Pending Policies - Surgery


Kidney Transplant

Number:SUR703.007

Effective Date:05-15-2018

Coverage:

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

A kidney transplant alone with either a living or cadaver donor may be considered medically necessary for carefully selected candidates with end-stage renal disease (ESRD) who have been evaluated and accepted by the facility’s transplant center committee.

Kidney retransplant after a failed primary kidney transplant may be considered medically necessary in patients who meet criteria for kidney transplantation.

Kidney transplant is considered experimental, investigational and/or unproven in all other situations.

NOTE 1: Refer to SUR703.001, Organ and Tissue Transplantation for general donor and recipient information.

Description:

Kidney transplant, a treatment option for end-stage renal disease (ESRD; chronic irreversible renal-failure), involves the surgical removal of a kidney from a cadaver, living-related donor, or living-unrelated donor and transplantation into the recipient.

Background

ESRD 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; and 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., hemodialysis, peritoneal dialysis, and renal transplantation). (25)

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 eGRF 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. (26) Table 2 provides the normal eGFR for infants, toddlers, and children.

Table 2. Normal Glomerular Filtration Rate in Children <12 Years of Age (27)

Age

Average eGFR

(mL/min/1.73m2)

Average eGFR 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) 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 depended 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).

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.

Kidney transplant, using kidneys from deceased or living donors, is an accepted treatment of ESRD. Based on data from the Organ Procurement and Transplantation Network, between 1998 and October 2016, 401,913 kidney transplants had been performed in the U.S. (2) Of these, 66% of the kidneys came from deceased donors and 34% from living donors.

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

Acute tubular necrosis,

Amyloid disease,

Analgesic nephropathy,

Anti-glomerular base-membrane disease,

Chronic pyelonephritis,

Cortical necrosis,

Cystinosis,

Diabetes mellitus,

Fabry's disease,

Focal glomerulosclerosis,

Glomerulonephritis,

Gout nephritis,

Heavy metal poisoning,

Hemolytic uremic syndrome,

Henoch-Schönlein purpura,

Horseshoe kidney,

Hypertensive nephrosclerosis,

IGA nephropathy,

Medullary cystic disease,

Myeloma in remission,

Nephritis,

Nephrocalcinosis,

Obstructive uropathy,

Oxalosis,

Polyarteritis,

Polycystic kidney disease,

Renal artery or vein occlusion,

Renal-cell carcinoma,

Systemic lupus erythematosus,

Trauma requiring nephrectomy,

Tuberous sclerosis,

Wegener's granulomatosis,

Wilms’ tumor.

General Considerations for Kidney Transplantation

Potential Contraindications Subject to the Judgment of the Transplant Center:

1. Known current malignancy, including metastatic cancer;

2. Recent malignancy with high risk of recurrence;

3. History of cancer with a moderate risk of recurrence;

4. Systemic disease that could be exacerbated by immunosuppression;

5. Untreated systemic infection making immunosuppression unsafe, including chronic infection;

6. Other irreversible end-stage disease not attributed to kidney disease;

7. Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

HIV (human immunodeficiency virus)-positive patients, who meet the following criteria, as stated in the 2001 guidelines of the American Society of Transplantation, could be considered candidates for kidney transplantation:

CD4 count >200 cells per cubic millimeter for >6 months;

HIV-1 RNA undetectable;

On stable antiretroviral therapy >3 months;

No other complications from AIDS (acquired immune deficiency syndrome) (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidiosis mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm); and

Meeting all other criteria for transplantation.

Kidney Specific Concerns

In addition to measuring the eGFR, discussed earlier, indications for renal transplant also include a rising serum creatinine level. However, consideration for listing for renal transplant may start well before reaching CFK, based on the anticipated time that a patient may spend on the waiting list.

Regulatory Status

Kidney transplant is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

Rationale:

The policy was originally created in 1990 with updated searches of the MedLine database. The most recent literature search was conducted through April 2, 2018.

