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    v1.0.30
    OpenPayerPolicy UpdatesTransplantFallon Health Autologous Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentFallon Community Health Plan IncPolicy N/A

    Autologous Stem Cell Transplantation Clinical Coverage Criteria

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    This policy governs medical necessity, coverage, prior authorization, and coding considerations for autologous stem cell transplantation for Fallon Health members. Coverage pathways vary by product and may rely on InterQual criteria, Medicare requirements, MassHealth requirements, Fallon criteria, or case-by-case medical director review.

    Policy Summary
    PayerFallon Community Health Plan Inc
    PolicyAutologous Stem Cell Transplantation Clinical Coverage Criteria
    Policy CodePolicy N/A
    Change TypeAnnual review — no coverage changes
    Effective DateSep 1, 2026
    Last ReviewAug 18, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization before requesting autologous stem cell transplantation.
    SourceLink
    POLICY UPDATE CHANGES

    Clarifying language was added for Medicare Advantage, NaviCare, and PACE members in 2021.

    New sections for Medicare and MassHealth variations were added during the 2025 annual review.

    RequiredPrior authorization

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    2InterQual criteria references
    4Nationally covered Medicare indication categories
    7Nationally non-covered Medicare condition categories
    5Products subject to policy
    No changes2026 annual review outcome

    Coverage Criteria

    InterQual® Criteria — MassHealth and Community Care

    Effective for dates of service on or after August 1, 2024, Fallon Health uses InterQual® Criteria when making medical necessity determinations for autologous stem cell transplantation for MassHealth and Community Care members.

    Applicable criteria

    • Apply InterQual® CP:Procedures, Transplantation, Autologous Stem Cell, in effect on the date of service.
    • For pediatric requests, apply InterQual® CP:Procedures, Transplantation, Autologous Stem Cell (Pediatric), in effect on the date of service.

    Medicare Nationally Non-Covered Indications

    The following indications are not considered reasonable and necessary under §1862(a)(1)(A) and are not covered under Medicare because insufficient data exist to establish definite conclusions regarding the efficacy of autologous stem cell transplantation.

    Nationally non-covered indications

    • Acute leukemia not in remission.
    • Chronic granulocytic leukemia.
    • Solid tumors other than neuroblastoma.
    • Multiple myeloma through September 30, 2000.
    • Tandem transplantation (multiple rounds of autologous stem cell transplantation) for multiple myeloma.
    • Non-primary AL amyloidosis effective October 1, 2000.
    • Primary AL amyloidosis for Medicare beneficiaries age 64 or older, effective October 1, 2000, through March 14, 2005.

    MassHealth does not have Guidelines for Medical Necessity Determination for autologous stem cell transplantation. Fallon Health Clinical Coverage Criteria therefore apply to MassHealth members.

    The Plan considers autologous stem cell transplantation not medically necessary when a significant comorbid condition would significantly compromise the member’s clinical care or chances of survival.

    The Plan considers autologous stem cell transplantation experimental or investigational, and therefore not medically necessary, for any indication that does not meet the coverage criteria described in this policy.

    Autologous stem cell transplantation is not medically necessary when significant comorbid conditions materially compromise the member’s ability to receive appropriate clinical care or substantially reduce the chances of survival.

    Requests that fail to meet the applicable InterQual® Criteria, Medicare national coverage requirements, Fallon Health Clinical Coverage Criteria, or an applicable individual medical-necessity determination are not covered under the relevant coverage pathway.

    Coding and Billing

    CPT stem cell collection and preparation codesCPT
    38206Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous.
    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, without washing, per donor.
    38210Transplant preparation of hematopoietic progenitor cells; specific cell depletion with 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.
    38215Transplant preparation of hematopoietic progenitor cells; cell concentration in plasma, mononuclear, or buffy coat layer.
    CPT autologous harvesting, transplantation, and boost codesCPT
    38232Bone marrow harvesting for transplantation; autologous.
    38241Hematopoietic progenitor cell (HPC); autologous transplantation.
    38243HPC boost.
    HCPCS codesHCPCS
    S2140
    S2142
    S2150
    Medicare National Coverage Determinationmixed
    110.23Stem Cell Transplantation; formerly 110.8.1.
    Multiple myeloma stage
    Eligible stageDurie-Salmon Stage II or III
    Multiple myeloma partial response
    Required responseAt least a partial response to prior chemotherapy, defined as a 50% decrease either in measurable paraprotein (serum and/or urine) or in bone marrow infiltration
    DurationSustained for at least 1 month
    Primary AL amyloidosis organ involvement
    Maximum organ involvement

    Provider Actions and Authorization

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for autologous stem cell transplantation for applicable Fallon Health products, including Fallon Medicare Plus, MassHealth ACO, NaviCare HMO SNP, PACE, and Community Care.

    Billing Rule

    CPT Codes Requiring Authorization

    Prior authorization is required for the following CPT codes associated with autologous stem cell transplantation.

    • 38206 — Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous.
    • 38232 — Bone marrow harvesting for transplantation; autologous.

    Background

    Autologous stem cell transplantation is generally performed after high-dose chemotherapy or combined chemotherapy and radiation that may damage the bone marrow. The patient’s peripheral blood or bone marrow hematopoietic stem cells are collected and frozen before treatment, then returned afterward to help restore blood-cell production. Most patients receive one autologous transplant; a tandem transplant involves a planned second autologous transplant.

    Definitions

    Tandem transplant
    DefinitionA planned second autologous stem cell transplant performed after the first autologous transplant
    Partial response
    Response definitionA 50% decrease either in measurable paraprotein (serum and/or urine) or in bone marrow infiltration
    Required durationSustained for at least 1 month

    Candidate Criteria

    Medicare Candidate Disease Criteria

    Medicare-covered candidates must meet at least one of the following condition-specific disease criteria.

