Health Care Week in Review | President Trump Announces Actions to Lower Prescription Drug Costs; House Committees Mark Up Their Portions of the Budget Reconciliation Bill

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, President Trump issued an executive order to implement “Most-Favored-Nation” pricing for prescription drugs, and the budget reconciliation bill advanced through two key House committees before being blocked in the Budget Committee.

1. Regulations, Notices & Guidance

• On May 12, 2025, the Executive Office of the President (EOP) released an executive order (EO) entitled, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. This EO directs the U.S. Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the U.S. The EO instructs the Administration to communicate price targets to pharmaceutical manufacturers and facilitate patients’ ability to purchase drugs directly from manufacturers. It also directs the Secretary of the Department of Health and Human Services (HHS) to enforce price regulations, combat anticompetitive practices, and take other “aggressive” measures to significantly reduce the cost of prescription drugs.
• On May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Preserving Medicaid Funding for Vulnerable Populations--Closing a Health Care-Related Tax Loophole. This proposed rule is intended to address a loophole in a regulatory statistical test applied to State proposals for Medicaid tax waivers. The test is designed to ensure, as required by statute, that non-uniform or non-broad-based health care-related taxes, authorized under a waiver, are generally redistributive. The loophole currently allows some health care-related taxes, especially taxes on managed care organizations (MCOs), to be imposed at higher tax rates on Medicaid taxable units than non-Medicaid taxable units, contrary to statutory and regulatory intent for health care-related taxes to be generally redistributive. The proposed provisions would better implement the statutory requirements by adding additional safeguards to ensure that tax waivers that exploit the loophole because they pass the current statistical test, but are not generally redistributive, are not approvable. Additionally, the proposed rule, if finalized, would immediately revoke waivers of taxes that are not generally redistributive that were approved in the two years preceding the final rule’s effective date.
• On May 13, 2025, CMS released a notice entitled, Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Draft Guidance. CMS is announcing an opportunity for the public to comment on CMS’ draft guidance for the third cycle of the Medicare Drug Price Negotiation Program, the first cycle of renegotiation, and manufacturer effectuation of the maximum fair price (MFP) for 2026, 2027, and 2028 for the implementation of the IRA. Comments must be received by June 26, 2025.
• On May 13, 2025, HHS published a notice of recissions entitled, Notification of HHS Documents Identified for Rescission. HHS provides notice that it is rescinding four informal guidance documents. HHS states that this action will reduce the burdens on regulated parties and allow HHS to refocus on its core mission to Make America Healthy Again.
• On May 13, 2025, HHS released a notice entitled, Request for Information: Ensuring Lawful Regulation and Unleashing Innovation to Make American Healthy Again. To implement the President’s Deregulatory Initiatives, including the Department of Government Efficiency (DOGE) Deregulatory Agenda, and to better promote the health and well-being of the American people, HHS states that it is planning the largest deregulatory effort in its history. To facilitate this effort, HHS seeks input from all interested parties on how to dramatically deregulate across all areas HHS touches. HHS also welcomes other submissions explaining how regulations, guidance, paperwork requirements, and other regulatory obligations can be repealed.
• On May 13, 2025, the Food and Drug Administration (FDA) released a notice entitled, Request for Information: Infant Formula Nutrient Requirements. FDA is requesting information and data to begin the nutrient review process for infant formula. FDA is taking this action, in part, to continue to ensure the nutritional adequacy of infant formula sold in the U.S. FDA intends to use the information and data to help determine what type(s) of actions, if any, should be taken.
• On May 14, 2025, CMS published a notice with a request for comment entitled, Request for Renewal of Deeming Authority of the Utilization Review Accreditation Commission (URAC) for Medicare Advantage Health Maintenance Organizations and Preferred Provider Organizations. This proposed notice announces that CMS is considering granting approval of the Utilization Review Accreditation Commission’s renewal application for Medicare Advantage (MA) “deeming authority” of Health Maintenance Organizations (HMOs) and Preferred Provider Organizations (PPOs) to continue participation in the Medicare or Medicaid program.
• On May 14, 2025, CMS published a request for information (RFI) entitled, Request for Information; Health Technology Ecosystem. This RFI seeks input from the public regarding the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure. Responses to this RFI may be used to inform the efforts of CMS, the Assistant Secretary for Technology Policy (ASTP), and the Office of the National Coordinator for Health Information Technology (ONC) to lead infrastructure progress to cultivate this market, increasing beneficiary access to effective digital capabilities needed to make informed health decisions, and increasing data availability for all stakeholders contributing to health outcomes.
• On May 15, 2025, CMS released a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—January through March 2025. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the three-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On May 16, 2025, the Administration for Children and Families (ACF) published a request for public comment entitled, Protocol for the Pathways to Work Evidence Clearinghouse: Methods and Standards, Version 2.0. ACF oversees the Pathways to Work Evidence Clearinghouse (Pathways to Work). ACF seeks comments on proposed revisions to existing standards and on new standards for including and rating the quality of program cost studies in the “Protocol for the Pathways to Work Evidence Clearinghouse: Methods and Standards, Version 2.0.”
• On May 16, 2025, FDA released a notice of public meeting and request for comment entitled, Reauthorization of the Prescription Drug User Fee Act. FDA is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FY) 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as it begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA’s website. Electronic or written comments on this public meeting are due by August 14, 2025.
• On May 16, 2025, FDA released a notice of public meeting and request for comment entitled, Reauthorization of the Generic Drug User Fee Amendments. FDA is hosting a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for FY 2028 to 2032. At the end of September 2027, new legislation will be required for FDA to continue to collect generic drug user fees for future FYs. The FD&C Act requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, FDA publish a notice in the Federal Register requesting public input on the reauthorization; hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027; provide a period of 30 days after the public meeting to obtain written comments from the public; and publish the comments on FDA’s website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA’s website. Electronic or written comments on this public meeting are due by August 11, 2025.

