Kidney Transplant

POLICY NUMBER

A.7.03.01

DESCRIPTION

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

Solid organ transplantation offers a treatment option for patients with different types of end-stage organ failure that can be lifesaving or provide significant improvements to a patient’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. Patients 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 2024, 48,149 transplants were performed in the United States procured from 41,119 deceased donors and 7,030 living donors. Kidney transplants were the most common procedure with 27,759 transplants performed from both deceased and living donors in 2024. Since 1988, the cumulative number of kidney transplants is 609,382. Of the cumulative total, approximately 69% of the kidneys came from deceased donors and 31% 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 (ie, 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. Patients 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 patient 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 and pancreas transplants and management of acute rejection of kidney transplant using either intravenous immunoglobulin or plasmapheresis are discussed in separate policies.

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 Regulation Title 21, parts 1270 and 1271. Solid organs used for transplantation are subject to these regulations.

Related policies -

• Allogeneic Pancreas Transplant

• Immunoglobulin Therapy

• Plasma Exchange

POLICY

No benefits will be provided for a covered transplant procedure unless the Member receives prior authorization through case management from Blue Cross & Blue Shield ofMississippi.

Kidney transplants are considered medically necessary for carefully selected candidates including, but not limited to, any one of the conditions (and ICD-10 diagnosis codes listed in the "Code Reference" section) which cause end-stage renal disease.

Kidney transplantation is not medically necessary in individuals with the following absolute contraindications:

• Known current malignancy, including metastatic cancer;

• Recent malignancy with a high risk of recurrence;

• Untreated systemic infection making immunosuppression unsafe, including chronic infection; or

• Other irreversible end-stage disease not attributed to kidney disease.

HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients. (See Policy Guidelines).

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

Kidney transplant is considered investigational in all other situations.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Candidates for a kidney transplant need documentation of a progressive or terminal end-stage renal disease who otherwise have no immediate life threatening conditions, psychological impairments, and have a good support system.

Relative contraindications to kidney transplantation:

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

2. Systemic disease that could be exacerbated by immunosuppression;

3. Psychosocial conditions or chemical dependence affecting the ability to adhere to therapy; or

4. Lack of adequate cardiopulmonary reserve.

HIV-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:

1. CD4 count >200 cells per cubic millimeter for >6 months

2. Undetectable HIV-1 RNA

3. On stable anti-retroviral therapy >3 months

4. No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma, or other neoplasm), and

5. Meeting all other criteria for transplantation.

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.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

8/1998: Approved by Medical Policy Advisory Committee (MPAC).

5/1/2002: Type of Service and Place of Service deleted.

7/21/2005: Reviewed by MPAC; "HIV positivity is not an absolute contraindication to transplant. Each individual transplant center will determine patient selection criteria for HIV positive patients."

10/17/2005: Code Reference table updated: CPT codes 50323, 50325, 50327, 50328, 50329, 50380 added; ICD-9 procedure codes 55.52, 55.53, 55.54, 55.61, 55.69, 00.91, 00.92, 00.93 added; diagnosis codes 250.40, 250.42, 274.11, 403.01, 403.11, 403.91, 581.81, 584.7, 753.3 added, 275.49 5th digit added, V42.0 deleted, other codes were moved and placed in numerical order.

10/25/2005: Code Reference Table updated: CPT codes revised: 50300, 50320, 50340, 50360, 50365. ICD-9 Diagnosis codes revised: 189.0, 203.00, 203.01, 250.40-250.43, 270.0, 271.8, 272.7, 274.10, 274.11, 274.19, 275.49, 277.3, 287.0, 446.0, 453.3, 582.1, 583.6, 583.89, 583.9, 584.5, 590.00-590.01, 593.81, 599.6, 710.0, 753.0, 753.12, 753.13, 753.14, 753.16, 866.00-866.03, 866.10, 866.11, 866.12, 866.13, 963.8, 996.81.

