Chimeric antigen receptor T-cell (CAR-T) therapy is a cellular therapy that uses genetic engineering to alter an individual's own T-cells to produce unique receptors on their cell surface that recognize a specific protein.
CAR-T therapies are only available through their specific restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Providers must enroll and comply with REMS requirements.
Brexucabtagene autoleucel (TecartusTM) may be considered medically necessary when the following criteria are met:
Mantle Cell Lymphoma (MCL)
Acute Lymphoblastic Leukemia (ALL)
Out of specification product administration is considered experimental/investigational and, therefore, non-covered for ANY indication. There is insufficient scientific evidence to support its effectiveness and safety for ANY indication.
Additional infusions of brexucabtagene autoleucel (Tecartus) or infusion of alternative CAR-T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime.
The use of brexucabtagene autoleucel (Tecartus) not meeting the criteria as indicated in this policy is considered not medically necessary.
Q2053 |
0537T |
0538T |
0539T |
0540T |
|
|
Idecabtagene vicleucel (Abecma®) may be considered medically necessary when the following criteria are met:
Out of specification product administration is considered experimental/investigational and, therefore, non-covered for ANY indication. There is insufficient scientific evidence to support its effectiveness and safety for ANY indication.
Additional infusions of idecabtagene vicleucel (Abecma) or infusion of alternative CAR-T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime.
The use of idecabtagene vicleucel (Abecma) not meeting the criteria as indicated in this policy is considered not medically necessary.
Q2055 |
0537T |
0538T |
0539T |
0540T |
|
|
Lisocabtagene maraleucel (Breyanzi®) may be considered medically necessary for individuals 18 years of age or older when the following are met:
B-Cell Lymphoma
Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Follicular Lymphoma (FL)
Mantle Cell Lymphoma (MCL)
Out of specification product administration is considered experimental/investigational and, therefore, non-covered for ANY indication. There is insufficient scientific evidence to support its effectiveness and safety for ANY indication.
Additional infusions of lisocabtagene maraleucel (Breyanzi) or infusion of alternative CAR-T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime.
The use of lisocabtagene maraleucel (Breyanzi) not meeting the criteria as indicated in this policy is considered not medically necessary.
Q2054 |
0537T |
0538T |
0539T |
0540T |
|
|
Tisagenlecleucel (Kymriah®) may be considered medically necessary for ANY of the following indications:
Acute Lymphoblastic Leukemia (ALL)
Philadelphia Chromosome-Negative B-ALL
Philadelphia Chromosome-Positive B-ALL
Acute Lymphoblastic Leukemia – Pediatric
B-Cell Lymphomas
Follicular Lymphoma (grade 1-2), Histologic Transformation of Nodal Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma, or Post-Transplant Lymphoproliferative Disorders (PTLD)
Adult Relapsed or Refractory (r/r) Follicular Lymphoma
Out of specification product administration is considered experimental/investigational and, therefore, non-covered for ANY indication. There is insufficient scientific evidence to support its effectiveness and safety for ANY indication.
Additional infusions of tisagenlecleucel (Kymriah) or infusion of alternative CAR-T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime.
Refractory is defined by not achieving an initial complete remission after two (2) cycles of a standard chemotherapy regimen (primary refractory). Subjects who were refractory to subsequent chemotherapy regimens after an initial remission are considered chemorefractory.
**Relapse is defined by greater than 5% lymphoblasts and second or subsequent bone marrow (BM) relapse, or any BM relapse after allogeneic (stem cell transplant) SCT and must be greater than or equal to six (6) months from SCT at the time of tisagenlecleucel infusion.
The use of tisagenlecleucel (Kymriah) not meeting the criteria as indicated in this policy is considered not medically necessary.
Q2042 |
0537T |
0538T |
0539T |
0540T |
|
|
Axicabtagene ciloleucel (Yescarta®) may be considered medically necessary for individuals 18 years of age or older for ANY of the following indications:
B-Cell Lymphomas
AIDS-Related B-Cell Lymphomas, Diffuse Large B-Cell Lymphoma, or High-Grade B-Cell Lymphomas
Follicular Lymphoma (grade 1-2), Histologic Transformation of Nodal Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma, or Post-Transplant Lymphoproliferative Disorders (PTLD)
Limitation of Use: Axicabtagene ciloleucel (Yescarta) is not indicated for the treatment of patients with primary CNS lymphoma.