Event Notices—NOTE: Due to ongoing HHS changes, many of these meetings may be cancelled or postponed. We are continuing to monitor.

** - New addition

• May 20, 2025: The National Institutes of Health (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.
• ** May 29, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid 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: The Centers for Disease Control and Prevention (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, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. 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 11, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is an in-person meeting with some sessions open to the public.
• June 13, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a virtual 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 17, 2025: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
• ** June 17, 2025: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• June 25, 2025: 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 14, 2025: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act for FY 2028 through 2032. This is a hybrid meeting open to the public.
• ** July 14, 2025: FDA announced a meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for FYs 2028 to 2032. This is a hybrid meeting 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: The Health Resources and Services Administration (HRSA) announced a meeting of National Advisory Council on Nurse Education and Practice. 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 May 14, 2025, the U.S. Government Accountability Office (GAO) published a report entitled, Priority Open Recommendations: Department of Health and Human Services. GAO has identified 35 priority recommendations for HHS focusing on seven key areas, including public health emergency preparedness, Medicaid and Medicare oversight, FDA regulation, and cybersecurity improvements. The report outlines concerns related to FDA’s oversight of medical products and food safety, citing issues with foreign inspections and workforce shortages. Additionally, the report highlights improper payments in Medicaid and Medicare, estimating a total of approximately $85 billion in FY 2024, and recommends enhanced oversight and cost-effective initiatives to mitigate financial losses. The report also outlines deficiencies in public health emergency response and emphasizes the need for improved coordination and risk management for the Strategic National Stockpile.
• On May 16, 2025, the HHS Office of Inspector General (OIG) published a report entitled, CMS Is Not Systematically Tracking Whether States Return Federal Shares of Medicaid Managed Care Remittances. OIG conducted a review to assess CMS’s ability to track the return of Medicaid managed care plans’ minimum medical loss ratio (MLR) remittances by states. When states receive these remittances, they are required to return a portion to the federal government based on the federal matching rate. However, the report found that CMS lacks a systematic way to track whether and when states return these funds, and that CMS had to manually request information from states to determine whether they had returned the funds owed. OIG recommended five actions to improve oversight, including (1) obtaining outstanding federal shares from states; (2) developing systematic tracking capabilities; (3) enhancing internal communication; (4) routinely confirming state compliance; and (5) establishing procedures to monitor expected remittance timelines. CMS concurred with the five recommendations.

