Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS issued the NBPP final rule for health plans on federal and state exchanges and President Biden issued an executive order to support caregivers and early educators. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On April 19, 2023, the Food and Drug Administration (FDA) issued draft guidance entitled, Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment. The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule. Comments on this guidance are due by July 19, 2023.
- On April 19, 2023, the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Patient Protection and Affordable Care Act: HHS Notice of Benefit and Payment Parameters for 2024. This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation programs, as well as 2024 user fee rates for issuers offering qualified health plans (QHPs) through federally-facilitated exchanges (FFEs) and state-based exchanges on the federal platform (SBE-FPs). This final rule also has requirements related to updating standardized plan options and reducing plan choice overload; the automatic re-enrollment hierarchy; plan and plan variation marketing name requirements for QHPs; essential community providers (ECPs) and network adequacy; failure to file and reconcile; special enrollment periods (SEPs); the annual household income verification; the deadline for QHP issuers to report enrollment and payment inaccuracies; requirements related to the State Exchange improper payment measurement program; and requirements for agents, brokers, and web-brokers assisting FFE and SBE-FP consumers. These regulations are effective June 18, 2023.
- On April 20, 2023, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a request for nominations entitled, Solicitation of Nominations for Organizations to Serve as Non-Voting Liaison Representatives to the Advisory Committee on Women’s Services (ACWS) Subcommittee on Maternal Mental Health; Second Notice. SAMHSA is soliciting nominations from qualified organizations to be considered for non-voting liaison representative positions on a subcommittee of the Advisory Committee for Women’s Services (ACWS) focused on maternal mental health. The ACWS’s role is to advise the Associate Administrator for Women’s Services (AAWS) on appropriate activities to be undertaken by the agencies of the Administration with respect to women’s substance use and mental health services, including services which require a multidisciplinary approach. The nomination period will remain open until May 31, 2023.
- On April 21, 2023, the National Institutes of Health (NIH) issued a request for information (RFI) entitled, RFI on Recommendations for Improving NRSA Fellowship Review. The purpose of this RFI is to solicit public input on proposed changes to the peer review of Ruth L. Kirschstein National Research Service Award (NRSA) fellowship applications that would restructure the review criteria and modify some sections of the Public Health Service (PHS) Fellowship Supplemental Form within the application. The goal of this effort is to facilitate the mission of NRSA fellowship peer review: to identify the most promising trainees and the excellent, individualized training programs that will help them become the outstanding scientists of the next generation. The proposed changes will allow peer reviewers to better evaluate the applicant’s potential and the quality of the scientific training plan without undue influence of the sponsor’s or institution’s reputation; and ensure that the information provided in the application is aligned with the restructured criteria and targeted to the fellowship candidate’s specific training needs. Comments to the RFI are due by June 23, 2023.
- May 8, 2023: HHS announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias (ADRD) on people with the disease and their caregivers. During the meeting, the Advisory Council will hear presentations about the drug approval and coverage decision processes. A panel will also present on progress and challenges in translating research into clinical impact. Federal agencies will provide updates on activities during the last quarter.
- May 16, 2023: NIH announced a partially open meeting of the National Advisory Dental and Craniofacial Research Council (NIDCR). The open agenda will include a report from the NIDCR Director and concept clearances. The closed agenda will include review and evaluation of grant applications.
- June 6-7, 2023: NIH announced a partially open meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Advisory Child Health and Human Development Council (NACHHD) . The open agenda will include opening remarks, discussion of administrative matters, the NICHD Director’s report, and discussion on other business of NACHHD. The closed agenda will include review and evaluation of grant applications.
- June 8, 2023: FDA, in co-sponsorship with the Duke-Margolis Center for Health Policy, announced a public workshop entitled, Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches. This workshop will address innovative manufacturing technologies for drug and biological products and will include a discussion of potential best practices, case studies from previous submissions, potential barriers to adoption, corresponding regulatory strategies, and the Advanced Manufacturing Technologies Designation Program.