Assessment of efficacy for therapeutic intervention involves a determination of whether an intervention improves health outcomes. The optimal study design for this purpose is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes, but are prone to biases such as noncomparability of treatment groups, placebo effect, and variable natural history of the condition.

Kidney Transplantation

Survival

According to data analysis from the Organ Procurement and Transplantation Network (OPTN), between 2008 and 2015, the 1-year survival of patients undergoing an initial kidney transplant was 97.0% (95% confidence interval [CI], 96.8% to 97.1%). Five-year survival was 85.8% (95% CI, 85.5% to 86.1%). (2)

In 2015, Krishnan et al. published a study of 17,681 patients in a U.K. transplant database who either received a kidney transplant or were on a list to receive a kidney transplant. (3) Authors found significantly higher 1- and 5-year survival in patients who underwent a kidney transplant than in those who remained on dialysis (authors did not report exact survival rates).

Organ Donation

The United Network for Organ Sharing (UNOS) proposed an Expanded Criteria Donor (ECD) approach in 2002 to include brain-dead donors over 60 years or between 50 and 59 years old with 2 or more of the following criteria: serum creatinine level greater than 1.5 mg/dL, death caused by cerebrovascular accident, or history of high blood pressure. (4) In 2016, Querard et al. conducted a systematic review and meta-analysis of studies comparing survival outcomes with ECD versus Standard Criteria Donor (SCD) kidney transplant recipients. (4) Reviewers identified 32 publications, 5 of which adjusted for potential confounding factors. A pooled analysis of 2 studies reporting higher rates of patient-graft failure for ECD kidney recipients found a significantly higher adjusted hazard ratio (HR) for patient-graft survival (HR=1.68; 95% CI; 1.32 to 2.12). Meta-analyses were not conducted for patient survival outcomes; however, 1 study (n=189) found a higher but nonsignificant difference in patient survival with ECD than with SCD (HR=1.97; 95% CI, 0.99 to 3.91) and another (n=13,833) found a significantly increased risk of death with ECD than with SCD (HR=1.25; 95% CI, 1.12 to 1.40).

Several studies have reported on long-term outcomes in live kidney donors. The most appropriate control group to evaluate whether donors have increased risks of morbidity and mortality are individuals who meet the criteria for kidney donation but who did not undergo the procedure. These types of studies have provided mixed findings. For example, Segev et al. (2010) found that donors had an increased mortality risk. (5) The authors analyzed data from a national registry of 80,347 live donors in the U.S. who donated organs between April 1994, and March 2009, and compared their data with data from 9364 participants of the National Health and Nutrition Examination Survey (NHANES) (excluding those with contraindications to kidney donation). There were 25 deaths within 90 days of live kidney donation during the study period. Surgical mortality from live kidney donation was 3.1 per 10,000 donors (95% CI, 2.0 to 4.6) and did not change over times, despite differences in practice and selection. Long-term risk of death was no higher for live donors than for age- and comorbidity-matched NHANES III participants for all patients and also stratified by age, sex, and race.

Candidate Acceptance to Waiting List to Kidney Allocation

According to OPTN/UNOS, for a patient to be placed on a waiting list for kidney allocation, the recipient must meet the following recipient must meet the following parameters: (2)

Waiting Time for Candidates Registered at Age 18 Years or Older

If a kidney candidate is 18 years or older on the date the candidate is registered for a kidney, then the candidate’s waiting time is based on the earliest of the following:

1. The candidate’s registration date with a measured or calculated creatinine clearance or glomerular filtration rate (GFR) less than or equal to 20 mL/min.

2. The date after registration that a candidate’s measured or calculated creatinine clearance or GFR becomes less than or equal to 20 mL/min.

3. The date that the candidate began regularly administered dialysis as an End Stage Renal Disease (ESRD) patient in a hospital based, independent non-hospital based, or home setting.”

Waiting Time for Candidates Registered prior to Age 18

If a kidney candidate is less than 18 years old at the time of registration on the waiting list, then the candidate’s waiting time is based on the earlier of the following:

1. The date that the candidate registered on the waiting list regardless of clinical criteria.

2. The date that the candidate began regularly administered dialysis as an ESRD patient in a hospital based, independent non-hospital based, or home setting.”

