340B Hospital Classification Program Update

Hospital Classification Documentation for Registration

The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB), Office of Pharmacy Affairs (OPA) is providing additional information for hospitals registering for the 340B Drug Pricing Program (340B Program). Hospitals registering for the 340B Program must meet the criteria for one of three classifications described in section 340B(a)(4)(L) of the Public Health Service Act:

1. Owned or operated by a unit of State or local government;
2. Public or private non-profit corporation which is formally granted governmental powers by a unit of State or local government; or
3. Private non-profit hospital which has 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 Program.

HRSA requires hospitals to have the necessary documentation that demonstrates they meet statutory requirements for eligibility. HRSA has updated the hospital registration instructions to provide additional information regarding acceptable documentation that can be provided to HRSA and maintained as part of a hospital’s 340B auditable records. Starting April 1, 2019, HRSA will be conducting additional program integrity reviews and hospitals may be asked to submit these documents upon registration. Please visit our website for more information and please review the UPDATED hospital instructions (PDF - 94 KB) regarding the required documentation.