ACE 340B Patient Definition & Eligibility 3

Question 1

A Ryan White HIV/AIDS Program grantee is determining whether a patient qualifies for 340B. Which factor is MOST critical in this determination?

Accepted Answer

Whether the covered entity maintains the patient's health records and provides ongoing care

Answer

The geographic distance between the patient's home and the covered entity

Answer

The patient's CD4 count and current viral load status

Answer

Whether the patient also receives Ryan White-funded services at a different location

Question 2

What is the significance of the 'responsible for ongoing care' requirement in the 340B patient definition?

Accepted Answer

It ensures the prescribing provider's accountability for the patient's care remains with the covered entity

Answer

It requires covered entities to schedule mandatory follow-up appointments for all 340B patients

Answer

It mandates that covered entities accept new patients regardless of capacity

Answer

It requires covered entities to provide 24/7 emergency services to all 340B patients

Question 3

What type of records must a covered entity maintain to demonstrate patient eligibility during a 340B audit?

Accepted Answer

Medical records or other documentation establishing the patient care relationship

Answer

Financial records showing the cost savings generated from 340B purchases

Answer

Pharmacy dispensing logs approved by the state board of pharmacy

Answer

Annual certification statements signed by each 340B patient

Question 4

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:

Accepted Answer

A potential diversion violation requiring immediate corrective action

Answer

An acceptable use of 340B as a fringe benefit for healthcare staff

Answer

A minor administrative error with no significant compliance implications

Answer

A permissible practice if the employees are low-income workers

Question 5

What term describes the practice of intentionally excluding Medicaid claims from 340B drug purchases to avoid duplicate discounts?

Accepted Answer

Carve-out

Answer

Bifurcation

Answer

Ring-fencing

Answer

Carve-in

Question 6

How does HRSA's patient definition apply to patients seen via telehealth visits at a covered entity?

Accepted Answer

Telehealth patients may qualify if the care relationship and record-keeping requirements are satisfied

Answer

Telehealth patients can never qualify as 340B patients under current guidance

Answer

Telehealth visits automatically qualify all patients for 340B drugs without additional documentation

Answer

Only synchronous video telehealth visits qualify; asynchronous store-and-forward visits do not

Question 7

A covered entity found to be in violation of the 340B patient definition and diversion prohibitions may face which consequence?

Accepted Answer

Termination from the 340B program and potential repayment of improperly obtained discounts

Answer

A warning letter from FDA with a 90-day corrective action period and no further penalty

Answer

A fine issued by the state board of pharmacy and mandatory staff retraining

Answer

Suspension of Medicare billing privileges for all covered entity providers