ACE Program Management & Optimization 2 — Questions and Answers
Question 1: Under the 340B program, which entity is primarily responsible for ensuring that duplicate discounts do not occur when a covered entity uses contract pharmacies?
- The contract pharmacy
- The covered entity (Correct answer)
- HRSA
- The drug manufacturer
Correct answer: The covered entity
The covered entity bears primary responsibility for preventing duplicate discounts, including implementing systems to separate 340B and non-340B claims at contract pharmacy locations.
Question 2: A 340B covered entity wants to maximize savings on specialty drugs. Which strategy best aligns with 340B program compliance requirements?
- Purchase all specialty drugs through the GPO to stack discounts
- Use 340B pricing only for patients who meet the definition of a 340B patient (Correct answer)
- Extend 340B benefits to any patient who visits the facility regardless of payer
- Negotiate rebates directly with manufacturers on top of 340B pricing
Correct answer: Use 340B pricing only for patients who meet the definition of a 340B patient
340B savings may only be used on drugs dispensed to patients who meet the program's definition, ensuring the benefit is tied to eligible patient encounters.
Question 3: Which of the following metrics is most useful for evaluating the financial performance of a 340B program?
- Total number of prescriptions filled
- 340B savings as a percentage of total drug spend (Correct answer)
- Number of contract pharmacy locations
- Average wholesale price of formulary drugs
Correct answer: 340B savings as a percentage of total drug spend
Measuring 340B savings as a percentage of total drug spend provides a direct indicator of the program's financial impact and efficiency.
Question 4: What is the primary purpose of a 340B third-party administrator (TPA)?
- To negotiate drug prices on behalf of manufacturers
- To manage claims data and ensure proper 340B accumulation at contract pharmacies (Correct answer)
- To audit covered entities on behalf of HRSA
- To provide legal counsel for 340B disputes
Correct answer: To manage claims data and ensure proper 340B accumulation at contract pharmacies
TPAs manage the data flow between covered entities and contract pharmacies to accurately identify, accumulate, and replenish 340B-eligible claims.
Question 5: A federally qualified health center (FQHC) discovers it has been charging Medicaid fee-for-service patients full price while purchasing those drugs at 340B pricing. What must occur?
- The FQHC must repay the 340B savings to the manufacturer
- The FQHC must refund the overcharge to Medicaid and implement corrective measures (Correct answer)
- No action is required if the savings were reinvested in patient care
- The FQHC should notify HRSA but is not required to repay funds
Correct answer: The FQHC must refund the overcharge to Medicaid and implement corrective measures
Charging Medicaid at full price while using 340B pricing constitutes a duplicate discount, and the covered entity must refund improperly received amounts and correct its systems.
Question 6: Which approach is considered a best practice for a 340B program coordinator managing multiple contract pharmacy agreements?
- Centralizing all contract pharmacy claims in a single spreadsheet updated monthly
- Implementing real-time data analytics to monitor eligibility and accumulation (Correct answer)
- Relying solely on contract pharmacy audits to verify compliance
- Limiting contract pharmacy agreements to reduce administrative complexity
Correct answer: Implementing real-time data analytics to monitor eligibility and accumulation
Real-time data analytics enables proactive identification of eligibility issues and ensures accurate 340B accumulation across all contract pharmacy locations.
Question 7: When a 340B covered entity transitions from an in-house pharmacy to a contract pharmacy model, which compliance step is most critical immediately after the transition?
- Renegotiating manufacturer pricing agreements
- Registering the contract pharmacy with HRSA before dispensing 340B drugs (Correct answer)
- Notifying all patients of the pharmacy change
- Updating the formulary to reflect contract pharmacy drug availability
Correct answer: Registering the contract pharmacy with HRSA before dispensing 340B drugs
Contract pharmacy locations must be registered with HRSA prior to dispensing 340B drugs to ensure the arrangement is authorized under the program.
Under the 340B program, which entity is primarily responsible for ensuring that duplicate discounts do not occur when a covered entity uses contract pharmacies?