9/15/2025 – House Republicans Reintroduce “340B Access Act”

On September 10th, 2025, Representatives Carter (R-GA) and Harshbarger (R-TN) reintroduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (340B ACCESS Act). The partisan bill, previously introduced last Congress, was largely panned by the 340B covered entity community.

The bill is based on principles advocated for by ASAP 340B, a group spearheaded by the trade association PhRMA and previously the National Association of Community Health Centers (NACHC). NACHC indicated that it no longer supports the legislation this Congress, stating that the bill has “major flaws.”^[1]

The bill’s language, nearly identical to the bill from last year, proposes significant changes to the 340B program, including

• • Narrowing the intent of the 340B program to a program that solely increases access to affordable drugs;
  • Requiring hospitals to implement mandatory sliding fee scales;
  • Requiring grantees to provide “sufficient” discounts to patients;
  • Applying the patient definition on a prescription-by-prescription basis;
  • Limiting the use of contract pharmacies to designated service areas;
  • Requiring covered entities to submit certain claims level data to the Secretary and a newly established national clearinghouse; and
  • Establishing that the 340B program is governed exclusively by federal law, nullifying all nineteen (19) state laws enacted to protect covered entity contract pharmacy arrangements.

The bill was introduced just one day after the Congressional Budget Office (CBO) released a report concluding that the 340B program “encourages behaviors . . . that tend to increase federal spending.” CBO concludes that the “evidence about the behaviors is limited” and “the magnitude of their effects is unknown,” undermining the credibility of the report’s findings. Supporters of the 340B program have long asserted that the program saves taxpayer dollars.^[2]

The report contends that “the 340B program mainly affects the federal budget by encouraging behaviors that tend to increase federal spending because they lead to higher prices or an increased use of drugs and other health care services,” citing the following “behaviors”

• • Clinicians prescribe more drugs and drugs that cost more.
  • Pharmaceutical manufacturers reduce rebates for 340B drugs.
  • Participating facilities expand the services they provide.
  • More hospitals and off-site clinics integrate.

The CBO report was requested by the Republican chairs of the House Energy and Commerce committee (Brett Guthrie (R-KY)) and the Senate HELP committee (Bill Cassidy (R-LA)). Representative Carter (R-GA) used the CBO report as a primary talking point in advocating for reintroduction of the new bill.  Sponsors Carter and Harshbarger (R-TN) stated that the bill is necessary to “ensure patient access to affordable, quality health care” and to “protect and strengthen” the 340B program “for rural and safety net providers.”

This legislation stands in stark contrast to draft bipartisan legislation – Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act (SUSTAIN Act), legislation expected to be advanced by the Senate 340B Working Group this Congress. The Senate 340B Bipartisan Working Group – Senators Moran (R-KS), Baldwin (D-WI), Capito (R-WV), Kaine (D-VA), Mullin (R-OK), and Hickenlooper (D-CO) – solicited input from all 340B stakeholders beginning in June of 2023.

Unlike the 340B Access Act, the SUSTAIN Act is the more likely legislative vehicle for any 340B changes given the 340B program’s bipartisan support in Congress and strong, now unified, opposition from all leading 340B covered entity associations against the 340B ACCESS Act.

Powers will continue to closely monitor these legislative proposals.

^[1] See Shannon Young & William Newton, Carter, Harshbarger Reintroduce Controversial 340B ACCESS Act in U.S. House—This Time Without a Key Supporter, 340B Report (Sept. 10, 2025), https://340breport.com/carter-harshbarger-reintroduce-controversial-340b-access-act-in-u-s-house-this-time-without-a-key-supporter.

^[2] See Touchstones and Truths for the Public and Policymakers, Community Voices for 340B, https://cv340b.org/4-truths-about-340b.