1. The National ESRD Program and HIT Infrastructure The Forum of ESRD Networks 3/9/2011

2. ESRD NETWORK REPRESENTATIVES Louis Diamond, MB, ChB, FACP President, Quality Healthcare Consultants Franklin W. Maddux, MD, FACP Senior Vice President; Chief Medical Information Officer, Fresenius Medical Care of North America Jenny Kitsen Executive Director, ESRD Network of New England, Inc. Nancy Armistead, MPA Executive Director, Mid-Atlantic Renal Coalition 3/9/2011

3. OBJECTIVES Discuss the current state of HIT infrastructure in support of oversight of the ESRD and CKD programs Discuss how to fill the gap between the current state and the evolving national HIT Infrastructure Identify next steps 3/9/2011

4. OUTLINE Outline the ESRD and CKD programs Describe the Network structure and programs Outline the current of the HIT infrastructures Make recommendations for next steps 3/9/2011

5. ESRD PROGRAM 440,000 Medicare beneficiaries with ESRD 1.3% of Medicare population consuming 7.9% of Medicare’s Budget ($26.8 Billion annually) 5,574 Dialysis Providers 31% Fresenius Medical Care (FMC) 28% DaVita 4% Dialysis Center, Inc. (DCI) 35% Independent/Regional Chains 2% Military/State/Veterans Medicare’s 1st bundled payment and Quality Incentive Program 3/9/2011

6. QUALITY METRICS Vascular Access ◦ 54.7% of patients dialyze with AV Fistula (AVF) ◦ 81.8% of patients start dialysis with a central venous catheter (CVC) Anemia Management ◦ 61.5% of patients have a hemoglobin between 10-12 gm/dL  6.2% of patients have hemoglobin < 10 gm/dL  15.9% of patients have hemoglobin > 12.1 gm/dL Dialysis Adequacy ◦ 95.3% of patients have Kt/v > 1.2 Mortality ◦ 1 year mortality approximately 20% 3/9/2011

7. DISTRIBUTION OF MEDICARE PATIENTS & COSTS FOR CKD, CHF, DIABETES, & ESRD: 2008 FIGURE P.1 (CONTINUED; VOLUME 2) Period prevalent general (fee-for-service) Medicare patients. Diabetes, CKD, & CHF determined from claims, 1997–1998 & 2007– 2008; costs are for calendar years 1998 & 2008. 3/9/2011

8. NETWORK BACKGROUND Networks currently focus on Vascular Access (Fistula First & Catheter Reduction) Patient Safety End of Life and Palliative Care Emergency Preparedness Health Acquired Infections Clinical Management – Anemia & Adequacy CrownWeb There are 18 Networks under contract with CMS to conduct quality improvement initiatives, provide technical assistance, maintain data systems and process patient complaints and grievances. 3/9/2011

9. CKD-ESRD CONTINUUM Adverse outcomes of chronic kidney disease can often be prevented or delayed through early detection and treatment 26 million American adults have CKD and millions of others are at increased risk. Diabetes, hypertension and cardiovascular disease are much more common in patients with CKD than those without CKD In 2008 the prevalence of CKD in Medicare patients reached 7.6%, up from 1.7% in 1995 3/9/2011

10. PRIORITIES FOR THE NATIONAL KIDNEY FAILURE PREVENTION & TREATMENT PROGRAM 2012-2021 1. Prevent health care association infections 2. Promote efforts to develop and deploy appropriate and efficient care transition processes 3. Provide beneficiary protection services 4. Improve timely referral of patients with chronic kidney disease 5. Deploy shared decision making tools to prevent ESRD, promote informed modality choice, advocate for appropriate mental health interventions, teach health literacy, and promote rehabilitation 3/9/2011

11. GOAL For patients with CKD and ESRD, over time and across settings Better care for individuals Better care for populations Lower costs through improvement 3/9/2011

12. Ref: NPP 2010 3/9/2011

13. HIT INFRASTRUCTURE CMS Claims data REMIS (Renal Management Information System) STAR (Surveyor Technical Assistance for Renal Disease) CROWNWeb ◦ SIMS (Standard Information Management System) ◦ National Renal Administrator Association – health information exchange ◦ eLab (electronic laboratory data collection) 3/9/2011

14. HIT INFRASTRUCTURE CONTINUED USRDS (United States Renal Data System) UMKECC (University of Michigan Kidney Epidemiology Cost Center) UNOS (United Network of Organ Sharing) One LDO Example 3/9/2011

15. CROWNWEB Consolidated Renal Operations in a Web-enabled Network CrownWeb is intended to be a secure, web-based system that captures clinical and administrative data from dialysis facilities and will replace many of the paper- based data-collection methods currently utilized The system has been in production since 1998 with no definitive date for full implementation announced 3/9/2011

16. CROWNWEB 3/9/2011

17. CROWNWEB Examples of Challenges in Design and Data Model Validation Rules ◦ Vascular Access Date inconsistency ◦ Residual Renal Function exclusion ◦ Lab Data rejection and inconsistencies Design and Data Model Errors ◦ Withdrawals and Date of Death exclusiveness ◦ Iron Infusion Data incomplete ◦ Batch and Single User Interface conflicts ◦ Patient Matching incompatibilities ◦ Non NQF approved measure collection 3/9/2011

18. ELAB PROJECT Electronic collection of hemodialysis and peritoneal dialysis clinical laboratory indicators for the fourth quarter of each year Started in 1998 by Network 11 and expanded to all 18 Networks 2009 data collection represented 97% of all patients receiving dialysis Measures collected ◦ Anemia management ◦ Dialysis adequacy ◦ Nutrition ◦ Bone and mineral metabolism Development of Facility-specific reports providing comparison at facility, State, Network and US levels for quality improvement 3/9/2011

19. FRESENIUS MEDICAL CARE A Large Dialysis Organization Internal Clinical Applications (eCube ® Brand) ◦ 1850 facilities, 35,000 POC connected workstations ◦ ~140,000 patients dialyzing with 10,000 at home ◦ ~1,000 Acute Hospital Based Dialysis Programs External Clinical Applications (Acumen ® Brand) ◦ CCHIT, ONC Certified EHR for Nephrology ◦ 200+ Practices, PQR Registry Reporting Health Information Exchange ◦ CROWNWEB, Fistula First, USRDS, CPMs ◦ > 600 data interchanges Analytical Data Warehouse ◦ Reporting & Research 3/9/2011

20. MEANINGFUL USERS ---BUT NOT ELIGIBLE Multiple Venues of Care ◦ Hospitals: 13 hospitalization days per patient per year ◦ Clinical Laboratories: 30 lab tests per patient per month ◦ Pharmacies: 8 to 14 drugs per patient ◦ Vascular Centers: 1.5 vascular interventions per patient per year ◦ Patient Home Setting: 8% dialyze in the home (moving to 12+%) 3/9/2011

21. ISSUES HIT infrastructure build out and plan needed A national infrastructure exists and can be built upon Existing efforts lack co-ordination Current efforts not standards based CROWNWeb not a component of an overarching plan Dialysis facilities not included under ARRA and MU 3/9/2011

22. IDEAL NEXT STEPS Describe and analyze the current state of HIT infrastructure Map current state to the Meaningful Use (MU) requirements and ESRD program needs and identify the gaps Facilitate policies and standards to support business model for the ESRD program Develop a phased implementation plan to bridge the gap identified, including exploration of avenues to include dialysis facilities and the home setting into the CMS MU directed incentive program Explore avenues to showcase current experience Secure support and funding to conduct these activities Create a public-private sector group to coordinate activities 3/9/2011