CaptureRx recently hosted a webinar on the 5 keys to 340B success in 2020. Presented by Holly Russo, President and CEO of Patient Craft, the webinar covered several key items to focus on to get your 340B compliance in check for 2020.

Here are the key takeaways:

  1. Assess eligibility requirements and documents
    • Review the Sites Registered on OPAIS (Link) and compare with eligibility documents
      • If you are a health center, review your EHB handbook 5B and the OPAIS to ensure the site names and addresses match and all active sites are listed on OPAIS
      • If you are a grantee, make sure your grant number and site IDs on your Notice of Grant award is listed correctly on OPAIS
      • If you are a hospital, review your cost report and trial balance to ensure all locations on the OPAIS are eligible
  1. Review your Contract Pharmacies & PSAs
    • Carefully review what is on OPAIS –the pharmacy name, d/b/a (if applicable), address, city, state, zip code to what is listed on the associated PSA with the pharmacy.
      • The DEA sends this information over to OPAIS, so make sure they match
    • Ensure all PSAs are signed and dated by the Covered Entity and Contract Pharmacy
      • Examine all PSA’s to make sure they are dated prior to go live
    • Check any amendments – if you receive a HRSA audit notification, you need to supply the original contract and any amendments
    • Amendments to an original PSA should be signed and dated.
  1. Examine the Medicaid Exclusion File
    • Are you carving in Medicaid FFS?
      • If carving in, where are you carving in- in-house pharmacies, eligible outpatient locations (Administered Drugs)
      • Do you have multiple NPIs and Medicaid Numbers if carving in? Have you listed the correct numbers on the MEF?
      • Have you checked your Medicaid or NPI numbers to ensure they are correct and there are no transposed numbers?
      • Are you checking billing records for outpatient administered drugs where the patient is a Medicaid FFS beneficiary and adjudicated claims in owned pharmacies for any required modifiers and that you are billing per the state’s policy?

Following from the last point, If you are carving out Medicaid FFS, you should have answered “No” to the question on the OPAIS MEF. There should not be any NPI or Medicaid numbers  listed

Note: At PatientCraft, we’ve noticed many transposed NPI numbers. Make sure you are listing things correctly!

  1. Do you have 340B Policy and Procedures(P&Ps) in place for:
  • Why is it important? P&Ps help in mitigating the risk of non-compliance and are requested as part of the HRSA audit data request
  • Need to be carefully monitored, evaluated and modified to reflect needs and work of the organization

Do you have 340B Policy and Procedures in place for (not a comprehensive list):

  • Description of CE’s registration/recertification process
  • Description of procurement processes
  • Referral/responsibility of care remained with CE
  • Medical/patient health record
  • Provider eligibility (relationship)
  • Service in the scope of grant
  • Documenting/accounting for wastage of a drug not administered
  • Expired drugs and how they are handled
  1. Program Oversight
    • Do you have a program oversight committee?
      • What departments are represented?
        • Assigned roles & responsibilities
        • How often do you meet? What is reviewed?
        • Training for participants?
      • How often are you performing self-audits, and what are you auditing?
        • In-house and contract pharmacy claims
        • Pharmacy claims associated with specialist encounters where patient was referred by the CE
        • Administered drugs in eligible outpatient locations

Note: It is more important than ever to understand what data and filters/configurations or conditions you are applying in your 340B TPA software program to determine patient/claim eligibility to prevent diversion and duplicate discounts.

CaptureRx will be hosting a series of 340Briefs throughout 2020. Be on the lookout for future webinar announcements!

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