CHA News

HRSA Issues Proposed Guidance for 340B Drug Pricing Program

This post has been archived and contains information that may be out of date.

The Health Resources and Services Administration (HRSA) has released “mega guidance” for its proposed 340B Drug Pricing Program. The guidance is included in a notice with a 60-day comment period. In the guidance, HRSA provides clarification on the areas of covered entity eligibility, patient definition, group purchasing organization prohibition, contract pharmacy, duplicate discounts and covered entity audits. It also includes enhanced program integrity requirements for pharmaceutical manufacturers participating in the program. CHA is reviewing the proposed guidance and will seek member input on the anticipated hospital impact. Comments are due Oct. 26.