New Collaborative Effort Launched by the Department of Justice and Health and Human Services: False Claims Act Working Group

New Collaborative Effort Launched by the Department of Justice and Health and Human Services: False Claims Act Working Group

The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) have established a joint False Claims Act (FCA) Working Group, with a primary focus on enhancing enforcement efforts to combat healthcare fraud. The Working Group, which held its first meeting in July 2025, is co-led by Deputy Assistant Attorney General Brenna Jenny of DOJ's Civil Division.

The Working Group has identified six priority enforcement areas: Medicare Advantage, drug pricing, patient access to care, kickbacks, defective medical devices, and manipulation of electronic health records. These areas have been chosen to address key concerns in the healthcare sector, including fraudulent practices related to pricing, patient care, and the use of technology.

In the realm of Medicare Advantage, the Working Group aims to scrutinise any potential fraudulent activities that may impact the programme's integrity. For drug, device, or biologics pricing, the focus will be on arrangements related to discounts, rebates, service fees, formulary placement, and price reporting.

The Working Group also seeks to address barriers to patient access to care, including violations of network adequacy requirements. Kickbacks related to drugs, medical devices, durable medical equipment, and other federally funded healthcare products are another area of concern, as are materially defective medical devices that may pose risks to patient safety.

Manipulation of electronic health record systems to drive inappropriate utilisation of Medicare-covered products and services is another priority for the Working Group. This area underscores the Administration’s ongoing commitment to enhanced FCA healthcare enforcement.

The Working Group will employ various tools to expedite investigations, such as data mining, and will assess early whether novel legal theories are viable and supported by leadership. There is potential for an uptick in payment suspensions going forward due to the Working Group's activities.

HHS defines a credible allegation of fraud as an allegation from any source, including tips verified by further evidence, claims data mining, or patterns identified through provider audits, civil false claims cases, and law enforcement investigations. The Working Group will also consider HHS's payment suspension authority for "credible allegations of fraud."

Participants in federal healthcare programmes should monitor whether the Working Group identifies additional considerations bearing on when HHS should exercise this authority. The Working Group will meet on a monthly basis, starting in July, and upcoming meetings may provide more details about the group's focus and priorities.

WilmerHale, a leading international law firm, is monitoring the Working Group's efforts and priorities and stands ready to assist clients in investigations and enforcement actions brought against them. The firm's team brings the full breadth of experience needed to successfully defend against FCA investigations and litigation brought by qui tam relators and the government. WilmerHale's team includes highly experienced former DOJ and Defense Department litigators and government-contract attorneys.

The shift announced by DAAG Jenny could have implications for largely unfounded complaints that have resulted in multi-year investigations in the past. The Working Group's discussions will also include factors for DOJ in determining whether to dismiss qui tam complaints. The DOJ Justice Manual lists several factors that can serve as the basis for dismissal of a claim, including duplication of a preexisting government investigation, interference with government policies or programs, and implication of classified information and national security interests.

As the DOJ-HHS False Claims Act Working Group continues its work, it is expected to bring increased scrutiny and enforcement actions to the identified priority areas. Healthcare providers and organisations should be vigilant and ensure compliance with relevant regulations to avoid potential investigations and enforcement actions.

[1] DOJ Press Release, DOJ and HHS Announce Joint False Claims Act Working Group to Combat Healthcare Fraud (July 2, 2025). [2] HHS Press Release, HHS and DOJ Establish Joint False Claims Act Working Group (July 2, 2025). [3] DOJ Fact Sheet, DOJ-HHS False Claims Act Working Group (July 2, 2025). [4] HHS Fact Sheet, DOJ-HHS False Claims Act Working Group (July 2, 2025).

1. The DOJ and HHS have united to enhance healthcare fraud enforcement with the creation of the False Claims Act Working Group.
2. The Working Group is concentrating on six priority areas, such as Medicare Advantage, drug pricing, and electronic health record manipulation.
3. In Medicare Advantage, the Working Group seeks to combat fraud that jeopardizes the program's integrity.
4. For drug, device, or biologics pricing, the primary focus will be on discounts, rebates, service fees, formulary placement, and price reporting.
5. The Working Group also comprises efforts to tackle barriers to patient access to care caused by violations of network adequacy requirements.
6. Kickbacks related to healthcare products are of concern, along with materially defective devices that may endanger patient safety.
7. The group aims to curb the manipulation of electronic health records to prompt excessive utilization of Medicare-covered products and services.
8. Data mining and novel legal theories could help expedite investigations and assess their viability.
9. A credible allegation of fraud, according to HHS, is an allegation that has been verified or substantiated through further evidence, claims data mining, or provider audits.
10. The Working Group will scrutinize cases using HHS's payment suspension authority in response to credible allegations of fraud.
11. Healthcare providers and organizations should pay close attention to the Working Group's actions to ensure continued compliance with regulations.
12. WilmerHale, a prominent international law firm, is following the Working Group and stands ready to help clients defend against investigations or enforcement actions.
13. The team at WilmerHale combines extensive experience in FCA investigations and litigation, with lawyers who have previously worked at the DOJ and Defense Department.
14. The Working Group's efforts could impact multi-year investigations based on questionable complaints.
15. The DOJ will consider factors like duplication of a previous investigation, government policies, and national security interests when dismissing qui tam complaints.
16. The enactment of the Working Group is expected to lead to heightened scrutiny and enforcement actions in the identified priority areas.
17. Healthcare providers and organizations must remain vigilant and uphold regulatory compliance to mitigate the risks of investigations and enforcement actions.
18. The Working Group's first meeting took place in July 2025 and it plans to conduct monthly meetings moving forward.
19. The DOJ Press Release, DOJ and HHS Announce Joint False Claims Act Working Group to Combat Healthcare Fraud, outlines the initial efforts of the group.
20. The HHS Press Release, HHS and DOJ Establish Joint False Claims Act Working Group, provides additional insights into the joint initiative by both departments.
21. DOJ Fact Sheet, DOJ-HHS False Claims Act Working Group, offers a fact sheet detailing the group's objectives, focus areas, and potential enforcement actions.
22. HHS Fact Sheet, DOJ-HHS False Claims Act Working Group, offers another factual summary of the working group's roles, focus areas, and enforcement priorities.
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