3. Hearings & Markups

• On May 13, 2025, the Senate Judiciary Committee held a hearing entitled, PBM Power Play: Examining Competition Issues in the Prescription Drug Supply Chain. Witnesses included: Ms. Sharon Faust, Chief Pharmacy Officer, Navitus Health Solutions; Dr. Sheetal M. Kircher, Associate Professor of Hematology and Oncology, Northwestern Medicine; Dr. Randy P. McDonough, Pharmacist & Co-owner, CEO of Towncrest Pharmacy Corporation and President of the American Pharmacists Association; Mr. Juan Carlos Scott, President & CEO, Pharmaceutical Care Management Association; and Dr. Neeraj Sood, Professor, USC Schaeffer Institute for Public Policy & Government Service and USC Price School of Public Policy.
• On May 13, 2025, the House Energy and Commerce Committee held a markup entitled, Full Committee Markup of Budget Reconciliation Text. The Committee considered legislative recommendations for budget reconciliation. The Committee considered four committee prints drafted as individual subtitles relating to: (1) Energy; (2) Environment; (3) Communications; and (4) Health. The Committee voted along party lines, 30-24, to transmit the four Committee Prints to the House Committee on the Budget.
• On May 13, 2025, the House Ways and Means Committee held a markup entitled, Full Committee Markup of Legislative Proposals to Comply with the Reconciliation Directive Included in Section 2001 of the Concurrent Resolution on the Budget for Fiscal Year 2025, H. Con. Res. 14. The bill includes numerous provisions, including permanent extensions of tax cuts from the Tax Cuts and Jobs Act (TCJA) and an increase of the cap on the state and local tax (SALT) deductions. The Committee voted along party lines, 26-19, to transmit the Committee Print as amended to the House Committee on the Budget.
• On May 14, 2025, the House Appropriations Committee Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Budget Hearing – U.S. Department of Health and Human Services. The Honorable Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services served as the sole witness.
• On May 14, 2025, the House Judiciary Committee Subcommittee on the Administrative State, Regulatory Reform, and Antitrust held a hearing entitled, The MATCH Monopoly: Evaluating the Medical Residency Antitrust Exemption. Witnesses included: Dr. James Lin, Geriatric Medicine Specialist, Clinical Professor, and President, Lake Erie College of Osteopathic Medicine Institute for Successful Living; Mr. Sherman Marek, Attorney and Principal, Marek Health Law; Mr. Thomas Miller, Senior Fellow, American Enterprise Institute; and Dr. William B. Feldman, Associate Physician, Division of Pulmonary and Critical Care Medicine Faculty, Program On Regulation, Therapeutics, And Law.
• On May 14, 2025, the Senate Committee on Indian Affairs held a hearing entitled, Delivering Essential Public Health and Social Services to Native Americans – Examining Federal Programs Serving Native Americans Across the Operating Divisions at the U.S. Department of Health and Human Services. Witnesses included: The Honorable Janet Alkire, Chairwoman, Standing Rock Sioux Tribe; The Honorable Loni Greninger, Vice Chair, Jamestown S’Klallam Tribal Council; Ms. Melissa Charlie, Executive Director, Fairbanks Native Association; Ms. Lucy Simpson, Executive Director, National Indigenous Women’s Resource Center; and Ms. Sheri-Ann Daniels, Chief Executive Officer, Papa Ola Lōkahi.
• On May 14, 2025, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, FY2026 Department of Health and Human Services Budget. The Honorable Robert F. Kennedy, Jr., Secretary of HHS, served as the sole witness.

