Latest Review Date: August 2024

Category: Surgery                                                      

POLICY:

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 in individuals who meet criteria for kidney transplantation.

Kidney transplant in all other situations is considered investigational.

POLICY GUIDELINES:

Contraindications

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

• Known current malignancy, including metastatic cancer;
• Recent malignancy with a high incidence 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.

Renal-Specific Criteria

There are no medical criteria that must be met for an individual to be listed for a kidney transplant. Certain medical factors are utilized for calculating an individual's waiting time after being listed for a kidney transplant, which is used as a component of the kidney allocation system. These include the earliest date on which the registered candidate's glomerular filtration rate or measured or estimated creatinine clearance was less than or equal to 20 mL/min or regularly-administered dialysis was initiated for end-stage renal disease; however, consideration for listing for renal transplant may start well before kidney function reaches this point, based on the anticipated time that an individual may spend on the waiting list.

DESCRIPTION OF PROCEDURE OR SERVICE:

Solid organ transplantation offers a treatment option for individuals with different types of end-stage organ failure that can be lifesaving or provide significant improvements to an individual’s quality of life. Many advances have been made in the last several decades to reduce perioperative complications. Available data supports improvement in long-term survival as well as improved quality of life particularly for liver, kidney, pancreas, heart, and lung transplants. Allograft rejection remains a key early and late complication risk for any organ transplantation. Transplant recipients require life-long immunosuppression to prevent rejection. Individuals are prioritized for transplant by mortality risk and severity of illness criteria developed by Organ Procurement and Transplantation Network (OPTN) and United Network of Organ Sharing (UNOS).

Kidney Transplant

In 2023, 46,623 transplants were performed in the United States procured from 39,670 deceased donors and 6,948 living donors. Kidney transplants were the most common procedure with 27,332 transplants performed from both deceased and living donors in 2023. Since 1988, the cumulative number of kidney transplants is 581,744. Of the cumulative total, approximately 67% of the kidneys came from deceased donors and 33% from living donors.

Kidney transplant, using kidneys from deceased or living donors, is an accepted treatment of end-stage renal disease (ESRD). 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, is also known as chronic kidney disease stage 5 and is defined as a glomerular filtration rate (GFR) less than 15 mL/min/1.73 m2. Individuals with advanced chronic kidney disease, mainly stage 4 (GFR 15 to 29 mL/min/1.73 m2) and stage 5 (GFR <15 mL/min/1.73 m2), should be evaluated for transplant. Being on dialysis is not a requirement to be considered for kidney transplant. Severe non-compliance and substance abuse serve as contraindications to kidney transplantation, but even those could be overcome with clinician support and individual motivation. All kidney transplant candidates receive organ allocation points based on waiting time, age, donor-recipient immune system compatibility, prior living donor status, distance from donor hospital, and survival benefit.

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

KEY POINTS:

The most recent literature review was conducted through June 14, 2024.

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 individuals and significantly higher survival rates for individuals undergoing kidney transplant compared with those who remained on a waiting list. Kidney transplantation is contraindicated for individuals 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 an improvement in the net health outcome.

For individuals who have a failed kidney transplant without contraindications to kidney transplant who receive a kidney re-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 have demonstrated reasonably high survival rates after kidney re-transplant (e.g., 5-year survival rates ranging from 87% to 96%) for appropriately selected individuals. Kidney retransplantation is contraindicated for individuals in whom the procedure is expected to be futile due to comorbid disease or for whom post-transplantation care is expected to significantly worsen comorbid conditions. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Society of Transplant Surgeons et al

In 2011, the American Society of Transplant Surgeons, American Society of Transplantation, Association of Organ Procurement Organizations, and the United Network for Organ Sharing (UNOS) issued a joint position statement recommending modification of the National Organ Transplant Act of 1984. 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 wait 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 individuals already infected with HIV. In 2013, the HIV Organ Policy Equity Act permitted the use of this group of organ donors.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Kidney Transplant; Renal Transplant; Transplant, Renal

APPROVED BY GOVERNING BODIES:

Solid organ transplants are a surgical procedure and, as such, are not subject to regulation by the U.S. Food and Drug Administration.

