Waiver Services Agreement Attachment, APD Form 65G-14.004 A; removing any reference to the MWSA between and Qualified Organization and the Agency; removing the incorporation of Qualified Organization Medicaid Waiver Services Agreement, APD Form 65G-14.002 B; removing the termination of a MWSA from the disciplinary chart; removing redundant violations from the disciplinary chart; removing Qualified Organizations after it ceases to provided services for 180 days. In Georgia: * House Resolution 768 (2021 GA H.R. 768 (NS)) called for the creation of the House Study Committee on Expanding Long-Term Care Options. The resolution noted the increasingly high number of individuals residing in nursing homes and the shortage of bed space. It also noted the disproportionately high death rate among nursing home residents during the pandemic, 72% of who are insured by Medicaid. The authors of the resolution pointed to the success of smaller, person-centered communities and assert that Medicaid reimbursement rates could be used to incentivize the adoption of such models. It called for the committee to study such options. The bill was introduced on February 14, 2022; it did not pass before the legislature adjourned. ¢ Senate Bill 610 (2021 GA S.B. 610 (NS)) will require the Department of Health to conduct a study of reimbursement rates for specified Medicaid home-and community-based services waiver programs. The first study will need to be completed in 2024 and then repeated at least every four years. Based on this review, the department will be required to develop proposed rate models, related documentation, and associated changes to the policies of each waiver program. The department will also be required to provide the projected fiscal impact of implementing the proposed rate models. The bill directs the department to submit a waiver request to CMS to authorize Medicaid reimbursement for private institutions for mental disease (IMDs) that provide mental health and substance use disorder treatment services to Medicaid enrollees. Governor Brian Kemp (R) signed the bill into law on May 9, 2022. In Illinois: ¢ A House bill, 2021 IL H.B. 4573 (NS), would change an existing statutory provision on managed care organization reimbursement for nursing facilities in the Medicare-Medicaid Alignment Initiative. Current law calls for reimbursement based on quarterly facility-specific RUG-IV per diem rates, and House Bill 4573 would change that to quarterly facility-specific fee-for-service rates. The bill would also add this new language: No managed care contract shall provide for a level of reimbursement lower than the fee-for-service rate in effect for the facility at the time service is rendered. Managed care organizations are expressly prohibited, at any time and for any reason, from offering, THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -31- negotiating, or entering into contracts with a nursing facility for a level of compensation less than the fee-for-service rate in effect at the time the service is rendered. ¢ Aresolution, 2021 IL S.J.R. 42 (NS), notes the enormity of the Medicaid program, both in terms of enrollment and in cost. It also notes that many people are treated in managed care, often mandatorily, at great expense to the state; however, lawmakers know little about that spending and about outcomes for people in managed care. It therefore calls for a Medicaid Administrative Solutions Task Force to study: (1) Best practices for the administration of the Medicaid program; (2) Alternative methods for administration of the Medicaid program beyond the fee-for-service and managed care models; and (3) Successful models used by other states for the administration of the Medicaid program[.] The resolution has not yet passed. ¢ In 2018, Illinois received approval of its Behavioral Health Transformation Section 1115 demonstration. It will expire on June 30, 2023. [FN215] House Bill 5043 (2021 IL H.B. 5403 (NS)) calls for implementation of that waiver. The findings supplied with the bill note the high number of individuals insured by Medicaid, and they note that one-quarter of all such individuals have behavioral health needs. Moreover, the Medicaid budget is massive, and preventive services are crucial. The legislative findings read, in part, It is urgent that Illinois puts a focus on prevention by paying for value and outcomes. Building a behavioral health strategy will address the opioid pandemic, reduce violent crime and violent encounters with the police, and have a large financial payoff as Medicaid members with behavioral health needs represent approximately one-quarter of the total Illinois Medicaid members. The goals of the demonstration are these: (1) Rebalance the behavioral health ecosystem, reducing overreliance on institutional care and shifting to community-based care. (2) Promote integrated delivery of behavioral and physical health care for behavioral health members with high needs. (3) Promote integration of behavioral health and primary care for behavioral health members with lower needs. (4) Support development of robust and sustainable behavioral health services that provide both core and preventative care to ensure that behavioral health members receive the full complement of high-quality treatment they need. (5) Invest in support services to address the larger needs of behavioral health members, such as housing and employment services. (6) Create an enabling environment to more behavioral health providers toward outcomes and value-based payments. The bill calls for the Department of Healthcare and Family Services to conduct a 60-day rulemaking process and then to implement the waiver. The bill remains pending in the House. In lowa: ¢ The Human Services Department intends to amend existing regulatory provisions relating to the In-Home Health-Related Care Program to remove the requirement of registered nursing supervision for unskilled care. In a notice published at 2022 IA REG TEXT 624710 (NS) (Sept. 21, 2022), the department summarized the proposed amendments and the reasoning for the proposal: Currently the In-Home Health-Related Care (IHHRC) program requires a registered nurse to provide supervision of a client's care plan in order for the client to receive services. Over the past several years, the Department has experienced more nursing agencies opting out of providing supervision services for this program. Several counties have no nursing agencies willing to provide the supervision necessary for the program services. This results in individuals being enrolled in the program with physicians having to provide supervision, which is an unreasonable expectation, or individuals being enrolled in the program without a supervising practitioner, which requires an exception to the administrative rule. Medicaid programs providing similar services under the home- and community- based programs do not require a supervising practitioner when the service being provided is considered unskilled or is for personal care services. These proposed amendments remove the requirement of nursing supervision for unskilled personal care services and maintain the requirement of nursing supervision for skilled services. Proposed amendments also identify how the program is implemented from the application process through termination, if termination is necessary. In Kentucky: * House Bill 651 (2022 KY H.B. 651 (NS)) would have directed the Cabinet for Health and Family Services to ensure that all home- and community-based waiver programs provided these services: ¢ attendant care or non-skilled in-home care services; ¢ skilled nursing visits for adult day health care and home health care providers; and ¢ participant-directed services. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -32- The bill would have also specified that participant-directed service providers and agencies that provide registered nurse specialized respite would not be required to be on call 24 hours per day, seven days per week, and it would have directed that all home- and community-based waiver application processes be consolidated under the Department for Medicaid Services. Finally, the bill would have directed the cabinet to apply for a State Plan home health benefit for individuals with chronic conditions. House Bill 651 did not pass before adjournment. In Louisiana: ¢ The Department of Public Health promulgated an emergency rule relating to Medicaid telehealth services during a declared emergency or disaster. The rule, which is published at 2022 LA REG TEXT 549477 (NS) (Apr. 20, 2022), provides as follows: A. In the event that the federal or state government declares an emergency or disaster, the Medicaid Program may temporarily cover services provided through the use of an interactive audio telecommunications system, without the requirement of video, if such action is deemed necessary to ensure sufficient services are available to meet beneficiaries' needs. ¢ Governor John Bel Edwards (D) signed 2022 LA H.B. 278 (NS) on June 15, 2022. An earlier version of the bill would have ensured Medicaid coverage for mental health and substance abuse services delivered through the Psychiatric Collaborative Care Model. It would have also required that medical necessity determinations made by Medicaid managed care organizations comply with the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 the state's Medicaid Managed Care Independent Claims Review Process. In the version that passed, Medicaid was not listed as a health coverage plan subject to the bill. ¢ A Senate resolution, 2022 LA S.R. 38 (NS), urges the Department of Health to study programs or Medicaid waivers in other states that allow elderly people to receive care in a home- or community-based setting rather than in an institution. The findings supplied with the resolution note the growing number of elderly individuals in the state: By 2030, those over the age of 85 are projected to number 126,000. Most of these individuals prefer to receive care in a home- or community-based setting, and the resolution seeks a way to keep elders in the least restrictive setting for as long as possible. The resolution, which was adopted by the Senate on April 21, 2022, sets out six questions that the study should answer. ¢ The Public Health Department gave notice of an emergency rule amending existing administrative provisions on Medicaid coverage of Applied Behavior Analysis-Based Therapy services. Currently, the regulation does not allow coverage when the services are rendered in 'non-conventional settings," including resorts, spas, therapeutic programs, and camps. The emergency rule eliminates those limitations. Please