Legal Ease: Key Legislative & Regulatory Updates Impacting Plan Sponsors in 2025

Transparency remains the defining theme in this year’s legislative and regulatory efforts impacting the pharmacy benefit industry. From ownership disclosures to rebate reporting requirements, both federal and state governments are advancing measures aimed at increasing visibility into how pharmacy benefits are priced, managed and reimbursed.  

At Navitus, transparency has never been an afterthought. For more than two decades, we’ve championed a 100% pass-through, transparent model that delivers full visibility into pricing, rebates and discounts. As policymakers sharpen their focus on pharmacy benefits, we continue to equip consultants and plan sponsors with the insights and partnership needed to navigate this evolving landscape. 

In this overview of our national Legal Ease webinar event, we highlight key federal and state developments shaping the conversation around PBM reform – and what they mean for your clients.  

Presented by Robyn Crosson, JD, ARM,
VP of Government Relations
Navitus Health Solutions

Important Federal Updates

Attorneys General Push for PBM Reform

A coalition of 38 state attorneys general recently signed a letter urging Congress to stop pharmacy benefit managers (PBMs) from also owning pharmacies. They expressed concerns about conflicts of interest, steering patients toward PBM-owned pharmacies, and how vertical integration may distort drug prices and negatively impact patients. If adopted, this recommendation could lead to sweeping changes in how PBMs and pharmacy networks are structured. This could also impact efficiencies and positive results experienced from integration. Navitus advocates for disclosure and that no PBM can require a plan sponsor to use their affiliated pharmacy rather than a complete ban.

Federal PBM Reform Bills

At the federal level, we are seeing developments with the potential to reshape PBM operations: 

• Expanded reporting requirements: The proposals include extensive transparency measures, mandating detailed disclosures on pricing and business practices. 
• Medicaid changes: Spread pricing would be prohibited and PBM reimbursement must reflect the National Average Drug Acquisition Cost (NADAC). 
• PBM Act: Pharmacies would be prohibited from being owned by a PBM or insurer. 
• Bona fide fees: The proposed rules would clearly define acceptable compensation through bona fide service fees. 
• Inflation Reduction Act (IRA) pharmacy reimbursement provisions: Specific reimbursement provisions would apply to the reimbursement of negotiated drugs. 

“Transparency in Coverage” Rule 

On February 25, 2025, an executive order provided updated guidance on the “Transparency in Coverage” rule, requiring health insurers and group health plans to: 

• Publish machine-readable files online, detailing in-network rates and historical out-of-network allowed amounts. 
• Provide members with real-time, user-friendly, cost-sharing estimates for all covered services, including prescription drugs.
• Provide paper versions of cost information upon request.

Additional federal guidelines were provided on May 22 in FAQs About the Affordable Care Act Implementation Part 70. Additionally, the Tri-Agencies released a Request for Information Regarding the Prescription Drug Machine-Readable File Requirements in Transparency in Coverage Final Rule. Comments are due 30 days after publication in the Federal.

Executive Orders on Drug Pricing and Competition 

The administration has issued two executive orders in 2025 aimed at increasing transparency and competition in drug pricing and PBM operations. 

Lowering Drug Prices by Once Again Putting Americans First (April 15, 2025): This executive order seeks to address drug pricing issues through a comprehensive evaluation of the pharmaceutical supply chain. Important updates include: 

• By July 19, 2025, the Office of Management and Budget (OMB) and the National Economic Council must submit recommendations to improve drug pricing transparency and competitiveness. 
• By October 12, 2025, the Food and Drug Administration (FDA) will suggest strategies on improving over-the-counter (OTC) drug reclassifications. 
• Department of Labor to propose new Employee Retirement Income Security Act (ERISA) regulations enhancing PBM fee transparency. 
• U.S. Department of Justice (DOJ), Federal Trade Commission (FTC) and Department of Commerce (DOC) to hold public listening sessions and issue recommendations addressing anti-competitive behavior among PBMs. 

Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients (May 12, 2025): This executive order urges pharmaceutical manufacturers to align U.S. drug prices with the lowest prices paid internationally – often referred to as a “most-favored-nation” pricing approach. If implemented effectively, this could substantially lower drug prices domestically. 

TRENDS AND EMERGING ISSUES  

Several additional regulatory trends are shaping pharmacy benefit management in 2025. Plan sponsors should closely monitor the following developments: 

Copay accumulator adjustments: An increased number of states now require that manufacturer coupons count toward a patient’s deductible and out-of-pocket maximums. This discourages the use of generic drugs or moving to lower cost alternatives, and also means that patients are meeting their out-of-pocket maximums more quickly, which leaves the plan sponsor shouldering 100% of all medical and prescription costs, including that higher-cost drug.

Frozen formularies: New state laws require at least 90 days’ advance notice before a drug can be removed from formularies or limit the ability to remove a drug, except for once a year. This means that a plan may not realize the financial benefits of combining lower-cost biosimilars or generics released mid-plan year. This could prevent plans from realizing millions in savings.

Point-of-sale rebates: New proposals would require PBMs to apply a significant portion of rebates – typically 85% or more – directly at the pharmacy counter, reducing out-of-pocket costs for members at the time of purchase, but increasing costs to plan sponsors who normally benefit from the rebates throughout the year.

Prompt payment requirements: New proposals would require PBMs to pay pharmacy claims within a set number of days. Delays or underpayments may result in interest and penalties.  

Utilization management restrictions: Legislation is increasingly limiting prior authorization requirements for certain drugs, including insulin, inhalers and substance-use disorder treatments. 

Vertical integration restrictions: Some states are explicitly prohibiting PBMs from owning pharmacies to reduce perceived or actual conflicts of interest. This can reduce competition and result in fewer patient options to access care.

Reimbursement standards: States continue to fix pharmacy prices — often mandating NADAC plus minimum dispending fees or wholesale acquisition cost (WAC)-based reimbursements.

Navitus Actions and Your Next Steps

At Navitus, we actively engage with policymakers to support transparency and advocate for responsible policies that will lead to lower health care costs. In 2024, we participated in 228 legislative meetings and submitted comment letters to 17 state and federal agencies. 

As advisors and plan sponsors, you play a critical role in this evolving environment. Here’s how you can take action:  

• Actively engage with your clients and local legislators 
• Voice your concerns and ask questions to stay ahead of regulatory changes 
• Stay informed through Navitus updates, newsletters and webinars 

Learn More

For more information on how these developments may affect your clients and your strategic planning, please reach out to [email protected].