HumanaCommercial Clinical Policy

Humana Autologous and Allogeneic Bone Marrow Transplants Form


autologous bone marrow transplant

Notes: Coverage for autologous bone marrow transplant requires evaluation of medical necessity based on the patient meeting the appropriate clinical criteria and their specific diagnostic condition as outlined in the Humana members' plan. Coverage for hematopoietic stem cell transplants is limited to certain indications that are not deemed experimental/investigational. Stem cell harvesting for future use and storage of umbilical cord blood when not part of a preapproved transplant are typically not covered.

Indications

(791768) Is the bone marrow transplant being done in conjunction with a clinical trial for a Commercial Plan member? 
(791769) Does the patient's DLCO measure greater than 60%? 
(791770) Does the patient have an ECOG performance status of two or an age-appropriate status or a Karnofsky score greater than 60 (or a Lansky Performance Score greater than 60 if 16 years of age or younger)? 
(791771) Is the patient's ejection fraction greater than 45%? 
(791772) If the patient does not meet the cardiac, respiratory, or hepatic criteria, has clearance been obtained from the appropriate medical specialty? 

YesNoN/A
YesNoN/A
YesNoN/A

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Effective Date

05/25/2023

Last Reviewed

NA

Original Document

  Reference



Description

Hematopoietic stem cell transplantation includes collection of bone marrow, cord blood stem cell, and peripheral stem cell. This includes services for donors.

Routine collection and storage/freezing of umbilical cord blood or stem cells for possible future use is generally not a covered benefit. Refer to the member’s certificate for additional information.

Requests for collection and storage/freezing of umbilical cord blood or stem cells for an actual impending transplant are processed through the Humana Transplant Department. (Refer to Coverage Limitations section)

Autologous and Allogeneic Bone Marrow Transplants/Peripheral Stem Cell Transplants/Umbilical Cord Blood Transplants

Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0468-022

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Allogeneic bone marrow transplants (BMT) or myeloablative transplants are procedures in which healthy marrow is taken from a matched (related or unrelated) donor and transplanted into the individual after high-dose chemotherapy and/or radiation.

Autologous BMT involves taking the marrow from an affected individual and purging it. After the marrow is purged with chemicals to remove any malignant cells that may be present, it is preserved in a frozen state until needed. Following high-dose chemotherapy and/or radiation therapy, which destroys the remaining marrow, the stored marrow is thawed and transplanted back into the treated individual via intravenous infusion.

Mini transplants or nonmyeloablative transplants are types of allogeneic transplants. This approach involves administering low doses of chemotherapy and/or radiation therapy followed by an infusion of peripheral blood stem cells from a matched (related or unrelated) donor. The primary goal is to achieve graft versus tumor effect. These interventions usually occur after initial attempts of therapy have failed. It is also used for an individual who may not be able to tolerate a myeloablative transplant. Tumor cell death is not the goal of chemotherapy in this situation; the goal is adequate immunosuppression for engraftment and the creation of room in the marrow for engraftment.

Peripheral stem cell transplants (PSCT) are procedures in which stem cells are taken directly from the blood stream instead of using bone marrow. Both allogeneic and autologous transplants can be performed using peripheral stem cells. Peripheral stem cells may also be utilized to supplement a BMT.

Syngeneic transplants are types of allogeneic transplants in which the donor is an identical twin with identical tissue types. This is a rare type of transplant since few people are identical twins. The advantage of this type of transplant is that graft-versus-host disease is not a problem, however, it does not destroy any remaining cancer cells.

Tandem transplants are types of autologous transplants in which an individual receives two sequential courses of high-dose chemotherapy with a stem cell transplant.

Typically, the two courses are given several weeks to several months apart.

Umbilical cord blood transplants are procedures in which umbilical cord blood from a matched (related or unrelated) donor newborn that is rich in stem cells is used as the donor source for a transplant.

For information regarding cord blood/stem cell transplantation for autism spectrum disorder (ASD), please refer to Autism Spectrum Disorders Diagnosis and Treatments Medical Coverage Policy.

