Clinical Policy: Nonmyeloablative Allogeneic Stem Cell Transplants Form

CENTENE
Corporation

Clinical Policy: Nonmyeloablative Allogeneic Stem Cell Transplants
Reference Number: CP.MP.141
Date of Last Revision: 02/24

Coding Implications
Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description
Allogeneic hematopoietic stem cell transplants that do not destroy all of the hematopoietic cells in the bone marrow are termed reduced-intensity or nonmyeloablative conditioning regimens. Although there are no clear definitions, reduced-intensity conditioning (RIC) generally destroys more hematopoietic cells and is more toxic than nonmyeloablative conditioning, but less so than myeloablative conditioning. Both nonmyeloablative and RIC regimens are categorized as non-fully ablative regimens and are used interchangeably in this policy, unless otherwise noted. RIC/nonmyeloablative approaches can circumvent the need for high-dose conditioning regimens that are associated with organ toxicity and mortality depending on graft vs. tumor and immunosuppressive mechanisms.¹

Note: Please refer to CP.MP.108 for requests for Allogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and β-Thalassemia.

Please refer to CP.MP.162 Tandem Transplant if request is for an allogeneic reduced conditioning transplant for multiple myeloma in a tandem transplant.

II. It is the policy of health plans affiliated with Centene Corporation that current evidence does not support the use of nonmyeloablative/RIC allogeneic transplants for any of the following indications:
A. Solid tumors including, but not limited to:

1. Brain tumors;
2. Ovarian epithelia and mixed epithelial/germ cell cancers;
3. Primitive neuroectodermal tumors (PNET), including medulloblastoma and ependymoma;
4. Renal cell carcinoma;
5. Testicular cancer;
6. Wilms tumor;
7. Ewing sarcoma;
8. Melanoma;
9. Osteosarcoma;
10. Rhabdomyosarcoma;
11. Retinoblastoma;
12. Germ cell tumors;
13. Neuroblastoma;
14. Multiple myeloma (except in tandem transplant- refer to CP.MP.162);
    B. Autoimmune disorders including, but not limited to:
15. Multiple sclerosis;
16. Rheumatoid arthritis;
17. Juvenile idiopathic arthritis;
18. Systemic lupus erythematosus;
19. Systemic sclerosis;
20. Dermatomyositis;
21. Polymyositis;
22. Scleroderma;
    C. Hemoglobinopathies including, but not limited to:
23. Thalassemias;
24. Sickle cell anemia.

Background
Allogeneic hematopoietic cell transplantation (HCT) has been used as a treatment for cancer and diseases of the blood system for decades. For this treatment, stem cells are collected from either related or unrelated donors.¹ During the conditioning phase, high doses of chemotherapy (HDC), with or without radiation therapy, are used to eradicate the disease, and this is followed by infusion of stem cells to rescue bone marrow and restore normal immune function. Major limitations of this technique include the increased risk of high morbidity and mortality related to increased age, relapsed or refractory disease or disease with an elevated risk of relapse following HCT, a history of aggressive chemotherapy, and comorbidities.² All stem cell transplants (SCTs) preparative regimens have the potential for extensive toxicity. Loss of appetite and energy, alopecia, and nausea/vomiting occur frequently and contribute to poor physical and emotional tolerance of the transplant procedure. In addition, mucositis, diarrhea, and transient pancytopenia are inevitable side effects of most preparative regimens, and these complications are synergistic in dramatically increasing the risk of infections during and post-transplant.³ Any decrease in toxicity, without concomitant loss of efficacy, would be desirable.

Myeloablative means that the treatment kills (ablates) the stem cells in the bone marrow; the cells that produce new blood cells. Several less intense conditioning regimens have been developed and rely more on immuno-suppression than cytotoxic effects to permit engraftment of donor cells. These regimens are collectively termed nonmyeloablative. Studies have shown that donor allogeneic stem cells can engraft in recipients using less-intensive conditioning regimens that are sufficiently immunosuppressive to permit graft-host tolerance. This manifests as a stable mixed donor-host hematopoietic chimerism, a term which means coexistence of donor and recipient cells. Nonmyeloablative allogeneic transplants, also referred to as “mini-transplant” or “transplant lite”, are thought to be potentially as effective as conventional HDC followed by an allogeneic stem cell transplantation, but with decreased morbidity and mortality related to the less intense, nonmyeloablative chemotherapy conditioning regimen.¹,⁴

Coding Implications
This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted

2023, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

28. Storb R, Sandmeier BM. Nonmyeloablative allogeneic hematopoietic cell transplantation. Haematologica. 2016;101(5): 521 to 530. doi:10.3324/haematol.2015.132860
29. Tefferi A. Management of primary myelofibrosis. UpToDate. www.uptodate.com. Updated October 7, 2022. Accessed January 25, 2024.
30. Velázquez-Sánchez-de-Cima S, Zamora-Ortiz G, Hernández-Reyes J, et al. Oral versus intravenous fludarabine as part of a reduced-intensity conditioning for allogeneic stem cell transplantation. Acta Haematol. 2014;132(1):125 to 128. doi:10.1159/000357108
31. Rajkumar SV. Multiple myeloma: Use of allogeneic cell transplantation. UpToDate. www.uptodate.com. Updated March 28, 2022. Accessed January 25, 2024.

Important Reminder
This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and any available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan

retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members/enrollees. This clinical policy is not intended to recommend treatment for members/enrollees. Members/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members/enrollees and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members/enrollees and their representatives agree to be bound by such terms and conditions by providing services to members/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare members/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

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