Out of specification product administration is considered experimental/investigational and, therefore, non-covered for ANY indication. There is insufficient scientific evidence to support its effectiveness and safety for ANY indication.
Additional infusions of axicabtagene ciloleucel (Yescarta) or infusion of alternative CAR-T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime.
The use of axicabtagene ciloleucel (Yescarta) not meeting the criteria as indicated in this policy is considered not medically necessary.
Q2041 |
0537T |
0538T |
0539T |
0540T |
|
|
Ciltacabtagene autoleucel (Carvykti™) may be considered medically necessary when ALL of the following criteria are met:
Out of specification product administration is considered experimental/investigational and, therefore, non-covered for ANY indication. There is insufficient scientific evidence to support its effectiveness and safety for ANY indication.
Additional infusions of ciltacabtagene autoleucel (Carvykti) or infusion of alternative CAR-T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime.
The use of ciltacabtagene autoleucel (Carvykti) not meeting the criteria as indicated in this policy is considered not medically necessary.
Q2056 |
J3590 |
0537T |
0538T |
0539T |
0540T |
|
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.
Afamitresgene autoleucel (Tecelra®) may be considered medically necessary when the following criteria are met:
Synovial Sarcoma
Out of specification product administration is considered experimental/investigational and, therefore, non-covered for ANY indication. There is insufficient scientific evidence to support its effectiveness and safety for ANY indication.
Additional infusions of afamitresgene autoleucel (Tecelra) or infusion of alternative CAR-T products after an initial infusion of one product are considered experimental/investigational and therefore, non-covered. Scientific evidence does not support more than one (1) dose of a single CAR-T product per lifetime.
The use of afamitresgene autoleucel (Tecelra) not meeting the criteria as indicated in this policy is considered not medically necessary.
J3590 |
0537T |
0538T |
0539T |
0540T |
|
|
Refer to medical policy I-31 Tocilizumab (Actemra) for additional information
Refer to medical policy S-11 Pheresis Therapy for additional information.
Refer to Medical Policy I-249 Pennsylvania Cancer Treatment Mandate, for additional information.
Covered Diagnosis Codes for Q2042, 0537T, 0538T, 0539T, and 0540T
B20 |
C82.00 |
C82.01 |
C82.02 |
C82.03 |
C82.04 |
C82.05 |
C82.06 |
C82.07 |
C82.08 |
C82.09 |
C82.10 |
C82.11 |
C82.12 |
C82.13 |
C82.14 |
C82.15 |
C82.16 |
C82.17 |
C82.18 |
C82.19 |
