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Fundamentals for clinicians
Defining value to patients, clinicians, and systems
Learning objective:
Smit Patel
Director of Digital Medicine
Digital Medicine Society
Learning Objectives
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The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
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The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Source: Add source
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The value cycle of how the digital clinical measures act as an integral part of broader digital measurement system improving human health and outcomes
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DRAFT FOR PUBLIC COMMENT
Value considerations for three separate entities:
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Source: https://www.nature.com/articles/s41746-020-0237-3, Playbook team analysis
System
Patient
Clinician
Clinics/sites may consider workflow considerations:
“Software-integration perspective,” refers to considerations related to the needs to transfer, visualize, and/or analyze of data, e.g,:
For the person wearing the technology may consider:
Provider taking care of the patients may consider:
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DRAFT FOR PUBLIC COMMENT
What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
Where, how long and how often is the tool worn? What’s the battery life? Technical support available? What’s tool compatibility? Easy to use and track?
Does it aim for value-based care for all patients? How does it manage & compile patient health data from tools?
What kind of outcomes does the tool measure? What are clinical outcome assessments. Need human intermediary to collect digital measures?
Defining Clinical Value
Defining Outcomes Value
Defining Economic Value
Defining Patient Experience Value
Defining Population health Value
Source: DiMe team analysis
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The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Crafting the value framework for the fit-for-purpose digital sensing products
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DRAFT FOR PUBLIC COMMENT
What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
Where, how long and how often is the tool worn? What’s the battery life? Technical support available? What’s tool compatibility? Easy to use and track?
Does it aim for value-based care for all patients? How does it manage & compile patient health data from tools?
What kind of outcomes does the tool measure? What are clinical outcome assessments. Need human intermediary to collect digital measures?
Defining Clinical Value
Defining Outcomes Value
Defining Economic Value
Defining Patient Experience Value
Defining Population health Value
Source: DiMe team analysis
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The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Crafting the value framework for the fit-for-purpose digital sensing products
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DRAFT FOR PUBLIC COMMENT
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Without patient-focused measurement, stakeholders risk entrenching digital versions of poor traditional assessments and proliferating low-value tools that are ineffective, burdensome, and reduce both quality and efficiency in clinical care and research.
For more resources on how to incorporate patient engagement in the measurement selection process, please read the cited paper below.
SPOTLIGHT
Patient engagement is vital to the success of this process
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Source: Playbook team analysis
CASE STUDY: Clinical Care
Screening for asymptomatic atrial fibrillation at home
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The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Dr. Steve Steinhubl
Scripps Research
Dr. Steve Steinhubl is a cardiologist whose clinical practice is in Alaska - with a population density of 1.2 people/square mile and where 75% of the communities are not connected by road to a city with a hospital.
The mHealth Screening to Prevent Strokes trial (mSToPS) was the first-direct to-participant, fully digital clinical trial that to participate only required internet access and mail service.
Due to its pragmatic design, the lessons learned in mSToPS can be seamlessly applied into clinical care - not only for screening for atrial fibrillation, but really for any heart rhythm diagnostic or management clinical program.
Steve would like to know:
How can he identify what digital clinical measures - and what connected sensor products - could help create new systems of care in Alaska, and everywhere else?
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DRAFT FOR PUBLIC COMMENT
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Source: Playbook team analysis
Ed Ramos, PhD
Director, Digital Clinical Trials
Principal Science Officer, CareEvolution
Ed is helping lay the groundwork for a new center focused on implementing digital health strategies applicable across a broad range of biomedical and public health interests.
In a public-private effort, one of the center’s initial projects is towards developing new methodologies for tackling chronic conditions such as diabetes and its impact on the nation’s health. The PRediction Of Glycemic RESponse Study (PROGRESS) is aimed at developing a predictive model of individual glycemic response by leveraging data collection from an ever-growing collection of digital health and personal technologies.
Ed would like to know:
“How do we shift the paradigm on clinical studies and implement a strategy for remote, continuous capture of comprehensive, individual-level health data? Can we build models that allow for prediction of how glycemic response differs across individuals, especially for persons with diabetes? How do we build an experience that promotes broad participation with lasting, meaningful engagement of participants?
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CASE STUDY: Research
Individualized Prediction of Glycemic Response
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
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This manuscript in BMJ presents some guiding principles on how to choose between telephone and video appointments and also considerations for when and how to collect digital clinical measures using connected sensors a virtual visit.
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
SPOTLIGHT
Covid-19: a remote assessment in primary care
Source: https://www.bmj.com/content/368/bmj.m1182, Playbook team analysis
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What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
Where, how long and how often is the tool worn? What’s the battery life? Technical support available? What’s tool compatibility? Easy to use and track?
Does it aim for value-based care for all patients? How does it manage & compile patient health data from tools?
What kind of outcomes does the tool measure? What are clinical outcome assessments. Need human intermediary to collect digital measures?
Defining Clinical Value
Defining Outcomes Value
Defining Economic Value
Defining Patient Experience Value
Defining Population health Value
Source: DiMe team analysis
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The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Crafting the value framework for the fit-for-purpose digital sensing products
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DRAFT FOR PUBLIC COMMENT
Remote monitoring is only valuable if the information is used to drive patient outcomes
Source: Playbook team analysis, Figure: Coravos, Andrea & Goldsack, Jennifer C & Karlin, Daniel & Nebeker, Camille & Perakslis, Eric & Zimmerman, Noah & Erb, M. Kelley. (2019). Digital Medicine: A Primer on Measurement. Digital Biomarkers. 3. 31-71. 10.1159/000500413.
