Photo of Michael Sutton

Michael Sutton is an associate in the Corporate Practice Group in the firm's Dallas office.

Emerging technologies are prompting a revolution in women’s healthcare through advanced diagnostic testing. In the sixth episode of Sheppard Mullin’s Health-e Law Podcast, Deirdre O’Neill, Chief Commercial & Legal Officer at Hertility Health, shed light on trends in women’s healthcare and technology with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading FemTech Meets DiagnosTech: A Discussion with Deirdre O’Neill

In the rapidly evolving landscape of digital health, gamification has emerged as a powerful tool to enhance patient engagement and improve health outcomes. In the fifth episode of Sheppard Mullin’s Health-e Law Podcast, Craig Lund, co-founder and CEO of Mightier, shed light on this innovative technology with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Gamification – Playing for Health: A Discussion with Craig Lund

On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2 (Part 2).Continue Reading HHS Announces 42 Part 2 Final Rule to Align with HIPAA

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) concerning pharmaceutical manufacturers’ offers of cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries. The opinion under review was Advisory Opinion No. 22-19,[1] which we previously wrote about[2] and in which the OIG advised that if pharmaceutical manufacturers offered the proposed cost-sharing subsidies to Part D beneficiaries via PCPA, they could be subject to liability under the Federal health care program Anti-Kickback Statute (the “AKS”), even though the proposed subsidies would not violate the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition (“BIP”).Continue Reading District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The 21st-century healthcare landscape has been dramatically shaped by the rise of digitized healthcare solutions aimed at making healthcare more accessible, affordable, and personalized. In the third episode of Sheppard Mullin’s Health-e Law Podcast, Viveka Rydell-Anderson, the CEO of Pacific Vision Foundation, delved into the increasing relevance of digital health technology, particularly in the area of specialized care, with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Digital Health to the Rescue – Improving Access to Specialized Care: A Discussion with Viveka Rydell-Anderson

Recent developments in Artificial Intelligence (AI) have been transforming several sectors, and the healthcare industry is no exception. In the second episode of Sheppard Mullin’s Health-e Law Podcast, Jim Gatto, a partner at Sheppard Mullin and the co-leader of its AI Team, explores the significant implications and challenges of incorporating AI into the healthcare industry with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading AI as an Aid – Emerging Uses in Healthcare: A Discussion with Jim Gatto

In the inaugural episode of Sheppard Mullin’s Health-e Law podcast, renowned expert Dr. Laura Tully, Vice President of Clinical Services at ChatOwl, discussed emerging issues for health-tech’s data collection and use activities with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading In Tech We Trust? The Case for Transparency: A Discussion with Dr. Laura Tully

Sheppard Mullin’s Healthcare Team has launched “Health-e Law”, a new podcast dedicated to the interaction between technology and health. Each episode will cover innovations that impact health care in bite-sized, 15-minute episodes, that will keep listeners updated on the fascinating health-tech topics and trends of the day. Our Digital Health Team, alongside experts and thought leaders, will share how innovations can solve some of health care’s (and maybe the world’s) biggest problems, if properly navigated. Health-e Law is hosted by partners Sara Shanti and Phil Kim and associate Michael Sutton.Continue Reading Health-e Law Launches: New Podcast Covers Health-Tech and Law

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

The expanded use of artificial intelligence (AI) in the delivery of health care continues to receive increased attention from lawmakers across the country. Although AI regulation is still in its early developmental stages, there are various efforts underway to address the unintended negative consequences stirred by AI technology, particularly in health care and other key sectors.[1] Of particular interest are regulatory efforts to restrict discrimination through AI and related technologies.Continue Reading At a Glance: Legal Efforts to Limit Discrimination Through AI