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340B Recertification Ends Sept. 12

The Health Resources and Services Administration (HRSA) annual recertification process for hospitals participating in the 340B Drug Pricing Program will end on Sept. 12.

Covered entities that fail to complete recertification will be removed from the 340B program for a minimum of one quarter.

OPA hosted a webinar on the hospital recertification process on Aug. 8,

Government Official Attestation

As part of 340B recertification, hospitals must identify and provide information about the government official attesting to the hospital’s classification as either:

  • a hospital owned or operated by a state or local government (or formally granted powers by a unit of state or local government); or
  • a private, nonprofit hospital that has a contract with a state or local government to provide health care services to low-income individuals not covered by Medicare or Medicaid.

The government official must be someone outside the hospital organization who can certify that the hospital falls under one of these classifications.

340B primary contacts and authorizing officials should have received a notice from HRSA on Aug. 27 explaining this requirement.

OPAIS

Hospitals must complete their recertification through the Office of Pharmacy Affairs Information System (OPAIS). Authorizing officials and primary contacts must create their own OPAIS accounts before recertifying.

user guide, webinars, and other educational resources are available on the Office of Pharmacy Affairs (OPA) website.

Questions regarding recertification should be directed to Apexus at apexusanswers@340bpvp.com or 888.340.2787. Questions also can be directed to OPA directly by contacting Samuel Cardarella, RN, BSN at 301.945.0930 or scardarella@hrsa.gov.

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

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About the Author

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