II. Hearings & Markups
U.S House of Representatives
- On April 18, 2023, the House Committee on Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing entitled, Investigating the Origins of COVID-19, Part 2: China and the Available Intelligence. Witnesses present included: John L. Ratcliffe, Former Director of National Intelligence, Former U.S. Representative; Dr. Mark Lowenthal (Minority Witness), Former Assistant Director of Central Intelligence for Analysis and Production, Former Vice Chairman for Evaluation for the National Intelligence Council (NIC), Former Deputy Assistant Secretary of State for Intelligence and Research; and David Feith, Adjunct Senior Fellow, Center for a New American Security (CNAS), Former Deputy Assistant Secretary of State for East Asian and Pacific Affairs.
- On April 18, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Insights from the HHS Inspector General on Oversight of Unaccompanied Minors, Grant Management, and CMS. Witnesses present included: the Honorable Christi A. Grimm, Inspector General, Office of Inspector General (OIG), HHS.
- On April 19, 2023, the House Committee on Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies held a budget and oversight hearing entitled, Fiscal Year 2024 Request for the Centers for Disease Control and Prevention, Administration for Strategic Preparedness and Response, and National Institute of Health. Witnesses present included: the Honorable Dawn O’Connell, Assistant Secretary for Preparedness and Response, Administration for Strategic Preparedness and Response (ASPR); Dr. Lawrence Tabak D.D.S, Ph.D., Performing the Duties of the Director, NIH; and Dr. Rochelle Walensky M.D, M.P.H., Director, Centers for Disease Control and Prevention (CDC).
- On April 19, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Examining Existing Federal Programs to Build a Stronger Health Workforce and Improve Primary Care. Bills discussed included: H.R. 2559, the Strengthening Community Care Act of 2023; H.R. 2569, the Doctors of Community (DOC) Act; H.R. 2547, the Special Diabetes Program for Indians Reauthorization Act of 2023; H.R. 2544, the Securing the U.S. Organ Procurement and Transplantation Network Act; H.R. 2411, the National Nursing Workforce Center Act of 2023; To Amend the Public Health Service Act with Respect to the Covered Countermeasure Process Fund; and H.R. 2550, the Special Diabetes Program Reauthorization Act of 2023. Witnesses present included: the Honorable Carole Johnson, Administrator, Health Resources and Services Administration (HRSA).
- On April 19, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Who is Selling Your Data: A Critical Examination of the Role of Data Brokers in the Digital Economy. Witnesses present included: Justin Sherman,Senior Fellow & Research Lead Data Brokerage Project Duke University Sanford School of Public Policy; Marshall Erwin, VP & Chief Security Officer Mozilla Corporation; and Prof. Laura Moy, Associate Professor of Law; Faculty Director, Center on Privacy & Technology Georgetown Law Center.
- On April 19, 2023, the Senate Committee on Agriculture, Nutrition, and Forestry Subcommittee on Food and Nutrition, Specialty Crops, Organics, and Research held a hearing entitled, SNAP and Other Nutrition Assistance in the Farm Bill. Witnesses present included: Ty Jones Cox, Vice President of Food Assistance Policy, Center on Budget and Policy Priorities (CBPP); Heather Reynolds, Managing Director, Wilson Sheehan Lab for Economic Opportunities, University of Notre Dame; Loree D. Jones Brown, Chief Executive Officer (CEO), Philabundance; James Whitford, Executive Director, Watered Gardens; and Whitley Hasty, Outreach Specialist, Hunger Free America & Foodlink.
- On April 19, 2023, the Senate Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a hearing entitled, A Review of the President’s Fiscal Year 2024 Budget Request for the Food and Drug Administration. Witnesses present included: the Honorable Dr. Robert Califf, Commissioner, FDA.
