Pending Policies - Therapy


Daily Hemodialysis and Hemodialysis in the Home Setting

Number:THE802.002

Effective Date:08-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

NOTE: Within this medical policy, the terms hemodialysis and dialysis are used interchangeably and are always referring to hemodialysis. This medical policy does not address peritoneal dialysis, which is usually a continuous, daily process.

Conventional hemodialysis (HD), up to 3-times-per-week, may be considered medically necessary, in the home setting for patients who have end-stage renal disease (ESRD) and meet ALL the following criteria:

Is stable during HD treatment; and

Is free of complications and significant concomitant disease that would render home hemodialysis (HHD) unsuitable or unsafe; and

Has a stable, well-functioning vascular access (i.e., arteriovenous [AV] fistula or graft); and

Has demonstrated a positive commitment to following the ESRD plan of care, including regularly attending HD and following prescribed diet, medication regimen, fluid restriction, etc.; and

Has the ability and motivation to learn and carry out the HD procedure, and the commitment to maintain the HD treatment regimen; and

Has at least one caregiver (e.g., friend or family member) who has also made an informed decision and commitment to assist with the HD treatment, and who is capable of learning and carrying out the treatment process; and

Has suitable space and facilities within the home in which to set up and perform the HD treatment; and

Has access to support of healthcare professionals, through a HD facility, who can be contacted easily and will respond rapidly.

A fourth HD treatment in a week may be considered medically necessary for any of the following conditions, when the condition is refractory to routine 3-times-per-week HD:

Hyperkalemia; or

Pregnancy; or

Fluid overload (greater than 5-pound weight gain per day and/or symptoms [e.g., dyspnea, hypertension, etc.]); or

Acute pericarditis; or

Congestive heart failure; or

Pulmonary edema, (e.g., exhibited by blood gases, hypoxemia, chest x-ray, or physical exam); or

Severe catabolic state, including rapidly rising creatinine (faster than 3-4 mg/dl per day) and increasing muscle enzymes (e.g., y-glutamyl transferase [GT], lactate dehydrogenase [LD], creatine kinase [CK], aspartate aminotransferase [AST/SGOT]); or

Evidence that fluid volume cannot be reduced by other means, (e.g., ultrafiltration) and must be removed by HD.

Daily HD is considered experimental, investigational and/or unproven in any setting.

Wearable and/or implantable HD devices (“artificial kidney”) are considered experimental, investigational and/or unproven.

Description:

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), also known as end-stage kidney disease (ESKD), 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. Dialysis is an artificial replacement for some kidney functions. Dialysis is used as a supportive measure in patients who do not want kidney transplants or who are not transplant candidates, and can also be used as a temporary measure in patients awaiting kidney transplant.

Background

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. More than 661,000 Americans have kidney failure, 468,00 of who are on dialysis (hemodialysis [HD] or peritoneal) and approximately 193,000 of whom live with a functioning kidney transplant. Patients with kidney disease who undergo frequent at-HHD (home hemodialysis) take fewer hypertensive medications, have decreased restless leg syndrome, and have increased energy levels.

End-Stage Renal Disease (ESRD)

ESRD or end-stage kidney disease (ESKD) refers to the inability of the kidneys to perform their functions (i.e., filtering wastes and excess fluids from the blood). ESRD, which is life-threatening and a chronic, permanent failure of the kidneys, is also known as stage 5 chronic renal-failure. ESRD is defined as a glomerular filtration rate (GFR) less than 15 mL/min/1.73 m2. (1) Some sources however, define ESRD as stage 6 (non-official designation), which is an addition to the current accepted stages of chronic kidney failure (CKF), as referenced in Table 1 below. Once the estimated glomerular filtration rate (eGFR) declines to less than 30 mL/min per 1.73 m2 in children less than 12 years of age and the child has stage 4 chronic kidney disease, the child and the family should be prepared for renal replacement therapy (i.e., HD, peritoneal dialysis, and renal transplantation). (2)

The eGFR is calculated from the results of serum creatinine and the patient’s age, body size, and gender. Refer to Table 1 for the stages of CKF with the associated eGFRs for all patients greater than the age of 2 years.

