Only nonprofit health care organizations that have certain Federal designations or receive funding from specific Federal programs are eligible organizations (covered entities) that can register, be enrolled and purchase discounted drugs through the 340B Program. These include Federally Qualified Health Centers, Ryan White HIV/AIDS Program grantees, and certain types of hospitals and specialized clinics.
Ryan HIV/AIDS Program Grantees
To be eligible to receive 340B-purchased drugs, patients must receive health care services other than drugs from the 340B covered entity. The only exception is patients of State-operated or –funded AIDS drug purchasing assistance programs.
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:
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.
Generally, the 340B Program covers the following outpatient drugs:
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.
Covered entities must recertify their eligibility every year and notify the Office of Pharmacy Affairs whenever there is a change in their eligibility. Learn more: Recertification
If there is a change in a covered entity's eligibility status, the covered entity has a responsibility to immediately notify OPA and should stop purchasing drugs through the 340B Program.
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