On December 29, 2025, the Centers for Medicare & Medicaid Services (“CMS”) announced that it will distribute award amounts to all 50 states under the first year of the Rural Health Transformation Program (the “Program”).[i] CMS also established a new Office of Rural Health Transformation (“ORHT”) within the Center for Medicaid that will be responsible for overseeing the program and leading CMS’ engagement with state and local governments and other stakeholders.[ii] The Program is a first of its kind $50 billion initiative to improve and strengthen healthcare in rural communities nationwide via collaboration between CMS and all 50 states to realize their transformative visions for rural health.Continue Reading CMS Announces $50 Billion Rural Health Transformation Program: What Providers and States Need to Know

Due to surging interest in cosmetic and wellness treatments, the Medical Spa (“MedSpa”) industry is experiencing rapid and dynamic growth. This growth presents exciting opportunities, but interested parties must exercise caution as they navigate the industry’s complex legal and regulatory landscape. Unlike traditional day spas that focus on relaxation and personal care, MedSpas offer medical-grade treatments – like injectables, laser hair removal, and body contouring – that are often regulated as the “practice of medicine.” This means MedSpas must be structured, staffed, and operated in compliance within the relevant healthcare regulatory framework.Continue Reading Launching A MedSpa Practice? Here are Five Key Legal Considerations

Earlier this week, the District of Massachusetts held a hearing on defendants’ motion to dismiss in United States ex rel. Shea v. eHealth, Inc., et al. (No. 21-cv-11777-DJC), a notable False Claims Act (FCA) case examining the intersection of Medicare Advantage marketing, broker compensation, and FCA and Anti-Kickback Statute (AKS) compliance.Continue Reading Federal Court Hears Arguments on Motion to Dismiss in Medicare Advantage Whistleblower Lawsuit

On December 31, 2025, the Drug Enforcement Administration (“DEA”) and the Department of Health and Human Services (“HHS”) jointly issued a Fourth Temporary Rule again extending the telemedicine flexibilities of the Ryan Haight Act (the “RHA”), now through December 31, 2026.Continue Reading 2026 Extension of Telemedicine Prescribing Flexibilities: Impacts on Patients and Providers

The ABA’s 2026 False Claims Act Mock Trial Institute, held in New Orleans this year and sold out, once again offered a bevy of lessons, information, and insight. As always, the FCA Mock Trial Institute provided a valuable opportunity for members of the government, relator, and defense bars to network and talk cheerfully outside the occasionally adverse litigation atmosphere. Sheppard Mullin was again well represented among faculty and attendees by five attorneys from its experienced FCA team and hosted a well attended Thursday evening reception at Compare Lapin.Continue Reading Notes From The ABA’s 2026 False Claims Act Mock Trial Institute

I have to admit to an instinctive gut reaction of skepticism when Kimberly Powell of NVIDIA on Monday said that “AI is a once-in-a-lifetime shift for the healthcare industry.” Intellectually, I am excited by AI and its possibilities, but I well know healthcare’s slow and steady approach and rigid workflows can chew up technology gains and the harsh realities that present when technology meets a highly regulated industry. Continue Reading Day 3 Notes from the 44th Annual J.P. Morgan Healthcare Conference

The One Big Beautiful Bill Act (OBBBA), enacted in July 2025, is no longer a policy debate or a future concern. It is already changing how coverage works, how Medicaid dollars flow, and how much operational friction health systems will face over the next several years.Continue Reading The OBBBA Is Here: What Health System Leaders Should Be Focused on Now

At the 44th Annual J.P. Morgan Healthcare Conference, Jamie Dimon (CEO of J.P. Morgan) told the audience that we should be teaching healthcare in school from kindergarten to 12th grade. He was right…but we don’t. And, therefore, artificial intelligence will come to dominate the U.S. healthcare system, which spent over $5.6 trillion in 2025. Wait, you might say, how did you jump from kindergarten straight to artificial intelligence (AI)? What’s the connection between healthcare education, rising healthcare costs which put financial pressures on American citizens and employers, and economic transformation? Continue Reading Notes from Day 1 of the 44th Annual J.P. Morgan Healthcare Conference

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, coordinated services—in person, virtually, asynchronously, or through other technology-enabled modalities—to Medicare patients to manage those patients’ chronic conditions for a twelve-month period. Participants must designate a Medicare-enrolled Medical Director to oversee care quality and compliance. The Model will initially encompass four non-mutually-exclusive clinical tracks corresponding to common chronic conditions[2]: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