Heart Rhythm 2008Heart Rhythm 2008

San Francisco San Francisco

May 15, 2008May 15, 2008

Stephen Hammill, MDStephen Hammill, MD

Heart Rhythm 2008Heart Rhythm 2008

San Francisco San Francisco

May 15, 2008May 15, 2008

Stephen Hammill, MDStephen Hammill, MD

CP1262561-1

Using the ICD Registry to Evaluate Using the ICD Registry to Evaluate Practice Patterns and Improve QualityPractice Patterns and Improve Quality

Overview of the Development of the ICD Overview of the Development of the ICD RegistryRegistry

Using the ICD Registry to Evaluate Using the ICD Registry to Evaluate Practice Patterns and Improve QualityPractice Patterns and Improve Quality

Overview of the Development of the ICD Overview of the Development of the ICD RegistryRegistry

ICD RegistryHighlights to Date

ICD RegistryHighlights to Date

CP1262561-2

• 1,490 hospitals

• >260,000 implants (+10,000/month)

55% are primary prevention CMS patients

• 88% of implants from hospitals entering all patients (1° and 2° prevention, all ages)

• Version 2.0 in development

• Longitudinal registry developed (CED)

• Research and publications in progress

• 1,490 hospitals

• >260,000 implants (+10,000/month)

55% are primary prevention CMS patients

• 88% of implants from hospitals entering all patients (1° and 2° prevention, all ages)

• Version 2.0 in development

• Longitudinal registry developed (CED)

• Research and publications in progress

Getting to this pointGetting to this pointand moving forwardand moving forward

ICD RegistryDeveloping the Baseline Registry

ICD RegistryDeveloping the Baseline Registry

CP1262561-3

9/28/04: CMS published proposed NCD• Following SCD-HeFT release• National data base proposed• HRS asked to chair the Working Group to develop

the registry

9/28/04: CMS published proposed NCD• Following SCD-HeFT release• National data base proposed• HRS asked to chair the Working Group to develop

the registry

National ICD Registry Working GroupNational ICD Registry Working Group

HRS, chair ACCHFSA AHAMedtronic BiotronikGuidant St JudeBCBS NCDRUnited HealthCare AetnaAm Hlth Ins Plans AHRQFDA Am Hosp AssocCMS At large members

HRS, chair ACCHFSA AHAMedtronic BiotronikGuidant St JudeBCBS NCDRUnited HealthCare AetnaAm Hlth Ins Plans AHRQFDA Am Hosp AssocCMS At large members

ICD RegistryDeveloping the Baseline Registry

ICD RegistryDeveloping the Baseline Registry

CP1262561-3

9/28/04: CMS published proposed NCD• Following SCD-HeFT release• National data base proposed• HRS asked to chair the Working Group to develop

the registry

11/22/04: Working Group recommendations sent to CMS• Purpose of the registry• Patients to be enrolled• Patient and device data elements to be collected• Defining providers as competent and qualified to

implant ICDs

9/28/04: CMS published proposed NCD• Following SCD-HeFT release• National data base proposed• HRS asked to chair the Working Group to develop

the registry

11/22/04: Working Group recommendations sent to CMS• Purpose of the registry• Patients to be enrolled• Patient and device data elements to be collected• Defining providers as competent and qualified to

implant ICDs

ICD RegistryDeveloping the Baseline Registry

ICD RegistryDeveloping the Baseline Registry

CP1262561-4

1/27/05: CMS published final NCD• Expanded ICD indications

• CED process described

• Data collection using QNet

Temporary data collection tool

1/27/05: CMS published final NCD• Expanded ICD indications

• CED process described

• Data collection using QNet

Temporary data collection tool

CEDCoverage with evidence development

“Develop evidence on what works best in clinical practice . . . explicit, rapid, evidence based on a process that is predictable with transparency . . . to improve the knowledge base by which patients and providers can make better treatment decisions.”

Mark McClellanAdministrator, CMS2/14/05 Conference call

CEDCoverage with evidence development

“Develop evidence on what works best in clinical practice . . . explicit, rapid, evidence based on a process that is predictable with transparency . . . to improve the knowledge base by which patients and providers can make better treatment decisions.”

