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    OpenPayerPolicy UpdatesTransplantpriority health stem cell transplant Coverage Upda…
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    Modifiedpriority healthPolicy 91066

    STEM CELL OR BONE MARROW TRANSPLANTATION

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    Defines medical necessity criteria, coverage scope, and facility/authorization requirements for allogeneic and autologous hematopoietic cell transplants for Priority Health members.

    Policy Summary
    Payerpriority health
    PolicySTEM CELL OR BONE MARROW TRANSPLANTATION
    Policy CodePolicy 91066
    Change TypeMaterial changes to exclusions, age limit, and tandem therapy criteria
    Effective DateJun 1, 2026
    Last ReviewMay 1, 2026
    Next Review Date
    Key ActionObtain Priority Health prior authorization and submit required documentation demonstrating medical necessity before scheduling any transplant.
    SourceLink
    POLICY UPDATE CHANGES

    Removed exclusion for persistent or active substance or alcohol abuse.

    Lower age limit of 18 for autologous hematopoietic stem cell transplantation for multiple sclerosis was removed.

    Added risk-adapted criteria for tandem therapy for multiple myeloma, amyloidosis, or POEMS.

    1Exclusion deleted
    1Age-limit removal (MS AHSCT)
    1Tandem therapy addition
    1 yrStandard follow-up period
    2.0-6.0MS EDSS eligibility range
    4%Transplant-related mortality (AHSCT)

    Coverage Criteria and Indications

    inv-01: General Coverage Criteria

    Covered when ALL of the following general preconditions are met:

    General candidate requirements: Member meets all: adequate major organ function (liver, cardiac, pulmonary, renal); predicted ability to tolerate the surgical procedure and post-transplant immunosuppression; emotional and psychiatric stability with documented social support (formal social work evaluation); ability to understand the risks of the procedures; absence of psychiatric disease that would interfere with compliance; no significant history of medical noncompliance; willingness and ability to adhere to post-transplant lifestyle restrictions and medical regimen.

    See Priority Health prior authorization and facility requirements; all transplants must be pre-authorized and performed at Priority Health–approved facilities (chunks 3–4)

    inv-02: Non-malignant Conditions

    Allogeneic bone marrow transplant is covered for selected non-malignant disorders when indication-specific criteria are met:

    Non-malignant indications: Allogeneic BMT may be covered for one of the following: sickle cell anemia (children/young adults with prior stroke or high stroke/end-organ risk and with an HLA-identical donor); severe or very severe aplastic anemia (including congenital forms) meeting cytopenia thresholds and failed ATG therapy; homozygous beta-thalassemia (thalassemia major); Wiskott–Aldrich syndrome; severe combined immunodeficiencies; Chediak–Higashi syndrome; infantile malignant osteopetrosis; selected mucopolysaccharidoses (neurologically intact); selected mucolipidoses failing conventional therapy and neurologically intact; Kostmann syndrome (severe congenital neutropenia); leukocyte adhesion deficiencies; X-linked lymphoproliferative syndrome.

    See indication-specific details in chunk 8

    inv-03: Autoimmune Disease (Multiple Sclerosis)

    Autologous HSCT for multiple sclerosis is covered when ALL of the following are met:

    MS eligibility: Relapsing‑remitting multiple sclerosis (RRMS) (or progressive MS with superimposed inflammatory activity) AND documented breakthrough inflammatory disease despite high‑efficacy disease‑modifying therapy as evidenced by either: (1) two or more clinical relapses at separate times within the prior 12 months, OR (2) one relapse plus an MRI gadolinium‑enhancing lesion at a separate time within the prior 12 months; Expanded Disability Status Scale (EDSS) between 2.0 and 6.0; age criteria per policy (age considerations favor younger patients; explicit lower age limit of 18 was removed); disease duration <10 years (younger, ambulatory patients with shorter disease duration favored).EDSS 2.0–6.0; disease duration <10 years; age considerations per guideline references

    Candidate selection and prior authorization should align with guideline statements (EBMT/ASTCT/NMSS) and documented relapses/MRI activity; see chunks 9, 52–57 for evidence and guideline support.

    inv-04: Solid Tumors in Adults (Not Covered)

    Stem cell transplantation for adult solid tumors is considered:

    Adult solid tumors (not covered): Autologous or allogeneic HSCT (ablative or non‑myeloablative) for the listed adult solid tumors is considered experimental and investigational because effectiveness has not been established.

