The 2024 annual recertification period for 340B covered entity (CE) hospitals is August 12 through September 9. CEs must complete recertification through the Office of Pharmacy Affairs Information System (OPAIS) during this period or face termination from the 340B program. 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 CEs achieve a smooth and compliant experience.
Confirm Access to OPAIS
The CE’s Authorizing Official (AO) and Primary Contact (PC) are critical roles within the 340B program. Before recertifying, both must have active and accurate accounts in OPAIS.
- Ensure that both the AO and PC can access their OPAIS accounts. If they need new accounts, then an 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 CE search tool.
Gather Necessary Information
To complete recertification, you'll need your most recent Medicare Cost Report (MCR) and supporting documentation for your hospital’s classification.
- MCR: Obtain the latest filed MCR 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 on the Health Resources and Services Administration’s (HRSA) 340B Registration Instructions.
Prepare for Attestations of Compliance
Attestation carries legal implications. If there is any uncertainty about the CE’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 and procedures: Ensure 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.
Begin Early
Start the recertification process early and address any issues immediately. It is encouraged to take screenshots throughout the process so that CEs have a record of all entered information. Recertifying the parent site first is advised, as the parent’s OPAIS information will carry over to the child site 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 the HRSA during the recertification period. Remember to go over these emails to stay informed about recertification activities.
Following these steps can help your CE 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.