    Eligible disease indications: The candidate has acute leukemia in remission with a high probability of relapse and no HLA-matched donor; resistant non-Hodgkin lymphoma or non-Hodgkin lymphoma with poor prognostic features following an initial response; recurrent or refractory neuroblastoma; advanced Hodgkin disease after failure of conventional therapy with no HLA-matched donor; Durie-Salmon Stage II or III multiple myeloma that is newly diagnosed or responsive; or primary AL amyloidosis meeting the applicable organ-involvement and cardiac-function requirements.

    Additional donor, response, organ-function, organ-involvement, and cardiac-function requirements apply according to the indication.

    Additional Candidate Requirements

    For qualifying Medicare indications, all applicable additional disease-specific and physiologic requirements must be met.

    Additional candidate requirements: As applicable to the indication, the candidate must have no HLA-matched donor; a high probability of relapse; failure of conventional therapy; responsive disease; adequate cardiac, renal, pulmonary, and hepatic function; amyloid deposition in no more than two organs; and cardiac left ventricular ejection fraction greater than 45%.

    Contraindications

    Significant comorbid conditions that would significantly compromise the member’s clinical care and chances of survival are a contraindication to medical necessity coverage for autologous stem cell transplantation.

    Under the Medicare National Coverage Determination, autologous stem cell transplantation is not covered for acute leukemia not in remission, chronic granulocytic leukemia, or solid tumors other than neuroblastoma. It is also not covered for multiple myeloma through October 1, 2000, tandem transplantation for multiple myeloma, non-primary AL amyloidosis effective October 1, 2000, or primary AL amyloidosis for Medicare beneficiaries age 64 or older during the period from October 1, 2000, through March 14, 2005.

    Evaluation Requirements

    Documentation Required

    Provide records for individual review

    For indications not addressed in InterQual criteria, submit medical records and evidence supporting the request for individual case-by-case review by a Plan Medical Director.

    Note

    Request review when criteria are not established

    When applicable Medicare or Fallon criteria are not fully established, the request may be reviewed individually in accordance with the definition of medical necessity. In the absence of applicable Clinical Coverage Criteria, submit the request for case-by-case review.

    Policy Summary
    PayerFallon Community Health Plan Inc
    PolicyAutologous Stem Cell Transplantation Clinical Coverage Criteria
    Policy CodePolicy N/A
    Change TypeAnnual review — no coverage changes
    Effective DateSep 1, 2026
    Last ReviewAug 18, 2026
    Next Review DateN/A
    Key ActionObtain prior authorization before requesting autologous stem cell transplantation.
    SourceLink
    On This Page
    Coverage CriteriaCoding and BillingProvider Actions and AuthorizationBackgroundDefinitionsCandidate CriteriaContraindicationsEvaluation Requirements
    Amyloid deposition in 2 or fewer organs
    Primary AL amyloidosis cardiac function
    Minimum cardiac functionCardiac left ventricular ejection fraction greater than 45%
  1. 38241 — Hematopoietic progenitor cell (HPC); autologous transplantation.
    2. Documentation Required

    Medical Records and Supporting Evidence

    For indications not addressed by the applicable InterQual® Criteria, requests are reviewed individually by a Plan Medical Director. Submit medical records and evidence supporting the request.

    • Use the InterQual® Criteria in effect on the date of service, including the pediatric criteria when applicable.
    Documentation Required

    Multiple Myeloma Clinical Documentation

    For single autologous stem cell transplantation in multiple myeloma, document that the member has Durie-Salmon Stage II or III disease and meets the applicable disease-response and organ-function requirements.

    • Newly diagnosed or responsive multiple myeloma, including previously untreated disease, responsive relapse, or at least a partial response to prior chemotherapy.
    • Partial response means a 50% decrease in measurable serum and/or urine paraprotein or bone marrow infiltration, sustained for at least 1 month.
    • Adequate cardiac, renal, pulmonary, and hepatic function.
    Documentation Required

    Primary AL Amyloidosis Documentation

    For high-dose melphalan with autologous stem cell transplantation for primary AL amyloidosis, document the required organ involvement and cardiac function.

    • Amyloid deposition in no more than 2 organs.
    • Cardiac left ventricular ejection fraction (EF) greater than 45%.
    Denial Risk

    Significant Comorbidities

    The Plan considers autologous stem cell transplantation not medically necessary when significant comorbid conditions would significantly compromise the member's clinical care and chances of survival.

    Denial Risk

    Indication Does Not Meet Coverage Criteria

    The Plan considers autologous stem cell transplantation experimental/investigational and not medically necessary for any indication that does not meet the coverage criteria described in the policy.

    • Verify that the indication satisfies the applicable coverage criteria before submitting the request.
    Denial Risk

    Nationally Non-Covered Medicare Indications

    The following indications are not considered reasonable and necessary under Medicare and are not covered under Medicare because insufficient data exist to establish definite conclusions regarding AuSCT efficacy.

    • Acute leukemia not in remission.
    • Chronic granulocytic leukemia.
    • Solid tumors other than neuroblastoma.
    • Multiple myeloma, for services up to October 1, 2000.
    • Tandem transplantation (multiple rounds of AuSCT) for multiple myeloma.
    • Non-primary AL amyloidosis, effective October 1, 2000.
    • Primary AL amyloidosis for Medicare beneficiaries age 64 or older, effective October 1, 2000, through March 14, 2005.

    Requirements apply according to the candidate's transplant indication.