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H H S Department of Health and Human Services
Health Resources and Services Administration
Health Resources and Services Administration

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Eligibility & Registration

Eligible Organizations

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.

Eligible Patients

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.

See the complete definition of eligible patients

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

Eligible Drugs

Generally, the 340B Program covers the following outpatient drugs:

  • FDA-approved prescription drugs;
  • Over-the-counter (OTC) drugs written on a prescription;
  • Biological products that can be dispensed only by a prescription (other than vaccines); or
  • FDA-approved insulin.

See more about eligible 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.

Changes in Eligibility

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.

Registration Now

RegisterStart Date
January 1-15April 1
April 1-15July 1
July 1-15October 1
October 1-15January 1
Definitions

340B Glossary of Terms (PDF - 299 KB)

Questions, contact ApexusAnswers@340BPVP.com or call 1-888-340-2787 Monday through Friday 8:30am to 6:30pm