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Aetna Aetna
Clinical Policy Bulletin:
Home Dialysis
Number: 0541


Policy

Hemodialysis

Aetna considers home hemodialysis medically necessary when prescribed by a physician for members with end stage renal disease. The following conditions/equipment and supplies are considered medically necessary for administration of hemodialysis in the home:

  1. Periodic monitoring of the member's condition by a nurse (skilled nursing visit) in accordance with a care plan that is prepared and periodically reviewed by a physician; and

  2. Dialysis equipment and supplies

    1. Equipment

      Note: Because Medicare primary coverage of the dialysis equipment listed below commences after the person's first 30 months of hemodialysis, this equipment is usually covered by Aetna on a rental basis during the member's first 30 months of hemodialysis, because 30-month's rental is usually less expensive than purchase:

      1. Adjustable reclining chairs, when required as a component of the home dialysis system;
      2. Delivery system accessories:

        • Blood pumps
        • Heparin infusion pumps
        • Monitoring devices
        • Water purification systems (either a deionization system or a reverse osmosis system are considered medically necessary, but not both in the same member at the same time)
        • Water softening systems for members who have a reverse osmosis purification system if the member's water is of a lesser quality than required for the reverse osmosis purification system
           
      3. Dialyzers and dialysis delivery systems.

    2. Supplies

      The following hemodialysis supplies may be considered medically necessary:

      • Activated carbon filters used as a component of water purification systems to remove unsafe concentrations of chlorine or chloramines
      • Antibiotic ointment
      • Blood pressure monitors
      • Blood tubing
      • Centrifuge readacrit (hematocrit measuring equipment)
      • Cleansing agents
      • Dialysates
      • Dialysate testing supplies
      • Fistula cannulation sets
      • Fluid administration sets
      • Gun to secure tubing
      • Heparin
      • Needles
      • Nylon locking ties
      • Reagents (to detect residual traces or cleansing and sterilizing agents)
      • Saline solution components
      • Sterile dressing
      • Sterile saline
      • Sterilizing agents
      • Stethoscope when needed for blood pressure monitoring
      • Syringes
      • Winthrop tubes.

Aetna considers the NxStage System portable hemodialysis machine an equally acceptable alternative to standard hemodialysis machines for medically necessary home hemodialysis, as it has not been proven to be more effective than standard hemodialysis machines for use in the home. Aetna considers wearable hemodialysis machines experimental and investigational because their effectiveness has not been established.

Peritoneal Dialysis

Aetna considers continuous ambulatory peritoneal dialysis (CAPD) or continuous cycling peritoneal dialysis (CCPD) medically necessary when prescribed by a physician for persons with end-stage renal disease.

Other Dialysis Equipment and Supplies

  1. Back up equipment supplied in anticipation of the need for substitution or replacement is not considered medically necessary. Rental of equipment is considered medically necessary while member-owned equipment is being repaired
  2. Peridex filter sets are not considered medically necessary for peritoneal dialysis.
  3. Short wave (radiofrequency) diathermy machines are not covered as they are not appropriate for home use. See CPB 0540 - Heating Devices.
  4. Spare deionizing tanks are not considered medically necessary since they are essentially a precautionary supply.
  5. The Crit-Line In-Line Monitor is a device used to measure a member's hematocrit and oxygen saturation during hemodialysis. This device is considered experimental and investigational as there is inadequate evidence of the Crit-Line In-Line Monitor in improving the management of persons receiving hemodialysis. See CPB 0373 - Crit-Line In-Line Monitor.
  6. Ultrafiltration monitors are not considered medically necessary when ultrafiltration is independent of conventional hemodialysis.

    Note: Charges for repair and maintenance of rented equipment are included in the rental fees. Charges for repair of rented equipment will be denied as included in the rental charges.

  7. Emergency reserve supplies are usually provided when a member initiates dialysis in anticipation of short-term increases in use of supplies or delays in supply delivery. Up to 1 month's supplies in reserve in case of emergency are considered medically necessary; this is a one-time allowance.


