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    v1.0.28
    OpenPayerPolicy UpdatesTransplantAmbetter Nevada nonmyeloablative HCT Coverage Upda…
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    ModifiedAmbetter NevadaPolicy CP.MP.141

    Nonmyeloablative / Reduced‑Intensity Allogeneic Hematopoietic Stem Cell Transplantation

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    Defines medical necessity criteria, exclusions, and coding implications for nonmyeloablative (reduced‑intensity conditioning, RIC) allogeneic hematopoietic stem cell transplants for members of the health plans affiliated with Centene (Ambetter Nevada). Applies to requests for allogeneic HCT using nonfully ablative regimens and describes diagnoses supported and not supported for coverage.

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    Policy Summary
    PayerAmbetter Nevada
    PolicyNonmyeloablative / Reduced‑Intensity Allogeneic Hematopoietic Stem Cell Transplantation
    Policy CodePolicy CP.MP.141
    Change TypeMaterial revisions and threshold updates
    Effective Date01/26
    Next Review Date
    Key ActionObtain prior authorization and submit supporting clinical documentation showing diagnosis and organ function thresholds (bilirubin, INR, EF, FEV1, DLCO) to meet medical necessity criteria.
    SourceLink
    POLICY UPDATE CHANGES

    Added Hodgkin lymphoma as a covered indication in Criteria I.A.9.

    Updated pulmonary function DLCO threshold from ≤50% to ≤60% of predicted value in contraindication criteria I.B.4.b.

    Expanded indication list to include macrophage disorders and added polycythemia vera under myeloproliferative neoplasms.

    Combined and rephrased certain contraindications and updated substance use language to exclude prescribed medical marijuana and require commitment to reduce substance use if urgent transplant timelines exist.

    ≥14Listed diagnoses
    ≤60%DLCO threshold
    <45%EF threshold
    K/L <70% or ECOG >2Performance status
    18-36References
    4Reminder sections

    Medical Necessity and Coverage Rules

    Medical necessity (Covered indications and suitability)

    Nonmyeloablative/RIC allogeneic transplants are medically necessary when ALL of the following are met:

    Primary clinical indication: Candidate for allogeneic stem cell transplantation for one of the specified diagnoses (see policy I.A.1–I.A.14).

    Full diagnosis list in policy sections I.A.1–I.A.14

    Suitability for reduced intensity regimen: Member is unsuitable for conventional high‑dose myeloablative allografting because of untreatable significant dysfunction of another major organ system and/or severe comorbidities; examples include: total bilirubin > 2 mg/dL; hemostasis abnormality with INR > 1.6 (unless on oral anticoagulants); cardiac ejection fraction (MUGA or echo) < 45%; pulmonary function with FEV1 ≤ 50% predicted or DLCO ≤ 60% predicted; or impaired performance status (Karnofsky or Lansky score < 70% or ECOG > 2).

    Criteria listed under I.B.1–5

    Not supported / Experimental indications

    The policy states current evidence does not support nonmyeloablative/RIC allogeneic transplants for the following:

    Solid tumors — including but not limited to brain tumors; ovarian epithelial and mixed epithelial/germ cell cancers; primitive neuroectodermal tumors (PNET) including medulloblastoma and ependymoma; renal cell carcinoma; testicular cancer; Wilms tumor; Ewing sarcoma; melanoma; osteosarcoma; rhabdomyosarcoma; retinoblastoma; germ cell tumors; neuroblastoma; and multiple myeloma (except when performed as a tandem transplant per CP.MP.162).

    Listed under II.A.1–14

    Autoimmune disorders — including but not limited to multiple sclerosis; rheumatoid arthritis; juvenile idiopathic arthritis; systemic lupus erythematosus; systemic sclerosis; dermatomyositis; polymyositis; and scleroderma.

    Listed under II.B.1–8

    Hemoglobinopathies — including thalassemias and sickle cell anemia (requests for sickle cell anemia and β‑thalassemia are directed to CP.MP.108).

    Listed under II.C.1–2 and cross-referenced to CP.MP.108

    Requests specifically for sickle cell anemia and β‑thalassemia should be directed to policy CP.MP.108. For allogeneic reduced‑intensity conditioning transplants requested for multiple myeloma, coverage is limited to the tandem transplant context and such requests should be reviewed in conjunction with policy CP.MP.162.

