The drug pricing regulatory and legislative landscape continues to evolve rapidly at both federal and state levels. Below, we highlight significant changes that occurred between September 1, 2025, and December 2, 2025. Download the full Q4 2025 Regulatory and Legislative Activity Update .
Federal regulatory activity
Medicare
- CY 2027 Medicare Part C and Part D Technical Proposed Rule: On November 25, 2025, CMS issued a proposed rule for Medicare Advantage and Part D programs for CY 2027, including policies under the Inflation Reduction Act. Feedback on risk adjustment and quality bonuses is requested, due by January 26, 2026.
- CY 2026 Physician Fee Schedule Final Rule: Released on October 31, 2025, it maintains refund thresholds for discarded drugs and clarifies ASP reporting for Maximum Fair Price drugs.
General drug updates
- Most Favored Nation (MFN) Agreements: The White House has entered agreements with pharmaceutical companies to align U.S. drug prices with international standards by 2026, offering discounts and temporary tariff relief in exchange for expanded domestic manufacturing commitments.
- White House Agreement with Eli Lilly & Novo Nordisk: Announced on November 6, 2025, this MFN pricing agreement aims to reduce costs for GLP-1 medications, pricing certain drugs at $245 per month with Medicare copays capped at $50, extending coverage under Medicare and Medicaid.
- Action on IVF: On October 16, 2025, new guidance from HHS, Labor, and Treasury seeks to help employers offer standalone fertility benefits, including IVF, and plans propose new rules to expand eligibility for these benefits.
Tariffs and trade agreements
- Pharmaceutical Tariffs: Announced on September 25, with the potential for 100% tariffs on imported pharmaceuticals, delayed as negotiations continue for pricing deals. A U.S.-UK agreement on December 1 removes tariffs on U.K. origin pharmaceuticals and pauses certain trade actions.
FDA/DEA updates
- FDA Request on OTC Medications: Issued on December 1, 2025, seeking stakeholder input to improve access, with comments due by the end of January 2026.
- Hormone Replacement Therapy Labeling: On November 10, 2025, the FDA began removing black box warnings from certain therapies, citing updated evidence.
Vaccine updates
- Advisory Committee on Immunization Practices (ACIP): On November 13, 2025, the CDC announced that the ACIP would convene on December 4–5, 2025, to discuss and potentially update recommendations on childhood immunization schedules and hepatitis B vaccines.
- Immunization Schedule Updates: On October 8, 2025, the CDC updated the U.S. immunization schedules to include a new shared clinical decision-making approach for the COVID-19 vaccine, emphasizing provider-patient discretion. The schedule also recognizes standalone varicella immunization for toddlers, expanding pediatric care options.
340B program
- HRSA Rebate Model Pilot Program: At the end of October, HRSA approved eight drug manufacturers to participate in the 340B Rebate Model Pilot Program, launching on January 1, 2026. Covered entities will buy drugs at full price and submit claims data within 45 days of dispensing, with manufacturers required to issue rebate payments within 10 days. This pilot may inform future 340B program reforms.
Congressional activity
Legislation and hearings
- Lowering Drug Costs for American Families Act: Introduced on November 20, expanding Medicare's drug price negotiations and capping out-of-pocket costs.
- No Big Blockbuster Bailouts Act: Introduced on October 21, to restore Medicare’s negotiation authority over high-cost drugs.
- Senate Aging Committee: On November 18, focused on strengthening the domestic pharmaceutical supply chain.
State legislative activity
- Emerging issue: Regulatory measures on PBMs continue, with over 300 PBM-related bills enacted in 2025, focusing on utilization management and transparency.
Recently enacted state legislation
- California: SB 41 was signed into law, introducing significant PBM regulations.
Pending state activity
- Ohio & New Jersey: Significant PBM licensure and reporting bills are pending.
Conclusion
This summary reflects the dynamic changes in drug pricing and regulatory frameworks at federal and state levels, capturing critical issues under review as of December 2, 2025.
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