Legislation & Regulation

Discover essential legislative and regulatory resources tailored for managed care pharmacy professionals. Stay informed with the latest updates, policies, and advocacy tools to effectively navigate and influence the health care landscape.

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amcp policy - DC capitol dome

Federal Update: Trump Admin Unveils GLOBE, GUARD Models, Plus Nine Additional MFN Arrangements

On Dec. 19, the Trump administration closed out a year of international pharmaceutical reference pricing announcements with the publication of CMS’s proposed Global Benchmark for Efficient Drug Pricing (GLOBE) and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) models, as well as the release of nine additional Most-Favored-Nation (MFN) pricing arrangements with major pharmaceutical manufacturers. The announcements align with the Trump administration’s goal of lowering the prices that American patients pay for prescription drugs to the prices paid in similarly developed countries, as well as May 12 Executive Order on delivering MFN prices to patients.
Legislation & Regulation
PBM Reform

Federal Update: Senate Introduces Comprehensive PBM Reform Legislation

On Dec. 4, Senators Mike Crapo (R-ID) and Ron Wyden (D-OR), Chair and Ranking Member of the Senate Committee on Finance, introduced the PBM Price Transparency and Accountability Act (S. 3345). The bill’s introduction signifies Congress’ appetite towards passing pharmacy benefit manager (PBM) reform, with many of the bill’s provisions included in earlier reform proposals adopted at the state level. This includes bans on the use of spread pricing arrangements, delinking PBM compensation from the price of a drug, and increased transparency into PBM contracts and business practices.
Legislation & Regulation
Capitol Hill, U.S. Capitol, IRA Workshop

Regulatory Update: CMS Releases CY 2026 Hospital Outpatient Prospective Payment System (OPPS)

On Friday, November 21, the Centers for Medicare and Medicaid Services (CMS) released CY 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) payments Final Rule, updating Medicare rates and announcing policy changes. The rule includes payment increases for hospitals and ASCs meeting quality reporting requirements and outlines significant reforms related to drug payment and procedural lists. There is a 30-day notice for comments on IRA negotiation factors for 2028 (comment period will begin once forms are published).
Legislation & Regulation
A photo of vaccines, syringes and needles

ACIP Sign-on Letter

As mostly non-pediatric organizations representing public health, older adults, patients, family caregivers, consumers and healthcare workers, we support everyone having access to every vaccine they need, regardless of their age. In the United States alone, routine childhood vaccinations for children born between 1994 and 2023 are projected to prevent about 1.13 million deaths, and hundreds of millions of illnesses and hospitalizations. Put simply, childhood vaccines make healthy adults.
Legislation & Regulation
AMCP Regulatory NewsBreaks

Regulatory NewsBREAK: CMS Releases the Maximum Fair Price (MFP) for Selected Drugs for IPAY 2027

On November 25, 2025, the Centers for Medicare & Medicaid Services (CMS) released the maximum fair price (MFP) for each of the 15 selected drugs for IPAY 2027, which will go into effect beginning January 1, 2027. These negotiated prices reflect a marked increase in savings compared to the initial 2026 cohort, influenced by newer drugs and expanded pricing benchmarks.
Legislation & Regulation
Capitol Behind Trees

Federal Update: Senators Reach Deal to End Shutdown

On Sunday, November 9, Senate Majority Leader Thune announced that he had reached an agreement with a group of 8 Democratic senators and the White House on a deal to end the longest shutdown in U.S. history. On Monday, November 10, the Senate approved the government funding bill by a vote of 60-40, which sends the legislative package back to the House of Representatives.
Legislation & Regulation
AMCP Regulatory NewsBreaks

Regulatory NewsBREAK: CMS Releases the GENEROUS Model (Generating Cost Reductions for U.S. Medicaid Model)

On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS) released the GENEROUS Model (Generating Cost Reductions for U.S. Medicaid Model). The model aims to achieve Most Favored Nation (MFN) international pricing for Covered Outpatient Drugs (CODs) while maintaining or improving the quality of care for Medicaid beneficiaries.
Legislation & Regulation
AMCP Regulatory NewsBreaks

Regulatory NewsBREAK: CMS Releases the GENEROUS Model (Generating Cost Reductions for U.S. Medicaid Model)

On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS) released the GENEROUS Model (Generating Cost Reductions for U.S. Medicaid Model). The model aims to achieve Most Favored Nation (MFN) international pricing for Covered Outpatient Drugs (CODs) while maintaining or improving the quality of care for Medicaid beneficiaries.
Legislation & Regulation