Comprehensive Surveillance of Kidney Disease in the United States

1. Surveillance of Kidney Disease Principles and Practice Rajiv Saran, MBBS, MD, MRCP, MS Florence E. Bingham Professor of Nephrology Professor of Medicine and Epidemiology Director, USRDS Coordinating Center University of Michigan Ann Arbor, Michigan

2. Public Health Surveillance – Systems: (Significance / Purpose) • Surveillance is fundamental to the practice of modern public health • It is vitally important to have data and information required to characterize the epidemiology of the disease/condition • Guide public health intervention for population health improvement • Advocacy, decision making, program planning and implementation

3. COLLECT LINK TO PUBLIC HEALTH PRACTICE ANALYZE DISSEMINATE INTERPRET Public Health Surveillance – Definition “Ongoing, systematic, collection, analysis and interpretation of health data essential to the planning, implementation and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know”and ACT upon that information Thacker and Berkelman, 1988

4. Types of Surveillance • Passive • Utilize already collected data typically for other purposes (e.g., health care claims, death and birth registries, census data) • Passively accumulating data in health systems (EMR based) • Active • Community-wide screening efforts (e.g., BRFSS, NHANES, WHO STEPS Surveys, NKF’s - KEEP) • Ongoing, population-based cohort studies (Framingham, DOPPS)

5. Desirable Attributes of a Surveillance System • Simple • Quality • Timely • Representative • Well-defined denominator • Sensitive • Specific • Flexible • Stable & • Sustainable Impactful

6. Key Examples ofKidney Disease Specific Surveillance Systems [in the US] • US Renal Data System (USRDS) • CDC – CKD Surveillance System • VA Renal Information System (VA REINS)

7. Comprehensive Surveillance & Epidemiology of Kidney Disease in the United States

8. USRDS: Major Objectives • High Quality Epidemiology & Surveillance of Kidney Disease for the United States • “The finest kidney disease data system in the world!” – Dr. Paul Eggers, NIDDK • A go to resource for data and trends related to kidney disease for the US • Conduct and Stimulate Research, Inform Public Health Priorities and Policy: • Conduct and Facilitate High Impact Research that impacts policy and practice

9. USRDS Annual Data Report – 2017 www.usrds.org

10. ESRD Database at the University of Michigan – KECC • Development of the ESRD Database began in 1988, with the first USRDS contract (Dr. Philip Held, PhD, Director) • Covers a broad spectrum of patient information • Over 3 million patients • Over a trillion events • e.g., dialysis sessions, transplants, deaths, hospitalizations • Contains information on ~ 7,000 facilities in the United States

11. Sources of Medicare ESRD Database • CMS ESRD Sources • CROWNWeb • Medicare Claims • Part A • Part B • Part D • Enrollment Database • Dialysis Facility Data ESRD Database • CMS/OPTN Data Source • Transplant Data

12. Trends in the Annual Number of ESRD Incident Cases, by Modality, in the U.S. population, 1980-2015

13. Map of the Adjusted Incidence Rate of ESRD, by Health Service Area, in the U.S. Population2011-2015 Data Source: Special analyses, USRDS ESRD Database. Standardized for age, sex, and race. The standard population was the U.S. population in 2011. Values for cells with 10 or fewer patients are suppressed. Abbreviation: ESRD, end-stage renal disease.

14. Lifetime Risk of ESRD in the United States(2013) Cumulative incidence (%) of ESRD from birth to age 100+, by race/ethnicity(a) Males (b) Females Albertus, P. et al. Am J Kid Dis 2016 Albertus, P. et al. Am J Kid Dis 2016

15. Day of the Week and Emergency Room Visits by Hemodialysis Schedule Zhang S, Morgenstern H, He K, Albertus P, Nallamothu B, Saran R. Submitted

