340B Program Omnibus Guidance: Definition of a Qualified Patient

By Scott Drugan, Pharm.D.
The Health Resources and Services Administration released its 340B Program Omnibus Guidance on August 27, 2015, which was published in the Federal Register on August 28, 2015. This 90-page document contains the most comprehensive set of clarifications that have been proposed since the initiation of the act in 1992.

This white paper discusses some of the highlights on proposed guidance changes to the qualified patient definition. As anticipated, the proposed guidance seeks to clarify the qualified patient definition. Currently, the 1996 guidance is a two-part test to determine if the individual is a patient of the covered entity for enrolled hospital qualified entity types.

  • The covered entity has established a relationship with the individual, such that the covered entity maintains records of the individual’s healthcare
  • The individual receives healthcare services from a healthcare professional who is either employed by the covered entity or provides healthcare under contractual or other arrangements (e.g., referral for consultation) such that responsibility for the care provided remains with the covered entity
340B

The proposed guidance for defining if an individual is a patient of the covered entity for enrolled hospital qualified entity types would be the following:

  • The individual receives a healthcare service at a facility or clinic site which is registered or the 340B Program and listed on the public 340B database
  • The individual receives a healthcare service provided by a covered entity provider who is either employed by the covered entity or who is an independent contractor for the covered entity, such that the covered entity may bill for services on behalf of the provider
  • An individual receives a drug that is ordered or prescribed by the covered entity provider as a result of the service described in statement above
  • The individual’s drug is ordered or prescribed pursuant to a healthcare service that is classified as outpatient
  • The individual’s patient records are accessible to the covered entity and demonstrate that the covered entity is responsible for care

The full white paper discusses these proposed changes in more detail.

Download the full white paper

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