The Health Resources and Services Administration (HRSA) issued its proposed omnibus guidance on the 340B Drug Pricing Program in the Aug. 28 Federal Register in the form of a notice with a 60-day comment period.

The proposed guidance seeks “to provide increased clarity in the marketplace for all 340B Program stakeholders and strengthen the [Department of Health and Human Services’] ability to administer the 340B Program effectively” by clarifying, reiterating, and/or modifying existing guidance, memoranda, and practices. The guidance proposes a new definition for eligible patients, requiring that the individual meet specific criteria for the covered entity to access the discounted drug pricing. Among other issues, the proposed guidance addresses contract pharmacy arrangements; eligibility and registration of hospitals and outpatient facilities; drugs eligible for purchase under the program; duplicate discounts; notice and hearing processes for noncompliance; and manufacturer compliance.

HRSA will accept public comment on the proposed guidance through October 27th. Read the proposed guidance here.

Last updated: September 14, 2015