WASHINGTON – U.S. Senators Jerry Moran (R-Kan.), John Thune (R-S.D.), Debbie Stabenow (D-Mich.), Shelley Moore Capito (R-W.Va.), Tammy Baldwin (D-Wis.) and Ben Cardin (D-Md.) – all members of the Senate 340B bipartisan working group – today released a legislative discussion draft that includes proposed updates to the 340B program.

Last year, the Senate 340B working group sought input on bipartisan policy solutions that would provide stability and transparency to the 340B program to ensure the program can continue to achieve its original intent of supporting entities serving eligible patients.

“We believe it is necessary to pass legislation in the 118th Congress that provides clarity, transparency and accountability in the 340B program in order to ensure the program remains strong, long into the future,” wrote the senators. “Today, we are releasing a legislative discussion draft in an effort to address areas of concern in the program and achieve these goals. While our discussion draft aims to address the key areas, we asked stakeholders about in our RFI, in light of comments from stakeholders, recent court decisions and developments in the program we are also seeking more information on additional areas, specifically: patient definition, child sites and contract pharmacy arrangements.”

The 340B program has been critical to Kansas hospitals, health centers and safety-net providers by allowing them to provide quality care to patients and communities. The program requires that drug manufacturers who participate in Medicaid and Medicare provide certain non-profit health care providers, hospitals and clinics (covered entities) a discount on outpatient drugs. The 340B program enables covered entities to use these savings to provide more comprehensive services to eligible patients and their communities.

Find additional background on the discussion draft here.

Full letter below:

To 340B Stakeholders,

As long-time supporters of the 340B program, we believe the program provides a critical benefit to eligible health care providers that enables them to stretch federal resources to provide healthcare services for the patients they serve. However, we acknowledge that there have been concerns from stakeholders about ambiguity in the program and transparency is needed to ensure the program is serving eligible patients as originally intended.

Last year, we began a process to seek information from stakeholders on bipartisan policy solutions to ensure the 340B program has the stability and oversight to continue to achieve its original intention of serving eligible patients. We issued a Request for Information on June 16, 2023, and received over 250 responses from stakeholders. We spent months reviewing these responses and holding additional meetings with stakeholders. We are committed to addressing the concerns that have been raised by stakeholders as part of this process, including HRSA’s authorities and resources; contract pharmacy arrangements; the role of PBMs in the program; duplicate discounts; and the promotion of transparency and program integrity.

We believe it is necessary to pass legislation in the 118th Congress that provides clarity, transparency, and accountability in the 340B program in order to ensure the program remains strong, long into the future. Today, we are releasing a legislative discussion draft in an effort to address areas of concern in the program and achieve these goals.

While our discussion draft aims to address the key areas, we asked stakeholders about in our RFI, in light of comments from stakeholders, recent court decisions, and developments in the program we are also seeking more information on additional areas, specifically: patient definition, child sites, and contract pharmacy arrangements. We have included specific questions in the attached explanatory document.

We request stakeholders submit any comments and edits to the discussion draft in writing no later than April 1, 2024. Responses may be submitted to Bipartisan340BRFI@email.senate.gov. Our intent is to continue to keep these responses internal and they will not be posted publicly. 

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