AMCP Legislative & Regulatory Briefing — November 2025

AMCP Submits Comments to ACIP

From Dec. 4 to 5, the Advisory Committee on Immunization Practices (ACIP) met to discuss additional changes to the childhood vaccination schedule, including recommendations on hepatitis B immunizations and vaccine safety. On Nov. 24, AMCP submitted a comment letter to ACIP outlining concerns with the Centers for Disease Control and Prevention’s vaccine priorities. Specifically, the letter commends ACIP’s commitment to regularly reviewing the scientific evidence underlying national immunization recommendations but is concerned that federal health policy officials have begun to promote outdated and disproven claims that vaccines cause autism in children. AMCP urges ACIP to uphold its commitment to updating recommendations based on sound evidence, without regard to political influence, to maintain public trust in government health care agencies. Regarding the hepatitis B vaccine, AMCP’s comments support maintaining the longstanding universal birth dose recommendation, which ensures robust infant immunity and carries a proven safety record.

Trump Administration Announces Deal to Bring Most-Favored-Nation Pricing to GLP-1s 

Over the past several weeks the Trump administration has unveiled a series of agreements with major pharmaceutical manufacturers in response to the Executive Order on Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. On Nov. 6, President Trump announced additional agreements for Eli Lilly and Company and Novo Nordisk to offer Most-Favored-Nation pricing on semaglutide (branded Ozempic and Wegovy) and tirzepatide (branded as Mounjaro and Zepbound). The manufacturers agreed to make their GLP-1s indicated for chronic weight management available on TrumpRx, the administration’s soon-to-be released platform that connects cash paying patients with direct-to-consumer pharmaceutical purchasing sites. Additional products to be offered on TrumpRx include the migraine treatment Emgality and diabetes treatments Trulicity, NovoLog, and Tresiba. Eli Lilly and Novo Nordisk also agreed to price the injectable forms of their GLP-1s, for all indications, at $245 for both Medicare and state Medicaid programs. Finally, Eli Lilly will guarantee MFN prices for all new medications guarantee, repatriate increased foreign revenue on existing products and make MFN prices available to all state Medicaid programs, as was outlined in the July 31 demand letters which were sent to 17 manufacturers.

Congress Ends Longest Federal Government Shutdown in History

On Nov. 12, President Trump signed a continuing resolution to extend government funding at current levels until Jan. 30, 2026, ending the longest federal government shutdown in history at 43 days. The bill also authorizes expired health provisions including Medicare telehealth flexibilities, delays on cuts to Medicaid Disproportionate Share Hospitals, and Graduate Medical Education funding until Jan. 30, 2026, in addition to full FY 2026 appropriations for the Department of Agriculture, Department Veterans Affairs, and the Legislative Branch. Congressional Democrats also secured commitments from Senate Majority Leader John Thune (R-SD) to hold votes in mid-December to extend the expiring Affordable Care Act (ACA) enhanced premium tax credits (PTCs), as well as a rescindment of the thousands of Reduction in Force (RIFs) notices sent to federal workers during the shutdown. Roughly 1,200 Department of Health and Human Services employees were previously affected by the impending RIFs. In addition to votes on the expiring PTCs, Congress must now continue negotiations on the nine additional full-year appropriations bills to avoid another government shutdown should funding expire again on Jan. 30.

House Ways & Means, Senate Finance Committees Hold Hearings on the Care Coordination and Rising Health Care Costs

Following the conclusion of the recent government shutdown, which was partially driven by efforts to extend or revise the expiring ACA enhanced PTCs, House and Senate committees held several hearings with the ACA top of mind. On Nov. 19, the Senate Committee on Finance held a hearing to discuss solutions to lower Americans’ health care costs, while the House Committee on Ways & Means Subcommittee on Health followed that afternoon with a hearing on Modernizing Care Coordination to Prevent and Treat Chronic Disease. During the Senate Finance hearing, Republican senators offered a number of ACA policy proposals that would shift financial assistance directly to patients, increasing consumer choice using Health Savings Accounts (HSAs), Flexible Spending Accounts (FSAs), and flexible coverage options such as association health plans for small businesses and short-term limited duration plans. Senate Democrats instead pointed to the need for a short-term, clean extension of the enhanced PTCs, as any substantive policy change would not affect the expiration of enhanced PTCs for plan year 2026. The Ways & Means Health Subcommittee hearing also featured testimony of Ms. Allison Reichert, an independent pharmacist working in Illinois. Ms. Reichert spoke to the essential contributions of pharmacists in rural communities, including their ability to manage and prevent chronic disease in coordination with other providers. Ms. Reichert also spoke to the fact that pharmacists are often the most accessible providers for rural and underserved patients.

CMS Releases Negotiated Prices for 15 Additional Drugs Under Medicare Drug Price Negotiation Program

On Nov. 25, the Centers for Medicare and Medicaid Services (CMS) released the Maximum Fair Prices (MFPs) for 15 Part D drugs selected for negotiation under the Medicare Drug Price Negotiation Program, with the prices set to take effect on Jan. 1, 2027. This marks the second round of negotiated prices released by CMS since passage of the Inflation Reduction Act in 2022, with negotiations expanding to include both Part D and Part B drugs next year for the Initial Price Applicability Year 2028 (IPAY 2028). The Trump administration estimates that the 15 additional MFPs, which cover drugs including Ozempic, Trelegey Ellpta, and Pomalyst, represent a 44% net reduction in the prices Medicare paid for these treatments in 2024. However, this analysis reflects prices paid in 2024 and does not account for changes in net prices between 2024 and 2027, which may lower the estimated savings. The release of the IPAY 2027 MFPs coincides with the Trump administration’s recent Most-Favored-Nation (MFN) drug pricing agreements, which cover a number of drugs already selected for negotiation. CMS and the White House have yet to clarify how such drugs covered under Part D for instances in which the MFP differs from the MFN price. AMCP will continue to monitor updates.

Download Full Briefing