It is worth noting, indications for renal transplant include a creatinine level of greater than 8 mg/dL, or greater than 6 mg/dL in symptomatic diabetic patients; however, consideration for listing for renal transplant may start well before the creatinine level reaches this point, based on the anticipated time that a patient may spend on the waiting list. In other instances, the patient may have been classified at CKF stage 5 with an eGFR of <15mL/min/1.73m2.

Potential Contraindications to Kidney Transplantation

HIV (human immunodeficiency virus) Infection Transplant Recipents

In 2001, the American Society of Transplantation (AST) proposed that HIV-positive (+) patients who met the following criteria could be considered candidates for kidney transplantation: (6)

CD4 count greater than 200 cells/mm3 for more than 6 months;

Undetectable HIV-1 RNA;

On stable anti-retroviral therapy for more than 3 months;

No other complications from AIDS (acquired immune deficiency syndrome) (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi sarcoma, or other neoplasm);

Meeting all other criteria for transplantation.

(NOTE 2: These criteria may be extrapolated to other organs.)

Several studies have evaluated outcomes of kidney transplantation in HIV+ patients. In 2015, Locke et al. examined outcomes in 499 HIV+ kidney transplant recipients identified in the Scientific Registry of Transplant Recipients (SRTR). (7) Compared with early era transplants (2004-2007), patients transplanted more recently (2008-2011) had a significantly lower risk of death (HR=0.59; 95% CI, 0.39 to 0.90). The 5-year patient survival rate was 78.2% for patients transplanted in the early era and 85.8% for more recent transplants. In another study, Locke et al. (2015) compared outcomes in 467 adult kidney transplant recipients with 4670 HIV-negative (-) controls, matched on demographic characteristics. (8) Compared with HIV- controls, survival among HIV+ transplant recipients was similar at 5 years post-transplant (83.5% versus 86.2%, p=0.06). At 10 years, HIV+ transplant recipients had a significantly lower survival rate (51.6%) than HIV- patients (72.1%; p<0.001). The lower 10-year survival rate was likely due to HIV and hepatitis C virus (HCV) coinfection; survival rates at 10 years in HIV-monoinfected patients and HIV- patients were similar (88.7% versus 89.1%, p=0.50). In a 2017 analysis, Locke et al. found a significantly lower 5-year mortality rates in HIV-infected patients with SSRD who had kidney transplants compared with continued dialysis (adjusted relative risk [RR], 0.21; 95% CI, 0.10 to 0.42; p<0.001). (9)

In addition, in 2015, Sawinski et al. analyzed survival outcomes in patients infected with HIV, HCV, or HIV plus HCV. (10) Analysis included 492 HIV-infected patients, 5605 HCV-infected patients, 147 coinfected patients, and 117,791 noninfected patients. In a multivariate analysis, compared with noninfected patients, HIV-infected patients did not have an increased risk of death (HR=0.90; 95% CI, 0.66 to 1.24). However, HCV infection (HR=1.44; 95% CI, 1.33 to 1.56) and HIV and HCV coinfection (HR=2.26; 95% CI, 1.45 to 3.52) were both significantly associated with an increased risk of death.

Hepatitis C Infection

A 2014 meta-analysis by Fabrizi et al. identified 18 observational studies comparing kidney transplant outcomes in patients with and without HCV infection. (11) The studies included 133,350 transplant recipients. In an adjusted analysis, the risk of all-cause mortality was significantly higher in HCV+ versus HCV- patients (RR=1.85; 95% CI, 1.49 to 2.31). Risks were elevated in various study subgroups examined by investigators. When the analysis was limited to the 4 studies from the U.S., the adjusted RR was 1.29 (95% CI, 1.15 to 1.44). In an analysis of 10 studies published since 2000, the RR was 1.84 (95% CI, 1.45 to 2.34). An analysis of disease-specific mortality suggested that at least part of the increased risk of mortality among HCV+ individuals must have been due to chronic liver disease. In a meta-analysis of 9 studies, the risk of liver disease-related mortality was highly elevated in patients infected with HCV than in those uninfected (odds ratio [OR], 11.6; 95% CI, 5.54 to 24.4).

