NOTE: Within this policy, the terms hemodialysis and dialysis are used interchangeably and are always referring to hemodialysis. This policy does not address peritoneal dialysis, which is usually a continuous, daily process.
Healthy kidneys filter about 200 quarts of fluid every 24 hours; about two 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% 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;
- Bone pain;
- Brain and nervous system symptoms;
- Breath odor;
- Drowsiness and confusion;
- Easy bruising, nosebleeds, or blood in the stool;
- Excessive thirst;
- Frequent hiccups;
- General ill feeling and fatigue;
- Generalized itching (pruritus) and dry skin;
- Loss of appetite;
- Low level of sexual interest and impotence;
- Muscle twitching or cramps;
- 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; or
- 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, and
- Limit fluids, salt, potassium, phosphorous, and other electrolytes.
Complications of ESRD may include:
- 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;
- Increased risk of infections;
- Phosphorous levels become too high;
- Potassium levels become too high;
- Skin dryness, itching/scratching, leading to skin infection;
- Stroke; or
- 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 3-5 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 longstanding 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, and
- 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.