Background

This policy was adapted from Medicare DMERC Local Medical Policy.

More frequent hemodialysis has the potential to improve survival as well as quality of life of patients with chronic kidney disease.  New means of delivering hemodialysis are being explored.  Kraus et al (2007) carried out a feasibility study to examine the safety of center-based versus home-based daily hemodialysis with the NxStage System One portable hemodialysis device.  These investigators also performed a retrospective analysis to determine if clinical effects previously associated with short-daily dialysis were also seen using this novel device.  They conducted a prospective, 2-treatment, 2-period, open-label, cross-over study of in-center hemodialysis versus home hemodialysis in 32 patients treated at 6 centers.  The 8-week In-Center Phase (6 days/week) was followed by a 2-week transition period and then followed by the 8-week Home Phase (6 days/week).  These researchers retrospectively collected data on hemodialysis treatment parameters immediately preceding the study in a subset of patients.  Twenty-six out of 32 patients (81 %) successfully completed the study.  Successful delivery of at least 90 % of prescribed fluid volume (primary endpoint) was achieved in 98.5 % of treatments in-center and 97.3 % at home.  Total effluent volume as a percentage of prescribed volume was between 94 % and 100 % for all study weeks.  The composite rate of intra-dialytic and inter-dialytic adverse events per 100 treatments was significantly higher for the In-Center Phase (5.30) compared with the Home Phase (2.10; p = 0.007).  Compared with the period immediately preceding the study, there were reductions in blood pressure, anti-hypertensive medications, and inter-dialytic weight gain.  The authors concluded that daily home hemodialysis with a small, easy-to-use hemodialysis device is a viable dialysis option for end-stage renal disease (ESRD) patients capable of self/partner-administered dialysis.

The Canadian Agency for Drugs and Technologies in Health's report on portable home hemodialysis for kidney failure (Scott, 2007) stated that while home hemodialysis is less costly than conventional in-center programs, it is unknown if these savings extend to portable devices.  Presently, the NxStage System One is the only really portable hemodialysis system licensed in the United States.  It weighs 30 kg and is the size of an older style computer monitor.  This device operates on standard electric current; do es not require any water supply, plumbing, or disinfection; and is portable enough for travel.  The NxStage System consists of a computer-controlled delivery unit and a disposable cartridge containing the dialyser and fluid circuits.  The dialysate comes in sterile, pre-mixed bags, which eliminates the need for a water purification system.  An optional accessory can produce dialysate from purified home tap water.  Another manufacturer, Home Dialysis Plus Ltd., has developed a portable hemodialysis machine that is smaller and more efficient than existing systems.  The Home Dialysis Plus machine weighs approximately 14 kg and is the size of a large suitcase. 

The CADTH (Scott, 2007) stated that the only publications on the NxStage System are brief reports and conference presentations of case series studies, some of which pooled results from different dialysis machines.  One anecdotal report and three conference abstracts provided separate results.  Furthermore, it is not yet clear if the use of the portable hemodialysis machine (e.g. the NxStage System) improves long-term survival and quality of life.

The CADTH report noted that the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study may address this lack of evidence by comparing clinical outcomes and cost-effectiveness data from 500 patients on NxStage daily hemodialysis with a matched conventional in-centre hemodialysis cohort from the U.S. Renal Data System database (Scott, 2007). The results of this and other ongoing trials will influence the uptake of portable hemodialysis devices.

An assessment by the National Horizon Scanning Centre (NHSC, 2007) found a lack of evidence for the NxStage and other portable systems that utilize new means of generating dialysate from tap water. An assessment of the NxStage System by the Adelaide Health Technology Assessment National Horizon Scanning Unit (Purins and Hiller, 2008) found that the evidence for the NxStage System was from small, low to medium quality studies.

