Risks to the 340B Drug Pricing Program—Reply

Abstract

In Reply Pharmaceutical manufacturers have unilaterally adopted a range of policies concerning the delivery of 340B discounted drugs to contract pharmacies, from requiring that certain covered entities submit insurance claims data for 340B drugs dispensed at these locations to limiting the number of contract pharmacies a covered entity can engage. We believe that it is accurate to label the former policy, which imposes a limiting condition, as a restriction. We also believe, contrary to Dr Daifotis’ assertion, that the US District Court for the District of Columbia’s discussion of using insurance claims data “to implement the antifraud audit and dispute resolution provisions” of the 340B statute did not constitute an endorsement of the practice. The court explicitly noted that “[b]ecause the parties had not adequately argued their respective positions” on whether conditions were permitted under the 340B statute, it declined to rule on the issue.¹ Of note, the US District Court for the District of New Jersey referred to a similar policy requiring the submission of insurance claims data as a restriction and held that the policy violated the 340B statute.²