ACE 340B Patient Definition & Eligibility 2

Question 1

Which of the following scenarios represents a violation of the 340B patient definition?

Accepted Answer

A covered entity dispenses 340B drugs to an ER patient who has no established ongoing care relationship with the covered entity

Answer

A covered entity dispenses 340B drugs to a patient referred by an employed provider

Answer

A covered entity dispenses 340B drugs to a patient whose records are maintained by the CE

Answer

A covered entity dispenses 340B drugs to a patient seen by a contracted specialist

Question 2

What is 'diversion' in the context of the 340B program?

Accepted Answer

Transferring 340B-purchased drugs to patients who do not meet the patient definition

Answer

Using 340B funds to purchase non-covered outpatient drugs

Answer

Switching from one wholesaler to another without HRSA notification

Answer

Billing Medicaid before seeking a manufacturer rebate for the same drug

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:

Accepted Answer

May violate the patient definition since no health care services were provided beyond dispensing

Answer

Is acceptable if the patient was previously seen by any licensed healthcare provider

Answer

Fully complies with the 340B patient definition as long as records exist

Answer

Is compliant as long as the FQHC maintains the patient's insurance records

Question 4

The 340B duplicate discount prohibition means a covered entity cannot:

Accepted Answer

Receive both a 340B discounted purchase price and a Medicaid rebate for the same unit of drug

Answer

Claim 340B savings and receive government grant funds for the same patient encounter

Answer

Purchase the same drug from two different wholesalers at 340B prices

Answer

Sell 340B drugs through both retail and mail-order pharmacies simultaneously

Question 5

Which of the following is NOT required under HRSA's 340B patient definition?

Accepted Answer

The patient must be uninsured or underinsured to qualify

Answer

The covered entity maintains records of the individual's health care

Answer

A healthcare professional employed by or contracted with the CE is responsible for care

Answer

The patient receives a drug based on the care relationship with the covered entity

Question 6

When a covered entity 'carves in' Medicaid patients to 340B, what must it do to maintain compliance?

Accepted Answer

Implement a mechanism to prevent Medicaid from billing for 340B drugs in a way that triggers manufacturer rebates

Answer

Limit 340B dispensing to Medicaid patients only during that plan year

Answer

Obtain prior written authorization from the state Medicaid agency

Answer

Report all carved-in Medicaid patients to HRSA within 30 days

Question 7

Which organization(s) have authority to audit covered entities for compliance with the 340B patient definition?

Accepted Answer

HRSA and the Office of Inspector General (OIG)

Answer

State boards of pharmacy exclusively

Answer

Centers for Medicare & Medicaid Services (CMS) only

Answer

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)