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False Claims Act (FCA) Anti-Kickback Statute Patient Protection and Affordable Care Act (PPACA)

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Goodwin

Health Headlines: January 2025

Goodwin on

Welcome to the second issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. In this issue, we cover expected changes under the new Trump administration, the Food and Drug Administration’s...more

Proskauer - Health Care Law Brief

Fault Lines Expected to Deepen: Major False Claims Act Circuit Split

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...more

Stevens & Lee

Welcome to the Post-Chevron World: HHS on the Defensive

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The Supreme Court’s recent ruling in Loper Bright Enterprises v. Raimondo (and its companion case, Relentless v. Department of Commerce), in which it overruled the Chevron doctrine, has received a great deal of attention...more

Stevens & Lee

Two Recent Federal Court Cases Tackle Three Critical Components of the Anti-Kickback Statute

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Two recently decided federal court cases hone in on the proper interpretation and application of three critical components of the Anti-Kickback Statute (“AKS”), namely: •the requirement that a violation of the AKS must...more

Benesch

Dialysis & Nephrology Digest - December 2022

Benesch on

Benesch: AKS claims against Azura dropped; FCA allegations to continue with DOJ intervention - The DOJ filed an Amended Intervenor Complaint in Aug. alleging between 2012 and 2018, Fresenius Medical Care’s business unit,...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q3 2022

Bass, Berry & Sims PLC on

The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | August 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more

Mintz - Health Care Viewpoints

Eighth Circuit Adopts Stricter But-For Causation Standard for False Claims Act Claims based on Anti-Kickback Violations

In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth...more

Sheppard Mullin Richter & Hampton LLP

Eighth Circuit: In False Claims Act Cases Based On Kickback Violations, the Kickback Violation Must Be the “But For” Cause of the...

The Eighth Circuit Court of Appeals recently tossed a $5.5 million jury verdict finding that a physician violated the False Claims Act (“FCA”) by submitting claims for items and services ordered subsequent to a violation of...more

McGuireWoods LLP

District Court finds that AKS Violations are Per Se Material

McGuireWoods LLP on

Last month, the Central District of California granted the government’s affirmative motion for partial summary judgment in U.S. v. Reliance Medical Sys., 2022 WL 524062 (C.D. Cal. Feb. 2, 2022). The Reliance Medical case...more

Rivkin Radler LLP

Medtronic Settles Kickback And Open Payments Violations For $9.2M

Rivkin Radler LLP on

The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more

Holland & Knight LLP

Healthcare Law Update: October 2019

Holland & Knight LLP on

In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Foley & Lardner LLP

Healthcare Law Review: Overview of the U.S. Healthcare System

Foley & Lardner LLP on

The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Sheppard Mullin Richter & Hampton LLP

Temporal Proximity Is Not Enough: Third Circuit Nixes FCA/Anti-Kickback Suit For Failure To Link Alleged Scheme to Claims

On January 19, 2018, the United States Court of Appeals for the Third Circuit affirmed a district court’s ruling granting summary judgment to a specialty pharmacy that was accused of violating the Anti-Kickback Statute and...more

McDermott Will & Schulte

New OIG Exclusion Regulations About to Go into Effect

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Arnall Golden Gregory LLP

Stretching the Rules: HHS-OIG Expands its Exclusionary Authority

On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more

Bradley Arant Boult Cummings LLP

OIG Expands Exclusionary Authority

The Department of Health and Human Services, Office of Inspector General (OIG) published a final rule on January 12, 2017, expanding the OIG’s authority to exclude providers from participation in federal healthcare programs....more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

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With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

Mintz - Health Care Viewpoints

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

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