Convergence of Virtual Care & Artificial Intelligence

Outline/Objectives

• Identify the Problem

• Digital Transformation

• Understanding VCaaS Model

• Understanding AIaaS Model

• Convergence & Synergy between VCaaS & AIaaS

• Legal and Regulatory

• FDA’s role

• Reimbursement

• VCaaS and AIaaS in practice (e.g. Stroke)

Identify the Problem

• Production Gap
• Proof-of-Concent

• Data, Data & Data

• Scaling

• Trust
• Precision of Evidence

• Who will pay for it?

Digital Transformation

Digitization → Digitalization → Digital Transformation

Understanding VCaaS Model

Virtual Care Continuum

Data Pipeline

VCaaS is the data-pipeline for AI in Healthcare

Apple Plans Blood-Pressure Measure, Wrist Thermometer in Apple Watch

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Apple Inc. is working on new health-related features for its smartwatch, including a tool to tell users when their blood pressure is increasing and a thermometer to help with fertility planning, according to people familiar with the plans and internal company documents.

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Virtual Hospital @ Home

• Labs-on-wheel

• Mobile radiology

• Telerehab

• Continuous & remote monitoring

Understanding AIaaS Model

• Moduler

• Plug & Play

• Interoperable

• Integrated with VCaaS

• Risk

• Trust

• Integration

• Value of Evidence

• Evidence of Value

Convergence & Synergy between VCaaS & AIaaS

• Concentrate on Value exchange
• Patient centric
• Provider centric

• Problem to Solution
• Avoid Type 3 Error

• VCaaS with HealthIoT - Data pipeline

• AIaaS Data Insight to prediction

• A vicious circle of continuous improvement and new services

Legal and Regulatory

• Approval
• FDA's software as a medical device (SaMD)
• Modular Approval (not platforms)

• Interoperability
• Curse Act
• Information Blocking

• FDA’s role
• FDA has grown to encourage the use of virtual care to improve data quality, volume, variety & velocity
• 343 Entries in the database with none showing continous improvement! Why?
• Risk
• Data Shift

Reimbursement

• Compensation for AI services in its early stages

• New Technology Add-On Payment (NTAP) - CMS

• Burden
• Of Proof (It works!)
• Also of Value (It Saves!)

VCaaS and AIaaS in practice (e.g. Stroke)

Role of Artificial Intelligence in TeleStroke: An Overview

VCaaS and AIaaS in practice (e.g. Stroke)

• Why Pay for Virtual Care?
• Pre-Pandemic
• Lack of Physicians (e.g. Stroke, Psychiatry) > Proven Value
• Pandemic
• Contactless Care
• Post-Pandemic
• Convenience & Value
• Genie is out of the bottle

• AI in Healthcare
• NTAP for Stroke
• Rapid.ai
• Viz.ai
• Why?
• Creates Value

Stroke Care in Evolution

• Cost of Stroke (2016 US-dollar values)
• 103.5 billion
• Direct Cost - $38 billion
• Indirect Cost - $38.1 billion
• Premature mortality - $30.4 billion

• VCaaS
• Acute Care
• At home Care
• Chronic Care

• AIaaS
• Acute imaging
• Patient monitoring
• Rehab monitoring

Colossal Opportunity

• 1 Trillion a Year

• If 10% that is 10 billion a year

References

References

Role of Artificial Intelligence in TeleStroke: An Overview

Despite current challenges, these synergistic technologies hold immense promise in enhancing the clinician experience, helping to reduce physician burnout while improving patient health outcomes at a lower cost. This brief overview discusses the multifaceted potential of AI use in telestroke.

https://junaidkalia.com/posts/role-of-artificial-intelligence-in-telestroke-an-overview

Vision of Stroke Care - Leveraging Artificial Intelligence & Telemedicine

Stroke has always been at the forefront of technological breakthrough with first to be added as reimbursable telemedicine service to state of the art AI based large vessel occlusion and perfusion mismatch. In this animation we explain how we can leverage both to decrease latency and save limbs and lives.

https://junaidkalia.com/posts/vision-of-stroke-care-leveraging-artificial-intelligence-and-telemedicine

New Medical Services and New Technologies

Application Information for FY 2023 The deadline to submit (and for CMS to receive) an application for FY 2023 new technology add-on payments is Friday October 8, 2021. See the Downloads section below to download the FY 2023 New Technology Application Packet.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/newtech

ONC's Cures Act Final Rule

https://www.healthit.gov/curesrule/

Software as a Medical Device (SaMD)

As technology continues to advance all facets of health care, software has become an important part of all products, integrated widely into digital platforms that serve both medical and non-medical purposes. Software, which on its own is a medical device - Software as a Medical Device - is one of three types of software related to medical devices.

https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

FDA's support of AI in telemedicine

About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug and combination product companies on a wide range of FDA regulatory, reimbursement and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.

https://www.mobihealthnews.com/news/fda-s-support-ai-telemedicine

Artificial intelligence as Service (AIaaS)

Artificial intelligence in healthcare will develop as service (AIaaS) Model. This will develop in synergy with Virtual Care as a service (VCaaS). The biggest issue is reimbursement. We need to prove that AI will provide value and then only qualify for CMS new technology addon program (NTAP).

https://junaidkalia.com/posts/Artificial-intelligence-as-Service

Virtual Care Continuum

Virtual Care Continuum

https://junaidkalia.com/posts/Virtual-Care-Continuum

NTAP Guide - New Technology Add on Payment (NTAP) Resource

In 2020, CMS determined that a New Technology Add-on Payment (NTAP) could be applied to technology that assists with LVO triage and notification for stroke, such as Rapid LVO, as it was seen to significantly improve the care of Medicare beneficiaries. In August 2021, CMS extended the NTAP through fiscal year 2022.

https://www.rapidai.com/guide/ntap

Viz.ai NTAP Reimbursement

In a stand alone center with 500 suspected ischemic strokes per year, an estimated 131 cases will qualify for NTAP, receiving up to $1,040 per patient. Hence, resulting in a total projected impact of $136,240. In a hub and spoke model with 1,500 suspected ischemic strokes per year, an estimated 394 will qualify for NTAP, receiving up to $1,040 per patient.

https://www.viz.ai/ntap

New Technology Add-On Payment (NTAP) for Viz LVO: a win for stroke care

The Centers for Medicare and Medicaid Services (CMS) recently granted a New Technology Add-on Payment (NTAP) for Viz ContaCT (Viz LVO) by Viz.ai, Inc, an applied artificial intelligence healthcare company.1 This is the first time CMS has reimbursed an artificial intelligence (AI)-based software using this designation.

https://jnis.bmj.com/content/13/5/406

Abuse Notice

https://jamanetwork.com/journals/jama/article-abstract/2752664

Artificial Intelligence and Machine Learning (AI/ML) Medical Devices

As technology continues to advance every aspect of health care, software incorporating artificial intelligence (AI), and specifically the subset of AI known as machine learning (ML), has become an important part of an increasing number of medical devices.

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices