Healthcare Law Blog

Shaping the World of Healthcare Law

The Centers for Medicare & Medicare Services’ (“CMS”) Innovation Center will begin accepting applications on January 12 for the recently announced Advancing Chronic Care with Effective, Scalable Solutions (“ACCESS”) Model—a nationwide voluntary alternative payment model for Medicare Part B commencing July 5, 2026 that will run for 10 years and focus on chronic conditions affecting over two-thirds of Medicare beneficiaries such as diabetes, high blood pressure, and depression.[1]­ Health care organizations, such as physician groups, must be enrolled in Medicare Part B to be eligible to participate as an ACCESS “Participant” and must take responsibility for delivering integrated,
Continue Reading Application Window Opens Soon for CMS ACCESS Model Expanding Technology-Supported Care Options for Traditional Medicare

The Centers for Disease Control and Prevention (“CDC”) Advisory Committee on Immunization Practices (“ACIP”) develops recommendations for how vaccinations are used to control disease in the United States. Earlier this month, the ACIP voted 8-3 to narrow the CDC’s guidance on newborn hepatitis B vaccination administration. Hepatitis B is an infection that causes inflammation in the liver. When chronic, the infection can lead to liver cancer, liver failure, or cirrhosis, which is the serious scarring of the liver. The ACIP’s vote is being closely scrutinized and the decision will likely lead to changes in clinical practice.
Continue Reading Navigating Clinical Practice with the CDC Advisory Committee on Immunization Practices’ Updated Hepatitis B Recommendation for Newborns

Earlier this month, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that it opened a new investigation into a state health department’s behavioral-health licensing practices. The investigation will examine whether the state’s licensing standards, interpretations, or enforcement activities for behavioral-health facilities and licensed professionals comply with federal conscience and equal-treatment laws.
Continue Reading HHS OCR Investigates State Licensing: Enforcement Focus on Federal Conscience and Religious-Liberty Protections

Providers and suppliers participating in the Medicare program should take note of new requirements and compliance considerations related to Medicare enrollment, information updates, changes of ownership, and increased risk for revocation, set to take effect on January 1, 2026. The most consequential changes are found in the CY 2026 Home Health Agency Prospective Payment System (HH PPS) final rule (“Final Rule”), which was published on December 2, 2025.[1] In this Final Rule, Centers for Medicare & Medicaid Services (“CMS”) finalized substantial expansions to its authority to retroactively revoke enrollment for all types of Medicare providers and suppliers, including hospitals,
Continue Reading Medicare’s New Enrollment, Reporting and Oversight Landscape: What Providers and Suppliers Need to Know for 2026

The rapid advancement of artificial intelligence (“AI”) has spurred remarkable innovation for the healthcare industry, while also resulting in swiftly emerging regulatory frameworks. On October 13, 2025, Governor Gavin Newsom signed into law California Senate Bill 243 (“SB 243”) – the first law in the nation to address the “human interface” of AI chatbots, especially those used by minors, by establishing strict requirements around transparency, safety, and behavioral integrity. Healthcare providers, technology companies, and digital platform operators must now anticipate and prepare for a regulatory landscape that establishes meaningful obligations around AI’s emotional and psychological impact on users. SB 243
Continue Reading California SB 243: Setting New Standards for Regulating and Ensuring Integrity of AI Companion Chatbots

The Centers for Medicare & Medicaid Services (“CMS”) final rule for Medicare payment for services provided in hospital outpatient departments (paid under the Outpatient Prospective Payment System or “OPPS”) and ambulatory surgery centers (“ASCs”) during calendar year (“CY”) 2026 (the “Final Rule”) largely adopts CMS’ proposed changes to advance President Trump’s policy directives to:
Continue Reading CMS Finalizes Medicare Payment Policies for Hospital Outpatient and Ambulatory Surgery Center Services

The Centers for Medicare and Medicaid Services (“CMS”) recently announced the first six participating states in the Wasteful and Inappropriate Service Reduction (“WISeR”) Model that will begin on January 1, 2026: Arizona, New Jersey, Ohio, Oklahoma, Texas, and Washington.[1] As its hallmark objective, the Model aims to refine prior authorization processes for traditional fee-for-service Medicare through the use of enhanced technologies, such as artificial intelligence (“AI”), to reduce the performance of, and payment for, services that are deemed to be “low value.” Model participants will receive a percentage of the savings associated with avoided “wasteful, inappropriate care” as a
Continue Reading New WISeR Model Aims to Leverage AI Technology to Reduce Costs and Inefficiencies