    See chunk 10 for the enumerated tumor types (e.g., breast, epithelial ovarian, CNS tumors, kidney, lung, soft tissue sarcoma, etc.)

    inv-05: Childhood Solid Tumors

    Autologous HSCT is covered for the following childhood solid tumors:

    Pediatric solid tumors covered: Relapsed Wilms' tumor; metastatic non‑CNS retinoblastoma; relapsed or progressive Ewing family of tumors (autologous HSCT covered).

    See chunk 11 for coverage statement

    inv-06: Neuroblastoma

    Neuroblastoma coverage:

    Neuroblastoma: Autologous SCT is covered for high‑risk neuroblastoma; a maximum of three tandem autologous HSCTs are covered. Allogeneic SCT from an appropriately matched HLA donor is covered when the individual is not a candidate for autologous HSCT.Maximum 3 tandem autologous HSCTs

    See chunk 12

    inv-07: PNET and Ependymoma

    PNET and ependymoma coverage distinctions:

    PNET/Medulloblastoma: Autologous SCT is a covered benefit for PNET including medulloblastoma and pineoblastoma; allogeneic SCT is considered experimental and investigational for PNET/medulloblastoma.

    See chunk 14

    Ependymoma: Autologous SCT is covered if the patient is ineligible for radiotherapy; allogeneic SCT is considered experimental and investigational for ependymoma.

    See chunk 14

    inv-08: Ovarian/Testicular Germ Cell Tumors

    Germ cell tumors:

    Germ cell tumors: Single or tandem autologous SCT is covered for relapsed or refractory testicular and ovarian germ cell tumors. Autologous SCT as front‑line therapy and allogeneic SCT are considered experimental/not covered. SCT is not covered for epithelial ovarian cancer.

    See chunk 15

    inv-09: Hodgkin's Disease

    Hodgkin's disease:

    Hodgkin's disease: High‑dose chemotherapy with autologous or allogeneic stem cell support may be covered for refractory, primary progressive, or recurrent Hodgkin's disease. Non‑myeloablative allogeneic SCT is covered for relapsed/refractory Hodgkin disease following a prior SCT. Tandem stem cell transplant for Hodgkin's disease is considered investigational.

    See chunk 16

    inv-10: Non-Hodgkin's Lymphomas

    Non-Hodgkin's lymphoma:

    Non-Hodgkin's lymphoma: Autologous or allogeneic stem cell transplant is covered for relapsed or primary refractory NHL. Transplantation as initial therapy is investigational. Non‑myeloablative allogeneic HCT may be covered when preferred by transplant center. Tandem transplants for NHL are investigational.

    See chunk 17

    inv-11: Myelofibrosis

    Myelofibrosis:

    Myelofibrosis: Allogeneic (ablative and non‑myeloablative) SCT is covered when any of the following are met: transfusion (RBC or platelet) dependence; resistance to conservative therapy; or intermediate‑ or high‑risk MF. Repeat allogeneic SCT is covered for primary graft failure or relapse. Autologous SCT is experimental.

    See chunk 18

    inv-12: Myelodysplastic Syndrome

    Myelodysplastic syndrome (MDS):

    MDS: Allogeneic (ablative and non‑myeloablative) SCT is covered for intermediate‑risk or high‑risk MDS when the individual has not responded to prior therapy and an available HLA‑matched donor. Repeat allogeneic SCT is covered for primary graft failure or failure to engraft; repeat allogeneic SCT for relapsed MDS is considered experimental. Autologous SCT is experimental for MDS.

