340B PROGRAM
OPERATIONS PRACTICE
EXAM Question 1: Which federal agency is primarily responsible for administering the 340B Drug Pricing Program?
Choices:
1) Centers for Medicare & Medicaid Services (CMS) 2) Food and Drug Administration (FDA) 3) Health Resources and Services Administration (HRSA) 4) Drug Enforcement Administration (DEA)
Correct Answer: Health Resources and Services Administration (HRSA)
Explanation: HRSA, through its O�ce of Pharmacy A�airs (OPA), administers the 340B Drug Pricing Program.Page 1
Question 2: What is the primary intent of the 340B Program as stated by Congress?
Choices:
1) To provide free medication to all uninsured patients.2) To stretch scarce federal resources, reaching more eligible patients and providing more comprehensive services.3) To regulate the pricing of generic drugs across all pharmacies.4) To eliminate the need for Medicaid drug rebates.Correct Answer: To stretch scarce federal resources, reaching more eligible patients and providing more comprehensive services.Explanation: The congressional intent of the 340B program is to allow covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.Question 3: Which of the following hospital types is strictly subject to the Group Purchasing Organization (GPO) prohibition?
Choices:
1) Critical Access Hospitals (CAH) 2) Disproportionate Share Hospitals (DSH) 3) Rural Referral Centers (RRC) 4) Sole Community Hospitals (SCH)
Correct Answer: Disproportionate Share Hospitals (DSH)
Explanation: Disproportionate Share Hospitals (DSH), Children’s Hospitals (PED), and Free- Standing Cancer Hospitals (CAN) are subject to the GPO prohibition.Page 2
Question 4: How frequently must covered entities recertify their information in the HRSA OPAIS database?
Choices:
1) Quarterly 2) Bi-annually 3) Annually 4) Every 3 years
Correct Answer: Annually
Explanation: HRSA requires all covered entities to recertify their eligibility and update their information annually.
Question 5: What constitutes a 'duplicate discount' in the 340B program?
Choices:
1) When a manufacturer provides both a 340B discount and a commercial rebate.2) When a drug is purchased at 340B pricing and also generates a Medicaid rebate.3) When two di�erent covered entities claim the same patient.4) When a patient uses both a manufacturer coupon and 340B pricing.Correct Answer: When a drug is purchased at 340B pricing and also generates a Medicaid rebate.Explanation: A duplicate discount occurs when a drug purchased at 340B pricing is also billed to Medicaid in a way that generates a Medicaid manufacturer rebate, violating federal law.Page 3