PBM Policy And Legislative Update — Spring 2026

The PBM regulatory landscape is evolving rapidly at both the federal and state levels, making it critical for our 
clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team 
actively monitors these to provide you with this quarterly PBM Policy and Legislative Update. This update builds 
on prior issues and highlights federal and state activity from October 2025 to mid-February 2026.  

Federal Legislative Activity

Congress Enacts Landmark PBM Reforms in the 2026 Spending Bill. On February 3, 2026, Congress passed  –  and  the  President  signed  – the Consolidated Appropriations Act, 2026 (CAA 2026). The legislation includes a long-anticipated

and far-reaching package of PBM reforms. These reforms draw from the PBM Reform Act of 2025 and other legislative proposals and will significantly reshape PBM operations across the commercial market and Medicare Part D beginning in 2028– 2029. The reforms center on rebate pass-through, increased transparency, standardized reporting, and expanded federal oversight. Stakeholders should begin preparing for material operational and contractual changes well ahead of the effective dates. See our blog post for more information.

DOL Proposes New PBM Fee Disclosure Rule. On January 30, 2026, the Department of Labor released a proposed rule that would end long-running confusion about how ERISA disclosure obligations apply to PBMs under the Consolidated Appropriations Act, 2021, and give fiduciaries of ERISA-covered self-insured group health plans significantly expanded visibility into PBM services and compensation. The proposal pairs broad compensation transparency with comprehensive audit rights covering PBMs and their affiliates, agents, and subcontractors, including PBM-affiliated brokers and consultants. See our blog post for more information.

// Featured Webinar Recording

PBM Reform 2026: What Recent Legislation Means for the Industry

PBM reform 2026 is reshaping how PBMs and plan sponsors operate, as

Congress and federal agencies introduce new compliance requirements and enforcement standards. With multiple reforms moving forward at once, many organizations are asking: what changed, what’s required, and what comes next?

Mintz attorneys led a practical discussion on what these changes mean for

organizations. They broke down the key provisions of the CAA 2026 PBM reforms, explored the DOL’s proposed rule and its implications for plan sponsors and

PBMs, examined recent FTC settlements, and assessed how the administration’s drug pricing initiatives might shape the market going forward.

Watch the webinar recording to gain practical insights into navigating PBM reform and preparing for what’s next.

Break Up Big Medicine Act Reignites Debate Over Vertical Integration. Senators Warren and Hawley introduced the Break Up Big Medicine Act, which proposes structural separation requirements across multiple segments of the health care market. Compared to the earlier Patients Before Monopolies Act, the Break Up Big Medicine Act includes broader bans on common ownership between insurers, PBMs, pharmacies, wholesalers, and a wide range of health care providers. It would also accelerate divestiture timelines, introduce new private rights of action, and authorize treble damages. Although the bill’s prospects remain uncertain, its introduction reflects bipartisan interest in addressing consolidation across the health care delivery and financing ecosystem.

Senate Finance Committee Democrats Outline 2026 Drug Pricing Priorities. Senate Finance Committee Democrats circulated a policy letter outlining their goals for lowering drug costs. Priorities include expanding Medicare’s negotiation authority, incorporating international prices as reference points within the negotiation process, accelerating negotiation timelines, and addressing generic drug price markups. The letter also calls for delinking PBM compensation from list prices and improving cost-sharing alignment for patients. Committee staff indicated that draft legislative text would follow later in the year.

Congress Intensifies Scrutiny of PBMs and Drug Supply Chain Practices. Congress continued high- profile oversight of the prescription drug supply chain in early 2026, with the House Committee on Energy & Commerce Health Subcommittee holding a wide-ranging hearing on February 11. Witnesses from pharmaceutical manufacturers, PBMs, wholesalers, GPOs, community pharmacies, and employer groups described a system defined by consolidation, limited transparency, and conflicting incentives. Members of both parties pressed PBM executives on formulary design, rebate structures, offshore GPO arrangements, and reimbursement practices that independent pharmacies say pay below acquisition cost. Lawmakers on both sides expressed interest in increasing transparency and strengthening biosimilar competition, while noting that newly enacted PBM reforms in the FY2026 appropriations bill will require continued oversight as implementation progresses.

