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

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?

Accepted Answer

340B compliance audits

Answer

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?

Accepted Answer

Dispensing drugs to ineligible individuals

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

340B Program Integrity guidance

Answer

The 340B Program Integrity requirements and associated federal guidance outline the responsibilities of covered entities.

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