Compliance & Oversight Flashcards

A 340B covered entity discovers a vendor error resulted in a small number of drugs being purchased at non-340B prices when 340B prices should have applied. What is the appropriate first step?

Answer: Document the discrepancy and work with the wholesaler or manufacturer to obtain a retroactive adjustment or credit

When pricing errors are discovered, the covered entity should document the issue and pursue a retroactive credit or adjustment through the wholesaler or manufacturer.

Under 340B compliance requirements, which type of entity is generally NOT eligible for the 340B Program?

Answer: For-profit hospitals without a disproportionate share adjustment

For-profit hospitals without a qualifying disproportionate share hospital (DSH) adjustment or other qualifying designation are not eligible for 340B participation.

Which mechanism do manufacturers use to report 340B ceiling prices to the federal government?

Answer: Manufacturers report AMP and URA data to CMS, which HRSA uses to calculate ceiling prices

Manufacturers report Average Manufacturer Price (AMP) and Unit Rebate Amount (URA) data to CMS, and HRSA uses this information to calculate and enforce 340B ceiling prices.

What is the consequence for a manufacturer that knowingly and intentionally overcharges a covered entity above the 340B ceiling price?

Answer: The manufacturer may be subject to civil monetary penalties and must refund the overcharge

Manufacturers that knowingly overcharge covered entities face civil monetary penalties and must refund the amount overcharged, as established under the 340B statute.

Which covered entity type must meet a 'minimum disproportionate share hospital (DSH) percentage' to qualify for the 340B Program?

Answer: DSH hospitals (excluding children's, cancer, and rural referral hospitals which have lower thresholds)

DSH hospitals must meet a minimum DSH adjustment percentage (11.75% for most) to qualify for 340B, while other covered entity types have different or no such threshold.

An ACE-certified professional is asked to review a potential compliance issue involving a covered entity's GPO prohibition. What does this prohibition restrict?

Answer: Covered entities generally may not purchase covered outpatient drugs through a Group Purchasing Organization using 340B pricing

The GPO prohibition prevents covered entities from purchasing covered outpatient drugs through a GPO at 340B prices, though inpatient GPO purchasing is generally permitted.

Which of the following best describes the role of a 340B Third Party Administrator (TPA)?

Answer: A TPA provides technology and administrative services to manage 340B inventory and claims accumulation on behalf of covered entities

Third Party Administrators provide software and administrative services — such as inventory management, claims accumulation, and reporting — to help covered entities manage their 340B programs.