ACE 340B Patient Definition & Eligibility 2 — Questions and Answers
Question 1: Which of the following scenarios represents a violation of the 340B patient definition?
- A covered entity dispenses 340B drugs to an ER patient who has no established ongoing care relationship with the covered entity (Correct answer)
- A covered entity dispenses 340B drugs to a patient referred by an employed provider
- A covered entity dispenses 340B drugs to a patient whose records are maintained by the CE
- A covered entity dispenses 340B drugs to a patient seen by a contracted specialist
Correct answer: A covered entity dispenses 340B drugs to an ER patient who has no established ongoing care relationship with the covered entity
An ER patient with no established ongoing care relationship with the covered entity typically does not meet the patient definition requirements for 340B.
Question 2: What is 'diversion' in the context of the 340B program?
- Transferring 340B-purchased drugs to patients who do not meet the patient definition (Correct answer)
- Using 340B funds to purchase non-covered outpatient drugs
- Switching from one wholesaler to another without HRSA notification
- Billing Medicaid before seeking a manufacturer rebate for the same drug
Correct answer: Transferring 340B-purchased drugs to patients who do not meet the patient definition
Diversion occurs when 340B-purchased drugs are provided to individuals who do not qualify as patients of the covered entity under the program's patient definition.
Question 3: A Federally Qualified Health Center registers a patient who will only receive prescription refills through its 340B contract pharmacy but has never been seen by an FQHC provider. This situation:
- Is acceptable if the patient was previously seen by any licensed healthcare provider
- Fully complies with the 340B patient definition as long as records exist
- Is compliant as long as the FQHC maintains the patient's insurance records
- May violate the patient definition since no health care services were provided beyond dispensing (Correct answer)
Correct answer: May violate the patient definition since no health care services were provided beyond dispensing
The patient definition requires more than drug dispensing; an individual is not a 340B patient if the only service received from the covered entity is drug dispensing.
Question 4: The 340B duplicate discount prohibition means a covered entity cannot:
- Claim 340B savings and receive government grant funds for the same patient encounter
- Purchase the same drug from two different wholesalers at 340B prices
- Receive both a 340B discounted purchase price and a Medicaid rebate for the same unit of drug (Correct answer)
- Sell 340B drugs through both retail and mail-order pharmacies simultaneously
Correct answer: Receive both a 340B discounted purchase price and a Medicaid rebate for the same unit of drug
The duplicate discount prohibition prevents covered entities from receiving both the 340B discounted purchase price and a Medicaid drug rebate for the same unit of drug.
Question 5: Which of the following is NOT required under HRSA's 340B patient definition?
- The covered entity maintains records of the individual's health care
- The patient must be uninsured or underinsured to qualify (Correct answer)
- A healthcare professional employed by or contracted with the CE is responsible for care
- The patient receives a drug based on the care relationship with the covered entity
Correct answer: The patient must be uninsured or underinsured to qualify
The 340B patient definition does not require patients to be uninsured or underinsured; eligible patients can have any insurance status.
Question 6: When a covered entity 'carves in' Medicaid patients to 340B, what must it do to maintain compliance?
- Limit 340B dispensing to Medicaid patients only during that plan year
- Obtain prior written authorization from the state Medicaid agency
- Report all carved-in Medicaid patients to HRSA within 30 days
- Implement a mechanism to prevent Medicaid from billing for 340B drugs in a way that triggers manufacturer rebates (Correct answer)
Correct answer: Implement a mechanism to prevent Medicaid from billing for 340B drugs in a way that triggers manufacturer rebates
When carving in Medicaid patients, covered entities must ensure Medicaid does not also generate a manufacturer rebate claim for the same drug, preventing duplicate discounts.
Question 7: Which organization(s) have authority to audit covered entities for compliance with the 340B patient definition?
- State boards of pharmacy exclusively
- HRSA and the Office of Inspector General (OIG) (Correct answer)
- Centers for Medicare & Medicaid Services (CMS) only
- Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
Correct answer: HRSA and the Office of Inspector General (OIG)
Both HRSA (through program audits) and the OIG (through investigations) have authority to audit covered entities for compliance with 340B requirements, including the patient definition.
ACE 340B Patient Definition & Eligibility 2
Which of the following scenarios represents a violation of the 340B patient definition?