Yesterday, the OIG released a Special Fraud Alert related to: (1) marketing arrangements between Medicare Advantage Organizations (“MAOs”) and health care professionals (“HCPs”), and (2) arrangements between HCPs and MA plan agents and brokers. In the Alert, OIG states that these types of arrangements may implicate the Federal anti-kickback statute (the “AKS”) and could result in unfair competition and improper steering of Medicare beneficiaries. Despite flagging these concerns, the Alert fails to offer specific, practical guidance on the types of arrangements that would or would not violate the law, and therefore does little to alleviate industry-wide confusion as to how to compliantly engage in beneficiary outreach and support.Continue Reading Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

An Indiana appellate court recently declined to enforce an executive’s non-compete on the grounds that the covenant’s activity restriction was overbroad.Continue Reading Indiana Appellate Court Rules Medical Company’s Non-Compete with Chief Operating Officer Overbroad and Unenforceable 

Where Physician Burnout and Value-Based Care Intersect

This series explores legal issues related to physician burnout and potential solutions, and here we explore the potential impact of value-based care (“VBC”). Our first post addressed how healthcare organizations can foster the psychological safety and emotional well-being of their physicians. Our second post discussed artificial intelligence solutions as a potential way to attract, support and retain overwhelmed clinicians. Here, we explore how VBC can promote physician satisfaction and physician wellness by:Continue Reading Healing the Healers: Using Value-Based Care Strategies to Mitigate Physician Burnout

In less than two months, Donald Trump will be sworn in as the 47th President of the United States. President-elect Trump has already announced that he will nominate Republican Congresswoman Lori Chavez-DeRemer as his pick to serve as the next Secretary of the Department of Labor (“DOL”). It remains to be seen if the Trump DOL will continue the current administration’s targeting of the healthcare industry.Continue Reading Will the Trump Labor Department Continue the Current Sharp Focus on the Healthcare Industry?

On September 28, 2024, Governor Gavin Newsom signed into law California Assembly Bill 3030 (“AB 3030”), known as the Artificial Intelligence in Health Care Services Bill. Effective January 1, 2025, AB 3030 is part of a broader effort to mitigate the potential harms of generative artificial intelligence (“GenAI”) in California and introduces new requirements for healthcare providers using the technology.Continue Reading California Passes Law Regulating Generative AI Use in Healthcare

California is poised to pass a ballot measure aimed at imposing 340B spending restrictions for certain healthcare entities participating in the 340B Program who have historically engaged in spending that is not directly related to patient care and have also owned or operated multifamily dwellings with significant safety issues.Continue Reading California Votes to Impose 340B Spending Restrictions on Targeted 340B Providers

California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health care provider oversight when payors use AI to assess the medical necessity of requested medical services, and by extension, coverage for such medical services.Continue Reading California Limits Health Plan Use of AI in Utilization Management

On October 28, 2024, the Centers for Medicare & Medicaid Services (“CMS”) announced the latest states to participate in the voluntary state total cost of care (“TCOC”) model: the All-Payer Health Equity Approaches and Development (“AHEAD”) Model. The initiative aims to curb healthcare costs and improve population health by allowing states to assume responsibility for their own healthcare systems. Specifically, the program holds states accountable for meeting state-specific Medicare targets, reducing cost growth, primary care investment, and advancing health equity principles. As of August 2024, Maryland, Vermont, Connecticut, Hawai’i, Rhode Island, and five downstate counties of New York have been selected to implement AHEAD.  Continue Reading CMS Continues to Plan AHEAD Amid Rising Healthcare Costs

The Centers for Medicare & Medicaid Services (“CMS”) and its contractor, Wisconsin Physicians Service Insurance Corporation (“WPS”), recently notified over 940,000 Medicare beneficiaries of a data breach that has potentially exposed their protected health information (“PHI”) and personally identifiable information (“PII”). CMS reported on the breach portal of the U.S. Department of Health and Human Services (“HHS”) that the total number of impacted people was 3,112,815 individuals.Continue Reading Over 940,000 Medicare Beneficiaries Impacted by Data Breach

The wait is over!

On October 10th, the Federal Trade Commission (FTC) unanimously approved the first significant revisions to the Hart-Scott-Rodino (HSR) Act premerger notification regime since its inception over 40 years ago.[1] The Antitrust Division of the U.S. Department of Justice (“DOJ”) also endorsed the new rules (“Final Rule”).[2] The Final Rule will not only substantially increase the complexity of filings and the time required to prepare them, but also the burden and costs borne by reporting parties. Unless enjoined by a federal court, these rules will likely go into effect mid-January 2025 (90 days after publication in the Federal Register). The FTC will publish compliance guidance in advance of the Final Rule’s effective date.Continue Reading The FTC Adopts New Premerger Notification Rules Implementing the Hart-Scott-Rodino (HSR) Act

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