Program Management & Optimization Flashcards

A 340B program coordinator is evaluating whether to add a new specialty drug to the 340B formulary. Which consideration should take priority?

Answer: Whether the drug is a covered outpatient drug eligible under the 340B statute

Only covered outpatient drugs as defined by the 340B statute are eligible for 340B pricing, making statutory eligibility the threshold requirement for formulary decisions.

Which scenario represents an appropriate use of 340B program savings by a safety-net hospital?

Answer: Expanding medication assistance programs for uninsured and underinsured patients

While 340B law does not mandate specific uses of savings, using them to expand services for vulnerable populations aligns with the program's mission and is widely recognized as appropriate use.

When preparing for a HRSA audit, which document is most critical for demonstrating 340B patient eligibility?

Answer: Medical records or encounter data linking prescriptions to covered entity patient encounters

Medical records and encounter data are the primary evidence that a patient met the 340B patient definition at the time the drug was dispensed.

A 340B program manager notices that a contract pharmacy is dispensing 340B drugs to patients not seen at the covered entity. What type of violation does this represent?

Answer: Drug diversion

Dispensing 340B-priced drugs to patients who do not meet the 340B patient definition constitutes drug diversion, a serious compliance violation.

Which of the following is a key benefit of participating in the Apexus Prime Vendor Program (PVP) beyond 340B ceiling prices?

Answer: Sub-ceiling pricing on select drugs and value-added services negotiated by Apexus

The Apexus PVP negotiates sub-ceiling pricing and additional value-added services (such as vaccines and non-covered drugs) that provide savings beyond the statutory 340B ceiling price.

A covered entity's 340B split-billing software flags a prescription as 'non-340B eligible.' What is the most likely reason?

Answer: The prescription cannot be linked to a qualifying covered entity patient encounter

Split-billing software denies 340B eligibility when it cannot match a prescription to a qualifying encounter record, indicating the patient does not meet the 340B patient definition.

How does the 340B program define a 'covered outpatient drug' for the purpose of determining pricing eligibility?

Answer: A drug subject to a rebate agreement under Medicaid, including most FDA-approved prescription drugs and biologics

A covered outpatient drug is defined by reference to the Medicaid rebate statute (42 U.S.C. § 1396r-8) and includes most FDA-approved prescription drugs and biologics covered under manufacturer rebate agreements.