FCA Litigation: Leveraging Statistical Sampling and Extrapolation to Prove or Disprove Liability

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Health
- event Date
Friday, July 26, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE course will guide counsel on the use of statistical sampling and extrapolation in False Claims Act (FCA) litigation. The panel will examine how courts are treating the issue and offer best practices for addressing sampling issues.
Faculty

As a litigation and management consultant, Mr. Boedeker focuses on the application of economic, statistical, and financial models to areas such as solutions to business issues, economic impact studies, and complex litigation cases. Over the course of his 30-year career, Mr. Boedeker has provided economic, financial, and statistical consulting and expert services to clients across a wide range of industries. He has issued hundreds of expert reports and given deposition and trial testimony in state and federal courts, arbitrations, and regulatory hearings over 140 times. Mr. Boedeker’s extensive work in the healthcare, pharmaceuticals, and life sciences space, includes providing statistical and economic consulting to clients such as providers, payors, and federal, state, and local government agencies. He has experience in assisting healthcare organizations facing disputes where complex economic issues must be assessed and where complex statistical methods are necessary to answer questions of liability, over/underpayments, and damages. Mr. Boedeker has also helped clients negotiate and present statistical methodology to government agencies such as the Office of Inspector General (OIG), Centers for Medicare & Medicaid Services (CMS), and Department of Justice (DOJ) when assessing the appropriateness of claims submission and payment practices based on statistical samples. He also has coordinated statistical sampling methodology on numerous healthcare audits.

Mr. Clark is an accomplished litigator with years of experience in the federal government and subsequently in private practice. He has served as lead counsel in over 100 jury trials and handled dozens of appeals. Among other matters, Mr. Clark represents clients in complex litigation, including civil False Claims Act cases and investigations, advises clients on regulatory compliance and corporate governance matters, handles arbitration matters, and represents clients in internal investigations and trials. Before private practice, he had a distinguished government career and served as an Assistant U.S. Attorney for the Southern District of Texas, where he was selected to be a chief of its Financial Fraud Division and then was elevated to be the chief of its Criminal Division. Mr. Clark is the former Chair of the ABA's Section of Health Law and a former Chair of the White-Collar Crime Committee in the ABA Section of Business Law.
Description
2023 was the 15th consecutive year in which the government recovered more than $2 billion through FCA settlements and judgments. The government's focus on FCA enforcement in the healthcare context remains steadfast, as healthcare cases made up over two-thirds of FCA recoveries in 2023. For example, in July an EHR vendor settled FCA and AKS charges for $31 million. The agreement resolved allegations that the vendor misrepresented its software's capabilities and falsely obtained HHS certification under an incentive program.
The use of statistical sampling and extrapolation evidence to demonstrate proof of liability in FCA cases is an important and timely issue. The law on the use of sampling in FCA cases continues to evolve. Attorneys for the government, relators, and healthcare companies should consider how sampling could be used in different kinds of FCA cases, especially those involving liability and issues of medical judgment. Further, the role of experts and Daubert challenges will be important when the parties rely on sampling.
Listen as our authoritative panel of healthcare attorneys examines how statistical sampling and extrapolation are used to prove or disprove liability in FCA litigation. The panel will also examine how different courts have treated statistical sampling and extrapolation and offer best practices for leveraging sampling or combating it to determine liability and damages.
Outline
- How statistical sampling and extrapolation are used
- Cases involving liability
- Cases involving medical judgment
- In off-label cases: showing falsity vs. causation
- Court treatment
- Best practices for leveraging sampling or combating it
Benefits
The panel will review these and other key issues:
- How are the courts treating statistical sampling and extrapolation in FCA cases?
- How can statistical sampling be used to demonstrate falsity versus using it to show causation in an off-label case?
- What role will Daubert challenges play in FCA cases where a party seeks to offer expert testimony that relies on sampling?
- How can parties use statistical sampling and extrapolation to prove liability?
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