HRSA Calls for Comment on Proposed Clarifications to 340B Drug Pricing Program Regarding Contract Pharmacy Arrangements, Patient Definition

The Health Resources and Services Administration (HRSA) today published two notices soliciting public comment in the Federal Register relating to proposed guidelines under the 340B Drug Pricing Program.

“All interested individuals and organizations are encouraged to review the proposed guidelines and submit comments to HRSA prior to the publication of final guidelines,” stated Jimmy Mitchell, Director of HRSA’s Office of Pharmacy Affairs (OPA), which manages the 340B program. “We are committed to hearing the concerns from all parties that might be affected by these proposed clarifications, and we will consider them carefully.”

The first notice seeks to clarify the definition of a 340B-eligible patient under the 340B program. The 340B program requires drugs purchased under the program to be used only for individuals who are patients of the covered entity that purchased the drugs.

The proposed guidelines further clarify the relationship that must exist between a covered entity and an individual for that individual to be considered a patient of the covered entity. If adopted, the proposed guidelines would replace all previous guidance addressing the definition of a patient.

The second notice addresses the use of multiple contract pharmacy arrangements by eligible covered entities. Currently, program guidelines permit each site of an eligible covered entity to contract with a single external pharmacy to provide services to entities’ patients.

The proposed guidelines allow covered entities to contract with multiple pharmacies to dispense 340B outpatient drugs to the covered entity’s patients. The proposed guidelines also allow covered entities with an in-house pharmacy to supplement those services with a contract pharmacy arrangement.

For additional information on the proposed guidelines, view the following supplementary materials (not a U.S. Government web site).

For more information on HRSA’s 340B Drug Pricing Program, access the OPA website.

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