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Premier Comments on Senate Draft Legislation to Reform 340B

Premier submitted comments in response to a bipartisan Senate discussion draft of legislation to reform the 340B drug discount program, the Supporting Underserved and Strengthening Transparency, Accountability and Integrity Now and for the Future of 340B Act or “SUSTAIN 340B Act.” Premier applauded the Senators for adopting our recommendations to codify that 340B covered entities may dispense covered outpatient drugs through contract pharmacies, require manufacturers to offer each covered outpatient drugs at or below the applicable ceiling price regardless of when a covered outpatient drug is dispensed through a contract pharmacy, and impose civil monetary penalties on drug manufacturers that refuse to offer, sell or deliver eligible 340B drugs. Premier also urged the Senators to make improvements to these provisions by:

  • Ensuring these requirements apply to all covered outpatient drugs subject to an agreement with limited distribution drugs except those that under FDA REMS requirements;
  • Removing the registration and contract review requirements;
  • Prohibiting contract pharmacies from discriminating against covered entities that are unwilling to enter into contract pharmacy arrangements with pharmacies that are not expected to provide meaningful pharmacy services to the covered entities’ patients; and
  • Delaying the requirement for covered entities to extend their financial assistance programs to dispensing by contract pharmacies for two years.

Among other comments on the draft legislation, Premier also recommended that:

  • The SUSTAIN 340B Act either not codify a definition of “patient” or codify HRSA’s 1996 patient definition;
  • Reporting requirements be limited to qualitative information describing covered entities’ 340B savings spending;
  • Changes to provisions intended to prevent duplicative discounts; and
  • Oversight of the 340B program be equitably weighted between manufacturers and 340B entities.
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