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
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What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
Where, how long and how often is the tool worn? What’s the battery life? Technical support available? What’s tool compatibility? Easy to use and track?
Does it aim for value-based care for all patients? How does it manage & compile patient health data from tools?
What kind of outcomes does the tool measure? What are clinical outcome assessments. Need human intermediary to collect digital measures?
Defining Clinical Value
Defining Outcomes Value
Defining Economic Value
Defining Patient Experience Value
Defining Population health Value
Source: DiMe team analysis
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The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Crafting the value framework for the fit-for-purpose digital sensing products
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DRAFT FOR PUBLIC COMMENT
The costs are associated by the resources consumed as a result of the intervention in the health sector, other sectors, for the patient, their families and any losses of productivity.
Health economics considerations
Health economics is the study of the allocation of resources within the health economy to optimize productivity and outcomes.
Economic evaluation analysis can include:
The likely costs and consequences of different interventions can be assessed with varying degrees of confidence.
Intervention
Consequences
The assessment of consequences mirrors the resources map but looks for savings and also includes changes to the state of health - often in Quality Adjusted Life Years (QUALYs).
Costs
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
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Source: https://www.cms.gov/apps/physician-fee-schedule/search/search-criteria.aspx, Playbook team analysis
There are currently four reimbursable CPT codes that QHPs can use to bill for services related to clinical digital measures
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
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“Collection and interpretation of physiologic data (e.g. ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified healthcare professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time, each 30 days.”
CPT code 99091:
“Remote monitoring of physiologic parameter(s) (e.g, weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment.”
CPT code 99453:
“Device(s) supply with daily recording(s) or programmed alert(s) transmission, each �30 days.”
CPT code 99454:
“Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month.”
CPT code 99457:
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DRAFT FOR PUBLIC COMMENT
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What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
Where, how long and how often is the tool worn? What’s the battery life? Technical support available? What’s tool compatibility? Easy to use and track?
Does it aim for value-based care for all patients? How does it manage & compile patient health data from tools?
What kind of outcomes does the tool measure? What are clinical outcome assessments. Need human intermediary to collect digital measures?
Defining Clinical Value
Defining Outcomes Value
Defining Economic Value
Defining Patient Experience Value
Defining Population health Value
Source: DiMe team analysis
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The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Crafting the value framework for the fit-for-purpose digital sensing products
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DRAFT FOR PUBLIC COMMENT
Tools that have better usability and operational features generally have improved adherence / data collection.
Human Factors (e.g., patient experience, acceptability, tolerability, site on body)
Battery life (e.g., length of use, charging break)
Water-resistance (e.g., shower-proof or not)
Interoperability (e.g., APIs, connectivity)
Firmware, operating systems (e.g., iOS, Android)
Patient experience factors
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Source: https://www.nature.com/articles/s41746-020-0237-3, Playbook team analysis
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What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
What’s is the reimbursement framework? What is risk/benefit budget impact model? Is cost a one-time or subscription model?
Any support for upfront capital?
Where, how long and how often is the tool worn? What’s the battery life? Technical support available? What’s tool compatibility? Easy to use and track?
Does it aim for value-based care for all patients? How does it manage & compile patient health data from tools?
What kind of outcomes does the tool measure? What are clinical outcome assessments. Need human intermediary to collect digital measures?
Defining Clinical Value
Defining Outcomes Value
Defining Economic Value
Defining Patient Experience Value
Defining Population health Value
Source: DiMe team analysis
18
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Crafting the value framework for the fit-for-purpose digital sensing products
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DRAFT FOR PUBLIC COMMENT
Source: Playbook team analysis
Sensor
Person/Patient Data Platform
Person generated data flow
Person generated data flow
Value elements in the digital measurement system
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
Algorithm & Data Science Platform
Digital Measurement
System
This is the combined technologies: the sensor, the algorithms, and the platforms used to manage the system.
Preparing and validating the digital measurement system will include:
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To optimize remote monitoring, non-traditional care providers must be considered as part of the ecosystem
Future work to optimize remote monitoring in clinical care must consider these non-traditional providers alongside well established healthcare systems and clinics embracing digital clinical measures.
The advent of digital measurement products has coincided with—and in some cases have been driven by—the growth of new approaches to clinical care. For example:
Many primary, preventative and urgent care services are now being delivered at retail locations (e.g., HealthHUB expansion by CVS and Walmart Health's Health Center).
“Virtual first” medical practices exist completely online and are not anchored to a traditional healthcare system or clinic (e.g., Amazon’s Oasis Medical Group, Omada Health, and Remedy) are flourishing.
Source: https://hbr.org/2020/07/how-to-make-remote-monitoring-tech-part-of-everyday-health-care, Playbook team analysis
The Playbook / Fundamentals for clinicians / Defining value to patients, clinicians and systems
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DRAFT FOR PUBLIC COMMENT
Now you’ve completed this learning module, “Defining value to patients, clinicians and systems”, what’s next?
Source: Playbook team analysis
The Playbook / Conclusion / Provide feedback
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