In the analysis by Sawinski et al. (described above), HCV infection was associated with an increased risk of mortality in kidney transplant patients compared with noninfected patients. (10)

Obesity

Several studies have found that obese kidney transplant patients have improved outcomes compared with patients on a waiting list matched by body mass index (BMI). Study results on whether morbid obesity is associated with an increased risk of adverse outcomes after kidney transplant are conflicting.

In a 2015 analysis of kidney transplant data from the U.K., BMI data were available for 13,536 patients. (3) Authors devised several BMI categories (i.e., <18.5 kg/m2, 18.5 to <25 kg/m2, 25 to <30 kg/m2, 30 to <35 kg/m2, and 35 to <40 kg/m2). For each BMI category, patient survival was significantly higher in those who underwent kidney transplants compared with those who remained on a waiting list. In a similar analysis of U.S. data, published by Gil et al. (2013), risk of mortality at 1 year was significantly lower in patients who underwent transplantation than in those who remained on the waiting list for all BMI categories. (12) For example, the risk was lower for patients with a BMI of at least 40 kg/m2 who received organs from donors who met standard criteria (HR=0.52; 95 CI, 0.37 to 0.72) and for patients with BMI 35 to 39 kg/m2 who received organs from SCD donors (HR=0.34; 95% CI, 0.26 to 0.46).

In 2014, Pieloch et al. retrospectively reviewed data from the OPTN database. (13) The sample included 6055 morbidly obese patients (i.e., BMI, 35-40 kg/m2) and 24,077 normal weight individuals who underwent kidney transplant between 2001 and 2006. After controlling for potentially confounding factors, the overall 3-year patient mortality did not differ significantly between obese and normal weight patients (HR=1.03; 05% CI, 0.96 to 1.12). Similar results were found for 3-year graft failure (HR=1.04; 95% CI, 0.98 to 1.11). In subgroup analyses, obese patients who were non-dialysis-dependent, nondiabetic, younger, receiving living-donor transplants, and needing no assistance with daily living activities had significantly lower 3-year mortality rates than normal weight individuals. For example, the odds ratio for mortality between nondiabetic obese and normal weight patients was 0.53 (95% CI, 0.44 to 0.63).

A 2016 multivariate analysis of the effect of obesity on transplant outcomes by Kwan et al. included 191,091 patients from the SRTR database. (14) Covariates in the analysis included age, sex, graft type, ethnicity, diabetes, peripheral vascular disease, dialysis time, and time period of transplantation. Multivariate regression analysis indicated that obese patients had a significantly increased risk of adverse transplant outcomes including delayed graft function, urine protein, acute rejection, and graft failure (p<0.001 for all outcomes). The risk of adverse outcomes of obesity increased with increasing BMI (e.g., see Table 1), and was independent of the effect of diabetes.

Table 3. Hazard Ratio of Graft Failure Relative to a Body Mass Index of 18.5 to 24.9 kg/m2

Body Mass Index, kg/m2

Hazard Ratio

95% Confidence Interval

p

25 to 29.9

1.015

0.983 to 1.047

0.416

30 to 34.9

1.104

1.065 to 1.145

<0.001

35 to 39.9

1.216

1.158 to 1.276

<0.001

40+

1.248

1.156 to 1.348

<0.001

Type 2 Diabetes

Lim et al. (2017) evaluated all-cause mortality following kidney transplantation in patients with type 2 diabetes from the Australia and New Zealand Dialysis and Transplant (ANZDT) registry. (15) Of 10,714 transplant recipients during the study period, 985 (9%) had type 2 diabetes. The 10-year unadjusted overall survival in patients with an intact graft was 53% for individuals who had diabetes compared with 83% for transplant recipients who did not. The adjusted HR for all-cause mortality in patients with diabetes was 1.60 (95% CI, 1.37 to 1.86; p<0.001), with the excess risk of death attributable to both cardiovascular disease and infection. Graft survival rates at 1, 5, and 10 years were 94%, 85%, and 70% in patients with diabetes compared with 95%, 89%, and 78% in transplant recipients without diabetes (p<0.001), respectively.

