HRSA launches 340B rebate pilot tied to Medicare drug negotiations, signaling major program shifts amid legal rulings and stakeholder concerns.

President Trump issues executive orders and letters to curb drug costs, promote MFN pricing, and reform Medicare’s Negotiation Program.

CMS proposes OPPS payment cuts and a drug cost survey, signaling major 340B reimbursement shifts and renewed scrutiny of hospital payment rates.

States and manufacturers clash over 340B contract pharmacy laws as litigation mounts and courts weigh in on the future of pharmacy access protections.

Senate HELP Committee releases 340B report urging transparency, oversight, and reforms amid uncertainty over future federal legislative action.

U.S. District Court for the Southern District of Iowa issued a comprehensive preliminary injunction blocking enforcement of key provisions of Iowa Senate File 383.

On June 11, 2025, Iowa enacted Senate File 383 (the “Act”), a comprehensive bill aimed at regulating pharmacy benefit managers (PBMs) with the stated goals of increasing transparency, supporting independent pharmacies, and reducing prescription drug costs. However, on June 30, 2025, just one day before the Act’s effective date, the U.S. District Court for the Southern District of Iowa issued a temporary restraining order (TRO), enjoining enforcement of the Act against the lawsuit’s named plaintiffs. The court found that the plaintiffs, a coalition of Iowa employers and ERISA-governed health plans, demonstrated a likelihood of success on the merits of their claims that the Act is preempted by the Employee Retirement Income Security Act of 1974 (ERISA) and violates the First Amendment. The lawsuit aligns with other recent challenges against similar comprehensive legislation and further demonstrates the long-lasting conflict between PBM reform legislation and preemption by federal law.

The PBM Policy and Legislative Update — Spring 2025 edition builds upon prior issues and summarizes activity from January through March (2025) that affects the PBM industry. It highlights federal activities, state activities, and other noteworthy events and trends affecting the PBM industry.

Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these federal actions through our quarterly PBM Policy and Legislative Updates). Despite the rhetoric in Washington about bipartisan support to regulate PBMs, Congress has not been able to pass meaningful PBM reform.  This brings us to the One Big Beautiful Bill (Reconciliation Bill), which includes some PBM measures but remains  far from the sweeping reform Congress previously introduced and  from what we are seeing at the state level. The House passed the Reconciliation Bill on May 22, 2025, with a slim margin of 215 to 214.  The Reconciliation Bill will now move to the Senate, where the Senate will need to approve it with a simple majority for it to become law. 

On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including pharmacy benefit manager (“PBM”) competition and transparency, Medicare and Medicaid drug pricing, international importation, and drug manufacturer competition (the “Executive Order”).

The Executive Order, which is the first significant action taken by the current Administration to address drug prices, echoes initiatives and policy statements announced during the first Trump Administration. However, most of the drug pricing reforms announced during the first Administration were never fully implemented. It is unclear how many of the proposals in this Executive Order will ultimately be implemented, but it does provide the clearest outline yet of the Administration’s policy priorities regarding drug prices.