ACE Compliance & Oversight 2

Question 1

Under the 340B Program, which entity is responsible for performing annual recertification of covered entity eligibility?

Accepted Answer

HRSA Office of Pharmacy Affairs

Answer

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?

Accepted Answer

To set the maximum price a manufacturer can charge covered entities for covered outpatient drugs

Answer

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?

Accepted Answer

Diversion of 340B drugs to ineligible patients

Answer

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?

Accepted Answer

Duplicate discounting

Answer

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?

Accepted Answer

It must be registered and listed before 340B drugs are purchased for that site

Answer

All child sites must be registered in the 340B database prior to purchasing 340B drugs; retroactive registration is not permitted.

(ACE) Apexus Certified Expert Practice Test

(ACE) Apexus Certified Expert Practice Test

ACE Compliance & Oversight 2