16. www.cdc.gov/ckd/surveillance

18. BURDEN OF CKD RISK FACTORS AWARENESS of CKD MAJOR TOPICS PROCESSES OFCARE HEALTH OUTCOMES HEALTH SYSTEM CAPACITY Saran et al. CJASN 2010

19. Data Sources CKD in the US National Surveys NHANES BRFSS Health Care Administrative Data CMS, VAHS Managed Care Data Special Populations Children Elderly Nat American Uninsured Medicaid Large Cohort Studies CRIC, CKID ARIC National Registries SRTR USRDS (ESRD) Saran et al. CJASN 2010 19

20. US State-Level Awareness of CKD Dharmarajan S, et al. Am J Prev Med 2017

21. Provider ‘Awareness’ of CKD has been Low but Increasing • eGFR defined by MDRD, using outpatient creatinine values • Provider documentation = ICD9 codes • 2005-2012 26.9%  41.4% CKD Surveillance System- United States website: http://nccd.cdc.gov/CKD

22. The Veterans Affairs Renal Information System (VA-REINS) An Introduction / Overview

23. Background • High prevalence and high cost of kidney disease amongst US veterans • A need was recognized to develop a comprehensive kidney disease data system that could potentially serve both operational and research needs for the Department of Veterans Affairs • The VAREnalINformationSystem (VA-REINS) was conceptualized and developed by a team at the University of Michigan • Under a contract with the Department of Veterans Affairs’ Office of Innovation • In collaboration with a VA Advisory Group

24. VA-REINS Conceptual Framework: Data Sources

25. Prevalence of CKD Among US Veterans

26. Aggregate VA Spending on VA Users with CKDFY 2006 – FY 2014 Aggregate spending is defined as total spending both internal and external to the VA and allocated to the care received by VA users identified as having CKD. Total spending may not be specific to, or attributable, to CKD per se.

27. VA-REINS: Potential Functions – 1 • Population Health Management for CKD • Identify individuals at risk for CKD or progression • Reporting and Evaluative Function • Quality Measures for CKD • Point-of-care (POC) patient management • POC Dashboards • Decision Support • Link with PCMH / Telehealth / Patient portal

28. VA-REINS: Potential Functions – 2 • Research Function : • In the future, the VA-REINS could also be used to provide datasets for analysis to researchers upon request. • Disease Information System: • The principles utilized in the development of VA-REINS have the potential to be leveraged for other conditions such as diabetes, hypertension, cardiovascular disease, mental health, etc.

29. COLLECT LINK TO PUBLIC HEALTH PRACTICE ANALYZE DISSEMINATE INTERPRET Public Health Surveillance – Definition “Ongoing, systematic, collection, analysis and interpretation of health data essential to the planning, implementation and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know”and ACT upon that information Thacker and Berkelman, 1988

30. Analogy to a Learning Health System Courtesy Charles Friedman, PhD Courtesy Charles Friedman, PhD

31. The LHS Learns and Improves through “Virtuous, Rapid Cycles” of Study and Change Interpret Results Analyze Data Tailored Messages Assemble Data Take Action Record Actions Courtesy Charles Friedman, PhD

32. The Big Idea:A Health System or Community Can Learn & Improve • Every participating patient’s characteristics and experience are available to learn from • Best practice knowledge is immediately available to support decisions • Improvement is continuous through ongoing study • An infrastructure enables this to happen routinely and with economy of scale • All of this is part of the culture Courtesy Charles Friedman, PhD

33. Thank You – The USRDS Team !

34. Thank You CDC-CKD Surveillance Team!

35. Thank You: VA–REINS Team!

36. CKD Data Sources – 1 • NHANES (National Health and Nutrition Examination Survey) • Conducted by the CDC and the National Center for Health Statistics • Random stratified sample of the US population • Frequency: Biannual (every 2 years) • BRFSS: Behavior Risk Factor Surveillance System • State-level phone survey conducted by state health departments with CDC oversight

