On September 23, 2025, the US Department of Justice’s (DOJ’s) Criminal Division announced the expansion of its Healthcare Fraud Unit’s New England Strike Force into the District of Massachusetts, demonstrating a significant escalation in federal healthcare fraud investigations in the region. The move reflects what DOJ describes as its recognition of Massachusetts, particularly Boston, as a national hub for healthcare and life sciences innovation—and a high-risk zone for complex fraud schemes.
The expansion will be led by Fraud Section Assistant Chief Kevin Lowell, in coordination with Chief Mackenzie Queenin of the US Attorney’s Office’s Healthcare Fraud Unit in Massachusetts. This collaboration brings additional federal resources and investigative capacity to a jurisdiction already known for aggressive enforcement.
What is the DOJ Healthcare Fraud Strike Force?
Originally launched in 2007, the DOJ’s Healthcare Fraud Strike Force Program is a multi-agency operation designed to detect, investigate, and prosecute healthcare fraud. The Strike Force brings together federal partners, including the DOJ Criminal Division, FBI, HHS Office of Inspector General (HHS-OIG), FDA Office of Criminal Investigations, DEA, Homeland Security Investigations, IRS Criminal Investigation, and VA-OIG. It also involves the Massachusetts Medicaid Fraud Control Unit and the Insurance Fraud Bureau of Massachusetts, both key players in the state’s healthcare fraud enforcement efforts.
Why is DOJ targeting Massachusetts for healthcare fraud?
The DOJ’s expansion into Massachusetts reflects a strategic move, targeting one of the country’s most active healthcare and life sciences markets. Boston and the surrounding region are home to world-class hospitals, research institutions, and a thriving biotech, medtech, and startup ecosystem. That concentration of innovation draws a high volume of federal healthcare dollars, which may increase fraud and enforcement risk.
For providers and companies operating in Massachusetts, this expansion means more federal presence, more data analysis, and more scrutiny. The US Attorney’s Office here already has a national reputation for aggressive healthcare fraud enforcement. In FY 2025 alone, it recovered over $450 million through coordinated criminal and civil actions. With the DOJ’s Strike Force now embedded in the district, healthcare regulatory investigations are expected to move faster, go deeper, and focus on both individuals and organizations within the healthcare industry.
If your company receives federal reimbursements, works with regulated medical products, or operates in high-risk billing environments, this expansion directly affects your risk profile.
What are the DOJ’s enforcement priorities in Massachusetts?
The DOJ’s expansion into Massachusetts is part of a broader strategy outlined in its 2025 White-Collar Enforcement Plan, which prioritizes aggressive action against fraud that undermines public health systems and federal programs. For companies operating in healthcare, life sciences, or adjacent sectors, these priorities signal where enforcement is headed, and who’s likely to be in the crosshairs.
Key areas of focus include:
- Continuing focus on individual accountability. DOJ is increasingly focused on identifying individual responsibility within corporations for potential misconduct. DOJ has expressed a commitment to the “equal and fair application of criminal laws to individuals and corporations.”
- Regulatory scrutiny in the pharmaceutical and medical device sectors. Key areas of focus include financial relationships with providers, such as kickbacks, product misbranding, product safety, and safety-related disclosures, especially in high-growth biotech and medtech sectors.
- Oversight of billing and referral practices in federal healthcare programs. DOJ is examining patterns in coding, service documentation, and referral arrangements across Medicare, Medicaid, TRICARE, and VA networks, with particular attention to high-volume providers.
- Patient safety risks tied to product quality and care standards. Enforcement priorities include counterfeit drugs, substandard care, and practices that may disproportionately affect vulnerable populations.
- Compliance with the Controlled Substances Act (CSA) and the Federal Food, Drug, and Cosmetic Act (FDCA). Areas under review include opioid prescribing practices, distribution of unapproved drugs, and adherence to manufacturing and labeling requirements.
What does this expansion mean for providers and executives?
Healthcare providers, entities, executives, and life sciences companies operating in Massachusetts should take proactive steps to assess compliance risk under the expanded Strike Force model.
Key considerations include:
- How the entity’s compliance structure will withstand DOJ scrutiny
- How to prepare for audits, subpoenas, or civil investigative demands (CIDs)
- Legal exposure from whistleblower complaints
- Risks associated with parallel civil and criminal investigations
The DOJ has signaled a more aggressive timeline for investigations, meaning companies may face DOJ subpoenas or interview requests earlier in the process and with less time to respond.
Responding to a DOJ investigation: What healthcare and life sciences companies should know
With the DOJ’s Strike Force now active in Massachusetts, healthcare providers and companies may find themselves under investigation with little warning. Whether it’s a subpoena, a CID, or an unannounced visit from federal agents, the stakes are high and the timeline for response is often short.
While every situation is unique, companies should be prepared to:
- Engage experienced counsel immediately. Early legal guidance is critical to preserving rights, managing risk, and avoiding missteps that could escalate the matter.
- Protect attorney-client privilege during internal reviews. Internal investigations should be structured carefully to ensure privileged communications remain protected.
- Coordinate legal and communications strategies. Responding to subpoenas, search warrants, or media inquiries requires alignment between legal, compliance, and PR teams.
- Navigate parallel investigations across agencies. DOJ actions often involve multiple federal and state entities, each with different mandates and timelines.
- Evaluate the risks and benefits of voluntary self-disclosure. DOJ’s revised policies offer potential credit for proactive disclosure—but only under specific conditions and with strategic timing.
Companies operating in pharmaceuticals, medical devices, or federally reimbursed services should review their compliance procedures now, before an inquiry arises.
Nixon Peabody’s healthcare fraud defense capabilities
At Nixon Peabody, our Government Investigations & White-Collar Defense team is well-positioned to support entities facing scrutiny under the DOJ’s expanded Healthcare Fraud Strike Force enforcement in Massachusetts. If you’ve received a DOJ subpoena, target letter, or inquiry from federal agencies, such as the US Attorney’s Office in Massachusetts, HHS-OIG, or FDA, reach out to your Nixon Peabody attorney to discuss next steps.