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, CMS finalized a rule on the Medicaid Disproportionate Share Hospital (DSH) program, clarifying hospital-specific DSH payment limits, and the House launched a bipartisan Artificial Intelligence (AI) Task Force to study AI-specific legislative proposals.
I. Regulations, Notices & Guidance
- On February 20, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicaid Program; Disproportionate Share Hospital Third-Party Payer Rule. This final rule primarily addresses recent legislative changes to the Social Security Act as a result of the Consolidated Appropriations Act, 2021 changes to the hospital-specific limit on Medicaid disproportionate share hospital (DSH) payments. This final rule is meant to provide states and hospitals more clarity on how the limit will be calculated. Additionally, this final rule is meant to enhance administrative efficiency by making technical changes and clarifications to the DSH program.
- On February 21, 2024, the Food and Drug Administration (FDA) issued a final rule entitled, Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees. This final rule amends the standing advisory committees regulations to add the establishment of the Digital Health Advisory Committee to the list of standing advisory committees.
- On February 21, 2024, FDA released a notice entitled, Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Availability. FDA is announcing the availability of a final guidance entitled “Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.” Although the public health emergency (PHE) declared by the Department of Health and Human Services (HHS) under section 319 of the Public Health Services Act has ended, COVID-19 remains an ongoing public health problem requiring continued prevention and treatment efforts. FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects. This guidance supersedes the guidance of the same name issued on September 29, 2020.
- On February 21, 2024, FDA released a notice entitled, Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. FDA is announcing the availability of a draft guidance entitled “Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance.” The guidance includes select updates to the guidance entitled, “Medical Device User Fee Small Business Qualification and Certification,” which describe how FDA plans to determine if a small business is experiencing “financial hardship” which makes them eligible for a waiver of their registration fee. The guidance will detail what information FDA will review and consider in making this determination. This draft guidance is not final nor is it being implemented at this time.
- On February 22, 2024, the Administration for Children and Families (ACF) issued a proposed rule entitled, Adoption and Foster Care Analysis and Reporting System. ACF proposes to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations that require title IV-E agencies to collect and report data to ACF on children who enter out-of-home care, their providers, and children who have a title IV-E adoption or guardianship assistance agreement to collect additional data related to Indian children.
- On February 23, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Cytomegalovirus and Parvovirus B19 Sections and Draft Source Control Definition. CDC is opening a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Cytomegalovirus and Parvovirus B19 Sections (“Draft Guideline: Cytomegalovirus and Parvovirus B19 Sections”), and on the accompanying Draft “Source Control” Definition adapted for Infection Control in Healthcare Personnel to be added to the “Terminology” Appendix. The updated recommendations in the Draft Guideline: Cytomegalovirus and Parvovirus B19 Sections are intended for use by the leaders and staff of Occupational Health Services (OHS). These updated recommendations are intended to help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who have been exposed or infected and may be contagious to others in the workplace.
- On February 23, 2024, CDC released a notice entitled, Proposed Updates for Developing, Implementing, and Evaluating Infection Control Programs for Viral Hemorrhagic Fevers, Andes Virus, and Nipah Virus: Appendix A. CDC is opening a docket to obtain comment on Draft Proposed Updates for Viral hemorrhagic fevers, Andes virus, and Nipah virus: Appendix A (“Draft Updates: Appendix A”). The updated recommendations in the Draft Updates: Appendix A are intended for use by frontline healthcare personnel, as well as infection control personnel and other persons responsible for developing, implementing, and evaluating infection control programs for healthcare settings across the continuum of care.
Event Notices
February 27, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of SAMHSA’s Tribal Technical Advisory Committee (TTAC). This is a hybrid meeting open to the public.
February 27, 2024: SAMHSA announced a meeting of SAMSHA’s Center for Mental Health Services National Advisory Council. This is a hybrid meeting open to the public.
February 28-29, 2024: CDC announced a meeting of the Advisory Committee on Immunization Practices. This is a virtual meeting open to the public.
March 5, 2024: HHS announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
March 6, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Center for Health Statistics. This meeting is open to the public.
March 7, 2024: The Agency for Healthcare Research and Quality (AHRQ) announced a meeting for Software Developers on the Common Formats for Patient Safety Data Collection. This is a virtual meeting open to the public.
March 13, 2024: The National Institutes of Health (NIH) announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.
March 13, 2024: CDC announced a meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health. This is a virtual meeting open to the public.
March 13, 2024: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a virtual meeting open to the public.
March 14, 2024: The Health Resources and Services Administration (HRSA) announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is a virtual meeting open to the public.
March 18, 2024: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee. This is a virtual meeting open to the public.
March 19, 2024: CDC announced a meeting of the ICD-10 Coordination and Maintenance Committee. This is a virtual meeting open to the public.
