The US Departments of Justice and Health and Human Services recently issued a press release on the formation of a new False Claims Act Working Group, signaling to the healthcare industry an increased focus on anti-fraud enforcement efforts.
On July 2, 2025, the US Department of Justice (DOJ) and US Department of Health and Human Services (HHS) announced the creation of a False Claims Act Working Group (the Working Group), building upon their “long history of partnering” with one another “to combat healthcare fraud.”
The Working Group aligns with the US administration’s priority of focusing on combating waste, fraud, and abuse in government spending. The announcement of the Working Group sends a strong signal to the healthcare industry that the federal government expects to ramp up its anti-fraud enforcement efforts, including through greater reliance on data analytics to identify potential FCA enforcement targets. It will also likely lead to an increase in qui tam complaints.
Healthcare companies, including insurers, manufacturers of drug products, medical devices, and medical supplies, should remain vigilant and continue to assess their internal policies and procedures to remain compliant with complex federal and state laws that govern the delivery and billing of healthcare items and services.
The DOJ-HHS FCA Working Group includes the HHS Office of General Counsel, the Centers for Medicare and Medicaid Services Center for Program Integrity, the Office of Counsel to the HHS Office of Inspector General (HHS-OIG), and DOJ’s Civil Division, with representatives from US Attorney offices.
The inclusion of CMS and HHS officials and staff on this FCA Working Group, and not just HHS OIG members, demonstrates the importance the Working Group is placing on hearing potential fraud issues directly from HHS and CMS program operators and their counsel. Historically, the HHS-OIG had served as the lead representative for HHS on all FCA matters, although in the 1990s, CMS (then HCFA) also held review and approval authority on many FCA settlements.
These new FCA Working Group members reflect the critical importance of CMS’s Center for Program Integrity, which oversees an array of program integrity post-pay auditors as well as the team that oversees front-end Medicare provider and supplier enrollments and billing revocations for abusive practices. Medicare and Medicaid enforcement, including FCA investigations, has traditionally been part of a larger “pay-and-chase” system.
This cross-agency healthcare FCA Working Group with input from CMS officials, however, demonstrates a shift in enforcement approach and may help identify FCA enforcement targets at an earlier stage to protect the integrity of those federal healthcare programs before payments are made.
The Working Group will be jointly led by Acting HHS General Counsel Sean R. Keveney, Acting Chief Counsel to HHS-OIG Susan Edwards, and Deputy Assistant Attorney General of the Commercial Litigation Branch Brenna E. Jenny. Jenny recently replaced Michael Granston, who served as deputy assistant attorney general since 2019 and had served in DOJ for nearly 30 years. Jenny, a former partner at Sidley Austin who worked on FCA defense matters in the healthcare industry, also previously served as deputy general counsel of HHS, chief legal officer of CMS, and has prior experience in DOJ’s Civil Division overseeing FCA matters. The Working Group’s initial enforcement efforts may shed further light on the types of cases Jenny will prioritize and how she will shape the Civil Division’s FCA efforts.
The Working Group will refer potential FCA violations of the following “priority enforcement areas” to DOJ:
The Working Group aims to “maximize cross-agency collaboration to expedite ongoing investigations in these priority areas and identify new leads, including by leveraging HHS resources through enhanced data mining and assessment of HHS and HHS-OIG report findings.” It will also consider whether HHS should suspend payments under 42 CFR § 405.370 et seq. or whether DOJ should move to dismiss a relator’s qui tam complaint under 31 USC § 3730(c)(2)(A).
Former Deputy Assistant Attorney General Granston previously announced various criteria that DOJ would review to determine whether to dismiss meritless qui tam actions in the January 2018 Granston Memo. One of those factors included the strength of the legal theories and facts supporting a qui tam complaint. In practice, however, DOJ rarely dismissed qui tam complaints.
During an American Health Law Association panel on July 2, Brenna E. Jenny stated that the Working Group will assess “early whether novel legal theories are viable and supported by leadership.” Given that the Working Group may lead to an increase in qui tam complaints, including those that will undoubtedly be meritless or frivolous, Jenny’s comments may provide some small measure of reassurance to healthcare companies that the Working Group will follow through on its mandate and dismiss meritless qui tam complaints that only hamstring a company’s ability to conduct its ongoing operations.