III. Reports, Studies & Analyses
- On April 17, 2023, the Congressional Research Service (CRS) published a report entitled, Regulating Reproductive Health Services After Dobbs v. Jackson Women’s Health Organization. In Dobbs v. Jackson Women’s Health Organization (Dobbs), the Supreme Court overruled prior decisions in Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey, holding that the U.S. Constitution does not confer a right to an abortion. Since then, many bills that both provide protection for and impose restrictions on abortion have been introduced in Congress. This report evaluates Congress’s authority to regulate reproductive health services and examines the regulation of medication abortion, which represents a sizable portion of all abortions in the U.S. Specifically, the report notes that although states generally have broad authority to enact legislation on matters related to health, Congress can preempt state laws and utilize its powers under the Commerce Clause, the Spending Clause, and Section 5 of the Fourteenth Amendment, if it chooses to legislate on reproductive health-related matters. Specifically, under the Commerce Clause, because lower courts have found that providing reproductive health services is commercial activity, Congress can legislate on reproductive health care issues to protect interstate commerce. Under the Spending Clause, Congress can influence state policy by attaching conditions to the receipt of federal funds. Finally, although Dobbs held that the Fourteenth Amendment does not include a Constitutional right to abortion, Congress could use Section 5 of the Fourteenth Amendment to prevent and deter other constitutional violations related to abortion access. The report concludes by noting potential Congressional activity related to medication abortion, including: (1) considering legislation addressing FDA’s regulation of medication abortion drugs and (2) clarifying the degree to which federal regulation of medication abortion drugs preempts state policies.
- On April 18, 2023, the RAND Corporation (RAND) published an article entitled, A Potential Backslide in Mental Health Care for Millions of Americans. The author – Ryan K. Babin, a policy researcher at RAND and an assistant professor at Harvard Medical School – expresses concern that upon the end of the COVID-19 public health emergency (PHE), millions of Americans could lose access to expanded mental health care services provided under emergency flexibilities and waivers during the pandemic. Specifically, Mr. Babin notes that prior to the pandemic, over 95 percent of outpatient mental health services were provided in-person, but because of expanded telehealth flexibilities provided during the pandemic, that number declined to about 50 percent. He also noted that the number of Americans seeking mental health care also skyrocketed during the pandemic, growing by over six million individuals between 2019 and 2021. Upon the end of the COVID-19 PHE, important telehealth flexibilities, such as allowing for audio-only visits, requiring state payment parity for mental health services furnished in-person or via telehealth, waiving requirements for in-person visits in order for patients to receive prescriptions, and allowing for providers to use non-Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant video platforms (e.g., Facetime), also end. The author describes that despite studies showing comparable clinical assessments and outcomes for patients receiving in-person or telehealth mental health care, these flexibilities have not yet been extended. He noted that the end of these flexibilities could exacerbate the mental health, homelessness, and substance use disorder (SUD) crisis in the U.S. The article concludes by noting that although states and federal agencies are taking efforts to prevent such loss of mental health care coverage, the end of the COVID-19 PHE is fast-approaching and warrants swifter action to protect telehealth access.
- On April 18, 2023, CRS published a report entitled, Private Health Insurance: A Primer. Authors note that private health insurance is the most common form of health coverage in the U.S. and knowledge of various core concepts related to private health insurance may better help Members of Congress legislate reforms to the system. As such, the report describes various features of private health insurance coverage, including premiums, benefits, cost-sharing requirements, and provider networks. The authors also explain that consumers most often obtain private health insurance coverage through their employers and private health insurance plans are subject to federal and/or state requirements. Finally, the report describes information on risk (e.g., the likelihood and magnitude of financial loss for consumers and insurers) as well as data on enrollment and premiums.
- On April 19, 2023, the Kaiser Family Foundation (KFF) published an issue brief entitled, Ending the Public Health Emergency for Medicaid Home- and Community-Based Services. People who utilize home- and community-based services (HCBS) are at heightened risk of serious illness or death from COVID-19. However, as with many other sectors of the health care industry, the HCBS industry also experienced significant workforce shortages and strains during the COVID-19 pandemic and as such, the federal government provided new authorities and flexibilities to states to help them maintain people’s access to HCBS. For example, states were able to utilize Appendix K changes to Section 1915(c) waivers to change processes for determining beneficiary eligibility for HCBS and for expanding the types of HCBS providers and payments to them. Additionally, states were able to utilize telehealth to also expand access to HCBS for these particularly vulnerable individuals. As the COVID-19 PHE comes to an end on May 11, 2023, some of these flexibilities may change or end. For example, during the PHE, 39 states reported responding to workforce challenges by allowing family caregivers to be paid, but only 20 states plan to continue that policy after the end of the PHE. Additionally, although most states plan to continue telehealth flexibilities, pre-pandemic utilization limits (e.g., prior authorization) that will resume upon the end of the COVID-19 PHE may restrict access to telehealth HCBS. The report concludes by noting that the loss of PHE flexibilities could exacerbate HCBS workforce challenges and create barriers to access of HCBS (e.g., long waiting lists).
