Rep. Earl L. “Buddy” Carter (R-GA) and Rep. Diana Harshbarger (R-TN) have introduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act, known as the 340B ACCESS Act. The bill aims to increase oversight and transparency in the federal 340B drug pricing program, which allows certain hospitals and clinics to buy prescription drugs at reduced prices.
The legislation follows a recent report from the Congressional Budget Office that found the 340B program is costing taxpayers and lacks evidence of direct benefits to patients.
“340B was intended to give low-income and vulnerable patients access to affordable medicines. The program has rapidly expanded, and a lack of transparency has allowed some entities to pocket the savings without passing them on to patients. Congress must act to restore the integrity of the program to better protect vulnerable patients served by safety-net providers. The 340B ACCESS Act will save lives and improve outcomes by ensuring patient access to affordable, quality health care. I want to thank Rep. Harshbarger for joining me to fix the 340B drug pricing program for Georgians and all Americans,” said Rep. Carter.
“340B is a lifeline for safety-net providers serving low-income and vulnerable patients, but gaps in the program have let these discounts be misused and diverted from the goal of better access and lower costs for patients most in need. As a pharmacist, I know how critical it is to keep medicines and care affordable. That’s why I’m proud to partner with Congressman Carter on the 340B ACCESS Act that would implement commonsense reforms to inject much needed transparency and oversight into the 340B program and protect and strengthen it for rural and safety-net providers in Tennessee and across the country,” said Rep. Harshbarger.
The 340B drug pricing program was established in 1992 as a way for hospitals serving low-income or uninsured populations to obtain medications at significant discounts. Over time, its scope has grown significantly, but critics argue that there is insufficient evidence that these discounts are being passed on directly to patients who need them most.
Key elements of the proposed legislation include making sure discounted prescriptions reach eligible patients, updating definitions around patient eligibility, establishing clearer rules for contract pharmacy arrangements, preventing middlemen from profiting excessively from the program, tightening hospital eligibility requirements, creating standards for child site participation, setting up a neutral claims data clearinghouse, requiring public reporting on how funds are used, and strengthening federal oversight.
Specifically, new affordability requirements would ensure that low-income or uninsured patients benefit directly through reduced out-of-pocket costs when they receive medicines via covered entities or their affiliates. Currently there are no such requirements under existing law.
The bill also seeks to clarify who qualifies as a patient under the statute—an area previously defined only through broad guidance—and codifies those criteria into law.
Contract pharmacies would be formally recognized under new statutory rules designed both for manufacturers’ obligations regarding delivery of discounted drugs as well as proper use by covered entities.
Hospital eligibility would be more strictly defined according to hospital type so that only true safety net institutions participate fully in the program.
Additional provisions require covered entities with subsidiary sites (“child sites”) seeking participation in 340B demonstrate compliance with new standards before joining; non-compliance could result in penalties if not properly disclosed or corrected.
Restrictions are also placed on pharmacy benefit managers (PBMs), contract pharmacies, and third-party administrators modeled after earlier legislative efforts aimed at curbing excessive profits among supply chain intermediaries.
Transparency measures require grantees report usage of their savings according to standardized rules similar to those used by federally qualified health centers’ Uniform Data System reporting.
Rep. Buddy Carter has maintained strong electoral support over several election cycles: he won his most recent general election against Patti Hewitt in 2024 with about 62% of votes; previous victories include defeating Wade Herring in 2022 with roughly 59%, Joyce Griggs in 2020 with about 58%, Lisa Ring in 2018 with nearly 58%, and Brian Reese in 2014 with almost 61%.
More information about Rep. Carter’s work can be found at https://buddycarter.house.gov/.
