The Health Resources and Services Administration has set the annual recertification of eligibility for 340B drug discounts for hospitals to begin August 17, 2020 and end September 14, 2020.

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 failing 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 and accurate.
• 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 compliant based on all OPAIS requirements, if applicable.
• Covered entity acknowledges its responsibility to notify OPAIS if there are changes in 340B eligibility or a material breach by the covered entity.
• Covered entity acknowledges that if there is a material breach in the requirements pertaining to duplicate discounts or diversion, the covered entity might be liable to drug manufacturers and depending on the circumstances, may be subject to removal from the 340B Program.

New This Recertification Cycle

The Medicaid billing question asked during recertification has changed slightly. It now asks the covered entity specifically “at this site, will the covered entity bill Medicaid Fee-for-Service for drugs purchased at 340B prices?” This further highlights HRSA is focused solely on Medicaid Fee-for-Service when evaluating duplicate discount prohibition.

Additionally, 340B OPAIS will now prompt the Authorizing Official and Primary Contact to upload supporting documentation for the “Hospital Classification” selected at the time of registration of a parent hospital.

For hospitals contracted with state or local governments, the hospitals will need to provide documentation the hospitals are private non-profits and there are established contracts to provide health care services for low-income individuals who are not entitled to benefits under Title XVIII of the Social Security Act or eligible for the state plans under this title. For hospitals owned or operated by state or local governments, some form of official documentation describing hospital ownership is required.

Helpful Tips

• Review all documentation needed for accuracy, verifying signatures and dates.
• Print the recertification guide and have it available for reference.
• Have a hard copy of the Hospital’s Medicare Cost Report available during the recertification process.
• Do not wait until the last day 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 reach out to one of our Apexus Certified 340B Experts.