Desensitization Treatment for Heart and Renal Transplant

Policy ID: I-25-022

Section: Injections

Effective Date: October 01, 2019

Revised Date: March 25, 2024

Revision Effective Date: May 06, 2024

Last Reviewed: March 19, 2024

Applies To: Commercial and Medicaid Expansion

Description

Desensitization prior to transplantation is for those individuals who are HLA-sensitized have broadly reactive alloantibodies, e.g., due to previous pregnancy, transfusion of blood or blood products, or transplantation. HLA-sensitized individuals are difficult to match for donor organs because of high risks of hyperacute rejection and graft loss with cross-matched organs.

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Renal Transplant

Desensitization for renal transplant may be considered medically necessary when the following criteria are met:

A suitable non-reactive live or cadaveric donor is unavailable; and
Living Donors - individuals should exhibit:
- A current positive cross-match may be defined by any of the following:
  - Flow cytometric crossmatch (FCXM) positive for T and/or B cells; or
  - National Institute of Health Complement dependent cytotoxicity (NIH-CDC) positive and dithiothreitol (DTT) treated; or
  - Antihuman globulin (AHG-CDC) assay positive; and
- ABO blood group incompatibility (ABOi) with or without splenectomy:
  - May be defined as isoagglutinin titer greater than 1:4; and
Deceased Donors-the following must be met:
- Panel reactive antibody (PRA) of HLA greater than 50%; and
- Donor specific antibody (DSA) positive; and
- ABO blood group incompatibility (ABOi) with or without splenectomy.

The use of a desensitization treatment protocol not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

36514

J9312

Q5115

Q5119

Q5123

Heart Transplant

The following criteria for the risk-assessment and prophylaxis strategies for allosensitized heart transplant candidates are as follows:

Class IIa:
- A complete sensitization history, including previous PRA (panel reactive antibody) determinations, blood transfusions, pregnancies, implant of homograft materials, previous transplantation, and use of a VAD is required to assess the risk of heart allograft anti-body-mediated rejection; and
- A PRA greater than or equal to 10% indicates significant allosensitization and it should raise the question of whether therapies aimed at reducing allosensitization should be instituted to minimize the need for a prospective donor/recipient crossmatch; and
- The results of the retrospective donor recipient crossmatch may be considered to make decisions regarding immunosuppressive therapy.
Class IIb:
- Desensitization therapy should be considered when the calculated PRA is considered by the individual transplant center to be high enough to significantly decrease the likelihood for a compatible donor match or to decrease the likelihood of donor heart rejection where unavoidable mismatches occur; and
- Choices to consider as desensitization therapies include IV immunoglobulin (Ig) infusion, plasmapheresis, either alone or combined, rituximab (Rituxan(R)), and in very selected cases, splenectomy.

Plasmapheresis may be considered medically necessary as a desensitization therapy for kidney or heart transplantation if the following are met:

Prior to solid organ transplant, treatment of individuals at high risk of antibody-mediated rejection, including highly sensitized individuals, and those receiving an ABO incompatible organ; and
Following solid-organ transplant, treatment of antibody-mediated rejection.

The use of a desensitization treatment protocol not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Code

36514

Rituximab (Rituxan, Truxima®, Ruxience®) may be considered medically necessary as a desensitization therapy for kidney or heart transplantation if the following are met:

Prior to solid organ transplant, treatment of individuals at high risk of antibody-mediated rejection, including highly sensitized individuals, and those receiving an ABO incompatible organ; and
The efficacy of more than two (2) infusions in 48 weeks is unknown.

The use of a desensitization treatment protocol not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

J9312

Q5115

Q5119

Q5123

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for J9312, Q5115, Q5119, and Q5123

I27.0

I27.89

I50.1

I50.20

I50.21

I50.22

I50.23

I50.30

I50.31

I50.32

I50.33

I50.40

I50.41

I50.42

I50.43

I50.810

I50.811

I50.812

I50.813

I50.814

I50.82

I50.83

I50.84

I50.89

I50.9

N18.1

N18.2

N18.30

N18.31

N18.32

N18.4

N18.5

N18.6

N18.9

Q21.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2020 Coding update

Added Procedure codes Q5115 & Q5119

Internal Medical Policy Committee 11-23-2021 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-29-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-15-2023 Coding update - Effective January 01, 2024

Added procedure code Q5123

Internal Medical Policy Committee 3-19-2024 Revision- Effective May 06, 2024

Updated verbiage from considered experimental/investigational to not medically necessary.

