WHI Medicare Data. Joe Larson, Roberta Ray, Mary Pettinger September 9, 2016

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WHI Medicare Data Joe Larson, Roberta Ray, Mary Pettinger September 9, 2016

Outline Linkage between WHI and Medicare What is available on the Virtual Data Enclave (VDE) WHI Medicare Publications Agreement between Medicare and WHI Outcomes Suggested uses Analytic Issues

WHI CCC at Fred Hutch, through an Interagency Agreement with CMS, has obtained Medicare data linked to WHI participants. The DUA governs the use and sharing of the data.

Linkage between WHI and Medicare WHI has 161,808 participants 151,169 with a valid SSN were sent to CMS in a finder file 147,998 returned in linkage file from CMS 145,691 participants were then successfully linked by birth date, death date, and zip code 143,058 were matched exactly on birth and/or death date 2,633 were fuzzy matched using close birth/death dates and zip codes 54 participants were excluded for invalid Medicare enrollment type 145,637 participants had valid Medicare data post WHI enrollment

WHI Participants WHI Participants in Medicare Over Time 140000 120000 100000 80000 Any CMS 60000 FFS A+B MC 40000 20000 0 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Calendar Year

What is available on the VDE Enrollment MedPAR Outpatient CarrierB Durable Medical Equipment (DME) Home health Hospice

What is available on the VDE, cont. Files are presented as is from CMS, including denied claims, bad characters, and claims prior to WHI enrollment. Each enclave investigator should be responsible for their own cleaning of the data to ensure correct data use.

Enrollment File Current file: Data through 2012 Tracks participants Medicare status over WHI follow-up broken up into intervals defined by Medicare enrollment type. Fee For Service (FFS) A, B, or A+B Managed Care (HMO Enrolled) Participants have between 1 and 21 intervals

Enrollment File Participant total intervals Intervals N % 1 90081 61.9 2 35491 24.4 3 13076 9.0 4 4672 3.2 5 2317 1.6

Enrollment File id mdcrenrldt1 mdcrenddt1 mdcrstat1 mdcrelig1 mdcrenrldt2 mdcrenddt2 mdcrelig2 mdcrstat2 1 09/25/97 12/31/12 Medicare A+B Aged without ESRD.... 2 12/01/02 11/30/03 Medicare A Only Aged without ESRD 12/01/03 05/31/06 Aged without ESRD Medicare A+B 3 07/01/06 07/31/06 Medicare A+B Aged without ESRD 08/01/06 12/31/12 Aged without ESRD HMO Enrolled 4 03/19/98 02/28/02 HMO Enrolled Disabled without ESRD 03/01/02 12/31/12 Aged without ESRD Medicare A+B

Enrollment File Intervals change when Medicare type changes id mdcrenrldt1 mdcrenddt1 mdcrstat1 mdcrelig1 mdcrenrldt2 mdcrenddt2 mdcrelig2 mdcrstat2 1 09/25/97 12/31/12 Medicare A+B Aged without ESRD.... 2 12/01/02 11/30/03 Medicare A Only Aged without ESRD 12/01/03 05/31/06 Aged without ESRD Medicare A+B 3 07/01/06 07/31/06 Medicare A+B Aged without ESRD 08/01/06 12/31/12 Aged without ESRD HMO Enrolled 4 03/19/98 02/28/02 HMO Enrolled Disabled without ESRD 03/01/02 12/31/12 Aged without ESRD Medicare A+B

Enrollment File Intervals do not change when the eligibility reason changes; Eligibility status is the status at the start of the given interval id mdcrenrldt1 mdcrenddt1 mdcrstat1 mdcrelig1 mdcrenrldt2 mdcrenddt2 mdcrelig2 mdcrstat2 1 09/25/97 12/31/12 Medicare A+B Aged without ESRD.... 2 12/01/02 11/30/03 Medicare A Only Aged without ESRD 12/01/03 05/31/06 Aged without ESRD Medicare A+B 3 07/01/06 07/31/06 Medicare A+B Aged without ESRD 08/01/06 12/31/12 Aged without ESRD HMO Enrolled 4 03/19/98 02/28/02 HMO Enrolled Disabled without ESRD 03/01/02 12/31/12 Aged without ESRD Medicare A+B

