1. Network of New England 20 th Annual Meeting Where We Have Been and New Challenges in the Care of ESRD Patients Douglas Shemin, M.D. Jenny Kitsen October 16, 2008 Sturbridge, MA

3. Clyde Shields, first patient in the United States on chronic hemodialysis, Seattle, 1961

4. Who shall live? Who shall die? Shana Alexander, Life Magazine 1962

5. Hemodialysis Patients before 1972 l Dialyzed in some community, nonprofit centers and hospitals l Pilot programs in the VA and USPH systems l United Auto Workers members after 1971 l Predominately working aged men free of vascular disease and diabetes l No children or adolescents

7. Arguing for Public Law 92-603 l How do we explain that the difference between life and death is a matter of dollars? How do we explain that those who are wealthy have a greater chance to enjoy a longer life than those who are not? l Sen. Vance Hartke, (Indiana), 1972

8. Arguing for Public Law 92-603 l 60 % of them (prospective dialysis patients) with only a minor degree of retraining, and 40 % can return to their original employment with no retraining whatsoever. l -Sen. Vance Hartke, (Indiana), 1972

9. ESRD: 1972 vs. 2005 l 19722005*** l % on home HD40 %**< 1 % l % diabetes 5 %**45 % l Male/Female2.7**1.2 l Mean age44**58 l % Caucasian91 %*62 % l High school graduate73 %* l Married95 %* l 2 year mortality rate17 %**36 % l * Evans, JAMA 1981 l ** Lowrie, NEJM 1973 l *** USRDS

10. ESRD: 1973 vs 2005 l 1973*2005 ** l Dialysis patients10,000350,000 l ESRD Medicare costs283 million20 billion l Total Medicare costs14 billion350 billion l ESRD/Medicare costs2 %7 % l Reimbursement$ 607***$131 l * Levinsky, NEJM 1981 l ** USRDS l *** adjusted for 2005 dollars

11. ESRD Network Organization l ESRD Medicare Program Public Law 92-603 in 1972. l Medicare coverage for ESRD began July 1973 l ESRD remains the only disease based Medicare based entitlement in the United States l ESRD Network Coordinating Councils (32 areas) established in 1978, consolidated to 18 networks in 1988 l ESRD Networks were chartered by Congress to examine and insure quality in ESRD care, which is ultimately funded by United States Medicare beneficiaries and taxpayers.

12. ESRD Network Organization l Network Organizations are independent contractors. Performance evaluated by CMS annually. 2/18 networks now administered by QIOs 16/18 administered by fulltime staff committed to and knowledgeable about ESRD, and supported by volunteer dialysis professionals living and working in the geographic area they represent l Contracts renewed every 3 years based on performance. l Network of New England, Inc. (not-for-profit corporation) has held the ESRD Network contract for 31 years. l Most recent CMS contract effective July 1, 2006 for three years.

13. What do the Networks do? l Manage data (demographics, comorbidity, mortality information) on > 400,000 patients in > 4000 facilities l Quality assessment: identify QI needs on a local level, institute and administer QI projects, offer assistance to underperforming facilities l Respond to grievances, complaints, concerns by patients, families, and facilities. l Disaster Planning Coordination (new) l Special projects

14. Kidney Community Emergency Response (KCER) Coalition www.KCERcoalition.com l KCER is a national coalition formed in 2006 to ensure that national resources are in place to assist state and local response efforts in the event of a disaster. l Comprised of partners in renal community representing: –patient and professional organizations –practitioners, such as nurses, technicians, dietitians, social workers, and physicians; –providers, including independent dialysis facilities, large dialysis organizations and transplant facilities; –hospitals; –suppliers; –ESRD Networks; –state emergency and survey representatives –federal agencies, including the FDA, CDC, NIH and CMS.

16. New England Provider Distribution

17. Patients with ESRD, Network 1 December 31, 2007 l Center HDHome HDPDTotal Connecticut2,926175233,466 Maine8601670946 Massachusetts4,671604445,175 New Hampshire676276754 Rhode Island891328922 Vermont277612295 Total10,301 (89 %)104 (1 %)1,198 (10 %)11,588

18. Most Significant Medical Challenges in our Future l Disease burden l Hospitalizations l Transplants for patients

19. Unadjusted rates of diabetes in the U.S. population, by age Data from the National Diabetes Surveillance System, at http://www.cdc.gov/diabetes/statistics/prev/national/figage.htm.

20. Incident counts of ESRD patients with diabetes as primary diagnosis Incident ESRD patients.

21. Hospitalization Rates

22. Cumulative incidence of infectious hospitalizations at 36 months Incident dialysis & first-time, kidney-only transplant patients with Medicare as primary payor, 1995–2002 combined.

