CHA News Article

340B Drug Program Regulation Withdrawn
Would have established tight controls on qualifying for prescription discounts

This week, the Office of Management and Budget withdrew a pending regulation for the 340B drug program that would have tightened controls on which patients, drugs and providers qualify for steep discounts on prescription medicines. CHA previously submitted a comment letter on the guidance, which was released in August 2015, urging the Health Resources and Services Administration (HRSA) to consider several important changes to the guidance so that hospitals could continue to stretch scarce federal resources as far as possible. Specifically, CHA urged HRSA to change the proposed definition of an eligible patient and an eligible drug; accept alternative forms of documentation to show that a clinic is an integral part of the hospital; reduce the burdensome audit requirements associated with contract pharmacy arrangements; and limit all disclosures to those that rise to the level of being material.

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