Recertification (340B)
Definition
HRSA requires all 340B covered entities to complete an annual recertification process through OPAIS. During recertification, an authorizing official from the covered entity certifies the accuracy of the entity’s registration information, confirms continued eligibility, and attests to compliance with program requirements, including the GPO Prohibition for applicable hospital types.
Recertification windows are entity-type specific and occur at designated times during the year. Missing a recertification deadline can result in the covered entity being terminated from the program. Entities must review and update all registered sites, contract pharmacies, and Medicaid billing designations before certifying.
Recertification is not a passive checkbox exercise. It is an opportunity to audit the accuracy of OPAIS data, confirm that all registered sites remain eligible, and ensure that contract pharmacy and Medicaid billing information reflects current operations. Errors discovered post-recertification can be more difficult to remediate.
Frequently Asked Questions
Why Recertification (340B) Matters
Recertification is a formal attestation to HRSA. Certifying inaccurate information—even unintentionally—creates compliance risk. Covered entities should treat recertification as a structured review process, not just an administrative task.
How Virtue 340B Uses It
Virtue 340B helps covered entities prepare for recertification by reviewing OPAIS data accuracy, confirming site eligibility, and identifying any discrepancies between registered information and actual operations before the recertification window opens.