340B Drug Pricing Program:  The 340B Drug Pricing Program is a U.S. federal program created in 1992 that requires drug manufacturers participating in Medicaid to sell outpatient drugs at significantly discounted prices to eligible healthcare organizations, such as safety-net hospitals and community clinics, called “covered entities”.  The Purpose of this program is to help these safety-net providers stretch limited resources and to allow these providers to offer more comprehensive care to low-income/uninsured patients, support community health services, and reduce medication costs for vulnerable patients.

However, the 340B Program has a lack of transparency and accountability. The law does not require covered entities (hospitals/clinics) to show how they spend revenue from 340B discounts, or even to pass savings directly to low-income/uninsured patients.  It often unclear whether the program benefits the people it was designed for — or whether profits are diverted elsewhere.  The program’s structure effectively allows a covered entity to “buy low (at 340B discounted price), sell high (bill insurers or payers at full price)”, thus creating a profit incentive rather than a cost-saving incentive.  There is no statutory provision defining clearly which patients must benefit from 340B discounts.

ACCESS Act:  The 340B ACCESS Act (H.R. 5256) was introduced September 10, 2025, by Rep. Buddy Carter (GA-1) and co-sponsored by Rep. Diana Harshbarger (R-TN).   Its full title is the “340B Affording Care for Communities and Ensuring a Strong Safety-net Act.”   This bill aims to reform the 340B program — changing eligibility, oversight, and how benefits are delivered — rather than expand it.

If enacted, the bill would:

  • Make 340B governed strictly by federal law, overriding the patchwork of state laws that currently regulate contract pharmacy arrangements — effectively centralizing control over 340B eligibility and operations.
  • Institute patient-affordability safeguards: e.g. require hospitals/covered entities to use sliding fee scales for low-income/uninsured patients and prohibit aggressive medical-debt collection against such patients when 340B discounts apply.
  • Tighten eligibility requirements for which hospitals and “child sites” can participate in 340B, presumably limiting access to what supporters’ call “true safety-net providers.”
  • Limit and regulate “contract pharmacies” (third-party or retail pharmacies that many covered entities use to dispense 340B-discounted drugs). The bill would restrict contract-pharmacy use to designated service areas and tighten oversight of how and where 340B drugs are dispensed.
  • Create a national data clearinghouse & require data reporting. Covered entities would need to submit detailed claims-level data to a new neutral clearinghouse. This is intended to increase transparency about who gets 340B-discounted drugs, what drugs, how often, and to whom.

The Mended Hearts, Inc., the nation’s largest peer-to-peer support organization for cardiovascular disease patients and families, thanks Congressman Buddy Carter for introducing the 340B ACCESS Act.  This important legislation helps protect the 340B program so that true safety-net hospitals and clinics can continue delivering lifesaving medications, cardiac care, and support services to patients who need them most—especially in rural and underserved communities.