    See chunk 19

    inv-13: Stem Cell Transplantation for Myelofibrosis

    Allogeneic stem cell transplantation for myelofibrosis is covered when ANY of the following are met:

    Myelofibrosis - transfusion dependent: The individual is transfusion (RBC or platelet) dependent.

    See chunk 18

    Myelofibrosis - resistant to conservative therapy: The individual is resistant to conservative therapy.

    See chunk 18

    Myelofibrosis - intermediate/high risk: The individual has intermediate or high risk myelofibrosis.

    See chunk 18

    inv-14: Stem Cell Transplant for Myelodysplastic Syndrome

    Allogeneic stem cell transplantation for myelodysplastic syndrome is covered when ALL of the following are met:

    MDS - intermediate/high risk: Intermediate‑risk or high‑risk MDS.

    See chunk 19

    MDS - refractory to prior therapy: Individual has not responded to prior therapy.

    See chunk 19

    MDS - HLA‑matched donor available: An available HLA‑matched donor is identified.

    See chunk 19

    inv-15: Stem Cell Transplant for CML

    Chronic myelogenous leukemia:

    CML - covered (allogeneic): High‑dose chemotherapy with allogeneic stem cell support is a covered benefit for CML.

    See chunk 20

    CML - not covered (autologous): High‑dose chemotherapy with autologous stem cell support is considered investigational for CML.

    See chunk 20

    inv-16: Stem Cell Transplant for AML

    Acute myelogenous leukemia:

    AML - covered indications: Autologous or allogeneic SCT is covered for AML in first complete remission, primary refractory AML, or relapsed AML (both ablative and non‑myeloablative).

    See chunk 21

    AML - repeat transplant: Repeat autologous or allogeneic SCT is covered for primary graft failure, failure to engraft, or relapse.

    See chunk 21

    AML - investigational: Repeat SCT for persistent or progressive disease and tandem SCT are considered investigational and not covered.

    See chunk 21

    inv-17: Stem Cell Transplant for ALL

    Acute lymphocytic leukemia:

    ALL - allogeneic covered: Allogeneic SCT is covered for treatment of ALL, including primary refractory ALL, except for refractory relapse unresponsive to ≥3 months of adequate chemotherapy.

    See chunk 22

    ALL - mini‑allograft: Non‑myeloablative allogeneic SCT (mini‑allograft) is covered for members with no persistent disease who meet selection criteria; persons with persistent disease are not candidates.

    See chunk 22

    ALL - second myeloablative SCT: Second myeloablative allogeneic HSCT from an appropriately matched HLA donor is covered when relapsed disease occurs >6 months after first SCT.

    See chunk 22

    ALL - autologous: Autologous SCT is covered when no suitable donor is available.

    inv-18: Stem Cell Transplant for CLL / SLL

    Chronic lymphocytic leukemia / Small lymphocytic lymphoma:

    CLL/SLL - allogeneic: Allogeneic SCT is covered for CLL not responsive to standard therapy.

    See chunk 23

    CLL/SLL - autologous: Autologous SCT is covered for individuals in complete or good partial remission.

    See chunk 23

    inv-19: Stem Cell Transplant for Multiple Myeloma

    Multiple myeloma:

    MM - autologous covered: Autologous SCT is covered for active (symptomatic) multiple myeloma after response to primary therapy or for refractory/relapsed disease.

    See chunk 24

    MM - second autologous: A second autologous HCT may be medically necessary for responsive MM that relapsed after a durable remission following prior autologous SCT.

    See chunk 24

    MM - third autologous: A third autologous SCT is covered for progressive disease following a previous autologous HSCT.

    See chunk 24

    MM - tandem: Tandem autologous transplants or autologous followed by allogeneic are considered medically necessary if planned 1st and 2nd transplants are within 6 months and the member is high risk for progression/relapse.

    inv-20: Stem Cell Transplant for Amyloidosis

    Amyloidosis:

    Amyloidosis - autologous: Autologous stem cell support is covered for primary systemic (AL) amyloidosis.

