HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-25-022
Topic:
Desensitization Treatment for Heart and Renal Transplant
Section:
Injections
Effective Date:
February 19, 2024
Issued Date:
February 19, 2024
Last Revision Date:
December 2023
Annual Review:
December 2023
 
 

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 Position

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.

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®), 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 not meeting the criteria as indicated in this policy is considered not medically necessary.

36514

 

 

 

 

 

 




Rituximab (Rituxan, Truxima®, Ruxience®, RiabniTM) 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.

J9312

Q5115

Q5119

Q5123

 

 

 




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. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.


Related Policies

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) Rituximab Biosimilars, and Rituximab and Hyaluronidase Human (Rituxan Hycela), for additional information.


Covered Diagnosis Codes for J9312, Q5115, Q5119, 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



Place of Service: Outpatient

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



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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 or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

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.

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.

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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

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.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect 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:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • 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.