Coverage Determination

Commercial Plan members: requests for autologous bone marrow transplant done in conjunction with a clinical trial require review by a medical director.

Humana members may be eligible under the Plan for a transplant evaluation for any diagnosis to determine the medical necessity for a BMT/PSCT or umbilical cord blood transplant.

BMT/PSCT Humana members may be eligible under the Plan for BMT/PSCT when the following criteria is met:

  • Carbon monoxide diffusing capacity (DLCO) greater than 60%; AND
  • Eastern Cooperative Oncology Group (ECOG) performance status of two or age appropriate status or Karnofsky score greater than 60; however, if 16 years of age or younger, the Lansky Performance Score may be utilized (score greater than 60) instead of the Karnofsky Performance Scale or the ECOG Performance Status; AND
  • Ejection fraction greater than 45%; AND
  • If an individual does not meet the cardiac, respiratory or hepatic criteria, clearance is required from the appropriate medical specialty. If the appropriate medical specialty does not clear the individual, the case will need to be reviewed by the transplant medical director; AND
  • Total bilirubin less than 2.0 mg/dl
Pediatric Individuals:

Left ventricular fractional shortening (LVFS) must be greater than or equal to 30% for a bone marrow transplant. If the LVFS is less than 30%, cardiac clearance must be obtained

Humana members may be eligible under the Plan for autologous PSCT transplant for the following indications when the criteria above are met:

  • Amyloidosis; OR
  • Choriocarcinoma; OR
  • Combined T- and B-cell deficiencies
    • Severe combined immunodeficiency (SCID), all types; OR
  • Desmoplastic small round cell tumor; OR
  • Ewing’s sarcoma; OR
  • Germ-cell testicular cancer; OR
  • Hodgkin’s lymphoma; OR
  • Immune dysregulation diseases
    • Griscelli syndrome, type II; OR
  • Leukemia; OR
  • Medulloblastoma; OR
  • Multiple myeloma; OR
  • Neuroblastoma; OR
  • Non-Hodgkin’s lymphoma; OR
  • Phagocyte disorders
    • Kostmann syndrome
    • Shwachman-Diamond syndrome; OR

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Systemic sclerosis (scleroderma); OR
  • T-cell deficiencies
    • Ataxia telangiectasia; OR
    • DiGeorge syndrome; OR
  • Well-defined immunodeficiency syndromes
    • Wiskott-Aldrich syndrome

Allogeneic BMT/PSCT/Syngeneic/Umbilical Cord Blood Transplant

Commercial Plan members: requests for autologous bone marrow transplant done in conjunction with a clinical trial require review by a medical director.

Humana members may be eligible under the Plan for an allogeneic BMT/PSCT/ syngeneic/umbilical cord blood transplant for:

  • DLCO greater than 60%; AND
  • ECOG performance status of two or age appropriate status or Karnofsky score greater than 60; however, if 16 years of age or younger, the Lansky Performance Score may be utilized (score greater than 60) instead of the Karnofsky Performance Scale or the ECOG Performance Status; AND
  • Ejection fraction greater than 45%; AND
  • If an individual does not meet the cardiac, respiratory or hepatic criteria, clearance is required from the appropriate medical specialty. If the appropriate medical specialty does not clear the individual, the case will need to be reviewed by the transplant medical director; AND
  • Total bilirubin less than 2.0 mg/dl
Pediatric Individuals:

LVFS must be greater than or equal to 30% for a bone marrow transplant. If the LVFS is less than 30%, cardiac clearance must be obtained.

