Health Care

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.

Since May, the Trump administration has used tariffs and Most Favored Nation (MFN) drug pricing threats as a means to pressure pharmaceutical manufacturers to lower drug prices in the U.S. This pressure culminated in a first-of-its-kind deal with Pfizer.

Since our last update, four other manufacturers have struck deals with the Trump administration aimed at expanding drug access and improving affordability, particularly targeting the GLP-1 and fertility pharmaceutical markets. These agreements reflect the growing consumer demand for GLP-1 drugs and IVF treatments while aligning industry leaders with the federal agenda on health care affordability. In this blog post, we’ll explore the key developments that have followed the Pfizer deal, including how other pharmaceutical companies are responding.

On November 5, 2025, CMS published the CY 2026 Physician Fee Schedule Final Rule (Final Rule), which includes changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) in the context of Average Sales Price (ASP) submissions. In the Final Rule, CMS opted not to finalize its proposal to modify the BFSF definition to require fair market value (FMV) methodology standards, FMV reassessments, and independent third-party valuations. This is a notable departure from the proposed rule, which we covered in a prior blog post. However, CMS is moving forward with several important provisions that impact how manufacturers and other stakeholders document and report BFSFs when calculating ASP for Medicare Part B drugs. This update highlights the finalized requirements that stakeholders should now prepare to implement effective January 1, 2026.

Explore California’s new health care transaction laws in this episode of Health Law Diagnosed. Mintz experts discuss A.B. 1415, S.B. 351, and the rise of “mini HSR” rules—plus what health care entities must do now to stay compliant.

Known for its aesthetics and wellness culture, California continues to be a leading destination for new wellness and medical aesthetics practices (collectively, medical spas). Yet, unlike other states previously discussed in this series, California does not currently have any laws or regulations specifically intended to govern medical spas. Depending upon the level of clinical care provided, medical spas in California may be subject to less-restrictive cosmetology laws and regulations, or the stricter laws and enforcement mechanisms applicable to traditional medical practices, including a robust set of rules regulating ownership, supervision, scope of practice, and advertising. 

Understanding whether a medical spa is subject to medical practice laws is a critical analysis that owners and operators in California should determine prior to providing any services in the state. This post explores the fine line between medical spas subject to purely cosmetology requirements versus medical practice laws, highlighting the legal risks and compliance obligations faced by medical spas operating under the purview of traditional medical provider laws and regulations.

PBM policy reform heats up in Summer/Fall 2025. Tune in as Bridgette Keller and David Gilboa unpack stalled federal bills, state-level regulations, and key litigation in this episode of Health Law Diagnosed.