Who Qualifies to Receive 340B Discounted Drugs

One of the main restrictions in the 340B discount program is the condition that rebated medications can be dispensed only to patients of a covered entity. Presently there are numerous instances where CE could unintentionally furnish products to a consumer who is not a patient. As an example, a health center that operates an internal pharmacy may have non-patient members of the community buy medications from their pharmacy. Contracted pharmacies will surely serve both CE individuals along with other consumers.

CEs will need to make certain that procedures are in place to guarantee that only patients of the covered entity receive 340B priced medications while others receive non-340B priced medicines.

As indicating by HRSA, an individual is not regarded as a patient of the CE if the only health care services supplied by the health center to the individual is the dispensing of medications. Furthermore, OPA policy is that a covered entity individual is one who has an established affiliation with the covered entity and who obtains typical health care services by a health center provider.

The selling or delivering of a 340B priced drug to a non-patient is described as drug diversion. Covered entities are definitely accountable for making sure this type of diversion does not occur by developing appropriate tracking systems. Covered entities must possess some way to monitor drug buying and distributing separately for their 340B patients and their non-340B patients. Covered entities are required to manage both buying and distributing files and make these records available for audit by HHS. Furthermore, states may place conditions on health centers regarding splitting 340B and non-340B products for record keeping.

To be entitled to obtain 340B-purchased drugs, individuals need to receive medical care services apart from drugs from the 340B covered entity.

A person is a patient of a 340B CE only if:.

•   The CE has developed a relationship with the person, such that the health center maintains records of the individual's medical care; and...
•   The individual obtains medical services from a medical professional that is either employed by the health center or delivers healthcare under legal or other arrangements (e.g. referral for consultation) such that responsibility for the services supplied remains with the CE; and...
•   The person gets a healthcare service or variety of services from the CE that is consistent with the service or range of services for which grant funding or Federally-qualified health center look-alike status has been granted to the CE. 

A patient will not be regarded as a patient of the health center if the only healthcare service received by the patient from the covered entity is the dispensing of a drug or medications for subsequent self-administration or management in the home setting.

The obligation to guarantee compliance with 340B Program requirements stays with covered entities and manufacturers that participate. Information acquired from contractors, consultants and other third parties should not be presumed to be compliant with HRSA policy. Therefore we encourage all information and guidance obtained from external associations is confirmed by HRSA.