Desensitization Treatment for Heart and Renal Transplant

Section: Injections
Effective Date: October 01, 2019
Revised Date: October 03, 2019

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.

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

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®), 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 patients, and those receiving an ABO incompatible organ; and
  • Following solid-organ transplant, treatment of antibody-mediated rejection.

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

Rituximab (Rituxan) 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 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

J9312

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for J9312

I27.0 I27.89 I50.1 I50.9 I50.20 I50.21 I50.22
I50.23 I50.30 I50.31 I50.32 I50.33 I50.40 I50.41
I50.42 I50.43 N18.1 N18.2 N18.3 N18.4 N18.5
N18.6 N18.9 Q21.0 I50.810 I50.811 I50.812 I50.813
I50.814 I50.82 I50.83 I50.84 I50.89

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