Mark McClellanAdministrator, CMS2/14/05 Conference call

ICD RegistryDeveloping the Baseline Registry

ICD RegistryDeveloping the Baseline Registry

CP1262561-4

1/27/05: CMS published final NCD• Expanded indications

• CED process described

• Data collection using QNet

Temporary data collection tool

3/05: HRS asked to reconvene the Working Group• Define questions that should be answered

• Define the core characteristics of a national clinical registry

5/19/05: Recommendations sent to CMS

1/27/05: CMS published final NCD• Expanded indications

• CED process described

• Data collection using QNet

Temporary data collection tool

3/05: HRS asked to reconvene the Working Group• Define questions that should be answered

• Define the core characteristics of a national clinical registry

5/19/05: Recommendations sent to CMS

ICD RegistryDeveloping the Baseline Registry

ICD RegistryDeveloping the Baseline Registry

CP1262561-5

10/27/05: CMS selected the ICD Registry developed by ACC and HRS based on the NCDR

10/27/05: CMS selected the ICD Registry developed by ACC and HRS based on the NCDR

ICD RegistryDeveloping the Baseline Registry

ICD RegistryDeveloping the Baseline Registry

CP1262561-5

10/27/05: CMS selected the ICD Registry developed by ACC and HRS based on the NCDR

1/1/06: All data submitted to ICD Registry; QNet phased out 4/1/06

• Hospitals encouraged to submit data on all patients

SCD-HeFT – median age 60 yrs Medicare – median age 74 yrs

10/27/05: CMS selected the ICD Registry developed by ACC and HRS based on the NCDR

1/1/06: All data submitted to ICD Registry; QNet phased out 4/1/06

• Hospitals encouraged to submit data on all patients

SCD-HeFT – median age 60 yrs Medicare – median age 74 yrs

ICD RegistryDeveloping the Baseline Registry

ICD RegistryDeveloping the Baseline Registry

CP1262561-5

10/27/05: CMS selected the ICD Registry developed by ACC and HRS based on the NCDR

1/1/06: All data submitted to ICD Registry; QNet phased out 4/1/06

• Hospitals encouraged to submit data on all patients

SCD-HeFT – median age 60 yrs Medicare – median age 74 yrs

4/07: Quarterly benchmarking reports sent to hospitals• Data Quality Reporting process

• Random auditing

10/27/05: CMS selected the ICD Registry developed by ACC and HRS based on the NCDR

1/1/06: All data submitted to ICD Registry; QNet phased out 4/1/06

• Hospitals encouraged to submit data on all patients

SCD-HeFT – median age 60 yrs Medicare – median age 74 yrs

4/07: Quarterly benchmarking reports sent to hospitals• Data Quality Reporting process

• Random auditing

ICD Registry Data Quality Program

National Onsite Audit ProgramAnnual review

• 10% random sample of eligible sites

• Comparative analysis of audit findings and site’s original data submission (MD training discrepancy, lack of complications, etc)

National Onsite Audit ProgramAnnual review

• 10% random sample of eligible sites

• Comparative analysis of audit findings and site’s original data submission (MD training discrepancy, lack of complications, etc)

Why is Benchmarking Important to Hospitals?Why is Benchmarking Important to Hospitals?

Quarterly benchmarking compares a hospital’s outcomes with hospitals of similar size and a national aggregate

• Improved Patient Care

• Meet State Regulations and Payer Requirements

• Detect Inefficiencies

• Improved resource utilization

Quarterly benchmarking compares a hospital’s outcomes with hospitals of similar size and a national aggregate

• Improved Patient Care

• Meet State Regulations and Payer Requirements

• Detect Inefficiencies

• Improved resource utilization

Potential Benefits of the RegistryPotential Benefits of the Registry

• Reveal the degree to which clinicians are managing a disease in accordance with evidence-based medicine

• Enable clinicians to compare their own outcomes with those of other MDs

• Provide insights for clinical investigation

• Highlight a product’s performance outside of clinical trial constraints

• Reveal the degree to which clinicians are managing a disease in accordance with evidence-based medicine

• Enable clinicians to compare their own outcomes with those of other MDs

• Provide insights for clinical investigation

• Highlight a product’s performance outside of clinical trial constraints

Hammill, Phurrough, Brindis. HeartRhythm, 2006Hammill, Phurrough, Brindis. HeartRhythm, 2006Hammill, Phurrough, Brindis. HeartRhythm, 2006Hammill, Phurrough, Brindis. HeartRhythm, 2006

Potential Benefits of the RegistryPotential Benefits of the Registry

• Provide a detailed view of the morbidity, mortality, and resource utilization associated with a particular disease

• Perform local hospital needs for QA and QI

• Serve as a hospital and physician response to “Pay for Performance” initiatives of health plans