Section Summary: Kidney Transplantation

A large number of kidney transplants have been performed worldwide. Available data have demonstrated reasonably high survival rates after kidney transplant for appropriately selected patients and significantly higher survival rates for patients undergoing kidney transplant compared with those who remained on a waiting list. HIV infection has not been found to increase the risk of adverse events after kidney transplantation. Obesity and type 2 diabetes may increase the risk of adverse outcomes, and some data have suggested that kidney transplant recipients with HCV have worse outcomes than those without hepatitis C infection; however, data have not shown that patients with these conditions do not benefit from kidney transplants.

Kidney Retransplantation

Survival

According to data analysis from the OPTN between 2008 and 2015, the 1-year survival rate of patients undergoing a repeat kidney transplant was 97.1% (95% CI, 96.7% to 97.5%). (2) The 5-year patient survival rate after a repeat kidney transplant was 87.6% (95% CI, 86.8% to 88.4%).

In 2009, Barocci et al. in Italy reported on long-term survival after kidney retransplantation. (16) There were 100 (0.8%) second transplants of 1302 kidney transplants performed at a single center between 1983 and 2007. Among the second kidney recipients, 1-, 5-, and 10-year patient survival rates were 100%, 96%, and 92%, respectively. Graft survival rates at 1, 5, and 10 years were 85%, 72%, and 53%, respectively.

Children

In 2015, Gupta et al. retrospectively analyzed OPTN data, focusing on patients who had an initial kidney transplant as children. (17) A total of 2281 patients were identified who had their first transplant when they were younger than 18 years and a second kidney transplant at any age. In multivariate analysis, length of first graft survival and age at second graft were significantly associated with second graft survival. Specifically, first graft survival time of more than 5 years was associated with better second graft survival. However, patients who were between 15 and 20 years old at second transplant were at increased risk of second kidney graft failure compared with patients in other age groups.

HIV Infection Transplant Recipents

In 2017, Shelton et al. evaluated outcomes in HIV-infected patients undergoing kidney retransplantation. (18) In an adjusted survival analysis, HIV-infected retransplant patients had a significantly increased risk of death compared with HIV-negative patients (HR=3.11; 95% CI, 1.82 to 5.34). Other factors significantly associated with increased risk of death after kidney retransplantation included recipient infection with HCV (HR=1.77; 95% CI, 1.32 to 2.38) and grafts from older donors (HR=1.01; 95 CI, 1.00 to 1.02). The analysis included only 22 HIV-infected patients, which is too small to draw conclusions about the appropriateness of kidney retransplantation in HIV-infected individuals.

Section Summary: Kidney Retransplantation

Data have demonstrated reasonably high survival rates after kidney retransplant for appropriately selected patients (e.g., 5-year survival rates ranging from 87% to 96%). Data on retransplant in HIV-infected individuals is too limited to draw conclusions.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in March 2018 did not identify any ongoing or unpublished trials that would likely influence this review.

Practice Guidelines and Position Statements

European Renal Best Practice

In 2016, the European Renal Best Practice published guidance on managing older patients (age >65 years) with chronic kidney disease stage 3b or higher (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m2). (19) One of the clinical questions in the guidance involved the criteria and appropriateness of transplantation in older patients with end-stage renal failure. Because older patients are often excluded from trials, the evidence is limited and the panel issued a separate narrative on the topic. (20) The position statement asserted that patients should not be deemed ineligible for renal transplantation based on age alone, and that, for select elderly patients, transplantation is superior to dialysis in increasing survival. Before elderly patients should be considered for transplantation, psychological testing and assessments of comorbidities (in particular, cardiac evaluation and malignancy testing) should be performed.