March 21, 2024: The Administration for Community Living (ACL) announced a meeting of the President’s Committee for People with Intellectual Disabilities. This is a virtual meeting open to the public.
March 21, 2024: FDA announced a meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
March 22, 2024: NIH announced a meeting of the National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group.
March 25, 2024: NIH announced a meeting of the Center for Scientific Review Advisory Council. This is a hybrid meeting open to the public.
March 25-26, 2024: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
March 27, 2024: SAMHSA announced a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee. This is a hybrid meeting open to the public.
April 9-11, 2024: HRSA announced a Meeting of the National Advisory Committee on Rural Health and Human Services. This is a hybrid meeting open to the public.
II. Reports, Studies, & Analyses
- On February 21, 2024, the Government Accountability Office (GAO) released a report entitled, Maternal Health: HHS Should Improve Assessment of Efforts to Address Worsening Outcomes. GAO analyzed HHS’s data on maternal mortality, and found that compared to 2018 and 2019, maternal mortality and morbidity worsened significantly in 2020 and 2021 during the COVID-19 pandemic. Furthermore, there were significant disparities in maternal health outcomes based on race and ethnicity during this time; notably, Black women had a 2.5 times higher rate of maternal mortality compared to white women. GAO recommends that HHS establish a measurement strategy that adheres to best practices, including setting specific goals with qualitative targets and defined timeframes to assess efforts to improving maternal health. Additionally, GAO recommends that CDC establish qualitative goals for the Perinatal Quality Collaborative program.
- On February 21, 2024, Senator Bill Cassidy (R-LA), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report entitled, Strengthening Health Data Privacy for Americans: Addressing the Challenges of the Modern Era. Senator Cassidy previously requested information from stakeholders on ways to improve the privacy of health data under existing Health Insurance Portability and Accountability Act (HIPAA) protections, and additionally privacy protections that should be considered. The report builds on stakeholder recommendations and outlines several strategies to improve privacy protections of health data, such as modernizing HIPPA, securing data outside of HIPPA protections, and handling data in a HIPPA “gray area,” such as health data gathered from wearable devices. In the report, Senator Cassidy committed to advancing legislation that encompasses these recommendations to advance patient privacy and modernize HIPPA as health care technologies continue to change.
III. Other Health Policy News
- On February 20, 2024, House Speaker Mike Johnson (R-LA) and Minority Leader Hakeem Jeffries (D-NY) announced a bipartisan Task Force on Artificial Intelligence (AI) to explore ways that Congress can support AI innovation while establishing appropriate guardrails. House leadership appointed 24 members to the task force, including co-chairs Rep. Jay Obernolte (R-CA-23) and Rep. Ted Lieu (D-CA-36). The task force is charged with creating a comprehensive report containing recommendations and policy proposals on best to govern and regulate AI. Congress has been increasingly focused on the intersection of AI and health care, with both chambers hosting hearings on AI’s impact on health care in recent months. Furthermore, the task force’s announcement follows the recent launch of the House Digital Health Caucus, which will explore AI regulations in health care. The caucus and task force will likely work together to consider policies to regulate AI’s role in health care while still supporting innovation in the space.
- On February 21, 2024, House Energy & Commerce (E&C) Committee Ranking Member Frank Pallone (D-NJ-6), E&C Health Subcommittee Ranking Member Anna Eshoo (D-CA-14), and E&C Oversight and Investigations Subcommittee Ranking Member Kathy Castor (D-FL-14) sent a letter to FDA urging action to advance clinical trial diversity. Congress previously passed the Food and Drug Omnibus Reform Act of 2022 (FDORA) which required drug and device manufacturers to submit diversity action plans before beginning clinical trials. The legislation also required FDA to release draft guidance for manufacturers by December 29, 2023. FDA has failed to produce this draft guidance, delaying the FDORA provision requiring diversity action plans. The letter urged FDA to release this draft guidance to both provide clarity to manufacturers on diversity action plans and to promote strong diversity in clinical trials.
- On February 21, 2024, the National Association of Attorneys General (NAAG) sent Congressional leadership a letter urging action on pharmacy benefit manager (PMB) reform and regulation. The letter was signed by a bipartisan group of 39 state Attorneys General (AGs). The letter claims that PBMs have created a monopoly power allowing them to raise drug prices for patients and payers and harm independent pharmacies. The letter touts state efforts to regulate PBMs through legislation and investigations, but calls on Congress and the Federal Trade Commission (FTC) to pass more meaningful PBM reforms, especially around transparency. The AGs specifically call for the passage of the DRUG Act (S. 1542/H.R. 6283), the Protecting Patients Against PBM Abuses Act (H.R. 2880), and the Lower Costs, More Transparency Act (H.R. 5378) to better regulate PBMs on the federal level.
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