Pediatric icd registry next steps
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Pediatric ICD Registry Next Steps. Ralph Brindis, MD, MPH, ACC Stephen Hammill, MD, HRS Kathleen Hewitt, RN, MSN, CPHQ Christine Lang, RN, MSN. What is the NCDR?. 17 years in Evolution Benchmarks and Quality Improvement Standardized, evidence-based data collection

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Pediatric ICD Registry Next Steps

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Pediatric icd registry next steps

Pediatric ICD RegistryNext Steps

Ralph Brindis, MD, MPH, ACC

Stephen Hammill, MD, HRS

Kathleen Hewitt, RN, MSN, CPHQ

Christine Lang, RN, MSN


What is the ncdr

What is the NCDR?

  • 17 years in Evolution

  • Benchmarks and Quality Improvement

    • Standardized, evidence-based data collection

    • Quarterly benchmark reports

  • Performance Measurement Tool

  • Supports P4P and Pay for Reporting Programs

  • Platform for Outcomes Research

  • Solution of Post-Market Surveillance


Pediatric icd registry next steps

NCDR

Management

Board

Advisory Council

Industry

Federal

Health Plans

Patients

NCDR Operations Leadership Team

Scientific Oversight Committee

Data Safety Monitoring Board

Registries

Registry Projects

QIProjects

ambulatory

Committee structure

for each registry

ACTION Registry

IC3 Program

Steering Committee

Take ACTION Campaign

Planning Work Group

Steering

Committee

longitudinal

CathPCI Registry

ACHIEVE Registry

Steering Committee

NCDR-D2B Project

Managed by ACTION and CathPCI Steering Committees

Research &

Publications

longitudinal

ICD Registry

Clinical Support.Team

ICD Longitudinal Program

Steering Committee

QualityKIT/

CathKIT

TBD

QI Subcommittee

CARE Registry

Includes 30day

outcomes

Version 10/29/07


Ncdr is

NCDR is…

Ped.

Registry

Achieve

Building a true…

NationalCardioVascularDataRegistry

ICD Long

EP

Registry

Imaging

Registry

PracMgt

Registry

Congenital

Registry

PAD

Registry

IC3 CAD

ACTION

Registry

HF

Registry

CARE

Registry

CathPCI

Registry

ICD

Registry

1998…..20042005200620072008beyond


Magnitude of sca in the u s

Magnitude of SCA in the U.S.

167,366

Stroke3

SCA claims more lives each year than these other diseases combined

450,000

SCA4

LungCancer2

157,400

40,600

Breast Cancer2

42,156

AIDS1

1 U.S. Census Bureau, Statistical Abstract of the United States: 2001.

2 American Cancer Society, Inc., Surveillance Research, Cancer Facts and Figures2001.

3 2002Heart and Stroke Statistical Update, American Heart Association.

4 Zheng Z. Circulation. 2001;104:2158-2163.


Cms medicare coverage for icds 1990s

CMS (Medicare) Coverage for ICDs1990s

  • Cardiac arrest due to VF, not due to a reversible cause (effective 1991)

  • Spontaneous or induced VT, not associated with an acute MI or reversible cause (effective 1999)

  • Familial conditions at high risk such as LQTS, HCM (effective 1999)


What we don t know

The results of SCD-HeFT and MADIT I-II indicate that ICDs are effective for the primary prevention of sudden death. What we don’t know is if the results reflect the ICD experience in the “real world” outside the confines of the controlledtrials.

What we don’t know…..


Expanded cms coverage for primary prevention icds registry hypothesis

Expanded CMS Coverage for Primary Prevention ICDs Registry Hypothesis

Are the clinical characteristics, indications for ICD implantation, and in-hospital procedure related complications of the ICD Registry patients similar to those of patients involved in the primary prevention randomized trials

(MADIT I-II, SCD-HeFT )?


Icd data reporting

ICD Data Reporting

  • What will CMS do with the data?

    • Data will be used to determine that services provided are reasonable and necessary.

    • Address hypotheses related to patient characteristics, clinical indications, provider competency, complication variation across implanters, hospitals and device manufacturers.


