Health Care

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.

As we’ve covered again and again over the past five years, providers are once more facing the prospect of a telehealth “cliff” if Congress does not take action to extend the Medicare flexibilities for telehealth services that have been in place since March of 2020.  While news is focused on the pending government shutdown, providers and Medicare beneficiaries who have come to rely on the COVID-era waivers and other flexibilities that greatly increased the availability of telehealth are facing the prospect of significantly reduced access to virtual care as of October 1, 2025.  Here is a quick review of what telehealth providers and their patients stand to lose if Congress does not act to extend coverage: 

Over the 2025 summer, the Department of Health and Human Services’ Office of Inspector General (OIG) issued four advisory opinions—two favorable and two unfavorable—that provide valuable guidance for medical device companies and pharmaceutical manufacturers navigating the federal Anti-Kickback Statute (AKS). These opinions address warranty reimbursements, vendor access fees, physician ownership, and exclusion screening costs. Below is a summary of each.

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

President Trump issues executive orders and letters to curb drug costs, promote MFN pricing, and reform Medicare’s Negotiation Program.

While the pharmaceutical industry has reacted negatively to President Trump’s May 12 “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order), manufacturers appear to be leveraging one of Trump’s directives in the Executive Order, accelerating the industry’s shift toward a new model of drug delivery: direct-to-consumer (DTC) programs.

PhRMA’s 2025 agenda pushes back on drug pricing reforms, calling for innovation-friendly policies, 340B reform, and PBM accountability.