- On April 19, 2023, CRS published a legal sidebar entitled, Medication Abortion: New Litigation May Affect Access. Currently, ongoing litigation is determining the scope of federal and state authority to regulate medication abortion. Most recently, two federal district courts issued conflicting decisions in litigation over current federal requirements for medication abortion drugs and the Supreme Court is considering whether to stay enforcement of an order issued by a district court in one of those two cases. As such, this legal sidebar explores federal and state regulation of medication abortion drugs, litigation concerning medication abortion access, and selected legal considerations for Congress. The authors note that the lawsuits could transform the legal landscape surrounding medication abortion and affect its accessibility. As such, the authors propose several legislative options for Congress to consider, including: (1) codifying federal standards for the prescribing or dispending of medication abortion drugs, therefore cementing access to mifepristone as an FDA-approved drug; (2) clarifying the degree to which federal regulation of medication abortion drugs preempts state regulations that are inconsistent with federal policy; or (3) preserving states’ abilities to regulate medication abortion drugs in a manner that does not preempt other laws that provider greater protections for unborn children.
- On April 21, 2023, the Government Accountability Office (GAO) released a report entitled, Electronic Health Information Exchange: Use Has Increased, but Is Lower for Small and Rural Providers. "Electronic health information (EHI) exchange" enables the sharing of medical records electronically among health care providers, and between providers and patients. The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal enhanced Medicaid matching funds to states to encourage widespread adoption of EHI exchange through 2021 due to its potential to improve quality of health care and reduce costs. As such, GAO reviewed states' use of the HITECH funding and its effect on their EHI efforts, mechanisms states plan to pursue to continue EHI efforts once HITECH funding ends, and federal efforts that aim to address challenges to EHI exchange adoption. GAO found that states were using various EHI exchange methods and that the use of those methods increased in recent years. However, GAO found that small and rural providers were less likely to have the financial and technological resources to participate in or maintain EHI exchange capabilities. Although federal efforts, such as the Trusted Exchange Framework and Common Agreement (TEFCA), may help address some of the challenges providers face in implementing EHI exchanges, participation in TEFCA is voluntary and may not address tangential issues that may also affect providers’ abilities (e.g., workforce shortages or lack of broadband access).
IV. Other Health Policy News
- On April 17, 2023, the HHS 405(d) Program and the Health Sector Coordinating Council Cybersecurity Working Group (HSCC CWG) announced the release of three new resources to help address cybersecurity concerns in the Healthcare and Public Health (HPH) sector. The first resource, Knowledge on Demand, is a free online educational platform that offers trainings for health and public health organizations to improve cybersecurity awareness. The second resource, Health Industry Cybersecurity Practices (HICP) 2023 Edition, is a publication updated by over 150 industry and federal professionals that aims to raise awareness of cybersecurity risks and provide best practices to prevent and address the most pertinent cybersecurity threats to the HPH sector. The third resource, the Hospital Cyber Resiliency Initiative Landscape Analysis, is a report on U.S. hospitals’ current state of cybersecurity preparedness in order to identify best practices and opportunities for improvement in hospital cyber resiliency. More information on this announcement can be found here.
