340B Health

340B Insight Podcast

Episode Thirty-One: Preparing For 340B Recertification

July 26, 2021

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This week, we are joined by Steven Miller, vice president of pharmacy services at 340B Health. The Health Resources & Services Administration (HRSA) recently announced that annual 340B recertification for hospitals will begin on Aug. 16, 2021. Steve discusses what 340B hospitals need to know about preparing for recertification and avoiding common errors during the process. Prior to the interview, we provide news updates on the Centers for Medicare & Medicaid Services proposing to continue Medicare Part B cuts to many 340B hospitals and new legislation introduced in Congress to protect 340B hospitals from discriminatory payment rules by pharmacy benefit managers and health insurers. (Transcript).

Show Notes

  • The Purpose of Recertification 340B hospitals must go through the recertification process to confirm and validate the accuracy of their information and ensure they comply with all program requirements. Steve recommends that 340B hospitals begin getting into the habit of preparing for recertification as soon as they qualify for the program and look at their policies and procedures to confirm they align with the 340B statute. Specifically, hospitals must make sure that qualification, eligibility, and demographic information in the Office of Pharmacy Affairs Information System (OPAIS) is complete and accurate.
  • Eligibility Criteria Hospitals Must Meet for Recertification To qualify for 340B, hospitals must be nonprofit. They can be either public or private hospitals, but if they are privately owned they must have a contract with local or state government. In addition, all 340B hospitals, except for critical access hospitals, must meet or exceed a minimum disproportionate share (DSH) adjustment percentage.
  • The Recertification Steps Steve explains the steps of the recertification process. He stresses the importance of reviewing information for the parent hospital first and then any child sites. The hospital will need to review the qualification information to confirm that the information on the most recent Medicare cost report matches with the information in OPAIS. If the information does not match, the hospital can make the changes in the recertification task and upload the supporting documentation. Steve also explains the Medicaid Exclusion File and why it is a critical component to recertification.
  • Best Practices For 340B Hospitals Recertifying Steve shares common errors made when recertifying. The most common error is the authorizing official (AO) not checking every single qualification requirement. These include DSH percentage and Medicare cost report filing date. Steve recommends having both the primary contact and the AO review the information separately to ensure accuracy. He also encourages checking to ensure everything in OPAIS is saved correctly and taking screenshots of each screen in case the information does not save.
  • Resources For 340B Recertification Members of 340B Health have access to several resources to prepare for recertification and registration. Members can reach out to 340B Health to set up a technical assistance call with a 340B Health staff expert. Steve also recommends members attend a webinar on Aug. 12, 2021, that will review the recertification process and highlight any new changes for this year.

Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at podcast@340bhealth.org.


  1. 340B Health Statement on Proposed Medicare Payment Cuts to 340B Hospitals In 2022

  2. 340B Health Statement on the Bipartisan Protect 340B Act to Stop Discriminatory Actions by PBMs and Insurers

  3. 340B Health Member Resources on Program Registration and Recertification

  4. 340B Health Webinar on Recertification on Aug. 12, 2021