ACE Compliance & Oversight

Question 1

What is a key responsibility of covered entities under 340B program compliance?

Accepted Answer

Preventing diversion of 340B drugs to ineligible patients

Answer

Dispensing to all patients regardless of eligibility

Answer

Sharing 340B inventory with contract pharmacies

Answer

Refusing to disclose pricing data to HRSA

Question 2

What does HRSA conduct to ensure compliance with the 340B Program?

Accepted Answer

340B compliance audits

Answer

Quarterly financial audits

Answer

Site visits without notice

Answer

Inventory checks from CMS

Question 3

Which of the following is an example of non-compliance in the 340B Program?

Accepted Answer

Dispensing drugs to ineligible individuals

Answer

Only using contract pharmacies for dispensing

Answer

Conducting internal self-audits

Answer

Participating in Apexus education modules

Question 4

What is a duplicate discount in the context of 340B compliance?

Accepted Answer

Receiving a 340B discount and a Medicaid rebate on the same drug

Answer

Giving the same drug to two patients

Answer

Dispensing expired medications

Answer

Failing to report pricing data

Question 5

Which document outlines the responsibilities for maintaining 340B compliance?

Accepted Answer

340B Program Integrity guidance

Answer

Medicare Enrollment Manual

Answer

State Board of Pharmacy regulations

Answer

Hospital internal policy manual

Question 6

Why should covered entities perform self-audits regularly?

Accepted Answer

To detect and address potential compliance risks internally

Answer

To meet state licensing requirements

Answer

To ensure only pharmacists administer vaccines

Answer

To increase inventory turnover

Question 7

What action must be taken if a covered entity identifies a compliance violation?

Accepted Answer

Report it to HRSA and take corrective action

Answer

Notify the FDA immediately

Answer

Suspend all drug purchases

Answer

Ignore it if it was unintentional

Question 8

Who has oversight authority for enforcing 340B compliance?

Accepted Answer

HRSA

Answer

DEA

Answer

FDA

Answer

CMS

Question 9

How can a covered entity maintain oversight over its contract pharmacies?

Accepted Answer

Implement written policies and conduct regular audits

Answer

Rely on the pharmacy's internal procedures

Answer

Avoid written agreements

Answer

Conduct surprise visits without documentation