BlueCross and BlueShield of Montana Medical Policy/Codes
Kidney Transplant
Chapter: Surgery: Procedures
Current Effective Date: February 01, 2014
Original Effective Date: December 27, 2013
Publish Date: January 15, 2014
Revised Dates: January 15, 2014
Description

A kidney transplant involves the surgical removal of a kidney from a cadaver, living-related, or living-unrelated donor and transplantation into the recipient.

Background

Based on data from the Organ Procurement and Transplantation Network in 2011, about a third of kidney transplants in the U.S. (5,769 of 16,812) were performed using organs from living donors. (1) As of March 23, 2012, the 5-year survival rate for kidney transplants performed between 1997 and 2004 was 66.5% for organs from deceased donors and 79.7% for organs from living donors.

Combined kidney-pancreas transplant and management of acute rejection of kidney transplant using either intravenous immunoglobulin (IVIg) or plasmapheresis are discussed in separate policies.

End-stage renal disease (ESRD) is stage 5 chronic renal disease; ESRD is chronic, permanent failure of the kidneys, as measured by serum creatinine and the glomerulofiltration rate. There are many causes of ESRD including, 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 aplasia or hypoplasia
  • Renal artery or vein occlusion
  • Renal-cell carcinoma
  • Systemic lupus erythematosus
  • Trauma requiring nephrectomy
  • Tuberous sclerosis
  • Wegener's granulomatosis
  • Wilms’ tumor

Potential contraindications to solid organ transplant (subject to the judgment of the transplant center):

  • Known current malignancy, including metastatic cancer;
  • Recent malignancy with high risk of recurrence;
  • History of cancer with a moderate risk of recurrence;
  • Systemic disease that could be exacerbated by immunosuppression;
  • Untreated systemic infection making immunosuppression unsafe, including chronic infection;
  • Other irreversible end-stage disease not attributed to kidney disease;
  • 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.

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.

Policy

Each benefit plan or contract defines which services are covered, which are excluded, and which are subject to dollar caps or other limits.  Members and their providers have the responsibility for consulting the member's benefit plan 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 or contract, the benefit plan or contract will govern.

Coverage

Kidney transplants with either a living or cadaver donor may be considered medically necessary for carefully selected candidates with end-stage renal disease.

Kidney retransplant after a failed primary kidney transplant may be considered medically necessary.

Rationale

Organ donation

Kidney transplant is an accepted treatment of end-stage renal (ESRD) disease that results from a variety of etiologies, most commonly diabetic nephropathy. An insufficient supply of donor organs continues to be a challenge. Potential strategies for increasing organ donation, as described in a 2009 review by Shrestha, include providing adequate information on the process and benefits of donation and the use of kidneys from donors who do not fulfill the criteria for brain death. (2) Other strategies discussed include the use of desensitization protocols in patients with antihuman leukocyte antigen antibodies, matching age, sex, and human leukocyte antigens between donor and recipient, lowering the rate of delayed graft function by such methods as hypothermic machine perfusion of transplanted kidneys, reducing the incidence of acute rejection and calcineurin inhibitor toxicity, identification and treatment of viral infections, and treatment regimens that reduce the risk of post-transplant new-onset diabetes after transplant. A 2012 review article by Schold and Segev focused on strategies to increase the pool of organs available for kidney transplantation from deceased donors. (3) Interventions discussed included an “opt-out” policy in which individuals are presumed to give consent to organ donation unless they specify non-consent, expanded use of donors such as commercial sex workers who are considered to be at increased risk of disease transmission by using rigorous screening and expanded use of donors with documented infections in selected situations e.g. transplantation of organs from HIV-positive donors to HIV-positive recipients.

Living donors

Several papers have reported on long-term outcomes in live kidney donors. For example, Segev and colleagues analyzed data from a national registry of 80,347 live donors in the U.S who donated organs between April 1, 1994 and March 31, 2009 and compared them with data from 9,364 participants of the National Health and Nutrition Examination Survey (NHANES) (excluding those with contraindications to kidney donation). (4) 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% confidence interval [CI]: 2.0-4.6) and did not change during the last 15 years, 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.

In 2012, Fournier and colleagues in France reported on long-term follow-up of individuals who had donated a kidney between 1952 and 2008. (5) Of a total of 398 donors at a single institution, 266 (67%) were alive, 44 (11%) were documented as having died and 88 (22%) were lost to follow-up. Among individuals who were known to have died, death occurred at a mean of 29.6 years after donation. Donor survival did not differ from that of the general population in France. Fifty-nine of 68 (87%) living individuals who had donated a kidney more than 30 years ago responded to a questionnaire. According to questionnaire responses, the mean serum creatinine level was 93.2 +/- 22.5 umol/L, no patient had an estimated GFR less than 30 mL/min per 1.73 m2 and none had ESRD.

