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 540 - 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 373 - 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.

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."