|MP 7.03.01||Kidney Transplant|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/5:2013
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
A kidney transplant involves the surgical removal of a kidney from a cadaver, living-related, or living-unrelated donor and transplantation into the recipient.
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.
Kidney transplants with either a living or cadaver donor may be considered medically necessary for carefully selected candidates with end-stage renal disease.
Etiologies of end-stage renal disease include, but are not limited to, any of the following conditions associated with end-stage renal disease:
- Obstructive uropathy 599.60, 599.69
- Systemic lupus erythematosus 710.0
- Polyarteritis 446.0
- Wegener's granulomatosis 446.4
- Cortical necrosis 583.6
- Henoch-Schönlein purpura 287.0
- Hemolytic uremic syndrome 283.11
- Acute tubular necrosis 584.5
- Hypertensive nephrosclerosis 403.01, 403.11, 403.91
- Renal artery or vein occlusion 593.81/artery, 453.3/vein
- Chronic pyelonephritis 590.00
- IGA nephropathy 583.9
- Anti-glomerular base-membrane disease 583.89
- Focal glomerulosclerosis 582.1
- Analgesic nephropathy 583.89/584.7 with medullary necrosis
- Heavy metal poisoning 963.8
- Glomerulonephritis 583.9
- Polycystic kidney disease 753.12–753.14
- Medullary cystic disease 753.16
- Nephritis 583.9
- Nephrocalcinosis 275.49
- Gout nephritis 274.10–274.19
- Amyloid disease 277.30-277.39
- Fabry's disease 272.7
- Cystinosis 270.0
- Oxalosis 271.8
- Diabetes mellitus 250.41–250.43, 581.81
- Horseshoe kidney 753.3
- Renal aplasia or hypoplasia 753.0
- Wilms’ tumor 189.0
- Renal-cell carcinoma 189.0
- Myeloma in remission 203.01
- Tuberous sclerosis 759.5
- Trauma requiring nephrectomy 866.00–866.13 injury to kidney
Kidney retransplant after a failed primary kidney transplant may be considered medically necessary.
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.
BlueCard/National Account Issues
Transplant requests are generally reviewed by the Plan Medical Director or his or her designee. Only those patients accepted for transplantation by an approved transplantation center and actively listed for transplant should be considered for precertification or prior approval. Guidelines should be followed for transplant network or consortiums, if applicable.
Kidney transplants should be considered for coverage under the transplant benefit.
What is covered under the scope of the human organ transplant (HOT) benefit needs to be considered. Typically, the following are covered under the HOT benefit:
- hospitalization of the recipient and living donor for medically recognized transplants from a donor to a transplant recipient;
- evaluation tests requiring hospitalization to determine the suitability of both potential and actual donors, when such tests cannot be safely and effectively performed on an outpatient basis;
- hospital room, board, and general nursing in semi-private rooms;
- special care units, such as coronary and intensive care;
- hospital ancillary services;
- physicians’ services for surgery, technical assistance, administration of anesthetics, and medical care;
- acquisition, preparation, transportation, and storage of organ;
- diagnostic services;
- drugs that require a prescription by federal law.
Expenses incurred in the evaluation and procurement of organs and tissues are benefits when billed by the hospital. Included in these expenses may be specific charges for participation with registries for organ procurement, operating rooms, supplies, use of hospital equipment, and transportation of the tissue or organ to be evaluated.
Administration of products with a specific transplant benefit needs to be defined as to:
- when the benefit begins (at the time of admission for the transplant or once the patient is determined eligible for a transplant, which may include tests or office visits prior to transplant);
- when the benefit ends (at the time of discharge from the hospital or at the end of required follow-up, including the immunosuppressive drugs administered on an outpatient basis).
Coverage usually is not provided for:
- HOT services, for which the cost is covered/funded by governmental, foundational, or charitable grants;
- organs sold rather than donated to the recipient;
- an artificial organ.
This policy was originally created in 1995 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period March 2012 through April 4, 2013.
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.
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.
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).
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).
Medicare National Coverage
The Medicare Benefit Policy Manual includes a chapter on end-stage renal disease. (14) In a section on identifying candidates for transplantation (140.1), it 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.”
- U.S. Department of Health and Human Services Organ Procurement and Transplantation Network. Available online at: http://optn.transplant.hrsa.gov/latestData/step2.asp. Last accessed April, 2013.
- Shrestha BM. Strategies for reducing the renal transplant waiting list: a review. Exp Clin Transplant 2009; 7(3):173-9.
- Schold JD, Segev DL. Increasing the pool of deceased donor organs for kidney transplantation. Nat Rev Nephrol 2012; 8(6):325-31.
- Segev DL, Muzaale AD, Caffo BS et al. Perioperative mortality and long-term survival following live kidney donation. JAMA 2010; 303(10):959-66.
- Fournier C, Pallet N, Cherqaoui Z et al. Very long-term follow-up of living kidney donors. Transpl Int 2012; 25(4):385-90.
- 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.
- Trullas JC, Cofan F, Tuset M et al. Renal transplantation in HIV-infected patients: 2010 update. Kidney Int 2011; 79(8):825-42.
- 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.
- Mazuecos A, Fernandez A, Andres A et al. HIV infection and renal transplantation. Nephrol Dial Transplant 2011; 26(4):1401-7.
- Organ Procurement and Transplantation Network. Data reports. Available online at: http://optn.transplant.hrsa.gov/latestData/step2.asp? Last accessed April, 2013.
- 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.
- Johnston O, Rose CL, Gill JS et al. Risks and benefits of preemptive second kidney transplantation. Transplantation 2013; 95(5):705-10.
- 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.