More recently, and assessment from the National Health Service (Gossage-Worrall, et al., 2010) found that “the evidence for the use of portable hemodialysis devices is limited. The available evidence consists of comparison studies, case series, poster presentations, product specific reviews and editorials.... There is a paucity of evidence on the use of this device in relation to its portability.”

A report by the National Horizon Scanning Centre (NHSC, 2012) found no published evidence comparing the compact transportable home hemodialysis machines (NxStage or Selfcare+)  to standard hemodialysis machines. "Research comparing the costs associated with transportable machines and standard home haemodialysis machines would be needed to further understand and quantify any potential benefits or risks of these machines. The results of the Freedom study and further research into adolescents and children are awaited, as are trials of the Selfcare+ system. Further long-term studies of various possible treatment regimes on these transportable machines compared with standard machines are needed to assess whether they offer improvements in health outcomes for patients."

Jaber et al (2009) noted that conventional thrice-weekly hemodialysis (HD) has limited the ability to generate further improvements in patient quality of life, morbidity, and mortality. Daily HD (DHD) offers the promise of providing clinical and economical benefits. The authors reported that the objectives of the FREEDOM Study, and observational study with a lack of control arm, were to evaluate outcomes of DHD (6 times/week) with the NxStage System One device. The DHD group will include up to 500 participants at 70 clinical sites, enrolling for 3 years with a minimum of 1-year follow-up. Study candidates include adult patients (age greater than or equal to 18 years) with ESRD who are considered suitable candidates for DHD with the NxStage System One device by the treating physician and who have Medicare as their primary insurance payer. The control group will consist of a matched thrice-weekly in-center HD cohort derived from the U.S. Renal Data System database using a 10:1 ratio, totaling 5,000 patients. The primary intent-to-treat analysis compares hospitalization days/patient-year between the DHD and thrice-weekly HD groups. Other outcomes recorded in both groups include non-treatment-related medical expenditures. In addition, in the DHD cohort, changes in quality-of-life measures (baseline, 4 and 12 months, and every 6 months thereafter); urea kinetics; parameters related to anemia, bone and mineral metabolism, and nutrition; vascular access interventions; and use of medications will be examined. This authors concluded that this study has the potential to elucidate the health and economic benefits of DHD and complement results of current clinical trials.

In an interim report from the FREEDOM study, Jaber, et al. (2010) reported on the impact of daily hemodialysis on depressive symptoms and post-dialysis recovery time. The authors found that daily hemodialysis is associated with long-term improvement in depressive symptoms and postdialysis recovery time.. In this interim report, as part of an a priori planned analysis, the investigators examined the long-term impact of daily hemodialysis on depressive symptoms, measured using the Beck Depression Inventory (BDI) survey, and postdialysis recovery time, measured using a previously validated questionnaire, in adult patients intitiating daily hemodialysis. The BDI survey and postdialysis recovery time question were administered at baseline, and changes were assessed at months 4 and 12. The investigators reported that 239 participants were enrolled (intention-to-treat cohort) and 128 completed the study (per-protocol cohort). Mean age was 52 years, 64% were men, 55% had an arteriovenous fistula, and 90% transitioned from in-center hemodialysis therapy. In the per-protocol cohort, there was a significant decrease in mean BDI score over 12 months (11.2 [95% CI, 9.6-12.9] versus 7.8 [95% CI, 6.5-9.1]; P<0.001). For robustness, the intention-to-treat analysis was performed, yielding similar results. The percentage of patients with depressive symptoms (BDI score > 10) significantly decreased during 12 months (41% versus 27%; p = 0.03). Similarly, in the per-protocol cohort, there was a significant decrease in postdialysis recovery time over 12 months (476 [95% CI, 359-594] versus 63 minutes [95% CI, 32-95]; p < 0.001). The intention-to-treat analysis yielded similar results. The percentage of patients experiencing prolonged postdialysis recovery time (> 60 minutes) also significantly decreased (81% vs 35%; p = 0.001).