Table 1. Stages of Chronic Kidney Failure (CKF)

Stage

Description

Symptoms

eGFR for Greater than 2 Years of Age (mL/min/1.73m2)

At Increased Risk

Risk factors for kidney disease (e.g., diabetes, high blood pressure, family history, older age, ethnic group, genetic disease)

No symptoms

More than 90

1

Kidney damage with normal kidney function

Normally no symptoms

90 or above

2

Kidney damage with mild loss of kidney function

Normally no symptoms

89 to 60

3a

Mild to moderate loss of kidney function

Normally no symptoms

59 to 45

3b

Moderate to severe loss of kidney function

May start to have symptoms of CKF

44 to 30

4

Severe loss of kidney function

Increasing CKF symptoms and planning for treatment options for next stage

29 to 15

5

Kidney failure

ESRD, starting renal replacement therapy

Less than 15

Table Key:

eGFR: estimated glomerular filtration rate;

CKF: chronic kidney failure;

ESRD: end-stage renal disease.

As a result of renal maturation, the eGFR will be considerably lower in children less than 12 years of age than children greater than 12 years of age. For the same conclusion of renal maturation, the stages of CKF cannot be applied to children lesser than 2 years. (3) Table 2 provides the normal eGFR for infants, toddlers, and children.

Table 2. Normal Glomerular Filtration Rate in Children <12 Years of Age (33)

Age

Average eGFR

(mL/min/1.73m2)

Average Range

(mL/min/1.73m2)

2 to 8 days

39

17 to 60

4 to 28 days

47

26 to 68

37 to 95 days

58

30 to 86

1 to 6 months

77

39 to 114

6 to 12 months

103

49 to 157

12 to 19 months

127

62 to 191

2 to 12 years

127

89 to 165

Table Key:

eGFR: estimated glomerular filtration rate.

Creatinine is a marker for eGFR to assess renal function. Increasing creatinine levels signify the inability of the kidney(s) to remove waste from the body. As the levels rise, kidney function decreases. Serum creatinine levels varies in gender, ethnicity, and race. The following are considered within the normal ranges for serum creatinine:

Adult males: 0.5-1.2 mg/dL.

Adult females: 0.4-1.1 mg/dL.

Children (<12 years of age): 0.0-0.7 mg/dL.

Urine creatinine concentrations may vary depending on fluid intake/hydration status. The following are examples of normal ranges for urine creatinine:

Adult males: 20-25 mg/kg/day (roughly 1575 mg/day for a 70-kg male).

Adult females: 15-20 mg/kg/day (roughly 1050 mg/day for a 60-kg female).

Symptoms of ESRD may include, but are not limited to, any of the following conditions:

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; 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; or

Limit fluids, salt, potassium, phosphorous, and other electrolytes.

Complications of ESRD may include, but are not limited to, any of the following conditions:

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; or

Weakening of the bones, fractures, joint disorders.

Hemodialysis (HD)

During HD, 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.

HD is generally carried out in an outpatient clinic setting. While HD can be performed at home, HHD is not suitable for everyone. Suitability for HHD 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 HD patients in the U.S. undergo HD 3-times-a-week for 3-to 5-hours at each session. Some patients may receive this intermittent HD in the home. Medicare payment policy for dialysis, referred to as the “composite rate,” is premised on thrice-weekly intermittent HD.

There has been longstanding interest in exploring different schedules for HHD to create a more physiologic approach to potentially improve the morbidity and mortality associated with intermittent HD. There are 3 types of HHD: (4)

Short Daily HHD – Performed 5- or 6-times-a-week, typically for 2- to 3-hours per-session.

Traditional (Conventional) Daily HHD – Performed 3-times-per-week, typically for about 4-hours per session. This is similar to the treatments received at a local dialysis center.

Nocturnal HHD – Performed during sleep, typically 6- to 8-hours a night, 3- or more nights-a-week. Patients may prefer these sessions for the ability to spend the night dialyzing and not lose time during the day that could be spent at work or with family.

While daily HD has been investigated in the clinical setting, both short or traditional daily HD and nocturnal hemodialysis (NHD) are more feasible in the home setting.

Wearable or Implanted “Artificial Kidney”

Recent technological advances have led to the construction of a truly wearable or implanted “artificial kidney”. This device offers the promise of regulation of volume status and provision of adequate solute clearances, while at the same time allowing its user to receive continuous therapy while going on with the normal activities of daily life.

