New 340B Registration and Recertification Requirements

The Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) is introducing new requirements and enhancements to the new covered entity registration and recertification in the 340B Office of Pharmacy Affairs Information System (340B OPAIS). These new requirements and enhancements became effective in the registration component of 340B OPAIS beginning August 1, 2020. Some of the requirements/enhancements only impact certain entity types.

The Medicaid billing question is modified as follows: “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?” This change was made to clarify that the question is specific to Medicaid fee-for-service to a covered entity site and to clearly delineate each Medicaid state that is billed for 340B drugs, and the billing number(s) listed on the bill to the Medicaid state. For more information, please review the OPA Program Update – July 2020.