1. Women’s Health Initiative Scientific Symposium May 3-4 2012
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
Cardiovascular SIG and Health Services Research SIG
Session Chair: Marcia Stefanick, PhD
Medicare Linkage to WHI: Progress Since May 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

2. Medicare Linkage to WHI: 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

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

4. Why Medicare Data are Important to WHI
During the 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

5. Why Medicare Data are Important to WHI (cont.)
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

6. Advantages of Medicare Data
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

7. WHI CMS Implementation Working Group
Garnet Anderson
Mary Pettinger
Ross Prentice
Karen Margolis
Beth Virnig
Marian Limacher
Dale Burwen

8. 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

9. WHI CMS Implementation
Working Groups
CHD
WHI CMS Implementation
Group
Stroke
HSR SIG
CVD-DM Subgroup HF
VTE
PAD

10. Validation Strategy
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

11. Validation Strategy (cont.)
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

12. Progress Report Topic* Status of Validation Effort 1
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.
* Potential future topics: Atrial fibrillation, Valvular disease, Dementia

13. Medicare Data Update 1991-2007 data previously linked by CCC
e.g., MedPAR, Carrier, Outpatient, Home Health, Hospice
received by CCC in February 2012
2011 onwards to be requested annually
Part D prescription drug data request
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

14. Data Security 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

15. Foundation for Future Research
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