California is among a handful of states that seeks to regulate the use of artificial intelligence (“AI”) in connection with utilization review in the managed care space. SB 1120, sponsored by the California Medical Association, would require algorithms, AI and other software tools used for utilization review to comply with specified requirements. We continue to keep up to date on AI related law, policy and guidance. The Sheppard Mullin Healthcare Team has written on AI related topics this year and those articles are listed here: i) AI Related Developments, ii) FTC’s 2024 Privacy ..read more

On April 22, 2024, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-2439-F), effective July 9, 2024, aimed at advancing healthcare access, quality of care, and health equity for Medicaid and Children’s Health Insurance Program (CHIP) managed care enrollees. Managed care serves as the predominant delivery system in these programs, where healthcare services are organized through networks of providers overseen by managed care organizations (MCOs). These organizations employ strategies such as utilization rev ..read more

As we previewed last year regarding SB 184 and the establishment of the California Office of Health Care Affordability (OHCA), California now has taken a significant regulatory step aimed at restraining growth in health care costs. On April 24, 2024, OHCA’s board (the “Board”) voted to implement its long anticipated statewide health care cost target, beginning with a 3.5% cap on spending growth in 2025 and decreasing in the following years. As with OHCA’s cost and market impact review (CMIR) reporting regime,[1] this cap will apply to “health care entities,” which include providers such as hos ..read more

On April 23, 2024, the Federal Trade Commission (“FTC”) issued its Final Rule banning employers from imposing post-employment noncompete requirements on their workers (the “Final Rule”). The FTC has indicated that it will continue to prioritize enforcement in the healthcare industry, with objectives seeming to include alleviating physician shortages and improving access to healthcare. What the Final Rule means for healthcare organizations generally, and for nonprofits in particular, is not entirely clear and is likely to be challenged.  Focus on Healthcare The FTC received ..read more

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. Future of Reproductive Health O’Neill shared insight into the opportunities and challenges ahead for reproductive health, highlighting at the outset that neither women’s health nor reproductive health should be a ta ..read more

Effective October 20, 2024, New York hospitals must have in place State-mandated changes to their financial assistance (“FA”) programs (including FA eligibility criteria and debt collection practices) and their practices related to consent forms, and patient use of credit cards and medical financial products. The new requirements were enacted as part of the State’s health and mental hygiene budget legislation for fiscal year 2024 through 2025, signed into law by Governor Hochul on April 20, 2024. The legislation expands financial assistance eligibility to a wider range of patients and implemen ..read more

Our clients report that addressing and preventing burnout for their physicians and other caregivers continues to be a critical priority in the aftermath of the pandemic. Healthcare organizations need high functioning, engaged clinicians to provide outstanding care and meet goals for quality patient outcomes. However, many grapple with how to create and maintain a robust organizational culture where physicians feel psychologically safe and well resourced, and in which they report lower rates of burnout. In light of ongoing physician shortages, particularly in primary care and high-demand specia ..read more

In a long-awaited and controversial Final Rule posted on April 22, 2024,[1] the Centers for Medicare and Medicaid Services (CMS) adopted new federal minimum staffing requirements that will require long-term care facilities to (1) ensure the presence of a registered nurse (RN) on-site 24 hours per day, seven days per week; and (2) provide a minimum of 3.48 total nurse staffing hours per resident day (HPRD), which includes at least 0.55 HPRD for RNs and 2.45 HPRD for nurse aides (NAs). Despite industry-wide opposition to federal minimum staffing standards and the lack of any new funding, CMS bel ..read more

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