Glossary Category: Drug Pricing & Pharmacy Operations
These terms explain how 340B pricing works in practice and where operational complexity creates risk, especially in contract pharmacy and TPA workflows. Use these definitions to interpret pricing discussions, purchasing ratios, and compliance controls.
A unique 10- or 11-digit, three-segment number that serves as the universal product identifier for human drugs in the United States, used throughout the 340B program for drug purchasing, eligibility determination, and compliance tracking.
The ongoing oversight and management of all third-party vendors involved in a covered entity’s 340B program, including TPAs, contract pharmacies, split-billing software vendors, and data analytics providers.
Structured education programs that ensure covered entity staff understand 340B program requirements, their specific roles and responsibilities, and the compliance obligations relevant to their positions.
The use of technology systems to automate data collection, eligibility determination, inventory management, and reporting processes in a 340B program, reducing manual effort and improving data accuracy.
The process of linking data elements across multiple systems—such as EHR, pharmacy, and split-billing software—to ensure that patient eligibility, prescriber, and drug information flow correctly to support accurate 340B eligibility determinations.
The address field in OPAIS used to denote the verified address belonging to the covered entity, which may be a P.O. box or mailing address and is not required to be a physical location.
A physical address registered in OPAIS where a covered entity may have 340B drugs delivered, including in-house pharmacies, entity-owned warehouses, and central fill facilities—but not contract pharmacies.
A pharmacy that is owned by and is a legal part of the 340B covered entity, typically listed as a shipping address in OPAIS and used to directly dispense 340B drugs to the entity’s eligible patients.
A covered entity’s election in OPAIS regarding whether it will (carve-in) or will not (carve-out) bill Medicaid fee-for-service for drugs purchased at 340B prices, which determines duplicate discount prevention obligations.
A quarterly file generated by HRSA from OPAIS data that identifies which covered entity sites are billing Medicaid fee-for-service for 340B drugs, used by state Medicaid agencies to exclude those claims from manufacturer rebate requests.