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. Dialyzers and dialysis delivery systems;

      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. Adjustable reclining chairs, when required as a component of the home dialysis system

   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 wearable or portable hemodialysis machines (e.g. the NxStage System) experimental and investigational because their effectiveness has not been established.

Peritoneal Dialysis

Aetna considers continuous cycling peritoneal dialysis (CCPD) medically necessary if the member has any of the following indications:

1. Member has frequent episodes of peritonitis; or
2. Member is incapable of performing peritoneal dialysis without assistance; or
3. Member cannot be adequately dialyzed with continuous ambulatory peritoneal dialysis (CAPD).

Other Dialysis Equipment/Supplies

1. Spare deionizing tanks are not considered medically necessary since they are essentially a precautionary supply.
2. Ultrafiltration monitors are not considered medically necessary when ultrafiltration is independent of conventional hemodialysis.
3. Peridex filter sets are not considered medically necessary for peritoneal dialysis.
4. Short wave (radiofrequency) diathermy machines are not covered as they are not appropriate for home use. See CPB 540 - Heating Devices 
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. 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.

   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 one 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.

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.

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.  It could be available for marketing as early as 2010.

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 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 US Renal Data System database (Scott, 2007). The results of this and other ongoing trials will influence the uptake of portable hemodialysis devices.