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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

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

$12M Default Judgment Results from Purchasing Prescriptions

A large damage award serves as a significant reminder to file an appearance in a False Claims Act (FCA) case. In late August of 2022, the Government filed suit against AZ Diabetic and the owner, Hisham Zaghal (Zaghal),...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

DOJ Settles Self-Reported Referral Incentives With Dermatology Practice Manager

On Sept. 13, 2023, the U.S. Attorney’s Office for the Northern District of Texas announced a settlement with Oliver Street Dermatology Management LLC. Oliver Street agreed to pay the United States $8.892 million to resolve...more

Regional Hospital System and Two Physicians Pay More Than $69 Million to Settle False Claims Act, Involving Allegations of...

On March 29, 2023, the U.S. District Court for the Eastern District of Michigan granted the parties’ joint stipulation for dismissal in U.S. ex. rel. Godsholl v. Covenant Healthcare, following three settlements of the...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

OIG to Expand Informal Guidance with New FAQs

The Office of Inspector General (OIG) has announced that it is expanding the topics it considers for new Frequently Asked Questions (FAQs) submitted by healthcare stakeholders. OIG will now answer general questions about the...more

Pharmaceutical Suppliers Beware: Expect Increased Scrutiny of Average Wholesale Pricing Methodology and Marketing “The Spread”

A Texas federal court recently denied a pharmaceutical supplier’s motion to dismiss claims brought by a whistleblower under the federal False Claims Act (FCA) alleging violations of the Anti-Kickback Statute (AKS) and...more

Potential Anti-Kickback Prosecution Does Not Give Blanket Fifth Amendment Protection in a Medical Malpractice Suit

An Ohio Court of Appeals recently weighed in on the proper protocols one must take in order to successfully assert one’s Fifth Amendment Constitutional Right against self-incrimination in relation to a discovery request in a...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

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

District Court Embraces Expansive View of “Referrals” to include Accessing Records

In Stop Illinois Health Care Fraud, LLC v. Sayeed, No. 12-CV-09306, 2021 WL 2331338 (N.D. Ill. June 8, 2021), an Illinois district court issued an order after a recent bench trial finding that the defendants violated the...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

Texas Court Allows FCA Case to Proceed Based on Purchasing “Future Referrals”

In United States ex rel. Roshan v. E. Tex. Med. Ctr., 2020 U.S. Dist. LEXIS 252092, 2020 WL 8918651 (E.D. Tex. (Nov. 24, 2020)), a Texas federal court partially dismissed a relator’s claim alleging the defendants engaged in...more

Request to File Amended Complaint for Fraud Rejected for Failure to Allege Facts with Particularity

After granting defendants’ motion to dismiss and dismissing plaintiff’s action with prejudice, the U.S. District Court for the Middle District of North Carolina recently denied relator’s motion to alter or amend the judgment...more

Court Dismisses FCA Retaliation Complaint Involving Speaker Fees

In U.S. ex rel. Manieri v. Avanir Pharmaceuticals, Inc., 2021 WL 857102 (N.D. Oh. Mar. 8, 2021), the Northern District of Ohio dismissed a relator’s claim that he had been improperly retaliated because he had raised concerns...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

District of Minnesota Rejects But-For Causation in the AKS Context

In a recent opinion from the U.S. District Court for the District of Minnesota, the court analyzed the interplay between the False Claims Act and the Anti-Kickback Statute. See United States ex rel. Fesenmaier v....more

CMS statement clarifies agency’s view that the Stark Law final rule is effective

Industry publication BVWire quoted a statement from the Centers for Medicare & Medicaid Services (CMS) that gives healthcare providers more certainty to rely on the much heralded final rule modernizing the physician...more

Reimbursement Consultant Could be Liable Under the FCA

The Northern District of Illinois recently denied a hospital reimbursement consultant’s motion for summary judgment, finding that the consultant could be held liable under the FCA based on the theory that the consultant’s...more

MedMal Plaintiff Uses Anti-Kickback and Stark to Avoid Summary Judgment

A federal court recently allowed a plaintiff’s state law negligence claim, which utilized the Anti-Kickback Statute (“AKS”) and federal physician self-referral law (the “Stark Law”) as legal support to survive a motion for...more

Eleventh Circuit Holds “Knowingly and Willfully” Does Not Require Motive for Kickback Recipient

A recent Eleventh Circuit opinion clarified the mens rea burden the Government must prove to establish criminal intent to violate the Federal Anti-Kickback Statute (“AKS”) for a recipient or payee of a kickback or bribe under...more

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