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 receive advance notice of and review a large scope of healthcare transactions in the coming months, reflecting a dramatic change to California’s healthcare regulatory landscape moving forward. Please tune in to this important webinar where our knowledgeable presenters will present an overview of the key components and practical considerations surrounding this new law, including: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 any entity that provided items or services paid for by any Federal healthcare program, and (iii) received compensation from the physician practices that did not vary based on whether the physician practices received a greater or lesser reimbursement from Medicare based on the Requestor’s services. The Opinion concluded that this proposed arrangement would not generate prohibited remuneration under Section 1128B(b) of the Social Security Act (the “Act”), also known as the Federal Anti-Kickback Statute (“Anti-Kickback Statute”), and thus OIG would not impose administrative sanctions under Section 1128A(a)(7) (exclusion) or Section 1128(b)(7) (civil monetary penalty) of the Act on the Requestor. As always, the Opinion stipulated that it may only be relied on by the Requestor on the specific facts presented to OIG, and that certain state and federal laws may continue to limit similar arrangements. However, the Opinion indicates that the tight scope of potential marketing options for physician practice vendors could expand a bit for those who are similarly situated to the Requestor.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 (hospital and facility costs), while conversely their “healthy” membership of 74% accounted for only 5% of their institutional costs. These days, institutional costs and pharmaceutical costs are almost equal, according to the Advisory Board, and together far outweigh professional physician and other provider costs. Therefore, keeping patients out of the hospital and post-acute facilities as medically possible and appropriate and effectively managing medications should result in a large reduction in the total cost of care, right? So, what’s not happening that should be?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 prior to that catastrophic event, and 90% of kidney disease patients are undiagnosed. For a disease that has a total spend of approximately $420 billion, how is our system missing these patients?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 scope of healthcare transactions in the coming months of 2024, reflecting a dramatic change to California’s healthcare regulatory landscape. To refresh and update our readers regarding the CMIR regulations, this article will provide an overview of the key components and practical considerations regarding this new reporting regime, while also commenting on the key final tweaks to (and omissions from) the regulations.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

Last week the Federal Trade Commission (FTC) issued a press release highlighting recent and forthcoming actions by the FTC, Department of Justice (DOJ), and the Department of Health and Human Services (HHS), which they say will further promote competition, thereby lowering costs and increasing the quality of care in the U.S. health care market. In addition to highlighting recent actions by each of the agencies (e.g., the FTC’s proposed non-compete rule), the release states that the three agencies are entering into new partnerships to increase interagency cooperation and advance a “whole-of-government” approach to protect health care competition, including:Continue Reading FTC, DOJ, and HHS Announce Interagency Initiatives to Promote Healthcare Competition