    See chunk 25

    Amyloidosis - not covered: Second autologous SCT, tandem autologous SCT, and allogeneic SCT are considered experimental and not covered for amyloidosis.

    See chunk 25

    inv-21: Stem Cell Transplant for POEMS

    POEMS syndrome:

    POEMS - autologous: Autologous SCT is a covered benefit for POEMS syndrome.

    See chunk 26

    inv-22: Nonmyeloablative Allogeneic Stem Cell Transplantation

    Nonmyeloablative allogeneic (reduced intensity) transplants:

    Nonmyeloablative - covered list: Nonmyeloablative (reduced intensity) allogeneic SCT may be medically necessary for listed malignancies and disorders when the patient otherwise meets selection criteria for high‑dose chemotherapy and allogeneic SCT (includes NHL, Hodgkin's, MDS, AML, CML, ALL, CLL, MM, aplastic anemia, myelofibrosis, neuroblastoma, sickle cell anemia, thalassemia major).

    Other applications (e.g., patients who do not meet criteria due to age/comorbidities or other solid tumors) are investigational.

    inv-23: Tandem Stem Cell Transplants

    Tandem transplants:

    Tandem - conditional: Tandem stem cell transplants may be a covered benefit for specific conditions if noted as covered in the applicable section; use for some conditions is investigational (see condition sections for specifics).

    See chunk 28 and individual disease sections (e.g., neuroblastoma, multiple myeloma)

    inv-24: Umbilical Cord Blood Stem Cell Transplant

    Umbilical cord blood stem cell transplant (UCBSCT):

    UCBSCT - coverage: UCBSCT is covered for patients who meet all eligibility requirements for an allogeneic stem cell transplant. UCBSCT is not covered for patients who do not meet allogeneic selection criteria.

    See chunk 29

    inv-25: Coverage considerations (MS vs other indications)

    Coverage stance and criteria suggested by the evidence and guideline statements in these sections

    AHSCT for Multiple Sclerosis (suggested coverage conditions): Candidate selection consistent with EBMT/ASTCT/NMSS guidance: relapsing‑remitting MS with inflammatory activity or SPMS/PPMS with active inflammation; documented clinical relapses or MRI lesion activity despite appropriate DMT(s) (especially high‑efficacy DMTs); younger, ambulatory patients with acceptable comorbidity profile; treatment at experienced transplant centers and individualized risk–benefit assessment.Refer to guideline statements (chunks 52–57)

    Supported by randomized trial and meta‑analyses showing improved EDSS, relapse‑free and progression‑free outcomes but with nontrivial transplant‑related mortality and hematologic adverse events.

    HSCT considered investigational or high-risk for other indications: For indications such as refractory Crohn's disease and many regenerative applications (cardiac, erectile dysfunction, ALS, etc.), evidence is limited or shows significant safety concerns (e.g., halted Crohn's RCT with multiple serious adverse events and deaths); these uses should be considered investigational or require individual case review at specialized centers.N/A

    See chunk 36 for Crohn's safety concerns and chunks 38–43 for other investigational uses

    inv-26: AHSCT candidate criteria (MS)

    Coverage considerations for AHSCT and MSC therapies vary by indication; guideline-aligned candidate criteria for AHSCT in MS include:

    AHSCT candidate criteria (MS): Patient with relapsing MS (RRMS) or progressive MS with superimposed inflammatory activity AND documented high clinical or MRI inflammatory activity (clinical relapses or Gd‑enhancing/new T2 lesions) despite use of one or more approved DMTs OR 'aggressive' disease with severe disability accumulation in the prior 12 months; ambulatory status and age/duration considerations apply (EDSS ≤5.5 preferred; younger age and disease duration <10 years favored).EDSS ≤5.5 preferred; age <45–50 and disease duration <10 years favored

    Guideline statements from EBMT, ASTCT, NMSS cited (chunks 56–57)

    When AHSCT may be considered without exhausting DMTs: Patients with 'aggressive' MS who develop severe disability in the previous 12 months may be considered for AHSCT even before failing a full course of DMT, per guideline caveats.

