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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

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act (FCA) – described in the announcement as “one of the government’s most effective and successful tools” for fighting fraud. In Fiscal Year 2024, the Department of Justice recovered more than $2.9 billion through settlements and judgments under the FCA, with $1.6 billion (57%) coming from healthcare-related matters.Continue Reading DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities

At the end of May, the Department of Justice (DOJ) announced the formation of a Civil Rights Fraud Initiative to “utilize the False Claims Act to investigate and, as appropriate, pursue claims against any recipient of federal funds that knowingly violates federal civil rights laws.” In connection with the Initiative, we will see DOJ’s False Claims Act practitioners in the Civil Division and the U.S. Attorneys’ Offices pairing with DOJ’s Civil Rights Division to “identify and root out instances in which recipients of federal funds fail to uphold their basic obligations under federal civil rights laws.”Continue Reading DOJ Civil Rights Fraud Initiative Will Use the False Claims Act to Target Antisemitism and DEI Programs

The wait is over!

On October 10th, the Federal Trade Commission (FTC) unanimously approved the first significant revisions to the Hart-Scott-Rodino (HSR) Act premerger notification regime since its inception over 40 years ago.[1] The Antitrust Division of the U.S. Department of Justice (“DOJ”) also endorsed the new rules (“Final Rule”).[2] The Final Rule will not only substantially increase the complexity of filings and the time required to prepare them, but also the burden and costs borne by reporting parties. Unless enjoined by a federal court, these rules will likely go into effect mid-January 2025 (90 days after publication in the Federal Register). The FTC will publish compliance guidance in advance of the Final Rule’s effective date.Continue Reading The FTC Adopts New Premerger Notification Rules Implementing the Hart-Scott-Rodino (HSR) Act

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?

On June 6, 2024, California Attorney General Rob Bonta announced that he led a multistate coalition of eleven (11) state attorneys general in in submitting a comment letter (the “Comment Letter”) in response to the Federal Trade Commission, the U.S. Department of Justice, and the U.S. Department of Health and Human Services’ (together the “Agencies”) request for information regarding consolidation in healthcare by private equity. On March 5, 2024, the Agencies issued a “Request for Information on Consolidation in Healthcare Markets,” on the same day the Agencies hosted a public workshop regarding the impact of private equity investment in the healthcare system. Continue Reading California Attorney General Advocates for Greater Antitrust Enforcement in Private Equity in Healthcare

The health care industry has been a particular focus of antitrust concern in recent years, including recent policy initiatives, private equity warnings, and enforcement actions from both the Department of Justice (DOJ) and Federal Trade Commission (FTC). The new Task Force on Health Care Monopolies and Collusion (HCMC), announced this month by the DOJ, is the latest example of antitrust scrutiny on the industry.Continue Reading New DOJ Health Care Task Force Portends Continued Aggressive Antitrust Enforcement

Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed payments set by Medicare, as well as, in some cases, significant additional payments from health plans. Concerned over the potential for abuse, these arrangements have been the subject of Congressional scrutiny and an enforcement priority for both the Department of Justice (“DOJ”) and the Department of Health and Human Services Office of the Inspector General (“HHS OIG”). The Biden Administration and the Centers for Medicare & Medicaid Services (“CMS”) are tackling this issue head-on in a recently published final rule that addresses both marketing tactics and compensation methodologies used by Medicare Advantage organizations (“MAOs”) to pay MA agents or brokers.[1]Continue Reading Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space

Last week the Federal Trade Commission (FTC) issued a press release highlighting recent and forthcoming actions by the FTC, Department of Justice (DOJ), and the Department of Health and Human Services (HHS), which they say will further promote competition, thereby lowering costs and increasing the quality of care in the U.S. health care market. In addition to highlighting recent actions by each of the agencies (e.g., the FTC’s proposed non-compete rule), the release states that the three agencies are entering into new partnerships to increase interagency cooperation and advance a “whole-of-government” approach to protect health care competition, including:Continue Reading FTC, DOJ, and HHS Announce Interagency Initiatives to Promote Healthcare Competition

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting continued enforcement and recovery actions under the Health Care Fraud and Abuse Control Program (HCFAC). During fiscal year 2022 (FY 2022), over $1.7 billion was returned through HCFAC’s enforcement actions.Continue Reading HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment Centers, Among Other Initiatives