News/Blogs

Navigating the Shifting Landscape: Your Q3 2025 Pharmacy Benefits Regulatory Roundup

The pharmacy benefits landscape continues to evolve at a rapid pace, and staying informed is more critical than ever for serving your clients effectively. This quarter brought significant developments across federal policy, state legislation, and the courts—each with potential implications for the health plans you manage. From new drug pricing agreements and innovative purchasing platforms to sweeping state PBM reforms and ongoing legal battles over ERISA preemption, understanding these changes will help you anticipate questions, address concerns, and position your clients for success.  

Federal Events

There have been many developments affecting pharmacy benefits at the federal level since our last quarterly update. Here are selected items: 

  • The Trump administration has finalized five drug pricing agreements with Pfizer, AstraZeneca, EMD Serono, Novo Nordisk, and Eli Lilly. These include a new deal with Eli Lilly and Novo Nordisk to cap Medicare and Medicaid prices for GLP-1 drugs starting in 2026. 
  • The Centers for Medicare & Medicaid Services (CMS) announced the GENEROUS Model, a five-year initiative starting in 2026 to reduce Medicaid drug costs. Participating states will be able to access prices CMS negotiates with manufacturers using a Most Favored Nation (MFN)-based price for drugs included in the model. 
  • President Trump announced TrumpRx.gov, a federal direct-to-consumer (DTC) prescription drug purchasing platform that will allow patients to purchase discounted drugs directly.  
  • The Pharmaceutical Research and Manufacturers of America (PhRMA) plans to launch AmericasMedicines.com, a website that will allow patients to buy prescription drugs directly from manufacturers.
  • COVID-19 vaccines are no longer broadly recommended for adults 65+. Instead, vaccination for adults 65+ and for people ages 6 months to 64 years is now recommended based on “shared decision-making” between patients and clinicians.  
  • The CDC’s Acting Director adopted the Advisory Committee on Immunization Practices’ (ACIP) recommendations for 2025-2026 MMRV vaccines. For children ages 12 months to 3 years, the CDC now recommends giving MMR and varicella as separate shots (MMR + V) instead of the combined MMRV vaccine.  
  • On 8/21/25, HHS published an Interim Final Rule modifying administrative simplification provisions under HIPAA, updating standards for electronic health care transactions to reduce administrative burden and improve data exchange.  
  • The U.S. Department of Labor’s (DOL) Employee Benefits Security Administration (EBSA) used its recent regulatory update to preview several new rules, including a proposed new fee disclosure rule concerning PBMs. This high-priority proposal would require more detailed reporting of direct and indirect PBM compensation, in line with an executive order aimed at increasing drug price transparency.  

State Laws and Regulations

Several states passed extensive new PBM laws. Many of these laws ban spread pricing between PBMs and plan sponsors and require PBMs to submit detailed transparency reports to state insurance departments and/or plan sponsors. 

  • California SB 41 requires PBMs to move to a pass-through pricing model, effectively banning spread pricing and limiting PBM compensation to transparent fees in contracts issued or renewed after 2025. 
  • Connecticut H.B. 7192 requires PBMs to offer health plans the option to be charged the same price for prescription drugs that the PBM pays pharmacies for those drugs.  

Litigation Highlights


A few court decisions this quarter highlight the continuing battle on ERISA preemption: 

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About Serve You Rx®   
Serve You Rx is a full-service pharmacy benefit manager (PBM) with unquestionable flexibility and an unwavering commitment to doing what’s best for its clients. With a fervent focus on those it serves, including insurance brokers, consultants, third-party administrators, and their clients, Serve You Rx delivers exceptional service and tailored, cost-effective benefit solutions. Independent and privately held for nearly 40 years, Serve You Rx can implement new groups in 30 days or less and say “yes” to a wide variety of viable solutions. Known for its adaptability, quality, and client-centricity, Serve You Rx aims to be a benchmark for better client service.