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340B Recertification Ends Sept. 16

The Health Resources and Services Administration (HRSA) annual recertification process for hospitals participating in the 340B Drug Pricing Program will end on Sept. 16.

Hospitals must complete their recertification through the Office of Pharmacy Affairs Information System (OPAIS). Covered entities that fail to complete recertification will be removed from the 340B program for a minimum of one quarter.

OPA held an Aug. 14 webinar on the recertification process.

Revised Recertification Instructions

HRSA revised the requirements for demonstrating 340B Drug Pricing Program eligibility in the annual recertification process.

The agency now will require hospitals to submit documents supporting the hospital classification they select during 340B program registration. These classifications include:

  • owned or operated by a unit of state or local government;
  • a public or private nonprofit corporation formally granted governmental powers by a unit of state or local government; or
  • a private nonprofit hospital with a contract with a state or local government to provide health care services to low-income individuals who are not entitled to benefits under the Medicare or Medicaid programs.

While HRSA always has required that hospitals maintain documentation of their status in the event of an audit, hospitals previously only were required to provide an attestation of their status from a government official during recertification.

The OPA website includes a user guide, additional webinars, and other educational resources. Direct questions regarding recertification to or 888.340.2787.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with additional questions.


About the Author

Rachel Schwartz is a former policy associate at America's Essential Hospitals.

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