ACE Purchasing & Inventory Management 2 — Questions and Answers
Question 1: Under the 340B program, which inventory management method uses a single physical stock for both 340B and non-340B drugs, with software tracking eligibility at the point of dispensing?
- Virtual inventory (Correct answer)
- Physical separation
- Replenishment model
- WAC purchasing
Correct answer: Virtual inventory
Virtual inventory (also called virtual replenishment or commingled inventory) uses software to track 340B eligibility without physically separating drug stock.
Question 2: A 340B covered entity purchases a drug at WAC and later replenishes it at the 340B price. This is the basis of which inventory model?
- Accumulation
- Replenishment (Correct answer)
- Split billing
- Direct purchase
Correct answer: Replenishment
In the replenishment model, drugs are initially purchased at non-340B prices and later replenished at the 340B price after a qualifying patient encounter is confirmed.
Question 3: Which federal requirement prohibits a 340B covered entity from obtaining a discounted 340B drug AND a Medicaid rebate for the same drug dispensed to the same patient?
- GPO exclusion
- Orphan drug exclusion
- Duplicate discount prohibition (Correct answer)
- Diversion prohibition
Correct answer: Duplicate discount prohibition
The duplicate discount prohibition in the 340B statute prevents covered entities from receiving both a 340B discount and a Medicaid rebate on the same drug transaction.
Question 4: A 340B hospital has a mixed-use oncology infusion area where both 340B-eligible and non-eligible patients are treated. Which documentation practice is essential to maintain compliance?
- Purchase all drugs at GPO pricing only
- Maintain encounter-level records linking each drug to patient eligibility (Correct answer)
- Use two separate pharmacies for the same area
- Dispense only to inpatients
Correct answer: Maintain encounter-level records linking each drug to patient eligibility
Mixed-use areas require encounter-level documentation to demonstrate that each 340B drug dispensed was linked to an eligible patient encounter.
Question 5: Under HRSA guidance, which of the following is the primary responsibility of a 340B covered entity when using a contract pharmacy?
- The pharmacy assumes full compliance liability
- The covered entity retains ultimate compliance responsibility (Correct answer)
- HRSA directly oversees contract pharmacy operations
- The wholesaler certifies pharmacy eligibility
Correct answer: The covered entity retains ultimate compliance responsibility
Regardless of contract pharmacy arrangements, the covered entity retains full compliance responsibility for all 340B transactions processed through its contract pharmacies.
Question 6: What is the term for a 340B drug that is diverted to a patient who does not meet the program's definition of an eligible patient?
- Duplicate discount
- Diversion (Correct answer)
- WAC overbuy
- Orphan exclusion
Correct answer: Diversion
Diversion occurs when a 340B-priced drug is dispensed to a patient who is not eligible under the program, violating the statute.
Question 7: Which document must a 340B covered entity submit annually to HRSA to maintain program participation and ensure inventory data accuracy?
- Drug utilization report
- Annual recertification (Correct answer)
- UPIN registration form
- WAC pricing attestation
Correct answer: Annual recertification
Covered entities must complete annual recertification through HRSA's Office of Pharmacy Affairs Information System (OPAIS) to confirm ongoing eligibility and data accuracy.
ACE Purchasing & Inventory Management 2
Under the 340B program, which inventory management method uses a single physical stock for both 340B and non-340B drugs, with software tracking eligibility at the point of dispensing?