British Transplantation Society (BTS)

In 2014, the BTS published guidelines on the management of the failed kidney transplant. (21) Among the recommendations, the guidelines stated that appropriate patients with failing kidney transplants can undergo retransplantation when the graft eGFR falls to 10 to 15 mL/min. In addition, the guidelines included a suggestion that joint transplant or advanced kidney care be initiated at least 6 to 12 months before the expected need for dialysis or retransplantation, or when the eGFR is less than 20 mL/min. These recommendations were based on low-quality evidence.

American Society of Transplant Surgeons (ASTS) et al.

In 2011, the ASTS, the AST, the Association of OPTN, and the UNOS issued a joint position statement recommending modifications to the National Organ Transplant Act of 1984. (22) The joint recommendation stated that the potential pool of organs from HIV-infected donors should be explored. With modern antiretroviral therapy, the use of these previously banned organs would open an additional pool of donors to HIV-infected recipients. The increased pool of donors has the potential to shorten waiting times for organs and decrease the number of waiting list deaths. The organs from HIV-infected deceased donors would be used for transplant only with patients already infected with HIV. In 2013, the HIV Organ Policy Equity Act permitting use of this group of organ donors.

British HIV Association and British Transplantation Society (BTS)

In 2006, the British HIV Association and BTS published guidelines for kidney transplantation in patients with HIV disease. (23) The guidelines recommended that any patient with ESRD with a life expectancy of at least 5 years should be considered appropriate for transplantation under the following conditions:

a. “CD4 ≥ 200 cells/microlitre for at least six months;

b. Undetectable HIV viremia (< 50 copies/ml) for at least 6 months;

c. Demonstrable adherence and a stable HAART [highly active antiretroviral therapy] regimen for ≥ 6 months;

d. Absence of AIDS-defining illness following successful immune reconstitution after HAART.”

The document listed general and disease-specific exclusion criteria and immunosuppressant protocols. These recommendations were based on level III evidence (observational studies and case reports).

Medicare National Coverage

The Medicare Benefit Policy Manual includes a chapter on ESRD. (24) A section on identifying candidates for transplantation (140.1) states:

“After a patient is diagnosed as having ESRD, the physician should determine if the patient is suitable for transplantation. If the patient is a suitable transplant candidate, a live donor transplant is considered first because of the high success rate in comparison to a cadaveric transplant. Whether one or multiple potential donors are available, the following sections provide a general description of the usual course of events in preparation for a live-donor transplant.”

Summary of Evidence

For individuals who have end-stage renal disease (ESRD) without contraindications to kidney transplant who receive a kidney transplant from a living donor or deceased (cadaveric) donor, the evidence includes registry data and case series. Relevant outcomes are overall survival, morbid events, and treatment-related mortality and morbidity. Data from large registries have demonstrated reasonably high survival rates after kidney transplant for appropriately selected patients and significantly higher survival rates for patients undergoing kidney transplant compared with those who remained on a waiting list. Kidney transplantation is contraindicated for patients in whom the procedure is expected to be futile due to comorbid disease or in whom post-transplantation care is expected to significantly worsen comorbid conditions. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have a failed kidney transplant without contraindications to kidney transplant who receive a kidney retransplant from a living donor or deceased (cadaveric) donor, the evidence includes registry data and case series. Relevant outcomes are overall survival, morbid events, and treatment-related mortality and morbidity. Data have demonstrated reasonably high survival rates after kidney retransplant (e.g., 5-year survival rates ranging from 87% to 96%) for appropriately selected patients. Kidney retransplantation is contraindicated for patients in whom the procedure is expected to be futile due to comorbid disease or in whom post-transplantation care is expected to significantly worsen comorbid conditions. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

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

50300, 50320, 50323, 50325, 50327, 50328, 50329, 50340, 50360, 50365, 50370, 50547

HCPCS Codes

S2152

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. OPTN – Data Reports (March 1, 2017). Organ Procurement and Transplantation Network. Available at: <http://optn.transplant.hrsa.gov> (accessed November 7, 2017).

