The Health Resources and Services Administration has set the annual recertification of eligibility for 340B drug discounts for hospitals to begin August 15, 2018, and ends September 12, 2018.

Mandatory Requirement

Hospitals must complete their recertification through the Office of Pharmacy Affairs Information System (OPAIS). The Authorizing Official and Primary Contact must create their own OPAIS accounts before recertifying. Covered entities that fail to create OPAIS accounts and conduct recertification 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 Service 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

In addition, it is the hospital’s responsibility to ensure its 340B OPAIS record accurately reflects their 340B program participation. Specifically, hospitals registered for the 340B program must identify a Government Official (GO) that can attest to the classification of the hospital and this information will be required with recertification.

For hospitals with a contract with a state or local government, the GO must be an individual outside your organization who can certify that a valid contract is currently in place between your private, non-profit hospital and the state or local government to provide health care services to low-income individuals.

For hospitals that are owned or operated by a state or local government, the GO must be someone outside your organization that can certify the hospital organization is owned and/or operated by a unit of the state or local government.

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 as system issues might arise interrupting or preventing the completion of recertification
• The GO cannot be the authorizing official or anyone within your organization
• If you are unsure who the official should be, please check with your hospital’s general counsel.

If you have any questions regarding the recertification process or any other issues related to the 340B program, please contact Jason Prokopik at jprokopik@blueandco.com or 317-713-7916.