Kidney Transplant in HIV-Positive Patients

In 2001, the Clinical Practice Committee of the American Society of Transplantation proposed that HIV-positive patients who meet the following criteria, could be considered candidates for kidney transplantation. (6) (These criteria may be extrapolated to other organs.)

  • CD4 count >200 cells per cubic millimeter for >6 months;
  • HIV-1 RNA undetectable;
  • On stable anti-retroviral therapy >3 months;
  • No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidiosis mycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm);
  • Meeting all other criteria for transplantation.

A 2011 review article by European authors stated that there are adequate data suggesting that renal transplantation in adequately selected HIV-positive patients is safe in the short- and medium-term and that patient and graft survival rates are similar to those in HIV-negative patients. (7) Moreover, data do not suggest that immunosuppressive therapy has a negative impact on the course of HIV infection. However, rates of acute rejection after kidney transplantation are higher in HIV-positive patients. In addition, little is known about the management of co-infection with hepatitis C or about the optimal antiretroviral and immunosuppressive regimens. The authors concluded that more studies are needed to address these issues as well as long-term outcomes.

Several case series have evaluated outcomes of kidney transplantation in HIV-positive patients. For example, in 2010, Stock and colleagues published findings of the largest prospective study to date of outcomes following kidney and liver transplantation in HIV-positive recipients. (8) A total of 150 patients underwent kidney transplantation at 19 centers in the United States; 102 received kidneys from deceased donors and 48 from living donors. Twenty-eight (19%) of patients were hepatitis C virus (HCV)-positive. Patients were followed for up to 3 years. The median follow-up of survivors was 1.7 years. At the time data were analyzed, 53 patients had completed 3 years of follow-up. The patient survival rate at 1 year was 94.6% (standard deviation [SD] = 2.0%) and at 3 years was 88.2% (SD=3.8%). Eleven patients died; the graft was still functioning at the time of death in 8 patients. There were 7 deaths among the 122 HCV-negative patients (6%) and 4 deaths among the 28 HCV-positive patients (14%); the p-value for the difference in survival by HCV status was 0.09. Forty-nine of 150 (33%) patients had 67 acute rejection episodes. The cumulative incidence of allograft rejection was 31% (95% CI: 24 to 40) at 1 year and 41% (95% CI: 32 to 52) at 3 years. The time to first acute allograft rejection did not differ significantly among HCV-positive and HCV-negative patients, p=0.36 (exact numbers not reported). There was a low rate of HIV disease progression. Two patients had newly diagnosed cutaneous Kaposi’s sarcoma, 2 had newly diagnosed HIV-associated nephropathy, and 3 patients had other new HIV-related diagnoses. Infections requiring hospitalization were reported for 57 of 150 (38%) of patients. Patients who were HCV-positive had a higher rate of serious infection per follow-up year than those who were HCV-negative (0.8 and 0.5, respectively, p=0.02). The authors noted that that the rate of rejection was 2 to 3 times higher in this group of HIV-infected patients than in non-HIV infected patients who participated in a larger study by the research team. They concluded that kidney transplantation is feasible in carefully selected HIV-infected patients and that better strategies are needed for minimizing rejection and for controlling infections in patients who are co-infected with hepatitis C virus.

In 2011, a case-control study from France was published by Mazuecos and colleagues. (9) Outcomes in 20 HIV-positive patients who received kidney transplantation were compared to a matched cohort of 40 HIV-negative patients. Matching was done on a number of variables including type of donor, donor and recipient age, pre-transplantation laboratory values, hepatitis B and C status, and treatment at the same center within a short amount of time. There was a mean follow-up of 40.4 months among HIV-positive patients and 39.8 months among HIV-negative patients. Eight (40%) patients in the HIV-positive group and 9 (22.5%) in the HIV-negative group experienced acute rejection; this difference was not statistically significant, p=0.16. There were 4 graft failures (20%) in the HIV-positive group and 2 (5%) in the HIV-negative group; p=0.89. One patient (5%) died in the HIV-positive group, and there were no deaths in the HIV-negative group.

Kidney Retransplant

According to data from the Organ Procurement and Transplantation Network (OPTN), rates of 1-year, 3-year and 5-year survival are similar after a primary kidney transplant and a repeat transplant. (10) For example, for transplants performed between 2002 and 2004, the 1-year survival rate was 95.9% (95% CI: 95.7 to 96.1%) after primary transplantation (n=37,504) and 95.8% (95% CI: 95.3-96.4%) after repeat transplantation (n=4,924). Among patients undergoing transplantation between 1997 and 2000, the 5-year survival rate was 84.8% (95% CI: 84.5% to 85.2%) after primary kidney transplantation (n=29,422) and 85.1% (95% CI: 84.1 to 86.1%) after repeat kidney transplantation (n=3,697).

