Health Care Week in Review | President Trump Unveils FY 2026 Discretionary Budget Request; Budget Reconciliation Negotiations in the House Continue

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, President Trump released his FY 2026 discretionary budget proposal, which calls for large cuts to federal health agencies; and House Republicans continue negotiations over the policies that will be included in the budget reconciliation package.

I. Regulations, Notices & Guidance

• On April 28, 2025, the Executive Office of the President (EOP) released an executive order (EO) entitled, Protecting American Communities from Criminal Aliens. The EO reinforces federal authority over immigration and national security, condemning state and local sanctuary policies that obstruct enforcement. It mandates identifying and penalizing such jurisdictions by restricting federal funds and pursuing legal action. Additionally, it aims to prevent illegal immigrants in sanctuary areas from receiving federal benefits and challenges state policies that prioritize noncitizens over American citizens.
• On April 29, 2025, the National Science Foundation released a Request for Information (RFI) entitled, Request for Information on the Development of a 2025 National Artificial Intelligence (AI) Research and Development (R&D) Strategic Plan. The Networking and Information Technology Research and Development (NITRD) National Coordination Office (NCO), on behalf of the Office of Science and Technology Policy (OSTP), welcomes input on updating the National AI Research and Development Strategic Plan (2023 Update). The goal is to secure the United States’ leadership in AI by advancing R&D to accelerate innovation, strengthen economic and national security, and promote human flourishing. This update will focus on the Federal government’s unique role in AI research and development over the next three to five years. Through this RFI, the NITRD NCO invites ideas from AI researchers, industry leaders, and other stakeholders. Responses from the previous RFI on the Development of an AI Action Plan will also be considered in shaping the updated strategy. Interested persons are invited to submit comments on or before 11:59 p.m. (ET) on May 29, 2025.
• On April 29, 2025, the Department of Health and Human Services (HHS), Office of the Secretary released a notice entitled, Notification Regarding the Use of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Administrative Simplification Standards Exceptions Process by the Health Level Seven (HL7) International Da Vinci Project (Da Vinci) and the Availability of the Da Vinci Report. This notice provides the public with information about the availability and location of the Health Level Seven (HL7) International Da Vinci Project (Da Vinci) Report, which includes test results from the use of alternative standards for Referral Certification and Authorization and Eligibility for Health Plan transactions approved under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) exceptions process.
• On May 2, 2025, the Food and Drug Administration (FDA) released guidance entitled, Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This guidance provides updated recommendations for establishments responsible for determining donor eligibility for human cells, tissues, and HCT/Ps. It clarifies requirements under 21 CFR part 1271, subpart C, particularly regarding donor screening and testing for sepsis. This update aims to reduce infection transmission risks by improving the evaluation of donors for clinical signs of sepsis.
• On May 2, 2025, FDA released guidance entitled, Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This guidance outlines recommendations for screening donors of human cells, tissues, and HCT/Ps for Mtb. It aims to help establishments comply with donor eligibility and recommends interim safety measures to reduce the risk of Mtb transmission until suitable FDA-authorized screening tests become available. Once finalized, the guidance will classify Mtb as a relevant communicable disease agent or disease.

Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings may be cancelled or postponed. We are continuing to monitor. ** - New addition

• April 30, 2025: The National Institutes of Health (NIH) announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions 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 5, 2025: FDA announced a 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.
• May 5-6, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health. This is a hybrid meeting with some sessions open to the public.
• May 5, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• May 5, 2025: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
• May 6, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• May 8, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a virtual meeting open to the public.
• May 13, 2025: NIH announced a meeting of the National Advisory Council on Drug Abuse. This is a virtual meeting with some sessions open to the public.
• May 14, 2025: The Health Resources and 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.
• May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is virtual meeting with one session open to the public.
• May 14-15, 2025: NIH announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a virtual meeting with some sessions open to the public.
• May 20, 2025: NIH announced a meeting of the National Institute of Nursing Research. This is a virtual meeting with some sessions open to the public.
• May 22, 2025: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting with some sessions open to the public.
• ** May 23, 2025: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• May 28, 2025: NIH announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a virtual meeting with some sessions open to the public.
• ** June 2, 2025: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a hybrid meeting with some sessions open to the public.
• ** June 2-3, 2025: CDC announced a meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding. This is a hybrid meeting open to the public.
• June 3, 2025: NIH announced a meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This is a hybrid meeting with some sessions 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.
• June 5, 2025: NIH announced a meeting of the National Advisory Environmental Health Sciences Council. This is a hybrid meeting with some sessions open to the public.
• June 6, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a virtual meeting with some sessions open to the public.
• June 9, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting with some sessions open to the public.
• June 10, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a virtual meeting with one session open to the public.
• June 13, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• June 17, 2025: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions open to the public.
• June 25, 2025: The Centers for Medicare & Medicaid Services (CMS) announced a meeting of the Medicare Evidence Development and Coverage Advisory Committee. This is a virtual meeting open to the public.
• June 27, 2025: CMS announced a meeting regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year (CY) 2026. This is a hybrid meeting open to the public.
• July 1, 2025: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a virtual meeting with some sessions open to the public.
• July 7, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Cancer Institute. This is a virtual meeting with some sessions open to the public.
• July 23-24, 2025: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting 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 the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a hybrid meeting open to the public.
• September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. 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.

