HRSA- Recertification for Hospital Entities

    The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) is required to recertify all participating covered entities enrolled in the 340B Program annually to ensure covered entities are appropriately listed on the 340B database and that covered entities are in compliance with 340B Program requirements. For the following hospital types (Disproportionate Share Hospitals, Critical Access Hospitals, Pediatric Hospitals, Free Standing Cancer Centers, Sole Community Hospitals, and Rural Referral Centers) recertification will begin August 19, 2013 and end September 13, 2013. Hospital Authorizing Officials and Primary Contacts will receive advanced notification on August 16, 2013 and user names and passwords will be sent to only Authorizing Officials (AO) on August 19, 2013. In addition, OPA suggests the following steps to ensure a smooth recertification: •Print off the 340B recertification User Manual •For those hospital types that require a Disproportionate Share percentage (DSH%), please have on hand your latest filed CMS Medicare cost report Worksheet E Part A. Please be aware that without entering the DSH% and the cost reporting period you will not be able to complete recertification. Pediatric Hospitals will have additional questions in relation to their DSH% calculation. •As a result of the release of the recent orphan drug regulations affected entities (CAH, SCH, CAN, RRC) will be required to answer the following for the parent and all child sites: Orphan Drug Exclusion: 340B hospitals subject to the orphan drug exclusion (i.e., critical access hospitals, free-standing cancer hospitals, sole community hospitals and rural referral centers) are responsible for ensuring that any orphan drugs purchased through the 340B Program are not transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drugs are designated under section 526 of the Federal Food, Drug, and Cosmetic Act. Please choose one of the following: •The hospital will purchase orphan drugs under the 340B Program and maintain auditable records to demonstrate compliance with the orphan drug exclusion. •The hospital cannot or does not wish to maintain auditable records regarding compliance with the orphan drug exclusion and will purchase all orphan drugs outside of the 340B Program regardless of the indication for which the drug is used and will not use a Group Purchasing Organization (GPO) to purchase those drugs if the hospital is a free-standing cancer hospital. •The AO alone is responsible for completing the recertification process for all parent and child sites on-line during recertification. •We strongly suggest that the AO update their email spam filter to allow emails from ( to ensure the username and passwords arrive. If you encounter any issues with the 340B Program database or have questions about recertification, please have your 340B ID ready and contact or (888) 340-2787.