Nonmyeloablative Allogeneic Stem Cell Transplants
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Defines medical necessity and noncoverage criteria for nonmyeloablative/reduced-intensity conditioning (RIC) allogeneic hematopoietic stem cell transplants for members of Arizona Complete Health (Centene-affiliated plans). Applies to providers requesting authorization for these transplants.
Added Criteria I.A.9. for Hodgkin lymphoma as a covered indication.
Updated pulmonary function threshold DLCO from ≤ 50% to ≤ 60% of predicted value as a contraindication for myeloablative conditioning.
Added familial bone marrow failure syndromes (multiple named examples) to covered indications.
Coverage Criteria for Nonmyeloablative / RIC Allogeneic Transplant
Initial medical necessity criteria (Covered indications)
Covered when ALL of the following are met:
Overall covered conditions
- Covered diagnoses (I.A): Member has one of the enumerated diagnoses such as acute lymphoblastic leukemia; acute myelogenous leukemia; acquired bone marrow failure (eg, severe aplastic anemia); familial bone marrow failure syndromes (eg, dyskeratosis congenita; Shwachman-Diamond syndrome; Diamond-Blackfan anemia; Kostmann syndrome; Fanconi anemia); paroxysmal nocturnal hemoglobinuria; chronic lymphocytic leukemia; chronic myelogenous leukemia; congenital immunodeficiency syndromes; Hodgkin lymphoma that is primary refractory or relapsed (including recurrence following autologous transplant); non-Hodgkin lymphoma with specified subtypes (eg, primary refractory or relapsed excluding diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma in remission after second-line therapy); myelodysplastic syndromes; specified lysosomal storage disorders (eg, Hurler/Hurler-Scheie, Maroteaux [type VI], Sly [type VII]); macrophage disorders such as hemophagocytic lymphohistiocytosis (HLH); or myeloproliferative neoplasms (eg, chronic myeloid leukemia, juvenile myelomonocytic leukemia, primary myelofibrosis, essential thrombocytosis, polycythemia vera).
Full diagnosis list in policy text.
- Unsuitability for myeloablative transplant (I.B): Member has organ dysfunction or comorbidities making them unsuitable for conventional high-dose myeloablative allografting, including one or more of: bilirubin > 2 mg/dL; hemostasis: INR > 1.6 (unless on oral anticoagulants); cardiac EF < 45% measured by MUGA or echocardiogram; pulmonary function impairment defined by FEV1 ≤ 50% predicted or DLCO ≤ 60% predicted; or performance status with Karnofsky/Lansky score < 70% or ECOG > 2.See thresholds module
These criteria support use of nonmyeloablative/RIC approach.
Not supported indications
Not covered / not supported indications
See policy II.A–II.C for full enumerated lists and CP.MP.162 for tandem transplant guidance.
Nonmyeloablative/reduced-intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation is not supported for a number of disease categories listed in the policy. Specifically, these regimens are not indicated for the enumerated solid tumors (for example: brain tumors, ovarian epithelial cancers, PNET, renal cell carcinoma, testicular cancer, Wilms tumor, Ewing sarcoma, melanoma, osteosarcoma, rhabdomyosarcoma, retinoblastoma, germ cell tumors, neuroblastoma, and most cases of multiple myeloma except when performed as a tandem transplant), for the listed autoimmune disorders (including but not limited to multiple sclerosis, rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, polymyositis, and scleroderma), and for the specified hemoglobinopathies (including thalassemias and sickle cell anemia).
Coverage determinations under this policy are a guide to medical necessity and must be applied in the context of each member's benefit plan. All decisions are subject to the specific terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance) and to applicable state and federal requirements. When there is a conflict between this policy and state Medicaid provisions, the state Medicaid provisions take precedence.
Use of nonmyeloablative/RIC allogeneic transplants for the indications explicitly listed as not supported in the policy (see the policy subcategories for solid tumors, autoimmune disorders, and hemoglobinopathies) is considered not medically necessary based on the current evidence and policy guidance.
Coding and Measurable Clinical Thresholds
| 38204 | Management of recipient hematopoietic progenitor cell donor search and cell acquisition. |
| 38205 | Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic. |
| 38207 | Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage. |
| 38208 | Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing, per donor. |
| 38209 | Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, with washing, per donor. |
| 38210 | Transplant preparation of hematopoietic progenitor cells; specific cell depletion within harvest, T-cell depletion. |
| 38211 | Transplant preparation of hematopoietic progenitor cells; tumor cell depletion. |
| 38212 | Transplant preparation of hematopoietic progenitor cells; red blood cell removal. |
| 38213 | Transplant preparation of hematopoietic progenitor cells; platelet depletion. |
| 38214 | Transplant preparation of hematopoietic progenitor cells; plasma (volume) depletion. |
| S2142 | Cord blood-derived stem-cell transplantation, allogeneic. |
| S2150 | Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic 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 posttransplant care in the global definition. |
Candidate Selection for Nonmyeloablative / RIC Transplant
Candidate selection
Candidate is appropriate when both diagnosis and organ/function criteria are met:
Full diagnosis list is in policy I.A.
