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Defines Aetna's medical necessity and experimental/investigational determinations for non-myeloablative (reduced intensity) allogeneic hematopoietic cell transplantation, lists covered and not-covered ICD-10/CPT/HCPCS/J-codes when selection criteria are met, and provides clinical background and evidence references. This is Part 1 of 2; criteria are those present in this part only.
Last review recorded 02/20/2024 with no clinical policy statement changes indicated in this part of the document.
This policy (Policy Number 0634) defines Aetna's determinations for non-myeloablative hematopoietic cell transplantation (mini-allograft / reduced intensity conditioning transplant), specifying conditions under which the procedure is considered medically necessary versus experimental/investigational, and listing covered CPT/HCPCS/ICD-10/J-codes when selection criteria are met. This document is Part 1 of 2 and is current with an effective date 08/02/2002 and last review 02/20/2024.
Medically Necessary
Aetna considers non-myeloablative hematopoietic cell transplantation (mini-allograft) medically necessary for members with any of the following diseases for which conventional allogeneic hematopoietic cell transplantation is considered an established alternative:
Medically Necessary indications
see CPB 0640 - Hematopoietic Cell Transplantation for Selected Leukemias
see CPB 0640 - Hematopoietic Cell Transplantation for Selected Leukemias
see CPB 0627 - Hematopoietic Cell Transplantation for Aplastic Anemia and other Bone Marrow Failure Syndromes
see CPB 0494 - Hematopoietic Cell Transplantation for Non-Hodgkin's Lymphoma
see CPB 0674 - Hematopoietic Cell Transplantation for Chronic Myelogenous Leukemia
see CPB 0495 - Hematopoietic Cell Transplantation for Hodgkin's Disease
see CPB 0497 - Hematopoietic Cell Transplantation for Multiple Myeloma
see CPB 0838 - Hematopoietic Cell Transplantation for Myelofibrosis
see CPB 0836 - Hematopoietic Cell Transplantation for Myelodysplastic Syndrome
see CPB 0496 - Hematopoietic Cell Transplantation for Selected Childhood Solid Tumors
see CPB 0494 - Hematopoietic Cell Transplantation for Non-Hodgkin's Lymphoma
see CPB 0626 - Hematopoietic Cell Transplantation for Thalassemia Major and Sickle Cell Anemia
see CPB 0626 - Hematopoietic Cell Transplantation for Thalassemia Major and Sickle Cell Anemia
Experimental and Investigational (Not Covered)
Aetna considers non-myeloablative hematopoietic cell transplantation (mini-allograft) experimental and investigational for diseases for which conventional allogeneic hematopoietic cell transplant has not been established as effective:
Experimental / Not Covered indications
see CPB 0507 - Hematopoietic Cell Transplantation for Breast Cancer
see CPB 0606 - Hematopoietic Cell Transplantation for Autoimmune Diseases and Miscellaneous Indications
| 38204 | |
| 38205 | |
| 38207 | |
| 38208 | |
| 38209 | |
| 38210 | |
| 38211 | |
| 38212 | |
| 38213 | |
| 38214 |
| S2150 | Bone marrow or blood-derived stem cells (peripheral or umbilical), allogenic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition. |
| J7502 | Cyclosporine, oral, 100 mg |
| J7515 | Cyclosporine, oral 25 mg |
| J7516 | Cyclosporine, parenteral 250 mg |
| J7517 | Mycophenolate mofetil, oral, 250 mg |
| J8610 | Methotrexate, oral, 2.5 mg |
| J9185 | Fludarabine phosphate, 50 mg |
| J9250 | Methotrexate sodium, 5 mg |
| J9255 | Injection, methotrexate (accord) not therapeutically equivalent to j9250 or j9260, 50 mg |
| J9260 | Methotrexate sodium, 50 mg |
| C74.00 - C74.92 | Malignant neoplasm of adrenal gland |
| C81.00 - C81.99 | Hodgkin's lymphoma |
| C82.50 - C82.59 | |
| C83.10 - C83.19 | Mantle cell lymphoma |
| C83.30 - C83.39 | Diffuse large B-cell lymphoma |
| C83.80 - C83.89 | |
| C84.a0 - C84.z9 | |
| C84.90 - C84.99 | |
| C85.10 - C85.99 | Other lymphoma |