    EBMT guidance allows earlier consideration for aggressive disease (chunk 56–57)

    inv-27: Type 1 diabetes mellitus

    Stem cell therapies for type 1 diabetes mellitus are investigational with conflicting benefit and notable conditioning risks for HSCT:

    T1DM stem cell therapy considerations: Mesenchymal stem cell (MSC) therapies have shown improvements in glycemic indices and C‑peptide in small studies and meta‑analyses; however, autologous/allogeneic HSCT entails conditioning‑related risks (bone marrow aplasia, sepsis) that limit utility. Overall, stem cell transplantation for T1DM remains investigational.

    See chunks 58–60

    inv-28: Post-ET / Post-PV myelofibrosis

    Allogeneic HSCT can be curative for secondary myelofibrosis from ET or PV but carries substantial mortality and donor-related outcome differences:

    Post‑ET/post‑PV myelofibrosis HSCT considerations: Allogeneic HSCT is potentially curative for post‑ET/post‑PV myelofibrosis; selection should consider donor source (umbilical cord blood associated with lower neutrophil recovery and worse survival) and prior transfusion burden. Reported 1‑year nonrelapse mortality ranges ~27–35% and 4‑year overall survival ~46–65% in registry data.1‑year nonrelapse mortality 27–35%; 4‑year OS 46–65% (registry study)

    See chunks 62–63

    inv-29: RDEB

    Cell therapies for recessive dystrophic epidermolysis bullosa (RDEB) are experimental with limited data suggesting possible transient benefit but substantial risks with allogeneic BMT:

    RDEB cell therapy considerations: Allogeneic bone marrow transplantation has demonstrated wound‑healing benefits in small series but carries high‑risk adverse events (graft failure, sepsis, GVHD, renal insufficiency). BM‑MSC therapies showed possible transient clinical improvements and improved safety signals in small trials, but long‑term outcomes and risk–benefit remain uncertain; these approaches are experimental.

    See chunks 64–66

    inv-30: Retinitis pigmentosa

    Stem cell (mostly MSC) therapies for retinitis pigmentosa show short-term improvements in visual function in small studies; long-term benefit unproven.

    Retinitis pigmentosa MSC considerations: MSC therapies (umbilical cord or bone marrow derived) delivered subretinally or suprachoroidally demonstrated short‑term improvements in best‑corrected visual acuity and retinal function up to about 12 months in small studies; long‑term efficacy beyond 12 months is not established and further large randomized trials are needed.

    See chunks 67–68

    inv-31: Thrombotic thrombocytopenic purpura

    TTP is life-threatening and standard therapy is plasma exchange/infusion; stem cell therapies lack evidence.

    TTP: Stem cell therapy has been proposed for thrombotic thrombocytopenic purpura, but there is a lack of recent evidence to support its use; standard of care remains plasma exchange/infusion with adjunctive immunosuppression or caplacizumab as indicated.

    See chunk 69

    inv-32: Medical Necessity Review

    Coverage and medical necessity review

    Medical necessity review and prior authorization: Prior authorization may be required for certain drugs, devices, services and procedures; when required, providers must submit documentation demonstrating medical necessity. Individual case review may allow coverage for investigational yet promising treatments only with prior plan approval; determinations for experimental/investigational care will be made by a Priority Health medical director or clinical pharmacist.

    See chunk 137 for authorization process and lookup resources (EviCore, InterQual, TurningPoint)

    inv-33: Revisions affecting candidacy and indication-specific therapy

    Policy changes and referenced guideline support for transplant indications

    Policy changes: Operational policy revisions: removal of the exclusion for persistent or active substance or alcohol abuse, removal of the prior lower age limit of 18 for autologous HSCT in multiple sclerosis, and addition of risk‑adapted tandem therapy criteria for multiple myeloma/amyloidosis/POEMS. Clinical documentation and prior authorization processes should reflect these changes and align with cited guidelines (NCCN, EBMT, ASTCT, NMSS/ECTRIMS).

