Dr. Barry Straube
Chief Medical Officer
Centers for Medicare and Medicaid Services
7500 Security Boulevard,
Baltimore, MD 21244
Mailstop 30201

Dear Dr. Straube,

The Home Hemodialysis Work Group, a coalition made up of patients, patient organizations, providers, physicians, and other kidney care-related organizations, appreciates CMS’s recognition of the need to consistently assess and report dialysis adequacy. To that end, we wish to comment on the new reporting requirement for dialysis adequacy, which becomes effective on July 1, 2010.

We agree that KT/V is a more appropriate measure of adequacy than URR for hemodialysis therapies. The recent CMS CR Transmittal #R1898CP and MM6782 addressing the new requirement were helpful in understanding the intent of the change. However, the Home Hemo Group suggests that CMS should go further in defining the measure to be reported for home hemodialysis. We are concerned that a single-session Kt/V, as would be generally reported for thrice-weekly in-center hemodialysis, will misrepresent the adequacy of delivered home hemodialysis and inadvertently penalize providers offering home hemodialysis therapies at frequencies greater than three times per week.

Dialysis adequacy is a function of frequency (number of days per week) and intensity (characterized by Kt/V). For in-center hemodialysis, where virtually all patients are treated on a thrice-weekly schedule so frequency does not typically vary, a single-session Kt/V is the standard for adequacy reporting. For home peritoneal dialysis, where treatments are performed every day, a weekly Kt/V is reported. In home hemodialysis, therapy is prescribed to meet the medical needs of the patient, and is often administered at a frequency greater than three times per week but can vary patient to patient. As a result, a single session Kt/V will understate the adequacy of therapy delivered to these patients. Because this measure may be tied to payment in the future under the QIP program, dialysis facilities would be financially disincented to offer a therapy that is in the best medical interest of certain patients.

It is essential that a weekly, or standardized Kt/V (“stdKt/V” ), be used to measure adequacy, at least for home hemodialysis therapies. There is sufficient precedent and experience to support this. This method was first presented by Gotch in 1998 and then revised and updated by Leypoldt in 2004 . The use of a standardized weekly Kt/V is noted by the National Kidney Foundation in their clinician practice tools for staff working to implement the KDOQI recommendations for adequacy of dialysis administered at different frequencies. Importantly, in the NIH trials on more frequent hemodialysis, the researchers chose to use a standardized weekly Kt/V as their frequency-normalized expression of adequacy. And finally, reporting of a weekly Kt/V would be consistent with the other prevalent home dialysis modality, peritoneal dialysis, is handled.

We believe that it is important to note that the members of this work-group who are also dialysis providers all currently use the stdKt/V metric for internal reporting of home hemodialysis adequacy.

Ultimately, a weekly standard Kt/V measure could be used to harmonize adequacy reporting across modalities. It is essential, however, that this measure be implemented for home hemodialysis therapies in July so that CMS may capture meaningful information and not inadvertently implement disincentives to quality care.

Several references are included with this letter. Please do not hesitate to let us know if you require additional information. We would be happy to partner with CMS to better understand the assessment, outcomes and clinical benefits of home hemodialysis.

Sincerely,

Gotch FA: The current place of urea kinetic modelling with respect to different dialysis modalities. Nephrol Dial Transplant 13:S10–S14, 1998 (suppl 6)

Leypoldt JK, Jaber BL, Zimmerman DL: Predicting treatment dose for novel therapies using urea standard Kt/V. Semin Dial 17:142–145, 2004

American Journal of Kidney Diseases, Vol 48, No 1, Suppl 1, July 2006, pp. S51-52, and also at http://www.kidney.org/professionals/kdoqi/pdf/12-50-0210_JAG_DCP_Guidelines-HD_Oct06_SectionA_ofC.pdf pp 64-65

Kidney International (2007) 71, 349–359. doi:10.1038/sj.ki.5002032; published online 13 December 2006