2. Reports, Studies, & Analyses

• On April 28, 2025, the Government Accountability Office (GAO) released a report entitled Inflation Reduction Act of 2022: Initial Implementation of Medicare Drug Pricing Provisions. The GAO examined the implementation of the Inflation Reduction Act’s (IRA) Medicare drug price negotiation program and prescription drug inflation rebate program by CMS, as well as CMS’s plans for using appropriated funds for both programs. GAO found that CMS has made significant progress in implementing both programs, including hiring staff, issuing guidance, and building infrastructure to support their operations. For instance, CMS announced negotiated prices for ten high-expenditure drugs in August 2024, set to take effect in 2026, and plans to invoice manufacturers for inflation rebates starting in late 2025. Further, in January 2025, CMS published the 15 drugs selected for negotiation with prices to go into effect in 2027. GAO concluded that CMS’s plans for monitoring appropriated funds align with federal internal control principles, with approximately $2.9 billion obligated for the negotiation program from fiscal years 2022-2033, primarily for program support and administration.
• On April 28, 2025, the Trump Administration released a report to the President on the initial steps the Administration was taking to implement the Executive Order (E.O.) issued on January 28, 2025, entitled “Protecting Children from Chemical and Surgical Mutilation.” These include:

1. Rescinding or amending all policies reliant upon “Standards of Care Version 8” developed by the World Professional Association for Transgender Health (WPATH).
2. “Reviewing data tools to ensure that Federal data collection reflects biological reality and provides medically useful information.”
3. Ending grants for studies related to health care for transgender populations.
4. Issuing a Quality and Safety Special Alert Memo from the Centers of Medicare & Medicaid Services (CMS) as well as similar letters from the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Health Resources and Services Administration (HRSA) dissuading providers from providing certain forms of gender-affirming care.
5. Drafting guidance from the Department of Justice (DOJ) on enforcing existing laws against female genital mutilation and possible violations of the Food, Drug, and Cosmetic Act.

• The full report to the President can be viewed here.

3. Hearings & Markups

• On April 29, 2025, the House Energy and Commerce Committee held a markup of six bills, including:
  • R. 2483, SUPPORT for Patients and Communities Reauthorization Act of 2025;
  • R. 1520, Charlotte Woodward Organ Transplant Discrimination Prevention Act;
  • R. 2319, Women and Lung Cancer Research and Preventive Services Act of 2025;
  • R. 1669, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program;
  • R. 1082, Shandra Eisenga Human Cell and Tissue Product Safety Act; and
  • R. 2484, Seniors’ Access to Critical Medications Act.
• On April 29, 2025, the Senate Veterans’ Affairs Committee held a hearing entitled, Bridging the Gap: Enhancing Outreach to Support Veterans’ Mental Health. Witnesses included: Thomas O’Toole, MD, Acting Assistant Undersecretary for Health for Clinical Services and Deputy Chief Medical Officer, Veterans’ Health Administration, U.S. Department of Veterans Affairs; Michael Fisher, Chief Officer, Readjustment Counseling Service, Veterans Health Administration; Jim Lorraine, President & CEO, America’s Warrior Partnership; Gilly Cantor, MPA, Director of Evaluation and Capacity Building, D’Aniello Institute for Veterans & Military Families, Syracuse University; Steffen Crow, SSG Parker Gordon Fox Grant Program Manager, Oklahoma Veterans United; Heather Barr, U.S. Marine Corps Veteran; Austin Lambright, U.S. Marine Corps Veteran; and Lindsay Church, Executive Director & Co-Founder, Minority Veterans of America.
• On April 30, 2025, the House Veterans’ Affairs Committee Oversight and Investigations Subcommittee held a hearing entitled, Answering the Call: Examining VA’s Mental Health Policies. Witnesses included: Dr. Ilse Wiechers, Deputy Executive Director, Office of Mental Health, U.S. Department of Veterans Affairs, Veterans Health Administration; Dr. Anthony Stazzone, Chief Medical Officer, Veterans Integrated Service Network 9, U.S. Department of Veterans Affairs, Veterans Health Administration; and Dr. Julie Kroviak, MD, Principal Deputy Assistant Inspector General in the Role of Acting Assistant Inspector General for Healthcare Inspections, U.S. Department of Veterans Affairs, Office of the Inspector General.
• On April 30, 2025, the House Education and Workforce Committee Health, Employment, Labor, and Pensions Subcommittee held a hearing entitled, Investing for the Future: Honoring ERISA’s Promise to Participants. Witnesses included: Professor Max M. Schanzenbach, Seigle Family Professor of Law, Northwestern University Pritzker School of Law; Mr. Charles Crain, Managing Vice President of Policy, National Association of Manufacturers; Mr. Brandon Rees, Deputy Director, Corporations and Capital Markets, American Federation of Labor and Congress of Industrial Organizations; and Mr. Ike Brannon, President, Capitol Policy Analytics.
• On April 30, 2025, the Senate Appropriations Committee held a hearing entitled, Biomedical Research: Keeping America’s Edge in Innovation. Witnesses included: Sudip Parikh, Ph.D., Chief Executive Officer and Executive Publisher, Science, American Association for the Advancement of Science (AAAS); Hermann Haller, M.D., President, Mount Desert Island Biological Laboratory; Cartier Esham, Ph.D., Executive Director, Alliance for a Stronger Food and Drug Administration; Barry Paul Sleckman, M.D., Ph.D., Director, University of Alabama at Birmingham O’Neal Comprehensive Cancer Center; and Mrs. Emily Stenson, Mom and Patient Advocate.

