A bipartisan group of senators Feb. 2 released for stakeholder feedback a discussion draft of legislation to clarify in statute Congress’ intent for the 340B program to help safety net providers maintain, improve and expand patient access to health care services by requiring drug manufacturers that participate in Medicaid and Medicare Part B to provide discounts and rebates to covered entities that serve a disproportionate share of low-income and underserved patients. 

The draft Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act or the “SUSTAIN 340B Act” includes provisions intended to clarify that covered entities can use contract pharmacies in accordance with 2010 guidance from the Health Resources and Services Administration and associated requirements; and to clarify the definition of patient in the 340B statute. The draft bill also includes provisions intended to enhance program transparency and integrity and prevent duplicate discounts; and would require participating covered entities to pay a user fee of up to 0.01% of the savings they achieve under the 340B program, calculated as the difference between the wholesale acquisition cost and 340B price of the drugs purchased under the program. 

In an explanatory statement and Request for Information, Sens. John Thune, R-S.D., Debbie Stabenow, D-Mich., Shelly Moore Capito, R-W.Va., Tammy Baldwin, D-Wisc., Jerry Moran, R-Kan., and Benjamin Cardin, D-Md., specifically seek stakeholder feedback on how to achieve the correct balance of patient access, accountability and program integrity in contract pharmacy arrangements; how to appropriately structure the definition of patient; and how to ensure that “child sites” align with the program’s intent. 

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