DOJ-HHS Relaunches False Claims Act Working Group to Intensify Healthcare Fraud Enforcement
On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group, signaling a renewed and intensified focus on healthcare fraud enforcement, particularly where federal healthcare funding and compliance overlap. This relaunch formalizes and enhances collaboration between the DOJ and HHS, building on recent DOJ enforcement initiatives like the Civil Rights Fraud Initiative and expanded whistleblower incentive programs. The Working Group has identified six enforcement priorities, emphasizing areas like Medicare Advantage, Medicaid managed care, pharmaceutical supply chains, and digital health ecosystems.
The formalized partnership aims to leverage centralized oversight, interagency referrals, and advanced data analytics to accelerate FCA investigations and increase scrutiny on high-risk sectors within healthcare and life sciences. Notably, the Working Group plans to target novel enforcement theories such as network adequacy and utilize rarely applied tools including payment suspensions, indicating a strategic shift beyond traditional fraud penalties to reshape compliance expectations.
Healthcare entities and companies involved in federal healthcare programs should anticipate heightened enforcement activity, particularly related to pricing practices, network adequacy, EHR manipulation, and data submission accuracy. Even established business models, including rebate structures and risk adjustment submissions, may encounter renewed FCA scrutiny. Organizations are advised to reassess enterprise risk profiles, update internal controls, and enhance third-party reviews accordingly.
Strengthening internal reporting mechanisms and whistleblower protections is crucial as the FCA's qui tam provisions continue to motivate relators. The DOJ may exercise more discretion in evaluating whistleblower claims, potentially resulting in more selective yet sophisticated allegations. Businesses should ensure anonymous reporting tools are effective and that leadership fosters a transparent, supportive environment for internal compliance concerns.
The Working Group’s reliance on interagency data analytics will likely increase examination of outlier patterns related to coding intensity, pricing anomalies, physician usage patterns, and network adequacy metrics. Regular internal audits focusing on risk adjustment coding, EHR documentation, pricing arrangements, and compliance with Medicaid best price rules are recommended to mitigate investigation risks.
Financial agreements impacting formulary placement, rebates, and service fees, especially in the life sciences and pharmacy benefit manager (PBM) sectors, warrant thorough legal review. Ensuring fair market value documentation, justifiable business rationale, and compliance guardrails are essential to avoid FCA exposure.
EHR system usage remains under scrutiny due to concerns over potential manipulation to justify claims. Providers and health technology companies should assess EHR functionalities, clinical documentation practices, and training protocols to ensure alignment between billing claims and actual care delivered.
Finally, the Working Group indicates an increased likelihood of government remedies beyond civil settlements, notably payment suspensions, which can disrupt operations before legal liability is established. Developing comprehensive investigation response plans, including document retention protocols, external counsel engagement, and business continuity strategies, is advisable.
Overall, the DOJ-HHS FCA Working Group relaunch embodies a significant shift in healthcare fraud enforcement, emphasizing data-driven investigations, interagency cooperation, and proactive compliance strategies across federal healthcare programs. Industry stakeholders are encouraged to align operational and compliance frameworks with these evolving enforcement priorities to navigate the changing risk landscape effectively.