see 2022 LA REG TEXT 619274 (NS) (July 13, 2022). In Maine: ¢ Introduced on January 5, 2022, 2021 ME H.P. 1379 (NS) sought clarity on spending plans for the enhanced FMAP for the home- and community-based services waiver. The bill provided: This bill proposes to require the Department of Health and Human Services to provide timely updates on the new rules for the Medicaid home and community-based services waiver spending plans for enhanced federal medical assistance percentages using funds provided under the American Rescue Plan Act. The bill also proposes to require the Department of Health and Human Services to provide consistent and accurate information regarding the spending plans to providers through its communications portal. The bill did not pass this session. In Michigan: ¢ If passed, 2021 MI H.B. 5353 (NS) would provide for funding for mobile crisis prevention services. Funds would be used to pay the state share of the costs for Medicaid participants. The state would be directed to seek and maximize available federal funds for these services. ¢ Introduced in the Senate, 2021 MI S.B. 1135 (NS) would authorize Medicaid and Healthy Michigan coverage for telemedicine when rendered at a distant site allowed in the Medicaid manual. The bill defines distant site as follows: (a) 'Distant site' means the location of the health care professional providing the service at the time the service is being furnished by a telecommunications system. Distant site may include the provider's office or any established site considered appropriate by the provider as long as the privacy of the recipient and security of the information shared during the telemedicine visit are maintained. The bill specifies that these programs should cover a comprehensive set of telemedicine services, minimally medical, dental, behavioral, and substance use disorder services. The bill was introduced on June 30, 2022. In Minnesota: * Among other things, the latest version of Senate Bill 4165 (2021 MN S.F. 4165 (NS)), would have directed the Commissioner of Human Services to create a presumptive eligibility process for home- and community-based services applicants and applicants to the Alternative Care Program. [FN216] New statutory language would have read as follows: (b) The commissioner shall establish a presumptive eligibility process for home and community-based waiver services applicants and alternative care applicants. The process must allow counties, home and community-based services providers, hospitals, and other agencies, including local area agencies on aging, to determine presumptive eligibility under a Medicaid state plan or waiver authorities. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -33- (c) Prior to July 1, 2023, the commissioner of human services shall seek federal approval for an amendment to applicable 1915(c) home and community-based waivers to establish a presumptive eligibility process for home and community-based waiver services under this section. In Mississippi: « An amended version of Senate Bill 2969 (2022 MS S.B. 2659 (NS)) passed the Senate on February 10, 2022, but it died in a House Committee. The bill would have authorized the Division of Medicaid to award grants to carry out the activities the federal government approved in the state's American Rescue Plan Act Home- and Community-Based Services Spending Plan. In Nebraska: « A legislative bill, 2021 NE L.B. 376 (NS), will direct the Department of Health and Human Services to apply to CMS for a three-year waiver to implement a Medicaid family support home- and community-based services program for children with disabilities. The bill expresses the intent that any American Rescue Plan funds that come to the state should be used to satisfy the unmet needs of those requiring home- and community-based services. The family support program would: (a) Offer an annual capped budget for long-term services and supports of ten thousand dollars for each eligible applicant; (b) Offer a pathway for medicaid eligibility for disabled children by disregarding parental income and establishing eligibility based on a child's income and assets; (c) Allow a family to self-direct services, including contracting for services and supports approved by the division; and (d) Not exceed eight hundred fifty participants. Governor Pete Ricketts (R) signed the bill on April 20, 2022. In New Jersey: ¢ Introduced on February 7, 2022, 2022 NJ S.5. 875 (NS) would change eligibility for home- and community-based services by directing the Division of Medical Assistance and Health Services to accept a military permanent change of station order for the residency requirement for these services. « Introduced on May 26, 2022, 2022 NJ A.B. 4012 (NS) would require the Medicaid fee-for-service program to pay for managed long- term care services and supports when the patient is awaiting enrollment in the managed care program. The bill provides, in pertinent part, as follows: 1. The Division of Medical Assistance and Health Services in the Department of Human Services shall provide Medicaid coverage via the fee-for-service delivery system for eligible services provided by an assisted living residence, a comprehensive personal care home, an assisted living program, or an adult family care provider to an individual who is determined eligible for the Medicaid Managed Long Term Services and Supports program, but who is pending enrollment in a managed care organization contracted by the division to provide health care services to Medicaid recipients. Fee-for-service coverage provided under this section shall begin on the date on which the individual is determined clinically and financially eligible for the Medicaid Managed Long Term Services and Supports program, and shall end on the date on which the individual's enrollment in a Medicaid managed care organization becomes effective. ¢ Introduced on September 15, 2022, 2022 NJ A.B. 4467 (NS) would direct the Division of Medical Assistance and Health Services to establish a Medicaid Managed Care Oversight Program to ensure that ensure NJ FamilyCare and Medicaid enrollees have access to quality care. The findings supplied with the bill note that an audit by the Office of the State Auditor determined that managed care organizations did not provide adequate access to certain types service providers. ¢ Introduced on the same day, 2022 NJ A.B. 4466 (NS) would change certain Medicaid eligibility rules. For example, it would increase to 60 months the look-back period for those seeking long-term care services who disposed of income below the fair market value. It would also add language clarifying that an applicant would not be subject to a period of ineligibility as a result of transfers the applicant made that amount to less than $500 in a calendar month. Additionally, the bill would add language detailing how a county welfare agency is to handle incomplete Medicaid applications. ¢ Introduced on October 27, 2022, 2022 NJ S.B. 3228 (NS) would set out criteria to qualify for adult medical day care services. An enrollee would be eligible for these services if the enrollee: (1) requires assistance or supervision with an activity of daily living; (2) possesses a letter or prescription from a physician recommending adult medical day care services; and (3) furnishes an up-to-date copy of the individual's medical history and a current report of a physical examination of the individual completed by a physician. In New York: ¢ The Department of Social Services announced emergency rules relating to telehealth. Specifically, the rule would ensure the continuity of certain telehealth services that are offered through flexibilities the federal government authorized during the COVID-19 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -34- public health emergency. The agency explains that the rules are necessary to avoid disruption of services once the public health emergency ends. The notice is published at 2022 NY REG TEXT 604007 (NS) (Jan, 12, 2022). ¢ Assembly Bill 293 (2021 NY A.B. 293 (NS)) seeks to ensure adequate reimbursement for home care services. The need for the bill is set out in its stated legislative intent: ? 3614-f. Standards for home care services payments. 1. Legislative intent. Adequate reimbursement for home care services is essential to the policies set forth in section thirty-six hundred of this article [home care services] as well as state policies contingent on access, availability and quality of these services. The degree of variability across state regulated home care rates, episodic payments, fees for individual home care services, and negotiated payments, leaves the home care system without a standard basis of payment and stable revenue necessary to budget, plan and ensure sustainability. To help ensure the home care system's viability to deliver the needed services, the commissioner shall establish minimum standards and a minimum benchmark within the Medicaid program for payment of home health agency services, including the services of subcontracting licensed home care services agencies, that can also serve as the benchmark to be considered in rates paid by non-Medicaid thirdparty payors. The bill also calls for the Health Commissioner, for the rate year starting April 1, 2022, to provide for a 10% increase in the base episodic payment (and in the individual rates for services exempt from episodic payments), from available Medicaid funds. The bill was introduced in January 2021 and amended in January 2022. ¢ If passed, 2021 NY S.B. 8290 (NS) would authorize the Commissioner of Health to establish a portable diagnostic program to demonstrate the cost-effectiveness of providing Medicaid coverage for such services, which would include X-rays, electrocardiograms, echocardiograms and ultrasounds. The program would operate in both the fee-for-service and managed care programs. The bill was introduced on February 9, 2022. ¢ The Department of Social Service gave notice of emergency rulemaking to ensure the continuity of Medicaid telehealth services once the public health emergency ends. New language would specify that any provider authorized to render in-person services may also render them through telehealth, as long as the services are within the provider's scope of practice and the services are appropriate for the patient's health needs. As for allowed modalities, new language would provide that telehealth may be rendered using any of the modalities set out in statute as well as well as telephone and audio-only technologies. The notice is published at 2022 NY REG TEXT 611145 (NS) (Apr. 6, 2022). ¢ The Department of Mental Hygiene gave notice