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CARE Registry Insights to the Future. <Insert Presenter’s Name>. <Insert Event> <Insert Location> <Insert Date>. CP1262561-1. CMS. Participant Training. Partners. ACC. Follow-up. Institutional Reports. FAQs. Organization of Data. National Coverage Decision. Insurance Payors.
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CARE RegistryInsights to the Future <Insert Presenter’s Name> <Insert Event> <Insert Location> <Insert Date> CP1262561-1
CMS Participant Training Partners ACC Follow-up Institutional Reports FAQs Organization of Data National Coverage Decision Insurance Payors Hypertension EVA-3s Trial Stroke Proposed Coverage Decision AAN Site Profile SCAI Software Vendors Anti-Platelet Therapy Symptomatic AANS and CNS Embolic Protection Device Audit Carotid Stenting What’s important RIGHT NOW? Submitting Data SVMB Arterial Access Closure Method Carotid Duplex Ultrasound SIR Transient Ischemic Attack NASCET Trial Executive Summary Post-Procedure LOS ARCHeR FDA CAPTURE Carotid Endarterectomy High Risk for CEA Institutional Repositories Search Engines and Research User Interface Design
Carotid StentingUnique programmatic issues Why is this procedure different from all other procedures? • Organ system and Disease state • Unique anatomy, pathol, access, response to intervention • Procedure • New skill sets and different equipment • Unique access considerations • High risk; no room for error…Little errors cause a lot of hurt • Must be “on” all the time…never let guard down…
Carotid StentingUnique programmatic issues (cont.) • Milieu • Multidisciplinary disease • many specialties traditionally involved and have “stake” • unprecedented level of peer review and scrutiny • unique opportunity to set quality standards and benchmarks which cross specialty lines
CMS Coverage Decision • March 2005 – New coverage decision released • CMS agreed: • CAS with embolic protection is reasonable & necessary for certain populations of symptomatic and asymptomatic patients • Must use FDA approved devices • Covered under Category B IDE clinical trials and post-approval studies
AAN AANS/CNS ACC ACR ASITN ASNR SCAI SIR SVMB SVS March 2005Medical Societies Unite • In March 2005 stakeholder organizations met to discuss carotid stenting • All agreed to support the development of standardized data elements and definitions that would be used by Carotid Registries
May 2005Created a Definition Workgroup Workgroup Charge • Identify key questions to guide development of data elements and definitions • Create a standard set of elements and definitions
May – December 2005Evidenced-Based Definitions The Workgroup Reviewed • Clinical trials data elements • CMS coverage decision • Other occlusive disease registries • Clinical literature
Dec. 2005Type or Data Included • Patient demographics (e.g. age, race) • Patient identification – links patient records across data tables • Clinical risk factors • Procedural description • Outcomes reporting • Performance measurement • Risk Adjustment – Mortality/Adverse Outcomes • Health Services Research • Follow-up
Jan – May 2005CEA Added • Workgroup recognized the value of being able to compare Carotid Stent and CEA outcomes
Aug. 2006Alpha Test Review • 8 Participants reviewed the data elements, data collection form, and definitions
Aug. 2006Alpha Test Review 8 Participants reviewed the data elements, data collection form, and definitions The Purpose of the Alpha Test • “Feasibility Check” • Assess flow of form • Identify gaps or difficulties in data collection • Comprehension of data elements and definitions in practice • Who’s collecting data?
The CARE Registry was Launched September 2006 !!
Moving Forward • Meeting with CMS, FDA, Industry Stakeholders and Competitors • Focusing on Data Harmonization • Meet CMS-recommended benchmarks to • Determine appropriateness • Reimbursement • Measure for Data Consistency and Completeness • Begin using Outcomes Data for future research “Make Success Measurable”
Data Harmonization Guiding Principles: • Data harmonization is a process not a project and should begin as early as possible. • Identify key internal and external stakeholders. • Engage existing and potential stakeholders. • Understand and agree on scope of initiative. • Define requirements. • Review best practices. • Select a methodology and appropriate tools. • Identify relevant information exchanges and the data systems that support them. • Concepts and definitions must be universally accepted within the Community of Practice. • Publish work product so it can be consumed by practitioners and technologists.
Thank You Questions?
