Compliance & Oversight Flashcards
7 cards from real ACE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Compliance & Oversight flashcards as text
HRSA's 340B Program Integrity initiative introduced which of the following tools to improve manufacturer and covered entity transparency?
Answer: The 340B OPAIS (Office of Pharmacy Affairs Information System) database for public registration data
HRSA uses the 340B OPAIS database to publicly list registered covered entities, contract pharmacies, and authorizations, supporting transparency and program integrity.
Under 340B compliance, which scenario would constitute an appropriate use of 340B savings by a covered entity?
Answer: Reinvesting savings to expand pharmacy services for underserved patients
While there is no federal requirement dictating how savings must be used, the program's intent is for savings to benefit the covered entity's patient care mission, such as expanding services for underserved populations.
When must a covered entity remove a registered child site from the 340B database?
Answer: When the site is no longer part of the covered entity or no longer meets eligibility requirements
Covered entities must proactively remove child sites from the 340B database when they are closed, transferred, or no longer eligible, not just during annual recertification.
A state Medicaid fee-for-service program requires covered entities to use a 340B billing modifier when submitting claims. What is the primary purpose of this modifier?
Answer: To allow the state to identify 340B claims and avoid paying additional Medicaid rebates on the same drugs
The 340B billing modifier (often 'UD') notifies Medicaid that the drug was purchased at 340B price, preventing the state from also claiming a Medicaid manufacturer rebate and thus avoiding duplicate discounting.
Which of the following is a key element ACE candidates must understand about 340B manufacturer audit rights?
Answer: Manufacturers may audit covered entities to verify compliance with the duplicate discount prohibition and the patient definition
Under HRSA guidance, manufacturers have the right to audit covered entities to verify that duplicate discounts are not occurring and that 340B drugs are dispensed to eligible patients.
What is the significance of the 'penny pricing' rule for 340B ceiling prices?
Answer: When the calculated 340B ceiling price is zero or negative, the price is set at one cent ($0.01) to maintain a valid transaction
When the statutory formula produces a ceiling price of zero or below (due to a high rebate), the price is set at $0.01 (penny pricing) so a lawful commercial transaction can still occur.
Which of the following actions would a 340B compliance officer take to prepare for a potential HRSA audit?
Answer: Ensure policies, patient eligibility records, purchase logs, and contract pharmacy agreements are current and accessible
Audit readiness requires maintaining up-to-date policies, patient definition documentation, purchase records, and contract pharmacy agreements that auditors will review.