of an adopted rule expanding telehealth for mental health services. The new rule adds provisions specifying that audio-only and audio-video modalities are acceptable options for telehealth when the provider determines that they are appropriate. The new rule also specifies that these modalities will be covered under Medicaid and CHIP (the Children's Health Insurance Program). The notice is published at 2022 NY REG TEXT 600117 (NS) (Sept. 13, 2022). ¢ The Department of Mental Hygiene gave notice of an adopted rule expanding telehealth for mental health services. The new rule adds provisions specifying that audio-only and audio-video modalities are acceptable options for telehealth when the provider determines that they are appropriate. The new rule also specifies that these modalities will be covered under Medicaid and CHIP (the Children's Health Insurance Program). The notice is published at 2022 NY REG TEXT 600117 (NS) (Sept. 13, 2022). ¢ Senate Bill 9584 (2021 NY S.B. 9584 (NS)) would amend an existing statutory provision on Medicaid reimbursement for telehealth by removing a clause stating that the provision expires on April 1, 2024. In North Carolina: ¢ lf passed in North Carolina, 2021 NC H.B. 507 (NS) would have enacted the North Carolina Momnibus Act. The findings supplied with the bill noted the shocking statistics on maternal mortality and morbidity and the disparities in outcomes between white women and women of color. To work toward a solution, the bill would have established the Social Determinants of Maternal Health Task Force, which would have been charged with, among other things, making recommendations on leveraging Medicaid services to address social determinants of maternal health. The bill did not pass this session. In Ohio: ¢ The Developmental Disabilities Department gave notice of final filing of a regulation governing behavioral support strategies for those with developmental disabilities. The regulation addresses the use of different sorts of restraints (chemical, manual, etc.) and other strategies, such as time-out, as behavior support strategies. The regulation, which is published at 2022 OH REG TEXT 603386 (NS) (May 16, 2022), applies to home- and community-based services providers. ¢ The Medicaid Department gave notice of final rules that amend existing administrative provisions on telehealth. Among other things, it adds pharmacists to the list of providers eligible to provide telehealth services, and it adds pregnancy education services and diabetes self-management training services as services that may be rendered through telehealth. It also adds '[ojther services if specifically authorized in rule promulgated under agency 5160 of the Administrative Code." The final rules are published at 2022 OH REG TEXT 612218 (NS) (July 5, 2022). ¢ The Medicaid Department gave notice of final rules affecting home- and community-based services. The new rules amend definitions for the assisted living home- and community-based services waiver program, amend provider conditions of participation for that THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -35- program, and amend language in the section that sets out the covered services for that program. The final rules are published at 2022 OH REG TEXT 619647 (NS) (Oct. 4, 2022). In Oklahoma: ¢ Senate Bill 1577 (2021 OK S.B. 1577 (NS)) would have enacted new law designating the Oklahoma Health Care Authority as the state administering agency for administering PACE [FN217] program agreements. The bill would have authorized the authority to enter into PACE program agreements with PACE organizations and CMS, and it would have been responsible for enforcing all applicable federal laws relating to PACE. Additionally, the bill would have allowed the authority to enter into an agreement with the State Department of Health to carry out any duties or functions of the state administering agency. The bill was introduced on February 7, 2022, and it was amended, but ultimately it did no pass before adjournment. ¢ Senate Bill 1134 (2021 OK S.B. 1134 (NS)) has been adopted. It repeals the following residency requirements for Medicaid home- and community-based services: Applications for Home and Community Based Medicaid Waiver Services for the Community Waiver, In-Home Supports Waiver for Adults, and In-Home Supports Waiver for Children operated by the Department of Human Services shall not be made until an applicant has been a resident of Oklahoma for five (5) years prior to the date of application. The Department of Human Services shall promulgate rules as necessary for the implementation and administration of the provisions of this section. Governor Kevin Stitt (R) signed the bill on May 3, 2022. In Rhode Island: ¢ An amended bill, 2021 RI S.B. 2079 (NS), would have directed the Executive Office of Health and Human Services to conduct a pilot study to be known as the Rhode Island Pathways Project, which would have studied the impact of providing Medicaid coverage for treatment for the chronically homeless. The bill defined the term 'chronically homeless," and 'treatment' or 'treatment of underlying conditions that contribute to homelessness' would have included: (1) Behavioral health services, including mental health and substance abuse services; (2) Case management; (3) Personal care and personal assistance services; (4) Home and community-based services; and (5) Housing support services, including rental payment assistance. The bill set out exactly what the study would have considered, including things such as financing, available data, costs, administration of the benefit, impact on other programs, and so forth. An amended version of the bill passed the House on April 12, 2022; the bill did not advance in the Senate, and the legislature has now adjourned. In Utah: ¢ Governor Spencer Cox (R) signed 2022 UT H.B. 413 (NS) on March 24, 2022. It directs the Department of Health and Human Services to do the following for the targeted adult Medicaid program: (a) integrate the delivery of behavioral and physical health in certain counties; and (b) deliver behavioral health services through an accountable care organization where implemented. However, these adjustments cannot be made unless the department determines that certain metrics developed by the Behavioral Health Delivery Working Group have been met; that group is established by the bill. In Virginia: ¢ Aresolution (2022 VA S.J.R. 42 (NS)) would have directed the Joint Commission on Health Care to study how patients could benefit from hospitals, health systems, and other providers addressing their health-related social needs. The resolution specified what the commission should have considered: In conducting its study, the Joint Commission on Health Care shall (i) examine the impact and importance of hospital, health systems, and providers in addressing social determinates of health on health outcomes and overall cost; (ii) evaluate the benefits of providers improving |CD-10-CM coding for social determinants of health, including reimbursement by commercial insurance and managed care providers; (iii) determine the value to health outcomes and cost savings of providing a broad structure for a community-based workforce, including the ability to bill commercial insurance and managed care for the preventable service and social care they provide; and (iv) provide recommendations to the Department of Medical Assistance Services regarding the application to the Centers for Medicare and Medicaid Services for a Section 1115 demonstration waiver for Medicaid to cover evidence-based nonmedical services that address specific social needs that are linked to health and health outcomes. Though the bill passed the Senate on February 22, 2022, it was left in a House committee upon adjournment. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -36- * Also in Virginia, 2022 VA S.B. 426 (NS) will, among other things, add to the list of circumstances under which the Medicaid program will pay for remote patient monitoring. Remote patient monitoring will be covered for patients who have experienced an acute health condition and for whom the use of remote patient monitoring may prevent readmission to a hospital or emergency department. The bill was adopted on April 8, 2022. ¢ The Department of Medical Assistance Services announced that it is seeking a State Plan amendment to change provisions relating to the amount, duration, and scope of medical and remedial care services for PACE. The notice is published at 2022 VA REG TEXT 611962 (NS) (Apr. 11, 2022). In Washington: ¢ A House bill, 2021 WA H.B. 1821 (NS) amends the definition of 'established relationship" for purposes of audio-only telemedicine offered in private insurance plans and the Medicaid program. The was adopted on March 30, 2022. ¢ Current law in Washington directs the Department of Social and Health Services to contract with area agencies on aging to perform certain functions relating to home- and community-based services. Senate Bill 5866 (2021 WA S.B. 5866 (NS)) will allow the department to also contract with federally recognized Indian tribes to 'determine eligibility, including assessments and reassessments, authorize and reauthorize services, and perform case management functions within its regional authority." Governor Jay Inslee (D) signed the bill on March 31, 2022. ¢ Following previous recommendations and a report from a joint executive and legislative task force, Washington is committed to increasing community residential settings and supports for those with intellectual and developmental disabilities. A newly adopted bill, 2021 WA S.B. 5268 (NS), lays the ground work for accomplishing this by calling for a caseload forecast, studying Medicaid reimbursement rates for community residential providers, establishing a five-year plan, and so forth. Governor Jay Inslee (D) signed the bill on March 30, 2022. ¢ Ina notice published at 2022 WA REG TEXT 624566 (NS) (Sept. 21, 2022), the Department of Social and Health Services gave notice of emergency rules to amend the Developmental Disabilities Administration's home and community-based services waivers in order to reflect changes approved by CMS. The department summarized the major changes as follows: Major changes to the chapter: Adjust the yearly limits applicable to certain waivers; add assistive technology to multiple waivers; remove the positive behavior support and consultation service from all waivers except the community protection waiver; amend the definition of the specialized evaluation and consultation service; and make other changes necessary to implement amendments to [the Department of Social and Health