Last week, Apexus published a tool which states for the first time HRSA’s policy that all non-FQHC federal grantees are required to register each of their off-site locations as separate covered entities with unique 340B IDs in the Office of Pharmacy Affairs Information System (OPAIS), regardless of whether the locations are part of the same legal entity or operate under the same grant or subgrant. The practical consequence of this policy is that each location must maintain a separate 340B drug inventory and enter into separate contract pharmacy agreements. Apexus had previously informed some covered entities about this policy in informal conversations, but neither HRSA nor Apexus had published the policy through guidance, FAQs, or otherwise. We have recently been informed by Apexus that the guidance provided within this tool comes directly from HRSA.
HRSA acknowledges that there are situations in which sharing 340B inventory across the covered entity’s locations may be necessary. The tool provides instructions to assist non-FQHC grantees in submitting a proposal to implement a combined purchasing and distribution model to share 340B inventory across clinic locations.
The request letter must contain the following four main elements:
Powers is preparing a template request letter and accompanying policies and procedures to conform to the new tool. We hope to distribute the document to interested clients in early December.