340B Recertification for Hospitals began on August 12, 2024, and must be completed by September 9, 2024.
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 |
New Expectations from HRSA
Last year, HRSA began allowing updates to the hospital qualification data in OPAIS throughout the year rather than only during recertification. We understand that HRSA is now expecting hospitals to updateOPAIS with their updated MCR information immediately after filing the MCR and not wait until recertification.
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 hasbeen 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
- 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 Additionally, make sure to follow eachstate’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 atany time, they are not effective until the next quarter. The MEF’s snapshot is taken 15 days prior to the start of the 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 – 340B@Draffin-Tucker.com.