EnforceMintz

Learn the latest on EKRA enforcement and compensation rules for laboratory sales and marketing employees after the Ninth Circuit’s Schena decision. Explore DOJ’s stance, open compliance questions, and similar state law impacting clinical laboratories.

Discover key False Claims Act cybersecurity enforcement trends from 2025, including major DOJ settlements with defense contractors and health care companies. Learn best practices for compliance, self-disclosure, and risk mitigation as enforcement intensifies in 2026.

Explore 2025 managed care enforcement trends under the Trump administration. Learn about DOJ and CMS priorities, Medicare Advantage risk adjustment cases, key cases interpreting regulatory changes, and compliance strategies for MAOs.

Explore key constitutional challenges to the False Claims Act, including Article II disputes over qui tam provisions and Excessive Fines Clause litigation. Learn how recent court decisions impact FCA enforcement and penalty limits in 2026.

Learn how DOJ’s expanded Voluntary Self-Disclosure policy and evolving use of NPAs and DPAs create new opportunities for health care companies to resolve enforcement actions. Explore strategies for cooperation, remediation, and compliance.

Explore how consumer protection regulators tackled health care issues in 2025, from GLP-1 weight loss drugs to AI oversight and pricing transparency. Learn what enforcement trends mean for health care companies in 2026.

Explore DOJ health care enforcement trends under Trump 2.0. Learn how leadership changes, new False Claims Act (FCA) priorities, and political initiatives like gender-affirming care investigations are reshaping compliance risks for 2026.

Explore DOJ False Claims Act enforcement trends for 2025–2026 with insights from former US Attorney Erek Barron. Learn about data-driven investigations, AI risks, compliance strategies, and opportunities for self-disclosure.

Discover how health care organizations can prevent False Claims Act (FCA) retaliation claims. Learn best practices for compliance programs, whistleblower risk management, documentation protocols, and legal privilege strategies to reduce FCA litigation exposure.

Explore how AI is reshaping health care enforcement in 2026. Learn about emerging state regulations, federal oversight, enforcement risks, and best practices for compliance in an evolving AI-driven landscape.

Our 2025 edition of EnforceMintz reflects on health care enforcement trends, predicts how health care enforcement may evolve, and offers practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

Our 2025 edition of EnforceMintz reflects on health care enforcement trends, predicts how health care enforcement may evolve, and offers practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

Government scrutiny of value-based care (VBC) health care delivery models is expected to increase as VBC adoption grows. In 2024, the DOJ announced a large FCA settlement with a VBC primary care practice, and HHS’s Office of Inspector General issued a Special Fraud Alert focusing on VBC business arrangements.

In 2024, the Department of Justices and Centers for Medicare & Medicaid Services intensified enforcement in Medicare Advantage and Part D, with a focus on risk adjustment audits and Star Ratings disputes. Key developments, including litigation and regulatory changes, signal heightened scrutiny for MAOs, PDP Sponsors, and their vendors in 2025.

Following the Supreme Court’s decision in Securities and Exchange Commission v. Jarkesy, holding that the Seventh Amendment entitles defendants to a jury trial when the SEC seeks to impose civil monetary penalties for a securities fraud violation, parties are starting to assert Jarkesy-based arguments in appealing administrative actions of the Department of Health and Human Services.

In 2024, the COVID-19 Fraud Enforcement Task Force, in conjunction with five COVID Fraud Enforcement Strike Forces and other government agencies, has resolved many significant criminal and civil pandemic fraud cases. More civil pandemic fraud enforcement actions and continuing criminal actions are expected in 2025.

In 2024, the Department of Justice ramped up cybersecurity enforcement under the Civil Cyber-Fraud Initiative (CCFI), targeting entities that failed to safeguard PHI and PII in federally funded contracts. Key cases highlight trends in False Claims Act litigation and underscore the importance of cybersecurity compliance heading into 2025.

In 2024, DOJ and the OIG expanded telehealth enforcement beyond traditional telefraud schemes, addressing compliance with state corporate practice and telehealth-specific billing codes. Two cases, including the first criminal telemedicine prosecution, signal a trend of heightened regulatory scrutiny for the maturing telehealth industry.

In 2024, the FTC and state attorneys general pursued various theories of liability against a diverse array of entities offering health care or health care–related services, and employed numerous different enforcement tools and partnerships. We expect that the agencies will continue developing these strategies in 2025.