Allogeneic Transplant

Humana members may be eligible under the Plan for allogeneic transplant with a minimum of 3/6 HLA matches at A, B, Dr antigens for the following diagnoses (not all inclusive) if above criteria is met:

  • Additional allele/antigens may be provided (A, B, C, Dr, Dq) to indicate further degree of HLA match (8/8 or 10/10). However, A, B and Dr are the only recognizable antigens for review.
  • Acute lymphoblastic leukemia (ALL); OR
  • Acute myeloid leukemia (AML); OR
  • Anemias
    • Aplastic anemia; OR
    • Diamond-Blackfan anemia; OR
    • Fanconi's anemia; OR
    • Paroxysmal nocturnal hemoglobinuria; OR
  • Chronic lymphocytic leukemia (CLL); OR
  • Chronic myelogenous leukemia (CML); OR
  • Congenital thrombocytopenia; OR
  • Glycoproteinoses
    • Alpha-mannosidosis; OR
    • Aspartylglucosaminuria; OR
    • Fucosidosis; OR
    • Mucolipidosis II (I-cell disease); OR
  • Hematologic diseases
    • β thalassemia major (Cooley's anemia)

Autologous and Allogeneic Bone Marrow Transplants/Peripheral Stem Cell Transplants/Umbilical Cord Blood Transplants Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0468-022 Page: 6 of 22

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Hemoglobinopathies; OR
  • Hodgkin’s lymphoma; OR
  • I/H grade Non-Hodgkin’s lymphoma; OR
  • Innate immune deficiencies
    • NF-kappa-B essential modulator (NEMO) deficiency (inhibitor of kappa light polypeptide gene enhancer in B cells, gamma kinase deficiency); OR
  • Large B cell lymphoma; OR
  • Leukodystrophies
    • Adrenoleukodystrophy
    • Krabbe disease (globoid cell leukodystrophy)
    • Metachromatic leukodystrophy; OR
  • Low-grade lymphoma; OR
  • Mucopolysaccharidoses
    • Hunter syndrome (MPS II, iduronidase sulfate deficiency)
    • Hurler-Scheie syndrome (MPS I H-S)
    • Hurler syndrome (MPS I H, alpha-L-iduronidase deficiency)
    • Maroteaux-Lamy syndrome (MPS VI)
    • Morquio syndrome (MPS IV)
    • Sanfilippo syndrome (MPS III)
    • Scheie syndrome (MPS I S)
    • Sly syndrome (MPS VII); OR
  • Multiple myeloma with failed auto ONLY; OR
  • Myelodysplastic syndrome (MDS) (does not apply to Medicare members); OR
  • Myelodysplastic/myeloproliferative neoplasm (MDS/MPN)
    • Chronic myelomonocytic leukemia (CMML)
    • Juvenile myelomonocytic leukemia (JMML)
    • Myelofibrosis; OR
  • Neuroblastoma; OR
  • Select mucopolysaccharidosis; OR
  • Severe combined immunodeficiency disease (SCID); OR
  • Sickle cell disease; OR
  • Well-defined immunodeficiency syndromes
    • Wiskott-Aldrich syndrome
Living Donor

Humana members and their donors may be eligible under the Plan for living donor complications for the following indications:

  • Complications cause a functional impairment and are reasonably expected as a result of being a living donor (e.g., infection); AND
  • Complications have occurred within 1 year from donation; AND
  • Transplant recipient’s certificate contains donor benefits that allow for living donations

Coverage Limitations

Humana members may NOT be eligible under the Plan for hematopoietic stem cell transplants for any indications other than those listed above including, but may not be limited to:

  • Alzheimer’s disease
  • Crohn’s disease
  • Multiple sclerosis

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for hematopoietic stem cell harvesting for a future unscheduled transplant. This is considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for storage of umbilical cord blood unless it is an integral part of a preapproved transplant. This is considered not medically necessary as defined in the member’s individual certificate.

Background

Please refer to the member’s individual certificate for the specific definition.

