Federal Bill of the Month: September – H.R. 5256 – 340B ACCESS Act

H.R. 5256, the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act), introduced by Rep. Buddy Carter (R-Ga.), reforms the 340B drug pricing program to address issues such as patient definition, duplicate discounts, and additional oversight.

Originally created under the Veterans Health Care Act of 1992 (P.L. 102-585), the 340B drug pricing program was intended to assist vulnerable populations by providing access to discounted medications. However, the program has strayed far from its original intent, with profits diverted from patients, and taxpayers ultimately footing the bill.

This legislation would establish patient affordability requirements, ensuring low-income and uninsured patients benefit directly from 340B. Without these requirements, hospitals and covered entities have been permitted to pocket savings that were intended to go to patients. H.R. 5256 would also codify a detailed patient definition into law, specifying which drugs qualify for 340B pricing to provide much-needed oversight.

Importantly, the 340B ACCESS Act would increase transparency of the program by authorizing the Department of Health and Human Services (HHS) Secretary to audit how covered entities use their 340B profits in addition to requiring 340B hospitals to report comprehensive financial data.

Regarding child site eligibility, the 340B ACCESS Act would establish clear statutory standards and require covered entities to demonstrate that each site satisfies the new standards prior to participating in 340B, ensuring that qualifying locations are serving the intended patients. Under existing guidelines, child sites lack eligibility requirements concerning the treatment of low-income or vulnerable patients and charity care.

The Congressional Budget Office’s September 9th report on the 340B program is just the latest confirmation that the program has increased costs for taxpayers. The report found that 340B costs state and federal taxpayers an estimated $6.5 billion per year due to lost Medicaid rebates. The time is now to reform the misused and abused 340B drug pricing program, and if enacted, the ACCESS Act would implement much-needed reforms and restore much-needed integrity to the program.

It is for these reasons, among others, that TPA is proud to make H.R. 5256, as introduced by Rep. Buddy Carter, its Bill of the Month for September 2025.