MedPAR Includes both inpatient and skilled nursing facility (SNF) records Includes all facility charges, but not doctor or surgeon billing for visits in hospital Admission and discharge dates for each hospitalization Outcomes coded in 10 ICD-9 diagnosis code and 6 ICD-9 procedure code fields Next iteration of Medicare data will also include ICD-10

Outpatient Includes claims from hospital outpatient centers, ambulatory care surgical centers, rehabilitation facilities, rural health clinics, and community mental health centers Dates of service for each outpatient claim FROM_DT to THRU_DT 10 ICD-9 diagnosis codes (i.e. ICD_DGNS_CD1) 6 ICD-9 procedure codes (i.e. PRCDRCD1)

CarrierB Contains claims from individual physicians or specialists Also can include claims from clinical social workers, chiropractors, ambulances, nurse practitioners, and physician assistants. Dates of service for each claim FROM_DT to THRU_DT 10 ICD-9 diagnosis codes (i.e. ICD_DGNS_CD1)

Header Files vs. Line Items Most files are broken into header and line item files Header file contain ICD-9 codes Line item files contain additional information Healthcare Procedure Coding System Codes (HCPCS_CD) Provider specialty (HCFASPCL, Carrier only) Cost information (charge, payment, etc.) Merge records together by CLM_ID

Uses of the Medicare Billing Data in WHI WHI Medicare Publications Agreement between Medicare and WHI Outcomes Suggested uses

WHI Publications Using Medicare Data- Atrial Fibrillation Effects of postmenopausal hormone therapy on incident atrial fibrillation: the Women's Health Initiative randomized controlled trials. Perez MV, Wang PJ, Larson JC, et al. Circ Arrhythm Electrophysiol. 2012 Dec;5(6):1108-16. Risk factors for atrial fibrillation and their population burden in postmenopausal women: the Women's Health Initiative Observational Study. Perez MV, Wang PJ, Larson JC, et al. Heart. 2013 Aug;99(16):1173-8. Obesity, physical activity, and their interaction in incident atrial fibrillation in postmenopausal women. Azarbal F, Stefanick ML, Salmoirago-Blotcher E, et al. J Am Heart Assoc. 2014 Aug 20;3(4).

WHI Publications Using Medicare Data- Atrial Fibrillation, cont. Lean body mass and risk of incident atrial fibrillation in post-menopausal women. Azarbal F, Stefanick ML, Assimes TL, et al. Eur Heart J. 2016 May 21;37(20):1606-13. Racial and ethnic differences in atrial fibrillation risk factors and predictors in women: Findings from the Women's Health Initiative. Rodriguez F, Stefanick ML, Greenland P, et al. Am Heart J. 2016 Jun;176:70-7.

WHI Publications Using Medicare data Validity of diabetes self-reports in the Women's Health Initiative. Jackson JM, DeFor TA, Crain AL, Kerby TJ, et al. Menopause. 2014 Aug;21(8):861-8. Pre-existing diabetes and breast cancer prognosis among elderly women. Luo J, Hendryx M, Virnig B, et al. Br J Cancer. 2015 Sep 1;113(5):827-32. Use of administrative data to increase the practicality of clinical trials: Insights from the Women's Health Initiative. Anderson GL, Burns CJ, Larson J, Shaw PA. Clin Trials. 2016 Jun 30.

WHI Publications Using Medicare Data- Agreement between WHI and Medicare Cardiovascular Outcomes Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative. Hlatky MA, Ray RM, Burwen DR, et al. Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):157-62. Comparison of Medicare claims versus physician adjudication for identifying stroke outcomes in the Women's Health Initiative. Lakshminarayan K, Larson JC, Virnig B, et al. Stroke. 2014 Mar;45(3):815-21.

WHI Publications Using Medicare Data- Agreement between WHI and Medicare Cardiovascular Outcomes, cont. Evaluation of Medicare claims data to ascertain peripheral vascular events in the Women's Health Initiative. Mell MW, Pettinger M, Proulx-Burns L, et al. J Vasc Surg. 2014 Jul;60(1):98-105. Venous Thromboembolism Incidence, Recurrence, and Mortality Based on Data from the Women s Health Initiative and Medicare Claims. Burwen DR, Wu C, Cirillo D, et al. Submitted.

