Anti-Kickback Statute March 4, 2025

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

By Ryan B. Marcus, Brenna M. Molinare, Craig B. Bleifer, Michael J. Podberesky, Allyson M. Maur, Zoë Smith and Timothy Fry

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 (FCA). In United States v. Regeneron, the First Circuit held that for a violation of the AKS to constitute a false claim subject to the FCA, the government must demonstrate that the illicit kickback was the “but for” cause of a submitted claim.

This holding ended an intra-circuit split between two district court opinions including the lower court’s ruling in this case and aligns the First Circuit with the Sixth and Eighth circuits’ interpretations. The holding leaves the Third Circuit as the only circuit allowing the government to rely on a “causal link” standard between an AKS violation and the submission of a false claim subject to the FCA.

CMS Guidance, Settlements, Stark Law March 3, 2025

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

By Timothy Fry, Gretchen Heinze Townshend, Varsha Gadani and Kristen H. Chang

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 Law). In 2024, CMS settled an agency record 314 self-disclosures (an amount that the following chart shows towering over other years), with settlement amounts totaling over $24,700,000 in the aggregate.

FCA Litigation, OIG, Regulatory February 25, 2025

Fourth Circuit Upholds OIG Advisory Opinion Process

By Nicholas LeFever, Timothy Fry and Brett Barnett

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, Office of Inspector General (“OIG”). The case, Pharmaceutical Coalition for Patient Access v. United States, centered on whether the Advisory Opinion was appropriate when it found a proposed patient assistance program for Medicare Part D beneficiaries by the Pharmaceutical Coalition for Patient Access (the “Coalition”) could violate the Anti-Kickback Statute (“AKS”). In rejecting this challenge to the Advisory Opinion, the Fourth Circuit signaled the judiciary’s continued respect afforded to government agencies, including OIG’s issuing of advisory opinions, even in a post-Chevron world.

FCA Litigation, Regulatory February 24, 2025

Department of Justice Suggests “Aggressive” Enforcement of False Claims Act

By Edwin O. Childs, Brett Barnett, Jack White, Farnaz Farkish Thompson, Michael J. Podberesky, Todd R. Steggerda, Jason M. Vespoli, John Sullivan and Maura Naehr

On February 20, 2025, during a speech to the Federal Bar Association’s annual qui tam conference, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice (DOJ), said that the Trump Administration will seek to “aggressively” enforce the False Claims Act (FCA). In particular, Granston stated that active FCA enforcement is consistent with the Trump Administration’s priorities of increasing government efficiency and “rooting out waste, fraud and abuse.”

FCA Litigation, Plaintiff Strategies February 20, 2025

D.C. Circuit Prohibits Pro Se Plaintiffs from Bringing FCA Cases

By Timothy Fry and Brett Barnett

In United States ex rel. Feliciano v. Ardoin, the D.C. Circuit joined every other circuit to consider the issue, holding that a pro se litigant cannot bring a False Claims Act (FCA) case. The court’s reasoning was straightforward: FCA claims belong to the government, not the relator. While individuals may represent themselves in legal matters, they cannot represent another party—including the United States—without being a licensed attorney. The FCA does not provide an exception to this rule, leading the court to affirm the district court’s dismissal as pro se FCA cases cannot proceed.

Anti-Kickback Statute January 22, 2025

Second Circuit Joins Other Circuits with AKS One Purpose Test

By Michael J. Podberesky, Timothy Fry and Micaela Enger

Second Circuit Court of Appeals building

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 adopted what the Second Circuit called the “at least one purpose rule”. This rule provides that defendants have violated the Anti-Kickback Statute (“AKS”), 42 U.S.C. §1320a-7b so long as at least one purpose of the alleged remuneration at issue (as opposed to the sole or main purpose) was to induce patient referrals, even if there were other, legitimate reasons for the payment.

DOJ January 16, 2025

Cautionary Tale: Contractor Settles for $2.6M Over Alleged Falsely Obtained Small Business Contracts

By Edwin O. Childs, Jack White, Abram J. Pafford, Todd R. Steggerda, Brett Barnett, Michael J. Podberesky, Maura Naehr and Jason M. Vespoli

On Jan. 7, 2025, the Department of Justice announced that R&K Enterprises agreed to pay over $2.6 million to resolve allegations under the False Claims Act, 31 U.S.C. §§ 3729-3733, among other causes. The settlement was predicated on allegations that the company represented it was a small business eligible for certain small business set-aside contracts when it did not meet the program rules to qualify. This settlement underscores the importance of contractors making accurate small business certifications when bidding on set-aside contracts.

FCA Defenses December 9, 2024

Recent Decision from Eastern District of New York Confirms D&O Coverage for False Claims Act Defense Costs

By Shelby L. Peek, Shelby S. Guilbert Jr. and Nicholas G. Hill

A recent decision by the U.S. District Court for the Eastern District of New York illustrates how directors and officers (D&O) policies can provide valuable insurance coverage for defense costs and potential liabilities arising from False Claims Act (FCA) litigation. In Northern Metropolitan Foundation for Healthcare, Inc. v. RSUI Indemnity Company, the insured — an owner and operator of adult healthcare centers in Brooklyn, New York — sought coverage under a D&O policy for defense costs for a relators’ qui tam action alleging that the insured defrauded the federal and New York state governments in submitting claims for reimbursement. The government chose not to intervene, and the qui tam lawsuit was ultimately dismissed. The D&O policy at issue contained a Government Funding Defense Expense Coverage provision excluding “the return of funds which were received from any federal, state, or local government agency” from the policy’s definition of “Loss,” and limiting coverage for “any Claim arising out of the return, or request to return, such funds.”

Read on to learn more about the decision and how healthcare providers can protect themselves against the risk of expensive government investigations and FCA litigation.

OIG, Regulatory November 14, 2024

OIG Recommends Increased RPM Oversight

By Timothy Fry, Micaela Enger and Brenna M. Molinare

On September 24, 2024, the Department of Health and Human Services Office of Inspector General (“OIG”) published a report (the “Report), reviewing and recommending increased oversight of remote patient monitoring (“RPM”) services and billing in the Medicare program. In the Report, OIG focused on three main issues: (1) Patients and providers are not using RPM as intended; (2) RPM presents an increased risk of fraud and abuse; and (3) there is a lack of information and transparency related to enrollees’ use of RPM. Read on for additional background with regards to the growing use of RPM by Medicare providers, these three OIG findings, additional recommendations, and how regulators may respond.

CMS Guidance, FCA Litigation, Stark Law September 30, 2024

Stark Law Regulations Under the Microscope in a Post-Chevron World

By Taleena Nadkarni and Timothy Fry

Recently, in United States ex rel. Kyer v. Thomas Health Systems, the judge overseeinga whistleblower’s False Claims Act (FCA) suit against Thomas Health Systems Inc. stalled further decisions until both parties could file supplemental briefs addressing the U.S. Supreme Court’s decision in Loper Bright Enterprises v. Raimondo. The judge’s order requires the parties to articulate if the Stark Law regulations are consistent with the statute.

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