ACE Compliance & Oversight 2 — Questions and Answers
Question 1: Under the 340B Program, which entity is responsible for performing annual recertification of covered entity eligibility?
- HRSA Office of Pharmacy Affairs (Correct answer)
- CMS Center for Medicaid Services
- State Board of Pharmacy
- FDA Drug Safety Office
Correct answer: HRSA Office of Pharmacy Affairs
HRSA's Office of Pharmacy Affairs (OPA) administers the 340B Program and requires covered entities to recertify annually to confirm continued eligibility.
Question 2: What is the primary purpose of the 340B ceiling price calculation?
- To set the maximum price a manufacturer can charge covered entities for covered outpatient drugs (Correct answer)
- To establish minimum reimbursement rates for covered entities
- To define the markup pharmacies may add to 340B drugs
- To determine copay amounts for eligible patients
Correct answer: To set the maximum price a manufacturer can charge covered entities for covered outpatient drugs
The 340B ceiling price is the maximum price a manufacturer may charge a covered entity for a covered outpatient drug, calculated as AMP minus the Unit Rebate Amount.
Question 3: Which compliance violation would most directly result in a covered entity losing 340B Program eligibility?
- Diversion of 340B drugs to ineligible patients (Correct answer)
- Failure to update a contract pharmacy location within 30 days
- Minor documentation errors in patient records
- Using a non-preferred wholesaler for 340B purchases
Correct answer: Diversion of 340B drugs to ineligible patients
Drug diversion — providing 340B drugs to patients who do not meet the covered entity's patient definition — is a core prohibited act that can result in termination from the program.
Question 4: A 340B covered entity discovers it has been purchasing drugs at 340B prices for Medicaid patients and billing Medicaid for those same drugs. Which term describes this violation?
- Duplicate discounting (Correct answer)
- Drug diversion
- Price gouging
- Retroactive rebate stacking
Correct answer: Duplicate discounting
Duplicate discounting occurs when a covered entity obtains a 340B discount and a Medicaid rebate for the same drug transaction, which is prohibited.
Question 5: Under HRSA guidelines, how often must a covered entity's child site appear on the 340B database to be eligible to access 340B pricing?
- It must be registered and listed before 340B drugs are purchased for that site (Correct answer)
- Within 90 days of opening the site
- At the next annual recertification cycle
- Only if the site dispenses more than 500 prescriptions per month
Correct answer: It must be registered and listed before 340B drugs are purchased for that site
All child sites must be registered in the 340B database prior to purchasing 340B drugs; retroactive registration is not permitted.
Question 6: Which of the following best describes HRSA's audit authority over 340B covered entities?
- HRSA may conduct audits at any time and require corrective action or repayment for identified violations (Correct answer)
- HRSA audits are limited to entities with more than $10 million in 340B purchases annually
- HRSA may audit only when a formal complaint has been filed by a manufacturer
- HRSA audits are advisory only and carry no enforcement penalties
Correct answer: HRSA may conduct audits at any time and require corrective action or repayment for identified violations
HRSA has broad authority to audit covered entities at any time, and findings can require repayment, corrective action plans, or removal from the program.
Question 7: A hospital covered entity contracts with multiple pharmacies to dispense 340B drugs. What must the covered entity maintain to demonstrate compliance?
- Signed contract pharmacy agreements that include oversight and audit provisions (Correct answer)
- State licensure certificates for each contract pharmacy
- Monthly invoices showing 340B purchase volumes
- Manufacturer authorization letters for each contract pharmacy location
Correct answer: Signed contract pharmacy agreements that include oversight and audit provisions
HRSA requires covered entities to have written contract pharmacy agreements that include provisions for oversight, auditing, and ensuring compliance with 340B requirements.
ACE Compliance & Oversight 2
Under the 340B Program, which entity is responsible for performing annual recertification of covered entity eligibility?