Hospital Annual Recertification
HRSA will hold its annual recertification process for 340B hospitals starting on August 16 and ending at midnight on September 13. All hospitals participating in 340B as of August 16 without a termination date after September 13 are required to complete the recertification process in the HRSA Office of Pharmacy Affairs Information System (OPAIS).
340B covered entities must annually recertify their eligibility to remain in the 340B Drug Pricing Program and continue purchasing covered outpatient drugs at discounted 340B prices.
Advance email notifications with preliminary information about the recertification process are sent to the following contacts:
- Primary Contact
- Authorizing Official
Once the recertification period begins, the Authorizing Official only has access via their user accounts to perform recertification. The Authorizing Official will be required to log into the 340B OPAIS, update information as needed and attest to the covered entity’s compliance with 340B Program requirements.
The covered entity must ensure the contacts listed in the 340B database are accurate at all times to receive all recertification notifications.
Why? 340B statute requires the annual recertification of covered entities Failure to recertify may lead to removal from program
Who? Applies to ALL covered entities, child sites, and contract pharmacies in the 340B Program and without a future termination date as of the start of recertification period
How? Recertification is a two-step process:
- Confirm hospital information in OPAIS is correct
- AO attestation that certifies hospital is eligible and will comply with all 340B requirements including notice of eligibility changes or self-disclosures
All CEs must recertify annually that:
✓ Information in OPAIS is complete, accurate, and correct
✓ Meets eligibility requirements
✓ Will comply with all program requirements
✓ Maintains auditable records related to compliance with program requirements
✓ Any contract pharmacy arrangements will comply with program requirements and guidelines
✓ Will notify OPA regarding change in program eligibility or noncompliance
✓ May be liable to manufacturer for breach of program requirements and, depending upon circumstances, may be removed from the program