This Week (May 12-16)

Both the House and Senate are in session this week. The House Energy and Commerce Committee and the House Ways and Means Committee are scheduled to markup their portions of House Republicans' reconciliation bill.

House Energy and Commerce Committee will hold a markup of "Budget Reconciliation Text"

• Date: Tuesday, May 13 at 2PM ET
• More information available here.

House Ways and Means Committee will hold a 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."

• Date: Tuesday, May 13 at 2PM ET
• More information available here.

Senate Judiciary Committee will hold a hearing on PBM Power Play: Examining Competition Issues in the Prescription Drug Supply Chain

• Date: Tuesday, May 13 at 10:15AM ET
• More information available here.

Senate HELP Committee will hold a hearing on Hearing on Fiscal Year 2026 Department of Health and Human Services Budget. HHS Secretary Kennedy will testify in his first appearance in Congress as HHS secretary.

• Date: Wednesday, May 14 at 1:30PM ET
• More information available here.

House Budget Committee will hold a hearing on the "U.S. Department of Health and Human Services."

• Date: Wednesday, May 14 at 9:30AM ET
• More information available here.

Last Week (May 5-9)

Congressional Highlights

Reconciliation update. This week, House Republicans continued discussions on policies to be included in the House Ways and Means Committee and House Energy and Commerce Committee markups, scheduled to begin Tuesday (May 13) at 2pm ET. House Republican leaders are still working to address concerns from moderate Republicans and President Trump related to Medicaid cuts, as well as conservative Republican demands that the bill's tax extensions be fully offset. House Speaker Mike Johnson (R-LA) told members May 7 that leaders are targeting a smaller package of $1.5 trillion in spending cuts for $4 trillion in tax cuts, which followed House Budget Committee Chairman Jodey Arrington (R-TX) saying May 8 that tax cut plans may need to be scaled back without the requisite amount of savings, and therefore some policies may need to be temporary. Chairman Smith is set to me with President Trump today to discuss a pared-back package that still delivers on GOP priorities and release an initial portion of the package that will be marked up next week.

House leadership continues to say all policies are on the table, with some members indicating the markup could include pharmacy benefit manager reforms, Medicaid work requirements, and enhanced Medicaid eligibility checks. House leadership also is working to address a request from President Trump to include provisions targeting drug prices in the bill, including a "Most Favored Nations" policy for the Medicare program, aiming to tie drug costs in the US to those of other countries or an alternative. Committees will need to release language at least 24 hours before the markup — which means the markup could be delayed if member concerns are not addressed in time.

Senate Finance Democrats push back again proposed ACA marketplace rule. On Friday (May 9), Senate Finance Committee Ranking Member Ron Wyden (D-OR) and 16 Senate Democrats sent a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and Mehmet Oz, administrator for the Centers for Medicare & Medicaid Services (CMS), criticizing the 2025 Marketplace Integrity and Affordability Proposed Rule released in March. The lawmakers raise concerns that the proposals would result in 2 million people losing ACA exchange coverage, increase premiums, and increase administrative requirements.

House lawmakers raise concerns about drug price negotiation program impact on pharmacies. On Tuesday (May 6), a bipartisan group of House lawmakers sent a letter to HHS Secretary Kennedy and CMS Administrator Oz to examine the implementation of the Inflation Reduction Act's drug price negotiation program and its effect on pharmacies. The lawmakers note that the program is unsustainable for pharmacies who must provide a "financial float" for drugs selected for negotiation.

Administrative Highlights

FDA, NIH launch joint research initiative on nutrition. On Friday (May 9), the Food and Drug Administration (FDA) and National Institutes of Health (NIH) announced a new, joint innovative research initiative focused on US food and diet. The Nutrition Regulatory Science Program will aim to accelerate and expand nutrition research to learn more about the effects on ultra-processed foods and food additives on people's health, as well as the role of maternal and infant diets on future health outcomes.

FDA to integrate AI into review processed. On Thursday (May 8), the FDA announced plans to fully integrate generative AI into FDA centers' work by June 30 to help FDA scientists and subject matter experts accelerate product reviews and other tasks.

CMS, NIH launch new research platform pilot. On Wednesday (May 7), the NIH and the CMS announced plans to build a real-world data platform enabling advanced research into autism spectrum disorder (ASD) leveraging claims data, electronic medical records, and consumer wearables. NIH and CMS said ASD would be used to pilot the research program which the agencies said could be used by researchers to understand health care utilization, chronic disease etiology and treatment, and the economic burden of chronic conditions.

FDA policy on unannounced inspections. On Tuesday (May 6), the FDA announced plans to increase use of unannounced inspections at foreign manufacturing facilities that create food, essential medicines, and other medical products. The agency also will conduct a review of internal policies and practices related to overseas manufacturing inspections.

FDA leadership updates. On Tuesday (May 6), the FDA announced that Vinay Prasad, will serve as the next director of the FDA's Center for Biologics Evaluation and Research, replacing former CBER director Peter Marks. Prasad is an epidemiology professor at the University of California, San Francisco, who has been critical of the FDA, its approval processes, and industry involvement. The FDA this week also announced Jeremy Walsh, former chief technologist at Booz Allen Hamilton, to serve as its first Chief AI Officer.

