The 2021 Grantee 340B Recertification period for Consolidated Health Centers, Federal Qualified Health Center Look-Alikes, Ryan White, Comprehensive Hemophilia Treatment Centers, Native Hawaiian, Black Lung Programs, Urban Indian, and Tribal Compact 638 will be February 1 – March 1, 2021. A separate email will be sent out by HRSA with all of the information required to access the website to the Authorizing official and Primary Contact of the covered entity.

Mandatory Requirement of the 2021 Grantee Recertification Process

Health clinics must complete their recertifications through the Office of Pharmacy Affairs Information System (OPAIS). The Authorizing Officials and Primary Contacts must create their own OPAIS accounts before recertifying. Covered entities that fail to create OPAIS accounts and conduct recertifications will be removed from the 340B Program.

During recertification, the Authorizing Official attests to the following:

• All information listed on the 340B database is complete, accurate and correct
• The covered entity meets 340B Program eligibility requirements
• The covered entity will comply with all requirements under section 340B of the Public Health Services Act, including the prohibition against duplicate discounts and diversion
• The covered entity maintains auditable records pertaining to compliance with the program
• Contract retail pharmacy arrangements are performed in accordance with OPAIS requirements
• Covered entity acknowledges its responsibility to notify the OPAIS if there is any change in 340B eligibility or material breach by the covered entity
• Covered entity acknowledges that if there is a breach in the requirements pertaining to duplicate discounts or diversion; the covered entity might be liable to the manufacturer of the outpatient drug and depending on the circumstances, may be subject to removal from the 340B Program

The AO will be asked “At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at 340B prices?”

If you are a carve in entity and use 340B medications in your clinic, you should answer yes.

If you carve out and do not use 340B purchased medications in your clinic, you should answer no.

It is the health clinic’s responsibility to ensure its 340B OPAIS record accurately reflects its 340B Program participation. The health clinic must ensure the contacts listed in the 340B database are accurate at all times to receive all recertification notifications.

If you have any questions regarding the recertification process or any other issues related to the 340B Program, please contact one of our Apexus certified 340B experts:

• Kyle Smith, CPA | 317.713.7957
• Jason Prokopik, PharmD | 317.713.7916
• Chad Downing, RPh | 502.727.9664
• Ellie Clinesmith, RPh | 614.340.6796