Purchasing & Inventory Management Flashcards
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Read the first 7 Purchasing & Inventory Management flashcards as text
A 340B pharmacy manager notices that clinic staff are dispensing 340B-priced drugs to employees with no qualifying patient encounter. Under the statute, this constitutes:
Answer: Drug diversion
Dispensing 340B-priced drugs to individuals who are not eligible patients — including staff — constitutes diversion, which is explicitly prohibited by the 340B statute.
Which inventory replenishment approach is most commonly used by 340B hospitals that operate their own outpatient pharmacy and want to minimize audit risk?
Answer: Encounter-based virtual replenishment with audit trails
Encounter-based virtual replenishment with detailed audit trails is widely regarded as the lowest-risk approach because each 340B order is supported by documented eligible encounters.
When calculating the 340B ceiling price for a drug, the formula is based on:
Answer: Wholesale Acquisition Cost (WAC) minus the Unit Rebate Amount (URA)
The 340B ceiling price equals WAC minus the Unit Rebate Amount (URA) that manufacturers owe under the Medicaid Drug Rebate Program.
A covered entity is audited and found to have no written contract with its contract pharmacy specifying 340B compliance obligations. This finding most directly violates:
Answer: HRSA's contract pharmacy guidance requiring a written agreement
HRSA guidance requires that a written contract pharmacy agreement be in place, clearly defining each party's 340B compliance responsibilities.
In a 340B audit, which record is most critical for demonstrating that a drug was dispensed to an eligible patient at a registered site?
Answer: Patient encounter record linked to the dispensing event
An encounter record that links the specific patient visit to the 340B dispensing event is the foundational audit document proving patient eligibility.
Which of the following changes requires a covered entity to update its OPAIS registration BEFORE the change takes effect to remain compliant?
Answer: Adding a new child site or contract pharmacy
Adding new child sites or contract pharmacies must be registered in OPAIS prior to beginning 340B purchasing through those locations.
A federally qualified health center (FQHC) wants to use 340B drugs at a satellite clinic located 20 miles from the main site. What is the primary compliance requirement?
Answer: The satellite must be registered as a child site under the FQHC's OPAIS record
Off-site clinics must be registered as child sites in OPAIS under the parent covered entity's record before 340B purchasing can occur there.