Regulatory Status

On November 20, 2014, a high permeability HD system received U.S. Food and Drug Administration (FDA) 510(k) premarket clearance with the specific labeling for home use, the NxStage System One™ (NxStage Medical Inc., Lawrence, MA). The FDA approval for this device was based on data showing that HD 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. FDA Product Code: ODN.

In 2014, the Tablo™ Hemodialysis System (Outset Medical, San Jose/Sunnyvale, CA) received FDA 510(k) premarket clearance with specific labeling for use in clinics and hospitals. This system is a standalone, fully automated device and operates by connecting to and purifying tap water and making the dialysis fluid (i.e., dialysate) while the patient is dialyzing. This eliminates the need for centralized water-processing equipment. HHD using Tablo™ has not been FDA approved and is currently in clinical trials. FDA Product Codes: KDI, FIP.

Wearable or implanted “artificial kidney” devices have not received FDA approval; however, the FDA has approved human trials sometime in 2017. The devices may be called WAK (wearable artificial kidney) or RAD (renal assist device) and is still under development.

Rationale:

The medical policy was created in April 2008 from a MedLine database search of peer-reviewed, scientific literature, which revealed considerable published literature on daily hemodialysis (HD) and nocturnal hemodialysis (NHD) frequently performed in the clinic and not in the home setting. Published studies primarily included single institution case series with comparison of the outcomes of patients undergoing intermittent HD who switched to daily HD. The most recent literature review was performed through June 22, 2017. The following is a summary of key literature to date.

Daily HD

Case Series

In 2001, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD) convened a task force to address the issue of daily HD. (5) This task force reviewed the published data and noted that case series consistently reported that daily HD was associated with an improvement in nutritional parameters, normalization of serum phosphate (particularly with NHD), 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 (RCT) was warranted to further explore the outcomes, and discussion focused on trial design. The task force also discussed the economic impact of daily HD and Medicare reimbursement, which is currently based on 3-times weekly HD.

Williams et al. at the Mayo Clinic reported on the outcomes of 21 patients who were sequentially treated with intermittent and daily HD. (6) Patients served as their own control. The daily HD schedule was associated with improvements in blood pressure, urea kinetics, and symptoms between and during HD sessions. The authors concluded that this small short-term study demonstrated the feasibility of daily HD. In a similarly designed study from an overlapping group of investigators, Ting et al. reported on the outcomes of 42 patients with end-stage renal disease (ESRD) with a mean of 4 significant comorbidities. (7) After conversion to daily HD, there was an improvement in HD parameters, as measured by Kt/V (see the NOTE at the end of this paragraph), and a significant decrease in hospital days. In those remaining on daily HD 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. (NOTE: Kt/V is a number used to quantify HD and peritoneal dialysis treatment adequacy. K is the dialyzer clearance of urea; t is the dialysis time; and V is the volume of distribution of urea, which is approximately equal to patient's total body water.)

Comparative Studies

The prevalence of home hemodialysis (HHD) in the U.S. is growing, driven in part by improvements in dialysis machines for home use. (8) The London Daily/Nocturnal Hemodialysis Study was a prospective nonrandomized comparative study of home daily (n=11) and nocturnal HHD (n=12) with outcomes compared to matched controls receiving conventional HD. (9) The following results were reported in a series of publications. (Daily and nocturnal HHD are collectively known as quotidian [occurring everyday] HD.)

1. There were no differences between the groups in numbers of hospital days or emergency department visits. (9)

2. Weekly urea clearance is improved in quotidian HD. (10)

3. Quotidian HD was associated with an improvement in symptoms both during and between HD sessions, and all patients chose to remain on quotidian HD after switching from intermittent HD. (11)

4. Quotidian HD was associated with improvement in nutritional parameters. (12)

5. Because of the increased number of treatments, treatment supply costs for quotidian HD were twice that of the conventional groups, however, there were cost savings related to the reduction in direct nursing time, after training in HHD is completed. (13)

Reports describe the need for and plans for/status of randomized trials to compare clinical outcomes of short daily HD to conventional daily HD. (14, 15) Reports continue to be published with data from uncontrolled studies. For example, Blagg et al. compared mortality (survival) of 117 patients treated by short daily HD in 2003 and compared mortality to data from the U.S. Renal Data System. (16) While they report a 61% better survival in the daily HD group, the study design raises questions about comparability of the groups. The authors concluded randomized trials are needed.

