340B Eligibility

Who can participate in the 340B Drug Pricing Program?

Section 340B(a)(4) of the Public Health Service Act lists the covered entities that can participate in the 340B Drug Program.

Changes in eligibility

Covered entities must recertify their eligibility every year. Covered entities must immediately notify the Office of Pharmacy Affairs (OPA) in 340B OPAIS when there is a change in their eligibility, and stop purchasing drugs through the 340B Drug Pricing Program.

Secretary's Guidance to Covered Entities on Public Health Emergency Declarations

We understand that disaster relief efforts may allow flexibility to affected 340B entities during a declared emergency. A person receiving 340B drugs must be a patient of the covered entity. However, unique circumstances may be considered to decide if an individual fits the definition of patient (PDF - 31 KB), and if they qualify to receive 340B drugs.

A shortened health record may be enough for purposes of the 340B Drug Pricing Program. The health record must identify the patient, record the medical evaluation (including any tests, diagnoses, or clinical impressions), and the treatment provided or prescribed. It may be a single form or note page. It is the recorded information that creates the record. For example, during a declared public health emergency, individuals may not have their identification or insurance cards, and providers may not have access to documented medical histories. Therefore, self-reported identities, medical conditions, and history are enough to track patient care.

Also, when volunteer health professionals provide health care, documentation should show a clear relationship between the provider and the covered entity. It must clarify that the covered entity is responsible for providing care. It must include the name and address of the volunteer, their relationship to the clinic, and it should be filed by the covered entity. During emergencies, a covered entity must continue to make sure it has policies and procedures to address the situation. It must also maintain auditable records.

340B registration

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