California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health care provider oversight when payors use AI to assess the medical necessity of requested medical services, and by extension, coverage for such medical services.Continue Reading California Limits Health Plan Use of AI in Utilization Management
Ethical hackers are becoming crucial allies in the battle against healthcare data breaches and ransomware attacks. In the twelfth episode of Sheppard Mullin’s Health-e Law Podcast, Ilona Cohen, Chief Legal Officer and Chief Policy Officer of HackerOne, delved into the pressing issue of cybersecurity in the healthcare sector and the pivotal role that ethical hacking may play, with Sheppard Mullin’s Phil Kim, Sara Shanti, and Michael Sutton.Continue Reading Healthcare Needs More Hackers: A Discussion with Ilona Cohen
CMS recently published the First Annual Evaluation Report (the “Report”) highlighting its most significant observations in the first year following implementation of the Kidney Care Choices Model (the “KCC Model”). By way of background, the KCC Model is a payment model which creates certain incentives for providers that are intended to improve care management for Medicare patients with chronic kidney disease (“CKD”) (Stage 4 or 5) or end-stage renal disease (“ESRD”). The KCC Model is intended to, among other things, delay the dialysis progression and increase use of home dialysis, while also aiming to reduce the cost of care and improve quality of outcomes.Continue Reading CMS Releases First Annual Evaluation Report for Kidney Care Choices Model
With technology rapidly evolving and jurisdictions appearing blurred, it is increasingly important to be mindful of data flow and use. This is particularly true where patient data is being accessed by offshore subcontractors.Continue Reading Do You Catch Our Drift? Navigating the Waters of Offshoring and Patient Data
Gradually, data is being recognized as an asset in an increasingly data-hungry healthcare industry. In the tenth episode of Sheppard Mullin’s Health-e Law Podcast, Arti Bedi Pullins, President and Chief Healthcare Officer at QuestionPro, discusses how industry players can recognize the value of data as an asset with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Assessing Data Assets in Healthcare: A Discussion with Arti Bedi Pullins
The healthcare sector is undergoing a transformative phase due in large part to the integration of digital technologies into every-day care. At the forefront of this revolution is Remote Patient Monitoring (“RPM”), a technology that appears poised to redefine the industry’s approach to care. In the ninth episode of Sheppard Mullin’s Health-e Law Podcast, Vipul Kella, M.D., Chief Medical Officer at Physio AI, sheds light on how RPM is revolutionizing the healthcare landscape, with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Remote Patient Monitoring Innovating Health Tech: A Discussion with Dr. Vipul Kella
Emerging technologies are prompting a revolution in women’s healthcare through advanced diagnostic testing. In the sixth episode of Sheppard Mullin’s Health-e Law Podcast, Deirdre O’Neill, Chief Commercial & Legal Officer at Hertility Health, shed light on trends in women’s healthcare and technology with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading FemTech Meets DiagnosTech: A Discussion with Deirdre O’Neill
In the rapidly evolving landscape of digital health, gamification has emerged as a powerful tool to enhance patient engagement and improve health outcomes. In the fifth episode of Sheppard Mullin’s Health-e Law Podcast, Craig Lund, co-founder and CEO of Mightier, shed light on this innovative technology with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Gamification – Playing for Health: A Discussion with Craig Lund
On April 4, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued the contract year 2025 (CY2025) Medicare Advantage and Part D final rule (the “Final Rule”). In addition to finalizing its CY2025 proposed rule, CMS also addressed several key provisions that remained from the CY2024 proposed rule. According to CMS’ Fact Sheet, the Final Rule builds on existing Biden-Harris Administration policies to strengthen protections and guardrails, promote healthy competition, and ensure Medicare Advantage and Part D plans best meet the needs of enrollees. The Final Rule also promotes access to behavioral health care providers, promote equity in coverage, and improve supplemental benefits.Continue Reading CMS Issues CY2025 Medicare Advantage and Part D Final Rule
The U.S. Department of Health and Human Services (HHS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) recently released the long anticipated Final Rule to revise the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 C.F.R. Part 2 (Part 2).Continue Reading HHS Announces 42 Part 2 Final Rule to Align with HIPAA
The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department of Health and Human Services, Office of the Inspector General (“OIG”) concerning pharmaceutical manufacturers’ offers of cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries. The opinion under review was Advisory Opinion No. 22-19,[1] which we previously wrote about[2] and in which the OIG advised that if pharmaceutical manufacturers offered the proposed cost-sharing subsidies to Part D beneficiaries via PCPA, they could be subject to liability under the Federal health care program Anti-Kickback Statute (the “AKS”), even though the proposed subsidies would not violate the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition (“BIP”).Continue Reading District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute