End Stage Renal Disease (ESRD) Quality Measure Development and Maintenance Hemodialysis Adequacy Clinical Technical Expert Panel Summary Report Prepared by: Arbor Research Collaborative for Health and the University of Michigan Kidney Epidemiology and Cost Center Conducted April 16-17, 2013 in Baltimore, MD Sent to CMS on June 28, 2013 Contract No. 500-2008-00022I, Task Order No. HHSM-500-T0001 1 Table of Contents Technical Expert Panel Summary .................................................................................................................. 5 1. Introduction/Background: ........................................................................................................................ 7 2. Discussion of Urea Kinetics ....................................................................................................................... 8 2.1 Standardized (Std) Kt/V ....................................................................................................................... 9 2.1.1 Literature Review & Scientific Importance .................................................................................. 9 2.1.2 Scientific acceptability: .............................................................................................................. 10 2.1.3 Feasibility and usability: ............................................................................................................. 10 2.1.4 Review of existing measures: ..................................................................................................... 10 2.1.5 Recommendations ..................................................................................................................... 10 2.2 Surface Area Normalized (SAN) kt/V ................................................................................................ 10 2.2.1. Literature Review & Scientific Importance ............................................................................... 10 2.2.2 Scientific acceptability ............................................................................................................... 11 2.2.3 Feasibility and usability .............................................................................................................. 11 2.2.4 Review of existing measures ...................................................................................................... 11 2.2.5 Recommendations ..................................................................................................................... 11 3. Discussion of Adequacy Based on Nutritional Status ............................................................................. 12 3.1 Normalized Protein Catabolic Rate (nPCR) ....................................................................................... 12 3.1.1 Literature Review & Scientific Importance ................................................................................ 12 3.1.2 Feasibility & usability ................................................................................................................. 13 3.1.3. Scientific acceptability (reliability & validity) ............................................................................ 13 3.1.4 Review of existing measures ...................................................................................................... 14 3.1.5 Recommendations ..................................................................................................................... 14 3.1.6 Other recommendations ............................................................................................................ 14 3.2 Serum Albumin.................................................................................................................................. 14 3.2.1 Literature Review & Scientific Importance ................................................................................ 14 3.2.2 Scientific acceptability (reliability & validity) ............................................................................. 15 3.2.3 Feasibility & usability ................................................................................................................. 15 3.2.4 Review of existing measures: ..................................................................................................... 15 3.2.5 Recommendations ..................................................................................................................... 15 3.2.6 Other recommendations: .......................................................................................................... 16 2 4. Discussion of Adequacy Based on Considerations of Patient Safety as well as Optimum Fluid and Larger Molecular Clearance ........................................................................................................................ 16 4.1 Ultrafiltration Rate (UFR) .................................................................................................................. 16 4.1.1 Literature Review & Scientific Importance ................................................................................ 16 4.1.2 Feasibility & usability: ................................................................................................................ 17 4.1.3 Scientific acceptability (reliability & validity) ............................................................................. 17 4.1.4 Review of existing measures ...................................................................................................... 17 4.1.5 Recommendations* ................................................................................................................... 18 4.1.5 Other recommendations: .......................................................................................................... 18 4.2 Minimum time (length of dialysis) per session ................................................................................. 18 4.2.1 Literature Review & Scientific Importance: ............................................................................... 18 4.2.1 Feasibility & usability ................................................................................................................. 19 4.2.2 Scientific acceptability (reliability & validity) ............................................................................. 19 4.2.3 Review of existing measures ...................................................................................................... 20 4.2.4 Recommendation* *Please See Addendum for Revised Recommendations............................ 20 4.3 Rate of hospitalization due to fluid overload ................................................................................... 20 4.3.1 Literature Review & Scientific Importance: ............................................................................... 20 4.3.2 Review of existing measures ...................................................................................................... 21 4.3.3 Potential measure discussed at the TEP meeting, but not recommended ............................... 21 4.4 Interdialytic Weight Gain (IDWG) ..................................................................................................... 21 4.4.1 Literature Review & Scientific Importance: ............................................................................... 21 4.1.2 Scientific Acceptability (reliability & validity) ............................................................................ 21 4.2.2 Review of existing measures ...................................................................................................... 21 4.2.3 Measure discussed, but not recommended .............................................................................. 21 4.5 Intradialytic hypotension .................................................................................................................. 22 4.5.1 Literature Review & Scientific Importance ................................................................................ 22 4.5.2 Review of existing measures ...................................................................................................... 22 4.5.3 Measures discussed but not recommended .............................................................................. 22 4.6 Dialysate composition ....................................................................................................................... 22 4.6.1 Literature Review & Scientific Importance ................................................................................ 22 4.6.2 Review of existing measures ...................................................................................................... 23 4.6.3 Measures discussed but not recommended .............................................................................. 23 3 5. Additional Discussion on Impact of Timing on Kt/V: .............................................................................. 23 6. Conclusions ............................................................................................................................................. 24 7. Summary or Recommendations ............................................................................................................. 25 8. References .............................................................................................................................................. 27 4 Technical