ACE Compliance & Oversight 3 — Questions and Answers
Question 1: Which organization publishes the Apexus ACE exam and sets the standards for 340B compliance certification?
- Apexus, the HRSA-designated 340B Prime Vendor (Correct answer)
- The American Pharmacists Association
- ASHP
- The National Association of Specialty Pharmacy
Correct answer: Apexus, the HRSA-designated 340B Prime Vendor
Apexus serves as the HRSA-designated Prime Vendor for the 340B Program and administers the ACE certification to promote program integrity and compliance knowledge.
Question 2: Under 340B compliance, what is the significance of maintaining a 'patient definition'?
- It establishes which individuals qualify to receive 340B-priced drugs from the covered entity (Correct answer)
- It determines the reimbursement rate the covered entity receives from payers
- It defines the geographic service area for 340B purchasing
- It sets the income threshold for patient eligibility for free drug programs
Correct answer: It establishes which individuals qualify to receive 340B-priced drugs from the covered entity
The patient definition determines who qualifies for 340B drugs; dispensing 340B drugs to individuals outside this definition constitutes diversion.
Question 3: When a 340B covered entity uses a contract pharmacy, who bears primary responsibility for ensuring 340B compliance?
- The covered entity (Correct answer)
- The contract pharmacy
- The drug wholesaler
- HRSA directly
Correct answer: The covered entity
The covered entity retains primary compliance responsibility even when using contract pharmacies; it must have oversight mechanisms to ensure the pharmacy dispenses correctly.
Question 4: Which federal statute authorizes the 340B Drug Pricing Program?
- Section 340B of the Public Health Service Act (Correct answer)
- Title XVIII of the Social Security Act
- The Drug Price Competition and Patent Term Restoration Act
- The Affordable Care Act Section 2703
Correct answer: Section 340B of the Public Health Service Act
The 340B Program was created by Section 340B of the Public Health Service Act (PHSA), enacted as part of the Veterans Health Care Act of 1992.
Question 5: A Federally Qualified Health Center (FQHC) wishes to add a new service delivery site to its 340B registration. Which action is required before that site may purchase 340B drugs?
- Register the new site with HRSA OPA and wait for confirmation before purchasing (Correct answer)
- Submit a written request to the drug wholesaler only
- Notify the state health department within 14 days
- No action is required if the parent FQHC is already registered
Correct answer: Register the new site with HRSA OPA and wait for confirmation before purchasing
Each new service delivery site must be separately registered with HRSA OPA and confirmed in the 340B database before 340B purchases may begin at that location.
Question 6: In the context of 340B compliance, what is a 'split-billing' system designed to do?
- Segregate 340B-eligible prescriptions from non-340B prescriptions to prevent duplicate discounts (Correct answer)
- Divide drug costs between federal and state Medicaid funds
- Allocate 340B savings between the covered entity and the contract pharmacy
- Separate inpatient drug costs from outpatient drug costs for billing purposes
Correct answer: Segregate 340B-eligible prescriptions from non-340B prescriptions to prevent duplicate discounts
Split-billing software identifies which prescriptions qualify for 340B pricing versus non-340B pricing, preventing duplicate discounts with Medicaid and ensuring accurate purchasing.
Question 7: Which of the following is NOT a required element of a valid 340B contract pharmacy arrangement?
- The contract pharmacy must be owned by the covered entity (Correct answer)
- A written agreement must exist between the covered entity and the pharmacy
- The arrangement must be registered in the 340B database
- The covered entity must retain audit rights over the pharmacy
Correct answer: The contract pharmacy must be owned by the covered entity
Contract pharmacies do not need to be owned by the covered entity; they are independent pharmacies operating under a formal contract, which must be registered with HRSA.
ACE Compliance & Oversight 3
Which organization publishes the Apexus ACE exam and sets the standards for 340B compliance certification?