    Coverage determinations for nonmyeloablative/reduced‑intensity conditioning allogeneic transplants are made in the context of the member’s benefit documents and are subject to the Health Plan’s terms, conditions, exclusions and limitations (for example, evidence of coverage, certificate of coverage or policy). Where applicable, state Medicaid provisions take precedence over this clinical policy.

    Current evidence does not support use of nonmyeloablative/RIC allogeneic transplantation for a range of indications. These unsupported indications include numerous solid tumors (for example: ovarian epithelial and mixed epithelial/germ cell cancers; PNET including medulloblastoma and ependymoma; renal cell carcinoma; testicular cancer; Wilms tumor; Ewing sarcoma; melanoma; osteosarcoma; rhabdomyosarcoma; retinoblastoma; germ cell tumors; neuroblastoma), selected hematologic conditions such as multiple myeloma except when part of a tandem transplant (see CP.MP.162), and autoimmune disorders (for example multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and related disorders). Hemoglobinopathies (including thalassemias and sickle cell disease) are cross‑referenced and should be managed per CP.MP.108.

    Candidate Eligibility and Suitability

    Candidate criteria for reduced‑intensity allogeneic HCT

    Candidate must have one of the listed qualifying diagnoses and be unsuitable for myeloablative conditioning due to organ dysfunction/comorbidity thresholds.

    Diagnosis requirement: Member must be a candidate for allogeneic stem cell transplantation for one of the listed hematologic or marrow disorders (see I.A.1–I.A.14: acute lymphoblastic leukemia; acute myelogenous leukemia; acquired bone marrow failure including severe aplastic anemia; familial bone marrow failure syndromes (e.g., 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 (primary refractory or relapsed, including recurrence after autologous transplant); specified non‑Hodgkin lymphoma subtypes; myelodysplastic syndromes; specified lysosomal storage disorders (Hurler/Hurler‑Scheie, Maroteaux, Sly); macrophage disorders such as HLH; and myeloproliferative neoplasms (e.g., chronic myeloid leukemia; juvenile myelomonocytic leukemia; primary myelofibrosis; essential thrombocytosis; polycythemia vera)).

    See policy I.A.1–I.A.14 for full list

    Unsuitability for myeloablative conditioning: Presence of specified organ dysfunction or severe comorbidities that make conventional high‑dose myeloablative allografting unsuitable, including: total bilirubin > 2 mg/dL; INR > 1.6 (unless on oral anticoagulants); MUGA or echocardiogram EF < 45%; pulmonary function with FEV1 ≤ 50% predicted or DLCO ≤ 60% predicted; or performance status Karnofsky/Lansky < 70% or ECOG > 2.

    Contraindications and Limitations

    Policy revision history documents the removal of prior absolute contraindications and updates to substance use language. The policy now explicitly excludes medical marijuana use prescribed by a licensed practitioner from being treated as disqualifying, and when transplant timelines are urgent, it requires a documented commitment to reduce substance use behaviors rather than an absolute exclusion.

    Pre-Transplant Evaluation Requirements

    Documentation Required

    Pre‑transplant evaluation — document organ function, performance status, and comorbidities

    Document a comprehensive pre‑transplant evaluation that includes baseline organ function, functional/performance status, and comorbidities to support medical necessity and suitability for a reduced‑intensity allogeneic HCT.

    • Document hepatic function (total bilirubin) and coagulation (INR) per policy thresholds (e.g., total bilirubin > 2 mg/dL; INR > 1.6 unless on oral anticoagulants).
    • Document cardiac function with objective measurement (MUGA or echocardiogram) showing ejection fraction per policy threshold (e.g., EF < 45% indicates unsuitability for myeloablative conditioning).
    • Document pulmonary function testing with reported FEV1 and DLCO values (policy thresholds: FEV1 ≤ 50% predicted or DLCO ≤ 60% predicted).
    • Record performance status using Karnofsky/Lansky or ECOG (policy thresholds: Karnofsky/Lansky < 70% or ECOG > 2).
    • Include comorbidity assessment, age, prior therapies, and infection risk as part of the suitability determination.

