Lawmakers Seeking Stakeholder Input to Improve 340B Drug Pricing Program

A group of bipartisan lawmakers is seeking feedback from stakeholders on how Congress can improve the 340B Drug Pricing Program and ensure transparency and stability within the program.

US Sens. John Thune (R-SD), Debbie Stabenow (D-MI), Shelley Moore Capito (R-WV), Tammy Baldwin (D-WI), Jerry Moran (R-KS), and Ben Cardin (D-MD) are members of the Senate 340B bipartisan working group. The letter sent to stakeholders requested input on policy solutions that will help the 340B program continue supporting entities and eligible patients.

Under the 340B program, eligible healthcare organizations can receive outpatient drugs at discounted prices from drug manufacturers. Organizations are then supposed to invest the savings from the discounts into resources and services for low-income and rural populations.

The 340B program has had bipartisan support since its inception. The lawmakers noted they had heard concerns recently from stakeholders about ambiguity and a lack of oversight in the program.

The Health Resources and Services Administration (HRSA), which administers the 340B program, issued guidance over ten years ago allowing covered entities to dispense 340B drugs through contract pharmacies, as many entities do not have in-house pharmacies. However, the current 340B statute does not say the same, creating ambiguity in the treatment of drugs dispensed through contract pharmacies.

Some drug manufacturers have refused to offer 340B discounts on outpatient drugs dispensed at contract pharmacies, negatively impacting healthcare providers and their patients.

The letter also referenced stakeholder concerns about 340B program integrity measures and if the program is truly serving eligible patients as initially intended.

In response to these issues surrounding the program, the lawmakers are seeking feedback on ways to improve the operation and oversight of contract pharmacies, increase accountability of covered entities, and ensure transparency in the program.

“Our goal is to ensure the 340B program has improved integrity and stability, and that it continues to enable eligible healthcare providers to stretch federal resources to better provide healthcare for the patients they serve,” the lawmakers wrote. “We encourage stakeholders to provide information that will help Congress further the original intent of the program, strengthening the program’s ability to support entities serving eligible patients.”

The letter invited stakeholders to submit written responses to the following questions by July 28, 2023.

1. What specific policies should be considered to ensure HRSA can oversee the 340B program with adequate resources? What policies should be considered to ensure HRSA has the appropriate authority to enforce the statutory requirements and regulations of the 340B program?

2. What specific policies should be considered to establish consistency and certainty in contract pharmacy arrangements for covered entities? 

3. What specific policies should be considered to ensure that the benefits of the 340B program accrue to covered entities for the benefit of patients they serve, not other parties?

4. What specific policies should be considered to ensure that accurate and appropriate claims information is available to ensure duplicate discounts do not occur? 

5. What specific policies should be considered to implement common sense, targeted program integrity measures that will improve the accountability of the 340B program and give healthcare stakeholders greater confidence in its oversight?

6. What specific policies should be considered to ensure transparency to show how 340B healthcare providers’ savings are used to support services that benefit patients’ health?

The lawmakers intend to keep the responses internal and use the feedback to inform future 340B policies.