• Provide a detailed view of the morbidity, mortality, and resource utilization associated with a particular disease

• Perform local hospital needs for QA and QI

• Serve as a hospital and physician response to “Pay for Performance” initiatives of health plans

Hammill, Phurrough, Brindis. HeartRhythm, 2006Hammill, Phurrough, Brindis. HeartRhythm, 2006Hammill, Phurrough, Brindis. HeartRhythm, 2006Hammill, Phurrough, Brindis. HeartRhythm, 2006

ICD RegistryA “Quality Improvement Tool” AHRQ

ICD RegistryA “Quality Improvement Tool” AHRQ

CP1262561-5

“Observational registries can quickly accumulate large amounts of data on real-world practice and effectiveness of new treatments and procedures. Physicians and hospitals can use these data to further QI efforts at a local level and physician associations can evaluate data to determine the effectiveness of existing clinical guidelines.”

“Observational registries can quickly accumulate large amounts of data on real-world practice and effectiveness of new treatments and procedures. Physicians and hospitals can use these data to further QI efforts at a local level and physician associations can evaluate data to determine the effectiveness of existing clinical guidelines.”

Registries for Evaluating Patient Outcomes:Registries for Evaluating Patient Outcomes: A User’s Guide.A User’s Guide.

Agency for Health Care Research and QualityAgency for Health Care Research and Quality

Are payors and providersAre payors and providers adversaries or partners?adversaries or partners?

Hospital and Hospital and PhysicianPhysicianProfilingProfiling

CMSCMSHealth PlansHealth Plans

State and FederalState and FederalLawmakersLawmakers

State Departments State Departments Of HealthOf Health

PatientsPatientsAnd FamiliesAnd Families

InsurersInsurers

Administrative data Administrative data versus versus

Clinical dataClinical data

CP1265452-1

Conclusions – Cardiac surgery report cards using administrative data are problematic compared with those derived from audited and validated clinical data, primarily because of case misclassification and nonstandarized end points.

FLFL

MAMA

OO NJNJ

CACA MDMDILIL

MIMI

WVWV

State Regulators Are Using the Cath NCDR®

State Regulators Are Using the Cath NCDR®

Regulation PassedRegulation Pending Regulation PassedRegulation Pending

PAPAIAIA

ALAL

Payers and the ICD RegistryPayers and the ICD Registry

• May 24, 2007: “United Health Care, ACC and HRS announced an initiative that will improve patient care by expanding the collection and use of clinical outcomes data for heart rhythm devices by cardiac care facilities, cardiac surgeons, cardiologists, and other healthcare professionals”

• Hospitals seeking designation as a United Health Premium Cardiac Specialty Center will be required to submit data to the National ICD Registry

• May 24, 2007: “United Health Care, ACC and HRS announced an initiative that will improve patient care by expanding the collection and use of clinical outcomes data for heart rhythm devices by cardiac care facilities, cardiac surgeons, cardiologists, and other healthcare professionals”

• Hospitals seeking designation as a United Health Premium Cardiac Specialty Center will be required to submit data to the National ICD Registry

Developing the Developing the Longitudinal RegistryLongitudinal Registry

to Answer the CED Questionsto Answer the CED Questions

Developing the Developing the Longitudinal RegistryLongitudinal Registry

to Answer the CED Questionsto Answer the CED Questions

CP1262561-6

““It is particularly important that these It is particularly important that these factors factors (ICD firing data and survival)(ICD firing data and survival) be be determined in the actual population determined in the actual population receiving ICDs, who are older and receiving ICDs, who are older and present more comorbidities than present more comorbidities than represented in the trial populations. represented in the trial populations. Fortunately, these key factors will be Fortunately, these key factors will be tracked in the ICD Registry”tracked in the ICD Registry”

Lynne Warner Stevenson, MDLynne Warner Stevenson, MDCirculation. 2006;114:101Circulation. 2006;114:101

CED QuestionsCED QuestionsCED QuestionsCED Questions

• EF 31-15%EF 31-15%

• Non-ischemic cardiomyopathy Non-ischemic cardiomyopathy <9 months<9 months

• Class IV CRT-D patientsClass IV CRT-D patients

• EF 31-15%EF 31-15%

• Non-ischemic cardiomyopathy Non-ischemic cardiomyopathy <9 months<9 months

• Class IV CRT-D patientsClass IV CRT-D patients

Longitudinal RegistryStudy Design

Longitudinal RegistryStudy Design

CP1262561-13

• Primary endpointPrimary endpointFirst delivery of an appropriate ICD therapy First delivery of an appropriate ICD therapy (shock, ATP)(shock, ATP)