Although the Working Group is new, its mandate to investigate and prosecute healthcare fraud through the FCA is not. During the government’s last fiscal year (2024), DOJ recovered $2.9 billion through the FCA. Over half of that total, $1.68 billion, was through healthcare fraud cases. In the prior year (2023), DOJ recovered $1.86 billion through healthcare FCA cases. Many of these cases related to conduct that overlaps with the Working Group’s enforcement priorities, including Medicare Advantage, drug pricing, and kickbacks.
DOJ recently reaffirmed its commitment to combatting healthcare fraud through the White-Collar Enforcement Plan issued by Head of the Criminal Division Matthew R. Galeotti on May 12, 2025. The plan outlines key areas of focus for prosecutors and directs them to prioritize “investigating and prosecuting white-collar crimes” in “high-impact areas,” including combatting “[w]aste, fraud, and abuse, including health care fraud.”
Consistent with its ongoing FCA healthcare enforcement efforts, DOJ has announced several high-profile healthcare fraud actions over the past few months. In March, Seoul Medical Group agreed to pay more than $62 million to settle FCA claims related to the submission of false diagnosis codes to increase Medicare Advantage payments. In May, DOJ filed a complaint against several large health insurance companies and insurance brokers alleging violations of the FCA in connection with illegal kickbacks worth hundreds of millions of dollars and discrimination against Medicare beneficiaries with disabilities. Federal prosecutors and members of the whistleblower bar forecast at the Boston Bar Association’s May 8th White Collar Crime Conference that there would be future such Medicare Advantage cases against other plans and brokers engaged in what they view as an improper industry-wide practice.
DOJ’s enforcement efforts in the healthcare space are not limited to civil FCA cases. DOJ is also aggressively prosecuting criminal cases involving fraud against federal healthcare programs. In May, two individuals were arrested in connection with submitting more than $227 million in fraudulent claims to Medicare. In June, DOJ announced that the CEO of Power Mobility Doctor Rx LLC was convicted in connection with defrauding Medicare and other federal government healthcare programs of more than $1 billion. Further, earlier this year, a federal grand jury returned a rare indictment against a hospital as a result of billing federal healthcare programs for procedures performed by a physician who was previously convicted of two felonies and who had lost his privileges at another facility for performing unnecessary operations.
Finally, DOJ announced on June 30 a record-breaking healthcare fraud “takedown” that included criminal charges against 324 defendants, including 96 healthcare professionals. Notably, this operation included a “whole-of-government approach” that was coordinated across the DOJ Criminal Division’s Health Care Fraud Unit, various US Attorney offices, the HHS-OIG, the Federal Bureau of Investigation, and the Drug Enforcement Administration.
Thus, the Working Group’s mission to coordinate efforts among various government agencies and constituencies across the federal healthcare program operations and oversight spectrum is not unprecedented. In fact, the Fraud Section’s Health Care Fraud Unit investigates complex healthcare fraud cases based on a “cross-agency collaborative approach” with multiple other federal agencies and OIGs. [1] The Healthcare Fraud Unit and various US Attorney offices also utilize data analytics to identify potential fraud, similar to the Working Group’s stated goal of identifying priority areas and enforcement leads through data mining.
It remains to be seen how the Working Group will interact, coordinate, and work with the Health Care Fraud Unit and other federal agencies charged with combatting healthcare fraud. The bottom line is that while the Working Group may focus on certain aspects of healthcare fraud over others, the industry will continue to be a hotbed of enforcement and qui tam litigation.
The new Working Group should put healthcare companies on notice that they are likely to come under increasing scrutiny, both from the government’s own enforcement actions and from investigations initiated by whistleblowers filing qui tam complaints. The announcement of the Working Group serves as a signal to whistleblowers and the plaintiffs’ bar that the government will be interested and receptive to FCA complaints in the healthcare space, particularly with respect to the priority enforcement areas.
The announcement of the Working Group “encourages whistleblowers to identify and report violations of the federal False Claims Act involving priority enforcement areas” and “encourages healthcare companies to identify and report such violations.” It is yet to be determined whether the Working Group will use other enforcement tools to investigate and crack down on fraud in addition to the FCA.
The creation of the Working Group serves as a reminder to healthcare companies that they should continuously review and revamp, as necessary, their compliance and anti-fraud policies, procedures, and training. Companies should also carefully audit and continuously monitor their own internal data to find and address outliers before the government does.
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