The Centers for Medicare and Medicaid Services (CMS) is jointly sponsoring with the NIDDKD 2 clinical trials to evaluate the effectiveness of more frequent HD sessions compared with conventional thrice-weekly HD. (17) One of these trials compares daily in-center HD (6-times-per-week) with conventional in-center HD (3-times-per-week). The other compares nocturnal HHD (6-times-per-week in the home) with conventional in-center HD. CMS has agreed to pay for covered patient care-related expenses for Medicare beneficiaries enrolled in these trials. The duration of the nocturnal HHD trial will be 14 months after patient enrollment.

A prospective cohort study compared daily nocturnal hemodialysis (NHD) patients (n=32) to patients receiving standard conventional HD (n=42) over 3 years, including 1 year before and 2 years after the NHD patients were switched from one dialysis procedure to the other. (18) The groups were matched on several characteristics and were followed up for HD or cardiovascular-related hospitalizations and other clinical and biochemical parameters. The NHD group experienced significantly fewer composite admissions compared to pre-conversion hospitalizations (0.2/patient year versus 0.5/patient year) and compared to conventional HD (0.2/patient year versus 0.4/patient year). The distribution of admissions changed; vascular access was responsible for a greater proportion (56%) of the post-conversion admissions compared to the conventional HD group (37%), although the rate of admissions related to vascular access did not change. Other changes included improved blood pressure control and improved hemoglobin levels, in spite of reductions in the number of antihypertensive medications and reduced erythropoietin requirements. Whether all conventional HD controls were eligible for NHD is not addressed, although the authors acknowledge that their results may be subject to selection factors.

Survival was addressed with a cohort of 415 patients on short daily HD whose survival was compared to published estimates from the 2005 United States Renal Data System (USRDS). (19) In 1 of 3 survival comparisons, daily HD survival was 2.3–10.9 years longer than the predicted 50% survival of matched patients from the USRDS patients. Similar results, using other methodologic techniques, are reported to bolster this claim. While adding to the literature base, survival differences cannot be attributed to treatment without a rigorous comparison group. In addition, it is difficult to discern the effect of HHD because the authors did not separately report on the survival of in-center and at daily HHD, which represented 64% and 35% of the cohort, respectively.

In 2012, Hall et al. (20) reported a study that examined changes in physical performance and self-reported physical health and functioning among subjects randomized to frequent (6-times-per-week) compared with conventional (3-times-per-week) HD in both the Frequent Hemodialysis Network daily (n=245) and nocturnal (n=87) trials. The main outcome measures were adjusted change in scores over 12 months on the short physical performance battery (SPPB), RAND 36-item health survey physical health composite (PHC), and physical functioning subscale (PF) based on the intention to treat principle. The study concluded that frequent in-center HD compared with conventional in-center HD improved self-reported physical health and functioning but had no significant effect on objective physical performance. There were no significant effects of frequent NHD on the same physical metrics.

In April 2015, Rocco et al. reported the long-term effects of frequent NHD on mortality in their study, The Frequent Hemodialysis Network (FHN) Nocturnal Trial. (21) The FHN Nocturnal Trial randomly assigned 87 individuals to 6-times-weekly home NHD or 3-times-weekly HD for 1-year. Patients were enrolled starting in March 2006 and follow-up was completed by May 2010. After the 1-year trial concluded, FHN nocturnal participants were free to modify their HD prescription. They obtained dates of death and kidney transplantation through July 2011 using linkage to the USRDS and queries of study centers, and used log-rank tests and Cox regression to relate mortality to the initial randomization assignment. Median follow-up for the trial and post-trial observational period was 3.7 years. In the nocturnal arm, there were 2 deaths during the 12-month trial period and an additional 12 deaths during the extended follow-up. In the conventional arm, the numbers of deaths were 1 and 4, respectively. In the NHD group, the overall mortality HR (hazard ratio) was 3.88 (95% CI, 1.27-11.79; P=0.01). Using as-treated analysis with a 12-month running treatment average, the HR for mortality was 3.06 (95% CI, 1.11-8.43; P=0.03). Six-month running treatment data analysis showed an HR of 1.12 (95% CI, 0.44-3.22; P=0.7). These results should be interpreted cautiously due to a surprisingly low (0.03 deaths/patient-year) mortality rate for individuals randomly assigned to conventional HHD, low statistical power for the mortality comparison due to the small sample size, and the high rate of HD prescription changes. The trial concluded that patients randomly assigned to NHD had a higher mortality rate than those randomly assigned to conventional HD. The implications of this result require further investigation.