3. Krishnan N, Higgins R, Short A, et al. Kidney transplantation significantly improves patient and graft survival irrespective of BMI: a cohort study. Am J Transplant. Sep 2015; 15(9):2378-86. PMID 26147285

4. Querard AH, Foucher Y, Combescure C, et al. Comparison of survival outcomes between Expanded Criteria Donor and Standard Criteria Donor kidney transplant recipients: a systematic review and meta-analysis. Transpl Int. Apr 2016; 29(4):403-15. PMID 26756928

5. Segev DL, Muzaale AD, Caffo BS, et al. Perioperative mortality and long-term survival following live kidney donation. JAMA. 2010; 303(10):959-66. PMID 20215610

6. Steinman TI, Becker BN, Frost AE, et al. Guidelines for the referral and management of patients eligible for solid organ transplantation. Transplantation. 2001; 71(9):1189-204. PMID 11397947

7. Locke JE, Reed RD, Mehta SG, et al. Center-Level Experience and Kidney Transplant Outcomes in HIV-Infected Recipients. Am J Transplant. Aug 2015; 15(8):2096-104. PMID 25773499

8. Locke JE, Mehta S, Reed RD, et al. A National Study of Outcomes among HIV-Infected Kidney Transplant Recipients. J Am Soc Nephrol. Mar 19 2015; Epub ahead of print. PMID 25791727

9. Locke JE, Gustafson S, Mehta S, et al. Survival Benefit of Kidney Transplantation in HIV-infected Patients. Ann Surg. Apr 26 2016. PMID 27768622

10. Sawinski D, Forde KA, Eddinger K, et al. Superior outcomes in HIV-positive kidney transplant patients compared with HCV-infected or HIV/HCV-coinfected recipients. Kidney Int. Aug 2015; 88(2):341-9. PMID 25807035

11. Fabrizi F, Martin P, Dixit V, et al. Meta-analysis of observational studies: hepatitis C and survival after renal transplant. J Viral Hepat. May 2014; 21(5):314-24. PMID 24716634

12. Gill JS, Lan J, Dong J, et al. The survival benefit of kidney transplantation in obese patients. Am J Transplant. Aug 2013; 13(8):2083-90. PMID 23890325

13. Pieloch D, Dombrovskiy V, Osband AJ, et al. Morbid obesity is not an independent predictor of graft failure or patient mortality after kidney transplantation. J Ren Nutr. Jan 2014; 24(1):50-7. PMID 24070588

14. Kwan JM, Hajjiri Z, Metwally A, et al. Effect of the obesity epidemic on kidney transplantation: obesity is independent of diabetes as a risk factor for adverse renal transplant outcomes. PLoS One. 2016; 11(11):e0165712. PMID 27851743

15. Lim WH, Wong G, Pilmore HL, et al. Long-term outcomes of kidney transplantation in people with type 2 diabetes: a population cohort study. Lancet Diabetes Endocrinol. Jan 2017; 5(1):26-33. PMID 28010785

16. Barocci S, Valente U, Fontana I, et al. Long-term outcome on kidney retransplantation: a review of 100 cases from a single center. Transplant Proc. 2009; 41(4):1156-8. PMID 19460504

17. Gupta M, Wood A, Mitra N, et al. Repeat Kidney Transplantation After Failed First Transplant in Childhood: Past Performance Informs Future Performance. Transplantation. Aug 2015; 99(8):1700-8. PMID 25803500

18. Shelton BA, Mehta S, Sawinski D, et al. Increased mortality and graft loss with kidney retransplantation among human immunodeficiency virus (HIV)-infected recipients. Am J Transplant. Jun 15 2016. PMID 27305590

19. Farrington K, Covic A, Aucella F, et al. Clinical Practice Guideline on management of older patients with chronic kidney disease stage 3b or higher (eGFR <45 mL/min/1.73 m2). Nephrol Dial Transplant. Nov 2016; 31(suppl 2):ii1-ii66. PMID 27807144

