Federal enforcement of the False Claims Act (FCA) against healthcare and pharmaceutical companies—especially based on alleged Anti-Kickback Statute (AKS) violations—continues to change, with the Regeneron Pharmaceuticals case at the forefront of recent developments. Recall that in Regeneron, the government alleges that the pharmaceutical company is illegally subsidizing copayments for Medicare beneficiaries by making large donations to third party foundations offering copay assistance to strategically steer patients to its high-cost specialty drug, Eylea, instead of lower-cost alternatives, resulting in alleged FCA liability based on an AKS violation. After the First Circuit held that a FCA plaintiff in an AKS-based FCA case must…
Continue Reading Regeneron, the False Claims Act, and a New Era in Government Enforcement

On October 8, 2025, Governor Newsom signed the California Opt Me Out Act (the “Act”) into law, which expands on the California Consumer Privacy Act (“CCPA”). Most notably, the Act mandates that businesses developing or maintaining internet browsers must include functionalities enabling consumers to automatically communicate their preference to opt out of the sharing or selling of personal information. The functionalities must be readily accessible to consumers and must be “easy for a reasonable person to locate and configure,” which will spare consumers from the hardships of navigating oftentimes confusing mechanics to identify and enable opt outs.
Continue Reading Opting Out of Web Tracking Has Never Been Easier in California

Healthcare organizations of every shape and size are rapidly expanding their use of artificial intelligence solutions from high-risk applications like clinical decision-support interventions, ambient listening, and charting to lower-risk administrative activities like automated patient communications and scheduling. While adoption is widespread and increasing in depth and breadth across the industry, not every healthcare organization has established governance around AI or a monitoring process for exploration and adoption of new tools – including those contemplating a sale of assets or equity. For buyers in healthcare mergers and acquisitions today, AI diligence needs to be a focus, given the potential risk of…
Continue Reading AI Due Diligence in Healthcare Transactions

California’s physician assistant (“PA”) practice landscape is set to undergo significant transformation following the enactment of California Assembly Bill 1501 (AB 1501), which was signed into law by Governor Newsom on October 1, 2025, and will take effect on January 1, 2026. Among its key provisions, AB 1501 extends the authority of the California Department of Consumer Affairs’ Physician Assistant Board (the “Board”) through January 1, 2030, increases the physician-to-PA supervision ratio from 1:4 to 1:8 in all settings, and directs the Board to study scope-of-practice structures—with input from stakeholders—to evaluate potential models from other states that could benefit…
Continue Reading AB 1501 Becomes Law: How It Will Reshape California PA Practice

On October 11, 2025, Governor Gavin Newsom signed into law Assembly Bill 1415 (“AB 1415”), which amends the California Health Care Quality and Affordability Act (the “Act”) to require pre-transaction clearance and data reporting from private equity groups, hedge funds, and management services organizations (“MSOs”), and certain other entities involved in healthcare transactions. Effective January 1, 2026, the law represents a significant expansion of the authority of the California Office of Health Care Affordability (“OHCA”), which already has broad review power over transactions involving many different provider and payor entities.
Continue Reading Governor Newsom Signs AB 1415 Expanding OHCA Oversight to Private Equity and MSOs

On October 1st, certain key telehealth flexibilities created during the COVID-19 public health emergency (“PHE”) expired as the government shutdown began. The Centers for Medicare & Medicaid Services (“CMS”) issued a number of telehealth waivers during the PHE, some of which were extended through September 30, 2025 by the Full-Year Continuing Appropriations Act, 2025 (“CAA”). The flexibilities expired as legislative efforts to once again extend the flexibilities, including through the House Committee’s stop-gap government funding Continuing Resolution, failed to pass.
Continue Reading The Telehealth Cliff Has Arrived: What’s Changing and What to Watch

On Monday, October 6, 2026, Governor Gavin Newsom signed into law SB 351, which codifies restrictions on private equity firms and hedge funds from influencing the clinical decision-making of California physicians and dentists.
Continue Reading California Enacts SB 351: New Law Aimed at Limiting Private Equity Influence on Healthcare Businesses

On September 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published a highly anticipated Notice of Funding Opportunity (“NOFO”) announcement (the “Announcement”) to implement the Rural Health Transformation (“RHT”) Program (“RHTP”) established by the One Big Beautiful Bill Act (“OBBBA”) to allocate $50 billion over a five-year period (fiscal years 2026 to 2030) to approved states that meet applicable statutory and CMS requirements. The Announcement provides new insights to states and other stakeholders regarding how CMS will evaluate applications from states for RHTP funding, as well as detailed application instructions, eligibility standards, scoring methodology, strategic goals, policy priorities,…
Continue Reading CMS Announces Application Details for Rural Health Transformation Program

The intersection between birthright citizenship and access to healthcare has become increasingly complex following recent legal and policy developments. On January 20, 2025, President Trump issued Executive Order 14160, “Protecting the Meaning and Value of American Citizenship” (“EO 14160”), directing federal agencies to limit recognition of citizenship at birth in certain cases where the child’s parents lack permanent legal status.
Continue Reading Birthright Citizenship and Medicaid Coverage at a Constitutional Crossroads

A new chapter in the 340B Drug Pricing Program is unfolding as the Health Resources & Services Administration (“HRSA”) pursues its 340B Rebate Model Pilot Program (the “Pilot Program”)—a move signifying both innovation and the intensification of longstanding industry debate. After announcing the program in August, HRSA has since published several FAQs on the Pilot Program’s application process and operational considerations.[i] The comment period for the Pilot Program ended on September 8, 2025 and HRSA received over 1,200 comments from stakeholders.
Continue Reading HRSA’s 340B Rebate Pilot Program: Industry Debates, Congressional Response, and Program Implications

Regulators and courts are expanding enforcement against digital health apps and online platforms that share sensitive health data without true consent, though these companies fall outside the scope of the Health Insurance Portability and Accountability Act (“HIPAA”). In order to reach non-covered entities, agencies and private claimants are now drawing on a patchwork of authorities to rein in misleading or undisclosed data practices:…
Continue Reading A New Era of Privacy Enforcement: Lessons for Digital Health Players

The Executive Order

Earlier this summer, the White House confirmed that President Trump is actively reviewing policy proposals developed in response to his executive order (“EO”) aimed at expanding access to in vitro fertilization (“IVF”).[1] Signed on February 18, 2025, the EO acknowledges the importance of family formation and the high financial barriers to fertility treatments. Accordingly, the EO solicits policy proposals “protecting IVF access and aggressively reducing out-of-pocket and health plan costs for such treatments.” [2] The initial submission deadline passed in May.
Continue Reading Shifting Landscapes: How Federal and State Policies are Expanding Access to IVF

With increased consolidation of traditional medical practices and declining reimbursement rates, many physicians are turning to alternative models like concierge medicine to preserve their independence. Concierge medicine allows physicians to offer personalized, high-quality care to patients in exchange for a membership fee. This model is governed by private service agreements that outline the relationship between the patient and healthcare provider, detailing the services provided, terms of access, and financial obligations. Unlike traditional practices, concierge medicine operates with a smaller patient panel, fewer insurance constraints, and a focus on improved patient access.
Continue Reading So You Want to Start a Concierge Medicine Practice? Here are Five Key Legal Considerations