In a Final Rule issued on May 6, 2024, the U.S. Department of Health and Human Services (“DHHS”) finalized regulations implementing Section 1557 of the Affordable Care Act (“Section 1557”). The Final Rule updates and strengthens protections for individuals who participate in health programs or activities that receive Federal financial assistance (“Covered Entities,” as further defined below). Continue Reading DHHS Bolsters Non-Discrimination Protections for Recipients of Covered Health Care Services and Activities

On April 29, 2024, the U.S. Department of Labor (the “DOL”) issued a final rule (the “Final Rule”) rescinding the 2018 Association Health Plan rule (“2018 AHP Rule”), thereby marking a return to the more rigid pre-2018 regulatory framework governing association health plans. The 2018 AHP Rule, officially titled “Definition of Employer Under Section 3(5) of ERISA – Association Health Plans,” allowed these plans to bypass certain requirements under the Affordable Care Act (“ACA”). The Final Rule will take effect on July 1, 2024.Continue Reading U.S. Department of Labor Rescinds Trump-Era Rule on Association Health Plans (AHPs)

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 PrivacyCon Part 1, and iii) FTC’s 2024 PrivacyCon Part 2. Also, our Artificial Intelligence Team’s blog can be found here. Experts report that anywhere from 50 to 75% of tasks associated with utilization review can be automated. AI might be excellent at handling routine authorizations and modernizing workflows, but there is a risk of over-automation. For example, population trends of medical necessity can miss unusual clinical presentations. SB 1120 seeks to address these concerns. Continue Reading The Intersection of Artificial Intelligence and Utilization Review

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 hospitals, facilities, outpatient clinics, large physician groups and clinical laboratories, payors and fully integrated delivery systems.Continue Reading California is Capping Health Care Cost Increases – Starting at 3.5% in 2025

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. Continue Reading What the FTC’s Noncompete Ban Means for Healthcare

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

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 implements greater patient protections related to medical debt collection practices.Continue Reading New York Broadly Revises Hospital Financial Assistance, Medical Debt Collection and Related Requirements

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 specialties like radiology, effectively recruiting and retaining physicians is critical to delivering care, maintaining contractual staffing commitments, providing for more consistent revenue, and reducing associated costs. We hear often that physicians feel they are being asked to do more with less and adapt to a rapidly changing environment in terms of clinical care, medical record documentation, patient communication, mid-level supervision, and technological advancements. In response, many of our clients are actively exploring how to support providers, create and sustain a cohesive organizational culture, and reduce burnout rates. In this article, we discuss one piece of that larger puzzle – the importance of promoting psychological safety for physicians through both internal programming and participation in external opportunities.Continue Reading Solving for Physician Burnout: Creating a Culture of Psychological Safety

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 believes that these new standards will increase staffing in more than 79 percent of nursing facilities nationwide. Notably, the Final Rule establishes staffing requirements that exceed the current minimum staffing standards in all 50 states.Continue Reading CMS Finalizes Federal Minimum Staffing Standards for Nursing Homes

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