The US Department of Justice (DoJ) is tightening its focus on identifying fraud – with a particular focus on enterprise-wide abuses – across the medical device industry, according to research by legal firm Barnes & Thornburg.
The Indiana-headquartered law firm’s 2025 Healthcare Enforcement and Compliance Annual Report, released in April 2026, reveals that False Claims Act (FCA) recoveries for fiscal year 2025 (FY25) – running from 1 October 2024 to 30 September 2025, totalled $6.8bn, representing the highest total in a single year in the history of the FCA. More than $5.7bn of this total encompassed healthcare sector entities, according to the report, with around $76m in total recoveries for false claims in relation to the medical device industry.
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FCA recoveries in healthcare refer to the amount in settlements and judgments collected by the US government annually from healthcare entities that knowingly submit false claims for payment to federal programmes such as Medicare and Medicaid.
Barnes & Thornburg creates its report using an annual statistical report the DoJ issues, stating how many Qui tam actions (lawsuits filed by whistleblowers on behalf of the government under the FCA) have been filed and how many enforcement actions the DoJ is pursuing, along with other data emanating from the legal industry to identify what fraud enforcement trends are currently playing out.
With the $76m recovery figure spanning “five or six” enforcement actions in the medical device industry across FY25, Jackie Papish, partner at Barnes & Thornburg and a co-editor on the enforcement report, notes that the actions being seen are becoming “more enterprise-wide”.
“Enforcement actions are trending beyond little one-off discrepancies such as, for example, billing for unnecessary services in a confined, siloed space with one certain provider; it’s more enterprise-wide,” Papish tells Medical Device Network.
Broadening the application of the FCA
According to Papish, this trend is also raising questions around how the FCA can be applied and what other ‘theories of liability’ may be in scope of this law, beyond ‘run-of-the-mill’ fraud actions such as an individual medical practitioner receiving kickbacks.
“Whistleblowers are now considering whether there are broader theories regarding abuses that can be brought that will be more likely to result in high dollar recoveries. These may include pursuing theories of liability, such as whether there were falsities in a pre-clearance documentation, which then induced the government to approve the utilisation of a device for certain purposes,” Papish explains.
These considerations come against a backdrop of provisions enacted by the DoJ under the Trump administration that are seeking to enhance the detection of fraudulent practices in healthcare.
In June 2025, the DoJ launched the Health Care Fraud Data Fusion Center, a provision that is focused on using artificial intelligence (AI) and advanced data analytics to detect and investigate fraud schemes. And on 30 April 2026, the DoJ announced the formation of the West Coast Health Care Fraud Strike Force.
Uniting the DoJ’s National Fraud Enforcement Division (Fraud Division) with the US Attorney’s Offices for the District of Arizona, District of Nevada, and the Northern District of California, the scheme is designed to tackle more sophisticated forms of healthcare fraud across the US West Coast.
Meanwhile, such theories of liability being considered by whistleblowers, widen the spectrum of fraud liability, Papish says, while pairing dictates and potential violations by companies under the Federal Food, Drug and Cosmetic Act (FDCA) with the FCA are a type of allegation Barnes & Thornburg has been seeing, too.
Looking at 2026, Papish’s conclusion is that it is becoming clear now that the Trump administration is particularly interested in healthcare fraud and abuse matters and is undertaking new initiatives to incentivise whistleblowers to come forward and make filings.
Papish concludes: “I think that’s becoming more prominent [mechanisms to determine fraud sources] as we move forward, but generally it has been made very clear that this administration is interested in ferreting out fraud, whether it’s in the medtech space or otherwise, and effectively these aims depend on the areas in which these abuses are bubbling up and which theories of liability are sticking.”