In 2009, Barocci and colleagues in Italy reported on long-term survival after kidney retransplantation. (11) There were 100 (0.8%) second transplants out of 1,302 kidney transplants performed at a single center between January 1983 and June 2007. Among the second kidney recipients, 1-, 5- and 10-year patient survival was 100%, 96%, and 92%, respectively. Graft survival rates at 1, 5 and 10 years were 85%, 72% and 53%, respectively.

A 2013 study by Johnston and colleagues compared outcomes in 3,509 patients who underwent a preemptive second kidney transplant, defined as transplantation after fewer than 7 days of dialysis following graft failure, to outcomes in 14,075 patients who underwent a non-preemptive second kidney transplant. (12) Data from the U.S. Renal Data System (USRDS) were reviewed. In the first year after retransplantation, there was a significantly lower risk of acute rejection in patients receiving a preemptive second transplant (12%) compared to those with a non-preemptive second transplant (16%), p<0.0001. In a multivariate analysis adjusting for demographic differences between groups, there was a significantly lower risk of allograft failure by any cause including death after preemptive second transplants compared to non-preemptive second transplants (hazard ratio [HR]: 0.88, 95% CI: 0.81 to 0.96).

Summary

Kidney transplant is an accepted treatment of end-stage renal disease in appropriately selected patients and thus may be considered medically necessary. Registry and national survey data suggest that live donors of kidneys for transplantation do not have an increased risk of mortality or ESRD.

Kidney retransplantation after a failed primary transplant may be considered medically necessary, as national data suggest similar survival rates after initial and repeat transplants.

Kidney transplantation is not medically necessary in 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. Case series and case-control data indicate that HIV-infection is not an absolute contraindication to kidney transplant; for patients who meet selection criteria, these studies have demonstrated patient and graft survival rates are similar to those in the general population of kidney transplant recipients.

Practice Guidelines and Position Statements

In 2006, the British HIV Association and the British Transplantation Society Standards Committee published guidelines for kidney transplantation in patients with HIV disease. (13) The guidelines recommend that any patient with end-stage renal disease with a life expectancy of at least 5 years is considered appropriate for transplantation under the following conditions:

  • CD4 >200 cells/mL for at least 6 months;
  • Undetectable HIV viremia (<50 HIV-1 RNA copies/mL) for at least 6 months;
  • Demonstrable adherence and a stable HAART regimen for at least 6 months;
  • Absence of AIDS-defining illness following successful immune reconstitution after HAART.

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

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. 

ICD-9 Codes

55.51, 55.54, 55.69, 585.1-585.9

ICD-10 Codes

N18.1-N18.9, 0TT00ZZ , 0TT04ZZ , 0TT10ZZ , 0TT14ZZ , 0TY00Z0 , 0TY10Z0

Procedural Codes: 50300, 50320, 50323, 50325, 50327, 50328, 50329, 50340, 50360, 50365, 50370, 50380, 50547, S2152
References
  1. U.S. Department of Health and Human Services Organ Procurement and Transplantation Network. Available online at: http://optn.transplant.hrsa.gov . Last accessed April, 2013.
  2. Shrestha BM. Strategies for reducing the renal transplant waiting list: a review. Exp Clin Transplant 2009; 7(3):173-9.
  3. Schold JD, Segev DL. Increasing the pool of deceased donor organs for kidney transplantation. Nat Rev Nephrol 2012; 8(6):325-31.
  4. Segev DL, Muzaale AD, Caffo BS et al. Perioperative mortality and long-term survival following live kidney donation. JAMA 2010; 303(10):959-66.
  5. Fournier C, Pallet N, Cherqaoui Z et al. Very long-term follow-up of living kidney donors. Transpl Int 2012; 25(4):385-90.
  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.
  7. Trullas JC, Cofan F, Tuset M et al. Renal transplantation in HIV-infected patients: 2010 update. Kidney Int 2011; 79(8):825-42.
  8. Stock PG, Barin B, Murphy B et al. Outcomes of kidney transplantation in HIV-infected recipients. N Engl J Med 2010; 363(21):2004-14.
  9. Mazuecos A, Fernandez A, Andres A et al. HIV infection and renal transplantation. Nephrol Dial Transplant 2011; 26(4):1401-7.
  10. Organ Procurement and Transplantation Network. Data reports. Available online at: http://optn.transplant.hrsa.gov . Last accessed April, 2013.
  11. 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.
  12. Johnston O, Rose CL, Gill JS et al. Risks and benefits of preemptive second kidney transplantation. Transplantation 2013; 95(5):705-10.
  13. 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.
  14. Medicare Benefit Policy Manual. Chapter 11- End Stage Renal Disease (ESRD). Available online at: http://www.cms.gov . Last accessed April, 2013.
  15. Kidney Transplant. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (May 2013) Surgery 7.03.01.
History
September 2013  New 2013 BCBSMT medical policy.
February 2014 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.
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Kidney Transplant