A retrospective study using a matched population-based cohort by Weinhandl, et al. (2012) suggests that relative to thrice-weekly in-center hemodialysis, daily home hemodialysis with the NxStage System associates with modest improvements in survival.  The investigators used a matched-cohort design to assess relative mortality in daily home hemodialysis using the NxStage System and thrice-weekly in-center hemodialysis patients between 2005 and 2008. The investigators matched 1873 home hemodialysis patients with 9365 in-center patients (i.e., 1:5 ratio) selected from the prevalent population in the U.S. Renal Data System database. Matching variables included first date of follow-up, demographic characteristics, and measures of disease severity. The cumulative incidence of death was 19.2% and 21.7% in the home hemodialysis and in-center patients, respectively. In the intention-to-treat analysis, home hemodialysis using the NxStage was associated with a 13% lower risk for all-cause mortality than in-center hemodialysis (hazard ratio [HR], 0.87; 95% confidence interval [95% CI], 0.78–0.97). Cause-specific mortality HRs were 0.92 (95% CI, 0.78–1.09) for cardiovascular disease, 1.13 (95% CI, 0.84–1.53) for infection, 0.63 (95% CI, 0.41–0.95) for cachexia/dialysis withdrawal, 1.06 (95% CI, 0.81–1.37) for other specified cause, and 0.59 (95% CI, 0.44–0.79) for unknown cause. Findings were similar using as-treated analyses. The investigators reported that they did not detect statistically significant evidence of heterogeneity of treatment effects in subgroup analyses.

There is a lack of evidence supporting wearable hemodialysis devices. In a pilot study, Davenport and colleagues (2007) evaluated the safety and effectiveness of a wearable hemodialysis device.  A total of 8 patients with ESRD (3 women and 5 men, mean age of 51.7 years) who were established on regular hemodialysis were fitted with a wearable hemodialysis device for 4 to 8 hours.  Patients were given unfractionated heparin for anticoagulation, as they would be for standard hemodialysis.  There were no important cardiovascular changes and no adverse changes in serum electrolytes or acid-base balance.  There was no evidence of clinically significant hemolysis in any patient.  Mean blood flow was 58.6 (SD 11.7) mL/min, with a dialysate flow of 47.1 (7.8) mL/min.  The mean plasma urea clearance rate was 22.7 (5.2) mL/min and the mean plasma creatinine clearance rate was 20.7 (4.8) mL/min.  Clotting of the vascular access occurred in 2 patients when the dose of heparin was decreased and the partial thromboplastin time returned towards the normal reference range in both of these patients.  The fistula needle became dislodged in 1 patient, however safety mechanisms prevented blood loss, the needle was replaced, and treatment continued.  The authors concluded that this wearable hemodialysis device shows promising safety and effectiveness results, although more research is needed to confirm these results.

A review of the evidence on the wearable hemodialysis device by the Australia and New Zealand Horizon Scanning Network (Mundy & Hiller, 2009) concluded: "Preliminary evidence of the wearable artificial kidney indicates that it is successful in the clearance harmful solutes and molecules that accumulate in patients with chronic kidney disease. The benefits of more frequent dialysis has been established and therefore a device which would enable patients to undergo dialysis frequently whilst able to participate in normal activities (including work) without being tied to a hospital setting would be advantageous both to the patient and to the health system. Studies where the WAK device is used long-term on a greater number of patients are required." 

