Hospital 340B Recertification Program must be completed by September 11, 2023

InsightsClient Alert

340B Recertification for Hospitals began on August 14, 2023, and must be completed by September 11, 2023.

The annual 340B recertification is underway and provides an opportunity for a comprehensive review of your hospitals’ OPAIS registration(s). We wanted to share common opportunities to enhance compliance that we have identified when working with hospitals’ 340B Programs.

OPAIS Records

Covered entities are responsible for ensuring their OPAIS information is correct and up to date. HRSA audit findings related to incorrect OPAIS records have increased in the last few audit cycles.

Here are some items to keep in mind when completing recertification:

Hospital Qualification Information

Information used to complete this section during recertification will be found in your hospital’s most recently filed Medicare Cost Report (MCR).

Filing Date Worksheet S
Cost Reporting Period Worksheet S
Control Type Worksheet S-2, Part I, Line 21
DSH Percentage Worksheet E, Part A, Line 33

 Medicaid Exclusion File

Recertification is also a great time to review the information in the Medicaid Exclusion File (MEF), which is updated in OPAIS in the Medicaid Billing section. A common finding from HRSA audits of hospitals has been related to duplicate discounts or inaccurate/incomplete information in the MEF. Here are some items to keep in mind:

Does your hospital purchase drugs for administration through the 340B Program?

  • If yes, are those drugs billed to Medicaid fee-for-service (FFS)?
    • NO – You may answer “NO” to the Medicaid billing question in OPAIS.
    • YES – Make sure you answer “YES” to the Medicaid billing question in OPAIS and list the billing numbers used on the medical billing form for each state you bill Medicaid FFS. Each state you carve-in must specifically be identified in the MEF.

Does your entity-owned retail pharmacy carve-in to bill Medicaid FFS? 

  • YES – Ensure the pharmacy billing numbers are also listed in the MEF. Additionally, make sure to follow each state’s specific requirements when billing 340B purchased drugs from retail pharmacy.

It is important to point out 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. The MEF’s snapshot is taken 15 days prior to the start of next quarter.

Managing a 340B Program is complex. You don’t have to go at it alone. If you have questions, contact the Apexus Certified 340B Experts at Draffin Tucker –