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

Note: First published by ALM / Law.com in The Intellectual Property Strategist…
Continue Reading Medical Technology – Recent Decisions at the Federal Circuit and the Patent Trial and Appeal Board

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

Healthcare transactions are complicated endeavors and approaching them with your eyes wide open can be the difference between closing the deal and the negotiations falling apart. Failing to consider and navigate common pitfalls is an easy way to wreck a deal.
Continue Reading Sheppard Mullin 10 Ways to Screw Up Your Deal

As individuals continue to live longer beyond retirement and the U.S. population size of those 65 years and older continues to increase, the demand for long-term services and supports (“LTSS”) is also expected to increase.[1] LTSS represents the wide-ranging health and social services that individuals require over an extended period of time, including assistive services.[2] The increasing demand for these services will also likely proportionally increase health care expenditures of LTSS. According to the Congressional Research Service, which analyzed data from the Centers for Medicare & Medicaid Services (“CMS”) National Health Expenditure Accounts (“NHEA”) on the personal health…
Continue Reading The PACE Solution to Increasing Demands for Long-Term Services and Supports in the U.S.

Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June, Governor Ned Lamont signed into law “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (the “Act”), which imposes new registration, reporting, and disclosure requirements on pharmaceutical representatives in the State of Connecticut. The Act builds on Governor Lamont’s policy initiatives, which aim to improve the delivery of care and reduce healthcare costs for Connecticut residents and includes the initiative to regulate pharmaceutical marketing…
Continue Reading Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives

As we anticipated in our previous blog article, the Office of Health Care Affordability (OHCA) made revisions to its proposed regulations following the public workshop hosted by the California Department of Health Care Access and Information (HCAI) in August. On October 9, 2023, HCAI and OHCA published a revised draft of the regulations. Our August blog article outlined the substance of the original draft regulations; this article summarizes the critical takeaways regarding the revisions.
Continue Reading OHCA’s Revised Regulations Following Comments from Industry Stakeholders

The expanded use of artificial intelligence (AI) in the delivery of health care continues to receive increased attention from lawmakers across the country. Although AI regulation is still in its early developmental stages, there are various efforts underway to address the unintended negative consequences stirred by AI technology, particularly in health care and other key sectors.[1] Of particular interest are regulatory efforts to restrict discrimination through AI and related technologies.
Continue Reading At a Glance: Legal Efforts to Limit Discrimination Through AI