There are very clear and strict requirements on what the patient definition is for 340B drug qualification. Outside of state funded and/or operated AIDS drug purchasing assistance programs, There are a few stipulations to qualify for 340B medication from a Covered Entity.
- A patient must have an established relationship with a 340B covered entity who maintains that patient’s care, as well as their healthcare records
- That patient must receive care from a physician who is employed or contracted by that covered entity
- The services that the patient receives from the hospital must comply with the service range of grant funding to the Covered Entity (This mostly applies to FQHC [Federally Qualified Health Centers] as DSH [Disproportionate Share Hospitals] are exempt from this stipulation).
Common Misconceptions about Patient Eligibility
Employees of covered entities are NOT eligible to receive 340B drugs unless that employee meets the patient definition established by the 340B program. 340B drugs are limited to use by patients of the covered entity.
Patients referred to outside clinics or specialists may only receive 340B drugs to fill their prescription if that health provider is an employee of or works under contract with the covered entity. Only if the entity can demonstrate that it retained sole responsibility of the patient’s healthcare is that individual eligible to fill their prescription with 340B reduced price drugs.
Discharge patients do not all qualify for 340B drugs. 340B is an outpatient program and drugs can ONLY be used to fill outpatient prescriptions. 340B drugs can be used for discharge patients to the extent that the drugs are for outpatient use. Entities are responsible for maintaining auditable records that demonstrate how a 340B drug was used as part of an outpatient prescription that is associated with a discharge patient.