| C88.4 | Other non-follicular lymphoma |
| C43.0 - C43.9 | Malignant melanoma of skin |
| C50.011 - M50.929 | Malignant neoplasm of breast |
| C62.00 - C62.92 | Malignant neoplasm of testis |
| C64.1 - C65.9 | Malignant neoplasm of kidney and renal pelvis |
| D03.0 - D03.9 | Melanoma in situ [skin] |
| D45 | Polycythemia vera |
| D47.3 | Essential (hemorrhagic) thrombocythemia |
| D51.0 | Vitamin B12 deficiency anemia due to intrinsic factor deficiency |
| D76.1 | Hemophagocytic lymphohistiocytosis |
| D80.0 - D89.9 | Disorders involving the immune mechanism |
Selection criteria required for coverage
Transplant-related CPT/HCPCS/ICD-10 codes (listed in policy) are covered only if the member meets the policy selection criteria. Obtain prior authorization that documents eligibility per the policy before billing these codes.
Confirm conventional allogeneic HCT is established alternative
Document that the member has one of the diseases listed for which conventional allogeneic hematopoietic cell transplantation is an established alternative, or that the member cannot tolerate conventional allogeneic transplant which justifies a non‑myeloablative approach. This documentation should be included in the medical record and submitted with any coverage requests.
Policy Effective and Review Dates
Reference the policy effective and review dates to confirm policy currency when submitting documentation or requests.
Non-myeloablative or reduced-intensity conditioning (RIC) regimens are designed to permit donor engraftment while reducing regimen-related organ toxicity and mortality, thereby extending allogeneic transplantation to older patients or those with pre-existing organ dysfunction. Typical approaches include low-dose total body irradiation (TBI) or fludarabine-based regimens, often combined with short-course post-graft immunosuppression (e.g., cyclosporine, methotrexate, or mycophenolate mofetil).
Risks of RIC/min i-allograft include increased susceptibility to infections, acute and chronic graft-versus-host disease (GVHD), relapse due to lower upfront anti-malignancy cytotoxicity, and uncertain long-term outcomes. The evidence base is evolving and heterogeneous—mostly uncontrolled or early phase studies—with some promising results in selected indications but a need for larger, controlled trials to define long-term effectiveness and optimal indications.
Non-myeloablative / Reduced intensity conditioning (RIC): Less intensive preparative regimens (e.g., low-dose TBI or fludarabine-based) intended to facilitate donor engraftment with lower immediate toxicity than conventional myeloablative regimens.
| Citation | Key finding |
|---|---|
| Nagler et al (2000) | |
| Fludarabine-based low-intensity conditioning showed engraftment with moderate organ toxicity; survival and DFS at 37 months 40% in n=23 high-risk lymphoma patients. | |
| Martino et al (2001) | |
| Prospective multicenter (n=71): low early toxicity and stable engraftment; chronic GVHD significant; infections remain a threat. | |
| Burt et al (2009) | |
| Autologous non-myeloablative HSCT in relapsing-remitting MS (n=21) showed clinical improvements and progression-free outcomes at ~3 years; requires randomized confirmation. | |
| Literature citations | |
| Numerous peer-reviewed studies, systematic reviews, and meta-analyses (references 1-81) supporting reduced-intensity conditioning transplantation in various indications. |
Policy became effective 08/02/2002.
Last review recorded 02/20/2024; Last review recorded with no clinical policy statement changes indicated in this part of the document (no material clinical changes present).
see CPB 0811 - Hematopoietic Cell Transplantation for Solid Tumors in Adults
see CPB 0635 - Hematopoietic Cell Transplantation for Ovarian Cancer
see CPB 0811 - Hematopoietic Cell Transplantation for Solid Tumors in Adults
see CPB 0617 - Hematopoietic Cell Transplantation for Testicular Cancer