CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

September 2016

DARTMOUTH DEVICE DEVELOPMENT SYMPOSIUM

Lonny Reisman, MD, FACC

CEO and Founder

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CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

DEVICE EVALUATION BY PAYERS AND MECHANISMS FOR IMPLEMENTATION

•  Medical necessity à Clinical policy bulletins

•  Coverage à Plan design

•  Medical cost implications à Premium

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CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

ROLE OF BIG DATA

•  Clinical policy bulletins –  Collaboration on value-based studies

•  Plan design –  Access –  Adherence

•  Trend –  Transition to value (revenue vs. per member per month

orientation) •  Fee for service to bundled payments/ACOs

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BansilalS,etal.AssessingtheImpactofMedica,onAdherenceonLong-TermCardiovascularOutcomes.JAmCollCardiol.2016;68(8):789-801.

QUALITY-DRIVEN COST REDUCTION ADHERENCE TO GUIDELINE-D IRECTED STATINS/ACE INHIB ITORS Y IELDS S IGNIF ICANT VALUE

CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

ROLE OF BIG DATA

•  Clinical policy bulletins –  Collaboration on value-based studies

•  Plan design

–  Access –  Adherence

•  Trend –  Transition to value (revenue vs. per member per month

orientation) •  Fee for service to bundled payments/ACOs

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CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

PAYER-GENERATED DATA TO DRIVE INSIGHTS ABOUT PATIENT ADHERENCE

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CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

ROLE OF BIG DATA

•  Clinical policy bulletins –  Collaboration on value-based studies

•  Plan design

–  Access –  Adherence

•  Trend –  Transition to value (revenue vs. per member per month

orientation) •  Fee for service to bundled payments/ACOs

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CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

PREVAILING APPROACHES USING BIG DATA

•  Predictive analytics –  Detect high-risk patients (deploy traditional managed care

programs) –  Statistical vs. evidence-based

•  Adverse selection –  Attract and retain low-risk patients –  Risk-adjusted analytics for high-risk patients

•  New pricing models

–  Pay for performance –  Bundles –  Global capitation

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AORTIC VALVE REPLACEMENT

•  Medical necessity – evidence-based

•  Coverage – dictated by risk bearer

•  Medical cost implications –  Payment models –  Patient access –  Adverse selection

•  Quality measurement

–  Adequacy of identification of patients and associated outcomes –  Temporal considerations –  Measurement vs. improvement

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MERGING EVIDENCE-BASED STANDARDS WITH READILY AVAILABLE CLINICAL DATA DATA FOR ONE PATIENT

CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

MERGING EVIDENCE-BASED STANDARDS WITH READILY AVAILABLE CLINICAL DATA CLINICAL RULES FOR ONE CONDITION

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CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

TheAmericanHeartAssocia,onrecommendsthatpa,entswithsevereaor,cstenosisasevidencedbythepresenceofsystolicdysfunc,onhaveanaor,cvalvereplacementunlessotherwisecontraindicated.

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Data:

References:NishimuraRAetal.2014AHA/ACCguidelineforthemanagementofpa,entswithvalvularheartdisease:areportoftheAmericanCollegeofCardiology/AmericanHeartAssocia,onTaskForceonPrac,ceGuidelines.JAmCollCardiol.2014;63(22):e57-185.

MERGING EVIDENCE-BASED STANDARDS WITH READILY AVAILABLE CLINICAL DATA OUTPUT PROVIDES RECOMMENDATION, PERTINENT DATA, AND REFERENCES

CompanyConfiden,al–HealthReveal,Inc.–PleaseDoNotDistribute

CONCLUSION

•  Health plans have access to significant data and analytic capabilities

•  Medical necessity is determined by information derived from outside sources like clinical trials and regulatory bodies

•  Analytics are focused on risk mitigation and cost projections

•  Opportunities exist for device manufacturers to collaborate with payers to optimize appropriate access to life-saving technologies

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