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria is met:
99512
Hemodialysis:
HCPCS codes covered if selection criteria is met:
A4216 Sterile water, saline and/or dextrose, diluent/flush, 10 ml
A4217 Sterile water/saline, 500 ml
A4651 Calibrated microcapillary tube, each
A4652 Microcapillary tube sealant
A4657 Syringe, with or without needle, each
A4660 Sphygmomanometer/blood pressure apparatus with cuff and stethoscope
A4663 Blood pressure cuff only
A4670 Automatic blood pressure monitor
A4672 Drainage extension line, sterile, for dialysis, each
A4673 Extension line with easy lock connectors, used with dialysis
A4674 Chemicals/antiseptics solution used to clean/sterilize dialysis equipment, per 8 oz
A4680 Activated carbon filters for hemodialysis, each
A4690 Dialyzer (artificial kidneys), all types, all sizes, for hemodialysis, each
A4706 Bicarbonate concentrate, solution, for hemodialysis, per gallon
A4707 Bicarbonate concentrate, powder, for hemodialysis, per packet
A4708 Acetate concentrate solution, for hemodialysis, per gallon
A4709 Acid concentrate, solution, for hemodialysis, per gallon
A4728 Dialysate solution, non-dextrose, containing, 500 ml
A4730 Fistula cannulation set for hemodialysis, each
A4736 Topical anesthetic for dialysis, per gm
A4737 Injectable anesthetic, for dialysis, per 10 ml
A4740 Shunt accessory, for hemodialysis, any type, each
A4750 Blood tubing, arterial or venous, for hemodialysis, each
A4755 Blood tubing, arterial and venous combined, for hemodialysis, each
A4770 Blood collection tube, vacuum, for dialysis, per 50
A4771 Serum clotting time tube, for dialysis, per 50
A4772 Blood glucose test strips, for dialysis, per 50
A4773 Occult blood test strips, for dialysis, per 50
A4774 Ammonia test strips, for dialysis, per 50
A4802 Protamine sulfate, for hemodialysis, per 50 mg
A4860 Disposable catheter tips for peritoneal dialysis, per 10
A4890 Contracts, repair and maintenance, for hemodialysis equipment
A4911 Drain bag/bottle, for dialysis, each
A4913 Miscellaneous dialysis supplies, not otherwise specified
A4918 Venous pressure clamps, for hemodialysis, each
A4927 Gloves, non-sterile, per 100
A4928 Surgical mask, per 20
A4929 Tourniquet for dialysis, each
A4930 Gloves, sterile, per pair
A6010 - A6457 Dressings
C1881 Dialysis access system (implantable)
E1500 Centrifuge, for dialysis
E1510 Kidney, dialysate delivery system kidney machine, pump recirculating, air removal system, flowrate meter, power off, heater and temp control with alarm, IV poles, pressure gauge, concentrate container
E1520 Heparin infusion pump for hemodialysis
E1530 Air bubble detector for hemodialysis, each, replacement
E1540 Pressure alarm for hemodialysis, each, replacement
E1550 Bath conductivity meter for hemodialysis, each
E1560 Blood leak detector for hemodialysis, each, replacement
E1570 Adjustable chair, for ESRD patients
E1575 Transducer protectors/fluid barriers, for hemodialysis, any size, per 10
E1580 Unipuncture control system for hemodialysis
E1590 Hemodialysis machine
E1600 Delivery and/or installation charges for hemodialysis equipment
E1610 Reverse osmosis water purification system, for hemodialysis
E1615 Deionizer water purification system, for hemodialysis
E1620 Blood pump for hemodialysis, replacement
E1625 Water softening system, for hemodialysis
E1636 Sorbent cartridges, for hemodialysis, per 10
E1699 Dialysis equipment, not otherwise specified
G0154 Direct skilled nursing services of a licensed nurse (LPN or RN) in the home health or hospice setting, each 15 minutes
J1644 Injection, heparin sodium, per 1,000 units
J7030 Infusion, normal saline solution, 1,000 cc
J7040 Infusion, normal saline solution, sterile (500 ml = 1 unit)
S9123 Nursing care, in the home; by registered nurse, per hour (use for general nursing care only, not to be used when CPT codes 99500-99602 can be used)
S9124 Nursing care, in the home; by licensed practical nurse, per hour
S9335 Home therapy, hemodialysis; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing services coded separately), per diem
HCPCS codes not covered for indications listed in the CPB:
E1632 Wearable artificial kidney, each
E1635 Compact (portable) travel hemodialyzer system
Peritoneal Dialysis:
CPT codes covered if selection criteria are met:
90945
90947
HCPCS codes covered if selection criteria is met:
A4216 Sterile water, saline and/or dextrose, diluent/flush, 10 ml