Additional information about autologous and allogeneic bone marrow transplants/ peripheral stem cell transplants/umbilical cord blood transplants may be found from the following websites:

Medical Alternatives

To make the best health decision for the patient’s individual needs, the patient should consult his/her physician.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. Provider Claims Codes

Provider Claims Codes

CPT® Code(s) Description Comments

38205 Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic

38206 Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous

38230 Bone marrow harvesting for transplantation; allogeneic

38232 Bone marrow harvesting for transplantation; autologous

CPT® Category Ill Code(s) Description Comments

HCPCS Code(s) Description Comments

HCPCS Code(s) S2142 Cord blood-derived stem-cell transplantation, allogeneic

References

  • American Academy of Pediatrics (AAP). Policy Statement. Cord blood banking for potential future transplantation. www.aap.org. Published November 2017. Accessed May 17, 2023.
  • American Academy of Pediatrics (AAP). Policy Statement. Human embryonic stem cell (hESC) and human embryo research. www.aap.org. Published November 2012. Accessed May 17, 2023.
  • American College of Obstetricians and Gynecologists (ACOG). Committee Opinion. Umbilical cord blood banking. www.acog.org. Published December 2015. Updated March 2019. Accessed May 16, 2023.
  • American Society for Transplantation and Cellular Therapy. Hematopoietic cell transplantation in the treatment of adult acute lymphoblastic leukemia: updated 2019 evidence-based review from the American Society for Transplantation and Cellular Therapy. www.astct.org. Published August 16, 2019. Accessed May 17, 2023.
  • American Society for Transplantation and Cellular Therapy. Hematopoietic stem cell transplantation for multiple myeloma: guideline from the American Society for Blood and Marrow Transplantation. www.astct.org. Published August 16, 2019. Accessed May 17, 2023.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

American Society for Transplantation and Cellular Therapy. Indications for hematopoietic cell transplantation and immune effector cell therapy: guidelines from the American Society for Transplantation and Cellular Therapy. https://www.astct.org. Published February 29, 2020. Accessed May 17, 2023.

American Society for Transplantation and Cellular Therapy. Role of cytotoxic therapy with hematopoietic cell transplantation in the treatment of Hodgkin lymphoma: guidelines from the American Society for Blood and Marrow Transplantation. https://www.astct.org. Published February 25, 2015. Accessed May 17, 2023.

American Society of Clinical Oncology (ASCO). Treatment of multiple myeloma: ASCO and CCO joint clinical practice guideline. https://www.asco.org. Published 2019. Accessed May 16, 2023.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Stem cell transplantation (formerly 110.8.1) (110.23). https://www.cms.gov. Published January 27, 2016. Accessed May 17, 2023.

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    Autologous and Allogeneic Bone Marrow Transplants/Peripheral Stem Cell Transplants/Umbilical Cord Blood Transplants Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0468-022 Page: 13 of 22

    Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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    Autologous and Allogeneic Bone Marrow Transplants/Peripheral Stem Cell Transplants/Umbilical Cord Blood Transplants Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0468-022 Page: 18 of 22

    Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled.

    Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

    1. National Cancer Institute (NCI). Pediatric Hematopoietic Stem Cell Transplantation and Cellular Therapy for Cancer (PDQ) – health professional version. https://www.cancer.gov. Updated February 4, 2022. Accessed May 16, 2023.
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    Autologous and Allogeneic Bone Marrow Transplants/Peripheral Stem Cell Transplants/Umbilical Cord Blood Transplants Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0468-022 Page: 19 of 22

    Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

    1. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Myelodysplastic syndromes. https://www.nccn.org. Updated September 12, 2022. Accessed May 17, 2023.
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    3. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Pediatric acute lymphoblastic leukemia. https://www.nccn.org. Updated March 10, 2023. Accessed May 17, 2023.
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    https://www.uptodate.com. Updated April 2023. Accessed May 9, 2023.

