Session Chair: Marcia Stefanick, PhD

1. 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

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 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

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. 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 * 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 • 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

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