    Procedure and Billing Codes; Clinical Thresholds

    Referenced CPT procedure codesCPT
    38204Management of recipient hematopoietic progenitor cell donor search and cell acquisition.
    38205Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
    38207Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage.
    38208Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing, per donor.
    38209Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, with washing, per donor.
    38210Transplant preparation of hematopoietic progenitor cells; specific cell depletion within harvest, T-cell depletion.
    38211Transplant preparation of hematopoietic progenitor cells; tumor cell depletion.
    38212Transplant preparation of hematopoietic progenitor cells; red blood cell removal.
    38213Transplant preparation of hematopoietic progenitor cells; platelet depletion.
    38214Transplant preparation of hematopoietic progenitor cells; plasma (volume) depletion.
    1–10 of 13
    1/2
    Referenced HCPCS/S codesHCPCS
    S2142Cord blood-derived stem-cell transplantation, allogeneic.
    S2150Bone 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.
    inv-08: Performance status — thresholds
    Performance status thresholdsKarnofsky or Lansky score < 70% OR ECOG performance score > 2
    Karnofsky/Lansky detailAny documented Karnofsky or Lansky score under 70% meets the threshold for unsuitability for myeloablative conditioning.
    ECOG detailAn ECOG performance status greater than 2 (i.e., 3 or 4) meets the threshold for unsuitability for myeloablative conditioning.
    inv-09: Cardiac function — threshold
    Ejection fraction thresholdEjection fraction (MUGA or echocardiogram) < 45%
    Test modalitiesAcceptable measures: multigated acquisition (MUGA) scan or echocardiogram (EF reported).

    Authorization, Documentation, and Provider Responsibilities

    Prior Authorization

    Prior authorization required for RIC allogeneic transplant and associated codes

    Prior authorization is required for nonmyeloablative/RIC allogeneic transplant services and the listed CPT/HCPCS codes; approval is contingent on meeting the policy's medical necessity criteria.

    • Referenced CPT codes include 38204, 38205, 38207–38215, 38230, 38240
    • Referenced HCPCS/S codes include S2142 and S2150
    Note

    Prior authorization guidance: policy is a medical‑necessity guide; follow Health Plan processes

    This clinical policy serves as a guide to medical necessity to assist in coverage decisions and benefit administration; prior authorization requirements and processes are governed by the Health Plan and benefit documents.

    • Coverage decisions remain subject to plan terms, conditions, exclusions and limitations
    • Effective dates and legal/regulatory requirements may affect application of the policy

    Clinical Background and Scope

    Nonmyeloablative or reduced‑intensity conditioning (RIC) regimens use lower‑intensity chemotherapy and/or radiation compared with myeloablative regimens. These approaches rely more on immunosuppression than full marrow ablation to permit donor stem cell engraftment, can result in mixed donor‑host chimerism, and are intended to reduce transplant‑related toxicity and morbidity for patients who are unsuitable for conventional high‑dose conditioning due to age, comorbidity, or organ dysfunction.

    Key Terms and Definitions

    inv-22: Definition — Nonmyeloablative / reduced‑intensity conditioning (RIC)
    Core definitionNonmyeloablative / reduced‑intensity conditioning (RIC) regimens do not fully ablate recipient hematopoiesis and are categorized as nonfully ablative regimens.
    MechanismThese regimens rely more on immunosuppression than cytotoxicity to permit donor engraftment (less intense than myeloablative conditioning).
    Toxicity profileNonmyeloablative/RIC approaches are less toxic than myeloablative conditioning and can reduce transplant‑related morbidity and mortality.
    inv-23: Definition — Non‑myeloablative allogeneic HCT
    Description of non‑myeloablative allogeneic HCTConditioning regimens with lower dose intensity intended to permit donor engraftment with reduced toxicity (often produce mixed donor‑host chimerism).
    Alternate terminology

    Facility and Service Expectations

    Billing Rule

    Center requirements: coding and use of comprehensive transplant service codes (S2150)

    Use appropriate facility/place-of-service and provider coding for comprehensive transplant services; S2150 describes an inclusive bundled transplant service and providers should bill using the correct codes and meet payer credentialing/authorization requirements.

    • S2150 is an inclusive code covering harvesting, transplantation, pre/post care and related services
    • Bill using the appropriate CPT/HCPCS codes and facility place of service per payer guidance