Systematic Reviews and Observational Study Reviews

In 2013, Hakim et al. (22) reviewed a number of prospective randomized and multiple retrospective cohort studies of different HD prescriptions: longer HD time, at a frequency of at least 3-times-a-week, or a frequency of daily HD with a shorter HD time. They reported that interestingly, the retrospective analyses have generally found significant survival benefits in the intensive HD groups, whereas more modest effects were observed in the prospective randomized controlled trials. The reason for this discrepancy may be related to the retrospective nature of the studies and possible selection bias; for example, the patients who were prescribed more frequent HD may have had more difficulties with volume control or high blood pressure. In contrast, the randomized controlled trials of increased HD frequency, which have shown indirect and modest benefits in complex coprimary end points, have small sample sizes and are plagued with difficulties in recruitment and compliance with the randomly allocated more frequent HD. Their review, which attempted to balance the potential benefits of more frequent HD with the burden on the patient's lifestyle, an increased risk of access malfunction, as well as societal costs of such intensive HD prescriptions, concluded in favor of the conventional 3-times-per-week HD (at a minimum) but at longer HD times than is currently prescribed based on the Kt/V (urea) metric alone.

In January 2015, Zocalli, et al. reported that observational studies associate long dialysis intervals with an excess risk for mortality and cardiovascular disease hospitalizations; their findings follow. (23) The application of alternate day dialysis is an appealing possibility to reduce the cardiovascular burden of long HD intervals and a small pilot study demonstrated that this regimen allows safe reduction of dry body weight, blood pressure (BP) and left ventricular mass index. However, the actual impact of alternate day HD and of frequent HD in general on survival remains unknown. Frequent HD schedules may increase the risk of arteriovenous fistula problems and the burden of disease and eventually reduce treatment adherence. Furthermore, they could safely exclude that more frequent HD regimens may be harmful. On the other hand, increasing the duration of HD and/or frequency of HD in patients with refractory fluid overload, uncontrolled hypertension, hyperphosphatemia, malnutrition or cardiovascular disease is of unquestionable benefit in these problematic patients. Thus, their conclusion to the question of whether HD should be extended to a more frequent schedule is a “yes” and a hopeful "no". They stated that whenever and wherever possible, frequent HD regimens should be pro-actively applied more in problematic patients, starting with the alternate day approach. However, extensive application of frequent HD schedules is by now unjustified. Evidence that these regimens are beneficial mainly derives from observational studies, and the possibility that frequent schedules are harmful cannot be excluded. A clinical trial is needed.

According to UpToDate, patients using conventional 3-times-weekly HHD have an increased survival and better quality of life compared with those who use conventional in-center HD in the U.S. (24) HHD also costs significantly less than conventional in-center HD. Despite these benefits, relatively few patients use HHD either in the U.S. or internationally, although its use is increasing. The lack of popularity of HHD is probably due to a combination of various factors, such as:

The large number of older or seriously ill patients,

The rapid increase in the number of out-patient HD units/centers,

Concern that patients should not dialyze without direct supervision by a nurse,

Lack of satisfactory explanation of advantages and disadvantages of HHD,

Lack of patient and/or family motivation,

Patient fears regarding technical aspects,

Lack of attention given to HHD by nephrology training programs,

Lack of interest and experience among practicing nephrologists, and

Few experienced dialysis programs available to train patients.

Section Summary: Daily HD

In summary, published data are inadequate to permit scientific conclusions regarding daily HD. 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.

