The 2026 to 2027 annual recertification period for 340B covered entity hospitals is expected to begin in mid-August and run through early September. The Health Resources and Services Administration (HRSA) will notify each hospital’s Authorizing Official (AO) and Primary Contact (PC) by email when the 2026 dates are confirmed.
AOs must complete recertification through the Office of Pharmacy Affairs Information System (OPAIS) during this period, attesting that entity information is accurate, eligibility is intact, and the entity complies with all 340B requirements. This includes duplicate discount and diversion prohibitions, child site registrations, and contract pharmacy arrangements.
Covered entities that do not recertify are terminated from the 340B program, which can mean losing a year or more of discounted drug pricing that supports patient and pharmacy services.
The hospital types that must recertify are:
- Disproportionate Share Hospitals
- Children’s Hospitals
- Critical Access Hospitals
- Sole Community Hospitals
- Rural Referral Centers
- Freestanding Cancer Hospitals
Below are the key steps for recertification and important considerations to help covered entities achieve a smooth and compliant experience.
Confirm Access to OPAIS
The AO and PC are critical roles within the 340B program. Before recertifying, both must have active and accurate accounts in OPAIS.
- Confirm that both the AO and PC can access their OPAIS accounts. If they need new accounts, the organization should create them promptly. Accurate contact information is crucial as these individuals will receive all recertification-related notifications.
- Uncertain who your AO or PC is? Find the necessary information through the OPAIS covered entity search tool.
Gather Necessary Information
To complete recertification, you will need your most recent Medicare cost report and supporting documentation for your hospital’s classification.
- Medicare Cost Report: Obtain the latest filed cost report from your finance department. If an amended cost report was filed, use that as it reflects the most current data.
- Classification Supporting Documentation: Hospitals must provide supporting documentation demonstrating they meet one of the three classifications for 340B eligibility. Examples of supporting documentation can be found in HRSA’s 340B registration instructions.
Prepare for Attestations of Compliance
Attestation carries legal implications. If there is any uncertainty about the covered entity’s ability to comply with 340B requirements, consulting with legal counsel is advised. Your AO will be responsible for completing attestation. However, prior to recertification, both your AO and PC should delve into the following:
- Policies & Procedures: Confirm you have detailed policies in place, including those addressing material breach and self-disclosure processes.
- Material Breach Considerations: If a material breach has occurred, decide if recertification is possible or if self-disclosure is necessary prior to recertification.
- Child Sites & Contract Pharmacies: Review data for these entities to confirm accuracy.
- Medicaid Carve-In/Carve-Out Designations: Confirm these designations align with the covered entity’s actual practices.
Begin Early
Start the recertification process early and address any issues immediately. It is encouraged to take screenshots throughout the process so that covered entities have a record of all information. Recertifying the parent site first is advised, as the parent’s OPAIS information will carry over to the child site(s) recertification.
Supervise Returned Tasks
Returned tasks, sent only to the AO during the recertification process, will expire in five calendar days if not addressed. It is paramount that AOs search for notifications and log in to OPAIS daily until they have received confirmation that recertification is complete. This allows AOs to monitor and address any returned tasks promptly. AOs and PCs may receive daily status emails from HRSA during the recertification period. Remember to go over these emails to stay informed about recertification activities.
How Forvis Mazars Can Help With 340B Recertification
Following these steps can help your covered entity better prepare for 340B hospital recertification. If you have questions or need assistance with compliance or other 340B matters, please reach out to one of our experienced professionals at Forvis Mazars.