    Post-Transplant Services and Bundling

    inv-28: Comprehensive transplant services (S2150)
    S2150 descriptionS2150: Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; inclusive code for comprehensive transplant services including pheresis, cell preparation/storage, marrow ablative therapy, drugs, supplies, hospitalization with outpatient follow-up, and related services.
    Bundled scopeS2150 is described as an inclusive/comprehensive bundled code covering pre- and post-transplant care elements.
    Duration limitsPolicy does not provide explicit duration limits for services described by S2150.
    Policy Summary
    PayerAmbetter Nevada
    PolicyNonmyeloablative / Reduced‑Intensity Allogeneic Hematopoietic Stem Cell Transplantation
    Policy CodePolicy CP.MP.141
    Change TypeMaterial revisions and threshold updates
    Effective Date01/26
    Next Review Date
    Key ActionObtain prior authorization and submit supporting clinical documentation showing diagnosis and organ function thresholds (bilirubin, INR, EF, FEV1, DLCO) to meet medical necessity criteria.
    SourceLink
    On This Page
    Medical Necessity and Coverage RulesCandidate Eligibility and SuitabilityContraindications and LimitationsPre-Transplant Evaluation RequirementsProcedure and Billing Codes; Clinical ThresholdsAuthorization, Documentation, and Provider ResponsibilitiesClinical Background and ScopeKey Terms and DefinitionsFacility and Service ExpectationsPost-Transplant Services and Bundling

    Organ dysfunction and performance thresholds listed under I.B.1–5

    ImplicationEF < 45% indicates unsuitability for conventional high-dose myeloablative allografting per policy criteria.
    inv-10: Pulmonary function — thresholds
    Pulmonary function thresholdsFEV1 ≤ 50% of predicted OR DLCO ≤ 60% of predicted
    FEV1 detailForced expiratory volume in 1 second (FEV1) ≤ 50% of predicted meets the pulmonary dysfunction threshold.
    DLCO detailDiffusing capacity of the lung for carbon monoxide (DLCO) ≤ 60% of predicted meets the pulmonary dysfunction threshold.
    inv-11: Hepatic function — threshold
    Total bilirubin thresholdTotal bilirubin > 2 mg/dL
    ContextBilirubin > 2 mg/dL cited as an example of untreatable significant dysfunction rendering member unsuitable for myeloablative conditioning.
    DocumentationPre-transplant evaluation should document bilirubin level to support suitability assessment.
    inv-12: Hemostasis — threshold
    INR thresholdInternational normalized ratio (INR) > 1.6 (unless on oral anticoagulants)
    ExceptionElevated INR due to oral anticoagulant therapy is not counted as this contraindication per policy wording.
    Role in assessmentINR > 1.6 is listed among examples of significant dysfunction making a patient unsuitable for myeloablative conditioning.
    Note
    Note
    Documentation Required

    Required clinical and coding documentation to support authorization

    Submit supporting clinical documentation demonstrating the diagnosis that justifies allogeneic HCT and objective organ function measurements per policy thresholds; include relevant procedure and coding details.

    • Hepatic: total bilirubin > 2 mg/dL when relevant
    • Hemostasis: INR (note INR > 1.6 is a threshold unless on oral anticoagulants)
    • Cardiac: MUGA or echocardiogram EF (policy references EF < 45%)
    • Pulmonary: FEV1 and DLCO (FEV1 ≤ 50% predicted or DLCO ≤ 60% predicted)
    • Performance status: Karnofsky/Lansky or ECOG scores
    • Include CPT/HCPCS codes being requested (see policy code list)
    Documentation Required

    Follow Health Plan contract terms and documentation expectations

    Providers are bound by the Health Plan contract terms when submitting claims; unauthorized distribution of this clinical policy is prohibited and contractual provisions govern relationships and payment.

    • Providers, members, and representatives are bound by contract terms when providing services or submitting claims
    • State Medicaid provisions take precedence over this policy when conflicts exist
    Denial Risk

    Denial risk if medical necessity criteria or thresholds are not met

    Requests that do not meet the medical necessity criteria in the policy—such as lacking a supported diagnosis or failing to meet organ function, performance status, or comorbidity thresholds—are at risk for denial.

    • Denied if diagnosis is not among the listed qualifying indications
    • Denied if member does not demonstrate unsuitability for myeloablative conditioning per listed thresholds (bilirubin, INR, EF, FEV1, DLCO, performance status)
    Denial Risk

    Coverage conditional on plan terms; state/Medicare rules may supersede

    Coverage and payment decisions are subject to all plan terms, conditions, exclusions and limitations; applicable state Medicaid or Medicare determinations and plan administrative policies may supersede or alter coverage.

    • State Medicaid provisions take precedence over this clinical policy when in conflict
    • Review applicable NCDs, LCDs, and Medicare Coverage Articles for Medicare members
    Also referred to as 'mini‑transplant' or 'transplant lite' in the clinical background.
    Clinical rationaleUsed when patients are unsuitable for high‑dose myeloablative conditioning due to age, comorbidity, or organ dysfunction.