Healthcare Law Blog

Shaping the World of Healthcare Law

On Tuesday, January 9, 2024, the Centers for Medicare & Medicaid Services (“CMS”) approved a request from New York State (“NYS”) to amend its Medicaid section 1115(a) demonstration (the “Demonstration Amendment”),[1] which will allow for important expansion of the NYS Medicaid program, including:
Continue Reading 2024 Brings Expansion to Medicaid in New York State

Congress passed the Corporate Transparency Act (the “CTA”) in 2021 with the aim of enhancing transparency in entity structures and ownership as well as combating terrorism, money laundering, and other forms of corporate misconduct. This sweeping new rule is designed to cast a wide net over entities that, except in the case of taxes, do not regularly report to federal agencies (i.e., non-publicly traded entities), regardless of the degree to which they are already regulated at the state level. This post specifically speaks to medical groups and management services organizations (“MSOs”) that now need to navigate the new CTA requirements
Continue Reading The Corporate Transparency Act: A Reporting Guide for Medical Groups and MSOs

On December 13, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, titled Advancing Interoperability and Improving Prior Authorization Processes (“Proposed Rule”), to improve patient and provider access to health information and streamline processes related to prior authorizations for medical items and services. We provided key information about that proposed rule on our website here. Then, on January 17, 2024, CMS issued a final rule, titled CMS Interoperability and Prior Authorization (“Final Rule”), which affirms CMS’ commitment to advancing interoperability and improving prior authorization processes.
Continue Reading CMS Finalizes its Proposal to Advance Interoperability and Improve Prior Authorization Processes

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for submitting comments on the proposed rule, “Federal Independent Dispute Resolution (IDR) Operations” (the “Proposed Rule”) under the No Surprises Act (the “Act”).
Continue Reading Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

Will your business have to go through the new Office of Health Care Affordability (OHCA) reporting regime for material healthcare transactions? What would such a filing involve, and how long would it take to complete the process? Those questions will be among key discussion items addressed in Sheppard Mullin’s upcoming webinar on February 7, 2024, co-sponsored with America’s Physician Groups and Moss Adams LLP. As we have highlighted in our blog series[1] on SB 184 and OHCA throughout the past year, OHCA’s recently finalized cost and market impact review (CMIR) regulations set forth the framework for OHCA’s authority to
Continue Reading Webinar: New OHCA Rules Requiring Notice and Review of Material Healthcare Transaction

On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to physician practices in exchange for referring the Requestor’s practice optimization services (e.g., workflow and performance assessment, data analytics, and certain Medicare eligibility and performance assistance). Among other things, the Requestor: (i) did not itself provide any services that were eligible for reimbursement under any Federal healthcare program to any of its clients, (ii) did not have an ownership or investment interest in
Continue Reading New Marketing Possibilities for Vendors Contracted with Medicare Providers and Suppliers Following OIG’s Favorable Advisory Opinion on Limited Referral Bonuses

The 21st-century healthcare landscape has been dramatically shaped by the rise of digitized healthcare solutions aimed at making healthcare more accessible, affordable, and personalized. In the third episode of Sheppard Mullin’s Health-e Law Podcast, Viveka Rydell-Anderson, the CEO of Pacific Vision Foundation, delved into the increasing relevance of digital health technology, particularly in the area of specialized care, with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.
Continue Reading Digital Health to the Rescue – Improving Access to Specialized Care: A Discussion with Viveka Rydell-Anderson

Looking out at the San Francisco skyline from the top floor of the Westin St. Francis on Day 3 of the 42nd Annual J.P. Morgan Healthcare Conference, the iconic Transamerica pyramid is not too far away. But my mind, being chock-full of value-based care presentations, quickly imagines the building as the shining pyramid of patient segmentation and risk stratification, envisioning the proper way to sort patients for effective intervention and total cost of care reduction. John Kao, CEO of Alignment Healthcare, shared today that only 12% percent of their Medicare Advantage membership accounts for approximately 74% percent of their institutional cost
Continue Reading Day 3 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

Sustainability of our healthcare system was an interesting topic at Day 2 of the 42nd Annual J.P. Morgan Healthcare Conference. Paul Markovich, CEO of Blue Shield of California, expressed the concern that “[T]he status quo is an existential threat to our healthcare system.” Markovich is worried that the healthcare system is losing the public’s trust – which will make it harder to effectively fix our system – while also not delivering the quality of care and accessibility needed by our population. For example, Christopher Riopelle, CEO of Strive Health, shared today that 42% of U.S. patients whose kidneys fail never have seen a nephologist
Continue Reading Day 2 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas Adams’ “The Hitchhiker’s Guide to the Galaxy of Healthcare.” Well, not healthcare…for that you have to be here in San Francisco for the 42nd edition of this conference. It was indeed an intriguing day, for even without major announcements, there were very clear signs and portents of our coming year in the healthcare industry.
Continue Reading Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

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