Contraindications
Refer to policy section I.C. for the full contraindication language. Recent revisions removed previously listed absolute contraindications and instead emphasize contextual assessment: contraindications and transplant approach should be determined based on individual organ dysfunction, comorbidities, and substance use considerations. The policy now frames these factors as reasons to prefer nonmyeloablative/RIC approaches rather than as strict, universal exclusions.
Pre-Approval Evaluation Requirements
Pre-approval evaluation: document labs, PFTs, cardiac and performance status
Pre-authorization evaluation must document relevant laboratory and functional testing demonstrating organ function and performance status, including bilirubin, INR, cardiac ejection fraction (EF), pulmonary function (FEV1 and DLCO), and performance status (Karnofsky/Lansky or ECOG). Include diagnosis‑specific justification for choosing a nonmyeloablative/RIC allogeneic transplant approach.
- Bilirubin (note threshold > 2 mg/dL used to indicate unsuitability for myeloablative conditioning).
- Hemostasis: INR (threshold > 1.6 unless on oral anticoagulants).
- Cardiac EF (MUGA or echocardiogram EF < 45%).
- Pulmonary: FEV1 (≤ 50% predicted) and DLCO (≤ 60% predicted).
- Performance status: Karnofsky/Lansky < 70% or ECOG > 2.
Provider Actions, Authorization, and Documentation
Prior authorization required for listed transplant procedure codes
Prior authorization is required for the transplant and related procedure codes listed in the policy; requests should reference this policy's medical necessity criteria when requesting authorization.
Prior authorization follows Health Plan benefit and administrative rules
This clinical policy serves as a guide to medical necessity to assist in coverage decisions and benefit administration; prior authorization requirements follow the Health Plan's administrative procedures and benefit documents.
- Coverage and prior authorization are subject to the member's benefit terms, exclusions, limitations, and applicable administrative policies.
Cross-policy routing: refer to CP.MP.108 and CP.MP.162 when applicable
Refer requests for allogeneic transplants for sickle cell disease or β‑thalassemia to CP.MP.108 and for tandem transplant scenarios (e.g., multiple myeloma tandem transplant) to CP.MP.162 as noted in the policy.
- CP.MP.108 — Allogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and β‑Thalassemia.
- CP.MP.162 — Tandem Transplant (for tandem transplant scenarios).
Step therapy: none specified
No step therapy requirements are specified in this policy excerpt.
Required clinical documentation to support medical necessity
When requesting authorization, provide documentation that the member meets one of the covered diagnoses and the organ function/performance criteria (e.g., bilirubin, INR, EF, FEV1, DLCO, Karnofsky/Lansky or ECOG) that support use of a nonmyeloablative/RIC approach.
- Clinical notes supporting the listed diagnosis from the policy (see I.A).
- Results of laboratory tests and diagnostic studies demonstrating thresholds cited (bilirubin, INR, MUGA/echo EF, PFTs).
- Performance status documentation (Karnofsky/Lansky or ECOG).
Documentation submission and provider responsibility
Providers must submit documentation in accordance with Health Plan administrative policies and the member's coverage documents; providers retain professional medical judgment in treating members.
- Follow Health Plan submission procedures and documentation requirements.
- Clinical judgment by treating clinicians remains the responsibility of the provider.
Denial risk if covered indications or supported diagnoses are not met
Requests that do not meet the policy's listed covered diagnostic indications or that are for indications explicitly not supported by the policy (for example, listed solid tumors, autoimmune disorders, or hemoglobinopathies) are subject to denial.
- Non‑supported indications are enumerated in the policy (see II.A–II.C) and requests for those indications may be denied.
Coverage is subject to the member's benefit terms and applicable state Medicaid provisions
Coverage determinations are conditional on the member's coverage documents; when state Medicaid provisions conflict with this policy, state Medicaid provisions take precedence per the policy.
- Verify the member's evidence of coverage, certificate, or contract for applicable exclusions, limitations, and terms.
Center and Post-Transplant Care Notes
Center requirements and coding guidance: no explicit accreditation stated
No explicit center accreditation or specialized center requirements are listed in this policy excerpt; coding and procedural guidance reference standard CPT and HCPCS/S codes for transplantation services.
- Use the listed CPT and HCPCS/S codes for coding guidance; inclusion/exclusion of codes does not guarantee coverage and providers should reference current coding guidance.
Background
Nonmyeloablative and reduced-intensity conditioning regimens deliver less intensive cytotoxic therapy than traditional myeloablative regimens and rely more on immunosuppression to permit donor engraftment. The intended mechanistic effect is to achieve donor hematopoietic engraftment with mixed donor–host chimerism while reducing early morbidity and mortality associated with full myeloablation. These regimens are therefore used when patients are unsuitable for conventional high‑dose myeloablative allografting because of advanced age, significant comorbidities, organ dysfunction, or prior therapies that increase transplant risk.
Definitions
Post-Transplant Coverage Notes
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