The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulations Title 21, parts 1270 and 1271.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

REFERENCES:

1. American Society of Transplant Surgeons (ASTS), The American Society of Transplantation (AST), The Association of Organ Procurement Organizations (AOPO), et al. Statement on transplantation of organs from HIV infected deceased donors. 2011; asts.org/docs/default-source/position-statements/transplantation-oforgans-from-hiv-infected-deceased-donors-july-22-2011.pdf?sfvrsn=fbae5a20.
2. 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. May 2009; 41(4):1156-1158.
3. Chaudhry D, Chaudhry A, Peracha J, et al. Survival for waitlisted kidney failure patients receiving transplantation versus remaining on waiting list: systematic review and meta-analysis. BMJ. Mar 01 2022; 376: e068769.
4. 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):314-324.
5. Gill JS, Lan J, Dong J et al. The survival benefit of kidney transplantation in obese patients. Am J Transplant. Aug 2013; 13(8):2083-2090.
6. 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):1700-1708.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Kainz A, Kammer M, Reindl-Schwaighofer R, et al. Waiting Time for Second Kidney Transplantation and Mortality. Clin J Am Soc Nephrol. Jan 2022; 17(1): 90-97.
9. Kervinen MH, Lehto S, Helve J, et al. Type 2 diabetic patients on renal replacement therapy: Probability to receive renal transplantation and survival after transplantation. PLoS One. 2018; 13(8): e0201478.
10. 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):2378-2386.
11. 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.
12. 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.
13. Locke JE, Gustafson S, Mehta S, et al. Survival Benefit of Kidney Transplantation in HIV-infected Patients. Ann Surg. Mar 2017; 265(3): 604-608.
14. 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):2096-2104
15. Locke JE, Mehta S, Reed RD, et al. A national study of outcomes among HIV-infected kidney transplant recipients. J Am Soc Nephrol. Sep 2015; 26(9):2222-2229
16. Muller E, Barday Z, Mendelson M, et al. HIV-positive-to-HIV-positive kidney transplantation-results at 3 to 5 years. N Engl J Med. Feb 2015 372(7):613-620.
17. National Kidney Foundation. Glomerular Filtration Rate (GFR). n.d.; www.kidney.org/atoz/content/gfr.
18. Organ Procurement and Transplantation Network (OPTN). OPTN policies. optn.transplant.hrsa.gov/media/1200/optn_policies.pdf.
19. Organ Procurement and Transplantation Network. View Data Reports. n.d.; optn.transplant.hrsa.gov/data/view-data-reports/.
20. Pestana JM. Clinical outcomes of 11,436 kidney transplants performed in a single center - Hospital do Rim. J Bras Nefrol. Aug 28 2017; 39(3):287-295.
21. 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 2014; 24(1):50-57.
22. 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):403-415.
23. 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):341-349.
24. Segev DL, Muzaale AD, Caffo BS, et al.  Perioperative mortality and long-term survival following live kidney donation. JAMA. Mar 10 2010; 303(10):959-966.
25. 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. Jan 2017; 17(1): 173-179.
26. US Department of Health & Human Services. Educational guidance on patient referral to kidney transplantation. September 2015; optn.transplant.hrsa.gov/resources/guidance/educational-guidance-on-patient-referral-to-kidney-transplantation/. 
27. United Network for Organ Sharing (UNOS). How we match organs. 2023. unos.org/transplant/how-we-match-organs/.
28. United Network for Organ Sharing (UNOS). Transplant trends. Updated June 6, 2023; unos.org/data/transplant-trends/.
29. Working Party of the British Transplantation Society. Kidney and Pancreas Transplantation in Patients with HIV. Second Edition (Revised). British Transplantation Society Guidelines. Macclesfield, UK: British Transplantation Society; 2017. bts.org.uk/wp-content/uploads/2017/04/02_BTS_Kidney_Pancreas_HIV.pdf.
30. Zheng X, Gong L, Xue W, et al. Kidney transplant outcomes in HIV-positive patients: a systematic review and meta-analysis. AIDS Res Ther. Nov 20 2019; 16(1): 37.