Agreement between WHI and Medicare Cardiovascular Outcomes Training set results Test set results Sensitivity PPV Kappa Sensitivity PPV Kappa Stroke 87 68 0.75 87 65 0.74 MI 79 71 0.74 79 78 0.77 CABG 94 89 0.91 95 93 0.94 PCI 90 86 0.88 86 85 0.85 VTE 81 65 0.71 83 69 0.75 Carotid 92 81 0.86 92 81 0.86 AAA 90 63 0.74 71 62 0.66 LE PAD 73 58 0.65 76 56 0.64 Adapted from How Well Do Medicare Claims Identify Cardiovascular Outcomes in the Women s Health Initiative? by Dale Burwen, presented by Garnet Anderson at the MESA Steering Committee Meeting, April 24-26, 2013

Agreement between WHI and Medicare Invasive Cancer Outcomes Invasive Cancer Site WHI Yes, Medicare Yes WHI No, Medicare Yes WHI Yes, Medicare No WHI No, Medicare No Sens. PPV Kappa Breast 3451 1562 56 98,302 98 69 0.80 Colorectal 1145 613 39 104,947 97 65 0.78 Endometrial 621 146 17 61,642 97 81 0.88 Lung 1236 634 63 105,468 95 66 0.78 Melanoma 357 785 24 105,353 94 31 0.47 Ovarian 353 372 19 86,168 95 49 0.64 Medicare-derived cancers based on presence of relevant ICD-9 codes in MedPar (inpatient data), any position, or the first occurring combination of 2 outpatient or carrier claims containing these codes that are 1-365 days apart. Median follow-up in WHI and Medicare was 7.5 years (Interquartile range 3.2 to 11.8 years). Diagnosis dates between the two sources were within ± 30 days for the majority.

Why Were Outcomes Found in Claims But Not in WHI? CVD outcomes Key reason for a Medicare event without a WHI match was lack of a WHI report of hospitalization (participant did not recall, or participant was disabled/deceased and there was no proxy report). In such cases, there was no adjudicated medical record that would correspond to the Medicare event.

Why Were Outcomes Found in Claims But Not in WHI? Cancer outcomes We found WHI adjudicated cancer outcomes at adjacent or related sites (including adjudicated in situ outcomes of the cancer of interest) for about half. Only 5% had no self-report of any cancer or hospitalization and as such, no information available that would have initiated an adjudication process.

Suggested Uses for Medicare Data Validation of other WHI-adjudicated outcomes CHF Hip fracture Outcomes not collected by WHI Incident events defined by presence of diagnosis and procedure codes Glaucoma, Cataract surgery, Carpal tunnel syndrome Screening Mammograms, Colonoscopy, Lipid testing

Suggested Uses for Medicare Data, cont. Health care cost, expenditures Post-outcome care Continuity of care after MI Cancer treatment LILAC study is assembling cancer treatment information for women with selected cancers

Breast cancer treatment codes Surgery Breast conserving surgery ICD-9 diagnosis ICD-9 Procedure 85.20-85.23, 85.25 Healthcare Common Procedure Coding system 19110, 19120, 19125, 19126, 19160, 19162, 19301, 19302 Mastectomy 85.33-85.48 19180-19255, 19303-19307 Radiation V58.0, V66.1 V67.1 92.21-92.29 77401-77425, 77520-77525, 77750-77799, G0173, G0251, G0256, G0261, G0339, G0340 77427-77499, 77300-77399, G0243 19296, 19297, 19298, C9714, C9715, 0073T, G0174, 0082T, Revenue Center Codes: 0330, 0333 Chemotherapy V58.1, V66.2, V67.2 99.25 964XX, 965XX, Q0083-Q0085, J9000- J9999, J8510, J8520, J8521, J8530- J8999, G0355-G0362 Revenue center (0331, 0332, 0335) J Luo. Pre-existing diabetes and breast cancer prognosis among elderly women. Br J Cancer 2015. Supplement table 1.

