340B Recertification for Community Health Centers begins February 1, 2021 and must be completed by March 1.

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

Retail Pharmacy Shipping Address

Does your health center have an entity-owned retail pharmacy?

  • If so, does the pharmacy’s physical address match the address of any of your registered sites?
    • NO Listing an additional shipping address in OPAIS is required.
    • YES – Listing a separate shipping address is not required.

Note: Entity-owned pharmacies should not be registered as associated sites in OPAIS.

 Medicaid Exclusion File

This is 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 health centers has been related to duplicate discounts. Here are some items to keep in mind:

 Does your health center purchase drugs for clinic 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.

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.

Does your health center carve-in more than one state?

  • YES – Did you know that HRSA has recently enhanced the MEF to make it easier to identify carve-in/carve-out elections by state? Each state you carve-in must specifically be identified in the MEF. This may require listing the same NPI number for more than one state in addition to listing each state’s Medicaid Provider Number.

 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 – 340B@Draffin-Tucker.com.