Trump Administration Weighs 340B Drug Program Transparency Pilot
If the pilot moves forward, it would be the first federal mechanism requiring hospitals to document whether 340B discounts reach the low-income patients the program was designed to serve.
The Trump administration is considering a pilot program that would impose new disclosure requirements on participants in the 340B Drug Pricing Program, a federal initiative established under Section 340B of the Public Health Service Act (42 U.S.C. § 256b) that requires drug manufacturers to sell outpatient medications to qualifying hospitals and clinics at discounts averaging 25 to 50 percent below market price, according to reporting by the Washington Examiner published June 25, 2026.
The 340B program was created by Congress in 1992 to help safety-net providers — including disproportionate-share hospitals, federally qualified health centers, and rural referral centers — stretch federal resources and provide medications to low-income and uninsured patients. The Health Resources and Services Administration (HRSA), the agency within the Department of Health and Human Services that administers the program, reported in its most recent data that more than 50,000 covered entity sites participate in 340B nationally.
Critics of the program, including the Medicare Payment Advisory Commission (MedPAC) in its June 2023 Report to Congress, have documented that a significant share of 340B hospitals do not pass discounts through to patients at the point of sale, instead retaining the spread between the discounted acquisition cost and the full reimbursement rate billed to insurers and Medicare. MedPAC estimated that 340B hospitals received approximately $9.8 billion in discounts in 2021, per that same report, while patient-level benefit tracking has remained largely absent from program requirements.
Hospital industry groups, including the American Hospital Association, have opposed transparency mandates in the past, arguing in public comments submitted during prior HRSA rulemaking proceedings that current reporting requirements are sufficient and that additional disclosure burdens would strain safety-net providers. Drug manufacturers, including members of the Pharmaceutical Research and Manufacturers of America (PhRMA), have separately pursued litigation and congressional lobbying seeking program reforms; PhRMA's 2025 Lobbying Disclosure Act filings, available at lda.senate.gov, recorded $14.2 million in total lobbying expenditures across all issues for that year.
The specific structure, timeline, and statutory authority for the proposed pilot have not been formally announced in the Federal Register as of June 25, 2026, and no notice of proposed rulemaking has been published by HRSA. What remains unknown is which covered entity categories would be included in the pilot, whether participation would be voluntary or mandatory, and how patient-level discount data would be collected and verified. A formal HRSA rulemaking notice or a presidential executive order published in the Federal Register would be the public records that would answer those questions.