HHS OCR sends letter on race-based discrimination to medical schools. On Tuesday (May 6), HHS' Office for Civil Rights (OCR) sent a "Dear Colleague" letter to medical schools clarifying the office's position that medical schools cannot use race-based criteria or racial stereotypes in admissions, campus life, or hospital operations.

Trump Admin weighs in on mifepristone case. On Monday (May 5), the Department of Justice in a court filing continued the Biden Administration's defense of the FDA's rules for mifepristone, stating that the plaintiffs — the states of Missouri, Idaho, and Kentucky — lack standing, and that the case should be dismissed.

Democratic states challenge HHS restructuring. On Monday (May 5), 19 Democratic-led states and the District of Columbia filed a lawsuit against HHS Secretary Kennedy, alleging the HHS reorganization has disrupted core functions of the agencies and deprived states of federal funds and expertise.

HHS disburses funding for older and disabled Americans. On Monday (May 5), HHS' Administration for Community Living announced that it will disburse more than $1.1 billion over the next two week to support programs and services for older Americans and Americans with disabilities, including those related to nutrition, daily living activities, chronic disease management, and the prevention of abuse, neglect and exploitation.

FTC, DOJ seek information on anticompetitive regulations. On Monday (May 5), the Federal Trade Commission (FTC) and the Department of Justice (DOJ) Antitrust Division issued a joint letter that directs the heads of federal agencies, including HHS, to create a list of anticompetitive regulations that reduce competition, entrepreneurship, and innovation.

CMS rescinds Medicaid due process protections. On May 1, CMS rescinded a Biden-era guidance letter on due process protections for Medicaid beneficiaries accused of fraud or abuse. The letter had prohibited states from clawing back benefits or issuing benefit lockouts on Medicaid beneficiaries accused of fraud or abuse.

Executive Highlights

Trump nominee for Surgeon General. On Wednesday (May 7), President Trump announced that he will nominate Casey Means, a social media influencer that has worked with HHS Secretary Kennedy on the Make America Health Again movement, as US Surgeon General. The announcement came after Trump withdrew his nomination for Janette Nesheiwat ahead of her Senate confirmation hearing.

Trump says pharma tariffs on the horizon. On Monday (May 5), President Trump said tariffs on pharmaceutical imports would come within two weeks. The announcement came just one day before the public comment period for the Section 232 national security investigation into the volume and nature of pharmaceutical imports closed on Tuesday (May 6).

Trump signs executive orders impacting drug manufacturing and biological research. On Monday (May 5), President Trump signed two health-related executive orders (EOs). During the signing, Trump said the Administration next week would make an announcement related to the cost of drugs, which may include a "Most Favored Nations" proposal. The two EOs signed on Monday were:

• The Regulatory Relief To Promote Domestic Production of Critical Medicines EO directs federal health and environmental leaders to review and streamline existing regulations and guidance for domestic pharmaceutical manufacturing including facility inspections and approvals, emerging manufacturing technologies, data reporting enforcement, and more. The EO also directs agencies to enhance inspections of foreign manufacturing facilities, paid for by increased inspection fees
• The Improving the Safety and Security of Biological Research EO directs HHS and other agency leaders to establish guidance that halts federal funding for gain-of-function research and other life sciences research conducted by countries of concern or countries deemed to have inadequate standards and policies; Increase transparency into gain-of-function research; and create a strategy to govern non-federally funded gain-of-function research and other life sciences research, among other things.

Hearings, Markups, and Other Committee Activity

Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing on the "Nomination of James O'Neill to serve as Deputy Secretary of Health and Human Services." On Thursday (8), the Committee held a hearing during which they heard testimony from James O'Neill on his nomination to serve as HHS Deputy Secretary. Mr. O'Neill spoke critically of the US food quality and reliance on medications and the need to improve preventive care and modernize HHS. During the hearing, O'Neill fielded questions on the HIPAA data privacy rule and AI, Congressional oversight of HHS appropriations, and other topics. In response to questioning from Chair Bill Cassidy (R-LA) Mr. O'Neill emphasized his support for the CDC's vaccine schedule and suggested he would be open to a mandate for immigrants who enter the US illegally to have required vaccinations. The Committee also was scheduled to hear testimony from Janette Nesheiwat on her nomination to serve as US Surgeon General. However, President Trump on Wednesday (May 7) withdrew the nomination.

• More information available here.

Senate Finance Committee held a hearing to "Consider the Nominations of James O'Neill, of California, to be Deputy Secretary of Health and Human Services, and Gary Andres, of Virginia, to be an Assistant Secretary of Health and Human Services. On Tuesday (May 6), the Committee held a hearing during which they heard testimony from Mr. O'Neill and Mr. Andres on their respective nominations. During the hearing, the nominees fielded questions on rural health, pharmacy benefit managers (PBMs), as well as their positions on vaccines, the HHS reorganization, and proposed Medicaid cuts.

• More information available here.

Reports, Studies, and Journals

• Congressional Budget Office: Estimates for Medicaid Policy Options and State Responses. CBO estimated that budget deficit impact of five Medicaid policies under consideration as part of a reconciliation package, as well as potential state responses.
• Congressional Budget Office: The Federal Perspective on Coverage of Medications to Treat Obesity: Considerations From the Congressional Budget Office. CBO estimates that covering anti-obesity medications under Medicare Part D would increase the federal deficit by $35.5 billion over the next decade.