Eligibility & Registration

Health Centers

Federally Qualified Health Centers

Federally Qualified Health Center Look-Alikes

Native Hawaiian Health Centers

Tribal / Urban Indian Health Centers

Ryan HIV/AIDS Program Grantees

Ryan White HIV/AIDS Program Grantees

Hospitals

Children’s Hospitals

Critical Access Hospitals

Disproportionate Share Hospitals

Free Standing Cancer Hospitals

Rural Referral Centers

Sole Community Hospitals

Specialized Clinics

Black Lung Clinics

Comprehensive Hemophilia Diagnostic Treatment Centers

Title X Family Planning Clinics

Sexually Transmitted Disease Clinics

Tuberculosis Clinics

An individual is a patient of a 340B covered entity (with the exception of State-operated or funded AIDS drug purchasing assistance programs) only if:

• the covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual's health care; and
• the individual receives health care services from a health care professional who is either employed by the covered entity or provides health care under contractual or other arrangements (e.g. referral for consultation) such that responsibility for the care provided remains with the covered entity; and
• the individual receives a health care service or range of services from the covered entity which is consistent with the service or range of services for which grant funding or Federally-qualified health center look-alike status has been provided to the entity. Disproportionate share hospitals are exempt from this requirement.

An individual will not be considered a patient of the covered entity if the only health care service received by the individual from the covered entity is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting.

Exception: Individuals registered in a State-operated or funded AIDS Drug Assistance Program (ADAP) that receives Federal Ryan White funding ARE considered patients of the participant ADAP if so registered as eligible by the State program.

For more information: Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility

Drugs purchased through the 340B Program must be limited to outpatient use and provided to eligible patients. Whether a drug qualifies as outpatient and the individual meets the definition of patient depends upon the factual circumstances surrounding the care of that particular individual. For example, 340B drugs can be used for discharge prescriptions to the extent that the drugs are for outpatient use. 340B covered entities should have auditable records that demonstrate compliance with this requirement.

Some manufacturers may voluntarily offer discounted prices on inpatient drugs or medical  supplies, such as syringes, that are not 340-covered drugs, but that is a choice and is not related to the 340B Program.