Health Center's Responsibilities
To access 340B pricing, a health center must follow the Office of Pharmacy Affairs program requirements:
- Maintain 340B database information
- Recertify eligibility
- Prevent duplicate discounts
- Prevent diversion to ineligible patients
- Prepare for program audits
Every health center clinic site listed in the Electronic Hand Book (EHB) must be listed in the OPA database for patients seen at those sites to be eligible to fill their prescriptions at 340B pricing. Verify that the health center and the contracted retail pharmacy information posted in the OPA database is current and accurate. Make any necessary updates and corrections on the OPA database.
If a site is not yet listed in the OPA database, follow the guidance under How to Sign Up.
To ensure the integrity, compliance, transparency and accountability of the program, OPA requires each health center to annually recertify their health center specific information is correct in the OPA database. It is the health center’s responsibility to ensure the accuracy of the information in the OPA database, including any applicable contracted retail pharmacy information.
Your health center will need to:
- Update all information in the Electronic Hand Book (EHB)
- Review OPA’s database for each and every site of your health center at this link to verify ALL information is correct. Make certain the address (P.O. Box and physical address are both listed, if applicable) and contact information (names, phone numbers, emails) for each and every site are listed correctly. If not, follow the process for a change request
- Each Authorizing Official (AO) will receive an email from the OPA informing them of the recertification process which will include a username and password to use for the process
- The AO will be required to certify for all sites of the health center and contracted retail pharmacies (if applicable)
- Note that the OPA will review all certification and verify all information with EHB and all information must match perfectly. For example, if OPA has the AO as ‘Jane Smith’ and the EHB has ‘Bob Jones,’ the certification will be rejected.
Manufacturers are prohibited from providing a 340B price and a Medicaid drug rebate for the same drug to the same patient. A health center must accurately report if Medicaid is billed using 340B pricing via the Medicaid Exclusion File. This designation is part of the health center’s details in the OPA database.
A health center must only provide or dispense 340B drugs to active and current patients of their health center.
A health center must maintain auditable records documenting compliance with 340B program requirements. A health center can be audited by drug manufacturers or HRSA.