37. CKD Data Sources – 2 • Medicare 5% sample for those covered (majority are >65years old) • 1.1 million each year • National Veteran Health System Data • 8 million veterans actively seeking health care in the VA • Employer Based Insurance: Data on younger, employed population and their dependents: from a national health insurance company, has data on all age groups – Clinformatics Data Mart

38. vol 2 Figure 1.1 Trends in the (a) unadjusted and standardized incidence rates of ESRD, and (b) the annual percentage change in the standardized incidence rate of ESRD in the U.S. population, 1980-2015 (a) Incidence rate per million/year Data Source: Reference Table A.2(2) and special analyses, USRDS ESRD Database. Standardized for age, sex, and race. The standard population was the U.S. population in 2011. Abbreviation: ESRD, end-stage renal disease.

39. State-level SMR by % with >12months of Pre-ESRD Care Gillespie BW et al. Clin Kidney J. 2015;8(6):772-780

40. Awareness of CKD: Key to Improving Health Outcomes Provider Awareness Guideline-Based Care Health Outcomes Patient Awareness Behavior Change

41. Variation in Self-Reported CKD by State Estimated prevalence of self-reported kidney disease by state. BRFSS participants ages 18 and older, 2014 (n=464,617) https://www.usrds.org/2016

42. Objectives • To develop a high quality data system (with individual patient-level data) within the framework of VA’s existing IT infrastructure, that is capable of facilitating: • Surveillance of all aspects of kidney disease (at national, regional, facility and provider level) • Population health management • Continuous Quality Improvement • Facilitate direct patient care • Learning health system culture

43. Cost of VA Care for CKD • Total VHA spending for VA users with CKD has increased by 63% (26% increase when adjusted for inflation) • 12 billion in FY 2006 • 19 billion in FY 2014 • Over 75% of spending has been for stage 3A or 3B CKD • Majority of CKD users have stage 3A or 3B CKD • Cost per patient is highest for CKD Stage 5

44. Estimating Prevalence of CKD using Health System Data: Issues • Data collected for clinical/administrative purposes • Testing for creatinine and urine protein is not universal, and reflects clinical practice • Choosing the appropriate denominator critical • Applying KDIGO definition has potential to under estimate prevalence

45. Prevalence of CKD Among US Veterans • As part of the development of a VA Renal Information System (VA-REINS) for the US Department of Veterans Affairs, we sought to: • Explore ‘operational definitions’ of CKD to guide population health management of kidney disease for veterans utilizing the VA Healthcare System • Estimate the prevalence of CKD among ‘VA users’ during FY 2006-2014

46. Average VA Costs ($) per Patient per Year, by CKD Stage, FY 2006-2014

47. VA REINS Current Status and Future Potential

48. VA-REINS: Current Status – 1 • A (Foundational) VA Renal Information System (VA-REINS) – dedicated to coverage of all aspects of kidney disease, has been created for the National VA Health System • It builds upon VA’s existing IT infrastructure in VA’s corporate data warehouse (CDW) linked with data sources extrinsic to the VA, primarily derived from Medicare and National ESRD Databases

49. VA-REINS: Current Status – 2 • CKD, AKI, ESRD Surveillance: • VA-REINS can allow accurate and timely tracking of the burden of kidney disease (AKI, CKD, ESRD, individuals with risk factors for kidney disease) and kidney disease-related outcomes • Cost Tracking: • VA-REINS can be used to track the cost of kidney disease management (both in the VA health system and care that VA pays for to external entities – so called ‘fee-basis’ costs) to help inform cost-efficient care for US veterans while improving quality of care

50. COLLECT COLLECT LINK TO PUBLIC HEALTH PRACTICE LINK TO PUBLIC HEALTH PRACTICE ANALYZE ANALYZE DISSEMINATE DISSEMINATE INTERPRET INTERPRET Public Health Surveillance “Ongoing, systematic, collection, analysis and interpretation of health data essential to the planning, implementation and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know” Thacker and Berkelman, 1988 Thacker and Berkelman, 1988