A4217 Sterile water/saline, 500 ml
A4651 Calibrated microcapillary tube, each
A4652 Microcapillary tube sealant
A4653 Peritoneal dialysis catheter anchoring device, belt, each
A4657 Syringe, with or without needle, each
A4660 Sphygmomanometer/blood pressure apparatus with cuff and stethoscope
A4663 Blood pressure cuff only
A4670 Automatic blood pressure monitor
A4671 Disposable cycler set used with cycler dialysis macine, each
A4672 Drainage extension line, sterile, for dialysis, each
A4673 Extension line with easy lock connectors, used with dialysis
A4674 Chemicals/antiseptics solution used to clean/sterilize dialysis equipment, per 8 oz
A4714 Treated water (deionized, distilled, reverse osmosis) for peritoneal dialysis, per gallon
A4720 Dialysate solution, any concentration of dextrose, fluid volume greater than 249 cc, but less than or equal to 999 cc, for peritoneal dialysis
A4721 Dialysate solution, any concentration of dextrose, fluid volume greater than 999 cc, but less than or equal to 1999 cc, for peritoneal dialysis
A4722 Dialysate solution, any concentration of dextrose, fluid volume greater than 1999 cc, but less than or equal to 2999 cc, for peritoneal dialysis
A4723 Dialysate solution, any concentration of dextrose, fluid volume greater than 2999 cc, but less than or equal to 3999 cc, for peritoneal dialysis
A4724 Dialysate solution, any concentration of dextrose, fluid volume greater than 3999 cc, but less than or equal to 4999 cc, for peritoneal dialysis
A4725 Dialysate solution, any concentration of dextrose, fluid volume greater than 4999 cc, but less than or equal to 5999 cc, for peritoneal dialysis
A4726 Dialysate solution, any concentration of dextrose, fluid volume greater than 5999 cc
A4728 Dialysate solution, non-dextrose, containing, 500 ml
A4736 Topical anesthetic for dialysis, per gm
A4737 Injectable anesthetic for dialysis, per 10 ml
A4760 Dialysate solution test kit, for peritoneal dialysis, any type, each
A4765 Dialysate concentrate, powder, additive for peritoneal dialysis, per packet
A4766 Dialysate concentrate, solution, additive for peritoneal dialysis, per 10 ml
A4770 Blood collection tube, vacuum, for dialysis, per 50
A4771 Serum clotting time tube, for dialysis, per 50
A4772 Blood glucose test strips, for dialysis, per 50
A4773 Occult blood test strips, for dialysis, per 50
A4774 Ammonia test strips, for dialysis, per 50
A4860 Disposable catheter tips for peritoneal dialysis, per 10
A4911 Drain bag/bottle, for dialysis, each
A4913 Miscellaneous dialysis supplies, not otherwise specified
A4918 Venous pressure clamps, for hemodialysis, each
A4927 Gloves, non-sterile, per 100
A4928 Surgical mask, per 20
A4929 Tourniquet for dialysis, each
A4930 Gloves, sterile, per pair
A6010 - A6457 Dressings
C1881 Dialysis access system (implantable)
E1500 Centrifuge, for dialysis
E1510 Kidney, dialysate delivery system kidney machine, pump recirculating, air removal system, flowrate meter, power off, heater and temp control with alarm, IV poles, pressure gauge, concentrate container
E1570 Adjustable chair, for ESRD patients
E1592 Automatic intermittent peritoneal dialysis system
E1594 Cycler dialysis machine for peritoneal dialysis
E1630 Reciprocating peritoneal dialysis system
E1634 Peritoneal dialysis clamps, each
E1699 Dialysis equipment, not otherwise specified
G0154 Services of skilled nurse in home health setting, each 15 minutes
S9123 Nursing care, in the home; by registered nurse, per hour
S9124 Nursing care, in the home; by licensed practical nurse, per hour
S9335 Home therapy, hemodialysis; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing services coded separately), per diem
S9339 Home therapy; peritoneal dialysis, administrative services, professional pharmacy services, care coordination and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
HCPCS codes not covered for indications listed in the CPB:
A4870 Plumbing and/or electrical work for home hemodialysis equipment
E1637 Hemostats, each
E1639 Scale, each
Other HCPCS codes related to the CPB:
E1632 Wearable artificial kidney, each
J1642 Injection, heparin sodium, (Heparin Lock Flush), per 10 units
ICD-9 codes covered if selection criteria are met:
585.6 End stage renal disease
Other ICD-9 codes related to the CPB:
567.0 - 567.9 Peritonitis and retroperitoneal infections
V45.1 Renal dialysis status