4. Other Health Policy News

• On April 29, 2025, Republicans on the House Education and Workforce Committee advanced legislation that would significantly reshape federal student aid programs, cutting billions in funding to offset costs tied to the budget reconciliation proposal. The Student Success and Taxpayer Savings Plan, led by Chair Tim Walberg (R-MI-05), passed in a 21-14 party-line vote and is projected to reduce spending by $351 billion, surpassing the $330 billion reduction required by the budget resolution instructions.
• The measure would introduce stricter borrowing limits, repeal regulations on gainful employment and borrower defense, and enforce a risk-sharing provision that holds colleges accountable for unpaid student loan balances. Additionally, the bill would dismantle the Biden Administration’s Saving on a Valuable Education (SAVE) income-driven repayment plan, which had offered a path to student loan forgiveness. Additionally, beginning July 1, 2026, annual and aggregate loan limits for unsubsidized loans would be adjusted to reflect the median cost of a student’s program, with professional students capped at $150,000. Further, while medical and dental residency deferments would allow for zero interest accrual for up to four years, residency payments would no longer qualify for Public Service Loan Forgiveness (PSLF) for new borrowers after July 1, 2025.
• Republicans argue that these reforms are necessary to improve fiscal sustainability, while Democrats warn that they could limit access to higher education and disproportionately impact medical students. All Democratic amendments introduced during Tuesday’s markup were rejected.
• The full bill can be viewed here.
• Congressional Republicans are undergoing last minute negotiations over the legislation that will be included in their budget reconciliation package as they prepare for a series of “markups” tentatively scheduled for this month.
• The House Energy and Commerce Committee and House Ways and Means Committee were planning to hold a markup of their respective reconciliation bills during the week of May 5, but it was announced on May 1 that the markups would be delayed. It is during the Energy and Commerce Committee markup when it will be revealed what changes the Republicans are proposing to the Medicaid program. Republican members have been meeting to discuss specifics regarding the controversial Medicaid policies on the table. House Republicans appear eager to move the reconciliation process forward as quickly as possible—with a goal of passage before Memorial Day—but there is always the possibility of a lack of consensus delaying the process.
• In particular, the degree to which Medicaid spending will be affected has been a point of contention. On April 14, twelve Republican House members sent a letter to House leadership and Representative Brett Guthrie (R-KY-02), Chairman of the House Energy and Commerce Committee, voicing support for the Medicaid program and highlighting their opposition to potential Medicaid cuts. The letter states that the members “support targeted reforms to improve program integrity, reduce improper payments, and modernize delivery systems to fix flaws in the program that divert resources away from children, seniors, individuals with disabilities, and pregnant women – those who the program was intended to help. However, [the members] cannot and will not support a final reconciliation bill that includes any reduction in Medicaid coverage for vulnerable populations.”
• Additionally, it has been reported that President Trump has recently proposed aggressively expanding Medicare drug pricing policy in order to limit the degree to which Medicaid spending is cut. This would be through implementing a “Most Favored Nation” (MFN) policy with pharmaceutical companies to align American drug prices more closely to international prices, a policy that was proposed during the first Trump Administration. House Speaker Mike Johnson (R-LA-04) has indicated that he is “not a big fan” of this idea.
• The Senate has not yet announced their reconciliation plans.
• On May 2, 2025, President Trump released his FY 2026 discretionary budget proposal, which provides Congress with the administration's policy priorities in advance of a full fiscal plan. The proposal recommends allocating $93.8 billion to HHS, a 26.2 percent decrease from FY 2025 funding levels. NIH would see a reduction of nearly $18 billion, the largest of HHS agencies. The proposal also requests reductions in funding of approximately $1.7 billion for HRSA, $3.6 billion for the CDC, and $1 billion for SAMHSA. The Agency for Healthcare Research and Quality (AHRQ) and CMS would also see cuts of approximately $129 million and $674 million, respectively. The Administration requests $500 million for the Make America Healthy Again (MAHA) initiative, while all other listed programs would experience cuts, reductions, or consolidations. The budget does not specify funding requests for several agencies, including FDA and the Administration for Community Living. The proposal marks the first step in the FY 2026 appropriations process.

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