Services'] HCBS waivers as approved by CMS. ¢ The Health Care Authority proposed new and revised rules relating to store-and-forward technology and audio-only telemedicine. The proposed rules are published at 2022 WA REG TEXT 589970 (NS) (Oct. 5, 2022). ¢ The Health Care Authority adopted emergency rules to eliminate provisions relating to the Behavioral Health Ombuds Office for Medicaid managed care enrollees. Please see 2022 WA REG TEXT 626677 (NS) (Oct. 19, 2022). The department also published a preproposal notice in which it explains that these services will be replaced by a statewide ombuds service that became effective on October 1, 2022. The preproposal notice is published at 2022 WA REG TEXT 626723 (NS) (Oct. 19, 2022). In Wisconsin: ¢ The Department of Health Services gave notice of its intent to promulgate proposed rules governing certification of peer recovery providers and Medicaid reimbursement for such services. Please see 2022 WI REG TEXT 568618 (NS) (Sept. 26, 2022). ¢ The Department of Health Services gave notice that it intends to promulgate proposed rules adding requirements for personal care and home health electronic visit verification. According to the department, the amendments comply with the 21st Century Cures Act (Pub. L. 114-255). Please see 2022 WI REG TEXT 626195 (NS) (Oct. 10, 2022). X. additional resources In June 2022, CMS released 2020 Medicaid managed care data. One of the releases is an enrollment report that includes plan-specific data and national and regional data, IFN218] ond the other contains profiles of state programs and their program features. [FN219] Xi. Conclusion The COVID-19 pandemic has yielded some important lessons about health care delivery. For example, home- and community-based services and telehealth became crucial delivery models. Despite these lessons, it is unclear whether the extra financial investment in home- and community-based services and the flexibility in telehealth policies will become permanent features of our delivery system. Also, the pandemic exacerbated the mental health crisis in this country, and innovation in this area has been and will continue to be especially important as the pandemic presses on. The public health emergency has required many temporary changes to health care policy. We will continue to report on those as they are issued, and when the emergency period ends, we will report on the transition to pre-COVID-19 policy. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -37- © Copyright Thomson/West - NETSCAN's Health Policy Tracking Service [FN2] . Universal Declaration of Human Rights, Article 25, available at: http:/Avww.un.org/en/documents/udhr/index.shtml#a25. [FN3] . Elizabeth Hinton, et al., "How the Pandemic Continues to Shape Medicaid Priorities: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2022 and 2023," Kaiser Family Foundation, Oct. 25, 2022, available at: https:/Avww.kff.org/report-section/ medicaid-budget-survey-for-state-fiscal-years-2022-and-2023-delivery-systems/. [FN4] . Elizabeth Hinton, et al., "How the Pandemic Continues to Shape Medicaid Priorities: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2022 and 2023," Kaiser Family Foundation, Oct. 25, 2022, available at: https:/Avww.kff.org/report-section/ medicaid-budget-survey-for-state-fiscal-years-2022-and-2023-telehealth/. [FN5] . Elizabeth Hinton, et al., "How the Pandemic Continues to Shape Medicaid Priorities: Results from an Annual Medicaid Budget Survey for State Fiscal Years 2022 and 2023," Kaiser Family Foundation, Oct. 25, 2022, available at: https:/Awww.kff.org/report-section/ medicaid-budget-survey-for-state-fiscal-years-2022-and-2023-telehealth/. [FN6] . Fact Sheet, 'Accountable Care Organizations: What Providers Need to Know, Oct. 20, 2011, available at: http:/Avwww.cms.gov/ Newsroom/MediaReleaseDatabase/Fact-Sheets/201 1-Fact-Sheets-ltems/2011-10-207.html. [FN7] . 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/. [FN8] . 'Shared Savings Program Fast Facts ? As of Jan. 1, 2022," CMS, available at: https:/Awww.cms.gov/files/document/2022-shared- savings-program-fast-facts. pdf. [FN] . 'Beneficiary Engagement Toolkit," CMS, Nov. 2019, available at: htips://innovation.cms.gov/files/x/aco-beneficiary-engagement- toolkit.pdf. [FN10] . "Care Coordination Toolkit," CMS, Mar. 2019, available at: https://innovation.cms.gov/files/x/aco-carecoordination-toolkit.pdf/. [FN11] . "Provider Engagement Toolkit," CMS, July 2020, available at: https://innovation.cms.gov/media/document/2020-provider-engagement- toolkit. [FN12] . "Care Transformation Toolkit," CMS, Jan. 2021, available at: https://innovation.cms.gov/media/document/aco-caretransformation- toolkit. [FN13] . Operation Elements Toolkit, CMS, May 2021, available at: https://innovation.cms.gov/media/document/aco-operational-elements- toolkit. [FN14] . 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:/Awww.cms.gov/newsroom/press-releases/ cms-proposes-pathways-success-overhaul-medicares-aco-program. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -38- [FN15] . 'Medicare Shared Savings Program," CMS, available at: https:/Avwww.cms.gov/Medicare/Medicare-F ee-for-Service-Payment/ sharedsavingsprogram/about.html. [FN16] . Rajiv Leventhal, "EXCLUSIVE: Substantial ACO Reforms Could be Forthcoming," Healthcare Informatics, May 9, 2018, available at: https:/Avww.healthcare-informatics.com/article/payment/exclusive-substantial-aco-reforms-could-be-forthcoming; Farzad Mostashari and Travis Broome, "Medicare Advantage Holds the Key to Reforming the ACO Program," New England Journal of Medicine, March 20, 2018, available at: https://catalyst.nejm.org/medicare-advantage-key-aco-reform/. [FN17] . Fact Sheet, "New Accountable Care Organization Model Opportunity: Medicare ACO Track 1+ Model," updated July 2017, available at: https:/Avwww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/New-Accountable-Care- Organization-Model-Opportunity-Fact-Sheet. pdf. [FN18] . Fact Sheet, 'Advancing Care Coordination through Episode Payment Models (Cardiac and Orthopedic Bundled Payment Models) Final Rule (CMS-5519-F) and Medicare ACO Track 1+ Model,' CMS, Dec. 20, 2016, available at: https:/Avww.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-12-20.html? DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending. [FN19] . 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. [FN20] . Fact Sheet, "Speech: Remarks by CMS Administrator Seema Verma at the American Hospital Association Annual Membership Meeting," CMS, May 7, 2018, available at: https:/Avww.cms.gov/newsroom/fact-sheets/speech-remarks-cms-administrator-seema- verma-american-hospital-association-annual-membership-meeting. [FN21] . 83 F.R. 41786 (Aug. 17, 2018). [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/. [FN23] . Rajiv Leventhal, "EXCLUSIVE: Substantial ACO Reforms Could be Forthcoming," Healthcare Informatics, May 9, 2018, available at: https:/Avww.healthcare-informatics.com/article/payment/exclusive-substantial-aco-reforms-could-be-forthcoming [FN24] -Phil Galewitz, "Medicare to Overhaul ACOs but Critics Fear Less Participation," Kaiser Health News, Aug. 9, 2018, available at: https:// khn.org/news/medicare-to-overhaul-acos-but-critics-fear-fewer-participants/. "Medicare Shared Savings Program," CMS, available at: https:/Awww.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ sharedsavingsprogram/about.html. [FN25] . 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: htips:/Awww.cms.gov/newsroom/fact-sheets/final-policy-payment-and-quality-provisions- changes-medicare-physician-fee-schedule-calendar-year. [FN26] . Press Release, "CMS Finalizes ?Pathways to Success,' an Overhaul of Medicare's National ACO Program," CMS, Dec. 21, 2018, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-finalizes-pathways-success-overhaul-medicares-national-aco- program. [FN27] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -39- . Press Release, "CMS Finalizes ?Pathways to Success,' an Overhaul of Medicare's National ACO Program," CMS, Dec. 21, 2018, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-finalizes-pathways-success-overhaul-medicares-national-aco- program. [FN28] . Fact Sheet, "Final Rule Creates Pathways to Success for the Medicare Shared Savings Program," CMS, Dec. 21, 2018, available at: https:/Avww.cms.gov/newsroom/fact-sheets/final-rule-creates-pathways-success-medicare-shared-savings-program. [FN29] . Fact Sheet, "Final Rule Creates Pathways to Success for the Medicare Shared Savings Program," CMS, Dec. 21, 2018, available at: https:/Avww.cms.gov/newsroom/fact-sheets/final-rule-creates-pathways-success-medicare-shared-savings-program. [FN30] . 'Shared Savings Program Participation Options for Performance Year 2022," CMS, Apr. 2021, available at: https:/Awww.cms.gov/ Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/ssp-aco-participation-options. pdf. [FN31] . Seema Verma, "More ACOs Taking Accountability Under MSSP Through ? Pathways to Success'," Health Affairs, July 17, 2019, available at: https:/Awww.healthaffairs.org/do/10.1377/hblog20190717.482997/full/. [FN32] . Tina Reed, "CMS: ACOs Save Medicare $1.2B under 'Pathways to Success' Program," Health Affairs, Sept. 15, 202, available at: https:/Avww.fiercehealthcare.com/payer/cms-acos-save-medicare-1-2b-under-pathways-to-success-program. [FN33] . Press Release, "Medicare Shared Savings Program Continues to Grow and Deliver High-Quality, Person-Centered Care Through Accountable Care Organizations," Jan. 26, 2022, available at: https:/Avwww.cms.gov/newsroom/press-releases/medicare-shared- savings-program-continues-grow-and-deliver-high-quality-person-centered-care-through. From that page, you may link to the data. [FN34] . Press Release, "Medicare Shared Savings Program Saves Medicare More Than $1.6 Billion in 2021 and Continues to Deliver High- quality Care," CMS, Aug. 30, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/medicare-shared-savings-program- saves-medicare-more-16-billion-2021 -and-continues-deliver-high. [FN35] . Press Release, "CMS Redesigns Accountable Care Organization Model to Provide Better Care for People with Traditional Medicare," CMS, Feb. 24, 2022, available at: https:/Avwww.cms.gov/newsroom/press-releases/cms-redesigns-accountable-care-organization-model- provide-better-care-people-traditional-medicare. [FN36] . See Innovation Center Design Refresh, CMS, available at: https://innovation.cms.gov/strategic-direction-whitepaper. [FN37] . Press Release, "CMS Redesigns Accountable Care Organization Model to Provide Better Care for People with Traditional Medicare," CMS, Feb. 24, 2022, available at: https:/Avwww.cms.gov/newsroom/press-releases/cms-redesigns-accountable-care-organization-model- provide-better-care-people-traditional-medicare. [FN38] . Fact Sheet, "Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model," CMS, Feb. 24, 2022, available at: https:/Avww.cms.gov/newsroom/fact-sheets/accountable-care-organization-aco-realizing-equity-access-and- community-health-reach-model. [FN39] . Fact Sheet, "Accountable Care Organization (ACO) Realizing Equity, Access, and Community Health (REACH) Model," CMS, Feb. 24, 2022, available at: https:/Avww.cms.gov/newsroom/fact-sheets/accountable-care-organization-aco-realizing-equity-access-and- community-health-reach-model. [FN40] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -40- . See, e.g., "Public Health and Promoting Interoperability Programs," CDC, available at: https:/Avww.cdc.gov/ehrmeaningfuluse/ introduction.html. [FN41] . For a complete definition of interoperability, please see "Interoperability," HealthIT.gov, available at: https:/Avww.healthit.gov/topic/ interoperability. [FN42] . The 21st Century Cures Act, P.L. 114-255. [FN43] . 