- Medicare Benefit Policy Manual. Chapter 11- End Stage Renal Disease (ESRD). Available online at: http://www.cms.gov/manuals/Downloads/bp102c11.pdf. Last accessed April, 2013.
|CPT||50300||Donor nephrectomy (including cold preservation), from cadaver, unilateral or bilateral|
|50320||As above, but from living donor|
|50323||Backbench standard preparation of cadaver donor renal allograft prior to transplantation, including dissection and removal of perinephric fat, diaphragmatic and retroperitoneal attachments, excision of adrenal gland, and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches as necessary|
|50325||Backbench standard preparation of living donor renal allograft (open or laparoscopic) prior to transplantation, including dissection and removal of perinephric fat and preparation of ureter(s), renal vein(s), and renal artery(s), ligating branches as necessary|
|50327||Backbench reconstruction of cadaver or living donor renal allograft prior to transplantation; venous anastomosis, each|
|50328||arterial anastomosis, each|
|50329||ureteral anastomosis, each|
|50360||Renal allotransplantation; implantation of graft without recipient nephrectomy|
|50365||As above, but with recipient nephrectomy|
|50547||Laparoscopy, surgical; donor nephrectomy (including cold preservation) from living donor|
|55.69||Other kidney transplant|
|IDC-9 Diagnosis||585.1–585.9||Chronic kidney disease (previously known as chronic renal failure) code range (see Policy Guidelines for specific codes for underlying etiologies)|
|ICD-10-CM (effective 10/1/14)||N18.1-N18.9||Chronic kidney disease (CKD) code range|
|N13.8||Other obstructive and reflux uropathy|
|N13.9||Obstructive and reflux uropathy unspecified|
|M32.9||Systemic lupus erythematosus unspecified|
|M32.0-M32.8||Systemic lupus erythematosus|
|M31.30, M31.31||Wegner’s granulomatosis|
|N17.1||Acute kidney failure with acute cortical necrosis|
|N17.0||Acute kidney failure with tubular necrosis|
|N26.9||Renal sclerosis nos|
|N28.0||Ischemia and infarction of kidney|
|N11.9||Chronic tubule-interstitial nephritis unspecified|
|N05.0-N05.9||Unspecified nephritic syndrome unspecified code range|
|N03.0-N03.9||Chronic nephritic syndrome code range|
|T45.8x1-T45.8x6||Poisoning by adverse effect of and underdosing of other primarily systemic and hematologic agents code range|
|Q61.11-Q61.3||Polycystic kidney disease code range|
|Q61.5||Medullary cystic kidney|
|E83.50-E83.59||Disorders of calcium metabolism code range|
|M10.30-M10.39||Gout due to renal impairment code range|
|E85.0-E85.9||Amyloidosis code range|
|E77.0-E77.9||Disorders of glycoprotein metabolism code range|
|E72.4||Disorders of ornithine metabolism|
|E74.8||Other specified disorders of carbohydrate metabolism|
|E74.9||Unspecified disorders of carbohydrate metabolism|
|Q63.0-Q63.9||Other congenital malformations of the kidney code range|
|Q61.9||Cystic kidney disease unspecified|
|Q60.0-Q60.6||Renal agenesis and other defects code range|
|C90.00-C90.02||Multiple myeloma remission code range|
|S37.00-S37.099||Injury of kidney code range|
|ICD-10-PCS (effective 10/1/14)||0TT00ZZ||Surgical, resection of right kidney, open|
|0TT04ZZ||Surgical, resection of right kidney, percutaneous endoscopic|
|0TT10ZZ||Surgical, resection of left kidney, open|
|0TT14ZZ||Surgical, resection of left kidney, percutaneous endoscopic|
|0TY00Z0||Surgical, transplantation of right kidney, allogeneic, open approach|
|0TY10Z0||Surgical, transplantation of left kidney, allogeneic, open approach|
|Type of Service||Surgery|
|Place of Service||Inpatient|
|12/1/95||Add to Surgery section, Transplants subsection||New policy|
|07/12/02||Replace policy||Policy reviewed; no change to policy statement, updated with references|
|02/25/04||Replace policy||Policy reviewed with literature search; no change to policy statement; policy guidelines revised|
|03/15/05||Replace policy||Policy reviewed with literature search, with focus on transplantation in HIV+ patients. No change in policy statement|
|04/1/05||Replace policy||Policy revised; HIV positivity removed as an investigational indication for transplantation; further discussion provided in Rationale section|
|9/27/05||Replace policy||Policy corrected; HIV positivity statement removed from policy section and CPT coding updated|
|04/25/06||Replace policy||Policy reviewed with literature search; no change to policy statement|
|12/13/07||Replace policy||Policy reviewed with literature search; reference 11 added; no change to policy statement.|
|03/12/09||Replace policy||Policy reviewed with literature search; no change to policy statement.|
|05/13/10||Replace policy||Policy reviewed and extensively rewritten with literature search; new reference numbers 1-4 and 10 added; other references removed/renumbered; no change to policy statement; additional details added to policy guideline regarding absence of active infection|
|5/12/11||Replace policy||Policy reviewed with literature search. Reference 6-10 and 12 added; other references removed/renumbered. Not medically necessary statement added specifying criteria indicating absolute contraindications to kidney transplantation.|
|5/10/12||Replace policy||Policy reviewed with literature search. References 3 and 6 added; other references renumbered/removed. Policy statement unchanged.|
|5/09/13||Replace policy||Policy reviewed with literature search through April 4, 2013. References 10-12 added; other references renumbered/removed. Statement added that kidney retransplant after a failed primary kidney transplant may be considered medically necessary.|