Hemodialysis in the Home
Hemodialysis is a therapy that filters waste, removes extra fluid and balances electrolytes in individuals with end-stage renal disease. Hemodialysis can be performed in various settings, including home, outpatient or hospital. Conventional hemodialysis in a dialysis center is performed three times per week for approximately four hours. In the home setting, dialysis may be performed more frequently or for extended time periods. Before transitioning from the outpatient dialysis clinic to the home setting, individuals must be assessed and determined to be suitable candidates. They will receive intensive training, along with a care partner, that includes maintenance of equipment, placing needles into the vascular access, infection prevention, and responding to alarms. They will also be trained on vital signs, record keeping, ordering supplies and proper disposal of used supplies.
Home hemodialysis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Home hemodialysis is considered medically appropriate for individuals with end-stage renal disease if ALL of the following are met:
Individual meets ALL of the following:
Is stable during hemodialysis treatments
Is free of complications and significant concomitant disease that would render home hemodialysis unsuitable or unsafe
Has good functioning access (arteriovenous fistula or graft)
Has the ability and motivation to learn and carry out the hemodialysis procedure
Has demonstrated a commitment to maintain the hemodialysis treatment regimen
Has a minimum of one willing caregiver capable of learning and assisting with treatment
Home has suitable space and facilities in which to set up and perform hemodialysis treatment
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
There are currently two hemodialysis systems cleared through the FDA for home use: NxStage System One and Fresenius 2008K@home.
Centers for Medicare & Medicaid Services. CMS.gov. (2018, January). Medicare Benefit Policy Manual, Chapter 11 - End Stage Renal Disease (ESRD). Retrieved June 11, 2018 from http://www.cms.gov.
Ishani, A., Slinin, Y., Greer, N., MacDonald, R., Messana, J., Rutks, I., & Wilt, T. (2015). Comparative effectiveness of home-based kidney dialysis versus in-center or other outpatient kidney dialysis locations – a systematic review. VA ESP Project #09-009. (Level 1 evidence)
Kotanko, P., Garg, A. X., Depner, T., Pierratos, A., Chan, C. T., Levin, N. W., et al. (2015). Effects of frequent hemodialysis on blood pressure: Results from randomized frequent hemodialysis network trials. Hemodialysis International, 19 (3), 386-401. Abstract retrieved July 15, 2015 from PubMed database.
National Institute for Health and Care Excellence. (2018). Renal replacement therapy and conservative management. Retrieved May 20, 2019 from www.nice.org.uk.
National Institute of Diabetes and Digestive and Kidney Diseases. (2017). Home Hemodialysis. Retrieved May 12, 2017 from www.niddk.nih.gov/.
National Kidney Foundation. (2015). KDOQI clinical practice guidelines for hemodialysis adequacy: 2015 update. Retrieved June 23, 2016 from the National Guideline Clearinghouse (NGC:010896).
Susantitaphong, P., Koulouridis, I., Balk, E., Madias, N., & Jaber, B. (2012). Effect of frequent or extended hemodialysis on cardiovascular parameters: a meta-analysis. American Journal of Kidney Diseases, 59 (5), 689-699. (Level 2 evidence)
U. S Food and Drug Administration. (2006, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K060837. Retrieved May 18, 2017 from https://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2009, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080964. Retrieved July 6, 2010 from http://www.accessdata.fda.gov.
Weinhandl, E., Gilbertson, D., and Collins, A. (2016). Mortality, hospitalization, and technique failure in daily home hemodialysis and matched peritoneal dialysis patients: a matched cohort study. American Journal of Kidney Diseases. 67 (1), 98-110. (Level 2 evidence)
MOST RECENT REVIEW DATE: 7/11/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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