85 F.R. 25642 (May 1, 2020). [FN44] . Data Brief, Christian Johnson and Yuriy Pylypchuk, "Use of Certified Health IT and Methods to Enable Interoperability by U.S. Non- Federal Acute Care Hospitals, 2019, ONC, Jan. 2021, available at: https:/Awww.healthit.gov/sites/default/files/page/2021-02/Use-of- Certified-Health-IT-and-Methods-to-Enable-Interoperability-by-U.S.-Non-Federal-Acute-Care-Hospitals-201 9. pdf. [FN45] . Data Brief, Christian Johnson and Yuriy Pylypchuk, "Use of Certified Health IT and Methods to Enable Interoperability by U.S. Non- Federal Acute Care Hospitals, 2019, ONC, Jan. 2021, available at: https:/Awww.healthit.gov/sites/default/files/page/2021-02/Use-of- Certified-Health-IT-and-Methods-to-Enable-Interoperability-by-U.S.-Non-Federal-Acute-Care-Hospitals-201 9. pdf. [FN46] . "2022 Medicare Promoting Interoperability Program Requirements," CMS, available at: https:/Avww.cms.gov/regulations-guidance/ promoting-interoperability/2022-medicare-promoting-interoperability-program-requirements#:?:text=For CY 2022# the CEHRT,the full EHR reporting period. [FN47] . CMS email, "New CERHT Requirements for the Medicare Promoting Interoperability Program in 2023," Nov. 8, 2022. [FN48] . The rule is published at 87 F.R. 48780-01 (Aug. 10, 2022). [FN49] . "2022 Medicare Promoting Interoperability Program Requirements," CMS, available at: https:/Avww.cms.gov/regulations-guidance/ promoting-interoperability/2022-medicare-promoting-interoperability-program-requirements. [FN50] . Fact Sheet, "FY 2023 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule - CMS-1771-F," CMS, Aug. 1, 2022, available at: https:/Awww.cms.gov/newsroom/fact-sheets/fy-2023- hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective. [FN51] . 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:/Avww.hhs.gov/about/news/201 9/02/1 1/hhs-proposes-new-rules-improve- interoperability-electronic-health-information.html. [FN52] . 'Interoperability and Patient Access Fact Sheet," CMS, March 9, 2020, available at: https:/Awww.cms.gov/newsroom/fact-sheets/ interoperability-and-patient-access-fact-sheet. [FN53] . To receive email updates from CMS, visit cms.gov and complete the "Receive Email Updates" bar on the bottom right of the opening page. [FN54] . CMS email update, "Interoperability and Patient Access final rule (CMS-9115-F) Guidance and FAQs," May 10, 2021. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -41- [FN55] . 'Advance Copy- Interoperability and Patient Access Rule- Admission, Discharge, and Transfer Notifications for Hospitals, Psychiatric Hospitals, and Critical Access Hospitals (CAHs) Interpretive Guidance," QSO-21-18 Hospitals/CAHs, CMS, May 7, 2021, available at: https:/Avww.cms.gov/files/document/qso-21-18-hospitals-cahs. pdf. [FN56] . 'Interoperability and Patient Access Final Rule (CMS-9115-F) Frequently Asked Questions (FAQs)," CMS, available at: https:// www.cms.gov/files/document/faqs-interoperability-patient-access-and-cop-event-notifications-may-2021.pdf. [FN57] . ""ONC's Cures Act Final Rule Supports Seamless and Secure Access, Exchange, and Use of Electronic Health Information," available at: https:/Avww.healthit.gov/curesrule/. Click on the "Learn More" button in the left-hand corner. [FN58] . RA Berenson and N Cafarella, "The Center for Medicare and Medicaid Innovation," Robert Wood Johnson Foundation, Feb. 1, 2012, available at: https:/Awww.rwif.org/en/library/research/2012/02/the-center-for-medicare-and-medicaid-innovation.html. [FN59] . 'Innovation Center Strategy Refresh," CMS, available at: https://innovation.cms.gov/strategic-direction-whitepaper. [FN60] . 'Innovation Center Strategy Refresh," CMS, available at: https://innovation.cms.gov/strategic-direction-whitepaper. [FN61] . 'Innovation Center Strategy Refresh," CMS, available at: https://innovation.cms.gov/strategic-direction-whitepaper. [FN62] . 'Person-Centered Innovation ? An Update on the Implementation of the CMS Innovation Center's Strategy," CMS, Nov. 2022, available at: https://innovation.cms.gov/media/document/cmmi-strategy-implementation-update. [FN63] . 2020 Report to Congress, Center for Medicare and Medicaid Innovation, available at: https://innovation.cms.gov/data-and- reports/2021/rtc-2020. [FN64] . "Cancer Moonshot," The White House, available at: https:/Avww.whitehouse.gov/cancermoonshot/. [FN65] . Press Release, "Biden Administration Announces New Model to Improve Cancer Care for Medicare Patients," CMS, June 27, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/biden-administration-announces-new-model-improve-cancer-care- medicare-patients. [FN66] . Press Release, "Biden Administration Announces New Model to Improve Cancer Care for Medicare Patients," CMS, June 27, 2022, available at: https://(www.cms.gov/newsroom/press-releases/biden-administration-announces-new-model-improve-cancer-care- medicare-patients. [FN67] . Press Release, "Biden Administration Announces New Model to Improve Cancer Care for Medicare Patients," CMS, June 27, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/biden-administration-announces-new-model-improve-cancer-care- medicare-patients. [FN68] . MIPS is the Merit-based Incentive Payment System. [FN69] . Fact Sheet, "Enhancing Oncology Model," CMS, available at: https:/Avwww.cms.gov/newsroom/fact-sheets/enhancing-oncology-model. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -42- [FN70] . Fact Sheet, "Enhancing Oncology Model," CMS, available at: https:/Avww.cms.gov/newsroom/fact-sheets/enhancing-oncology-model. [FN71] . Medicare Diabetes Prevention Program (MDPP) Expanded Model, CMS, available at: https://innovation.cms.gov/initiatives/medicare- diabetes-prevention-program/. [FN72] . Medicare Diabetes Prevention Program (MDPP) Expanded Model, CMS, available at: https://innovation.cms.gov/initiatives/medicare- diabetes-prevention-program/. [FN73] . 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/. [FN74] . 'Medicare Diabetes Prevention Program Expanded Model," CMS, available at: https://innovation.cms.gov/initiatives/medicare- diabetes-prevention-program/. [FN75] . 86 F.R. 64996-01 (July 23, 2021). A Fact Sheet is available: Fact Sheet, "Final Policies for the Medicare Diabetes Prevention Program (MDPP) Expanded Model for the Calendar Year 2022 Medicare Physician Fee Schedule," CMS, Nov. 2, 2021, available at: https:// www.cms.gov/newsroom/fact-sheets/final-policies-medicare-diabetes-prevention-program-mdpp-expanded-model-calendar-year-2022- medicare. [FN76] . "CMS Community Health Access and Rural Transformation (CHART) Model," Medicaid.gov, available at: https:/Avww.medicaid.gov/ about-us/messages/101126. [FN77] . Press Release, "Trump Administration Announces Initiative to Transform Rural Health," CMS, Aug. 11, 2020, available at: https:// www.cms.gov/newsroom/press-releases/trump-administration-announces-initiative-transform-rural-health. [FN78] . "CMS Rural Health Strategy," available at: https:/Awww.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural- Strategy-2018.pdf. [FN79] . Press Release, "Trump Administration Announces Initiative to Transform Rural Health," CMS, Aug. 11, 2020, available at: https:// www.cms.gov/newsroom/press-releases/trump-administration-announces-initiative-transform-rural-health. [FN80] . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN81] . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN82] . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN83] . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN84] . "Chart Model," Innovation Center web site, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN85] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -43- . CHART Model, Center for Medicare and Medicaid Innovations, available at: https://innovation.cms.gov/innovation-models/chart-model. [FN86] . Email, "ACO Transformation Track Update," CMS, Feb. 22, 2022. [FN87] . 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:/Avww.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. [FN88] . 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:/Avww. healthaffairs.org/do/10.1377/hblog20190115.234942/full/ [FN89] . 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:/Avww.kff.org/disparities-policy/issue-brief/beyond-health-care-the- role-of-social-determinants-in-promoting-health-and-health-equity/. [FN90] . State Health Official Letter, "Opportunities in Medicaid and CHIP to Address Social Determinants of Health (SDOH)," #21-001, Jan. 7, 2021, available at: https:/Awww.medicaid.gov/federal-policy-guidance/downloads/sho21001.pdf. [FN91] . State Health Official Letter, "Opportunities in Medicaid and CHIP to Address Social Determinants of Health (SDOH)," #21-001, Jan. 7, 2021, available at: https:/Awww.medicaid.gov/federal-policy-guidance/downloads/sho21001 pdf. [FN92] . 