ACE 340B Patient Definition & Eligibility 1 — Questions and Answers
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?
- The patient must have Medicaid or Medicare coverage
- The covered entity must maintain records of the individual's health care (Correct answer)
- The patient must receive drugs exclusively through the covered entity's in-house pharmacy
- The individual must have visited the covered entity at least three times in the prior year
Correct 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.
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:
- A routine physical examination ordered by an employed provider
- Dispensing of a drug for subsequent self-administration at home (Correct answer)
- A referral to a specialist under contract with the covered entity
- Laboratory services ordered by the covered entity's provider
Correct 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.
Question 3: Which federal agency issued the original guidance defining the 340B patient definition in 1996?
- Centers for Medicare & Medicaid Services (CMS)
- Food and Drug Administration (FDA)
- Health Resources & Services Administration (HRSA) (Correct answer)
- Office of the Inspector General (OIG)
Correct 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.
Question 4: For a 340B patient to receive drugs through a contract pharmacy, which condition must be satisfied?
- The patient must meet the covered entity's patient definition criteria (Correct answer)
- The patient must reside within 10 miles of the contract pharmacy location
- The prescribing provider must be directly employed by the covered entity
- The contract pharmacy must be wholly owned by the covered entity
Correct 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.
Question 5: In the 340B Medicaid context, what does 'carve-out' refer to?
- Separating 340B inventory from non-340B inventory in the pharmacy
- Removing a covered entity from the 340B program for non-compliance
- Excluding Medicaid patients from using 340B-purchased drugs to prevent duplicate discounts (Correct answer)
- Removing certain drug classes from the 340B formulary
Correct 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.
Question 6: Under the 340B patient definition, the prescribing healthcare professional must:
- Hold an active DEA license in the covered entity's state
- Have treated the patient continuously for at least 12 months
- Be board-certified in the specialty relevant to the patient's condition
- Be employed by or providing care under a contract with the covered entity (Correct answer)
Correct 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.
Question 7: The 340B statute generally restricts eligible drug purchases to which patient care setting?
- Inpatient hospital care only
- Outpatient care only (Correct answer)
- Both inpatient and outpatient settings equally
- Long-term care facility residents only
Correct 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.
ACE 340B Patient Definition & Eligibility 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?