Description
NOTE: Within this policy, the terms hemodialysis and dialysis are used interchangeably and always refer to hemodialysis.

Healthy kidneys filter about 200 quarts of fluid every 24 hours; about 2 quarts are removed from the body in the form of urine. End-stage renal disease (ESRD) is the complete, or nearly complete, failure of the kidneys to perform the function of filtering waste and excess fluid from the body at a level needed to sustain day-to-day life; this is usually when kidney function is less than 10 percent of normal. Kidney failure is usually a slow, progressive disease, often taking years to culminate in ESRD, at which stage renal replacement therapy is required in the form of dialysis or a kidney transplant. During hemodialysis, the blood is removed from the body via tubing and flows through an "artificial kidney" where it is filtered to remove waste and excess fluid. When dialysis is adequate, the symptoms and complications of renal failure lessen or can be managed.

Symptoms of kidney failure may include:

• Abnormally dark or light skin and changes in nails.
• Amenorrhea.
• Bone pain.
• Brain and nervous system symptoms.
• Breath odor.
• Drowsiness and confusion.
• Easy bruising, nosebleeds or blood in the stool.
• Edema.
• Excessive thirst.
• Frequent hiccups.
• General ill feeling and fatigue.
• Generalized itching (pruritus) and dry skin.
• Headaches.
• Loss of appetite.
• Low level of sexual interest and impotence.
• Muscle twitching or cramps.
• Nausea.
• Numbness in the hands, feet or other areas.
• Problems concentrating or thinking.
• Sleep problems, such as insomnia, restless leg syndrome or obstructive sleep apnea.
• Vomiting, especially in the morning.
• Weight loss without trying.

 Treatment for ESRD includes:

• Dialysis or kidney transplant.
• Extra calcium and vitamin D.
• Medications to act as phosphate binders.
• Treatment of anemia.
• Low-protein diet that includes enough calories to prevent losing weight.
• Limit fluids, salt, potassium, phosphorous and other electrolytes.

Complications of ESRD may include:

• Anemia.
• Bleeding from the stomach or intestines.
• Bone, joint and muscle pain.
• Brain dysfunction, confusion and dementia.
• Changes in blood sugar (glucose).
• Changes in electrolyte levels.
• Congestive heart failure.
• Coronary artery disease.
• Damage to nerves of the legs and arms, peripheral neuropathy.
• Fluid buildup around the lungs.
• Heart and blood vessel complications.
• Hepatitis B, hepatitis C, liver failure.
• High blood pressure.
• Hyperparathyroidism.
• Increased risk of infections.
• Malnutrition.
• Pericarditis.
• Phosphorous levels become too high.
• Potassium levels become too high.
• Seizures.
• Skin dryness, itching/scratching, leading to skin infection.
• Stroke.
• Weakening of the bones, fractures, joint disorders.

Dialysis is usually carried out in a clinic setting. While dialysis can be performed at home, home dialysis is not suitable for everyone. Suitability for home dialysis depends on many factors, including the patient’s physical and mental abilities and medical condition; whether the patient has a dependable, suitable helper who can deal with emergencies; and whether the home environment has the space and facilities needed.

Most hemodialysis patients in the United States undergo dialysis three times a week for three to five hours at each session. Some patients may receive this intermittent dialysis in the home. Medicare payment for dialysis, referred to as the "composite rate," is premised on thrice-weekly intermittent hemodialysis.

There has been long-standing interest in exploring different schedules for hemodialysis to create a more physiologic approach to potentially improve the morbidity and mortality associated with intermittent hemodialysis. Daily hemodialysis, defined as dialysis six to seven days a week, has been investigated in two different schedules:

• Nocturnal hemodialysis, in which the patient undergoes a long period of dialysis while asleep on a daily basis
• Daily hemodialysis sessions of two hours each, such that the total dialysis time is similar to the conventional three-times-a-week schedule

While daily hemodialysis has been investigated in the clinical setting, both daily dialysis and nocturnal dialysis are more feasible in the home setting.

Recently, two dialysis devices have received U.S. Food and Drug Administration (FDA) clearance with the specific labeling for home use; the NxStage System One^™ (NxStage Medical Inc), and the PhD System^® (Aksys), which may create further interest in home daily dialysis. The FDA approval for both devices was based on data showing that hemodialysis delivered in the home setting was equivalent to that offered in the clinic setting, in terms of the amount of therapy and the incidence of adverse effects. Patients served as their own controls.

Policy
Home hemodialysis may be MEDICALLY NECESSARY up to three times per week in the home setting for patients who have end-stage renal disease (ESRD) and meet ALL of the following criteria:

• Are stable during hemodialysis treatment
• Are free of complications and significant concomitant disease that would render home hemodialysis unsuitable or unsafe
• Have a stable, well-functioning vascular access (i.e., arteriovenous [AV] fistula or graft)
• Have demonstrated a positive commitment to following the end-stage renal disease plan of care, including regularly attending hemodialysis and following prescribed diet, medication regimen, fluid restriction, etc.
• Have the ability and motivation to learn and carry out the hemodialysis procedure, and the commitment to maintain the hemodialysis treatment regimen
• Have at least one caregiver (friend or family member) who has also made an informed decision and commitment to assist with the hemodialysis treatment, and who is capable of learning and carrying out the treatment process
• Have suitable space and facilities within the home in which to set up and perform the hemodialysis treatment
• Have access to support of health care professionals, through a hemodialysis facility, who can be contacted easily and will respond rapidly
• Up to five treatments per week are allowed, treatment greater than five times per week is considered INVESTIGATIONAL.

