ACE Compliance & Oversight 1 — Questions and Answers
Question 1: What is a key responsibility of covered entities under 340B program compliance?
- Dispensing to all patients regardless of eligibility
- Sharing 340B inventory with contract pharmacies
- Preventing diversion of 340B drugs to ineligible patients (Correct answer)
- Refusing to disclose pricing data to HRSA
Correct answer: Preventing diversion of 340B drugs to ineligible patients
Covered entities must ensure that 340B drugs are not diverted to ineligible patients, which is a core compliance requirement.
Question 2: What does HRSA conduct to ensure compliance with the 340B Program?
- Quarterly financial audits
- Site visits without notice
- 340B compliance audits (Correct answer)
- Inventory checks from CMS
Correct answer: 340B compliance audits
HRSA performs audits of covered entities to verify compliance with program rules such as duplicate discounts and diversion.
Question 3: Which of the following is an example of non-compliance in the 340B Program?
- Only using contract pharmacies for dispensing
- Conducting internal self-audits
- Dispensing drugs to ineligible individuals (Correct answer)
- Participating in Apexus education modules
Correct answer: Dispensing drugs to ineligible individuals
Dispensing 340B drugs to individuals who do not meet patient definition is considered diversion and is non-compliant.
Question 4: What is a duplicate discount in the context of 340B compliance?
- Giving the same drug to two patients
- Receiving a 340B discount and a Medicaid rebate on the same drug (Correct answer)
- Dispensing expired medications
- Failing to report pricing data
Correct answer: Receiving a 340B discount and a Medicaid rebate on the same drug
Duplicate discounts occur when a 340B drug is also subject to a Medicaid rebate, which is prohibited under the program.
Question 5: Which document outlines the responsibilities for maintaining 340B compliance?
- Medicare Enrollment Manual
- 340B Program Integrity guidance (Correct answer)
- State Board of Pharmacy regulations
- Hospital internal policy manual
Correct answer: 340B Program Integrity guidance
The 340B Program Integrity requirements and associated federal guidance outline the responsibilities of covered entities.
Question 6: Why should covered entities perform self-audits regularly?
- To meet state licensing requirements
- To ensure only pharmacists administer vaccines
- To detect and address potential compliance risks internally (Correct answer)
- To increase inventory turnover
Correct answer: To detect and address potential compliance risks internally
Self-audits help entities detect compliance risks early and prepare for potential HRSA audits.
Question 7: What action must be taken if a covered entity identifies a compliance violation?
- Notify the FDA immediately
- Report it to HRSA and take corrective action (Correct answer)
- Suspend all drug purchases
- Ignore it if it was unintentional
Correct answer: Report it to HRSA and take corrective action
Entities must report violations to HRSA and may be required to repay manufacturers for inappropriately used 340B drugs.
Question 8: Who has oversight authority for enforcing 340B compliance?
- DEA
- FDA
- HRSA (Correct answer)
- CMS
Correct answer: HRSA
The Health Resources and Services Administration (HRSA) oversees compliance and conducts audits to enforce 340B rules.
Question 9: How can a covered entity maintain oversight over its contract pharmacies?
- Rely on the pharmacy's internal procedures
- Avoid written agreements
- Implement written policies and conduct regular audits (Correct answer)
- Conduct surprise visits without documentation
Correct answer: Implement written policies and conduct regular audits
Written policies, regular audits, and clearly defined roles help maintain compliance oversight of contract pharmacy arrangements.
ACE Compliance & Oversight 1
What is a key responsibility of covered entities under 340B program compliance?