The First Circuit has issued its long-anticipated opinion in United States v. Regeneron Pharmaceuticals, Inc., clarifying the standard for establishing False Claims Act (“FCA”) liability based on Anti-Kickback Statute (“AKS”) violations. The First Circuit held that an AKS violation must be the “but-for” cause of a claim for it
Fraud & Abuse
DEI and Government Contractors: A High-Stakes Shift
By Guy Brenner & Olympia Karageorgiou on
[This post has been re-published from Proskauer’s “Government Contractor Compliance & Regulatory Update” blog: DEI and Government Contractors: A High-Stakes Shift | Government Contractor Compliance & Regulatory Update.]
While much of the focus on President Trump’s recent Executive Order on Ending Illegal Discrimination and Restoring Merit-Based Opportunity (the “EO”)…
CMS Publishes Final Rule, Effective January 1, 2025, Addressing the Requirements for Reporting and Returning Overpayments
By Matthew J. Westbrook, Vinay Kohli & David Manko on
The standard for an “identified overpayment” under Medicare Parts A–D now aligns with section 1128J(d)(4)(A) of the Social Security Act, which incorporates by reference the Federal False Claim Act’s (the “FCA”) “knowledge” standard. The previous “reasonable diligence” standard, which, as it related to Part C, had been…
OIG Releases Special Fraud Alert About Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers
On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and referrals between Medicare Advantage (“MA”) health plans, health care professionals, and third-party marketers (e.g., agents and…
Arrangements Involving Intraoperative Neuromonitoring Continue to be Scrutinized under the Federal Anti-Kickback Statute
This week, the U.S. Attorney’s Office for the District of Colorado (“USAO”) announced that it entered into a series of interrelated settlement agreements with companies that provide intraoperative neuromonitoring (“IONM”) services, the companies’ founder, a neurosurgeon, and a businessman affiliated with the companies. IONM services involve the use of electrodes…
Fault Lines Expected to Deepen: Major False Claims Act Circuit Split
By Matthew J. Westbrook & Vinay Kohli on
The health care industry is anxiously awaiting the First Circuit’s ruling on the standard of causation for actions brought under the False Claims Act (FCA) predicated on a federal Anti-Kickback Statute (AKS) violation. The First Circuit will decide whether the FCA “result[s] from” a kickback if that claim would not…
Relator, No More? Florida Federal Court Declares Qui Tam Provisions of False Claims Act Unconstitutional, with Potentially Broad Implications for Government Fraud Litigation
By Vinay Kohli, G. Patrick Regan & D. Austin Rettew on
On September 30, 2024, the U.S. District Court for the Middle District of Florida issued an order dismissing a qui tam case under the False Claims Act (“FCA”) and holding the relator provisions of the FCA to be unconstitutional.[1] In reaching this conclusion, the Court reasoned that the…
CMS Proposes Additional Modifications to the Overpayment Rule Relating to the Deadline for Reporting and Returning Overpayments
By Matthew J. Westbrook & Whitney Phelps on
In the context of Medicare Advantage (“MA”) reform initiatives, we previously addressed the Centers for Medicare & Medicaid Services’ (“CMS”) December 27, 2022 proposal to amend its regulations set forth at 42 C.F.R. § 401.305(a) regarding the standard for an “identified overpayment” under Medicare Parts A–D…
Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA Violation Predicated on an AKS Violation
By Matthew J. Westbrook & Vinay Kohli on
In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute (“AKS”) is a predicate violation for the false claim. The spotlight is now on…
Using OIG’s Cross-Component Audit and Enforcement Data to Strengthen Your Compliance Program
By Matthew J. Westbrook on
The U.S. Department of Health and Human Services Office of Inspector General’s (OIG) core responsibility is to promote efficiency and economy in myriad programs by eliminating fraud, waste and abuse. For years, compliance professionals have come to rely on OIG’s advisory opinions, special fraud alerts, advisory bulletins and industry-specific guidance…