DOJ and HHS Relaunch False Claims Act Working Group, Sharpening Healthcare Enforcement Focus

U.S. Justice and Health Departments Revive False Claims Act Working Group with Expanded Healthcare Fraud Focus

The U.S. Department of Justice and Department of Health and Human Services jointly announced the reestablishment of their False Claims Act Working Group on July 2, 2025, signaling an intensified focus on healthcare fraud investigations. This formal revival strengthens the longstanding collaboration between the two federal agencies, particularly in sectors where federal healthcare dollars and compliance risks intersect.

Brenna Jenny, Deputy Assistant Attorney General for the DOJ Civil Division’s Commercial Litigation Branch, described the move as “reinvigorating” the Working Group founded in 2020 to “formalize and enhance” collaboration between the agencies. The initiative aligns with the Trump Administration’s broader agenda to aggressively enforce the False Claims Act as a primary tool for combating fraud against the federal government.

The announcement builds upon recent DOJ enforcement initiatives, including the Civil Rights Fraud Initiative and expanded whistleblower incentive programs.

The Working Group identified six enforcement priorities that will guide upcoming investigations and referrals from HHS to DOJ. Medicare Advantage tops the list, with investigators targeting alleged risk score inflation, unsupported diagnoses, and failures in data integrity reporting—issues that have grown increasingly significant as Medicare Advantage enrollment continues to expand nationwide.

Drug, device, and biologics pricing will face heightened scrutiny, particularly regarding discounts, rebates, formulary placement fees, and price reporting arrangements. The pharmaceutical supply chain, already under congressional pressure for pricing practices, now faces additional enforcement attention.

Barriers to patient access to care represent a relatively novel enforcement area, focusing on network adequacy violations and other access limitations in Medicare and Medicaid managed care plans. This signals regulators’ growing interest in ensuring patients receive the care promised by their health plans.

Traditional areas of enforcement will continue, including kickbacks related to drugs, devices, durable medical equipment, and services paid for by federal healthcare programs. The Working Group will also target materially defective medical devices, especially those affecting patient safety or clinical efficacy.

Electronic health records manipulation rounds out the priorities, with investigators focusing on improper documentation practices used to support medically unnecessary services or inflate claims—a growing concern as healthcare becomes increasingly digitized.

The Working Group’s formalized structure brings practical enforcement implications. It will coordinate payment suspensions under federal regulations, which can occur even before DOJ intervenes in qui tam actions. This means providers facing credible fraud allegations could see reimbursements halted early in an investigation, creating significant financial pressure.

The agencies will also coordinate on dismissal decisions for non-intervened qui tam suits, potentially curbing resource-draining or meritless litigation. This represents a potential check on whistleblower cases where the government declines to join but which continue to burden healthcare organizations.

Perhaps most significantly, the Working Group will leverage interagency data sharing and advanced analytics to detect outliers and refine case targeting. This data-driven approach may accelerate investigations and increase scrutiny on high-risk segments of the healthcare industry.

Industry experts view the announcement as a clear warning to stakeholders in federal healthcare programs, especially those in Medicare Advantage, life sciences, health technology, and managed care sectors. The focus on novel enforcement theories and rarely used tools suggests the agencies aim not only to punish wrongdoing but to reshape compliance expectations across the healthcare landscape.

Companies should anticipate heightened scrutiny driven both by whistleblower activity and the agencies’ advanced analytics capabilities. Even longstanding business models—including rebate structures, risk adjustment submissions, and data-driven utilization strategies—may now face renewed legal risk.

Healthcare organizations would be wise to strengthen internal reporting mechanisms and whistleblower protections. With DOJ encouraging meritorious filings while potentially exercising greater discretion to dismiss weak cases, companies may see more selective but also more sophisticated whistleblower claims.

The Working Group’s focus on data analytics means companies should implement regular audits of high-risk areas, particularly risk adjustment coding practices, EHR documentation, network adequacy metrics, and pricing arrangements subject to government reporting requirements.

The initiative marks a significant institutional shift in healthcare fraud investigations. As one healthcare compliance attorney noted, “This isn’t merely symbolic. It represents a fundamental change in how fraud cases will be prioritized, structured, and pursued across the federal healthcare system.”

For industry participants, the message is clear: the federal government is committing substantial resources to detect and prosecute healthcare fraud, with particular attention to emerging schemes and high-dollar programs. The consequences of non-compliance have never been higher.