Additional Reimbursement for Chronic Care Management and Principal Care Management Finalized in the 2022 MPFS

In the Final Medicare Physician Fee Schedule (“MPFS”) for 2022 (the “Final Rule”) issued on November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) added five new CPT codes in the categories of Chronic Care Management (“CCM”) and Principal Care Management (“PCM”) and increased reimbursement for already existing codes in the same categories. Despite stakeholder feedback, CMS refrained from making any changes to the existing rules for obtaining beneficiary consent for CCM and PCM.

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Under 2022 Medicare Physician Fee Schedule, Physician Assistants Will Be Paid Directly for Services

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released its Final Medicare Physician Fee Schedule for 2022 (the “Final 2022 MPFS”), revising certain payment policies for services provided to Medicare beneficiaries by healthcare practitioners. These policies take effect on January 1, 2022.

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New Reimbursement for Remote Therapeutic Monitoring in the Final 2022 Medicare Physician Fee Schedule

This article examines the new CPT codes for Remote Therapeutic Monitoring as finalized for reimbursement in the 2022 Medicare Physician Fee Schedule, discussing key takeaways and implications for digital health and remote patient monitoring companies.

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[Webinar Replay] The Top 3 Privacy Concerns for Digital Health Innovators

Discover how Privacy compliance impacts Digital Health Startup founders and executives in terms of access to capital and securing key vendor agreements in this webinar replay. You may not have ever looked at Privacy this way before, and we encourage you to explore this perspective so you can close those critical deals without unnecessary delay.

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[video] Digital Health Innovators: Does your solution qualify as Software as a Medical Device (SaMD)?

If you’re in the Remote Patient Monitoring (RPM) or Remote Therapeutic Monitoring (RTM) space, then you’ll want to understand the criteria and opportunities for qualifying as Software as a Medical Device (SaMD)

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Remote Therapeutic Monitoring in the 2022 MPFS: How CMS Can (and Should) Get it Right

This is our take on the approach CMS should follow in improving and finalizing the RTM codes and associated reimbursement that improve patient outcomes and lower the overall cost of care. It is based on our extensive work with remote patient monitoring and care management digital health companies along with the physician practices who use the existing care management codes – including Remote Patient Monitoring (“RPM”), Chronic Care Management, Principal Care Management, and Behavioral Health Integration.

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Intellectual Property for Digital Health Companies: How a Multi-Faceted Strategy Balances Patentability Barriers

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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Proposed 2022 MPFS: Expansion in Audio-Only Telehealth, Permanent Remote “Direct Supervision”, and Remaining Opportunities for New Permanent Telehealth Codes

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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New Remote Therapeutic Monitoring CPT codes introduced in Proposed 2022 Medicare Physician Fee Schedule

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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Can Biotech and Pharma Companies pay contracted sales teams a commission-based fee?

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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NGL Stands with the 2SLGBTQIA+ Community

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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4X growth in 5 years: Why investment in Mental and Behavioral Health is exploding

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.


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[VIDEO] How we think about Healthcare Innovation and what we're seeing in the market right now

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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What Happens When You Become a Nixon Gwilt Law Client

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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**Video Post** MedTech Study: NGL & UCLA Biodesign

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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**Video Post** The OIG is Watching: Why your telehealth or virtual care company should be focused on compliance right now.

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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