340B Patient Definition & Eligibility Flashcards
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Read the first 7 340B Patient Definition & Eligibility flashcards as text
Which of the following scenarios represents a violation of the 340B patient definition?
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.
What is 'diversion' in the context of the 340B program?
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.
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:
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.
The 340B duplicate discount prohibition means a covered entity cannot:
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.
Which of the following is NOT required under HRSA's 340B patient definition?
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.
When a covered entity 'carves in' Medicaid patients to 340B, what must it do to maintain compliance?
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.
Which organization(s) have authority to audit covered entities for compliance with the 340B patient definition?
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.