C82.20 |
C82.21 |
C82.22 |
C82.23 |
C82.24 |
C82.25 |
C82.26 |
C82.27 |
C82.28 |
C82.29 |
C82.30 |
C82.31 |
C82.32 |
C82.33 |
C82.34 |
C82.35 |
C82.36 |
C82.37 |
C82.38 |
C82.39 |
C82.40 |
C82.41 |
C82.42 |
C82.43 |
C82.44 |
C82.45 |
C82.46 |
C82.47 |
C82.48 |
C82.49 |
C82.50 |
C82.51 |
C82.52 |
C82.53 |
C82.54 |
C82.55 |
C82.56 |
C82.57 |
C82.58 |
C82.59 |
C82.60 |
C82.61 |
C82.62 |
C82.63 |
C82.64 |
C82.65 |
C82.66 |
C82.67 |
C82.68 |
C82.69 |
C82.80 |
C82.81 |
C82.82 |
C82.83 |
C82.84 |
C82.85 |
C82.86 |
C82.87 |
C82.88 |
C82.89 |
C82.90 |
C82.91 |
C82.92 |
C82.93 |
C82.94 |
C82.95 |
C82.96 |
C82.97 |
C82.98 |
C82.99 |
C83.30 |
C83.31 |
C83.32 |
C83.33 |
C83.34 |
C83.35 |
C83.36 |
C83.37 |
C83.38 |
C83.390 |
C83.398 |
C83.50 |
C83.51 |
C83.52 |
C83.53 |
C83.54 |
C83.55 |
C83.56 |
C83.57 |
C83.58 |
C83.59 |
C83.80 |
C83.81 |
C83.82 |
C83.83 |
C83.84 |
C83.85 |
C83.86 |
C83.87 |
C83.88 |
C83.89 |
C83.90 |
C83.91 |
C83.92 |
C83.93 |
C83.94 |
C83.95 |
C83.96 |
C83.97 |
C83.98 |
C83.99 |
C85.10 |
C85.11 |
C85.12 |
C85.13 |
C85.14 |
C85.15 |
C85.16 |
C85.17 |
C85.18 |
C85.19 |
C85.20 |
C85.21 |
C85.22 |
C85.23 |
C85.24 |
C85.25 |
C85.26 |
C85.27 |
C85.28 |
C85.29 |
C85.80 |
C85.81 |
C85.82 |
C85.83 |
C85.84 |
C85.85 |
C85.86 |
C85.87 |
C85.88 |
C85.89 |
C91.00 |
C91.01 |
C91.02 |
D47.Z1 |
|
|
Covered Diagnosis Codes for Q2041, 0537T, 0538T, 0539T, and 0540T
B20 |
C82.00 |
C82.01 |
C82.02 |
C82.03 |
C82.04 |
C82.05 |
C82.06 |
C82.07 |
C82.08 |
C82.09 |
C82.10 |
C82.11 |
C82.12 |
C82.13 |
C82.14 |
C82.15 |
C82.16 |
C82.17 |
C82.18 |
C82.19 |
C82.20 |
C82.21 |
C82.22 |
C82.23 |
C82.24 |
C82.25 |
C82.26 |
C82.27 |
C82.28 |
C82.29 |
C82.30 |
C82.31 |
C82.32 |
C82.33 |
C82.34 |
C82.35 |
C82.36 |
C82.37 |
C82.38 |
C82.39 |
C82.40 |
C82.41 |
C82.42 |
C82.43 |
C82.44 |
C82.45 |
C82.46 |
C82.47 |
C82.48 |
C82.49 |
C82.50 |
C82.51 |
C82.52 |
C82.53 |
C82.54 |
C82.55 |
C82.56 |
C82.57 |
C82.58 |
C82.59 |
C82.60 |
C82.61 |
C82.62 |
C82.63 |
C82.64 |
C82.65 |
C82.66 |
C82.67 |
C82.68 |
C82.69 |
C82.80 |
C82.81 |
C82.82 |
C82.83 |
C82.84 |
C82.85 |
C82.86 |
C82.87 |
C82.88 |
C82.89 |
C82.90 |
C82.91 |
C82.92 |
C82.93 |
C82.94 |
C82.95 |
C82.96 |
C82.97 |
C82.98 |
C82.99 |
C83.00 |
C83.07 |
C83.08 |
C83.30 |
C83.31 |
C83.32 |
C83.33 |
C83.34 |
C83.35 |
C83.36 |
C83.37 |
C83.38 |
C83.390 |
C83.398 |
C83.80 |
C83.81 |
C83.82 |
C83.83 |
C83.84 |
C83.85 |
C83.86 |
C83.87 |
C83.88 |
C83.89 |
C83.90 |
C83.91 |
C83.92 |
C83.93 |
C83.94 |
C83.95 |
C83.96 |
C83.97 |
C83.98 |
C83.99 |
C85.10 |
C85.11 |
C85.12 |
C85.13 |
C85.14 |
C85.15 |
C85.16 |
C85.17 |
C85.18 |
C85.19 |
C85.20 |
C85.21 |
C85.22 |
C85.23 |
C85.24 |
C85.25 |
C85.26 |
C85.27 |
C85.28 |
C85.29 |
