Demystifying the New Regulations: A User’s Guide to the Conditions for Coverage

1. Demystifying the New Regulations: A User’s Guide to the Conditions for Coverage Jan Deane, RN, CNN Network 11 Annual Meeting October 3, 2008

2. With a Special Thanks… To Glenda Payne and Judith Kari for their assistance in putting this presentation together.

3. Disclaimer Although this presentation has been reviewed by CMS, it does not substitute for facility’s responsibility to become familiar with all the regulations and make all necessary changes to be in compliance with the new regulations by October 14, 2008.

4. Chronic Hemodialysis • First successful patient in 1960 • Home hemodialysis became popular due to the high cost of treatment • Patient selection became an important part of the process • “Who shall receive care when not all can receive care?”

5. Medicare Coverage for Dialysis • Public Law 92-603, Section 2991 • Dialysis and transplant would be covered under the Medicare program regardless of age • Dialysis became available for anyone …Then in 1976…

6. The Long Journey Began

7. The ESRD Regulation Timeline • 1976: First ESRD regulations published • 70’s-90’s: Technical updates • 1994: Community Forum Meeting to begin complete rewrite of ESRD regulations • 2008: New ESRD regulations published 4

8. 1994 Community Forum: Outcome From To First: Patient safety Water Reuse Infection Control Physical Environment Change in Regulatory Focus • First: Paper reviews

9. 1994: Change in the Survey Process

10. 1994: Change in the Survey Process

11. Common Themes on the Long Journey CMS & Kidney Community partnership Survey process is driven by outcomes & data, not structure & paper Striving for consistency & common understandings

12. Rationale Behind the Changes

13. Rationale for ESRD Regulation Changes Increasing realization of the need for regulatory support for an outcomes focus across provider types Needed to drive improvements in care Critical if CMS moves to value-based pricing Necessary if CMS moves to bundled reimbursement for ESRD care

14. Reasons for Change Changes in technology Water treatment: more complex Changes in dialysis equipment Differences in care delivery 1970’s: few technicians; regulations are silent 2008: technicians provide most direct care; public is demanding regulation

15. Reasons for Changes Evidence Based Practice: ESRD community coming to consensus on minimum standards of care RPA’s Adequacy of Dialysis Report K/DOQI Guidelines Fistula First Breakthrough Initiative QAPI: accepted process of quality assessment across provider types Electronic data submission required to keep pace with growing ESRD population & need for current data

16. Introducing the new Conditions for CoverageOctober 14, 2008So what’s new??

17. Subpart A: General Provisions

18. Subpart B:Patient Safety

19. 494.30: Infection Control • Official adoption of the CDC Guidelines • “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients” MMWR 4/27/2001 • More focus – Condition level importance • Moved higher in the survey process • PPE Changes – GOWNS not APRONS!

20. 494.30: Infection Control • Isolation rooms for HBV infected patients • All new facilities built after 2/9/2009 • Older facilities may use a separated area • Infection control issues • Medical director involvement • QI process • Develop tracking process • Use comprehensive QI process to understand

21. 494.40: Water and Dialysate Quality • Meet AAMI standards for water and dialysate purity • “Dialysate for Hemodialysis” ANSI/AAMI RD52:2004 • Increased frequency of chlorine/chloramine testing • Quality assurance plan for adverse occurrences that assures patient safety

22. 494.50: Reuse of Hemodialyzers and Bloodlines • No reuse for HBV patients • Adherence to AAMI Guidelines • “Reuse of Hemodialyzers” ANSI/AAMI RD47:2002 • Expanded quality assurance processes including suspending reuse in the presence of clusters of adverse patient reactions

23. 494.60: Physical Environment • Patient care environment • Comfortable temperature • Patient privacy • Patients within view of care staff including vascular access and line connections

24. 494.60: Physical Environment • Emergency Preparedness • Staff training • Medical emergencies – CPR certification • Non-medical emergencies including weather related emergencies • Emergency equipment • Patient Education • Disconnect procedure • Where to go in the event of an emergency

25. 494.60: Physical Environment • Emergency Preparedness • Equipment • Oxygen, airways, suction • Defibrillator or Automatic External Defibrillator • Exemption for hospital based units with access to hospital resuscitation team if response is within a timely manner (4-5 minutes)

26. 494.60: Physical Environment • Fire Safety • Compliance with the applicable sections of the 2000 Life Safety Code (National Fire Protection Association) • Exemption to sprinklered sectionif facility was built before 1/1/2006 and state law permits • Must follow State law if State law is more strict than the LSC provisions.

