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Seventh Circuit Allows Percentage-Based Marketing Relationship

On April 14th, 2025, the U.S. Court of Appeals for the Seventh Circuit reversed the Anti-Kickback Statute (AKS) conviction of Mark Sorensen, the owner and operator of a Medicare-registered durable medical equipment...more

Marketing, Misconduct and Healthcare: Ninth Circuit Issues First EKRA Appellate Ruling

On July 11, 2025, in United States v. Schena, the U.S. Court of Appeals for the Ninth Circuit issued the first appellate decision interpreting the Eliminating Kickbacks in Recovery Act (“EKRA”). The decision marks a...more

DOJ and HHS Reestablish False Claims Act Working Group, Delineate Healthcare Enforcement Priorities

On July 2, 2025, the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) announced the reestablishment of the DOJ-HHS False Claims Act Working Group. Originally formed in December 2020 at...more

Fifth Circuit Concurrence Adds Voice to FCA Constitutionality Questions

A first appellate circuit judge has questioned the False Claim Act’s constitutionality. In the Fifth Circuit’s decision last month in United States ex rel Montcrief v. Peripheral Vascular Assocs., P.A., No. 24-50176, — F....more

First Circuit Adopts “But For” AKS Standard, Leaving Third Circuit Alone in Causal-Link Standard

On Feb. 18, 2025, the U.S. Court of Appeals for the First Circuit adopted the “but for” causality standard for violations of the federal Anti-Kickback Statute (AKS) that give rise to violations of the federal False Claims Act...more

CMS Nearly Doubles Prior Stark Self-Disclosure Dollar Record in 2024

The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2024 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark...more

Fourth Circuit Upholds OIG Advisory Opinion Process

On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services,...more

Second Circuit Joins Other Circuits with AKS One Purpose Test

On December 27, 2024, the United States Court of Appeals for the Second Circuit decided United States ex rel. Camburn v. Novartis Pharmaceuticals Corporation and joined a growing list of federal circuit courts that have...more

OIG’s New Compliance Guidance: 10 Action Items and Six Themes for Providers

On Nov. 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued the General Compliance Program Guidance (GCPG) for healthcare providers and other industry stakeholders. The GCPG...more

A Failed Constitutional Challenge to the AKS Safe Harbor Provision – More to come?

This past summer, in United States v. Booker, a North Carolina district court ruled against a challenge to the constitutionality of Congress’s delegation of authority to promulgate safe harbors to the Anti-Kickback Statue...more

The Growing Causal Divide: But-For Causation in AKS/FCA Actions

In United States v. Regeneron, the District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims...more

Lessons for Providers and Practice Entities: Ophthalmology Groups Pay Millions to Settle Co-Management, Optometrist Relationship...

Recently, two ophthalmology practice groups — Kleiman Evangelista Eye Centers of Texas (KEEC) and SouthEast Eye Specialists, PLLC (SEES) — reached large settlements with the U.S. government over allegations that the groups’...more

Eleventh Circuit Affirms Order for $1.195 Million in Restitution and 48 Month Sentence in Commercial Insurance Healthcare Fraud...

Last month, the Eleventh Circuit upheld a $1.195 million restitution order and 48-month sentence against Carlos Verdeza for three counts of healthcare fraud. See United States v. Verdeza, No. 21-10461, 2023 WL 3728960 (11th...more

Complex AKS/Stark Complaint Survives Rule 9(b) Particularity Challenge – A Guide for FCA Complaints

In U.S. v. Genesis Global Healthcare, 2023 WL 3656925 (S.D. Ga. May 25, 2023), a Georgia district court denied three (3) Motions to Dismiss the Second Amended Complaint filed in a qui tam action brought by relators under the...more

Home Cooking: Washington Transfers Venue to Court in State

Earlier this year, the U.S. District Court for the Western District of Oklahoma granted Washington state’s motion to intervene to transfer venue to the Western District of Washington in James Siegel, M.D. v. Novo Nordisk,...more

District Court Adopts Middle of the Road Approach in Determining Causation in Anti-Kickback Statute-Based False Claims Act Case

The U.S. District Court for the District of Maryland recently weighed in on the appropriate causation standard when evaluating whether a claim “result[s] from” a violation of the Anti-Kickback Statute sufficient to constitute...more

District Court finds that AKS Violations are Per Se Material

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

Eye Care Practice Settles with Government for Employing Excluded Individual

On March 18, the Department of Justice (“DOJ”) and the Connecticut Attorney General announced that a Connecticut eye care practice and its owners had agreed to pay $192,699 to resolve allegations that the practice improperly...more

Seventh Circuit Clarifies Pleading Standard for Anesthesiologist’s False Claims Action

The Seventh Circuit recently reversed a lower court’s ruling that an amended complaint in a qui tam lawsuit filed under the False Claims Act (FCA) alleging fraudulent anesthesiology billing practices failed to meet the...more

Will 2022 Be The Year? OIG’s 25 Top Recommendations to Reduce Healthcare Fraud

Every year the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) releases an annual Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Unimplemented Recommendations. HHS...more

Court Allows Superseding Indictment Twelve Days Before Trial, Failing to Find Prosecutorial Vindictiveness

In U.S. v. Georges, 2021 WL 3887183 (S.D. Oh. Aug. 30, 2021), a federal court recently dismissed a defendant’s motion to dismiss a superseding indictment, denying her claim of prosecutorial vindictiveness related to multiple...more

2021’s First-Half Notable Themes on The FCA Insider

As vaccination rates rise, the COVID-19 pandemic continues to reverberate through 2021. These reverberations also impacted the healthcare fraud and abuse landscape that is the basis of The FCA Insider’s coverage. To-date,...more

Alleged Emergency Room Advanced Professional Practitioner Billing Scheme FCA Case Proceeds

In U.S. ex rel. Sonyika v. ApolloMD, Inc. et al., 2021 WL 1222379 (N.D. Ga. Mar. 31, 2021), a Georgia federal court allowed a relator’s Amended Complaint alleging a fraudulent scheme involving improper billing for services...more

Fifth Circuit Vacates Fraud Conviction after Denying Codefendants’ Appeal

The U.S. Fifth Circuit recently reversed a former home health agency employee’s conviction and vacated his sentence related to three counts of healthcare fraud and abuse. Jonathan Nora was convicted by the trial court of...more

Fraud and Abuse Rules Part V: Easing Stark Law Compliance

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the regulations to the Physician Self-Referral Law (Stark Law), the federal...more

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