    Autologous and Allogeneic Bone Marrow Transplants/Peripheral Stem Cell Transplants/Umbilical Cord Blood Transplants

    Effective Date: 05/25/2023
    Revision Date: 05/25/2023
    Review Date: 05/25/2023
    Policy Number: HUM-0468-022
    Page: 20 of 22

    Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

    1. UpToDate, Inc. Collection and storage of umbilical cord blood for hematological cell transplantation. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    2. UpToDate, Inc. Disease-modifying therapies for multiple sclerosis: pharmacology, administration and adverse events. https://www.uptodate.com. Updated April 2023. Accessed May 9, 2023.
    3. UpToDate, Inc. Gaucher disease: treatment. https://www.uptodate.com. Updated April 2023. Accessed May 9, 2023.
    4. UpToDate, Inc. Hematopoietic cell transplantation (HCT) for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in children and adolescents. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    5. UpToDate, Inc. Hematopoietic cell transplantation for aplastic anemia in adults. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    6. UpToDate, Inc. Hematopoietic cell transplantation for non-SCID inborn errors of immunity. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    7. UpToDate, Inc. Hematopoietic cell transplantation for severe combined immunodeficiencies. https://www.uptodate.com. Updated April 2023. Accessed May 9, 2023.
    8. UpToDate, Inc. Hematopoietic cell transplantation for transfusion-dependent thalassemia. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    9. UpToDate, Inc. Hematopoietic cell transplantation in chronic lymphocytic leukemia. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    Autologous and Allogeneic Bone Marrow Transplants/Peripheral Stem Cell Transplants/Umbilical Cord Blood Transplants

    Effective Date: 05/25/2023
    Revision Date: 05/25/2023
    Review Date: 05/25/2023
    Policy Number: HUM-0468-022
    Page: 21 of 22

    Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

    1. UpToDate, Inc. Hematopoietic cell transplantation in chronic myeloid leukemia. https://www.uptodate.com. Updated April 2023. Accessed May 2023.
    2. UpToDate, Inc. Hematopoietic cell transplantation in classic Hodgkin lymphoma. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    3. UpToDate, Inc. Hematopoietic stem cell transplantation in sickle cell disease. https://www.uptodate.com. Updated April 2023. Accessed May 8, 2023.
    4. UpToDate, Inc. HLA-haploidentical hematopoietic cell transplantation. https://www.uptodate.com. Updated April 2023. Accessed May 9, 2023.
    5. UpToDate, Inc. Immunomodulatory and antifibrotic approaches to the treatment of systemic sclerosis (scleroderma). https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    6. UpToDate, Inc. Krabbe disease. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    7. UpToDate, Inc. Malignancy in primary immunodeficiency. https://www.uptodate.com. Updated April 2023. Accessed May 9, 2023.
    8. UpToDate, Inc. Management and prognosis of Fanconi anemia. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    9. UpToDate, Inc. Management of resistant or recurrent gestational trophoblastic neoplasia. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    10. UpToDate, Inc. Management of thalassemia. https://www.uptodate.com. Updated May 3, 2023.

    Accessed May 10, 2023.

    Autologous and Allogeneic Bone Marrow Transplants/Peripheral Stem Cell Transplants/Umbilical Cord Blood Transplants

    Effective Date: 05/25/2023
    Revision Date: 05/25/2023
    Review Date: 05/25/2023
    Policy Number: HUM-0468-022
    Page: 22 of 22

    Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

    1. UpToDate, Inc. Metachromatic leukodystrophy. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    2. UpToDate, Inc. Multiple myeloma: use of hematopoietic cell transplantation. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    3. UpToDate, Inc. Overview of stem cells. https://www.uptodate.com. Updated April 2023. Accessed May 9, 2023.
    4. UpToDate, Inc. Treatment and prognosis of paroxysmal nocturnal hemoglobinuria. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    5. UpToDate, Inc. Treatment of high or very high-risk myelodysplastic syndromes. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    6. UpToDate, Inc. Treatment of relapsed or refractory acute myeloid leukemia. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.
    7. UpToDate, Inc. Treatment of secondary progressive multiple sclerosis in adults. https://www.uptodate.com. Updated April 12, 2023. Accessed May 10, 2023.
    8. UpToDate, Inc. Treatment of Sezary syndrome. https://www.uptodate.com. Updated April 2023. Accessed May 10, 2023.