340B-Eligible Patient

Q: What makes a patient eligible for 340B drugs?

A patient is 340B-eligible if they have an established care relationship with the covered entity, receive care from a provider employed by or under contract with the entity, and receive a service consistent with the entity's qualifying grant or designation. Simply receiving a prescription is not sufficient.

Q: Are referral patients eligible for 340B?

Referral patients can be eligible for 340B drugs if the covered entity maintains responsibility for their care under a contractual or other arrangement with the referring provider. This is a nuanced area with specific documentation requirements. Virtue 340B recommends a written referral policy and clear data tracking.

Q: What happens if a 340B drug is dispensed to an ineligible patient?

Dispensing 340B drugs to ineligible patients constitutes diversion, which is prohibited by statute. HRSA can require repayment and a corrective action plan. Repeated or systemic diversion can result in program termination.

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Definition

Patient eligibility is one of the most critical and frequently misunderstood requirements in the 340B program. HRSA defines a 340B-eligible patient as an individual who has an established relationship with the covered entity such that the entity maintains records of the individual’s health care; who receives health care services from a provider employed by or under contractual arrangement with the covered entity; and who receives a service consistent with the grant funding or designation that qualifies the entity for 340B participation.

An individual is not considered a 340B-eligible patient if the only health care service they receive from the covered entity is the dispensing of a drug for self-administration at home. This is a common area of compliance risk, particularly for contract pharmacy arrangements where the dispensing location is separate from where care is delivered.

Diverting 340B drugs to ineligible patients—even unintentionally—is one of the two core statutory violations in the 340B program. Covered entities must have clear, documented patient eligibility policies and the data infrastructure to enforce them consistently across all dispensing channels, including contract pharmacies.

Frequently Asked Questions

What makes a patient eligible for 340B drugs?

Are referral patients eligible for 340B?

What happens if a 340B drug is dispensed to an ineligible patient?

Why 340B-Eligible Patient Matters

Every 340B drug dispensed to a patient who does not meet the eligibility criteria is a diversion violation. Without clear eligibility policies and robust data controls, covered entities can accumulate significant compliance exposure that may not surface until an HRSA audit.

How Virtue 340B Uses It

Virtue 340B evaluates patient eligibility policies and data controls as a core component of every audit and consulting engagement. We assess whether the entity's definition of eligible patient is documented, operationalized, and consistently applied across all dispensing channels.

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