AMCP Regulatory NewsBreaks

Regulatory NewsBREAK: CMS Issues Final Guidance on Medicare Drug Price Negotiation Program

On September 30, 2025, the Centers for Medicare and Medicaid Services (CMS) issued final guidance for the third cycle of the Medicare Drug Price Negotiation Program for Initial Price Applicability Year (IPAY) 2028. Negotiations for the Maximum Fair Prices (MFP) on up to 15 additional negotiation-eligible Part D and/or Part B drugs will occur in 2026, with the MFP effective in IPAY 2028.
Legislation & Regulation
Pills

White House Announces Deal to Lower Drug Costs

On September 30, 2025, the White House announced a deal with Pfizer to lower drug costs in line with most-favored nation (MFN) pricing. While specific terms of the agreement have not been disclosed, both Pfizer and the White House issued statements providing a broad outline of the agreement.
Legislation & Regulation
The United States Capitol Building

Legislative Update: Expected Impacts of a Federal Government Shutdown on Oct. 1

Under the current Continuing Resolution passed on March 15, government funding will expire at 12:01 AM ET on the morning of Oct. 1. A Continuing Resolution (CR) extends government funding at existing levels in lieu of passage of a regular appropriations bill—occasionally with minor fiscal changes or additional policy “rider” amendments included—for a predetermined amount of time. Unless Congress reaches a deal on an additional funding package, federal government activities and operations deemed “nonessential” will temporarily cease, while “essential” functions and mandatory spending such as Social Security and Medicare payments will continue under contingency plans determined by federal agencies and the Office of Management and Budget (OMB). Since 1980, there have been 14 government shutdowns, with the longest and most recent shutdown to date occurring from Dec. 22, 2018 – Jan. 25, 2019 under the first Trump administration.
Legislation & Regulation
A photo of vaccines, syringes and needles

Joint Comment Letter for Advisory Committee on Immunization Practices (ACIP)

As organizations representing public health, patients, family caregivers, and healthcare professionals, we have a clear stake in the availability of vaccines. Vaccines represent one of our most effective tools in preventing disease and improving quality of life, throughout the lifespan. The proceedings and recommendations of the CDC’s ACIP have a huge impact on trust and confidence in vaccines, and in Americans’ ability to access those life-saving vaccines. Recognizing the critical importance of this meeting, we respectfully submit the following recommendations.
Legislation & Regulation