The California Department of Health Care Services (“DHCS”) announced via a Policy Letter that the state has paused the application process for Program of All-Inclusive Care for the Elderly (“PACE”) organizations for a minimum of two years.[1] Beginning November 20, DHCS will not accept applications to establish new PACE organizations or accept service-area expansion requests from existing programs. The letter makes clear that the pause is tied to DHCS’s oversight responsibilities under the Welfare & Institutions Code and reflects the agency’s need to manage growth and maintain the integrity of the program.[2]
Continue Reading California Issues Two-Year Freeze on PACE Applications: What Providers Need to Know

On November 25, 2025, CMS released the Contract Year (“CY”) 2027 Medicare Advantage (“MA”) and Part D proposed rule (the “Proposed Rule”). The Proposed Rule would make significant changes to the MA and Part D programs, including revising measures under the Star Ratings program, creating a new special enrollment period for enrollees impacted by a provider termination, expanding access to risk adjustment data, relaxing requirements for marketing and communications materials, shortening certain record retention requirements, and easing certain requirements for offering dual eligible special needs plans (“D-SNPs”). In addition, as previewed in the CY2026 final rule and CMS memoranda
Continue Reading Happy Holidays? CMS Contract Year 2027 Medicare Advantage and Part D Proposed Rule Has Winners and Losers

In early August, Illinois enacted the Wellness and Oversight for Psychological Resources Act (HB 1806, or the “Act”), making it the first state to pass a law regulating the use of AI[1] in the delivery of therapy and psychotherapy services. The Act, which took immediate effect, imposes guardrails on the use of AI to provide decision-making therapeutic support services, but permits the use of AI for administrative and supplementary tasks, subject to certain consent requirements. This blog post summarizes the Act and addresses its potential implications for the use of agentic AI by Illinois therapy providers.
Continue Reading Illinois Becomes the First State to Regulate the Use of AI Mental Health Therapy Services

The Centers for Medicare & Medicaid Services (“CMS”) recently finalized a rule establishing the new Ambulatory Specialty Model (“ASM”)— a mandatory value-based payment model that could apply to nearly one-quarter of all physicians in select specialties starting January 1, 2027. The ASM applies to physicians providing services to address two high-expenditure chronic conditions among Medicare patients: heart failure (cardiology) and low-back pain (pain management, interventional pain, neurosurgery, orthopedic surgery, and physical medicine and rehabilitation). Participation will be mandatory for eligible clinicians practicing in geographic areas selected by CMS that will likely encompass approximately one-quarter of U.S. Core-Based Statistical Areas (“CBSAs”) or
Continue Reading CMS Finalizes Mandatory Ambulatory Specialty Model for Cardiology and Low-Back Pain

Persistent workforce shortages continue to define the post-pandemic healthcare landscape. Hospitals, health systems, and long-term care providers report enduring deficits in nursing, primary care, and behavioral health staffing, with projections indicating that these shortfalls are likely to persist through the next decade.[1]
Continue Reading Navigating Healthcare Workforce Shortages: Evolving Scope-of-Practice and Staffing Regulations

California continues to lead the nation in artificial intelligence (“AI”) regulation with the recent enactment of Senate Bill (“SB”) 53—the Transparency in Frontier Artificial Intelligence Act (“TFAIA” or the “Act”)[1]. Signed by Governor Gavin Newsom earlier this fall, the TFAIA takes effect January 1, 2026, and establishes significant oversight, accountability, and reporting requirements for advanced developers at the cutting edge of artificial intelligence. This law sets a framework for transparency and public safety, and is expected to set a nationwide precedent for future AI legislation to come.
Continue Reading California Enacts SB 53: A Defining Step in Responsible AI Governance for Frontier AI Developers

For years, the conversation around health insurer consolidation and vertical integration has simmered through antitrust inquiries, oversight hearings, and policy papers. The Patients Over Profit Act (the “POP Act”)[i], introduced in both chambers of Congress this fall, marks a decisive shift. Rather than regulating insurer-provider integration, the POP Act proposes to ban it outright.
Continue Reading Patients Over Profit Act: A Federal Inflection Point on Insurer-Provider Integration and What Comes Next

Leaders from across Sheppard Mullin’s national healthcare team gathered in Dana Point, California, for a day-long strategy session led by Co-Leaders, Eric Klein and Amanda Zablocki, to discuss the most impactful trends shaping the future of healthcare and how to best support our clients.
Continue Reading A Look Ahead: Major Industry Trends Our Healthcare Team is Tracking