Health Care

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.

In our July 11, 2025 blog post, we flagged the Department of Justice’s sweeping subpoenas targeting providers of gender-affirming care for minors as legally aggressive, politically charged, and likely to face serious judicial scrutiny. That prediction has now been borne out.

Federal courts in Massachusetts and Washington have quashed DOJ subpoenas issued to Boston Children’s Hospital and QueerDoc, respectively, finding that the government failed to demonstrate a proper investigative purpose and appeared motivated by political aims rather than legitimate enforcement concerns.

On October 11, 2025, California Governor Gavin Newsom signed Senate Bill 41 (SB-41) into law, introducing a comprehensive set of new regulations for pharmacy benefit managers (PBMs) operating in the state. As part of the broader California Prescription Drug Affordability legislative package, SB-41 reflects the state’s effort to combat high drug costs, standardize PBM pricing practices, enhance transparency, and address concerns around access to pharmacies. Among other things, SB-41 imposes fiduciary obligations on PBMs, establishes fee structure requirements and limitations, prohibits the use of spread pricing and steering to PBM-affiliated pharmacies, and requires 100% passthrough of rebates from PBMs and their affiliates and contracted rebate group purchasing organizations (GPOs) to health plan customers.

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

California legislative activity focused upon private equity (PE) group and hedge fund health care transactions has continued notwithstanding California Governor Gavin Newsom’s veto last fall of California Assembly Bill 3129 (AB-3129). As we discussed in previous posts here and here, AB-3129 would have authorized the California Attorney General (AG) to review certain PE group and hedge fund health care transactions, but Governor Newsom vetoed the bill based on his view that the California Office of Health Care Affordability (OHCA) rather than the AG should be assessing proposed health care transactions and their cost and market impacts.

The first week of October 2025 marked a significant shift in U.S. drug pricing policy as the Trump administration unveiled a series of sweeping actions to deliver on his promise to lower drug prices. From President Trump’s announcement of a 100% tariff on imported branded drugs to the Trump administration’s landmark pricing deal with Pfizer and the rollout of the TrumpRx.gov direct-to-consumer (DTC) platform, last week marked an escalation in the White House’s efforts to drive down prescription drug costs and bring pharmaceutical manufacturing back to U.S. soil. Below, we provide an overview of the Trump administration’s new policies and the stakeholder responses already reshaping the broader pharmaceutical landscape.

On September 30th, 2025, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with Cadia Healthcare Facilities for potential violations of the HIPAA Privacy and Breach Notification Rules. Cadia Healthcare Facilities (Cadia) is a group of five providers that specialize in rehabilitation, skilled nursing, and long-term care services in Delaware. This settlement follows an OCR investigation of Cadia in which Cadia posted a “success story” of a patient to its public website without first receiving a valid HIPAA authorization from the patient. The success story post included PHI such as the patient’s name, their photograph, and information regarding their condition, treatment, and recovery. OCR’s investigation further revealed that, through their “success story” program, Cadia compromised the PHI of 150 total patients.