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:
- A list of all affected 340B IDs and the grant number associated with that 340B ID;
- A description of the relationship between the covered entity’s main site and its satellite clinics;
- Proposed policies and procedures that describes that all 340B compliance elements are met, the inventory management process, articulates how the main site will take responsibility for the compliance of all 340B purchases under that 340B ID, and describes the covered entity’s method for keeping records of all inventory transfers between the main site and its satellite locations; and
- A statement explaining whether the covered entity intends to use the combined purchasing and distribution model for its contract pharmacies, and if so, a list of the pharmacies and a description of how the model will be operationalized in the contract pharmacy setting.
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.