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, Republicans won a slim majority in the House of Representatives, and CMS released a report on rural health innovation following the 2024 Rural Health Hackathon.
I. Regulations, Notices & Guidance
- On November 12, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Charter Renewal for the Advisory Committee on Heritable Disorders in Newborns and Children. In accordance with the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is giving notice that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) charter has been renewed.
- On November 12, 2024, the Administration for Strategic Preparedness and Response (ASPR) released a notice entitled, National Advisory Committee on Individuals with Disabilities and Disasters, National Advisory Committee on Seniors and Disasters, and the National Biodefense Science Board; Call for Member Nominees. ASPR is currently seeking applications from qualified individuals for memberships on the following national advisory committees (vacancies): The National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD) (7 vacancies); the National Advisory Committee on Seniors and Disasters (NACSD) (7 vacancies); and the National Biodefense Science Board (NBSB) (7 vacancies). The HHS Secretary will appoint new voting members.
- On November 14, 2024, the Food and Drug Administration (FDA) released draft guidance entitled, Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availability. This draft guidance, when finalized, will provide recommendations on approaches for the nonclinical safety evaluation of oligonucleotide-based therapeutics (ONTs) to support clinical development and marketing of these products. ONTs present unique challenges and opportunities in the nonclinical evaluation of safety that differ in many regards from those appropriate for small molecule drugs or therapeutic proteins.
- On November 15, 2025, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
- On November 15, 2025, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women. CDC is seeking nominations for membership on the Advisory Committee on Breast Cancer in Young Women (ACBCYW). The ACBCYW consists of up to 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women. Nominations for membership on the ACBCYW must be received no later than December 16, 2024.
- On November 15, 2024, the Drug Enforcement Agency (DEA) released a temporary rule entitled, Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. DEA, in concert with HHS, is issuing a third extension of telemedicine flexibilities for the prescribing of controlled medications through December 31, 2025.
Event Notices
November 20, 2024: AHRQ announced a meeting of the National Advisory Council for Healthcare Research and Quality. This is an in-person meeting open to the public.
November 20, 2024: CDC announced a meeting of the Board of Scientific Counselors, Office of Readiness and Response. This is a virtual meeting open to the public.
November 20, 2024: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Over-The-Counter (OTC) Monograph Drug User Fee Program (OMUFA) for fiscal years (FYs) 2026 through 2030. This meeting is open to the public.
November 21, 2024: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This is a virtual meeting open to the public.
November 21, 2024: The National Institutes of Health (NIH) announced a meeting of the National Science Advisory Board for Biosecurity. This is a virtual meeting open to the public.
November 22, 2024: NIH announced a meeting of the Muscular Dystrophy Coordinating Committee (MDCC). This is a hybrid meeting open to the public.
December 2-3, 2024: NIH announced a meeting of the National Cancer Advisory Board (NCAB) and National Cancer Institute Board of Scientific Advisors (BSA). This is a hybrid meeting open to the public.
December 2-3, 2024: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
December 3, 2024: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis. This is a virtual meeting open to the public.
December 3, 2024: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a meeting of the Center for Substance Abuse Prevention’s Drug Testing Advisory Board. This is a virtual meeting open to the public.
December 3, 2024: NIH announced a meeting of the Novel and Exceptional Technology and Research Advisory Committee. This is a virtual meeting open to the public.
December 4, 2024: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open for public comment.
December 4, 2024: ASPR announced a meeting of the National Advisory Committee on Children and Disasters. This is a virtual meeting open to the public.
December 5, 2024: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a virtual meeting open to the public.
December 9, 2024: NIH announced a briefing on the National Academies of Science, Engineering, and Medicine’s (NASEM) Assessment of NIH Research on Women’s Health. This is a hybrid meeting open to the public.
December 10, 2024: ASPR announced a meeting of the National Advisory Committee on Individuals with Disabilities and Disasters. This is a virtual meeting open to the public.
