The world of pharmacy benefits managers (PBMs) is undergoing a significant transformation. Driven by a nationwide push for greater transparency and affordability in healthcare, 2026 is shaping up to be a landmark year for PBM regulation. From Congress to state legislatures, new rules are changing how PBMs operate.
As 2026 gets into full swing, here are the five most important developments you need to know about the evolving PBM regulatory landscape:
1. Transparency is the Dominant Theme
The central force shaping PBM reform is the relentless demand for transparency. Lawmakers, regulators, benefits advisors, and employers are all pushing for a clearer view into how PBMs make money and influence drug prices. This movement is advancing on multiple fronts, including federal legislation, White House executive actions, and state-level bills.
This multi-pronged approach ensures constant pressure on the industry. The continuous news cycle and legal developments keep PBM practices under a microscope, forcing adaptation to a new era of openness and accountability.
2. Federal Government Enacts Major Reforms
The federal government has taken decisive action, with a significant bipartisan bill signed into law on February 3. The new rules are set to reshape PBM operations, particularly for self-funded health plans.
This law introduces critical changes aimed at increasing transparency and controlling costs:
- 100% rebate pass-through: PBMs must pass all rebates and fees from drug manufacturers directly to the commercial group health plans they serve. This aims to ensure savings are realized by employers and their employees.
- Enhanced reporting: PBMs must provide more detailed reports on drug utilization and spending, giving commercial group health plan sponsors unprecedented insight.
- Medicare delinking: The law changes how PBMs are compensated within Medicare, moving them away from traditional models in order to encourage more cost-effective choices.
- Medicare pharmacy networks: The law requires PBMs to offer “reasonable and relevant” terms and conditions open to any willing pharmacy provider.
In a related move, the Department of Labor (DOL) proposed a rule on January 30 to enhance fee disclosure. It would require PBMs to give employer-sponsored health plans a clear picture of all compensation, eliminating hidden fees. The rule is currently in a comment period.
3. The White House Intensifies Focus on Affordability
The executive branch is also focused on lowering drug costs. The administration’s “Great Healthcare Plan,” announced on January 15, outlines a broad strategy for making healthcare more affordable and transparent.
Key components of the plan include ending certain PBM payments to large brokerage firms and mandating greater price transparency from insurance companies and healthcare providers. It also requires insurers to use “plain English” in consumer materials, making it easier to understand benefits and costs. Although a full legislative text has yet to be released, the plan reinforces the government’s commitment to holding the industry accountable.
Additionally, the new TrumpRx online platform launched in February, offers discounted drug pricing for 43 commonly used medications. Right now, discounts available through the site are cash-pay only and not compatible with insurance. Consumers are required to have a prescription to purchase a discounted medication.
4. States Lead the Charge with Aggressive Legislation
State legislatures have been incredibly active in PBM reform. In 2025, over 1,500 bills were introduced, with 300+ enacted and around 500 carrying over into 2026 sessions.
State laws are targeting specific PBM practices with increasing precision:
- Pharmacy reimbursement: States are mandating how pharmacies get paid, often tying reimbursement to national benchmarks like NADAC.
- Rebate pass-through: Mirroring federal action, more states are requiring PBMs to pass manufacturer rebates to plan sponsors.
- ERISA erosion: A growing number of states are attempting to apply their PBM laws to self-funded ERISA plans, which have historically been exempt from state regulation.
- Utilization management: States are placing tighter restrictions on practices like prior authorization and step therapy.
These state-level actions create a complex regulatory map that PBMs and plan sponsors must navigate carefully.
5. Legal Challenges Create Uncertainty
With so many new laws, legal challenges are inevitable. A critical case to watch is in California, where the Pharmaceutical Care Management Association (PCMA) is challenging a law (SB 41) that would impose a fiduciary duty on PBMs, legally requiring them to act in the best financial interest of their clients. The outcome of this lawsuit, expected later in 2026, will have major implications. A victory for California could empower other states to enact similar laws, while a victory for PCMA would limit states’ ability to regulate PBMs serving self-funded plans.
At the federal level, the Federal Trade Commission (FTC) recently announced a settlement with Express Scripts, Inc. (ESI) over allegations of inflating insulin drug prices, requiring ESI to implement new transparency practices by Jan. 1, 2027. Key provisions of the settlement include basing out-of-pocket costs on net drug prices, eliminating spread pricing, disclosing drug costs, and relocating its group purchasing organization to the U.S. by 2028.
An Evolving Landscape
The regulatory environment for PBMs is more dynamic than ever. Federal, state, and legal actions are all converging to reshape the industry in pursuit of greater transparency and affordability. This article is the start of our ongoing series covering these critical developments in 2026. Be sure to check our blog for additional analysis and updates as the year unfolds.
Learn more:
The Four Forces That Shape – and Reshape – Healthcare in 2026, Feb. 2, 2026
Quarterly State-Level Regulatory Update, Oct. 23, 2025
PBM Reform: Changes on the horizon for employer drug plans, March 12, 2025
