ACE Contract Pharmacy & Third Party Administration Flashcards
6 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 6 ACE Contract Pharmacy & Third Party Administration flashcards as text
What is the most significant compliance risk associated with contract pharmacy arrangements in the 340B program?
Answer: Drug diversion — dispensing 340B drugs to ineligible patients
Drug diversion — providing 340B-purchased drugs to patients who do not meet the covered entity's eligibility criteria — is the primary compliance risk in contract pharmacy arrangements.
How frequently should a covered entity audit its contract pharmacy arrangements?
Answer: Regularly, with a formal internal audit at least annually
Best practice and HRSA guidance call for covered entities to conduct regular, at least annual, internal audits of contract pharmacy arrangements to proactively identify and correct compliance issues.
If a contract pharmacy is found to be non-compliant with 340B requirements, what is the covered entity's obligation?
Answer: Investigate, implement corrective actions, and potentially terminate the arrangement if violations persist
Upon discovering non-compliance, the covered entity must investigate, implement corrective actions, and — if violations cannot be remedied — terminate the contract pharmacy arrangement.
What documentation is essential for demonstrating contract pharmacy compliance during an HRSA audit?
Answer: Patient eligibility records, dispensing logs, purchase records, and the written contract pharmacy agreement
HRSA auditors will look for patient eligibility records, prescription dispensing logs, 340B purchase records, and the written contract pharmacy agreement to verify compliance.
Which of the following actions would constitute drug diversion in a contract pharmacy context?
Answer: Purchasing drugs at 340B ceiling prices for use at a non-covered-entity location
Purchasing drugs at 340B ceiling prices and dispensing them at a location not covered under the 340B program constitutes diversion, a serious violation.
What is the significance of the HRSA 340B OPAIS database in contract pharmacy compliance?
Answer: It serves as the official registry where contract pharmacy arrangements must be listed to be valid
The HRSA 340B OPAIS database is the official registry; a contract pharmacy arrangement must be registered there to be recognized and for 340B purchases to be valid at that location.