December 11, 2024: CDC announced a meeting of the Lead Exposure and Prevention Advisory Committee. This is a virtual meeting open to the public.
December 12, 2024: NIH announced a meeting of the Advisory Committee to the Director, National Institutes of Health. This is a hybrid meeting open to the public.
December 12, 2024: FDA announced a hearing of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
December 13, 2024: FDA announced a public workshop entitled “Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data.” This is a virtual meeting open to the public.
January 13, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting open to the public.
January 28, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is an in-person meeting open the public.
January 28, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is an in-person meeting open to the public.
April 3, 2025: NIH announced a meeting of the Board of Scientific Counselors for the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting open to the public.
II. Hearings and Markups
- On November 14, 2024, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held their final hearing entitled, Preparing for the Next Pandemic: Lessons Learned and The Path Forward. Witnesses present included: Henry Walke, M.D., M.P.H., Director of the Office of Readiness and Response, CDC; Hilary Marston, M.D., M.P.H., Chief Medical Officer, FDA; and, Lawrence Tabak, D.D.S, Ph.D., Principal Deputy Director, NIH.
III. Reports, Studies, & Analyses
- On November 12, 2024, the Centers for Medicare & Medicaid Services (CMS) released a report entitled, Rural-Urban Disparities in Health Care in Medicare. The report highlights persistent rural-urban disparities in healthcare quality and patient experiences among Medicare beneficiaries. According to the report, rural residents frequently fall below national averages on critical clinical care measures, with particularly notable gaps in kidney health evaluations for diabetes patients, osteoporosis screening and management, and avoiding drug-disease interactions. These disparities are compounded by lower flu vaccination rates among rural residents compared to urban ones, a trend observed across racial and ethnic groups. Behavioral health deficits are especially concerning for rural Hispanic Medicare Advantage (MA) enrollees, who lag significantly behind urban counterparts in areas such as depression treatment and follow-up care for substance dependence and mental health issues. The report showed that from 2017 to 2023, rural residents showed improved scores on several quality measures, narrowing gaps with urban residents. However, disparities in other areas, including preventive care like flu immunization, either remained stagnant or worsened, particularly for rural Fee-for-Service (FFS) enrollees.
- On November 13, 2024, the U.S. Government Accountability Office (GAO) released a report entitled, Healthcare Cybersecurity: HHS Continues to Have Challenges as Lead Agency. GAO found that HHS has faced ongoing challenges enforcing cybersecurity standards in the health care sector due to several factors, including: 1) lack of oversight of the sector’s adoption of cybersecurity best practices; 2) lack of evaluation practices to measure the efficacy of HHS guidance; 3) limited inclusion of non-medical devices in the health care sector; and, 4) inadequate coordination and collaboration between both the agencies within HHS and with cybersecurity requirements in different departments. GAO recommended that HHS coordinate with the Cybersecurity and Infrastructure Security Agency (CISA) to oversee sector adoption of cybersecurity practices and develop evaluation methods for HHS-issued guidance. GAO also recommended HHS include all Internet of Things and operational technology in their risk assessments and develop established collaboration practices for both its agencies and when developing cybersecurity standards that may conflict with standards developed by other departments.
- On November 13, 2024, GAO released a report entitled, Drug Safety: FDA Should Implement Strategies to Retain Its Inspection Workforce. The report showed that following disruptions due to the COVID-19 pandemic, FDA has struggled to resume in-person inspections of foreign and domestic drug manufacturers. In 2023, FDA conducted 36 percent fewer inspections than in 2019, largely as a result of increasing vacancies in the drug inspection workforce. As a result, FDA has utilized both reliance on inspection reports from trusted foreign partners and remote assessments of information from manufacturers. Moving forward, FDA has stated its intent to continue using the former method, as well as to implement action plans to address inspector pay and training to address inspection workforce retention. GAO recommended that FDA collaborate to develop and implement action plans to address the remaining root causes of investigator attrition, including travel, workload, and work-life balance, and balance inspection needs against the need to retain investigators. HHS agreed with this recommendation.
