If you’re building a digital health company, it is especially important to develop a multi-faceted intellectual property protection strategy. Here’s why: a strategy that includes multiple pathways for IP protection allows you to protect both tangible assets, like proprietary hardware, software, and documentation, as well as intangible assets, like branding, customer-facing website designs, pricing strategies, business models and projections.
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CMS didn’t propose to add any permanent telehealth codes, but did incrementally expand patient access to telehealth in other ways.
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On July 13th, the Centers for Medicare and Medicaid Services (“CMS”) released its proposed Medicare Physician Fee Schedule for Calendar Year 2022 (the “2022 Proposed MPFS” or the “Proposed Rule”). In doing so, it recognized five new CPT codes for Remote Therapeutic Monitoring (“RTM”) of “non-physiologic” patient data such as “musculoskeletal system status, respiratory system status, therapy (medication) adherence, and therapy (medication) response” as well as pain. While this new code set is welcomed by advocates for virtual care, the 2022 Proposed MPFS that discusses RTM may raise just as many questions as it answers.
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The U.S. Department of Justice (DOJ) just sent a strong message to pharmaceutical and biotechnology companies who rely on contracted sales teams to push their products into the market: “commission-based compensation violates the Federal Anti-Kickback Statute (AKS)”.
This message seems to undermine years’ worth of relative stability in how these companies evaluate risks associated with commission-based compensation that does not fit squarely into a legal safe harbor under the AKS.
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At Nixon Gwilt Law (NGL), we know that diversity is essential to innovation. We are committed to internal diversity, equity, and inclusion (DEI) and are continuously working to create a diverse workplace, ensure equitable treatment of our employees and our clients, and develop a strong and collaborative team environment. We strive to make our firm a place where everyone feels safe, respected, and supported, so we all have the opportunity to thrive.
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In honor of National Mental Health Month, we’re taking a look at how we’re using these apps in our business, what some of our mental and behavioral health clients are doing, three ways the market is growing and changing, and what’s driving this transformation. If you’re an investor, a digital health company, or a healthcare provider, then this conversation is especially relevant for you.
![[Webinar Replay] How to Maximize the Value of Your Digital Health Startup Before Your First Round of Funding](https://images.squarespace-cdn.com/content/v1/563c7acce4b028323896cb89/1619089421357-O1UIZ6R6B9DW3FRLKBRG/Pre-Raise+Prep+Package+Image.png)
If you’re a Digital Health Founder and want to know what you need to have in place before you start the complex journey of raising funds (or even if you've already started but have questions about whether you've skipped anything important), then this webinar replay is for you.
Read More![[VIDEO] How we think about Healthcare Innovation and what we're seeing in the market right now](https://images.squarespace-cdn.com/content/v1/563c7acce4b028323896cb89/1618507063514-XTZGRXEZNWAA36P9AT3H/Partner+vlog+ep2_blog+image_NGL.png)
We’re inviting you back for a bit of our weekly Partner meeting. This time we’re talking about Healthcare Innovation—what it is, the kind of innovative companies we’re seeing in the market, and what they’re doing that you should know about.
This conversation is especially relevant for those of you looking for emerging trends which may impact the market. (And hey, isn’t that everyone?)
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We’ve documented our processes here so you know exactly what to expect after you click one of the Get Started buttons on our website.
As always, we want our Provider, Digital Health, and Life Sciences clients to be informed, prepared, and confident in their decisions so they can innovate faster and grow their businesses.
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The UCLA Biodesign Hub for MedTech and Digital Health (UCLA Biodesign) is seeking executives from medical technology and digital health companies to participate in a new study focused on advancing regulatory and reimbursement for innovative technologies. This study aims to establish benchmarks, educate regulators, and potentially influence future decision-making at a local and national level. In furtherance of increasing our healthcare system’s capacity to deliver MedTech and digital health innovations to patients and providers, we invite you to participate in UCLA Biodesign’s landmark study, Innovation in MedTech and Digital Health: A New Decade!
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We’ve hit the record button during our weekly Partner meeting to talk about the increased scrutiny of telemedicine and virtual care service by the Office of the Inspector General (OIG), as reflected in the latest OIG work Plan and ongoing audits and evaluations.
This conversation is especially relevant for those of you in the telehealth/digital health space, whether you’re a healthcare provider or platform/tech providers.
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Nixon Gwilt Law’s Managing Partner, Carrie Nixon, was quoted in an article appearing in mHealth Intelligence discussing the January amendments by the Centers for Medicare & Medicaid Services to the 2021 Physician Fee Schedule to clarify reimbursement for remote patient monitoring programs.
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Join Nixon Gwilt Law’s Carrie Nixon and Kaitlyn O’Connor for a presentation and discussion about Remote Patient Monitoring and other virtual care services, with a particular focus on how these services are addressed in the 2021 Medicare Physician Fee Schedule and what that may mean for business and reimbursement models going forward.
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In a recent conversation with the tech news website Lifewire, Tommy Miller shared his take on whether smartwatches like the Apple watch could replace COVID testing in the near future.
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Dramatic changes to the Anti-Kickback Statute and the Stark Physician Self-Referral Law regulations present an unprecedented opportunity for healthcare providers and digital health companies to create new business arrangements that align incentives around care coordination and patient engagement. Such arrangements are the foundation of the Value-Based Enterprise.
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2020 was the year that showed us all that you can’t truly predict what lays ahead. But, for all the surprises of the last year, the industry didn’t collapse, it accelerated along familiar trend lines. So, after a year like 2020, should we even attempt to predict what will happen in 2021? We say yes. And here’s why…
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Nixon Gwilt Law’s Managing Partner, Carrie Nixon, was quoted in an article appearing in mHealth Intelligence discussing the recent changes to Telehealth and Remote Patient Monitoring with the new 2021 Medicare Physician Fee Schedule (learn about our take here and here).
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A Final Rule published by CMS makes several important changes to the Stark Law that will be a boon for physicians eager to more closely coordinate with other providers to (1) better manage patient care and (2) to participate in the shift to value-based reimbursement.
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