C85.80 |
C85.81 |
C85.82 |
C85.83 |
C85.84 |
C85.85 |
C85.86 |
C85.87 |
C85.88 |
C85.89 |
C88.40 |
D47.Z1 |
|
|
|
|
Covered Diagnosis Codes for Q2053, 0537T, 0538T, 0539T, and 0540T
C83.10 |
C83.11 |
C83.12 |
C83.13 |
C83.14 |
C83.15 |
C83.16 |
C83.17 |
C83.18 |
C83.19 |
C83.50 |
C83.51 |
C83.52 |
C83.53 |
C83.54 |
C83.55 |
C83.56 |
C83.57 |
C83.58 |
C83.59 |
C91.00 |
C91.01 |
C91.02 |
|
|
|
|
|
Covered Diagnosis Codes for Q2054, 0537T, 0538T, 0539T, and 0540T
B20 |
C82.00 |
C82.01 |
C82.02 |
C82.03 |
C82.04 |
C82.05 |
C82.06 |
C82.07 |
C82.08 |
C82.09 |
C82.10 |
C82.11 |
C82.12 |
C82.13 |
C82.14 |
C82.15 |
C82.16 |
C82.17 |
C82.18 |
C82.19 |
C82.20 |
C82.21 |
C82.22 |
C82.23 |
C82.24 |
C82.25 |
C82.26 |
C82.27 |
C82.28 |
C82.29 |
C82.30 |
C82.31 |
C82.32 |
C82.33 |
C82.34 |
C82.35 |
C82.36 |
C82.37 |
C82.38 |
C82.39 |
C82.40 |
C82.41 |
C82.42 |
C82.43 |
C82.44 |
C82.45 |
C82.46 |
C82.47 |
C82.48 |
C82.49 |
C82.50 |
C82.51 |
C82.52 |
C82.53 |
C82.54 |
C82.55 |
C82.56 |
C82.57 |
C82.58 |
C82.59 |
C82.60 |
C82.61 |
C82.62 |
C82.63 |
C82.64 |
C82.65 |
C82.66 |
C82.67 |
C82.68 |
C82.69 |
C82.80 |
C82.81 |
C82.82 |
C82.83 |
C82.84 |
C82.85 |
C82.86 |
C82.87 |
C82.88 |
C82.89 |
C82.90 |
C82.91 |
C82.92 |
C82.93 |
C82.94 |
C82.95 |
C82.96 |
C82.97 |
C82.98 |
C82.99 |
C83.00 |
C83.01 |
C83.02 |
C83.03 |
C83.04 |
C83.05 |
C83.06 |
C83.07 |
C83.08 |
C83.09 |
C83.30 |
C83.31 |
C83.32 |
C83.33 |
C83.34 |
C83.35 |
C83.36 |
C83.37 |
C83.38 |
C83.390 |
C83.398 |
C83.81 |
C83.83 |
C83.84 |
C83.85 |
C83.86 |
C83.87 |
C83.88 |
C83.89 |
C83.90 |
C83.91 |
C83.92 |
C83.93 |
C83.94 |
C83.95 |
C83.96 |
C83.97 |
C83.98 |
C83.99 |
C85.10 |
C85.11 |
C85.12 |
C85.13 |
C85.14 |
C85.15 |
C85.16 |
C85.17 |
C85.18 |
C85.19 |
C85.20 |
C85.21 |
C85.22 |
C85.23 |
C85.24 |
C85.25 |
C85.26 |
C85.27 |
C85.28 |
C85.29 |
C85.80 |
C85.81 |
C85.82 |
C85.83 |
C85.84 |
C85.85 |
C85.86 |
C85.87 |
C85.88 |
C85.89 |
C91.10 |
C91.12 |
D47.Z1 |
|
|
|
|
|
Covered Diagnosis Codes for Q2055, 0537T, 0538T, 0539T, and 0540T
C90.00 |
C90.02 |
C90.10 |
C90.12 |
C90.20 |
C90.22 |
C90.30 |
C90.32 |
|
|
|
|
|
|
Covered Diagnosis Codes for Q2056, J3590, 0537T, 0538T, 0539T, and 0540T
C90.00 |
C90.02 |
C90.10 |
C90.12 |
C90.20 |
C90.22 |
C90.30 |
C90.32 |
|
|
|
|
|
|
Covered Diagnosis Codes for J3590, 0537T, 0538T, 0539T, and 0540T
C38.0 |
C38.1 |
C38.2 |
C38.3 |
C38.4 |
C38.8 |
C48.0 |
C48.1 |
C48.2 |
C48.8 |
C49.0 |
C49.10 |
C49.11 |
C49.12 |
C49.20 |
C49.21 |
C49.22 |
C49.3 |
C49.4 |
C49.5 |
C49.6 |
C49.8 |
C49.9 |
|
|
|
|
|
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:
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:
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.