Cms medicare coverage for icds expanded coverage 1 27 05

CMS (Medicare) Coverage for ICDsExpanded Coverage, 1/27/05

  • Cardiac arrest due to VF, not due to a reversible cause (effective 1991)

  • Spontaneous or induced VT, not associated with an acute MI or reversible cause (effective 1999)

  • Familial conditions at high risk such as LQTS, HCM (effective 1999, (Registry required)


Cms medicare coverage for icds expanded coverage 1 27 051

CMS (Medicare) Coverage for ICDsExpanded Coverage, 1/27/05

  • CAD, prior MI, EF 35% or less, inducible sustained VT (EP test and ICD implant >4 weeks after MI, (Registry required)

  • Documented prior MI, EF 30% or less (Registry required)

  • IDCM, prior MI, Class II-III, EF 35% or less (Registry required)


Cms medicare coverage for icds expanded coverage 1 27 052

CMS (Medicare) Coverage for ICDsExpanded Coverage, 1/27/05

  • Non-IDCM, >3 months, Class II-III, EF 35% or less (Registry required)

  • CRT candidates, Class IV

    • (Registry required)


Pediatric icd registry next steps

  • Partnership with The Heart Rhythm Society which is the preeminent professional advocacy society for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders.

  • HRS represents more than 4,200 specialists in cardiac pacing and electrophysiology in 78 countries Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards.


Cms expands icd coverage icd registry mandated

CMS Expands ICD Coverage –ICD Registry Mandated

  • September, 2004:

    • Draft CMS Coverage Policy indicates interest in ICD Registry

  • October, 2004:

    • CMS names Heart Rhythm Society to lead National ICD Registry Working Group. Working Group (ACC, HRS, HFSA, registry experts, private insurance co, device manufacturers, AHA) advises CMS on ICD Registry issues

  • January, 2005:

    • CMS Announces and Implements new expanded ICD coverage policy with new mandated registry requirement (QNET)

    • Why CMS required data submission?

      • Clinical trials (MADIT I-II, SCD-HeFT etc) results were promising but not definitive.

      • Additional data may allow CMS to broaden policy.


Cms expands icd coverage icd registry mandated1

CMS Expands ICD Coverage – ICD Registry Mandated

  • May, 2005:

  • National ICD Registry Working Group submits recommendations to CMS

  • June, 2005:NCDR ICD Registry Launches!

  • October, 2005: CMS Announcement that ICD Registry sponsored by ACC/HRS will be the official ICD Registry replacing QNET

  • April 30, 2006: QNET sunsets, ICD Registry becomes the sole data repository for hospitals across the US.


Pediatric icd registry next steps

Registry

  • 1493 enrolled

  • 200,580 patient records

  • 74% are submitting all pts. premier

  • 26% CMS limited

    Funding

  • 2007 support from WellPoint

  • Hospital fee $1,895

    Analytic & Reporting Services

  • In May UHC added ICD Registry participation for sites with EP Labs

  • Discussions underway with BCBSA

  • Provide data to CMS for reimbursement

    Research

  • ICD Longitudinal Study – TBD

    • Funding Industry and Payors

    • YALE CRO/Analytics

  • Performing analysis for FDA


Pediatric icd registry next steps

  • Online data collection tool features include:

  • Access from any web browser

  • Submit data to the NCDR™

  • Data completeness reminders


Icd registry operations update

ICD Registry Operations Update

  • Software Vendors (* indicates certified)

    • *Axis Clinical Software, Inc.;

    • Emageon (formerly Camtronics Medical Systems);

    • *Cedaron Medical, Inc.;

    • GE Healthcare;

    • Goodroe Healthcare Solutions, LLC:

    • *Heartbase;

    • Intelligent Business Solutions;

    • *LUMEDX;

    • Philips Medical Systems;

    • TenFold Corporation;

    • Velos, Inc.


The first icd outcomes report launched

The First ICD Outcomes Report Launched


The first icd outcomes report launched1

The First ICD Outcomes Report Launched

  • Each facility has a choice in which patients they submit to the NCDR.

  • Each ICD Registry participant will receive two reports—an ICD Premier report and a CMS Limited report. These reports contain data on different populations of patients.


