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

Cohort of Postmenopausal WomenWomen’s Health Initiative Scientific Symposium May 3-4 2012

Cardiovascular SIG and Health Services Research SIG

Session Chair: Marcia Stefanick, PhDMedicare 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 Kamakshi Lakshminarayan, 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 Data Karen Margolis, MD,

MPH

Panel Discussion: Future HSR-CV research Mark Hlatky, MD, Beth Virnig, PhD

Medicare Linkage to WHI:Progress Since May 2011

Dale Burwen, MD, MPHMedical Officer

Women’s Health Initiative BranchPopulation and Prevention Sciences Program

Division of Cardiovascular SciencesNational Heart, Lung, and Blood Institute

WHI Investigator MeetingMay 4, 2012

Why Medicare data are important to WHI WHI CMS implementation working group Validation strategy Progress report Medicare Data Update Foundation for future research

Outline

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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

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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

Why Medicare Data are Important to WHI (cont.)

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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

Advantages of Medicare Data

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Garnet Anderson Mary Pettinger Ross Prentice Karen Margolis Beth Virnig Marian Limacher Dale Burwen

WHI CMS Implementation Working Group

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

WHI CMS Implementation Working Group

Working Groups

WHI CMS Implementation

Group

CHD

Stroke

PAD

HF

VTE

HSR SIGCVD-DM Subgroup

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

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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

Validation Strategy (cont.)

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Topic* Status of Validation Effort1 Coronary disease (e.g.,

myocardial infarction, revascularization)

Paper proposal approved. Focuses on comparing hormone trial results using Medicare versus WHI outcomes.

2 Stroke Paper proposal approved. Focuses on validation using neurologist adjudicated events.

3 Peripheral artery disease

Paper proposal approved. One paper on validation; another on hormone therapy analysis.

4 Venous thromboembolism

Working group drafting paper proposal that will include validation and broader analyses.

5 Heart failure Working group brainstorming about validation and broader analyses.

Progress Report

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

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

Medicare Data Update

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

Data Security

Foundation for Future Research

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

Outcomes AnalysesHealth Services Research

ValidationMethods Development

Data EnclaveMedicare Linkage

Outcomes AnalysesHealth Services Research

ValidationMethods Development

Data EnclaveMedicare Linkage