About the Program
Blank Rome partner Merle M. DeLancey, Jr. will serve as a presenter for Rx Drug Pricing & Rebate Fundamentals, an American Conference Institute (“ACI”) Virtual Proficiency Series program being held November 4 through December 4, 2025.
ACI’s Rx Drug Pricing & Rebate Fundamentals is an intensive training program that will give novices and experienced practitioners alike a thorough understanding of core pricing competencies and applicable changes in the reimbursement structures of key payor programs.
The program is designed to make attendees proficient in essential pricing and rebate concepts under Medicaid, Medicare, and other related government payor programs, including those under the auspices of PHS 340B, the Department of Veterans Affairs (“VA”), and the Department of Defense (“DOD”). The course agenda reflects the latest regulatory developments, including two major proposed rules released this summer that are poised to reshape government price reporting. These rules are part of the broader implementation of the “Big, Beautiful Bill” and include a new section focused on Medicare Part B, addressing significant changes to Average Sales Price calculations and reporting requirements.
Sessions will be held two days a week over the course of four weeks and examine:
- Drug Pricing and Rebate Essentials and Introduction to Medicaid
- PHS 340 B, VA and DoD Rx Pricing and Rebates
- Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics
- Pricing and Reimbursement for New Products and Therapies
About Merle's Sessions
Thursday, November 6 | 3:15–4:00 p.m. EST
Compendium of State Drug Price Transparency Laws
State drug price transparency laws continue to proliferate across the country and bring with them additional work for government price reporting teams and risk of penalties for manufacturers. This session will:
- Identify states with current and pending drug price transparency laws
- Manufacturer notification and justification requirements
- Enforcement actions taken under existing laws
- Address challenges with finding solutions for reporting under non-uniform and sometimes conflicting state laws
- Provide tips for developing a system to track and respond to these laws
- Discuss the impact of these laws on Medicaid and other state pricing
Thursday, November 13 | 1:00–2:15 p.m. EST
A Guide to the Essentials of FSS Contracting for Pharmaceuticals with the VA and DOD
Manufacturers of innovator drugs must, and those of generic drugs may, agree to participate in the Federal Supply Schedule (“FSS”) and Veterans Health Care Act programs. While these programs may not have underwent significant change in recent years, they remain important programs to manufacturers and carry with them detailed program requirements. This session will cover:
- The overall obligations of manufacturers contracting with the federal government with respect to:
- General Services Administration FSS
- VA/DOD
- Tricare
- What entities are entitled to the FSS price
- The significance of being a single v. dual pricer
- How the Federal Ceiling Pricing and FSS price are determined
- How non-Federal Average Manufacturer Price is calculated
For more information and to register, please visit the event webpage.