Wearable or Implanted “Artificial Kidney”

Recent technological advances have led to the construction of a truly wearable “artificial kidney”. This device offers the promise of regulation of volume status and provision of adequate solute clearances, while at the same time allowing its user to receive continuous therapy while going on with the normal activities of daily life. (25)

In 2013, Wester et al. reported on portable or wearable artificial dialysis devices. (26) Their report stated that these devices could increase treatment flexibility and dialysis patients' independence. They stated that current renal replacement therapies such as intermittent HD is extend life but are a burden, are time-consuming and immobilize patients. An additional disadvantage is the discontinuous nature of the treatment. Peritoneal dialysis is a good alternative, but is associated with relatively limited toxin clearance and a need for high glucose concentrations in the dialysate. Portable dialysis devices could be used as a replacement or to support existing dialysis techniques. At the time of their report, several initiatives, including some started in the Netherlands, aim at the development of a portable device. Some of them are so far into development that they are at a preclinical phase, but yet none has been approved for regular use in patients. The authors stated that to achieve the ultimate goal, an implantable artificial kidney, a lot of hurdles still have to be surmounted.

In 2011, Davenport et al. conducted a pilot proof-of-concept study in 8 stable adult HD patients using a wearable HD device with a sorbent-based regeneration system. All patients were safely treated for 4-8 hours. (27) Ultrafiltration was successfully performed without any cardiovascular effects, with a reduction in extracellular fluid to total body fluid ratio (from 0.339 ± 0.003 to 0.335 ± 0.003 after treatment; p=0.002). Respective clearances (ml/min) were: 22.6 ± 1.8 for urea, 20.7 ± 1.8 for creatinine, 21.7 ± 1.8 for phosphate and 11.6 ± 1.8 for β2-microglobulin. Although the small solute clearances are much lower than for conventional intermittent HD, this device has been designed to operate for sustained periods, and therefore would be predicted to have equivalent small solute clearances to continuous HD treatments (CRRT, continuous renal replacement therapy) in the intensive setting. Safety mechanisms were shown to operate promptly in a case of a venous needle disconnection, and in cases of circuit clotting. This was a pilot study designed to demonstrate the safety of a wearable HD device. In addition to confirming safety, they were able to confirm that the device not only had similar clearances to CRRT used in the intensive-care setting, but also increased clearances of middle molecules, such as β2-microglobulin and phosphate.

ECRI published a Health Technology Forecast in 2017. (28) They summarized that wearable “artificial kidneys” (WAKs) are intended to provide more continuous HD while relieving patients of the need for regular clinic-based HD sessions. Wearable devices that offer round-the-clock HD could theoretically reduce the incidence of side effects. Clinical trials are ongoing to compare WAKs to clinic-based or home-based HD, and whether using WAKs could become the standard of care for certain patients.

Section Summary: Wearable or Implanted “Artificial Kidney”

Although several articles were found that discuss the promising future of wearable or implanted “artificial kidney” devices, further clinical trials are needed to permit scientific conclusions regarding the portable “artificial kidney” device.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this policy are listed in Table 1.

Table 1. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02460263

The EvAluation of TaBlo In-CLinic and In-HOme (TABLO)

50

Dec 2018

Unpublished

NCT02128347

Effectiveness of an Online Portal for Delivery of Care to Home Dialysis Patients

39

Feb 2016 (completed)

Table Key:

NCT: National Clinical Trial.

Professional Guidelines and Position Statements

National Kidney Foundation (NKF)

The NKF released an updated clinical guideline, the Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline for Hemodialysis Adequacy: 2015 Update. (29) For Guideline 2, they recommended:

In-center Frequent Hemodialysis

2.1 We suggest that patients with end-stage kidney disease be offered in-center short frequent hemodialysis as an alternative to conventional in-center thrice weekly hemodialysis after considering individual patient preferences., the potential quality of life and physiological benefits, and the risks of these therapies. (2C [Conditional Recommendation – Low quality of evidence]).

2.2 We recommend that patients considering in-center short frequent hemodialysis be informed about the risks of this therapy, including a possible increase in vascular access procedures (1B [Strong Recommendation – Moderate quality of evidence]) and the potential for hypotension during dialysis. (1C [Strong Recommendation – Low quality of evidence]).”

Home Long Hemodialysis

2.3 Consider home long hemodialysis (6-8 hours, 3 to 6 nights per week) for patients with end-stage kidney disease who prefer this therapy for lifestyle considerations. (Recommendation and Quality of Evidence Not Graded).