The above policy is based on the following references:
  1. U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Medicare Coverage Issues Manual §§ 55-1 - 55-3. Baltimore, MD: HCFA; 1999.
  2. NHIC, Corp. LCD for Home Dialysis Supplies and Equipment (L11498). Durable Medical Equipment Medicare Administrative Contractor (DME MAC). Hingham, MA: NHIC; revised September 1, 2009.
  3. Association for the Advancement of Medical Instrumentation (AAMI), American National Standards Institute. Hemodialysis systems. In: AAMI standards and recommended practices. Volume 3: dialysis. Arlington, VA: AAMI; 1995.
  4. Medical Devices Directorate. Haemodialysis equipment: Review issue. London, UK: Department of Health; 1992.
  5. U.S. Department of Health and Human Services, National Institutes of Health (NIH), Office of Medical Applications of Research. Morbidity and mortality of dialysis. NIH Consensus Statement. Bethesda, MD: NIH; November 1-3, 1993; 11(2):1-33. Available at: http://odp.od.nih.gov/consensus. Accessed March 20, 2000.
  6. National Kidney Foundation (NKF). NKF-DOQI clinical practice guidelines for vascular access. National Kidney Foundation-Dialysis Outcomes Quality Initiative. Am J Kidney Dis. 1997;30(4 Suppl 3):S150-S191.
  7. National Kidney Foundation (NKF). NKF-DOQI clinical practice guidelines for hemodialysis adequacy. Am J Kidney Dis. 1997;30(3 Suppl 2):S15-S66.
  8. National Kidney Foundation (NKF). NKF-DOQI clinical practice guidelines for peritoneal dialysis adequacy. Am J Kidney Dis. 1997;30(3 Suppl 2):S67-S136.
  9. Steuer RR, Harris DH, Conis JM. A new optical technique for monitoring hematocrit and circulating blood volume: Its application in renal dialysis. Dialysis Transplantation. 1993;22(5):260-264.
  10. Steuer RR, Leypoldt JK, Cheung AK, et al. Hematocrit as an indicator of blood volume and a predictor of intradialytic morbid events. Am Soc Artificial Internal Organs J. 1994;40(3):M691-M695.
  11. Steuer RR, Harris DH, Conis JM. Continuous, in-line monitoring of oxygen saturation in hemodialysis. Dialysis Transplantation. 1995;24(11):615-620, 658.
  12. Steuer RR, Leypoldt JK, Cheung AK, et al. Reducing symptoms during hemodialysis by continuously monitoring the hematocrit. Am J Kidney Dis. 1996;17(4):525-532.
  13. Agraharkar M, Barclay C, Agraharkar A. Staff-assisted home hemodialysis in debilitated or terminally ill patients. Int Urol Nephrol. 2002;33(1):139-144.
  14. National Institute for Clinical Excellence (NICE). Guidance on home compared with hospital haemodialysis for patients with end-stage renal failure. Technology Appraisal Guidance 48. London, UK: NICE; September 2002. Available at: http://www.nice.org.uk/Docref.asp?d=36748. Accessed February 4, 2004.
  15. Mowatt G, Vale L, MacLeod A. Systematic review of the effectiveness of home versus hospital or satellite unit hemodialysis for people with end-stage renal failure. Int J Technol Assess Health Care. 2004;20(3):258-268.
  16. Vale L, Cody J, Wallace S, et al. Continuous ambulatory peritoneal dialysis (CAPD) versus hospital or home haemodialysis for end-stage renal disease in adults. Cochrane Database Syst Rev. 2004;(4):CD003963.
