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HRSA Revises 340B Recertification Instructions

The Health Resources and Services Administration (HRSA) published a revised notice on a new process and 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.

HRSA first announced this change in March. In May, the agency issued an information collection request to formally incorporate this and other revisions, including a change to a question around Medicaid billing and duplicate discounts.

HRSA will accept comments on these changes for 30 days after the notice is published in the Federal Register.

The 2019 340B recertification period begins Aug. 19. Covered entities will have until Sept. 16 to complete the process.

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


About the Author

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

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