Highmark Commercial Medical Policy - Pennsylvania

Medical Policy: I-25-014
Topic: Desensitization Treatment for Heart and Renal Transplant
Section: Injections
Effective Date: October 1, 2017
Issue Date: November 13, 2017
Last Reviewed: October 2017

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

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Renal Transplant

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

Procedure Codes
36514, J9310



Heart Transplant

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

  • Class IIa:
    • A complete patient 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, 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:

Procedure Codes
36514



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

Procedure Codes
J9310



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.



Refer to medical policy I-14 Immune Globulin Therapy, for additional information.

Refer to medical policy S-11 Pheresis Therapy, for additional information.

Refer to pharmacy policy J-500 Immune Globulin (Medical Injectable Policy),  for additional information.

Refer to medical policy I-38 Rituximab (Rituxan®), for additional information.



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Desensitization treatment for heart and renal transplant is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

A network provider can bill the member for the non-covered service.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer: If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.