DOJ May 30, 2025

Healthcare Fraud Enforcement in a Second Trump Administration: Trends, Priorities, and Implications

By Mindy Sauter, Clint Narver, Michael Elliott, Garen S. Marshall, Justin Givens, Michael J. Podberesky and Rhea Shahane

On May 12, 2025, the U.S. Department of Justice’s Criminal Division released a policy memorandum outlining its enforcement priorities for the upcoming year. The top priority for the division will be investigating and prosecuting white collar crimes related to waste, fraud and abuse — particularly healthcare fraud. This emphasis on prosecuting healthcare fraud reflects the administration’s broader goals of eliminating waste in federal programs, such as Medicare, Medicaid and TRICARE, and ensuring that taxpayer dollars are used efficiently and effectively.

Read on to learn more about the DOJ’s enforcement priorities and what proactive measures healthcare companies and providers should consider.

DOJ May 20, 2025

DOJ Announces Initiative to Use False Claims Act to Investigate DEI Practices

By Edwin O. Childs, Farnaz Farkish Thompson, Jack White, Michael J. Podberesky, Brett Barnett, John S. Moran, Steven McCool, John Sullivan, Jason M. Vespoli, Michael A. Brody and Maura Naehr

On May 19, 2025, the U.S. Department of Justice announced its new Civil Rights Fraud Initiative, which aims to use the False Claims Act (FCA) to investigate and pursue claims against entities that tolerate antisemitism, allow men to enter women’s spaces or compete in female athletic competitions, or engage in unlawful diversity, equity and inclusion practices. A central focus of the initiative appears to be pursuing claims against entities that certify compliance with civil rights laws while “knowingly” engaging in what the memorandum calls “racist preferences, mandates, policies, programs, and activities, including thorough [DEI] programs” that provide benefits based on race, ethnicity or national origin. The DOJ encourages private parties to engage as part of this process by filing lawsuits and litigating claims under the FCA as qui tam relators.

Read on to learn more about the initiative and how it could impact federal contractors, educational institutions and other entities that received federal funding.

DOJ April 28, 2025

DOJ Targets Neurofeedback Billing in $15 Million Behavioral Health Fraud Case

By Anna Timmerman, Amanda Roenius, Allyson M. Maur and Taleena Nadkarni

On March 6, 2025, federal prosecutors charged a Minnesota couple with orchestrating a $15 million healthcare fraud scheme involving overbilling and submission of false claims for neurofeedback and other behavioral health services performed by a network of behavioral health clinics. This newly unsealed federal indictment underscores the Department of Justice’s increasing focus on fraud involving neurofeedback and other emerging behavioral health treatments.

Read on to learn more about the federal indictment and what it portends for behavioral health practices and potential investors.

Defense Arguments, FCA Defenses, FCA Litigation April 10, 2025

Fifth Circuit Concurrence Adds Voice to FCA Constitutionality Questions

By Timothy Fry, Michael J. Podberesky, Edwin O. Childs and Michael A. Brody

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. 4th –, 2025 WL 939890 (5th Cir. Mar. 28, 2025), Judge Stuart Kyle Duncan separately wrote a concurring opinion to express skepticism regarding the constitutionality of the qui tam provision of the False Claims Act. Adding to a decision issued by a Florida federal district court last fall, Judge Duncan said that the qui tam provision of the False Claims Act violates the Appointments Clause of the Constitution because it allows private citizens to exercise the power of the executive branch despite not being appointed or confirmed as an officer of the United States.

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.

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