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First Circuit Holds ‘But For’ Causation Required to Demonstrate Falsity in Kickback-Based FCA Cases, Growing Circuit Split

In United States v. Regeneron Pharmaceuticals Inc., the US Court of Appeals for the First Circuit held that when the government seeks to establish False Claims Act liability under the 2010 amendment to the Anti-Kickback...more

New Supreme Court FCA Decision Avoids Thorny Claim Questions, Reiterates Interest in Constitutional Challenge

In its most recent False Claims Act decision, the US Supreme Court opted for a narrow “claim” definition analysis, limiting its impact to those involved in the E-Rate program, but signaled interest in addressing the...more

Tick-Tock: CMS Overpayment Refund Final Rule and Practical Implications

The Centers for Medicare & Medicaid Services issued its long-anticipated final rule clarifying the 60-day overpayment refund obligation (the 60-Day Rule) first established in a 2016 regulation for Medicare Part A and B...more

False Claims Act Enforcement Continues to Target Education Industry

A recent settlement agreement presents another example of how educational institutions can find themselves facing potential liability under the False Claims Act (FCA). The settlement illustrates how FCA liability remains a...more

CMS Proposes Small but Significant Change to 60-Day Overpayment Refund Rule

In a proposed rule issued on December 27, 2022 to make technical changes to the Medicare Advantage Program, the Centers for Medicare and Medicaid Services (CMS) buried in the regulatory arcana a material legal change to the...more

Eighth Circuit Decision on Anti-Kickback Statute Offers False Claims Act Defendants Additional Tool in Their Arsenal

In United States ex rel. Cairns v. DS Medical LLC, the US Court of Appeals for the Eighth Circuit set a higher bar for proving causation in False Claims Act cases where plaintiffs seek to establish liability under the 2010...more

Speaker Program Compliance: Biotech Company Settles False Claims Act Allegations for $900 Million

Biogen Inc., a global biotechnology company, denies that it violated the federal Anti-Kickback Statute and False Claims Act by paying healthcare professionals for fraudulent speaking engagements in order to incentivize them...more

CARES Act Relief Funds Offer Aid to Healthcare Providers, but Certifications and Overly Creative Use of Funds Are a Fraud Risk

Medicare (and in the future Medicaid) providers that receive grant money under the CARES Act Relief Fund must pay close attention to the terms and conditions of the assistance and rigorously document how the funds are used to...more

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