ACE Program Management & Optimization 3 — Questions and Answers
Question 1: A 340B program manager is reviewing quarterly utilization reports and notices a significant drop in 340B capture rate. What is the most appropriate first step?
- Immediately expand contract pharmacy locations
- Analyze claims data to identify where eligible prescriptions are being missed (Correct answer)
- Request a HRSA audit to identify the source of the problem
- Increase patient enrollment in the 340B program
Correct answer: Analyze claims data to identify where eligible prescriptions are being missed
Analyzing claims data is the foundational step to identify gaps in eligibility identification, dispensing workflows, or data accumulation before implementing solutions.
Question 2: Which of the following best describes the 'accumulation' step in a 340B contract pharmacy model?
- The process of ordering 340B-priced drugs from the wholesaler
- The tracking and crediting of 340B-eligible prescriptions dispensed at a contract pharmacy (Correct answer)
- The reconciliation of manufacturer invoices against purchase orders
- The enrollment of new patients into the covered entity's 340B program
Correct answer: The tracking and crediting of 340B-eligible prescriptions dispensed at a contract pharmacy
Accumulation refers to identifying 340B-eligible prescriptions dispensed at a contract pharmacy and building a replenishment credit that the covered entity uses to reorder drugs at 340B pricing.
Question 3: Under Apexus guidelines, which factor most directly determines whether a patient qualifies as a '340B patient' for an outpatient clinic encounter?
- The patient's insurance status
- Whether the covered entity has a healthcare relationship with the patient and is responsible for their care (Correct answer)
- The patient's income level relative to the federal poverty line
- Whether the patient's drug was on the 340B formulary
Correct answer: Whether the covered entity has a healthcare relationship with the patient and is responsible for their care
The 340B patient definition requires that the covered entity have an established healthcare relationship with the patient and maintain responsibility for that patient's care.
Question 4: A hospital's 340B program is being expanded to include an off-site clinic. What is the required action before the clinic can participate in 340B drug purchases?
- Submit a waiver request to CMS
- Register the child site with HRSA during an open enrollment period (Correct answer)
- Obtain approval from the state pharmacy board
- Notify the hospital's GPO administrator
Correct answer: Register the child site with HRSA during an open enrollment period
Off-site outpatient facilities must be registered with HRSA as child sites during an enrollment period before they are eligible to participate in 340B drug purchasing.
Question 5: Which internal control is most effective at preventing 340B drug diversion to ineligible patients?
- Limiting formulary access to high-cost specialty drugs only
- Implementing a robust patient eligibility verification process at the point of prescribing (Correct answer)
- Requiring all prescriptions to be filled at the covered entity's in-house pharmacy
- Auditing manufacturer invoices on a semi-annual basis
Correct answer: Implementing a robust patient eligibility verification process at the point of prescribing
Verifying patient eligibility at the point of prescribing ensures that 340B drugs are reserved for patients who meet the program definition, the most upstream and effective control.
Question 6: What is the significance of the 'ceiling price' in the 340B drug pricing program?
- It is the minimum price a covered entity must pay for 340B drugs
- It is the maximum price manufacturers may charge covered entities for covered outpatient drugs (Correct answer)
- It represents the average selling price across all purchasers
- It is the benchmark used to calculate Medicaid best price
Correct answer: It is the maximum price manufacturers may charge covered entities for covered outpatient drugs
The 340B ceiling price is calculated by statute as the average manufacturer price minus the Medicaid rebate percentage, and manufacturers cannot charge covered entities more than this amount.
Question 7: A covered entity's program manager wants to benchmark their 340B savings against peer organizations. Which source would provide the most relevant benchmarking data?
- The Federal Register
- Apexus 340B University and industry benchmarking reports (Correct answer)
- CMS drug pricing dashboards
- State pharmacy board licensure databases
Correct answer: Apexus 340B University and industry benchmarking reports
Apexus, as the HRSA-designated Prime Vendor Program contractor, provides 340B-specific educational resources and benchmarking tools tailored to covered entity program management.
ACE Program Management & Optimization 3
A 340B program manager is reviewing quarterly utilization reports and notices a significant drop in 340B capture rate.
What is the most appropriate first step?