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. Covered entities, manufacturers, contract pharmacies, and payers each carry distinct obligations under the program.

Litigation, rebate proposals, data-sharing requirements, and pending federal legislation continue to reshape how the program operates. The 340B Drug Pricing Program 101 gives you a working foundation in the statute, its compliance requirements, and the disputes now in front of courts, regulators, and Congress.

Who Should Take This Course?

This course serves professionals who advise or work within organizations that participate in or interact with the 340B Program:

• Health lawyers representing covered entities, manufacturers, contract pharmacies, or payers
• In-house and general counsel
• Compliance officers
• Finance and reimbursement professionals
• Pharmacy and regulatory professionals
• Health care consultants

What You'll Learn

This six-lesson course moves from the statutory framework to current litigation, regulatory activity, and legislative proposals.

Lesson 1 | 340B Program Overview

Start with the statutory foundation. This lesson traces the program from its 1992 origins in response to the Medicaid Drug Rebate Program. It also explains how the 340B ceiling price is calculated and examines HRSA’s narrow rulemaking authority under Section 340B of the Public Health Service Act.

Lesson 2 | Program Stakeholders

Each party in the 340B Program has distinct rights and obligations. This lesson covers the categories of covered entities and the obligations of drug manufacturers that sign a Pharmaceutical Pricing Agreement. It also covers the roles of contract pharmacies, payers, and pharmacy benefit managers.

Lesson 3 | Key Compliance Requirements

Diversion and duplicate discounts are central compliance risks for covered entities. This lesson reviews the diversion prohibition, the 1996 Patient Definition Guidelines, and the methods covered entities use to prevent duplicate discounts.

Lesson 4 | Payer Considerations

Reimbursement for 340B drugs varies by payer. This lesson compares reimbursement and rebate rules under Medicaid, Medicare Parts A through D, and commercial payers.

Lesson 5 | Current Program Activity

The 340B Program is the subject of active litigation, regulation, and legislation. This lesson addresses:

• Contract pharmacy restrictions and the state and federal litigation they have generated
• Proposed rebate models
• Manufacturer claims data-sharing requirements
• Inflation Reduction Act implementation
• Pending federal legislation

Lesson 6 | Key Takeaways

The final lesson brings the course together. It reviews the foundational obligations of covered entities and manufacturers, the current flashpoints, and the developments practitioners should monitor.

Why This Course?

• 340B-specific focus — covers the obligations of covered entities, manufacturers, contract pharmacies, and payers in one course
• Current developments — addresses contract pharmacy litigation, rebate models, and pending legislation alongside the statutory framework
• Practitioner faculty — taught by attorneys whose 340B work spans regulatory, legislative, litigation, and compliance matters
• Interactive format — instructor video segments and knowledge checks reinforce core concepts throughout the course

Enroll today and build a working knowledge of the 340B Program for your practice.