August 21, 2015—The Health Resources and Services Administration should clarify in a forthcoming 340B program rule that drugmakers must give refunds for all overcharges on 340B drugs above a reasonable dollar amount and within a reasonable amount of time after their discovery, including those due to routine average manufacturer price “true-ups,” groups representing healthcare providers urged in a public filing this week. They said HRSA also should clarify that providers are not required to request such refunds or credits.
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