- On April 17, 2023, CMS announced a new opportunity entitled the Medicaid Reentry Section 1115 Demonstration Opportunity, for states to better support care for individuals who are incarcerated in the period immediately prior to their release in order to help them succeed during reentry. This new opportunity would support state Medicaid programs’ abilities to address these individuals’ potential care needs, including treatment for SUDs and other chronic health conditions. The goal of this opportunity is to expand health care access for individuals who were incarcerated during reentry to their communities, a period during which it is critical to establish access to services (e.g., SUD and mental health treatment) in order to avoid rehospitalizations, worsening health care conditions, and recidivism. Specifically, this new program allows states to cover a pre-release services for up to 90 days prior to an individual’s release that could not otherwise be covered by Medicaid due to a longstanding statutory exclusion. More information on this announcement can be found here.
- On April 18, 2023, President Biden issued an Executive Order (EO) entitled, Executive Order on Increasing Access to High-Quality Care and Supporting Caregivers. The EO describes the importance of high-quality early care and education and long-term care to supporting young children and older Americans. It recognizes that many families in the U.S. are unable to access affordable, high-quality care and thus require support from family and other informal caregivers. In fact, nearly 53 million people in the U.S. are family caregivers, including 5.5 million of whom are caring for wounded or ill service members and veterans. As such, the Biden Administration affirmed its belief that all Americans should have access to high-quality and affordable care and that all caregivers and should have access to support and resources. The Biden Administration urges Congress to provide for transformative investments for these individuals, such as by increasing opportunities for children to enroll in preschool and Head Start. Specifically, the EO identifies seven recommendations to increasing compensation and job quality for caregivers, early educators, and long-term care workers; three recommendations to make care more accessible and affordable for families; and five recommendations to expand options for families by building the supply of care. More information on this EO can be found here.
- On April 18, 2023, HHS announced the HHS Bridge Access Program For COVID-19 Vaccines and Treatments Program (Program) to create a $1.1 billion public-private partnership that helps maintain access to COVID-19 vaccines for millions of uninsured Americans at their local pharmacies or other local health centers. Specifically, the Program has two major components. First, the program will support local health departments (LDHs) and HRSA- supported health centers by making COVID-19 vaccines available to these public health organizations and by providing a discount for the federal government to purchase COVID-19 products to send to these public health organizations. Second, the program will create a partnership with local pharmacy chains (and later smaller, independent pharmacies) to enable them to continue offering free COVID-19 vaccinations and treatments to the uninsured by offering a per-dose payment to these pharmacies or a one-time base payment to pharmacies targeting areas with low rates of access to COVID-19 products. The public health organizations and pharmacies are expected to help conduct outreach to populations regarding the availability of the free or low-cost COVID-19 products. More information on this announcement can be found here.
- On April 20, 2023, HHS released ownership data for all Medicare-certified hospice and home health agencies (HHAs). The information details data elements for more than 6,000 hospice and 11,000 home health agencies certified through the Medicare program such as: (1) enrollment information by organization name and CMS Certification Number (CCN); (2) direct or indirect ownership status; and (3) mergers, acquisitions, consolidations, and changes of ownership since 2016. The Biden Administration highlighted that by making such ownership information transparent, consumers will be able to make better and more informed decisions about their care. Additionally, researchers and enforcement agencies will be able to better identify common owners that have had histories of poor performance, analyze market consolidation trends and their impact on consumers and quality of care, and evaluate the relationships between ownership and changes in health care costs and outcomes overall. More information on this announcement can be found here.
- On April 21, 2023, HHS’ Office of Climate Change and Health Equity (OCCHE) released tools to support the health sector’s efforts to protect people from the threats of climate change. Specifically, the tool entitled, the Quickfinder for Leveraging the IRA for the Health Sector (the Quickfinder), will help how the health sectors can identify and utilize programs and incentives included in the Inflation Reduction Act (IRA) to advance climate action. The IRA provides billions of dollars in grant funding, loan programs, and tax credits to help the health industry reduce greenhouse gas emissions, strengthen climate resiliency, increase preparedness, and invest in renewable energy and sustainable practices. The Quickfinder is part of OCCHE’s Health Sector Resource Hub, which includes numerous other tools for health sector sustainability and climate preparedness. More information on this announcement can be found here.
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