PhRMA Petition to HHS for Rulemaking Regarding an Administrative Dispute Resolution Process for the 340B Drug Pricing Program

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PhRMA petitioned the Secretary of the Department of Health and Human Services and the Administrator of the Health Resources and Services Administration (HRSA), as well as the Director of HRSA’s Office of Pharmacy Affairs, to issue a new proposed rule establishing an administrative dispute-resolution (ADR) procedure for participants in the 340B Drug Pricing Program. PhRMA supports the goal of the 340B program, which is to make prescription medicines more accessible to uninsured or vulnerable patients, but there is significant new evidence that the 340B program is plagued by abuses that are undermining that goal and HRSA has been unwilling to hold covered entities accountable for those abuses. As part of this petition, PhRMA reiterated its prior requests that HRSA include a precise definition of “patient” as well as practical audit procedures. Both elements are essential to an efficient ADR process, which is in turn critical to maintaining the integrity of the 340B program and ensuring that the program achieves its intended purpose.

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