• Secondary endpointSecondary endpointSurvival probability at 3 and 5 yearsSurvival probability at 3 and 5 yearsDeath from CV causeDeath from CV causeTotal # and rate of device therapiesTotal # and rate of device therapiesRatio of inappropriate to total device Ratio of inappropriate to total device therapiestherapies

• Primary endpointPrimary endpointFirst delivery of an appropriate ICD therapy First delivery of an appropriate ICD therapy (shock, ATP)(shock, ATP)

• Secondary endpointSecondary endpointSurvival probability at 3 and 5 yearsSurvival probability at 3 and 5 yearsDeath from CV causeDeath from CV causeTotal # and rate of device therapiesTotal # and rate of device therapiesRatio of inappropriate to total device Ratio of inappropriate to total device therapiestherapies

Longitudinal RegistryStudy Design

Longitudinal RegistryStudy Design

CP1262561-14

• 350 randomly selected implanting MDs350 randomly selected implanting MDs

• 3,500 patients followed 3 years for events and 3,500 patients followed 3 years for events and 5 years for survival5 years for survival

Based on 10% rate of appropriate Based on 10% rate of appropriate therapy at 3 years (15% at 3 years in therapy at 3 years (15% at 3 years in SCD-SCD-HeFT)HeFT)

• Device therapy follow-upDevice therapy follow-up

Every 3 months for a minimum of 3 yearsEvery 3 months for a minimum of 3 years

Adjudication processAdjudication process

Data combined with NDI and Medicare Data combined with NDI and Medicare claims dataclaims data

• 350 randomly selected implanting MDs350 randomly selected implanting MDs

• 3,500 patients followed 3 years for events and 3,500 patients followed 3 years for events and 5 years for survival5 years for survival

Based on 10% rate of appropriate Based on 10% rate of appropriate therapy at 3 years (15% at 3 years in therapy at 3 years (15% at 3 years in SCD-SCD-HeFT)HeFT)

• Device therapy follow-upDevice therapy follow-up

Every 3 months for a minimum of 3 yearsEvery 3 months for a minimum of 3 years

Adjudication processAdjudication process

Data combined with NDI and Medicare Data combined with NDI and Medicare claims dataclaims data

ICD RegistryVersion 2.0 – Updating the Registry

ICD RegistryVersion 2.0 – Updating the Registry

CP1262561-17

• Redefine the registry purpose, target audience

• Enhance the data collection forms

• Add leads -- implant, revision, replacement

• Make the registry a performance reporting tool (Guidelines)

• Post market surveillance (FDA Sentinel Network)

• Coordinate with longitudinal data – Medicare Claims Data, National Death Index

• Redefine the registry purpose, target audience

• Enhance the data collection forms

• Add leads -- implant, revision, replacement

• Make the registry a performance reporting tool (Guidelines)

• Post market surveillance (FDA Sentinel Network)

• Coordinate with longitudinal data – Medicare Claims Data, National Death Index

ICD RegistryResearch and Publications

ICD RegistryResearch and Publications

CP1262561-20

• Research requests are reviewed and prioritized by R&P Subcommittee

34+ requests to date

• ICD-Registry provides financial support for data analysis

• Yale CORE assists with data analysis

• 6 abstracts presented at AHA, 11/07

• 5 manuscripts

• Research requests are reviewed and prioritized by R&P Subcommittee

34+ requests to date

• ICD-Registry provides financial support for data analysis

• Yale CORE assists with data analysis

• 6 abstracts presented at AHA, 11/07

• 5 manuscripts

Why a Registry?Why a Registry?

Science tells us what we can do;Science tells us what we can do;Guidelines what we should do; and Guidelines what we should do; and Registries what we are actually Registries what we are actually doingdoing.

Lukas Kappenberger MDLukas Kappenberger MDHRS ICD Policy ConferenceHRS ICD Policy ConferenceWashington DC, 9/16/05Washington DC, 9/16/05

Science tells us what we can do;Science tells us what we can do;Guidelines what we should do; and Guidelines what we should do; and Registries what we are actually Registries what we are actually doingdoing.

Lukas Kappenberger MDLukas Kappenberger MDHRS ICD Policy ConferenceHRS ICD Policy ConferenceWashington DC, 9/16/05Washington DC, 9/16/05