11/8/2005: Code Reference section updated, 5th digit added to ICD9 diagnosis codes 599.60, 599.69; 4th digit added to codes 585.1-585.9, description revised.

03/13/2006: Coding updated. CPT4 2006 revisions added to policy.

9/12/2006: Coding updated. ICD9 2006 revisions added to policy.

1/14/2008: Policy reviewed, no changes.

9/10/2008: Annual ICD-9 updates effective 10-1-2008 applied.

12/19/2008: Policy reviewed, prior authorization language removed.

4/23/2009: Policy reviewed, no changes.

9/29/2009: Code reference section updated. Description revised for ICD-9 codes 584.5 and 584.7.

08/11/2011: Policy statement updated to add the following absolute contraindications to kidney transplantation: known current malignancy, including metastatic cancer; recent malignancy with a high incidence of recurrence; untreated systemic infection making immunosuppression unsafe, including chronic infection; or other irreversible end-stage disease not attributed to kidney disease. Updated policy guidelines regarding patient selection criteria. Also added statement regarding prior authorization requirements to the policy statement. Deleted outdated references from the Sources section.

07/17/2012: Policy reviewed; no changes.

10/23/2013: Added policy statement to indicate that kidney retransplant after a failed primary kidney transplant may be considered medically necessary.

08/08/2014: Policy reviewed; description revised. Medically necessary policy statement on kidney retransplant after a failed primary kidney transplant updated to add "in patients who meet criteria for kidney transplantation." Added the following policy statement: Kidney transplant is considered investigational in all other situations.

08/31/2015: Code Reference section updated for ICD-10.

01/07/2016: Policy description updated. Policy statements unchanged.

06/01/2016: Policy number A.7.03.01 added. Policy Guidelines updated to add medically necessary and investigative definitions.

01/26/2017: Policy description updated regarding end-stage renal disease and data from the Organ Procurement and Transplantation Network. Policy statements unchanged.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis codes E85.81, E85.82 and E85.89. Effective 10/01/2017.

12/04/2017: Policy reviewed; no changes.

10/01/2018: Policy description updated regarding estimated kidney transplants in the U.S. Added information regarding FDA regulation. Policy statements unchanged. Code Reference section updated to revise description for ICD-10 diagnosis code E72.53. Removed deleted ICD-10 diagnosis code E85.8.

09/11/2019: Policy reviewed; no changes.

09/30/2020: Policy description updated regarding solid organ transplantation and data regarding kidney transplants. Policy statements unchanged. Code Reference section updated to add new ICD-10 diagnosis codes N18.30, N18.31, and N18.32, effective 10/01/2020.

12/10/2021: Policy description updated regarding new data for kidney transplants. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

09/19/2022: Code Reference section updated to add new ICD-10 diagnosis codes D59.30, D59.31, D59.32, and D59.39, effective 10/01/2022.

10/18/2022: Policy description updated regarding new data for transplants. Policy statement and Policy Guidelines updated to change "patients" to "individuals."

10/05/2023: Policy description updated regarding new data for transplants. Policy statement updated to change "patients" to "individuals" and "high incidence" to "high risk." Code Reference section updated to remove deleted ICD-10 diagnosis code D59.3.

10/01/2024: Code Reference section updated to add new ICD-10 diagnosis codes C81.7A and C88.91.

12/12/2024: Policy description updated regarding new data for kidney transplants. Policy statements unchanged. Policy Guidelines updated regarding renal-specific criteria.

04/01/2025: Code Reference section updated to add new ICD-10 Procedure codes 0TT00Z0, 0TT00Z1, 0TT10Z0, and 0TT10Z1, effective 04/01/2025.

09/18/2025: Policy description updated regarding new data for kidney transplants. Policy statements unchanged.

10/01/2025: Code Reference section updated to add new ICD-10 diagnosis codes E72.530, E72.538, and E72.539.

SOURCE(S)

Blue Cross & Blue Shield Association policy # 7.03.01

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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