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.
Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.
Week in Review Highlight of the Week:
This week, the House passed a budget resolution that calls for $4.5 trillion in tax cuts and $1.5 trillion in spending cuts and President Trump signed an Executive Order that directs certain agencies to quickly implement and enforce existing health care price transparency requirements.
I. Regulations, Notices & Guidance
Note: For many Executive Office of the President (EOP) actions, the stated day reflects when the action was submitted to the Federal Register, not when it was first released by the White House.
- On February 24, 2025, the Food and Drug Administration (FDA) released a final rule entitled, Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”. This final rule delays the effective date of the of the final rule entitled, “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy,’” to April 28, 2025.
- On February 25, 2025, the Executive Office of the President (EOP) published Executive Order (EO) 14221 entitled, Making America Healthy Again by Empowering Patients With Clear, Accurate, and Actionable Healthcare Pricing Information. This EO directs the Secretaries of Treasury, Labor, and Health and Human Services (HHS) to take all “necessary and appropriate action” to “rapidly implement and enforce” the healthcare price transparency regulations issued pursuant to EO 13877, Improving Price and Quality Transparency in American Healthcare to Put Patients First (June 24, 2019).
- On February 26, 2025, the Administration for Children and Families (ACF) released a direct final rule entitled, Name Change From Office of Child Support Enforcement to Office of Child Support Services; Reopening of Comment Period and Delaying Effective Date. This final rule reopens the public comment period for the direct final rule entitled, Name Change From Office of Child Support Enforcement to Office of Child Support Services. The public comment period ends on March 31, 2025 and, as of February 27, 2025, the effective date of the direct final rule is delayed to April 28, 2025. ACF states that if adverse comments are received, a timely notification of withdrawal will be published in the Federal Register.
- On February 26, 2025, EOP published EO 14222 entitled, Implementing the President’s ‘Department of Government Efficiency’ Cost Efficiency Initiative. This EO requires each agency head to undertake a variety of actions to reduce government spending including: developing a centralized technology system within the agency to record every payment issued by the agency that includes written justification for the payment by the agency employee who approved the payment; reviewing, within 30 days, certain existing contracts and grants and to terminate or modify them to reduce overall Federal spending or reallocate spending to promote efficiency and to advance the policies of the administration; reviewing each agency’s contracting policies, procedures, and personnel within 30 days, and to not issue or approve new contracting officer warrants during this time, unless approved by the highest-ranking official of an agency (or their designee); following the aforementioned contracting review, issuing guidance on signing new contracts or modifying existing contracts to promote government efficiency and the policies of the administration; restricting federally funded travel for conferences or other non-essential purposes; temporarily freezing credit cards held by agency employees for 30 days with exceptions; and reviewing the agency’s real property leases, reviewing termination rights under those leases, deciding whether to invoke those rights, and providing a plan for the disposition of government-owned real property that is no longer needed.
- On February 28, 2025, HHS issued a policy statement entitled, Policy on Adhering to the Text of the Administrative Procedure Act. This policy statement announces that HHS is rescinding the policy on Public Participation in Rule Making (Richardson Waiver) and re-aligning the Department’s rulemaking procedures with the Administrative Procedure Act (APA).
Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings have been cancelled or postponed. We are continuing to monitor.
- February 25, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
- February 25, 2025: FDA announced a public workshop entitled, Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development. This is a virtual workshop open to the public.
- February 26-28, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
- March 5, 2025: The Department of Veterans’ Affairs (VA) announced a meeting of the Rehabilitation Research and Development Service (RR&D) Scientific Merit Review Board. This is a virtual meeting, partially open to the public.
- March 5, 2025: VA announced a meeting of the National Research Advisory Council (NRAC). This is a virtual meeting open to the public.
- March 5-6, 2025: The Health Resources & Services Administration (HRSA) announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
- March 27-28, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.
- March 27-28, 2025: FDA announced a public workshop entitled, Optimizing Pregnancy Registries. This is an in-person workshop open to the public.
- April 2, 2025: Centers for Medicare & Medicaid (CMS) announced a hearing to reconsider its decision to disapprove Idaho’s Medicaid State Plan Amendment, numbered 24-0015. This is a hybrid hearing open to the public.
- April 3, 2025: The National Institutes of Health (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.
- April 10-11, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.
- April 30, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
- May 14, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
- May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with one session open to the public.
- June 3-4, 2025: FDA announced a public workshop entitled, Fiscal Year (FY) 2025 Generic Drug Science and Research Initiatives Workshop. This is a hybrid workshop open to the public.
- August 6-7, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
- August 8, 2025: HRSA announced a meeting of ACTPCMD. This is a hybrid meeting open to the public.
- September 11-12, 2025: HRSA announced a meeting of the COGME. This is a hybrid meeting open to the public.
- December 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
II. Hearings & Markups
- On February 25, 2025, the House Committee on Energy and Commerce held a markup entitled, Full Committee Markup. The Committee considered the Authorization and Oversight Plan for the Committee on Energy and Commerce for the 119th Congress.
- On February 26, 2025, the House Committee on Energy and Commerce, Subcommittee on Health, held a hearing entitled, An Examination of How Reining in PBMs Will Drive Competition and Lower Costs for Patients. Witnesses included: Mr. Hugh Chancy, RPh, Pharmacist and Owner, Chancy Drugs; Mr. Shawn Gremminger, MPH, President and Chief Executive Officer (CEO), National Alliance of Healthcare Purchaser Coalitions; Mr. Anthony Wright, Executive Director, Families USA; and Dr. Matthew Fiedler, PhD, Joseph A. Pechman Senior Fellow, Center on Health Policy, Brookings Institution.
