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Steps to Prepare for Upcoming Annual 340B Recertification

The Office of Pharmacy Affairs (OPA) at the Health Resources and Services Administration held a call with America’s Essential Hospitals and other hospital associations to relay important information regarding the annual 340B recertification process tentatively scheduled to begin Aug. 19. Participating 340B hospitals should already have received a general communication from OPA about the process. In addition, OPA held a conference call for 340B hospitals and has posted the slides and audio, including a question and answer session. We encourage hospitals to review the presentation and OPA’s recertification user guide as soon as possible.

  • OPA’s materials include guidance on steps that should be taken prior to the start of recertification in August. While technical, these steps could impact participation in the program.
  • Once the 340B authorizing official receives official information about the start of recertification, hospitals must complete the process within four weeks or will be removed from the program.
  • Hospitals should review the attestation language their organization will be asked to certify (included in OPA’s slides). The language includes certification of compliance with the group purchasing organization (GPO) replenishment guidance, which is required by Aug. 7.

OPA asks that questions be submitted through its contractor, Apexus, although hospitals can also contact OPA directly at 301-594-4353. Please contact America’s Essential Hospitals with concerns about recertification substance or process so we can seek clarification and address issues prior to recertification deadlines.


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