- On November 14, 2024, GAO released a report entitled, Private Health Insurance: Market Concentration Generally Increased from 2011 through 2022. GAO found that three or fewer insurers held at least 80 percent of the market share for the individual or employer group markets in at least 35 states. This is an increase in the number of states since 2011. However, GAO noted that after the number of states peaked in 2019, the individual market has become slightly less concentrated between 2019 and 2022. GAO provided a draft of this report to HHS for review and comment. The department did not have any comments on the report.
IV. Other Health Policy News
- Following the 2024 election on November 5, 2024, Republicans have gained control of both chambers of Congress, with a 53-47 majority in the Senate and a narrow margin in the House, though several races have yet to be called. With Republicans set to hold majorities in both chambers next year, it remains uncertain how key legislative priorities, such as a potential continuing resolution (CR) or an end-of-year funding package, will be addressed in the remaining weeks of the current Congress. This dynamic could impact health care funding measures, extensions of expiring health care programs, and Medicaid and Medicare provisions that might be included in such a package. Without clear bipartisan agreement, these decisions may be deferred until Republicans assume control, shaping the legislative landscape for 2025. Additionally, by controlling the Senate, the House, and the White House, Republicans are now likely to pass legislation in 2025 under the budget reconciliation process, which can include legislation that addresses Medicare and Medicaid spending.
- On November 11, 2024, Johnson & Johnson (J&J) announced a lawsuit against HRSA over the agency’s recent prohibition of a 340B rebate model proposed by J&J. On August 23, 2024, J&J announced a plan to charge hospitals full price upfront for the plaque psoriasis drug STELARA and the blood thinner XARELTO, and then require hospitals to apply for a 340B rebate through a third-party vendor following dispensing or administration. Following a September 17, 2024 letter from HRSA that threatened termination of J&J’s 340B Pharmaceutical Pricing Agreement and civil monetary penalties, J&J announced it was ceasing implementation of its rebate proposal. J&J’s lawsuit reflects the latest development in this ongoing legal battle. HRSA argues that all rebate models are subject to the approval of the Secretary of Health and Human Services. J&J argues in its suit that HRSA is misinterpreting the law, and its proposed rebate model prevents duplicative discounts, which drugs subject to Medicare price negotiations are supposed to be protected from. Both STELARA and XARELTO have been subject to negotiated prices in Medicare that will go into effect in 2026. J&J’s complaint against HRSA can be found here.
- On November 12, 2024, CMS published a report that compiled findings and proposals from the 2024 Rural Health Hackathon, a convention of rural health providers, community organizers, tech entrepreneurs, policy experts, and patients that was hosted by the CMS Innovation Center. The sessions generated a range of innovative concepts for addressing rural health challenges organized around care delivery, access, and workforce development. Participants discussed the importance of tailoring alternative payment models (APMs) to rural settings, which often serve as economic anchors in their communities. Recommendations included creating rural-focused quality measures to reflect community needs, engaging local stakeholders in model design, and ensuring financial sustainability for rural providers. Additionally, Hackathon participants suggested creating targeted incentives to improve care coordination, integrating primary and specialty care, and addressing social and behavioral health needs. To support a robust rural workforce, recommendations focused on developing local training pipelines to recruit and retain healthcare providers. CMS is exploring ways to incorporate these ideas, including expanding primary care through the Making Care Primary (MCP) model and adjusting Accountable Care Organization (ACO) policies to enhance rural provider participation. As a next step, CMS intends to issue a Request for Application to fill ten open spaces in the Rural Community Hospital Demonstration, which requires a test of cost-based payment for Medicare inpatient services for rural hospitals with fewer than 51 beds that are ineligible for Critical Access Hospital (CAH) status. The full report from the 2024 Rural Health Hackathon can be found here. The 2024 Rural Health Hackathon webpage is available here.
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