POLICY HISTORY:

Medical Policy Group, June 2010 (3)

Medical Policy Administration Committee, July 2010

Available for comment July 2-August 16, 2010

Medical Policy Group, June 2011 (3): Updated Policy, Key Points, & References

Medical Policy Administration Committee, June 2011

Available for comment June 23 – August 8, 2011

Medical Policy Group, May 2011 (3): Updated Description, Key Points & References

Medical Policy Panel, May 2013

Medical Policy Group, May 2013 (3):  2013 Update to Policy Statement, Key Points & References; policy statement updated to include kidney retransplant after a failed primary kidney transplant may be considered medically necessary

Available for comment May 22 through June 5, 2013

Medical Policy Group, October 2013 (3): Removed ICD-9 Diagnosis codes for DOS 5/9/13 and after; no change to policy statement.

Medical Policy Panel, June 2014

Medical Policy Group, June 2014 (3):  2014 Updates to Description, Key Points & References; updated Policy statements with verbiage clarifications; no change in policy context

Medical Policy Administration Committee, July 2014

Medical Policy Panel, June 2015

Medical Policy group, June 2015 (2): 2015 Updates to Description, Key Points, Approved by Governing Bodies, and References, no change to policy statement

Medical Policy Panel, December 2016

Medical Policy Group, May 2017 (7): Updates to Description, Key Points, and References. Policy statement: clarification to absolute contraindications and removed old criteria from 2013.

Medical Policy Administration Committee, June 2017

Available for comment May 20 through July 3, 2017

Medical Policy Panel, September 2017

Medical Policy Group, October 2017 (7): Updates to Key Points and References. Policy statement: updated HIV criteria and removed old criteria from 2013. No change intent.

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (3): Updates to Description, Key Points, and References. No change in policy statement.

Medical Policy Panel, August 2019

Medical Policy Group, September 2019 (3): 2019 Updates to Key Points. No change to policy statement or intent.

Medical Policy Panel, August 2020

Medical Policy Group, September 2020 (3): 2020 Updates to Description, Key Points, Approved by Governing Bodies, and References. No changes to policy statement or intent.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (3): 2021 Updates to Description, Key Points, and References. Policy statement updated to remove “not medically necessary”, no other changes to policy statement.

Medical Policy Panel, August 2022 (3): 2022 Updates to Description, Key Points and References. Removed HIV positive patient criteria from policy section to reflect standard of care  guidelines from the American Society of Transplantation. Removed absolute contraindications in policy guidelines and changed verbiage to “Potential contraindications to solid organ transplant (subject to the judgment of the transplant center).” No other changes to policy statement or intent.

Medical Policy Panel, August 2023

Medical Policy Group, August 2023 (3): Updates to Description, Key Points, Benefit Applications, and References. No changes to policy statement or intent.

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (3): Updates to Description, Key Points, and References. Policy guidelines Renal Specific Criteria updated removed the verbiage "Indications for renal transplant include a creatinine level of greater than 8 mg/dL, or greater than 6 mg/dL in symptomatic diabetic individuals" and added this verbiage "There are no medical criteria that must be met for an individual to be listed for a kidney transplant. Certain medical factors are utilized for calculating an individual's waiting time after being listed for a kidney transplant, which is used as a component of the kidney allocation system. These include the earliest date on which the registered candidate's glomerular filtration rate or measured or estimated creatinine clearance was less than or equal to 20 mL/min or regularly-administered dialysis was initiated for end-stage renal disease." No changes to policy statement or intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.