Healthcare Law Blog

Shaping the World of Healthcare Law

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
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,
Continue Reading California is Capping Health Care Cost Increases – Starting at 3.5% in 2025

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 review and case management to manage costs and ensure quality care, with
Continue Reading CMS Issues Final Rule on Medicaid and CHIP Managed Care Access, Finance, and Quality

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

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
Continue Reading CMS Finalizes Federal Minimum Staffing Standards for Nursing Homes

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
Continue Reading Solving for Physician Burnout: Creating a Culture of Psychological Safety

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

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.
Continue Reading Artificial Intelligence Highlights from FTC’s 2024 PrivacyCon

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”). The Biden Administration and the Centers for Medicare &
Continue Reading Increased Scrutiny into Agents & Brokers in the Medicare Advantage Space

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 access to behavioral health care
Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule

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. 
Continue Reading CMS Announces Medicare Advantage and Part D Rates for CY 2025

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 transparency to allow consumers to make informed, beneficial choices about their health coverage for enhanced
Continue Reading Closing the Loopholes: The Biden-Harris Administration’s Action Against “Junk Insurance”