Suggested Uses for Medicare Data, cont. Disease recurrence Challenging to assess if specific diagnosis codes for recurrence do not exist (e.g., cancer) Involves algorithm development in order to infer recurrence LILAC study is working on algorithms for breast, colorectal, and endometrial cancers

Analytic Issues Defining the study sample Exclusions Medicare coverage period Generalizability

Benefit Program - Original reason for entitlement: Among total linked to Medicare (N=145,637) Old Age and Survivors Insurance (OAIS) % 96.1 Disability Insurance Benefit (DIB) 3.9 End Stage Renal Disease (ESRD) 0.04 Both DIB and ESRD 0.01

Age at enrollment into Medicare: Based on first interval of coverage in WHI 63 years n=4,147 (2.9%) 64 years* n=70,815 (48.6%) 65 years n=70,675 (48.5%) * Coverage starts the first day of the month when the participant turns 65, or if born on the first of the month, starts at the beginning of the prior month.

Type of Coverage At WHI enrollment or when aged in: Among total linked to Medicare (N=145,637) N (%) Not enrolled 41 (0.03%) Medicare Advantage (aka: Managed Care, HMO, Part C) Fee-for-service (FFS) 30,981 (21.3%) Medicare Part A only (inpatient) 19,420 (13.3%) Medicare Part B only (outpatient and clinic/office visits) 757 (0.5%) Medicare Parts A and B 94,438 (64.8%)

Other possible exclusions: Denied claims Skilled Nursing Facility (SNF) claims in MedPAR Claims prior to WHI enrollment (not all WHI participants will have them) Length of coverage Require look-back period for defining prevalent disease

Medicare Enrollment Period Should analysis start at enrollment or allow participants to age into Medicare? N=68,556 (47.1%) linked participants were in Medicare at WHI enrollment Allow gaps in coverage?, i.e. change from FFS to MC and then back to FFS

Generalizability Are FFS beneficiaries in WHI representative of the overall WHI-Medicare linked sample? Recall ~25-35% are enrolled in Managed Care

Type of Coverage Over Time

Characteristics of Participants in FFS vs HMO, by Race/Ethnicity 100% 90% 80% 70% 60% 50% 40% 30% Am Indian Asian/PI Hispanic Black White 20% 10% 0% Total FFS MC

Characteristics of Participants in FFS vs HMO, by Education 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Total FFS MC <HS HS/GED Post HS College

Characteristics of Participants in FFS vs HMO, by Income 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Total FFS MC <$20K $20-<$35K $35-<$50K $50-<$75K $75K

Characteristics of Participants in FFS vs HMO, by Geographic Region 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Total FFS MC West Midwest South Northeast

Conclusion: FFS beneficiaries in WHI are fairly representative of the overall WHI-Medicare sample, although lower SES/minority women are underrepresented differences in coverage by geographic region exist Abstract:: Habermann et al, Medicare studies limited to fee-for-service beneficiaries: How generalizable are the results? ihea 9 th World Congress on Health Economics, July 2013

Important!! Restrictions when using CMS data: 1. Must adhere to CMS current cell size suppression policy. This policy stipulates that no cell size of 10 or less may be displayed. Also, no use of percentages or other mathematical formulas may be used if they result in the display of a cell 10 or less. 2. Written manuscripts must be approved by the WHI Publications & Presentation Committee, and will also be sent to CMS prior to submission for publication.

Helpful Resources Research Data Assistance Center (ResDAC) is a CMS contractor providing free assistance to users of CMS data for research: www.resdac.org* *Website has valuable training videos on use of Medicare data; also offers classes

Helpful Resources CMS Chronic Conditions Data Warehouse (CCW) source of data, and also provides useful algorithms for defining chronic conditions from claims 27 chronic conditions, for ex: alzheimer s, diabetes, lung cancer, hip fracture, stroke 33 other chronic or potentially disabling conditions, for ex: anxiety disorders, fibromyalgia, viral hepatitis Website: https://www.ccwdata.org/web/guest/conditi on-categories

Helpful Resources Join or reach out to WHI SIG on Health Services & Comparative Effectiveness, led by Karen Margolis (Karen.L.Margolis@HealthPartners.com)