Over two years into the post-Dobbs era, women’s health is taking center stage in the presidential election. In Dobbs v. Jackson, the Supreme Court overturned protections relating to abortion established in Roe v. Wade. Since then, approximately half of the states across the country have enacted or revived laws that ban or significantly restrict access to abortion. This case and the resulting cascade of legal disputes and legislative battles have created a highly dynamic and precarious legal landscape for women’s health. As a result, providers are left uncertain of their rights and obligations. Women in anti-abortion states face challenges obtaining reproductive care and, if pregnant, other medical treatments unrelated to reproductive care, while hospitals and clinics in nearby states without such restrictions are grappling with overwhelming patient loads. Continue Reading Women’s Health on the Ballot in November: What the Election Could Mean for Reproductive Care and Beyond

A federal district court in the Middle District of Florida issued a decision on Sept. 30th that threatens the federal government’s continued reliance on the False Claims Act (“FCA”) as the most powerful weapon in the Department of Justice’s enforcement arsenal. U.S. District Judge Kathryn Kimball Mizelle threw out a case against a group of Medicare Advantage organizations and providers on the grounds that an individual whistleblower suing on behalf of the federal government under the FCA, often called a “relator” in a “qui tam” lawsuit, violates the U.S. Constitution’s “appointments clause.” The Court concluded that relators, who are acting on behalf of the federal government, must be considered officers of the government and appointed in a manner consistent with Constitutional requirements. See U.S. ex rel Zafirov v. Florida Medical Associates, LLC, No. 8:19-cv-1236, 2024 U.S. Dist. LEXIS 176626, ECF No. 346 (M.D. Fl. Sept. 30, 2024).Continue Reading FCA Whistleblowers – No More?

On September 28, 2024, Governor Newsom vetoed Assembly Bill No. 3129 (AB 3129), which would have required private equity groups and hedge funds to obtain the Attorney General’s written consent at least 90 days prior to acquisitions or changes of control of certain health care facilities, provider groups, and other providers. More information on the background, evolution, and projected impact of AB 3129 is available at our AB 3129 blog series.[1]Continue Reading Update: Governor Newsom Vetoes California’s AB 3129 Targeting Healthcare Private Equity Deals

Ethical hackers are becoming crucial allies in the battle against healthcare data breaches and ransomware attacks. In the twelfth episode of Sheppard Mullin’s Health-e Law Podcast, Ilona Cohen, Chief Legal Officer and Chief Policy Officer of HackerOne, delved into the pressing issue of cybersecurity in the healthcare sector and the pivotal role that ethical hacking may play, with Sheppard Mullin’s Phil Kim, Sara Shanti, and Michael Sutton.Continue Reading Healthcare Needs More Hackers: A Discussion with Ilona Cohen

CMS recently published the First Annual Evaluation Report (the “Report”) highlighting its most significant observations in the first year following implementation of the Kidney Care Choices Model (the “KCC Model”). By way of background, the KCC Model is a payment model which creates certain incentives for providers that are intended to improve care management for Medicare patients with chronic kidney disease (“CKD”) (Stage 4 or 5) or end-stage renal disease (“ESRD”). The KCC Model is intended to, among other things, delay the dialysis progression and increase use of home dialysis, while also aiming to reduce the cost of care and improve quality of outcomes.Continue Reading CMS Releases First Annual Evaluation Report for Kidney Care Choices Model

This series explores legal issues related to physician burnout and potential solutions. Our first post addressed how healthcare organizations can foster the psychological safety and emotional wellbeing of their physicians. Clients regularly report that charting and documenting, and communicating with patients via EMR is a substantial contributor to physician burnout. Here, we discuss artificial intelligence as a potential way to attract, support and retain clinicians overwhelmed by ever-growing to-do lists, allowing them to focus on delivering clinical care.Continue Reading Solving for Physician Burnout: How Organizations Can Deploy AI Solutions to Effectively Support Physician Workloads and Avoid Legal Pitfalls

On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable by Medicare. Although the majority of telehealth waivers enacted during the COVID-19 public health emergency (the “PHE”) are set to expire at the end of 2024 in the absence of legislative action, CMS has proposed to leave certain key flexibilities in place, including the allowance for physicians and other practitioners to furnish remote “direct supervision” through their immediate availability via audio-video technology.Continue Reading Key Telehealth Updates in the CY 2025 Physician Fee Schedule Proposed Rule

The U.S. has long had a shortage of physicians in various practice areas. The shortage is even more pronounced in rural areas. International medical graduates (IMG’s) who come to the U.S. to complete a residency in a specialty area primarily come to the U.S. on J-1 visas. By statute, any physician who enters the U.S. on a J-1 must return home for 2 years before applying for H-1B status or permanent residency.Continue Reading Having Trouble Recruiting Physicians? The Conrad 30 Window is Opening Soon

In an era where artificial intelligence (AI) is reshaping landscapes in the healthcare industry and beyond, understanding the governance of AI technologies is paramount for organizations seeking to utilize AI systems and tools. AI governance encompasses the policies, practices, and frameworks that guide the responsible development, deployment, and operation of AI systems and tools within an organization. By adhering to established governance principles and frameworks, organizations can ensure their AI initiatives align with ethical standards and applicable law, respect human rights, and contribute positively to society. Various international organizations have set forth AI governance principles that provide organizations with a solid foundation to develop organizational AI governance based on widely shared values and goals.Continue Reading Navigating the Complex Landscape of AI Governance: Principles and Frameworks for Responsible Innovation

Leading up to the U.S. presidential election this November, our Antitrust & Competition team will offer thoughts and insights into what antitrust enforcement will look like under the next presidential administration. While there is at least some uncertainty regarding antitrust enforcement under either a Harris or Trump administration, there is no doubt that the current Biden administration has been extraordinarily active.Continue Reading Election 2024 Coverage: Examining the Future of Healthcare and Antitrust