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Cardiovascular Health Services Research: Maximizing the Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women Women’s Health Initiative Scientific Symposium May 3-4 2012 Cardiovascular SIG and Health Services Research SIG. Session Chair: Marcia Stefanick, PhD

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Cardiovascular Health Services Research: Maximizing the Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

Women’s Health Initiative Scientific Symposium May 3-4 2012

Cardiovascular SIG and Health Services Research SIG

Session Chair: Marcia Stefanick, PhD

Medicare Linkage to WHI: Progress Since May 2011 Dale Burwen, MD, MPH

CHD Outcomes Among Medicare - Eligible Women in WHI Mark Hlatky, MD

Validation of Acute Stroke in Medicare Data against WHI

KamakshiLakshminarayan, MD, PhD - presented by Dale Burwen, MD, MPH

Atrial Fibrillation in the WHI Hormone Trials and Observational Study: Findings with and without inclusion of CMS data Marco Perez, MD

CV Analyses Underway Using Medicare DataKaren Margolis, MD, MPH

Panel Discussion: Future HSR-CV research

Mark Hlatky, MD, Beth Virnig, PhD


Medicare linkage to whi progress since may 2011

Medicare Linkage to WHI: Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

Progress Since May 2011

Dale Burwen, MD, MPH

Medical Officer

Women’s Health Initiative Branch

Population and Prevention Sciences Program

Division of Cardiovascular Sciences

National Heart, Lung, and Blood Institute

WHI Investigator Meeting

May 4, 2012


Outline
Outline Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

Why Medicare data are important to WHI

WHI CMS implementation working group

Validation strategy

Progress report

Medicare Data Update

Foundation for future research


Why medicare data are important to whi
Why Medicare Data are Important to WHI Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

  • During the 2010-2015 extension, medical record sub-cohort is limited to 24% of participants

  • For 76% of participants, only self-report (of hospitalization or particular outcomes) will be available from WHI

    • Reliant on participant’s understanding of diagnosis and memory

    • Corroboration using standardized observable data is desirable

  • Medicare data may be a cost-effective approach to corroborate outcomes


Why medicare data are important to whi cont
Why Medicare Data are Important to WHI (cont.) Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

  • Virtually all current participants are >65 years old, and thus eligible for Medicare

    • Among those who were age eligible at baseline, 2/3 were enrolled in fee-for-service Medicare

    • Claims data are available for those enrolled in fee-for-service Medicare

  • Key outcomes increase substantially with age, outpacing resources for medical record review

  • Medicare data can potentially provide outcome data on a large proportion of WHI participants


Advantages of medicare data
Advantages of Medicare Data Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

  • Provide rich information about coded diagnoses and procedures in all settings, e.g.,

    • Inpatient, institutional outpatient, physicians’ offices, home health, hospice

  • Provide outcomes on an expanded sample

  • Include follow-up on former participants

  • Record all episodes of care, including subsequent events that may not be ascertained in WHI

  • Provide healthcare utilization and cost data, which can facilitate health services research

  • Link with WHI data for rich detail regarding participant characteristics


Whi cms implementation working group
WHI CMS Implementation Working Group Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

Garnet Anderson

Mary Pettinger

Ross Prentice

Karen Margolis

Beth Virnig

Marian Limacher

Dale Burwen


Whi cms implementation working group1
WHI CMS Implementation Working Group Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

To ensure program goals are met

To help optimize use of CMS data in WHI

To facilitate efficiency by addressing cross-cutting issues

To bring together expertise in both CMS and WHI data

To contribute methodologic expertise


Working groups
Working Groups Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

CHD

WHI CMS Implementation

Group

Stroke

HSR SIG

CVD-DM Subgroup

HF

VTE

PAD


Validation strategy
Validation Strategy Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

  • Validation effort initiated to assess whether Medicare data can be used for cardiovascular outcomes in WHI

  • Products envisioned for each outcome:

    • Useful coding algorithm

    • Publication of algorithm performance

      • e.g., sensitivity, specificity, PPV, NPV, kappa

      • May be a whole paper, or a paragraph or appendix in a paper focusing on a broader analysis


Validation strategy cont
Validation Strategy (cont.) Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

  • Validation is a highly important goal, but it is an intermediate goal

  • Ultimate goal is to demonstrate usefulness of Medicare data in WHI for

    • Outcomes analyses

    • Health services research

  • Some of the papers will combine validation and application in additional analyses

  • Working groups may serve as focal points for stimulating additional paper proposals using the Medicare outcomes


Progress report
Progress Report Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

* Potential future topics: Atrial fibrillation, Valvular disease, Dementia


Medicare data update
Medicare Data Update Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

  • 1991-2007 data previously linked by CCC

    • e.g., MedPAR, Carrier, Outpatient, Home Health, Hospice

  • 2008-2010 received by CCC in February 2012

  • 2011 onwards to be requested annually

  • Part D prescription drug data request 2006-2010

    • Submitted April 2012 for review before forwarding to CMS

  • Virtual Data Enclave

    • Potentially will allow access by field investigators

    • Description submitted as part of data use agreement (DUA)

  • Await CMS Privacy Board approval of DUA

  • WHI policies and processes for access are under development


Data security
Data Security Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

  • Medicare data are research identifiable files

  • CMS Data Use Agreement (DUA)

    • Describes purposes of use

    • Requires appropriate administrative, technical and physical safeguards

    • Indicates penalties for unauthorized disclosure

    • Requires destruction of data at end

  • Field sites using proposed data enclave need to be aware of security issues

  • WHI should be proactive in implementing best practices


Foundation for future research
Foundation for Future Research Value of CMS Linkage to the Unique Database of the WHI Cohort of Postmenopausal Women

  • Toolbox being developed to effectively use Medicare data within the WHI program

Outcomes Analyses

Health Services Research

Validation

Methods Development

Data Enclave

Medicare Linkage

Outcomes Analyses

Health Services Research

Validation

Methods Development

Data Enclave

Medicare Linkage


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