HRSA Audits of 340B Entities: Lessons Learned

    Posted on November 21, 2013 by - News

    On November 4, HRSA posted 7 additional audit results on its website, bringing the grand total to 49 published audit results. As HRSA continues to post 340B audit findings on its website, there are several important lessons 340B enrolled entities should be taking away from this information. Each 340B entity needs to ensure that every aspect of their 340B program is in compliance.

    Below find the information simplified into major categories, accompanied by examples and strategies to prevent non-compliance. This is an illustrative list, and does not represent all possible findings from HRSA. Interested in conducting a 340B self-audit? View the 340B University tools here.

    Category Examples of Audit Results Published on HRSA’s Website Strategies to Improve Compliance
    Diversion

    1. 340B drugs dispensed at ineligible sites and/or written by an ineligible provider
    2. 340B drug dispensed which was not supported by a medical record
    3. 340B drug dispensed to an inpatient
    4. 340B drugs dispensed to a non-patient at a contract pharmacy

    • Entity must maintain records to demonstrate responsibility of care remained with the entity.
    • If an individual has a referral, the CE still needs to maintain responsibility of care.
    • Tools:
    340B University Sample Policies/Procedures
    340B University Policy to Practice: Referral Relationships
    340B University Policy to Practice: Physician Contracts
    FAQs (search on specific keyword)

    Duplicate Discount

    1. Billing Medicaid contrary to the HRSA Medicaid Exclusion File listing
    2. 340B drugs used for Medicaid patients at a contract pharmacy, with no arrangement to prevent duplicate discounts
    3. Medicaid claims incorrectly coded when provided to the state, or submitted without state required NPIs or UD modifiers
    4. Incorrect Medicaid or NPI in the HRSA Medicaid Exclusion File
    5. Outpatient sites incorrectly listed in the HRSA Medicaid Exclusion File

    • The importance of the practice matching the policy and procedures and the HRSA Medicaid Exclusion File matching is critical.
    • Tools:
    HRSA website, Medicaid section
    HRSA Medicaid Policy Release
    340B U Notes, Medicaid Section (pg. 15)
    FAQs (search on specific keyword)

    Eligibility, Auditable Records

    1. Incorrect Authorizing Official
    2. Primary location and contact information incorrect
    3. Closed child sites remained registered
    4. Incorrect name listed for a child site
    5. Incorrect address for facility
    6. Incorrect ship-to address
    7. Pharmacy listed as an entity with a 340B ID
    8. No written contract in place for a contract pharmacy

    • HRSA website (registration section, OPA Database Guide for Entities)
    • Tools:
    340B U Notes (pgs. 20, 40, 42, 43)
    FAQs (search on specific keyword)