'Accountable Health Communities Model," CMS, available at: https://innovation.cms.gov/innovation-models/ahcm. [FN93] . Kate Abowd Johnson, ef a/., "Lessons from Five Years of The CMS Accountable Health Communities Model," Health Affairs, Aug. 8, 2022, available at: https:/Avww.healthaffairs.org/content/forefront/lessons-five-years-cms-accountable-health-communities-model. [FN94] . Kate Abowd Johnson, ef a/., "Lessons from Five Years of The CMS Accountable Health Communities Model," Health Affairs, Aug. 8, 2022, available at: https:/Awww.healthaffairs.org/content/forefront/lessons-five-years-cms-accountable-health-communities-model. [FN95] . Kate Abowd Johnson, ef a/., "Lessons from Five Years of The CMS Accountable Health Communities Model," Health Affairs, Aug. 8, 2022, available at: https:/Avww.healthaffairs.org/content/forefront/lessons-five-years-cms-accountable-health-communities-model. [FN96] . News Release, "HHS Approves Groundbreaking Medicaid Initiatives in Massachusetts and Oregon," HHS, Sept. 28, 2022, available at: https:/Avww.hhs.gov/about/news/2022/09/28/hhs-approves-groundbreaking-medicaid-initiatives-in-massachusetts-and-oregon.html. [FN97] . News Release, "HHS Approves Groundbreaking Medicaid Initiatives in Massachusetts and Oregon," HHS, Sept. 28, 2022, available at: https:/Avww.hhs.gov/about/news/2022/09/28/hhs-approves-groundbreaking-medicaid-initiatives-in-massachusetts-and-oregon.html. [FN98] . News Release, "HHS Approves Arizona's Medicaid Interventions to Target Health-Related Social Needs," HHS, Oct. 14, 2022, available at: https:/Awww.hhs.gov/about/news/2022/10/14/hhs-approves-arizonas-medicaid-interventions-target-health-related-social- needs.html. [FNg9] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -44- . News Release, "HHS Approves Arizona's Medicaid Interventions to Target Health-Related Social Needs," HHS, Oct. 14, 2022, available at: https:/Awww.hhs.gov/about/news/2022/10/14/hhs-approves-arizonas-medicaid-interventions-target-health-related-social- needs.html. [FN100] . 'HHS Approves Arkansas' Medicaid Waiver to Provide Medically Necessary Housing and Nutrition Support Services," Medicaid.gov, Nov. 1, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/33582a5. [FN101] . 'HHS Approves Arkansas' Medicaid Waiver to Provide Medically Necessary Housing and Nutrition Support Services," Medicaid.gov, Nov. 1, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/33582a5. [FN102] . 'HHS Approves Arkansas' Medicaid Waiver to Provide Medically Necessary Housing and Nutrition Support Services," Medicaid.gov, Nov. 1, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/33582a5. [FN103] . Robert Wood Johnson Foundation, 'Reform in Action: Can Implementing Patient-Centered Medical Homes Improve Health Care Quality?' April, 2012, available at: http:/Avww.rwif.org/qualityequality/product.jsp?id=73739&cid =XEM_A5896. [FN104] . 'HRSA Accreditation and Patient-Centered Medical Home Recognition Initiative," HRSA, available at: https://bphc.hrsa.goviinitiatives/ advancing-health-center-excellence/hrsa-accreditation-patient-centered-medical-home-recognition-initiative#:?:text=The HRSA Accreditation and Patient, Medical Home (PCMH) recognition. [FN105] . "'Patient-Centered Medical Home: What is a Patient-Centered Medical Home (PCMH)?" Primary Care Collaborative, Sept. 2015, available at: https:/Awww.pcpcc.org/resource/patient-centered-medical-home-what-patient-centered-medical-home-pcmh. [FN106] . 'Primary Care Practice Facilitation Curriculum," Agency for Health Care Research and Quality, Sept. 15, 2015, available at: https:// pemh.ahrq.gov/sites/default/files/attachments/pcpf-module-25-pcmh-principles. pdf. [FN107] . Primary Care Practice Facilitation Curriculum," Agency for Health Care Research and Quality, Sept. 15, 2015, available at: https:// pemh.ahrq.gov/sites/default/files/attachments/pcpf-module-25-pcmh-principles. pdf. [FN108] . 'Health Homes,' Medicaid.gov, available at: https:/Awww.medicaid.gov/medicaid/long-term-services-supports/health-homes/index.html; 'Health Homes (Section 2703) Frequently Asked Questions,' Medicaid.gov, available at: https://Awww.medicaid.gov/state-resource- center/medicaid-state-technical-assistance/health-home-information-resource-center/downloads/health-homes-faq-5-3-12_2.pdf. [FN109} . 'State-by-State Health Home State Plan Amendment Matrix," CMS, updated Mar. 2022, 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. [FN110] . State Medicaid Director Letter, #22-004, "Health Homes for Children with Medically Complex Conditions," CMS, Aug. 1, 2022, available at: https:/Awww.medicaid.gov/federal-policy-guidance/downloads/smd22004.pdf. [FN111] . State Medicaid Director Letter, #22-004, "Health Homes for Children with Medically Complex Conditions," CMS, Aug. 1, 2022, available at: https:/Awww.medicaid.gov/federal-policy-guidance/downloads/smd22004.pdf. [FN112] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -45- . Press Release, "CMS Offers Roadmap for States to Help Connect Children with Complex Medical Conditions to Critical Medicaid Services," CMS, Aug. 1, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/cms-offers-roadmap-states-help-connect- children-complex-medical-conditions-critical-medicaid. [FN113] . 'Health Home for Children with Medically Complex Conditions Notice of Funding Opportunity," CMS, Sept. 30, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/32fd9e0. The funding opportunity notice is available at: https:// www.grants.gov/web/grants/view-opportunity.html?oppld=343826. [FN114] . "CMS Releases Medicaid Health Home State Plan Option State Plan Amendment Template and Implementation Guide," CMS, Sept. 26, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/32efd07. [FN115] . Please see the Health Home Resource Center, available at: https:/Awww.medicaid.gov/State-Resource-Center/Medicaid-State- Technical-Assistance/Health-Homes-Technical-Assistance/Health-Home-Information-Resource-Center.html. [FN116] . CMCS Informational Bulletin, "2022 Updates to the Health Home Core Health Care Quality Measurement Sets," CMS, Feb. 16, 2022, available at: https:/Awww.medicaid.gov/federal-policy-guidance/downloads/cib02162022.pdf (emphasis in original, footnotes omitted). [FN117] . LTSS Models, CMS, available at: https:/Awww.cms.gov/Outreach-and-Education/American-Indian-Alaska-Native/AIAN/LTSS-TA- Center/info/hcbs. [FN118] . 'Home- and Community-Based Services," MACPAC, available at: https:/Avww.macpac.gov/subtopic/home-and-community-based- services/. [FN119] . 'Mandatory and Optional Benefits," Medicaid.gov, available at: https:/Awww.medicaid.gov/medicaid/benefits/mandatory-optional- medicaid-benefits/index.html. [FN120} . See, e.g., "Waivers," MACPAC, available at: https:/Avww.macpac.gov/medicaid-101/waivers/. [FN121] . Molly O'Malley Watts, et a/., "Medicaid Home and Community-Based Services Enrollment and Spending," Kaiser Family Foundation, Feb. 4, 2020, available at: https:/Avww.kff.org/medicaid/issue-brief/medicaid-home-and-community-based-services-enrollment-and- spending/. [FN122] . 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/smd1601 1.pdf. [FN123] . 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-201 9-and-2020/. [FN124] . State Medicaid Director Letter #22-003, "Home and Community-Based Services Quality Measure Set," CMS, July 21, 2022, available at: https:/Awww.medicaid.gov/federal-policy-guidance/downloads/smd22003.pdf. [FN125] . See, e.g. "Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government," The White House, Jan. 20, 2021, available at: https:/Avww.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive- order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -46- [FN126] . State Medicaid Director Letter #22-003, "Home and Community-Based Services Quality Measure Set," CMS, July 21, 2022, available at: https:/Awww.medicaid.gov/federal-policy-guidance/downloads/smd22003.pdf. [FN127] . "Fact Sheet: Summary of Key Provisions of the Home and Community-Based Services (HCBS) Settings Final Rule (CMS 2249- F/2296-F)," CMS, Jan. 10, 2014, available at: https:/Avww.medicaid.gov/sites/default/files/201 9-12/hcbs-setting-fact-sheet. pdf. [FN128] . 79 F.R. 2948-01 (Jan. 16, 2014). [FN129} . CMCS Informational Bulletin, 'Extension of Transition Period for Compliance with Home and Community-Based Settings Criteria,' May 9, 2017, available at: https:/Awww.medicaid.gov/federal-policy-guidance/downloads/cib050917.pdf. [FN130] . State Medicaid Director Letter #20-003, "Home and Community-Based Settings Regulation ? Implementation Timeline Extension and Revised Frequently Asked Questions," CMS, July 14, 2020, available at: https:/Avww.medicaid.gov/Federal-Policy-Guidance/ Downloads/smd20003.pdf. [FN131] . 'Home and Community-Based Services Final Rule Update: Final Statewide Transition Plan Submissions, Settings Criteria Not Impacted by the COVID-19 PHE, and Requests from States for Corrective Action Plans," Medicaid.gov, May 24, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/3193d28. [FN132] . 'Home and Community-Based Services Final Rule Update: Final Statewide Transition Plan Submissions, Settings Criteria Not Impacted by the COVID-19 PHE, and Requests from States for Corrective Action Plans," Medicaid.gov, May 24, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/3193d28. [FN133] . Dear Medicaid Director Letter, "Implementation of American Rescue Plan Act of 2021 Section 9817: Additional Support for Medicaid Home and Community-Based Services during the COVID-19 Emergency," #21-003, May 13, 2021, available at: https:/Awww.medicaid.gov/federal-policy-qguidance/downloads/smd21003.pdf. [FN134] . Press Release, "HHS Extends American Rescue Plan Spending Deadline for States to Expand and Enhance Home- and Community- Based Services for People with Medicaid," CMS, June 3, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/hhs- extends-american-rescue-plan-spending-deadline-states-expand-and-enhance-home-and-community. [FN135] . Elizabeth Williams and MaryBeth Musumeci, "Children with Special Health Care Needs: Coverage, Affordability, and HCBS Access," Kaiser Family Foundation, Oct. 4, 2021, available at: https:/Awww.kff.org/medicaid/issue-brief/children-with-special-health-care-needs- coverage-affordability-and-hcbs-access/?utm_. [FN136] . MaryBeth Musumeci, ef a/., "State Actions to Sustain Medicaid Long-Term Services and Supports During COVID-19," Aug. 26, 2020, available at: https:/Awww.kff.org/medicaid/issue-brief/state-actions-to-sustain-medicaid-long-term-services-and-supports-during- covid-19/. [FN137] . Elizabeth Williams and MaryBeth Musumeci, "Children with Special Health Care Needs: Coverage, Affordability, and HCBS Access," Kaiser Family Foundation, Oct. 4, 2021, available at: https:/Awww.kff.org/medicaid/issue-brief/children-with-special-health-care-needs- coverage-affordability-and-hcbs-access/?utm_. [FN138] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -47- . Elizabeth Williams and MaryBeth Musumeci, "Children with Special Health Care Needs: Coverage, Affordability, and HCBS Access," Kaiser Family Foundation, Oct. 4, 2021, available at: https:/Awww.kff.org/medicaid/issue-brief/children-with-special-health-care-needs- coverage-affordability-and-hcbs-access/?utm_. [FN139] . 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-ltems/2012-04-26.html. [FN140] . 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. [FN141] . 