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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

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