ACE Compliance & Oversight 3

Question 1

Which organization publishes the Apexus ACE exam and sets the standards for 340B compliance certification?

Accepted Answer

Apexus, the HRSA-designated 340B Prime Vendor

Answer

Apexus serves as the HRSA-designated Prime Vendor for the 340B Program and administers the ACE certification to promote program integrity and compliance knowledge.

Question 2

Under 340B compliance, what is the significance of maintaining a 'patient definition'?

Accepted Answer

It establishes which individuals qualify to receive 340B-priced drugs from the covered entity

Answer

The patient definition determines who qualifies for 340B drugs; dispensing 340B drugs to individuals outside this definition constitutes diversion.

Question 3

When a 340B covered entity uses a contract pharmacy, who bears primary responsibility for ensuring 340B compliance?

Accepted Answer

The covered entity

Answer

The covered entity retains primary compliance responsibility even when using contract pharmacies; it must have oversight mechanisms to ensure the pharmacy dispenses correctly.

Question 4

Which federal statute authorizes the 340B Drug Pricing Program?

Accepted Answer

Section 340B of the Public Health Service Act

Answer

The 340B Program was created by Section 340B of the Public Health Service Act (PHSA), enacted as part of the Veterans Health Care Act of 1992.

Question 5

A Federally Qualified Health Center (FQHC) wishes to add a new service delivery site to its 340B registration. Which action is required before that site may purchase 340B drugs?

Accepted Answer

Register the new site with HRSA OPA and wait for confirmation before purchasing

Answer

Each new service delivery site must be separately registered with HRSA OPA and confirmed in the 340B database before 340B purchases may begin at that location.

(ACE) Apexus Certified Expert Practice Test

(ACE) Apexus Certified Expert Practice Test

ACE Compliance & Oversight 3