'Community First Choice (CFC) 1915(k)," Medicaid.gov, available at: https:/Awww.medicaid.gov/medicaid/hcbs/downloads/community- first-choice-interim-report-to-congress. pdf. [FN142] . Program of All-Inclusive Care for the Elderly, CMS, available at: https:/Avww.medicaid.gov/medicaid/ltss/pace/index.html. [FN143] . Program of All-Inclusive Care for the Elderly, CMS, available at: https:/Avwww.medicaid.gov/medicaid/Itss/pace/index.html. [FN144] . Press Release, "HHS to Provide $110 Million to Strengthen Safety Net for Seniors and People with Disabilities," CMS, Mar. 31, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/hhs-provide-1 10-million-strengthen-safety-net-seniors-and-people- disabilities. [FN145] . Press Release, "HHS to Provide $110 Million to Strengthen Safety Net for Seniors and People with Disabilities," CMS, Mar. 31, 2022, available at: https:/Awww.cms.gov/newsroom/press-releases/hhs-provide-1 10-million-strengthen-safety-net-seniors-and-people- disabilities. [FN146] . News Release, "HHS Approves Groundbreaking Medicaid Initiatives in Massachusetts and Oregon," HHS, Sept. 28, 2022, available at: https:/Avww.hhs.gov/about/news/2022/09/28/hhs-approves-groundbreaking-medicaid-initiatives-in-massachusetts-and-oregon.html. [FN147] . News Release, "HHS Approves Groundbreaking Medicaid Initiatives in Massachusetts and Oregon," HHS, Sept. 28, 2022, available at: https:/Avww.hhs.gov/about/news/2022/09/28/hhs-approves-groundbreaking-medicaid-initiatives-in-massachusetts-and-oregon.html. [FN148] . Youssra Marjoua and Kevin J. Bozic, "Brief History of Quality Movement in US healthcare," National Library of Medicine, Sept. 9, 2012, available at: https:/Avww.ncbi.nim.nih.gov/pmc/articles/PMC3702754/#. [FN149] . See, e.g., "Report to Congress: National Strategy for Quality Improvement in Health Care," CMS, Mar. 2011, available at: https:// www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/qualityO321201 1a. [FN150] . Michelle Schreiber, ef a/., "The CMS National Quality Strategy: A Person-Centered Approach to Improving Quality," CMS Blog, June 6, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/31afec9. [FN151] . Michelle Schreiber, ef a/., "The CMS National Quality Strategy: A Person-Centered Approach to Improving Quality," CMS Blog, June 6, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/31afec9. [FN152] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -48- . Michelle Schreiber, et al., "The CMS National Quality Strategy: A Person-Centered Approach to Improving Quality," CMS Blog, June 6, 2022, available at: https://content.govdelivery.com/accounts/USCMSMEDICAID/bulletins/31afec9. [FN153] . See, "What is Telehealth? How is Telehealth Different from Telemedicine?" HealthIT.gov, available at: https://www.healthit.gov/faq/ what-telehealth-how-telehealth-different-telemedicine; "Telehealth: Technology Meets Health Care," Mayo Clinic, available at: https:// www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/telehealth/art-20044878. [FN154] . Justin Lo, et a/., "Outpatient Telehealth use Soared early in the COVID-19 Pandemic but has since Receded," Peterson-KFF Health System Tracker, Feb. 10, 2022, available at: https:/Avww.healthsystemtracker.org/ brief/outpatient-telehealth-use-soared-early-in-the-covid-19-pandemic-but-has-since-receded/? _hsmi=203522498&_hsenc=p2ANqatz-8iH_SA1vIH6quXFVAq3ZQ0SWIS908BhEseAH10z_W3v0PkAhCdQkdmnTcEoJkkHH4pP- s1T1kVG29AxqZbltgP-M1-xQ&utm_campaign=KFF-2022-Coronavirus&utm. [FN155] . News Release, "HHS Awards Nearly $55 Million to Increase Virtual Health Care Access and Quality Through Community Health Centers," HHS, Feb. 14, 2022, available at: https://www.hhs.gov/about/news/2022/02/1 4/hhs-awards-nearly-55-million-increase-virtual- health-care-access-quality-through-community-health-centers.html?utm. [FN156] . News Release, "HHS Awards Nearly $55 Million to Increase Virtual Health Care Access and Quality Through Community Health Centers," HHS, Feb. 14, 2022, available at: https://www.hhs.gov/about/news/2022/02/1 4/hhs-awards-nearly-55-million-increase-virtual- health-care-access-quality-through-community-health-centers.html?utm. [FN157] . Dobbs v. Jackson Women's Health Organization, U.S. Supreme Court, 142 S.Ct. 2228 (June 24, 2008). [FN158] . Laurie Sobel, et a/., "The Intersection of State and Federal Policies on Access to Medication Abortion Via Telehealth," Kaiser Family Foundation, Feb. 7, 2022, available at: https:/Avww.kff.org/womens-health-policy/issue-brief/the-intersection-of-state-and-federal- policies-on-access-to-medication-abortion-via-telehealth/?utm. [FN159] . Laurie Sobel, et a/., "The Intersection of State and Federal Policies on Access to Medication Abortion Via Telehealth," Kaiser Family Foundation, Feb. 7, 2022, available at: https:/Avww.kff.org/womens-health-policy/issue-brief/the-intersection-of-state-and-federal- policies-on-access-to-medication-abortion-via-telehealth/?utm. [FN160] . Bridget DeCoursey Bondoc, et a/., "FDA Oks Mail-Order Mifepristone: State Laws May Inhibit Its Use," JDSupra, Jan. 27, 2022, available at: https:/Awww.jdsupra.com/legalnews/fda-oks-mail-order-mifepristone-state-16041 28/. [FN164] . Laurie Sobel, et a/., "The Intersection of State and Federal Policies on Access to Medication Abortion Via Telehealth," Kaiser Family Foundation, Feb. 7, 2022, available at: https:/Avww.kff.org/womens-health-policy/issue-brief/the-intersection-of-state-and-federal- policies-on-access-to-medication-abortion-via-telehealth/?utm. [FN162] . Laurie Sobel, ef a/., "The Intersection of State and Federal Policies on Access to Medication Abortion Via Telehealth," Kaiser Family Foundation, Feb. 7, 2022, available at: https:/Avww.kff.org/womens-health-policy/issue-brief/the-intersection-of-state-and-federal- policies-on-access-to-medication-abortion-via-telehealth/?utm. [FN163] . Pub. L. 117-2. [FN164] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -49- . News Release, "HHS Announces $16.3 Million to Expand Telehealth Care in the Title X Family Planning Program," HHS, May 10, 2022, available at: https:/Avww.hhs.gov/about/news/2022/05/10/hhs-announces-16-million-expand-telehealth-care-title-x-family- planning-program.html?utm. [FN165] . News Release, "HHS Announces $16.3 Million to Expand Telehealth Care in the Title X Family Planning Program," HHS, May 10, 2022, available at: https:/Awww.hhs.gov/about/news/2022/05/10/hhs-announces-16-million-expand-telehealth-care-title-x-family- planning-program.html?utm. [FN166] . News Release, "Barrag?n Reintroduces Bill to Address Health Disparities by Improving the Social Determinants of Health," web site of Rep. Barragan, Jan. 21, 2021, available at: https://barragan.house.gov/barragan-reintroduces-bill-to-address-health-disparities-by- improving-the-social-determinants-of-health/. [FN167] . News Release, "Thompson, Welch, Johnson, Schweikert, Matsui Reintroduce the Protecting Access to Post-COVID-19 Telehealth Act," web site of Rep. Thompson, Jan. 19, 2021, available at: https://mikethompson.house.gov/newsroom/press-releases/thompson- welch-johnson-schweikert-matsui-reintroduce-the-protecting-access. [FN168] . Press Release, "Toomey and Brown Introduce Legislation to Reduce Maternal Deaths and Improve Health Outcomes for Mothers," web site of Sen. Toomey, Feb. 24, 2021, available at: https:/Awww.toomey.senate.gov/newsroom/press-releases/toomey-and-brown- introduce-legislation-to-reduce-maternal-deaths-and-improve-health-outcomes-for-mothers. [FN169] . Press Release, "Senator Fischer Reintroduces Telehealth Legislation," Senator Fischer's web site, Mar. 9, 2021, available at: https:// www.fischer.senate.gov/public/index.cfm/news?|D=37E247B4-C1 17-4EB1-91DA-AC3F400DF20F. [FN170] . Press Release, "Amid the Pandemic, Casey Introduces Bill to Expand Supportive Services to Help Low-Income Americans Remain in Their Homes," Senate Special Committee on Aging, Apr. 15, 2021, available at: https:/Avww.aging.senate.gov/press-releases/amid-the- pandemic-casey-introduces-bill-to-expand-supportive-services-to-help-low-income-americans-remain-in-their-homes. [FN171] . Press Release, "Scott, Warner Reintroduce the Prevent Diabetes Act," Sen. Scott's web site, June 22, 2021, available at: https:// www.scott.senate.gov/media-center/press-releases/scott-warner-reintroduce-the-prevent-diabetes-act. [FN172] . Press Release, "Durbin, Capito, Colleagues Introduce Bipartisan Legislation to Address Childhood Trauma," Sen. Durbin's web site, June 16, 2021, available at: https:/Avww.durbin.senate.gov/newsroom/press-releases/durbin-capito-colleagues-introduce-bipartisan- legislation-to-address-childhood-trauma. [FN173] . Press Release, "Durbin, Capito, Colleagues Introduce Bipartisan Legislation to Address Childhood Trauma," Sen. Durbin's web site, June 16, 2021, available at: https:/Avww.durbin.senate.gov/newsroom/press-releases/durbin-capito-colleagues-introduce-bipartisan- legislation-to-address-childhood-trauma. [FN174] . Press Release, "Kaine Introduces Legislation to Support Direct Care Workforce & Family Caregivers," Senator Kaine's web site, July 14, 2021, available at: https:/Awww.kaine.senate.gov/press-releases/kaine-introduces-legislation-to-support-direct-care-workforce-and- family-caregivers. [FN175] . 'Casey, Colleagues Unveil Key Legislation from President Biden's American Jobs Plan to Make Historic Investment in Care Economy," Sen. Casey's web site, June 24, 2021, available at: https:/Awww.casey.senate.gov/news/releases/casey-colleagues-unveil- key-legislation-from-president-bidens-american-jobs-plan-to-make-historic-investment-in-care-economy. [FN176] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -50- . Press Release, "Rosen Leads Bipartisan Group of Senators to Introduce Bipartisan Legislation to Expand Access to Telehealth Services," web site of Sen. Jacky Rosen, June 24, 2021, available at: https:/Avww.rosen.senate.gov/rosen-leads-bipartisan-group- senators-introduce-bipartisan-legislation-expand-access-telehealth. [FN177] - "Bilirakis, Soto and Kennedy Reintroduce Bill to Improve Access to Mental Health Treatment," Rep. Bilirakis' web site, June 23, 2021, available at: https://bilirakis.house.gov/media/press-releases/bilirakis-soto-and-kennedy-reintroduce-bill-improve-access-mental-health. [FN178] . Press Release, "Cardin, Thune, Kuster, Smith Reintroduce Legislation to Increase Telehealth Services in Nursing Facilities," web site of Sen. Cardin, July 30, 2021, available at: https:/Avww.cardin.senate.gov/newsroom/press/release/cardin-thune-kuster-smith- reintroduce-legislation-to-increase-telehealth-services-in-nursing-facilities. [FN179] . Press Release, "Congressman Schweikert Introduces Legislation to Expand Patient Access to Innovative Technologies in their Home," July 22, 2021, available at: https://schweikert.house.gov/media-center/press-releases/congressman-schweikert-introduces- legislation-expand-patient-access. [FN180} . 