The 340B Drug Pricing Program 101

Understand the Statute, Stakeholders, and Disputes Shaping the 340B Program 

A Self-Paced, On-Demand CLE Course for Health Care Law Practitioners 

The 340B Drug Pricing Program requires drug manufacturers to sell covered outpatient drugs at discounted prices to health care providers serving low-income and vulnerable patient populations. This on-demand AHLA course examines how the program operates and how it is changing.

Course Overview

The course traces the program from its 1992 origins in response to the Medicaid Drug Rebate Program through its current statutory framework. It covers the ceiling price calculation and HRSA's narrow rulemaking authority under Section 340B of the Public Health Service Act.

Attendees will examine the roles of covered entities, manufacturers, contract pharmacies, and payers. They will also review the compliance obligations around diversion and duplicate discounts, and how reimbursement rules differ across Medicaid, Medicare, and commercial payers.

The final lessons address current program activity. Topics include contract pharmacy restrictions and the state and federal litigation they have generated, proposed rebate models, manufacturer claims data-sharing requirements, Inflation Reduction Act implementation, and pending federal legislation.

Instructor video segments and knowledge checks throughout the course reinforce core concepts.

Learning Objectives

Upon completing this course, attendees will be able to perform the following:

• Describe the statutory origins of the 340B Program and the method for calculating the 340B ceiling price.
• Identify the categories of covered entities and the obligations of manufacturers that sign a Pharmaceutical Pricing Agreement.
• Explain the patient definition and duplicate discount prohibitions that govern 340B compliance.
• Compare 340B reimbursement and rebate rules across Medicaid, Medicare, and commercial payers.
• Assess how contract pharmacy litigation, rebate models, data-sharing requirements, and pending legislation affect covered entities and manufacturers.

Course Syllabus

The course proceeds through six lessons, moving from the statutory framework to current litigation, regulatory activity, and legislative proposals:

• Lesson 1: 340B Program Overview. Legislative history, statutory functions, ceiling price calculation, and HRSA rulemaking authority.
• Lesson 2: Program Stakeholders. Covered entities, drug manufacturers, contract pharmacies, and payers and pharmacy benefit managers.
• Lesson 3: Key Compliance Requirements. Diversion, the 1996 Patient Definition Guidelines, and duplicate discount prevention.
• Lesson 4: Payer Considerations. Medicaid, Medicare Parts A through D, and commercial payer reimbursement and rebates.
• Lesson 5: Current Program Activity. Contract pharmacy restrictions and litigation, rebate models, claims data-sharing requirements, IRA implementation, and federal legislation.
• Lesson 6: Key Takeaways. Foundational obligations, current flashpoints, and developments to monitor.