The NxStage System portable hemodialysis machine is an equally acceptable alternative to standard hemodialysis machines for NOT MEDICALLY NECESSARY home hemodialysis, as it has not been proven to be more effective than standard hemodialysis machines for use in the home.

Wearable hemodialysis machines are considered experimental and INVESTIGATIONAL because their effectiveness has not been established.

Daily hemodialysis is INVESTIGATIONAL in any setting.

Rationale
In 2001, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD) convened a task force to address the issue of daily hemodialysis. This task force reviewed the published data and noted that case series consistently reported that daily hemodialysis was associated with an improvement in nutritional parameters, normalization of serum phosphate (particularly with nocturnal hemodialysis) and improvement in blood pressure and hematocrit (with an associated decrease in transfusion requirements or erythropoietin dosages). The published data did not address the issue of mortality. The task force concluded that a randomized clinical trial was warranted to further explore the outcomes, and discussion focused on trial design. The task force also discussed the economic impact of daily hemodialysis and Medicare reimbursement, which is currently based on three-times-weekly dialysis.

A literature search of the MEDLINE database revealed considerable published literature on daily and nocturnal hemodialysis, frequently performed in the clinic and not the home setting. Published studies primarily include single institution case series with comparison of the outcomes of patients undergoing intermittent dialysis who have switched to daily dialysis; in addition, there has been one nonrandomized comparative study of patients receiving either daily or nocturnal dialysis compared to those receiving intermittent dialysis. A representative review of the more recent studies is presented below.

Williams and colleagues at the Mayo Clinic reported on the outcomes of 21 patients who were sequentially treated with intermittent and daily hemodialysis. Patients served as their own controls. The daily dialysis schedule was associated with improvements in blood pressure, urea kinetics and symptoms between and during dialysis sessions. The authors concluded that this small short-term study demonstrated the feasibility of daily hemodialysis. In a similarly designed study from an overlapping group of investigators, Ting and colleagues reported on the outcomes of 42 patients with end-stage renal disease with a mean of four significant comorbidities. After conversion to daily dialysis, there was an improvement in dialysis parameters, as measured by Kt/V, and a significant decrease in hospital days. In those remaining on daily hemodialysis for 12 months, there were significant improvements in quality of life compared to the preceding 12 months, a reduction in antihypertensive medications and a significant reduction in erythropoietin requirements.

The London Daily/Nocturnal Hemodialysis Study was a prospective nonrandomized comparative study of home daily (n = 11) and home nocturnal hemodialysis (n = 12) with outcomes compared to matched controls receiving conventional hemodialysis. The following results were reported in a series of publications. (Daily and nocturnal hemodialysis are collectively known as quotidian hemodialysis.)

• There were no differences between the groups in numbers of hospital days or ER visits.
• Weekly urea clearance is improved in quotidian hemodialysis.
• Quotidian hemodialysis was associated with an improvement in symptoms both during and between dialysis sessions, and all patients chose to remain on quotidian hemodialysis after switching from intermittent dialysis.
• Quotidian hemodialysis was associated with improvement in nutritional parameters.
• Because of the increased number of treatments, treatment supply costs for quotidian hemodialysis were twice that of the conventional groups; however, there were cost savings related to the reduction in direct nursing time, after training in home hemodialysis is completed.

Reports describe the need and plans for, and status of, randomized trials to compare clinical outcomes of daily hemodialysis to conventional dialysis. Reports continue to be published with data from uncontrolled studies. For example, Blagg compared mortality (survival) of 117 patients treated by short-daily hemodialysis in 2003 and compared mortality to data from the U.S. Renal Data System. While they report a 61 percent better survival in the daily dialysis group, the study design raises questions about comparability of the groups. Randomized trials are needed.

The Centers for Medicare & Medicaid Services (CMS) and the NIDDKD are jointly sponsoring two clinical trials to evaluate the effectiveness of more frequent hemodialysis sessions compared with conventional thrice-weekly hemodialysis. One of these trials compares daily in-center hemodialysis (six times per week) with conventional in-center hemodialysis (three times per week). The other compares nocturnal hemodialysis (six times per week in the home) with conventional in-center hemodialysis. CMS has agreed to pay for covered patient care-related expenses for Medicare beneficiaries enrolled in these trials. The duration of the nocturnal hemodialysis trial will be 14 months after patient enrollment.

In summary, there is inadequate published data to permit scientific conclusions regarding daily home hemodialysis. Larger controlled studies are needed to demonstrate whether the intermediate outcomes noted (urea clearance, nutritional parameters) translate to clinically significant improvements in patient-oriented outcomes, such as morbidity and mortality. Quality of life measures are also important.

In 2002, the National Institute for Clinical Evidence (NICE) published Technology Appraisal Guidance No. 48, titled Guidance on Home Compared with Hospital Haemodialysis for Patients with End-Stage Renal Failure. This guidance states: "In general, patients suitable for home haemodialysis will be those who:

• Have the ability and motivation to learn to carry out the process
• Have the commitment to maintain treatment
• Are stable on dialysis
• Are free of complications and significant concomitant disease that would render home haemodialysis unsuitable or unsafe
• Have good functioning vascular access
• Have a carer who has (or carers who have) also made an informed decision to assist with the haemodialysis unless the individual is able to manage on his or her own
• Have suitable space and facilities or an area that could be adapted within their home environment."

Several clinical trials evaluating the effectiveness of more frequent hemodialysis compared with thrice-weekly dialysis are still underway, and results have not yet been published. Therefore, published data is still inadequate to permit scientific conclusions regarding daily home hemodialysis. 

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