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. Gamification as a Bridge to Better Health Gamification in healthcare transcends traditional treatment methods by incorporating elements of play and entertainment into therapeutic practices. Craig Lund, with his rich ..read more

This is the second post in a two-part series on PrivacyCon’s key-takeaways for healthcare organizations. The first post focused on healthcare privacy issues.[1] This post focuses on insights and considerations relating to the use of Artificial Intelligence (“AI”) in healthcare. In the AI segment of the event, the Federal Trade Commission (“FTC”) covered: (1) privacy themes; (2) considerations for Large Language Models (“LLMs”); and (3) AI functionality. AI Privacy Themes The first presentation within the segment highlighted a study involving more than 10,000 participants and gau ..read more

Parties involved in or considering health care transactions in California have been focused on navigating the new rules set by California’s Office of Health Care Affordability (OHCA),[1] and newly proposed legislation could present additional challenges in consummating certain health care transactions, particularly those involving private equity. Introduced in February 2024, California’s Assembly Bill 3129 seeks to curb consolidation in the health care industry allegedly driven by private equity firms and hedge funds. As summarized in greater detail below, the bill would require that these par ..read more

Most Medicare Advantage (“MA”) beneficiaries rely on agents and brokers to help them navigate the complex process of selecting a health plan that will meet their needs. In exchange, brokers and agents received certain fixed payments set by Medicare, as well as, in some cases, significant additional payments from health plans. Concerned over the potential for abuse, these arrangements have been the subject of Congressional scrutiny and an enforcement priority for both the Department of Justice (“DOJ”) and the Department of Health and Human Services Office of the Inspector General (“HHS OIG ..read more

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 acce ..read more

On April 1st, the Centers for Medicare & Medicaid Services (“CMS”) announced its Medicare Advantage (“MA”) Capitation Rates and Part C and Part D Payment Policies for Calendar Year (“CY”) 2025. This announcement builds on the Advanced Notice of Methodological Changes for CY 2025 for MA Capitation Rates and Part C and Part D Payment Policies (“Advanced Notice”) that CMS released on January 31, 2024.  In the Advanced Notice, CMS (i) provided notification of the changes it planned to make in the MA capitation rate methodology and risk adjustment methodology applied under Part C of t ..read more

Last month, the Federal Trade Commission (“FTC”) hosted its annual PrivacyCon event, featuring an array of experts discussing the latest in privacy and data security research. This post, covering healthcare privacy issues, is the first in a two-part series on PrivacyCon’s key takeaways for healthcare organizations. The second post will cover topics on artificial intelligence in healthcare. In the healthcare privacy segment of the event, the FTC shined a spotlight on three privacy research projects that focused on: (1) tracking technology use by healthcare providers;[1] (2) women’s privacy conc ..read more

On March 28, 2024, the Biden-Harris Administration released final rules intended to lower health care costs and protect consumers from being induced into purchasing so-called “junk insurance” policies (the “Final Rules”).[1] According to the press release, the Final Rules are intended to close loopholes that have permitted “junk insurance” issuers to mislead consumers into buying highly restricted and discriminatory plans that provide inadequate coverage when consumers need it the most. The Final Rules primarily realign federal definitions with intended scopes of coverage and increase transpar ..read more

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug and biosimilar competition. In the case, Teva asserts that Amneal’s Abbreviated New Drug Application (“ANDA”) for an asthma inhaler infringes upon five patents it has listed in the FDA’s Orange Book–a challenge that under FDA regulations triggers a 30-month stay of FDA’s approval of the generic inhaler. Amneal’s counterclaims assert that the Teva patents, which relate ..read more

On March 28, 2024, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced that it is extending the temporary special enrollment period (the Unwinding SEP) for prior beneficiaries of Medicaid and Medicaid-expansion Children’s Health Insurance Programs (CHIP) to enroll in the Health Insurance Marketplace (Marketplace). The Unwinding SEP was previously scheduled to terminate on July 31, 2024, but now the end date is extended to November 30, 2024. This 4-month extension will help millions maintain insurance coverage as they ..read more