Complications reported

Complications Reported


Support

Support

  • Dedicated IT staff

  • Dedicated Clinical staff

  • Dedicated Customer Service staff

  • Professionally-Driven


Training

Training

  • Annual User Group Meetings

  • Annual Workshops

  • Training Manual

  • Webinars

  • NCDR Online


Focus towards innovation and improvement

Focus Towards Innovation and Improvement

  • Streamline data collection = continuum of care v2.0

  • New online query tools

  • Real-time reporting


Pediatric icd registry the challenge

Pediatric ICD Registry: The Challenge

  • Assess and understand the dynamic changes in the diagnosis, treatment, and outcomes of pediatric ICD patients who are at risk for sudden cardiac death and congenital heart disease.

  • Provide a basis for measuring performance, designing quality improvement initiatives, and improving the outcomes of Pediatric ICD patients.


A growing need

A Growing Need

  • Information is limited on pediatric patients with or at risk for sudden cardiac death, particularly with respect to the use and outcomes of ICD procedures.

  • Accumulation of pediatric data would allow for significant contributions to the knowledge and outcomes associated with pediatric sudden cardiac death.

  • Collection of these data would facilitate performance measurement, benchmarking, and quality improvement efforts.


A growing need1

A Growing Need

  • The rapid evolution in medical technology/procedures and the continued growth of the adult population with congenital heart disease suggest that considerable knowledge may be gained from a broad assessment of the Pediatric ICD population.

  • Significant need to characterize variability in procedures and impact on patient outcomes.


National pediatric icd registry

National Pediatric ICD Registry

  • US registry of pediatric patients undergoing implantation of Implantable Cardioverter defibrillators.

    • Prevalence

    • Demographics

    • Acute management

    • Peri-procedural outcomes

    • In-hospital outcomes


Registry data

Registry Data

  • A review of the ICD Registry Q1 2005 to Q4 2006 data showed that there were 135 pediatric patients originally listed ( <18 yr). Of the listed patients, 94 of those patients were key errors and 41 of those patients were in fact pediatric patients. Of note, the majority of Pediatric patients receiving ICDs are not entered into the ICD Registry at this time since they are not Medicare beneficiaries.

  • Following are the ages for the correctly documented implanted pediatric ICD’s in the Registry:

  • 9 years old (1)

  • 10 years old (1)

  • 11 years old (4)

  • 12 years old (5)

  • 13 years old (2)

  • 14 years old (4)

  • 15 years old (8)

  • 16 years old (8)

  • 17 years old (8)


Proposal

Proposal

  • Initial focus would include inpatient data collection for pediatric patients receiving ICD’s for Primary or Secondary Prevention.

  • At this time no longitudinal data would be collected.

  • Inclusion of the pediatric population achieved by expanding current ICD Registry sites and a stand-alone pediatric ICD centers.


Proposal1

Proposal

  • Multi-center registry that would be web-based, with simple data collection variables.

  • Collection of data relating to a growing but poorly understood subset population of patients who benefit from ICD implantation procedures that have not been adequately controlled or measured from a quality perspective.

  • To date, no registry has successfully collected sufficient data to provide reliable information relating to the broader pediatric population undergoing ICD implantation procedures or real-world procedural outcomes.


Proposal2

Proposal

  • Estimated 120 dedicated pediatric care hospitals in the US, an additional 180 hospitals perform procedures for patients with CHD.

  • ICD Registry Steering Committee continue to engage national thought leaders in Pediatric Cardiology and Electrophysiology (PACES) to provide guidance and facilitate recruitment of the leading Pediatric ICD centers in the US.

  • Comprehensive communication and recruitment program will be developed to ensure rapid and successful recruitment of target hospitals.


In conclusion

In Conclusion

  • ICD Registry Steering Committee requests feedback and endorsements to expand the scope .

  • Purpose to assess prevalence, demographics, management, and outcomes of peds patients undergoing implantation for ICDs for sudden cardiac death.

  • Initial focus to include inpatient data collection for Primary or Secondary Prevention. At this time no longitudinal data would be collected.

  • Steering Committee members believe implementing will expand the NCDR registry network, and will significantly increase the ability to conduct outcomes research across the continuum of cardiovascular adult and pediatric patient care.


Pediatric icd registry next steps

If I can ditch them

by 4pm I can still play

The front nine!!

Do I always have to

wear this Red Dress?

When do we

get to go

to Disney World?


Questions

Questions


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