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340B Mega-Guidance – Initial Summary

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340B Mega-Guidance – Initial Summary

The 340B “Mega-Guidance” was released yesterday and is scheduled will be formally published in the Federal Register today. We will be sending detailed summaries to all of our 340B clients in the coming days, but we wanted to provide you with some initial feedback as soon as possible. With that in mind, below please find a high-level summary of some of the most important issues addressed in the proposed guidance.

  • Comments due on or before October 27 – Murer will be submitting formal comments on behalf of our clients in the coming weeks
  • Reduced contract pharmacy prescription eligibility – as written, guidance appears to limit contract pharmacy prescriptions to only hospital outpatient services (i.e. no inpatient discharge scripts would qualify for 340B)
  • Patient definition clarification:
    • Telemedicine is included in the 340B program
    • Eligibility to be determined at the time of administration (no penalty for retroactive changes to patient status)
  • GPO – isolated instance of incorrect GPO dispensations will not be determined to be a violation of the GPO prohibition
  • External audits – imposing stricter audit requirements:

“HHS believes that covered entities that do not regularly review and audit contract pharmacy operations are at an increased risk for compliance issues. An annual audit of each contract pharmacy location will provide covered entities a regular opportunity to review and reconcile pertinent 340B patient eligibility information at the contract pharmacy and help prevent diversion. Conducting these audits using an independent auditor will ensure the pharmacy is following all 340B Program requirements. Additionally, as a separate compliance mechanism, the covered entity should compare its 340B prescribing records with the contract pharmacy’s 340B dispensing records at least quarterly to ensure that neither diversion nor duplicate discounts have occurred.”

  • Eligible location determination – OPA considered provider-based attestations and Medicare 855A enrollment forms for eligibility in 340B, but is soliciting additional suggestions
  • 340B terminations – any violations of 340B rules will be limited to individual child sites, the entire hospital network will no longer be removed from the program
  • Bundled drugs – to be eligible for 340B, drugs must be listed as a separately billable line item on the hospital claim form
  • Duplicate discounts – suggestion to work with states to establish separate NPIs for non-340B hospital departments

If you would like to set aside some time to discuss the implications of these or other proposed Mega-Guidance topics, please contact us to schedule a call.

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