340B Update: OPA Publishes Guidance on GPO and Medicaid Rules for Covered Entities

Tuesday, February 12, 2013
340B Update: OPA Publishes Guidance on GPO and Medicaid Rules for Covered Entities

The Office of Pharmacy Affairs (OPA) released guidance related to Group Purchasing Organization (GPO) use and Medicaid rebates for Covered Entities (CEs) participating in the 340B drug pricing program.

Sentry strongly urges its clients and any 340B stakeholders to read these key updates and stay informed on compliance and 340B integrity requirements. Both releases are available on the OPA site and are summarized below:

  • The GPO release is titled Statutory Prohibition on Group Purchasing Organization Participation and clarifies the requirement against 340B CEs using a GPO to acquire “covered outpatient drugs.”

    • OPA has further provided clarification that allows Covered Entities 60 days from the publication of the GPO policy release to make certain their drug replenishment practices comply with the prohibition program notice.  The post is on HRSA’s FAQ page and identifies the effective date for CE adherence to the GPO prohibition policy as April 7, 2013.  

      HRSA FAQ Link: http://www.hrsa.gov/opa/faqs/index.html#GPO
  • The Medicaid rebate release is titled Clarification on Use of the Medicaid Exclusion File and identifies procedures for choosing a Medicaid “carve-in” or “carve-out” strategy and how to properly register with the Health Resources and Services Administration (HRSA).

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Contributors

Travis Leonardi, RPh., C.P.
President, CEO
William D. Kirsh DO, MPH
Chief Medical Officer
Lidia Rodriguez-Hupp
SVP and 340B Compliance Officer
Dawn C. DeAngelo
Chief Pharmacy Officer

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