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, Senators Marsha Blackburn (R-TN) and Mark Kelly (D-AZ) introduced a bill to allow state Medicaid programs to develop direct primary care models and Congressional leadership has stepped up negotiations for an end-of-year funding package before the December 20 deadline.
I. Regulations, Notices & Guidance
- On December 2, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Draft CDC’s Recommendations for HIV Screening in Clinical Settings. CDC announces the opening of a docket to obtain comment on the draft recommendations for HIV Screening in Clinical Settings, that update portions of CDC’s Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, published in 2006.
- On December 3, 2024, the Food and Drug Administration (FDA) released a notice entitled, Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. Under the Federal Food, Drug, and Cosmetic Act, a manufacturer of a critical food (which includes infant formula) must notify FDA of a permanent discontinuance or an interruption of the manufacture of a critical food that is likely to lead to a meaningful disruption in the supply of the food in the United States. The draft guidance, when finalized, is intended to help the infant formula industry comply with this notification requirement as it pertains to infant formula.
- On December 3, 2024, FDA released guidance entitled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability. This guidance provides recommendations to include a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more artificial intelligence-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications; the associated methodology to develop, validate, and implement those modifications; and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for a device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.
- On December 3, 2024, the National Institutes of Health (NIH) released a final rule entitled, National Institute on Minority Health and Health Disparities Research Endowment Programs. NIH is amending the regulation governing the National Institute on Minority Health and Health Disparities (NIMHD) Research Endowment Programs (REP) to update the headings of the regulation,, the eligibility requirements for the program to indicate the new expanded eligibility for research endowment awards that is mandated by statute, and certain references to cited regulations and policies that apply to program grant awards.
- On December 5, 2024, FDA released a draft guidance entitled, Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability. This guidance provides information on FDA’s policies and procedures for the accelerated approval program, including discussions of which products may be candidates for accelerated approval, the standards for granting accelerated approval, and the procedures for withdrawing accelerated approval. When finalized, this draft guidance will replace the accelerated approval-related content in the final guidance for industry entitled Expedited Programs for Serious Conditions--Drugs and Biologics issued on May 30, 2014 (the 2014 final guidance).
- On December 5, 2024, the Health Resources and Services Administration (HRSA) released a notice entitled, Public Comment Request: Request for Information regarding HRSA Sickle Cell Disease Programs. HRSA’s Maternal and Child Health Bureau Sickle Cell Disease (SCD) Programs are requesting input from the public to inform future SCD program development.
- On December 5, 2024, the Administration for Strategic Preparedness and Response (ASPR) released a notice entitled, Request for Information on Hospital Preparedness Program Funding Formula. In accordance with section 319C-2 of the Public Health Service (PHS) Act, ASPR distributes Hospital Preparedness Program (HPP) cooperative agreement funding to recipients using a statutorily required formula. ASPR is seeking comment on the risk component of the HPP funding formula to inform potential future changes to the formula.
- On December 6, 2024, the Agency for Healthcare Research and Quality (AHRQ) released a notice entitled, Supplemental Evidence and Data Request on Medical Care for Adults with Down Syndrome. AHRQ is seeking scientific information to inform its review on Medical Care for Adults with Down Syndrome, which is currently being conducted by AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
- On December 6, 2024, FDA released draft guidance entitled, Standardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Drug Evaluation and Research Submissions; Guidance for Industry; Availability. This guidance describes the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research (CDER) in the planning of, and by FDA’s Office of Inspections and Investigations (OII) in the conduct of, BIMO inspections.
- On December 6, 2024, HRSA released a notice entitled, Notice of Availability of Draft Health Center Program Scope Policy Manual Guidance. HRSA requests public comments on the Draft Health Center Program Scope of Project Manual (draft Scope Policy Manual). The draft Scope Policy Manual provides updated policy guidance on what constitutes the Health Center Program scope of project under the PHS Act.
Event Notices
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 7, 2025: Department of Health and Human Services (HHS) announced a meeting of the Advisory Committee on Minority Health. 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 27, 2025: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions 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.
February 5, 2025: FDA announced a joint public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This is a hybrid 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 December 4, 2024, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a business meeting during which the Subcommittee voted to favorably report its final report entitled, After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward, along with a list of recommendations. Following the filing of the report, the Select Subcommittee will sunset on January 3, 2025.
- On December 5, 2024, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, What Is the FDA Doing to Reduce the Diabetes and Obesity Epidemics in America and Take on the Greed of the Food and Beverage Industry? Witnesses included: Robert Califf, MD, Commissioner, FDA and Jim Jones, Deputy Commissioner, Human Foods Program, FDA.
III. Reports, Studies, & Analyses
- On December 5, 2024, the RAND Corporation released a report entitled, Key Findings from RAND Health Care Research on Telehealth Policy. According to the report, telehealth usage rose dramatically—by over 4,000 percent—early in the COVID-19 pandemic due to temporary Medicare and Medicaid policy adjustments that removed reimbursement restrictions. While usage has since stabilized, behavioral health care continues to experience elevated telehealth adoption compared to pre-pandemic levels. The report emphasizes equity concerns, noting that rural and low-income populations often face barriers due to limited broadband access. RAND highlights the importance of hybrid care models and the need for ongoing research into telehealth’s cost-effectiveness, health outcomes, and accessibility. Policymakers, the report states, must address the sustainability of telehealth reimbursement policies as temporary pandemic provisions near expiration.