- On February 26, 2025, the Senate Special Committee on Aging held a hearing entitled, Combating the Opioid Epidemic. Witnesses included: The Honorable Dennis Lemma, Sheriff, Seminole County Sheriff’s Office; The Honorable Gregory Duckworth, Commissioner, Raleigh County; Ms. Elizabeth Mateer, Grandparent Caregiver; Dr. Malik Burnett, MD, MBA, MPH, Vice Chair, Public Policy Committee, American Society of Addiction Medicine; and Dr. Bradley D. Stein, Director, Opioid Policy, Tools, and Information Center, RAND Corporation.
- On February 27, 2025, the Senate Committee on the Judiciary held an executive business meeting entitled, Business meeting to consider S.331, to amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances. S.331 was ordered reported favorably in the nature of a substitute.
III. Reports, Studies, & Analyses
- On February 24, 2025, HHS Office of Inspector General (OIG), released a data brief entitled, Medicare Part D Spending for 10 Selected Diabetes Drugs Totaled $35.8 Billion in 2023, an Increase of 364 Percent From 2019. OIG found that Medicare Part D spending for 10 selected diabetes drugs increased from $7.7 billion in 2019 to $35.8 billion in 2023 (a 364-percent increase) and the number of Medicare Part D enrollees increased from 44.9 million to 50.5 million (a 12-percent increase). Of note, Medicare Part D spending for Ozempic increased from $552 million to $9.2 billion (a 1,567-percent increase). The number of Part D enrollees who filed a prescription for Ozempic increased from 142,479 to 1,465,482 (a 929-percent increase). OIG notes that the projected Medicare Part D spending by 2026 for the 10 selected diabetes drugs could reach $102 billion. OIG states that this significant increase could financially impact the Medicare program. OIG did not make any recommendations in the data brief, but states that the information in the data brief could be beneficial to CMS and other policymakers when developing future program guidance related to the 10 selected diabetes drugs.
- On February 24, 2025, the Kaiser Family Foundation (KFF) released an issue brief entitled, What Does the Federal Government Spend on Health Care?. KFF found that the federal government spent $1.9 trillion on health care programs and services in fiscal year (FY) 2024, 27 percent of all federal outlays in 2024, and together the largest category of federal spending. According to the issue brief, in FY 2024, forgone tax revenues to the federal government as a result from tax subsidies for employer sponsored insurance coverage (ESI) and part of the Affordable Care Act (ACA) premium tax credits totaled $398 billion. Over 80 percent of all federal support for health programs and services—including spending and tax subsidies—supports programs that provide or subsidize health insurance coverage. Of note, 36 percent goes to Medicare; 25 percent goes to Medicaid and Children's Health Insurance Program (CHIP); 17 percent goes to employment-based health coverage; and 5 percent goes to ACA subsidies. Further, the report notes that discretionary spending is a “relatively small component” of overall federal spending for health programs and services. Specifically, 52 percent ($128 billion) of discretionary health spending paid for hospital and medical care for veterans. In addition, discretionary health spending provides agencies (i.e., NIH (19 percent of discretionary health spending) and CDC (4 percent), as well as global health (4 percent)) funding.
IV. Other Health Policy News
House of Representatives Passes Budget Resolution
- On February 25, 2025, the House of Representatives passed a budget resolution in a 217-215 vote. Unlike the Senate’s two reconciliation bill approach with the first bill focusing on border security, defense and energy policies, the House is pursuing a single reconciliation bill approach. The House budget resolution therefore is all-inclusive and covers extending expiring tax policies and implementing new tax cuts in addition to policies impacting border security, energy and defense. Specifically, the House budget resolution includes $4.5 trillion in tax cuts as well as a $4 trillion increase to the national debt ceiling. It also calls for $1.5 trillion in spending cuts, including $880 billion in cuts under the discretion of the House Energy and Commerce Committee – many believe that the Committee’s recommended cuts could impact Medicaid and Medicare Part B. The House budget resolution will have to reconciled with a Senate’s version so that both chambers are operating under the same set of instructions.
- The text of the House budget resolution is available here.
White House Issues EO on Health Care Price Transparency
- On February 25, 2025, the White House issued an EO entitled, “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO states that it is the policy of the U.S. to “put patients first” and ensure that patients have the necessary information to make well-informed healthcare decisions. The EO directs the Secretaries of Treasury, Labor, and HHS to take all “necessary and appropriate action” to “rapidly implement and enforce” the healthcare price transparency regulations issued during the first Trump Administration pursuant to EO 13877, “Improving Price and Quality Transparency in American Healthcare to Put Patients First” (June 24, 2019).
- The “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” EO requires that, within 90 days of the date of the EO, the Secretaries must take action to: (1) require the disclosure of the actual prices of items and services, not estimates; (2) issue updated guidance or proposed regulatory action ensuring pricing information is “standardized and easily comparable” across hospitals and health plans; and (3) issue guidance or proposed regulatory action updating enforcement policies designed to ensure compliance with the transparent reporting of complete, accurate, and meaningful data.
- The full EO is available here. The fact sheet is available here.
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