  17. Rabindranath KS, Strippoli GF, Daly C, et al. Haemodiafiltration, haemofiltration and haemodialysis for end-stage kidney disease. Cochrane Database Syst Rev. 2006;(4):CD006258.
  18. Rabindranath KS, Adams J, Ali TZ, et al. Continuous ambulatory peritoneal dialysis versus automated peritoneal dialysis for end-stage renal disease. Cochrane Database Syst Rev. 2007;(2):CD006515.
  19. Topfer LA. Portable home hemodialysis. Emerging Technology List. No. 25. Ottawa, ON: Canadian Coordinating Office for Health Technology Assessment (CCOHTA); March 2005.
  20. Suri RS, Nesrallah GE, Mainra R, et al. Daily hemodialysis: A systematic review. Clin J Am Soc Nephrol. 2006;1(1):33-42.
  21. Danish Centre for Evaluation and Health Technology Assessment (DACEHTA). Dialysis in chronic renal failure - a health technology assessment. Danish Health Technology Assessment. Copenhagen, Denmark: DACEHTA; 2006;8(3). 
  22. McFarlane PA, Bayoumi AM, Pierratos A, Redelmeier DA. The impact of home nocturnal hemodialysis on end-stage renal disease therapies: A decision analysis. Kidney Int. 2006;69(5):798-805.
  23. Al-Hilali N, Al-Humoud H, Nampoory M, et al. Outcome and survival in different peritoneal dialysis modalities. Ther Apher Dial. 2007;11(2):101-106.
  24. Kraus M, Burkart J, Hegeman R, et al. A comparison of center-based vs. home-based daily hemodialysis for patients with end-stage renal disease. Hemodial Int. 2007;11(4):468-477.
  25. Davenport A, Gura V, Ronco C, et al. A wearable haemodialysis device for patients with end-stage renal failure: A pilot study. Lancet. 2007;370(9604):2005-2010.
  26. Scott A. Portable home hemodialysis for kidney failure. Issues in Emerging Health Technologies Issue 108. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health; 2007. Available at: http://cadth.ca/media/pdf/E0046_Portable-Home-Hemodialysis_cetap_e.pdf. Accessed June 25, 2008.
  27. National Horizon Scanning Centre (NHSC). Tap water home haemodialysis systems for end stage renal failure: Horizon scanning technology briefing. Birmingham, UK: NHSC; 2007.
  28. Purins A, Hiller JE. NxStage System One home dialysis for patients waiting for kidney transplantation. Australia and New Zealand Horizon Scanning Network. Prioritising Summary. Canberra, ACT: Australian Government; November 2008;22:1-5.
  29. Jaber BL, Finkelstein FO, Glickman JD, et al. Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study. Am J Kidney Dis. 2009;53(2):310-320.
  30. Mundy L, Hiller JE. Wearable artificial kidney (WAK): Portable dialysis for patients with chronic kidney disease. Adelaide, SA: Adelaide Health Technology Assessment (AHTA). Horizon Scanning Prioritising Summary; 2009;25.
  31. Jaber BL, Lee Y, Collins AJ, et al. ; FREEDOM Study Group. Effect of daily hemodialysis on depressive symptoms and postdialysis recovery time: Interim report from the FREEDOM (Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements) Study. Am J Kidney Dis. 2010;56(3):531-539.
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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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