ACE 340B Patient Definition & Eligibility

Question 1

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?

Accepted Answer

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

Answer

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.

Question 2

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:

Accepted Answer

Dispensing of a drug for subsequent self-administration at home

Answer

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.

Question 3

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

Accepted Answer

Health Resources & Services Administration (HRSA)

Answer

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

Question 4

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

Accepted Answer

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

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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.

(ACE) Apexus Certified Expert Practice Test

(ACE) Apexus Certified Expert Practice Test

ACE 340B Patient Definition & Eligibility