340B University with slides, notes and other tools
The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB), Office of Pharmacy Affairs (OPA) is providing additional information to non-health center grantees who do not share a 340B ID but wish to share inventory. Section 340B(d)(2)(B)(iv) of the Public Health Service Act provides that the Secretary of Health and Human Services establish a single, universal, and standardized identification system by which each covered entity site can be identified by manufacturers, distributors, covered entities, and the Secretary for purposes of facilitating the ordering, purchasing, and delivery of covered outpatient drugs under the 340B Program, including the processing of chargebacks for such drugs.
In accordance with the statute, HRSA has established unique 340B IDs for stakeholders to confirm eligibility and appropriate shipment of 340B drugs. Each covered entity is assigned a unique 340B ID once they are approved for participation in the Program and is considered a separate entity for purposes of the 340B Program. HRSA assigns 340B IDs in order for stakeholders to confirm eligibility and appropriate shipment of 340B drugs. Due to the complex nature of grantees (other than health centers) and their organizational structures and relationships, the sharing of 340B inventory across 340B IDs is not allowed unless first approved by HRSA. Since these types of covered entities do not have associated site or parent/child relationships in OPAIS, they each have distinct 340B IDs and generally may not share inventory or purchase on a single account.
HRSA recognizes that these covered entities may want to purchase under one account and share inventories due to various organizational structures and relationships. A CPD model may assist with meeting an entity’s specific organization needs. The Grantee Combined Purchasing and Distribution Request (DOCX - 60 KB) tool is currently available to assist covered entities with submitting a proposal to HRSA for review of a CPD model. HRSA will review the information provided prior to allowing the covered entities to conduct such a model.
Consider the following elements before submitting models to HRSA for review:
- Entities who share the same 340B entity type and grant number may be best positioned for this type of proposal (for example, a state STD program who purchases on a single account and distributes to the local health departments or STD clinic throughout the state);
- CPD model proposals should clearly state how 340B Program compliance elements are met and auditable records are kept; and
- The entity (340B ID) which is responsible for the combined purchasing is accepting responsibility for all 340B Program compliance for drugs purchased through this model and should be able to ensure that any receiving entities are also in compliance with the Program requirements.