27. Subpart C: Patient Care

28. 494.70: Patient Rights • Not a lot of changes but mostly expansion and clarification of existing patient rights • Addition of several new patient rights • Advance Care Planning discussions • Information regarding all treatment modalities and including scheduling options • Grievances – expanded to 3 tags

29. 494.70: Patient Rights • Involuntary Discharge • Included in Patient Rights Condition as well as patient assessment and governance • Under this Condition, specifically information regarding the facility policy for involuntary discharge AND the right to written 30 day notice

30. 494.80: Patient Assessment • Interdisciplinary team involvement – at a minimum • Patient or patient’s designee • Registered nurse • Patient’s nephrologist • Social worker • Dietitian

31. 494.80: Patient Assessment • Comprehensive initial assessment • All new patients within 30 days or 13 treatments • Follow-up comprehensive reassessment • All new patients within 3 months following the initial assessment • Additional reassessments • Stable patients – annually thereafter • Unstable patients – monthly until stable

32. 494.80: Patient Assessment • What is an unstable patient? • Extended or frequent hospitalizations • Marked deterioration in in health status • Significant change in psychosocial needs • Concurrent poor nutritional status, unmanaged anemia, and inadequate dialysis Facilities need to have a method of classifying patients

33. 494.80: Patient Assessment • Current health status • Appropriateness of dialysis prescription • BP and fluid management • Laboratory tests • Immunization and medications • Family and support • Physical activity • Anemia management • Renal bone disease • Nutritional status • Psychosocial needs • Dialysis access • Patient’s desired level of participation in care • Suitability for transplant

34. 494.80: Physical Assessment • Caveats • Emphasis is on TEAM – everyone working together – patient included • Interdisciplinary is different from multidisciplinary: more collaborative, more congruent • Policies and procedures are fine – they need to be operationalized. • Breakout session this afternoon will look at ways in which providers are making this work in real life.

35. 494.90: Patient Plan of Care • Interdisciplinary team involvement – at a minimum: • Patient or patient’s designee • Registered nurse • Patient’s nephrologist • Social worker • Dietitian • Be signed by all team members, including the patient or designee

36. 494.90: Patient Plan of Care • Implementation must begin within 30 days or 13 treatment of initiation of dialysis • Implementation of monthly or annual updates to the plan must be performed within 15 days of the completion of additional assessments or reassessment.

37. 494.90: Patient Plan of Care • Dose of dialysis • Meet and sustain Kt/V of 1.2 (HD) or 1.7 (PD) • Nutritional status • Mineral metabolism • Anemia • Home assessment for home patients • Response to ESAs • Vascular access type • Vascular access monitoring • Psychosocial status • Modality • Transplant status • Rehab status

38. 494.90: Patient Plan of Care • What QOL tool is recommended? • CPM to be implemented in 2009 calls for KDQOL • The CrownWeb system will require KDQOL domains to be entered. • So…

39. 494.90: Patient Plan of Care • Additional points to remember • If expected outcome for any areais not achieved and sustained • Documentation of revision for that portion of the POC and QI process • Nephrologist visits requiredmonthly • Can be Advanced practice RN or physician assistant • Transplant referral tracking • Workup process • Waitlist tracking

40. 494.90: Patient Care Planning • Patient education • Dialysis experience • Dialysis management • Infection control • Home dialysis and self dialysis • Quality of life, rehabilitation • Transplantation • Vascular access

41. 494.100: Care at Home • New as a Condition • Home dialysis services must be at least equal to that provided for in-center patients • Interdisciplinary team oversees training • Be conducted by a registered nurse who meets qualifications • Specific areas to be covered in the training

42. 494.100: Care at Home • Periodic monitoring of home adaptation including home visits • Assessment and care planning same as for in-center patients • Meet specific water and dialysate testing requirements – refer to conditions for specifics • Planning for back-up services

43. 494.110: Quality Assessment and Performance Improvement “The facility must develop, implement, maintain, and evaluate an effective, data driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team.”

44. 494.110: Quality Assessment and Performance Improvement • Facility-wide – all services must be included • In-center hemodialysis • Home hemodialysis • Peritoneal dialysis • Reprocessing • Water quality …Just to mention a few…

45. 494.110: Quality Assessment and Performance Improvement • Use of professionally accepted clinical practice guidelines to track health outcomes • Identification, prevention, and reduction of medical errors • Action towards improving outcomes not meeting target levels • Patient satisfaction is included – CAHPS tool is recommended by CMS

46. 494.110: Quality Assessment and Performance Improvement • Use of principles of CQI • Monitor data/information • Prioritize areas for improvement • Determining potential root causes • Developing, implementing, evaluating, and revising plans that will result in improvements in care

47. Adequacy of dialysis Nutritional status Bone and mineral metabolism Anemia management Vascular access Medical errors Hemodialyzer reuse Patient satisfaction and grievances Infection control including surveillance and immunization status 494.110: Quality Assessment and Performance Improvement

48. Measures Assessment Tool

49. Subpart DAdministration

50. 494.140: Personnel Qualifications • Registered nurse • Nurse manager • RN, full time, 12 months nursing + 6 months dialysis • Home training nurse • RN, 12 months nursing + 3 months in home therapy • Charge nurse • RN, LPN/LVN, 12 months nursing including 3 months dialysis • Staff nurse • RN, LPN/LVN