ACI Rx Drug Pricing & Rebate Fundamentals
Blank Rome partner Merle M. DeLancey, Jr. will serve as a presenter for three sessions of Rx Drug Pricing & Rebate Fundamentals, an American Conference Institute (“ACI”) Virtual Proficiency Series program being held November 1 through December 1, 2022.
Analysis of the National Rebate Agreement and the Mechanics of the Rx Drug Rebate System
1:00–2:00 p.m. EDT
- The National Rebate Agreement
- Understanding the agreement’s terms and purpose
- What is required to participate in the agreement?
- Why is participation in the Medicaid outpatient drug program contingent on participation in the PHS 340B and VA programs?
- How is the PHS 340B program linked to Medicaid?
- What relation does the agreement have to the Medicare Drug benefit? (i.e., Medicare Part D)
- Mechanics of the Rx Drug Rebate System
- Survey of applicable drug pricing legislation such as the MMA, DRA, and ACA
- Overview of Medicaid, Medicare, and PHS Programs relative to prescription drug coverage
- How is price established?
- How does the rebate system work?
- Under which of the payor systems are rebates available?
Analysis of State Drug Transparency Laws
3:15–4:00 p.m. EDT
- Identifying states with current and pending drug pricing transparency laws
- Manufacturer notifications and justifications requirements from the manufacturer
- Enforcement and actions taken under existing laws
- Addressing challenges with and finding solutions for reporting under non-uniform and sometimes conflicting state laws
- Can a state request supplemental rebates within these models?
- If the rebate is denied, can the state exclude the drug from Medicaid coverage?
- Developing a system to keep track of these laws as well as a compliance program to address them
- Impact of transparency laws on Medicaid pricing
Advanced VA and DOD Pricing and Contracting
2:30–4:00 p.m. EDT
- Reviewing criteria for a drug to be eligible for consideration under the Federal Supply Schedule
- Standardization versus therapeutic interchange contracts
- Analyzing how target drugs are chosen by VA/DoD/IHS/BOP for joint national contract targets
- What are the general requirements for issuing a drug contract?
- Package size considerations
- Bottle caps
- Safety seals
- 30 percent up front requirement for VA mail order
- Understanding the factors for creating the requirements in the estimated volume of purchase
- Formulary status changes
- Automatic substitution by Pharmaceutical Prime Vendor
- Changes with pricing for other drugs in the class
- Examining the contracting process
- Post-solicitation discussions
- What is the process for having the contract for a drug renewed?
- Identifying the factors considered by the agencies when a drug is up for renewal
- Supply considerations and challenges
- Comparative pricing
- Understanding the differences in the processes used by the VA National Acquisition Center and Defense Logistics Agency
ABOUT THE PROGRAM
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.
Sessions will be held Monday and Wednesday afternoons over the course of four weeks and examine:
- Drug Pricing and Rebate Essentials and Introduction to Medicaid
- Medicare Pricing and Rebate Essentials
- VA and DoD Rx Pricing and Rebates
- PHS 340 B
- Advanced CMS Pricing and Rebate Topics
- Pricing and Reimbursement for New Products and Therapies
For more information or to register, please visit the event webpage.