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, and examples of strategic initiatives that align with the goals of the RHTP.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 inexorable expansion of the False Claims Act (“FCA”) to cover virtually all types of cybersecurity breaches and violations – to include allegedly poor practices and failure to fully adhere to security controls – continues. At one time, an organization might have thought that it was unlikely to face a potential FCA investigation and litigation relating to its cybersecurity practices. That day is long past. Two recent FCA settlements illustrate the expansion: one is the first cybersecurity FCA settlement relating to healthcare Quality System Regulations (“QSR”) and the other involves the first settlement with a defense contractor that also pulls in its private equity owner.Continue Reading The Expanding Scope of FCA-Cybersecurity Liability
State oversight of healthcare transactions is continuing to undergo a significant transformation. As tracked in our updated Healthcare Merger Matrix, the number of states implementing or considering expanding antitrust laws targeting proposed deals continues to rise.[1] For instance, Washington and Colorado’s premerger notification laws went into effect on July 27 and August 6, 2025, respectively, and Indiana recently modified its existing transaction notice law to exempt certain practitioner-owned practices.[2] Additionally, New Mexico enacted a permanent version of its temporary transaction notification law with enhanced oversight and enforcement.[3]Continue Reading State Antitrust Enforcement Roundup: Updates to Healthcare Merger Matrix; New Potential Legislation Targeting Private Equity and Other For-Profit Entities in Healthcare
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
The White House announced it is launching a health data tracking system early next year that involves an unprecedented partnership between the federal government, providers, payors, and private sector technology companies. The stated objective is to enable patients to more easily access and share their personal health data and medical records across different platforms, including through apps operated by private technology companies (the “Tracking System”). While the initiative may ultimately aspire to improve patient care through expanded data sharing, it raises notable legal and privacy concerns.Continue Reading White House Announces National Health Data Tracking System of Personal Health Data