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-25-020

Section: Injections

Effective Date: October 01, 2019

Revised Date: November 11, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Archived Date: May 05, 2024

Applies To: Commercial and Medicaid Expansion

Description

Criteria

Renal Transplant

Desensitization for renal transplant may be considered medically necessary when the following criteria are met:

A suitable non-reactive live or cadaveric donor is unavailable; and
Living Donors - individuals should exhibit:
- A current positive cross-match may be defined by any of the following:
  - Flow cytometric crossmatch (FCXM) positive for T and/or B cells; or
  - National Institute of Health Complement dependent cytotoxicity (NIH-CDC) positive and dithiothreitol (DTT) treated; or
  - Antihuman globulin (AHG-CDC) assay positive; and
- ABO blood group incompatibility (ABOi) with or without splenectomy:
  - May be defined as isoagglutinin titer greater than 1:4; and
Deceased Donors-the following must be met:
- Panel reactive antibody (PRA) of HLA greater than 50%; and
- Donor specific antibody (DSA) positive; and
- ABO blood group incompatibility (ABOi) with or without splenectomy.

The use of a desensitization treatment protocol that does not meet these criteria or for any other transplant other than heart or renal is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support the use of desensitization for other types of transplant.

Procedure Codes

36514

J9312

Q5115

Q5119

Q5123

Heart Transplant

The following criteria for the risk-assessment and prophylaxis strategies for allosensitized heart transplant candidates are as follows:

Class IIa:
- A complete sensitization history, including previous PRA (panel reactive antibody) determinations, blood transfusions, pregnancies, implant of homograft materials, previous transplantation, and use of a VAD is required to assess the risk of heart allograft anti-body-mediated rejection; and
- A PRA greater than or equal to 10% indicates significant allosensitization and it should raise the question of whether therapies aimed at reducing allosensitization should be instituted to minimize the need for a prospective donor/recipient crossmatch; and
- The results of the retrospective donor recipient crossmatch may be considered to make decisions regarding immunosuppressive therapy.
Class IIb:
- Desensitization therapy should be considered when the calculated PRA is considered by the individual transplant center to be high enough to significantly decrease the likelihood for a compatible donor match or to decrease the likelihood of donor heart rejection where unavoidable mismatches occur; and
- Choices to consider as desensitization therapies include IV immunoglobulin (Ig) infusion, plasmapheresis, either alone or combined, rituximab (Rituxan(R)), and in very selected cases, splenectomy.

Plasmapheresis may be considered medically necessary as a desensitization therapy for kidney or heart transplantation if the following are met:

Prior to solid organ transplant, treatment of individuals at high risk of antibody-mediated rejection, including highly sensitized individuals, and those receiving an ABO incompatible organ; and
Following solid-organ transplant, treatment of antibody-mediated rejection.

Procedure Code

36514

Rituximab (Rituxan, Truxima®, Ruxience®) may be considered medically necessary as a desensitization therapy for kidney or heart transplantation if the following are met:

Prior to solid organ transplant, treatment of individuals at high risk of antibody-mediated rejection, including highly sensitized individuals, and those receiving an ABO incompatible organ; and
The efficacy of more than two (2) infusions in 48 weeks is unknown.

Procedure Codes

J9312

Q5115

Q5119

Q5123

Diagnosis Codes

Covered Diagnosis Codes for J9312, Q5115, Q5119, and Q5123

I27.0

I27.89

I50.1

I50.20

I50.21

I50.22

I50.23

I50.30

I50.31

I50.32

I50.33

I50.40

I50.41

I50.42

I50.43

I50.810

I50.811

I50.812

I50.813

I50.814

I50.82

I50.83

I50.84

I50.89

I50.9

N18.1

N18.2

N18.30

N18.31

N18.32

N18.4

N18.5

N18.6

N18.9

Q21.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2020 Coding update

Added Procedure codes Q5115 & Q5119

Internal Medical Policy Committee 11-23-2021 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-29-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-15-2023 Coding update - Effective January 01, 2024

Added procedure code Q5123

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