Hospital 340B Program Recertification must be completed by September 19, 2022

InsightsClient Alert

The annual recertification process for hospitals begins this week.  Many of you have already reached out to us for guidance with this process, including assistance reviewing key information in OPAIS.  For those of you still working through the recertification, we wanted to share a few areas that may need extra attention this year.


HRSA has issued findings in recent years related to incorrect OPAIS record, with a particular focus on the Qualifying Information.  When recertifying, the Qualification Information should accurately reflect your hospital’s most recently filed cost report.  Any changes made to this information in OPAIS may prompt you to upload additional documentation.  It is imperative you check the filing date and cost reporting period for the most recent Medicare Cost Report.  Additionally, the disproportionate share adjustment percentage in OPAIS should match the percentage on the hospital’s most recently filed cost report, if applicable.  Hospital control type and hospital classification are also areas that should be reviewed.

The Medicaid Exclusion File should accurately reflect your hospital’s decision to bill Medicaid fee-for-service for drugs purchased through the 340B Program.  Hospital’s that choose to carve-in Medicaid should list all billing numbers used on the medical billing form for each state billing Medicaid FFS.  It is important to note that the MEF is a quarterly file; although changes can be made in OPAIS at any time, they are not effective until the next quarter as long as changes are made before the quarterly snapshot taken on the 15th day prior the start of the next quarter.

Recertification is an excellent time to give your registration a detailed review and to verify each section in OPAIS accurately reflects your covered entity’s information.  If you have questions about your Hospital’s 340B Program or the recertification process, you don’t have to go through this alone.  Please feel free to contact our 340B Apexus Certified Experts at

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