4. Other Health Policy News

• On May 13 and 14, 2025, the House Energy and Commerce Committee approved its section of the FY 2025 reconciliation bill by a party-line vote of 30-24. The Committee was tasked with reducing budget deficits by $880 billion over a decade, prompting sweeping proposed changes to Medicaid and other health programs, including the Children’s Health Insurance Program (CHIP). The mark-up lasted over 26 hours and included extensive debate, as Democratic members of the Committee offered a number of amendments to the budget reconciliation text. The bill includes provisions such as Medicaid work requirements, restrictions on provider taxes, penalties for states funding coverage for undocumented immigrants, and changes to the Affordable Care Act (ACA) enrollment period. Republicans defended the provisions as necessary to sustain Medicaid, while Democrats argued they would result in major coverage losses.
• The House Ways and Means Committee also advanced its portion of the reconciliation package after a 17-hour session, which was approved by a party line 26-19 vote. The bill includes provisions such as permanent extensions of tax cuts from TCJA and an increase of the cap on SALT deductions. Republican members of the Committee emphasized the bonus deduction for senior citizens under a specific income threshold, increases to the standard deduction, and provisions supporting educational choice. Democratic members of the Committee argued that the bill is a tax giveaway to billionaires and large corporations at the expense of working Americans. Democratic members proposed numerous amendments, including those aimed at expanding health care coverage under the ACA and eliminating tax cuts for top earners. According to CBO budget projections, the tax provisions could add between $3.8 and $5.3 trillion to the federal deficit over ten years, depending on which measures are made permanent.
• Speaker Johnson is expected to meet with Republicans skeptical of the bill to garner support in time for a floor vote next week. However, the timeline remains fluid as negotiations continue on key provisions. Additional changes may be made to secure the votes needed to pass the bill through the House. Once passed, the Senate will then take up the proposal going into June and possibly throughout the summer months, which may bring about further changes. Since Republicans intend to include raising the debt ceiling in the reconciliation package, both chambers must pass it by August, which is when the Secretary of the Treasury announced that the country will reach its borrowing limit.
• The full House Energy and Commerce Committee bill text is available here. Additional information on the House Energy and Commerce Committee hearing can be found here. The full House Ways and Means Committee bill text is available here. Additional information on the House Ways and Means Committee hearing can be found here.
• On May 14, 2025, HHS Secretary Robert F. Kennedy Jr. testified before the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, and the Senate HELP Committee. Lawmakers from both parties questioned him about significant staffing reductions, budget cuts, and policy changes under his leadership. Secretary Kennedy defended the elimination of approximately 10,000 jobs and a proposed $18 billion cut to the NIH, describing these measures as efforts to reduce waste and improve efficiency. He emphasized that the agency will focus on improving nutrition and chronic disease prevention, proposing a $500 million boost for his “Make America Healthy Again” initiative. However, Democratic members expressed concern that these layoffs have impacted critical areas, including food safety research, firefighter health programs, infant formula safety, and studies on childhood lead exposure. Representative Rosa DeLauro (D-CT-03) highlighted that such cuts could hinder the Department’s ability to address public health challenges effectively.
• During the hearings, Secretary Kennedy’s stance on vaccines drew bipartisan scrutiny, especially amidst a significant measles outbreak affecting over 1,000 individuals across 31 states. When asked whether he would vaccinate his children today, Secretary Kennedy responded, “Probably,” but added, “I don’t think people should be taking medical advice from me.”
• In his testimony, Secretary Kennedy emphasized a focus on nutrition and chronic disease prevention, proposing a $500 million boost for his “Make America Healthy Again” initiative, while defending cuts to other areas of public health funding.
• The House Appropriations Subcommittee hearing can be viewed here. The Senate HELP Committee hearing can be viewed here.
• On May 13, 2025, the Center for Medicare and Medicaid Innovation (CMMI) announced a new strategy in alignment with President Trump and HHS Secretary Kennedy’s call to action to “Make America Healthy Again”. During a webinar accompanying the announcement, Abe Sutton, Director of CMMI and CMS Deputy Administrator, emphasized that the strategy is designed to improve patient outcomes while controlling costs. The strategy focuses on three pillars: (1) promoting evidence-based disease prevention; (2) empowering individuals with tools and information to manage their health; and (3) driving choice and competition among providers. Prevention will be integrated into all model designs through incentives, provider education, and waivers aimed at increasing access to preventive care. CMMI will also collaborate with community organizations to support nutrition and physical activity while exploring expanded use of holistic medicine. Additionally, patients will gain greater access to technology and data for informed decision-making, including provider performance metrics and cost transparency. The strategy also aims to reduce administrative burdens for providers, support independent practices, and enhance value-based care models.
• As part of this strategy, CMMI plans to implement new policies that promote site-neutral payments and expand shared savings and prospective payments to enhance participation of independent providers. Future initiatives may include MA payment models that promote whole health, expanded waivers for cost-sharing predictability, and working with states to drive multi-payer collaboration. While details on implementation timelines remain uncertain, CMMI stated that updates to existing models and the introduction of new initiatives will be announced in the coming months.

5. Additional Alston & Bird Publications

• We maintain an online tracker for all executive orders issued by the Trump Administration, which is updated regularly and can be found here.

View our Health Care Legislative & Public Policy team.

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