340B Patient Definition & Eligibility Flashcards

According to HRSA's 340B patient definition guidance, which of the following is a core requirement for an individual to qualify as a 340B patient?

Answer: The covered entity must maintain records of the individual's health care

HRSA's patient definition requires that the covered entity has established a relationship with the individual such that it maintains records of their health care.

Under the 340B program, an individual does NOT qualify as a patient of the covered entity if the only health care service they receive is:

Answer: Dispensing of a drug for subsequent self-administration at home

HRSA's guidance explicitly excludes individuals from the patient definition if the only service received is drug dispensing for subsequent self-administration or home administration.

Which federal agency issued the original guidance defining the 340B patient definition in 1996?

Answer: Health Resources & Services Administration (HRSA)

HRSA issued the original 340B patient definition guidance in 1996 and continues to administer and oversee the 340B Drug Pricing Program.

For a 340B patient to receive drugs through a contract pharmacy, which condition must be satisfied?

Answer: The patient must meet the covered entity's patient definition criteria

Patients receiving 340B drugs through contract pharmacies must still satisfy the covered entity's patient definition, including the established care relationship and maintained health records.

In the 340B Medicaid context, what does 'carve-out' refer to?

Answer: Excluding Medicaid patients from using 340B-purchased drugs to prevent duplicate discounts

Carve-out means Medicaid patients are excluded from receiving 340B-priced drugs, preventing both a 340B discount and a Medicaid rebate from applying to the same drug unit.

Under the 340B patient definition, the prescribing healthcare professional must:

Answer: Be employed by or providing care under a contract with the covered entity

The prescribing provider must be employed by the covered entity or provide care under a contractual arrangement where responsibility for care remains with the covered entity.

The 340B statute generally restricts eligible drug purchases to which patient care setting?

Answer: Outpatient care only

The 340B program generally restricts eligible drug purchases to outpatient settings; inpatient drugs at hospitals are not eligible for 340B pricing under the statute.