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Recent developments in Artificial Intelligence (AI) have been transforming several sectors, and the healthcare industry is no exception. In the second episode of Sheppard Mullin’s Health-e Law Podcast, Jim Gatto, a partner at Sheppard Mullin and the co-leader of its AI Team, explores the significant implications and challenges of incorporating AI into the healthcare industry with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.
Continue Reading AI as an Aid – Emerging Uses in Healthcare: A Discussion with Jim Gatto

At long last, the cost and market impact review (CMIR) regulations promulgated by the California Office of Health Care Affordability (OHCA) have been approved by the California Office of Administrative Law (OAL). The final regulations, which are available to view here, were submitted by OHCA on December 8, 2023 and approved by OAL on December 18, 2023. As we have highlighted in our series of posts[1] throughout the year, these regulations, in combination with the related statutory provisions in SB 184, set forth the framework for OHCA’s authority to receive advance notice of and review a large
Continue Reading The Stage is Set: California Finalizes OHCA Regulations Requiring Notice and Review of Material Healthcare Transactions in 2024

In the inaugural episode of Sheppard Mullin’s Health-e Law podcast, renowned expert Dr. Laura Tully, Vice President of Clinical Services at ChatOwl, discussed emerging issues for health-tech’s data collection and use activities with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.
Continue Reading In Tech We Trust? The Case for Transparency: A Discussion with Dr. Laura Tully

On November 24, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”) published a proposed rule to modify certain Patient Protection and Affordable Care Act (“ACA”) standards that apply to issuers and Marketplaces, as well as requirements for agents, brokers, web-brokers, direct enrollment entities, and assisters that help Marketplace consumers (the “Proposed Rule”).[1] These modifications are intended to further the Biden Administration’s goals of advancing health equity by addressing disparities in access to quality care while minimizing administrative burdens and ensuring program integrity.
Continue Reading CMS Promotes Health Equity through Marketplace Standards and More in New Proposed Rule

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may exercise “march-in” rights and take a pharmaceutical company’s drug patents developed with federal funds and share them with other companies. See Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, available here (“Draft Guidance”).
Continue Reading The March on Pharmaceutical Patents?

Sheppard Mullin’s Healthcare Team has launched “Health-e Law”, a new podcast dedicated to the interaction between technology and health. Each episode will cover innovations that impact health care in bite-sized, 15-minute episodes, that will keep listeners updated on the fascinating health-tech topics and trends of the day. Our Digital Health Team, alongside experts and thought leaders, will share how innovations can solve some of health care’s (and maybe the world’s) biggest problems, if properly navigated. Health-e Law is hosted by partners Sara Shanti and Phil Kim and associate Michael Sutton.
Continue Reading Health-e Law Launches: New Podcast Covers Health-Tech and Law

In the final days of November, the Office of Health Care Affordability (OHCA) published three updates related to its proposed regulations regarding the review of certain healthcare transactions in California:
Continue Reading OHCA Published Near-Final Draft of Regulations Requiring Notice and Review of Material Healthcare Transactions in 2024

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting continued enforcement and recovery actions under the Health Care Fraud and Abuse Control Program (HCFAC). During fiscal year 2022 (FY 2022), over $1.7 billion was returned through HCFAC’s enforcement actions.
Continue Reading HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment Centers, Among Other Initiatives

On November 17, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”) will publish a final rule requiring Medicare skilled nursing facilities (“SNFs”) and Medicaid nursing facilities (“Facilities”) to provide more detailed ownership, managerial and other information on Form CMS-855A (the “Final Rule”).[1] The Final Rule also includes new definitions of “private equity company” and “real estate investment trust” for Medicare enrollment purposes for all Medicare institutional providers and suppliers.
Continue Reading CMS Issues a Final Rule Requiring Nursing Facilities and Other Providers and Suppliers to Disclose Additional Ownership Information

The Healthcare Real Estate Team at Sheppard Mullin attended the SoCal Healthcare Real Estate Summit on October 18, 2023. This event offered valuable insights into critical issues for health systems and those involved in catering to their real estate requirements. Here are the key takeaways from the summit:
Continue Reading Transforming Healthcare Real Estate: Insights from the SoCal Summit

The Healthcare Real Estate team at Sheppard Mullin had the privilege of attending the Connect Healthcare Real Estate Conference in Newport Beach, California, on September 28, 2023. This event provided an invaluable opportunity for our team to engage with thought leaders and professionals within the industry. Here are the key takeaways that resonate with our commitment to advancing healthcare real estate solutions:
Continue Reading Enhancing Patient Care and Business Strategies: Insights from Connect Healthcare Real Estate Conference

Starting January 1, 2024, healthcare facilities and provider organizations engaging in certain transactions in Illinois, such as mergers and acquisitions, will have new reporting requirements. Illinois recently joined a growing number of states, including California and New York, in requiring expanded oversight and transparency of transactions involving healthcare facilities and provider organizations. Illinois’ Public Act 103-0526 (the “Act”), enacted in August 2023, amends the Illinois Antitrust Act, the State Finance Act and the Illinois Health Facilities Planning Act to increase oversight by the Illinois Attorney General’s (the “IL AG”) of certain “covered transactions” for healthcare facilities and provider organizations.
Continue Reading Illinois Proposes Heightened Oversight for Healthcare Transactions

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.
Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

Last week’s historic executive order (EO) on the development and use of artificial intelligence (AI) is teeming with urgency, both in caution and optimism, to keep pace with the technological advancements. The EO addresses the duality of AI—its promising utility and disconcerting risks—across a range of public and private sectors, including healthcare. Below are five key takeaways from the EO for the healthcare industry.
Continue Reading AI’s Executive Order and Its Key Healthcare Implications 

On November 2, 2023, the American Hospital Association and Texas Hospital Association, in conjunction with the Texas Health Resources and United Regional Health Care System, filed suit against the Secretary of the Department of Health and Human Services (“HHS”) and the Director of the HHS Office for Civil Rights (“OCR”) regarding OCR’s guidance on the use of online tracking technologies by HIPAA entities.[i] This action and its results will impact how healthcare entities must protect and may use certain information collected on their digital sites.
Continue Reading Caught in the Web: Hospital Associations Sue OCR on Third-Party Web Tracking Guidance