The February 11 hearing was the second in a three- part subcommittee series on health care affordability. The first, held January 22, featured testimony from CEOs of several major insurance companies, who faced bipartisan criticism on some of the same themes, particularly vertical integration and related consolidation concerns. A third hearing, focused on health care providers, was held in March.

House Judiciary Staff Report Highlights Concerns About CVS Practices. The House Judiciary Committee released an interim staf f report describing  CVS’s  actions  to  limit  independent pharmacy use of hub services and digital pharmacy platforms. The report asserts that CVS leveraged network contracts, audits, and cease-and-desist letters to discourage pharmacies from partnering with competing service providers, raising questions about the impact of vertical integration on competition. According to the report, CVS asserted that its oversight efforts were driven by plan sponsor fraud allegations and were not designed to single out competing pharmacy support platforms. The findings signal growing congressional concern about cross-entity ownership structures and their effects on patient access and pharmacy choice.

CMS Advances Drug Pricing Reform Through Four CMMI Models. The CMS Innovation Center announced several models aligned with the Trump administration’s  drug  pricing  initiatives.  The proposed models outline frameworks targeting different areas of federal health programs and introduce new ways to address the cost of high‑spend drug therapies:

• GLOBE (Global Benchmark for Efficient Drug Pricing). Mandatory rebates for certain Medicare Part B drugs if US prices exceed those paid in economically comparable countries, targeting high‑cost drugs administered in clinical settings such as oncology and autoimmune therapies.
• GUARD (Guarding US Medicare Against Rising Drug Costs). Mandatory rebates for certain Medicare Part D drugs if the US prices exceed those paid in economically comparable countries.
• GENEROUS (Generating Cost Reductions for US Medicaid). A voluntary supplemental model under which manufacturers, through CMS-led negotiations, will provide supplemental rebates to participating states for certain drugs to align Medicaid net prices with prices paid in certain other
• BALANCE (Better Approaches to Lifestyles and Nutrition for Comprehensive Health). A voluntary model that seeks to expand access to GLP‑1 medications alongside  lifestyle  interventions, aiming to prevent chronic disease and reducing the potential financial barriers to GLP‑1 access in Medicare and Medicaid. Additionally, the BALANCE model seeks manufacturer commitment to participate in lifestyle-focused patient interventions.

Collectively, the CMMI models further signal the administration’s commitment to formalizing international reference-based drug pricing as a federal policy tool and aim to embed global price comparisons into Medicare and Medicaid. For manufacturers, the proposed models signal continued scrutiny of US drug prices, along with the risk of substantial rebate obligations tied to international pricing benchmarks. In comments to CMS, industry groups (e.g., PhRMA and BIO) strongly opposed the models and questioned CMS’s authority to implement them, signaling that legal challenges are likely.

FTC UPDATES

On February 4, 2026, the FTC announced a settlement with Express Scripts Inc. (ESI) resolving its 2024 lawsuit alleging that ESI’s rebate practices were uncompetitive and led to the artificial inflation of insulin prices.

As part of the settlement, ESI agreed to, among other things:

• Stop preferring high-WAC drugs over low-WAC alternatives on its standard formulary
• Provide standard offering that ensures members’ OOP costs are based on drug’s net price, not list price
• Provide plans and beneficiaries with access to TrumpRx as part of its standard offering
• Provide a standard offering that allows plans to transition off rebate guarantees and spread pricing
• Delink manufacturer’s compensation to ESI from list prices as part of its standard offering
• Increase transparency with drug-level reporting
• Standard offering to include retail pharmacies will receive cost-plus reimbursement
• Move Ascent Health Services GPO from Switzerland to US
• Promote standard offerings to plans & retail pharmacies
• Increased Oversight, Access, and Enforcement by the FTC, including compliance with multiyear monitoring requirements, submission 0f compliance reports as required by the FTC, cooperation with litigation in certain contexts, and granting FTC access to facilities, personnel, and records as FTC deems necessary

These requirements align with federal PBM reform activities and will transform ESI’s offering. We expect CVS and Optum Rx to enter into similar settlement agreements.

Since we went to publication, CVS announced that it reached a settlement in principle with the FTC, which was sent to the Commission for review on March 23, 2026.

Click here to read the full report.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.