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

The patient must have Medicaid or Medicare coverage

Answer

The patient must receive drugs exclusively through the covered entity's in-house pharmacy

Answer

The individual must have visited the covered entity at least three times in the prior year

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

A routine physical examination ordered by an employed provider

Answer

A referral to a specialist under contract with the covered entity

Answer

Laboratory services ordered by the covered entity's provider

Question 3

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

Accepted Answer

Health Resources & Services Administration (HRSA)

Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

Food and Drug Administration (FDA)

Answer

Office of the Inspector General (OIG)

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

The patient must reside within 10 miles of the contract pharmacy location

Answer

The prescribing provider must be directly employed by the covered entity

Answer

The contract pharmacy must be wholly owned by the covered entity

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

Separating 340B inventory from non-340B inventory in the pharmacy

Answer

Removing a covered entity from the 340B program for non-compliance

Answer

Removing certain drug classes from the 340B formulary

Question 6

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

Accepted Answer

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

Answer

Hold an active DEA license in the covered entity's state

Answer

Have treated the patient continuously for at least 12 months

Answer

Be board-certified in the specialty relevant to the patient's condition

Question 7

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

Accepted Answer

Outpatient care only

Answer

Inpatient hospital care only

Answer

Both inpatient and outpatient settings equally

Answer

Long-term care facility residents only