The 2025 Grantee recertification period for Consolidated Health Centers, Federally Qualified Health Centers & Look-Alikes, Ryan White Clinics, Comprehensive Hemophilia Treatment Centers, Native Hawaiian, Black Lung Programs, Urban Indian, and Tribal Compact 638 will be January 27, 2025 to February 24, 2025.

Additionally, there will be a recertification webinar held prior to the start of this deadline. A separate email will be sent out by the Health Resources & Services Administration (“HRSA”) to the Authorizing Official and Primary Contact of each covered entity with all the information required to access the webinar.

Mandatory Requirement

Covered Entities 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. Organizations 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 Program 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 OPAIS if there is any change in 340B Program 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

In addition, it is the covered entity’s responsibility to ensure its 340B OPAIS record accurately reflects its 340B Program participation. Each organization must ensure the contacts listed in the 340B Program 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 three Apexus-certified 340B Program experts:

Kyle Smith, CPA, 340B ACE, Director 317.713.7957 | kcsmith@blueandco.com

Jason Prokopik, Pharm.D., 340B ACE, Senior Manager 317.713.7916 | jprokopik@blueandco.com

Alyssa Kramer, PharmD, 340B ACE, Manager 317.275.7404 | akramer@blueandco.com