Health Care

The January 2026 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

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.

In September 2025, the New York State Assembly introduced Assembly Bill A9042, which would require veterinary clinics to provide notice and undergo Attorney General review for certain “material change” transactions, such as mergers or significant asset transfers. Momentum is building in 2026, with the bill recently referred to the Agriculture Committee for review on January 7th. This initiative builds on New York’s 2023 action to regulate healthcare transactions by requiring notice to the Department of Health for similar changes, but it goes further by extending oversight to the veterinary sector. Unlike most states, which primarily regulate ownership through bans on the corporate practice of veterinary medicine, the law would require formal notice and Attorney General review of certain transactions in the veterinary industry. As private equity investment continues to reshape veterinary care, this proposal could signal a broader trend toward increased regulation in 2026, potentially making New York the first state to set this precedent and raising the question of whether others will follow. This post will examine the bill’s key provisions and explore how current state laws govern veterinary practice ownership across the United States.

The end of 2025 saw several notable developments for the telehealth industry with early 2026 poised to potentially challenge the industry with the impending expiration of the short-term extension of the Medicare telehealth flexibilities. Below we highlight activity from late 2025 and provide an outlook for 2026.

On December 23, 2025, the Centers for Medicare & Medicaid Services (CMS) announced the Better Approaches to Lifestyles and Nutrition for Comprehensive hEalth (BALANCE) Model, a voluntary, alternative payment model (APM), designed to expand access to GLP-1 medications.  At its core, the BALANCE Model intends to promote the use of both GLP-1 medications and lifestyle interventions to help prevent chronic conditions and combat obesity, while also managing the costs of such medications for Medicare and Medicaid beneficiaries and taxpayers. 

The Trump administration closes 2025 with nine major drug pricing deals, securing discounts on key medications and boosting U.S. pharmaceutical manufacturing investments.

CMS proposes two pilot programs: GUARD and GLOBE, to curb Medicare drug costs by tying rebates to international pricing benchmarks. Public comments open until Feb. 23, 2026.

The December 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.

Last week, the Centers for Medicare & Medicaid Services (CMS) released its proposed Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program (Proposed 2027 Rules).

As is common for the annual proposed rules, the Proposed 2027 Rules cover a broad range of topics. In the last few years, the agency has lost multiple legal cases challenging the validity of its rules and/or how it implements its rules – it has lost cases relating to Star Ratings, its updated marketing and communications rules that were adopted for 2025, and most recently, the risk adjustment extrapolation rule. The Proposed 2027 Rules broadly touch on all of these regulatory areas. In its very brief summary of the Proposed 2027 Rules, CMS also highlights changes to Part D drug coverage, the enrollment process, and special needs plans. The Proposed 2027 Rules also include multiple Requests for Information (RFI). Below are some initial takeaways.

The November 2025 edition of FDA in Flux highlights significant developments shaping the regulatory landscape for medical, life sciences, and consumer product sectors.