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Federal enforcement of the False Claims Act (FCA) against healthcare and pharmaceutical companies—especially based on alleged Anti-Kickback Statute (AKS) violations—continues to change, with the Regeneron Pharmaceuticals case at the forefront of recent developments. Recall that in Regeneron, the government alleges that the pharmaceutical company is illegally subsidizing copayments for Medicare beneficiaries by making large donations to third party foundations offering copay assistance to strategically steer patients to its high-cost specialty drug, Eylea, instead of lower-cost alternatives, resulting in alleged FCA liability based on an AKS violation. After the First Circuit held that a FCA plaintiff in an AKS-based FCA case must prove “actual causality, which in ordinary course takes the form of but-for causation,” United States v. Regeneron Pharms., Inc., 128 F.4th 324, 330 (1st Cir. 2025), the government is trying—again—to avoid having to prove a causal link between the alleged AKS violation and damages (i.e., financial harm to a government program). The government’s recent summary judgment brief in the United States District Court for the District of Massachusetts provides a detailed look at both its evolving legal theory and the practical compliance lessons for pharmaceutical manufacturers, providers, and health systems.Continue Reading Regeneron, the False Claims Act, and a New Era in Government Enforcement

On July 16, 2025, President Trump signed into law the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl Act or the Act), which significantly reformed the 1970 Controlled Substances Act (CSA). The HALT Fentanyl Act permanently reclassifies “fentanyl-related substances” as Schedule I controlled substances. Moreover, the Act simplifies Drug Enforcement Administration (DEA) research registration requirements in several ways, including (1) streamlining research registration processes for Schedule I or II controlled substances registrants performing research involving Schedule I controlled substances under active investigational new drug applications (INDs) or conducted or funded by certain federal agencies, (2) allowing agents or employees of a research institution to conduct research with a controlled substance without separately registering if another agent or employee of that institution is registered to conduct research with a controlled substance in the same schedule, and (3) expanding the ability of persons registered to perform research on a controlled substance to perform certain manufacturing activities coincident to that research without needing to obtain a manufacturing registration.Continue Reading HALT Fentanyl Act: Clarification of the Campus DEA Research Registration

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to investigations into healthcare fraud, false statements and other misconduct.[i] DOJ’s recent announcement, combined with the other actions described below, signal the government’s interest in pursuing action against providers that bill federal healthcare programs for gender-affirming care for minors, including puberty blockers, hormone therapy and surgeries. Specifically, these actions strongly suggest that the government will investigate not only criminal claims but also civil claims under the False Claims Act[ii] (“FCA”) against gender-affirming care providers that bill federal healthcare programs for services provided to minors, relying on bases related to miscoding/misbilling, lack of informed consent and lack of medical necessity. The FCA provides for treble damages and penalties of up to $28,619 per claim. We discuss each of these theories below and what providers can do to reduce potential exposure under these theories.Continue Reading Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

A federal district court in the Middle District of Florida issued a decision on Sept. 30th that threatens the federal government’s continued reliance on the False Claims Act (“FCA”) as the most powerful weapon in the Department of Justice’s enforcement arsenal. U.S. District Judge Kathryn Kimball Mizelle threw out a case against a group of Medicare Advantage organizations and providers on the grounds that an individual whistleblower suing on behalf of the federal government under the FCA, often called a “relator” in a “qui tam” lawsuit, violates the U.S. Constitution’s “appointments clause.” The Court concluded that relators, who are acting on behalf of the federal government, must be considered officers of the government and appointed in a manner consistent with Constitutional requirements. See U.S. ex rel Zafirov v. Florida Medical Associates, LLC, No. 8:19-cv-1236, 2024 U.S. Dist. LEXIS 176626, ECF No. 346 (M.D. Fl. Sept. 30, 2024).Continue Reading FCA Whistleblowers – No More?

An official from the Department of Justice (“DOJ”) recently announced the DOJ’s plans to “substantially” add to its current roster of 75 prosecutors specializing in healthcare fraud. On November 7, John “Fritz” Scanlon, assistant chief of the DOJ’s criminal division, fraud section, who spoke at a Healthcare Compliance Association conference in Washington, D.C., stated that the 75 prosecutors are distributed among seven strike forces across the U.S. The DOJ uses nine interagency strike force teams to root out alleged fraudulent activities, particularly focusing on Federal healthcare program fraud and abuse. These teams are spread throughout the country, focusing on regions in the U.S. like Florida and Texas, but several strike force teams also specialize in certain subject matters.Continue Reading Increased Enforcement in Healthcare? DOJ to Add More Prosecutors

Yesterday, the Supreme Court issued a unanimous decision holding that the aggravated identity theft statute –and its mandatory minimum of two years – is not triggered merely because someone else’s identification facilitates or furthers the offense in some way. See Dubin v. United States. We have seen a growing trend of the government adding aggravated identity theft in healthcare fraud cases. As a result of this decision, we may see that statute far less.Continue Reading Is this “Good-Bye” to the Two Year Mandatory Minimum in Healthcare Fraud Cases?