42 U.S.C.A. ?256i. [FN181] . Press Release, "Reps. Lizzie Fletcher and Jaime Herrera Beutler Introduce Bipartisan Legislation to Invest in and Improve Mental Health Care," web site of Congresswoman Fletcher, Sept. 10, 2021, available at: https://fletcher.house.gov/news/documentsingle.aspx? DocumentID=3444. [FN182] . Press Release, "Butterfield Introduces Bipartisan Bill to Cover Cancer Molecular Testing and Educate on Genetic Counseling," Rep. Butterfield's web site, Sept. 30, 2021, available at: https://butterfield.house.gov/media-center/press-releases/butterfield-introduces- bipartisan-bill-to-cover-cancer-molecular-testing. [FN183] . Press Release, "Ways & Means Health Leaders Author New Bipartisan Bill to Break Down Barriers to Telehealth," Dec. 9, 2021, available at: https://doggett.house.gov/media/press-releases/ways-means-health-leaders-author-new-bipartisan-bill-break-down- barriers. [FN184] . Press Release, "Cortez Masto & Young Introduce Bipartisan Legislation to Extend Coverage of Telehealth Services for Seniors," Feb. 7, 2022, web site of Sen. Cortez Masto, available at: https://www.cortezmasto.senate.gov/news/press-releases/02/07/2022/cortez- masto-and-young-introduce-bipartisan-legislation-to-extend-coverage-of-telehealth-services-for-seniors-1. [FN185] . Press Release, "Swalwell, Emmer Introduce Bipartisan Legislation to Help Prevent Adverse Drug Effects," Rep. Stalwell's web site, Feb. 28, 2022, available at: https://swalwell.house.gov/media-center/press-releases/swalwell-emmer-introduce-bipartisan-legislation- help-prevent-adverse. [FN 186] . Press Release, "Brownley Introduces Legislation to Support Home and Community Based Services for Veterans and Caregivers," Rep. Brownley's web site, Mar. 1, 2022, available at: https://juliabrownley.house.gov/brownley-introduces-legislation-to-support-home- and-community-based-services-for-veterans-and-caregivers/. [FN187] . Press Release, "Foster Introduces Bipartisan Medicaid CARE Act to Expand Access to Substance Use Disorder Treatment Under Medicaid," Rep. Foster's web site, Mar. 22, 2022, available at: https://foster.house.gov/media/press-releases/foster-introduces- bipartisan-medicaid-care-act-to-expand-access-to-substance. [FN188] THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -51- . Press Release, "CMS Announces Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge," CMS, Nov. 25, 2020, available at: https:/Awww.cms.gov/newsroom/press-releases/cms-announces-comprehensive-strategy-enhance-hospital-capacity- amid-covid-19-surge. [FN189] . Press Release, "Senators Carper, Scott Introduce Bill to Extend Hospital at Home Waiver Program," Sen. Carper's web site, Mar. 10, 2022, available at: https:/Awww.carper.senate.gov/public/index.cfm/pressreleases?ID=E21A7F2D-856C-4D1E-819F-A8A411C2A139. [FN190] . Press Release, "Sens. Capito, Shaheen, Reps. Mckinley, Thompson Introduce Bipartisan Access to Prescription Digital Therapeutics Act," Sen. Capito's web site, Mar. 10, 2022, available at: https:/Avww.capito.senate.gov/news/press-releases/sens-capito-shaheen-reps- mckinley-thompson-introduce-bipartisan-access-to-prescription_digital-therapeutics-act. [FN191] . Press Release, "Thune, Brown, Cardin Introduce Legislation to Expand Access to Mental Health Services," web site of Sen. John Thune (R-S.C.), Apr. 7, 2022, available at: https:/Awww.thune.senate.gov/public/index.cfm/press-releases?ID=ODDAD78D-5EB8-455E- AB00-8DC60665CE3A. [FN192] . Press Release, "Booker, Sewell Introduce Legislation to Advance Health Equity and Access to Care," Sen. Booker's web page, Apr. 13, 2022, available at: https://www.booker.senate.gov/news/press/booker-sewell-introduce-legislation-to-advance-health-equity-and- access-to-care. [FN193] . Press Release, "Booker, Sewell Introduce Legislation to Advance Health Equity and Access to Care," Sen. Booker's web page, Apr. 13, 2022, available at: https:/Awww.booker.senate.gov/news/press/booker-sewell-introduce-legislation-to-advance-health-equity-and- access-to-care. [FN194] . Press Release, "Reps. Blunt Rochester, Fitzpatrick, & Wasserman Schultz Introduce Bill Urging Americans to Get their Cancer Screenings," web site of Rep. Blunt Rochester, Apr. 28, 2022, available at: https://bluntrochester.house.gov/news/ documentsingle.aspx?DocumentID=2830. [FN195] . Press Release, "Casey, Cassidy Introduce Bill to Improve Mental Health Care Access for Kids," web site of Sen. Casey, June 23, 2022, available at: https:/Awww.casey.senate.gov/news/releases/casey-cassidy-introduce-bill-to-improve-mental-health-care-access-for- kids. [FN196] . Press Release, "Casey, Cassidy Introduce Bill to Improve Mental Health Care Access for Kids," web site of Sen. Casey, June 23, 2022, available at: https:/Awww.casey.senate.gov/news/releases/casey-cassidy-introduce-bill-to-improve-mental-health-care-access-for- kids. [FN197] . Press Release, "Portman, Casey Introduce Bipartisan Legislation to Invest in Children's Mental Health," Sen. Portman's web site, Aug. 3, 2022, available at: https://www.portman.senate.gov/newsroom/press-releases/portman-casey-introduce-bipartisan-legislation-invest- childrens-mental. [FN198] . Press Release, "Portman, Casey Introduce Bipartisan Legislation to Invest in Children's Mental Health," Sen. Portman's web site, Aug. 3, 2022, available at: https:/Awww.portman.senate.gov/newsroom/press-releases/portman-casey-introduce-bipartisan-legislation-invest- childrens-mental. [FN199] . Press Release, "New Medicaid Option Promotes Enhanced Mental Health, Substance Use Crisis Care," CMS, Dec. 28, 2021, available at: https:/Awww.cms.gov/newsroom/press-releases/new-medicaid-option-promotes-enhanced-mental-health-substance-use- crisis-care. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -52- [FN200] . Press Release, "New Medicaid Option Promotes Enhanced Mental Health, Substance Use Crisis Care," CMS, Dec. 28, 2021, available at: https:/Awww.cms.gov/newsroom/press-releases/new-medicaid-option-promotes-enhanced-mental-health-substance-use- crisis-care. [FN201} . Press Release, "HHS Approves Nation's First Medicaid Mobile Crisis Intervention Services Program, To Be Launched in Oregon," CMS, Sept. 12, 2022, available at: https:/Avwww.cms.gov/newsroom/press-releases/hhs-approves-nations-first-medicaid-mobile-crisis- intervention-services-program-be-launched-oregon. [FN202] . Press Release, "Rosen, Boozman Introduce Bipartisan Legislation to Create a National Advisory Commission on Long-Term Care Services," Sen. Rosen's web site, Sept. 15, 2022, available at: https:/Avww.rosen.senate.gov/2022/09/15/rosen-boozman-introduce- bipartisan-legislation-to-create-a-national-advisory-commission-on-long-term-care-servicesk-/. [FN203] . Press Release, "Rosen, Collins, Lee, Hudson Bipartisan, Bicameral Mobile Health Care Act Heads to President's Desk," Sen. Rosen's web site, Sept. 29, 2022, available at: https:/Awww.rosen.senate.gov/2022/09/29/rosen-collins-lee-hudson-bipartisan-bicameral-mobile- health-care-act-heads-to-presidents-desk/. [FN204] . Press Release, "Carper, Sullivan Lead Colleagues to Introduce Bipartisan, Bicameral Bill to Implement Holistic Approach to Children's Health Care," Sen. Carper's web site, Sept. 29, 2022, available at: https:/Avww.carper.senate.gov/public/index.cim/pressreleases? ID=AE4525E0-EB0A-4589-AB99-2247F57ACFC2. [FN205] . Press Release, "Carper, Sullivan Lead Colleagues to Introduce Bipartisan, Bicameral Bill to Implement Holistic Approach to Children's Health Care," Sen. Carper's web site, Sept. 29, 2022, available at: https:/Avww.carper.senate.gov/public/index.cfm/pressreleases? ID=AE4525E0-EB0A-4589-AB99-2247F57ACFC2. [FN206] . CHIP is the Children's Health Insurance Program. [FN207] . MACPAC is the Medicaid and CHIP Payment and Access Commission. [FN208] . Press Release, "HHS Finalizes Physician Payment Rule Strengthening Access to Behavioral Health Services and Whole-Person Care," CMS, Nov. 1, 2022, available at: https:/Avww.cms.gov/newsroom/press-releases/hhs-finalizes-physician-payment-rule- strengthening-access-behavioral-health-services-and-whole. [FN209] . Fact Sheet, "Calendar Year (CY) 2023 Medicare Physician Fee Schedule Final Rule," CMS, Nov. 1, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule. [FN210] . Fact Sheet, "Calendar Year (CY) 2023 Medicare Physician Fee Schedule Final Rule," CMS, Nov. 1, 2022, available at: https:// www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule. [FN211] . Please see the press release for links to other resources for the final rule. Press Release, "HHS Finalizes Physician Payment Rule Strengthening Access to Behavioral Health Services and Whole-Person Care," CMS, Nov. 1, 2022, available at: https://www.cms.gov/ newsroom/press-releases/hhs-finalizes-physician-payment-rule-strengthening-access-behavioral-health-services-and-whole. [FN212] . The unofficial version of the rule is published at: hitps:/Awww.cms.gov/files/document/cy2023-physician-fee-schedule-final-rule- cms-1770f.pdf. THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -53- [FN213] . Promotores de salud is the Spanish term for community health care workers. For more information about these workers, please see "Promotores de Salud/Community Health Care workers," CDC, available at: https://minorityhealth.hhs.gov/omh/content.aspx?ID=8929. [FN214] . For more information on ?Budget Florida, please see https://apd.myflorida.com/ibudget/. [FN215] - 'Illinois Behavioral Health Transformation," CMS, available at: https:/Awww.medicaid.gov/medicaid/section-1115-demo/demonstration- and-waiver-list/81581. [FN216] . The Alternative Care Program is a home- and community-based services program for low-income people who do not qualify for Medicaid. For more information, please see, "Alternative Care," Minnesota Department of Human Services, available at: https://mn.gov/ dhs/people-we-serve/seniors/services/home-community/programs-and-services/alternative-care.jsp. [FN217] . PACE is Programs of All-Inclusive Care for the Elderly, a Medicare and Medicaid home- and community-based care model. [FN218] . "Enrollment Report," Medicaid.gov, available at: https:/Avww.medicaid.gov/medicaid/managed-care/enrollment-report/index.html. [FN219] . "Profiles and Program Features," Medicaid.gov, available at: https:/Avww.medicaid.gov/medicaid/managed-care/profiles-program- features/index.html. Produced by Thomson Reuters Accelus Regulatory Intelligence 27-Jun-2023 THOMSON REUTERS © 2023 Thomson Reuters. No claim to original U.S. Government Works. -54-