20. Segall L, Nistor I, Pascual J, et al. Criteria for and appropriateness of renal transplantation in elderly patients with end-stage renal disease: a literature review and position statement on behalf of the European Renal Association-European Dialysis and Transplant Association Descartes Working Group and European Renal Best Practice. Transplantation. Oct 2016; 100(10):e55-65. PMID 27472096

21. Andrews PA, Standards Committee of the British Transplantation S. Summary of the British Transplantation Society Guidelines for Management of the Failing Kidney Transplant. Transplantation. Dec 15 2014; 98(11):1130-3. PMID 25299519

22. American Society of Transplant Surgeons (ASTS) TASoTA, The Association of Organ Procurement Organizations (AOPO) and the United Network for Organ Sharing (UNOS), Position Statement on Transplantation of Organs from HIV-infected deceased donors. 2011. Available at: <http://www.asts.org> (accessed August 1, 2015).

23. Bhagani S, Sweny P, Brook G. British H. I. V. Association Guidelines for kidney transplantation in patients with H. I. V. disease. HIV Med. 2006; 7(3):133-9. PMID 16494626

24. CMS –Benefit Policy Management for End-Stage-Renal Disease (ESRD) (Chapter 11). National Centers for Medicare and Medicaid Services. Available at: <http://www.cms.gov> (accessed March 24, 2017).

25. 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).

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

27. Hellerstein F. Fluids and electrolytes: physiology. Pediatr Rev. Feb 1993; 14(2):70-9. PMID 8493184

28. Kidney Transplant. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (September 2017) Surgery 7.03.01.

Policy History:

DateReason
5/15/2018 Document updated with literature review. Simultaneous Liver-Kidney Transplant removed from entire policy, including references 23-30. This topic is now addressed on SUR703.008, Liver Transplant and Combined Liver-Kidney Transplant. Title changed from Kidney Transplant, Including Simultaneous Liver-Kidney Transplant. References 14-15 added.
11/17/2017 Document updated with literature review. The kidney transplant alone coverage statement changed to the following: “A kidney transplant alone with either a living or cadaver donor may be considered medically necessary for carefully selected candidates with end-stage renal disease (ESRD) who have been evaluated and accepted by the facility’s transplant center committee.” Title changed from Kidney Transplant.
11/1/2017 Document updated with literature review. The following was added to kidney transplant alone criteria: “stage 5 with a glomerular filtration rate (GFR) of <15mL/min/1.732 and creatinine of >8 mg/dL or >6 mg/dL in symptomatic diabetic patients.” The following coverage statement was added: “A simultaneous (or combined) liver-kidney transplant (SLK) may be considered medically necessary for carefully selected candidates with end-stage liver failure/disease (ESLD)” when meeting specific criteria.
11/1/2016 Reviewed. No changes.
11/1/2015 Document updated with literature review. Coverage unchanged.
11/15/2014 Reviewed. No changes.
12/1/2013 Document updated with literature review. The following was added to Coverage: Kidney retransplant after a failed primary kidney transplant may be considered medically necessary. CPT/HCPCS code(s) updated
6/1/2008 Revised/updated entire document; this policy is no longer scheduled for routine literature and update
1/23/2004 Revised/updated entire document
11/1/1999 Revised/updated entire document
5/1/1996 Medical policy number changed
4/1/1996 Revised/updated entire document
1/1/1992 Revised/updated entire document
5/1/1990 New medical document

Archived Document(s):

Title:Effective Date:End Date:
Kidney Transplant10-15-202112-31-2022
Kidney Transplant10-01-202010-14-2021
Kidney Transplant05-15-201809-30-2020
Kidney Transplant, Including Simultaneous Liver-Kidney Transplant11-17-201705-14-2018
Kidney Transplant11-01-201711-16-2017
Kidney Transplant11-01-201610-31-2017
Kidney Transplant11-01-201510-31-2016
Kidney Transplant11-15-201410-31-2015
Kidney Transplant12-01-201311-14-2014
Kidney Transplant06-01-200811-30-2013
Kidney Transplant01-23-200405-31-2008
Kidney Transplant11-01-199901-22-2004
Back to Top