The Health Resources and Services Administration (HRSA) has set the annual recertification of eligibility for 340B drug discounts for hospitals to begin August 19, 2019, and end September 16, 2019.

Mandatory Requirement

The Authorizing Official (AO) and Primary Contact (PC) must request a User ID and Password prior to the start of the registration process.  If this is not completed, the AO and PC will NOT receive the advanced notification email from HRSA about recertification of their covered entity and the recertification period. If this has not been completed, it should be completed as soon as possible.

Increased HRSA Focus Area

Private nonprofit hospitals registered as an entity with a contract with the State or Local government in the 340B Drug Pricing Program (340B Program) must have such a contract in place to be compliant with the 340B Program.  Hospitals with expired contracts or ones that are due to expire during recertification period must provide updated contracts and update the 340B OPAIS record to reflect the new contract start and end dates during recertification. Hospitals that do not provide updated contracts by the recertification deadline, could be removed from the 340B Program. Guidance on hospital contracts can be found at 340B Program Hospital Registration Instructions and Public Health Service Act 340B(a)(4)(L).

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 the diversion
• The covered entity maintains auditable records pertaining to compliance with the program
• If applicable, contract retail pharmacy arrangements are performed in accordance with OPA requirements
• Covered entity acknowledges its responsibility to notify the OPA if there is any change in 340B eligibility or 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 eligible provider list

Helpful Tips

• Print the recertification guide and have it available for reference
• Print a hard-copy of the Hospital’s cost-report and have it available as you are completing the recertification process
• Do not wait until the last day to rectify as system issues might arise interrupting or preventing the completion of recertification

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

Jason Prokopik, Pharm.D., 340B ACE – jprokopik@blueandco.com or 317-713-7916