Nixon Gwilt Law

What policies and principles do healthcare innovators need to keep in mind when working with AI and machine learning? To answer that question, we've created a free resource library that's packed with information about the current regulatory landscape, compliance considerations, and much more. Simply fill out the form at https://lnkd.in/ehvtqcPP to get instant access to our: ✔️ AI in Digital Health Primer ✔️ Federal AI Law Overview ✔️ AI Policy Tracker by State ✔️ 8 Guiding Principles for Deploying AI for Digital Health ✔️ Key Takeaways for AI/ML Regulatory Success These resources will provide the foundation you need to better understand today's AI landscape, whether you're building new technologies or implementing AI tools within your digital health organization. Download the full library today at https://lnkd.in/ehvtqcPP

Last chance to sign up ⏳ You won’t want to miss this! Secure your spot now before it’s too late 🚀 https://lnkd.in/esFRCuQV

⏰The clock is ticking. Register before it’s too late! There are many considerations for digital health companies when building and deploying AI. Join Nixon Gwilt Law Founding Partner Rebecca E. Gwilt and Counsel Sam Pinson to start unpacking them all on October 9, 2924, at 1 PM EST. You won’t want to miss this free webinar, where we’ll guide you through the necessary considerations for creating and deploying a governance plan that prioritizes patient safety, fairness, transparency, privacy, and security. 📢 Spots are limited. Reserve yours now! 📢 https://lnkd.in/esFRCuQV

ICYMI: OIG recently released a report titled "Additional Oversight of Remote Patient Monitoring in Medicare Is Needed". SURPRISE, I have thoughts 😇 In the report, OIG notes the following key finding: "About 43 percent of enrollees who received remote patient monitoring did not receive all 3 components of it, raising questions about whether the monitoring is being used as intended." The report goes on to state that 28% of patients enrolled in RPM did not receive education and setup under CPT code 99453, 23% did not receive a device under CPT code 99454, and 12% did not receive treatment management. However, OIG also notes an important limitation in the full report which makes their finding misleading: "This analysis is based on analyses of Medicare claims and encounter data. We did not conduct a medical record review." Without conducting a medical record review, there is no way to tell whether a patient received services or whether the services are being used as intended. A lack of claims data does not equate to services not being performed. In reality, the 16-day requirement associated with 99453 and 99454 and the 20-minute requirement for 99457 have a sizable impact on which codes are billed in a given month regardless of what the patient received. For example, when (i) a patient transmits 12 readings during a month and (ii) the patient's care team spends 20+ minutes monitoring and managing the patient's care, the provider can bill for 99457 but cannot bill for 99454. If a patient transmits 16 readings but only requires 10 minutes of monitoring/management during the month, the provider can bill 99454 but not 99457. In an isolated review of claims data without contextual medical record information, both instances would appear to indicate that patients "received" one element of RPM and not the other. 💡BUT MAYBE this is a good thing! OIG recommends in the report that CMS provide additional oversight of remote monitoring services. If CMS understands the above as well as all of us here do, perhaps CMS could fulfill OIG's recommendation by removing or reducing the arbitrary 16-day and 20-minute thresholds associated with the RPM codes.* Then, CMS would be able to provide additional oversight and draw more accurate conclusions from the claims data they have without the added administrative burden of conducting audits. *According to the public agenda, the AMA CPT Editorial Panel discussed revisions to the 16-day and 20-minute requirements at its recent meeting. My understanding is that any changes they approved will be published in the 2026 CPT Codebook. CMS also cannot make permanent changes until 2026 because they've already published the proposed PFS for 2025 and did not include this. So, it is likely that any change will be effectuated in 2026 rather than 2025. But, maybe the OIG report will motivate CMS to issue an interim rule in the meantime. 🤷🏼♀️

🚨Attention all digital health leaders 🚨 AI in healthcare is growing rapidly, and we want to help you stay ahead of the curve! Join Nixon Gwilt Law’s Rebecca E. Gwilt and Sam Pinson on October 9 for an exclusive webinar where we’ll teach you how to establish an AI governance plan. You’ll walk away with an understanding of: 
 ⭐️ The importance of AI governance from a transparency and security perspective ⭐️ The risks and challenges associated with the sale of AI tools ⭐️ Best practices for building responsible, compliant AI Ready to sign up? ✅ https://lnkd.in/esFRCuQV

With all the buzz surrounding the #SB_1047 veto, it's important to also take a look at the significant AI regulations that did make it through. Sam Pinson from Nixon Gwilt Law does a great job breaking down the key AI legislation passed in California, guiding us through the complex AI regulatory landscape.

Hi. My name is Rebecca. And I love #Telehealth. Telehealth has always held incredible promise, and while the pandemic pushed telehealth into the spotlight, what’s truly exciting is that the enthusiasm and adoption continues to grow with the emerging technology tools and new entrants to the telehealth sphere 👉🏼 #FaM #ArtificialIntelligence #Dtx #VirtualReality 🎉🙌🏼 s/o to the amazing advocates at the American Telemedicine Association who continue to push for advances that make healthcare more accessible, affordable, and convenient for all. For the past decade, I've had the privilege of helping innovators build telehealth businesses that have expanded access to quality care across the US (and beyond!). I'm proud to have been part of this journey, and I can't wait to see where we go next! 🚀 #TelehealthAwarenessWeek #HealthcareInnovation #AccessToCare #TelehealthTransformation Carrie Nixon Kaitlyn O'Connor Kyle Zebley Ann Mond Johnson

I so clearly remember 6 years ago when I first joined Nixon Gwilt Law and had no idea what "telehealth" was. Between that and working from home when remote work was still a thing of the future, I'm pretty sure my family and friends didn't think I had a real job post law school. BUT I DID and here we are, thriving in an industry that continues to grow and amaze me every day. Not only is my job super cool, but earlier this year I threw my back out for the first time in my life and immediately had a panic attack because I couldn't breathe. If it weren't for telehealth (and my dog) I would have ended up in the emergency room for a slightly pulled muscle that ended up causing pain for only like 2 days...would you believe me if I told you I was voted "most dramatic" in high school?? For these reasons and so many more, I'm grateful for telehealth and for groups like the American Telemedicine Association continuing to push for policy that supports innovation in healthcare. I would be remiss not to mention that 6 years later we're still asking Congress for the same thing we were asking for when I first entered this space: telehealth expansion. I encourage everyone in my network to support ATA Action in their efforts to finally get this request granted and continue to push for telehealth access for ALL patients. #TelehealthAwarenessWeek Carrie Nixon Rebecca E. Gwilt Kyle Zebley

Happy #TelehealthAwarenessWeek from our team at Nixon Gwilt Law! We're thrilled to be partnering with the American Telemedicine Association this week, and our Managing Partner Carrie Nixon is hosting a free webinar on Tuesday at 3 p.m. ET: The Role of Remote Monitoring in the Primary Care Setting. Register now to reserve your spot, and make sure to check back here on LinkedIn throughout the week for more telehealth-related resources and insights from our team. https://lnkd.in/eCtFwzB4

Does your digital health startup have a cap table prepared? If you're gearing up for any fundraising round, investors will want to see a clear, organized picture of your company's ownership structure. To that end, a simple, clear cap table that breaks down who owns what and the status of any vesting schedules is an excellent place to start. We’ve put together a fillable cap table template to help you build yours. Download it now by filling out the form in this article: https://lnkd.in/eDjVUijc