23. Adjusted Five-year Survival, by First Modality

24. Wait list counts & listings Patients listed for kidney or kidney-pancreas transplant on December 31 of each year.

25. Most Significant ESRD Program Challenges l Increased Medicare costs for ESRD Program l Lack of professionals to care for ESRD patients l New ESRD Conditions for Coverage = Medicare certification as provider of service

26. Distribution of Medicare Patients and Cost

27. Medicare Improvements for Patients and Provider Act (MIPPI) Passed in 2008 l By 1/1/2011 Medicare will have a fully bundled payment system for ESRD including drugs l Providers must meet specific standards for quality of care based on case mix adjustments. If not, reduction in payment to providers l Adjustment in payment for geographic areas and unique patient population l Educational outreach for patients with Chronic Kidney Disease

28. New Conditions for Coverage* Key Provisions l Patient safety –Infection control –Water and dialysate quality –Reuse of hemodialyzers and bloodline –Physical environment *Available on Network website plus final interpretive guidelines www.networkofnewengland.orgwww.networkofnewengland.org

29. Key Provisions l Patient care –Patients rights –Patient assessment –Patient plan of care –Home care –Quality assessment and performance improvement (QAPI) –Special purpose dialysis facilities

30. Key Provisions l Administration –Personnel qualifications –Responsibilities of the Medical Director –Medical records –Governance

31. §494.80 Patient Assessment l Criteria for assessment –Current health status –Appropriateness of dialysis prescription, blood pressure and fluid management needs –Laboratory profile, immunization and medication history –Anemia management –Bone disease management –Nutritional status –Psychosocial needs, including family and other support systems –Access type –Patient goals including modality and setting (home vs. in-center) –Suitability for transplant –Evaluation of physical activity level –Evaluation for referral to vocational and/or physical rehabilitation services

32. §494.90 Patient Plan of Care l Required components of plan of care –Dose of dialysis –Nutritional status –Mineral metabolism –Anemia –Vascular access –Psychosocial status –Modality –Home dialysis –Transplantation status –Rehabilitation

33. §494.110 QAPI l Program scope must include, but not be limited to, the following: –Adequacy of dialysis –Nutritional status –Mineral metabolism and renal bone disease –Anemia management –Vascular access –Medical injuries and medical errors identification –Hemodialyzer reuse –Patient satisfaction and grievances –Infection control

34. §494.150 Responsibilities of the Medical Director l Responsible for the delivery of patient care and outcomes of the facility l Accountable to the governing body l Responsibilities include –QAPI program –Staff education, training and performance –Oversight of development, periodic review and adherence to of facility policies and procedures

35. Effective Dates New Conditions for Coverage 6 months 10/14/2008 Life Safety Code and Separate room for HBsAg+ patients 300 days 2/9/2009 Certification of technicians hired after 10/4/2008 18 months from hire Certification of existing technicians 24 months 4/15/2010 Electronic Data Submission As of 2/1/2009, every facility must electronically submit data on all patients, including data on clinical performance measures to CMS.

36. l Release of final Interpretive Guidelines –October 3, 2008 l Provider Training for CROWNWeb (one day training) –6 Sessions 1/12/2009, 1/13/2009 & 1/14/2009 (Westborough, MA) 1/16/2009, 1/19/2009, 1/20/2009 (Nashua, NH) CMS Deployment Plan

37. Technical Assistance Program Network of New England on Conditions for Coverage November 13 th 2008 9:00AM to 1:00PM Limited Space

38. 5 Diamond Patient Safety Program ESRD Network of New England (Network 1) Mid-Atlantic Renal Coalition (Network 5)

39. Objectives l To promote patient safety values l To create an awareness of patient safety issues l To help dialysis units learn more about specific areas of patient safety l To build a patient safety culture in every dialysis unit

40. Components l Hand Hygiene l Flu Vaccination l Slips, Trips and Falls l Medication Reconciliation l Emergency Preparedness l Sharps Safety l Decreasing Patient & Provider Conflict Under Development Staff Adherence to Procedures Dialyzer Set-up Errors Patient Safety Principles (required)

41. Components l Each topic is a complete educational module l Tools and resources are located on the Network of New England and MARC websites l Required and optional activities l PowerPoints for staff in-service presentations l Posters for display l Games and activities to engage patients

42. Recognition 5 Diamonds Completed l Acknowledged in Network Newsletter l Listed on Website l Special recognition at Annual Network Meeting l 2 free passes to Annual Meeting l $75.00 gift certificate for entertainment material for patients l Plaque to display in unit

43. Congratulations Diamond Providers! Facilities who have completed at least one module and have achieved diamond status (20 Providers enrolled)

44. Congratulations! Network Patient Advisory Committee (PAC) 10 Years of Service to the Network and Fellow Patients Questions are the Answer