- On December 5, 2024, the Congressional Budget Office (CBO) released a report entitled, The Effects of Not Extending the Expanded Premium Tax Credits for the Number of Uninsured People and the Growth in Premiums. The report highlights that the expanded tax credits introduced by the American Rescue Plan Act (ARPA) significantly reduced premium costs for Affordable Care Act marketplace enrollees and expanded eligibility to individuals with incomes above 400 percent of the federal poverty level. CBO projects that allowing these credits to expire after 2025 will result in an average increase in the number of uninsured individuals by 3.8 million per year from 2026-2034, as well as an increase in gross benchmark premiums by an average of 7.9 percent per year over the same 2026-2034 period.
- On December 2, 2024, the HHS Office of the Inspector General (OIG) released a report entitled, The Organ Procurement and Transplantation Network IT System’s Cybersecurity Controls Were Partially Effective and Improvements Are Needed. According to the report, while certain cybersecurity controls, such as protections against phishing attacks, were effective, the network monitoring of the Organ Procurement and Transplantation Network (OPTN) IT system was insufficient to detect or respond to most simulated cyberattacks. OIG stated that these deficiencies left the system vulnerable to attackers with moderate sophistication, who could potentially compromise the system and cause significant harm. The report identified 22 vulnerabilities across 16 cybersecurity controls, many tied to inadequate network monitoring. OIG attributed these issues to failures in implementing or maintaining federally required cybersecurity measures. The report recommended that HRSA ensure the OPTN contractor remediates these vulnerabilities, verifies the fixes, improves network monitoring, and maintains ongoing compliance with federal standards. HRSA concurred with all four recommendations.
IV. Other Health Policy News
- On December 6, 2024, Senator Ron Wyden (D-OR) introduced the Fast Track Apprenticeship Act to address the critical shortage of health care workers in the United States, projected to reach 100,000 by 2028. The bill seeks to make it easier for health care employers to establish registered apprenticeship programs, providing hands-on training for roles such as medical assistants, registered nurses, and home health aides. The legislation proposes modernizing the Department of Labor’s (DOL’s) application process, including requiring decisions on apprenticeship applications within 45 days, digitizing agreement forms, and improving accessibility for applicants. Senator Wyden emphasized the urgency of expediting the creation of such programs to support aspiring health professionals and address workforce gaps. The bill text is available here. A press release with more information is available here.
- On December 5, 2024, Senators Marsha Blackburn (R-TN) and Mark Kelly (D-AZ) introduced the Medicaid Primary Care Improvement Act, aiming to expand access to primary care for Medicaid beneficiaries by authorizing state Medicaid programs to adopt direct primary care (DPC) models. These models allow patients to pay a flat monthly fee for primary care services, which may reduce administrative burdens and improve access to care, particularly in rural and underserved areas. This Senate legislation parallels H.R. 3836, the Medicaid Primary Care Access Act, introduced by Representatives Dan Crenshaw (R-TX) and Kim Schrier (D-WA), which passed the House in March 2024. Both bills aim to provide states greater flexibility to implement DPC arrangements, leveraging this innovative model to improve care coordination, enhance preventive care, and address the anticipated national shortage of primary care physicians. The Senate bill text is available here. A press release with more information is available here. The House version of the bill is available here.
- House and Senate leadership are working to negotiate an agreement to fund the government before Fiscal Year (FY) 2025 government funding expires on December 20, 2024. A temporary funding patch known as a continuing resolution (CR) is looking increasingly more likely as the December 20 deadline approaches. A CR would likely extend federal funding until February or March 2025. It is also likely that a supplemental disaster aid package will be included in this CR: the Biden Administration has requested $98.6 billion, but Speaker Mike Johnson (R-LA) has faced some pressure from his party to either reduce that number or include policy changes that will offset some of the costs, so it remains to be seen how much disaster relief funding will be included. Several health programs are set to expire by the end of the year if they are not included within the funding package. These include Medicare telehealth flexibilities, the Medicare Acute Hospital Care at Home (AHCAH) program, the Medicare Dependent Hospital (MDH) and Low Volume Hospital (LVH) programs, the Teaching Health Center Graduate Medical Education (THCGME) program, the National Health Service Corps (NHSC), the Pandemic and All-Hazards Preparedness Act (PAHPA) programs, and the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) programs. In addition, a 2.83 percent cut to the Medicare Physician Fee Schedule (PFS) conversion factor is set for 2025 unless Congress intervenes. There have been bipartisan, bicameral efforts urging leadership to address these program expirations and the PFS cut in any potential end-of-year legislation package.
- President-elect Donald Trump has continued to announce nominations for his incoming Administration—including his picks for CDC Director, NIH Director, FDA Commissioner, and Surgeon General.
- CDC Director Nominee: Dr. David Weldon, a practicing internist and former U.S. Representative from Florida, has previously sponsored legislation aimed at expanding vaccine safety research and has been a vocal advocate for transparency in public health policy. His nomination aligns with the administration’s focus on reforming federal health agencies.
- NIH Director Nominee: Dr. Jay Bhattacharya, a professor of medicine and economics at Stanford University, gained prominence during the COVID-19 pandemic for advocating focused protection strategies and co-authoring the Great Barrington Declaration, which called for fewer lockdowns and a pandemic strategy centered on focused herd immunity. His research spans public health policy, the economics of aging, and global health.
- FDA Commissioner Nominee: Dr. Marty Makary, a Johns Hopkins surgeon and public health researcher, has called for greater transparency in regulatory decisions and has expressed concerns about vaccine mandates, emphasizing a data-driven approach to public health. His focus includes reducing regulatory burdens and encouraging innovation in healthcare.
- Surgeon General Nominee: Dr. Janette Nesheiwat, medical director at CityMD and a regular media commentator on Fox News, has been an advocate for preventive care and patient education, supporting COVID-19 vaccines while opposing mandates. Her experience in urgent care and public health communication is expected to shape her approach to the role.
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