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  • Washington Highlights

    Congressional Leaders Send Letters on 340B Program

    Jason Kleinman, Senior Legislative Analyst, Govt. Relations

    Leaders of the Senate Health, Education, Labor, and Pensions (HELP) Committee and House Energy and Commerce Committee sent an Aug. 27 bipartisan, bicameral letter to Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs Director Capt. Krista Pedley, PharmD, MS, on the 340B Drug Pricing Program.

    The letter is signed by Senate HELP Committee Chair Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) along with House Energy and Commerce Committee Chair Greg Walden (R-Ore.) and Ranking Member Frank Pallone (D-N.J.). It expresses strong bipartisan support for the 340B program and urges HRSA to better administer the program.

    The letter calls on HRSA to issue or implement regulations in the three areas where the agency has explicit rulemaking authority: establishing and implementing a binding administrative dispute resolution process for the resolution of certain disputes relating to compliance with program requirements; providing for the imposition of civil monetary penalties against manufacturers that knowingly and intentionally overcharge a covered entity for a 340B drug; and issuing precisely defined standards of methodology for calculation of 340B ceiling prices.

    The letter acknowledges previous requests from HRSA and a proposal in the President’s budget to provide the agency with additional rulemaking authority over the 340B program [see Washington Highlights, June 22]. However, the authors express concern that HRSA is not using its current regulatory authorities and notes that “HRSA action to issue or implement final regulations in an open and transparent process, in collaboration with all relevant stakeholders, could help clarify and update program requirements in pursuit of strengthening access to necessary care and proper administration of the program.”

    Additionally, Chairman Walden, Energy and Commerce Health Subcommittee Chair Michael Burgess, MD (R-Texas), and Energy and Commerce Oversight and Investigations Subcommittee Chair Gregg Harper (R-Miss.) sent an Aug. 30 letter to Medicare Payment Advisory Commission (MedPAC) Chair Francis Crosson, MD, requesting that the commission conduct additional research on hospital consolidation. One of the questions posed to MedPAC is whether the availability of 340B drug discounts create an incentive for hospitals to choose more expensive products in some cases and what the impact would be on Medicare patients’ cost-sharing in those cases. The commission will have 30 days to provide a response to the Energy and Commerce leaders.