340B Patient Definition & Eligibility Flashcards
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Read the first 7 340B Patient Definition & Eligibility flashcards as text
A Ryan White HIV/AIDS Program grantee is determining whether a patient qualifies for 340B. Which factor is MOST critical in this determination?
Answer: Whether the covered entity maintains the patient's health records and provides ongoing care
Regardless of the type of covered entity, the core patient definition requires an established care relationship with maintained health records and ongoing care responsibility.
What is the significance of the 'responsible for ongoing care' requirement in the 340B patient definition?
Answer: It ensures the prescribing provider's accountability for the patient's care remains with the covered entity
The 'responsible for ongoing care' requirement ensures the care relationship is anchored within the covered entity's context, not merely a one-time external referral with no continued accountability.
What type of records must a covered entity maintain to demonstrate patient eligibility during a 340B audit?
Answer: Medical records or other documentation establishing the patient care relationship
Covered entities must maintain records such as medical records or health documentation that establish the patient care relationship to demonstrate compliance during audits.
A covered entity's 340B coordinator discovers that 340B drugs were dispensed to employees of the covered entity who are not registered patients. This represents:
Answer: A potential diversion violation requiring immediate corrective action
Dispensing 340B drugs to individuals who do not qualify as patients—including employees—constitutes diversion, a serious compliance violation that can result in program termination.
What term describes the practice of intentionally excluding Medicaid claims from 340B drug purchases to avoid duplicate discounts?
Answer: Carve-out
Carve-out refers to excluding Medicaid fee-for-service patients or claims from 340B drug purchases, thereby preventing duplicate discounts on those drug units.
How does HRSA's patient definition apply to patients seen via telehealth visits at a covered entity?
Answer: Telehealth patients may qualify if the care relationship and record-keeping requirements are satisfied
HRSA has indicated that telehealth patients can meet the patient definition if the covered entity maintains their health records and the care relationship requirements are fulfilled.
A covered entity found to be in violation of the 340B patient definition and diversion prohibitions may face which consequence?
Answer: Termination from the 340B program and potential repayment of improperly obtained discounts
HRSA can terminate a covered entity from the 340B program and may require repayment of discounts obtained through improperly dispensed 340B drugs when patient definition or diversion violations are confirmed.