2.4 We recommend that patients considering home long frequent hemodialysis be informed about the risks of this therapy, including possible increase in vascular access complications, potential for increased caregiver burden, and accelerated decline in residual kidney function. (1C [Strong Recommendation – Low quality of evidence]).”

Pregnancy

2.5 During pregnancy, women with end-stage kidney disease should receive long frequent hemodialysis either in-center or at home, depending on convenience. (Recommendation and Quality of Evidence Not Graded).”

National Institute for Clinical Evidence (NICE)

In 2002, the NICE published Technology Appraisal Guidance No. 48, titled “Guidance on Home Compared with Hospital Haemodialysis for Patients with End-Stage Renal Failure”. (30) 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 and 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.”

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

90963, 90964, 90965, 90966, 99512

HCPCS Codes

G0420, G0421, S9335

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. NKF – Glomerular Filtration Rate (GFR), National Kidney Foundation. Available at https://www.kidney.org> (accessed March 24, 2017).

2. infoKID – Chronic Kidney Disease – Stage 3b to 5 (Version 1, December 2013). Prepared by British Kidney Disease Association. Available at <http://www.infoKID.org.uk> (accessed May 24, 2017).

3. Warady BA, Chadha V. Chronic kidney disease in children: the global perspective. Pediatr Nephrol. Dec 2007; 22(12):1999-2009. PMID 17310383

4. Home Hemodialysis. National Kidney and Urologic Diseases Information Clearinghouse (2017). Available at <http://www.nationalkidneycenter.org> (accessed April 21, 2017).

5. National Institute of Diabetes and Digestive and Kidney Disorders Task Force to Address Daily Hemodialysis (2001). Available at <http://www.niddk.nih.gov> (accessed February 19, 2014).

6. Williams AW, Chebrolu SB, Ing TS, et al. Early clinical, quality of life and biochemical changes of daily hemodialysis. Am J Kidney Dis. Jan 2004; 43(1):90-102. PMID 14712432

7. Ting GO, Kjellstrand C, Freitas T, et al. Long-term study of high-comorbidity ESRD patients converted from conventional to short daily hemodialysis. Am J Kidney Dis. Nov 2003; 42(5):1020-35. PMID 14582046

8. Brunelli SM, Wilson SM, Ficociello LH, et al. A comparison of clinical parameters and outcomes over 1 year in home hemodialysis patients using 2008K@home or NxStage System One. ASAIO J. Mar-Apr 2016; 62(2):182-9 PMID 28892402

9. Lindsay RM, Leitch R, Heidenheim AP, et al. The London Daily/Nocturnal Hemodialysis Study - study design, morbidity and mortality results. Am J Kidney Dis. Jul 2003; 42(1 suppl):5-12. PMID 12830437

10. Suri R, Depner TA, Blake PG, et al. Adequacy of quotidian hemodialysis. Am J Kidney Dis. Jul 2003; 42(1 suppl):42-8. PMID 12830443

11. Heidenheim AP, Muirhead N, Moist L, et al. Patients’ quality of life on quotidian hemodialysis. Am J Kidney Dis. Jul 2003; 42(1 suppl):36-41. PMID 12830442

12. Spanner E, Suri R, Heidenheim AP, et al. The impact of quotidian hemodialysis on nutrition. Am J Kidney Dis. Jul 2003; 42(1 suppl):30-5. PMID 12830441

13. Kroeker A, Clark WF, Heidenheim AP, et al. An operating cost comparison between conventional and home quotidian hemodialysis. Am J Kidney Dis. Jul 2003; 42(1 suppl):49-55. PMID 12830444

14. Suri RS, Garg AX, Chertow GM, et al. Frequent Hemodialysis Network (FHN) randomized trials: study design. Kidney Int. Feb 2007; 71(4):349-59. PMID 17164834

15. Walsh M, Manns BJ, Klarenbach S, et al. The effects of nocturnal hemodialysis compared to conventional hemodialysis on change in left ventricular mass: rationale and study design of a randomized controlled pilot study. BMC Nephrol. Feb 22 2006; 7:2. PMID 16504054

16. Blagg CR, Kjellstrand CM, Ting GO, et al. Comparison of survival between short-daily hemodialysis and conventional hemodialysis using the standardized mortality ratio. Hemodial Int. Oct 2006; 10(4):371-4. PMID 17014514

17. CMS – Frequent Hemodialysis Network Clinical Trials (Transmittal No. 145, March 11, 2005:1-12). Centers for Medicare and Medicaid Services. Available at <http://new.cms.hhs.gov> (accessed on June 23, 2017).

18. Bergman A, Fenton SS, Richardson RM, et al. Reduction in cardiovascular related hospitalization with nocturnal home hemodialysis. Clin Nephrol. Jan 2008; 69(1):33-9. PMID 18218314

19. Kjellstrand CM, Buoncristiani U, Ting G, et al. Short daily haemodialysis: survival in 415 patients treated for 1006 patient-years. Nephrol Dial Transplant. Oct 2008; 23(10):3283-9. PMID 18458034

20. Hall YN, Larive B, Painter P, et al. Effects of six versus three times per week hemodialysis on physical performance, health, and functioning: Frequent Hemodialysis Network (FHN) randomized trials. Clin J Am Soc Nephrol. May 2012; 7(5):782-94. PMID 22422538

21. Rocco MV, Daugirdas JT, Greene T, et al. Long-term Effects of Frequent Nocturnal Hemodialysis on Mortality: The Frequent Hemodialysis Network (FHN) Nocturnal Trial. Am J Kidney Dis. Sep 2015; 66(3):459-68. PMID 25863828

22. Hakim RM, Saha S. Dialysis frequency versus dialysis time, that is the question. Kidney Int. May 2014; 85(5):1024-9. PMID 24336033

23. Zoccali C, Dounousi E, Abd El Hafeez S, et al. Should we extend the application of more frequent dialysis schedules? A 'yes' and a hopeful 'no'. Nephrol Dial Transplant. Jan 2015; 30(1):29-32. PMID 25538160

24. Blagg CR, et.al. Home hemodialysis. In: UpToDate, Sheridan AM (Ed), UpToDate, Waltham, MA. Available at <http://www.uptodate.com> (accessed June 21, 2017).

25. Rosner MH, Ronco C. Remote monitoring for the wearable artificial kidney. Contrib Nephrol. 2011; 171:243-7. PMID 21625119

26. Wester M, Gerritsen KG, Boer WH, et al. The wearable artificial kidney: a promise for the future? Ned Tijdschr Geneeskd. 2013; 157(52):A6965. PMID 24382046

27. Davenport A, Ronco C, Gura V. From wearable ultrafiltration device to wearable artificial kidney. Contrib Nephrol. 2011; 171:237-42. PMID 21625118

28. ECRI Institute. Wearable Artificial Kidney for Kidney Dialysis. Plymouth Meeting (PA): ECRI Institute; 2017 April. 11 p. (Health Technology Forecast).

29. NKF – KDOQI clinical practice guideline for hemodialysis adequacy: 2015 update. National Kidney Foundation. Am J Kidney Dis. Mar 2015; 66(5):884-930. PMID 26498416

30. NICE – Guidance on home compared with hospital haemodialysis for patients with end-stage renal failure. National Institute for Clinical Excellence Technology Appraisal No. 48. Issue date September 26, 2002. Available at <http://www.nice.org.uk> (accessed June 21, 2017).

31. Daily Hemodialysis in the Home (Archived). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2008 June) Therapy 8.02.05.

Policy History:

Date Reason
8/15/2017 Document updated with literature review. Coverage unchanged.
4/15/2016 Reviewed. No changes.
7/1/2015 Document updated with literature review. Coverage unchanged.
8/1/2014 Document updated with literature review. The following was added: Wearable and/or implantable hemodialysis devices are considered experimental, investigational and/or unproven.
6/15/2011 Document updated with literature review. The following changes were made: 1) Requirement that the patient must be home-bound has been removed; 2) Home hemodialysis may be considered medically necessary when stated criteria are met; 3) A fourth hemodialysis treatment in a week may be considered medically necessary for any of the listed conditions when the condition is refractory to routine 3-times-per-week hemodialysis; 4) This policy is no longer scheduled for routine literature review and update.
4/15/2008 New Medical Document

Archived Document(s):

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