    See chunks 153–154 and guideline citations in chunks 144–149

    Transportation and lodging expenses for the patient, donor, or family are not covered benefits under this policy. Additionally, the policy excludes coverage for procedures that are deemed experimental, investigational, or unproven unless an exception is granted under Priority Health’s Experimental/Investigational/Unproven Care/Benefit Exceptions or applicable clinical trials policies. All bone marrow, peripheral stem cell, or other blood cell transplants must be pre-authorized by Priority Health and performed at a Priority Health–approved facility.

    The policy lists specific indications considered experimental/unproven and excluded from coverage. Examples include autologous stem cell transplantation for Crohn’s disease, stem cell therapy for erectile dysfunction, autologous bone marrow cell procedures for coronary artery disease/heart failure, age-related macular degeneration, amyotrophic lateral sclerosis, type I diabetes mellitus, recessive dystrophic epidermolysis bullosa, retinitis pigmentosa, thrombotic thrombocytopenic purpura, and spinal cord injury. The policy also states that stem-cell transplantation for autoimmune diseases other than multiple sclerosis is considered investigational or unproven.

    Use of immune‑ablative HSCT regimens for refractory Crohn’s disease carries substantial safety concerns based on a randomized trial that was halted for unexpected serious adverse reactions. The trial reported a high frequency of serious adverse events (including thrombotic microangiopathy, renal failure, and deaths) in HSCT recipients compared with controls, underscoring safety risks that support exclusion or high‑risk review for this indication.

    Autologous HSCT for type 1 diabetes mellitus is considered investigational. Although some small studies report improvements in glycemic measures, the conditioning component of HSCT imparts substantial risks — including life‑threatening bone marrow aplasia and sepsis — that limit the therapy’s clinical utility for T1DM.

    Allogeneic bone marrow transplantation for recessive dystrophic epidermolysis bullosa (RDEB) is classified as high‑risk and not established as standard therapy. Small series and systematic reviews report possible wound‑healing benefits but also significant adverse outcomes such as graft failure, sepsis, graft‑versus‑host disease, and renal insufficiency; these risks must be carefully weighed and the use considered investigational outside specialized contexts.

    Certain sections of the document refer readers to the U.S. Food & Drug Administration (FDA) Medical Device Databases for current regulatory information about devices used in transplant care. These references provide regulatory lookup instructions but do not specify coverage criteria or exclusions themselves.

    The policy repeatedly directs providers to consult the FDA Medical Device Databases (510(k), De Novo, PMA) for the most current premarket approval or clearance status of devices. The database references are informational only and do not establish coverage or exclusion criteria within the policy text.

    The following intramuscular autologous bone marrow cell therapy procedure codes are explicitly listed as Not Medically Necessary: 0263T, 0264T, and 0265T. Additionally, S2150 (bundled bone marrow or blood‑derived stem cell harvesting/transplantation service) is listed as Not Medically Necessary when billed for these intramuscular autologous bone marrow cell procedures.

    The policy fragment removes a previous exclusion for persistent or active substance or alcohol abuse; that exclusion is operationally deleted from the exclusions list in this revision.

    Autologous and allogeneic hematopoietic stem cell transplantation for the adult solid tumors listed in the policy (for example, epithelial ovarian cancer and other adult solid tumors enumerated in the section) are considered experimental and investigational and therefore not covered.

    Stem‑cell transplantation for autoimmune diseases other than multiple sclerosis (the policy lists several specific autoimmune conditions) is considered experimental, investigational, or unproven and is not a covered benefit.

    Tandem stem cell transplant (planned sequential transplants) is considered investigational and not a covered benefit for some conditions (for example, AML and ALL) unless the indication‑specific section explicitly states coverage. For multiple myeloma, tandem autologous transplants may be considered medically necessary when specific high‑risk and timing criteria are met.

    The policy identifies multiple regenerative and non‑oncologic indications for which stem cell therapies remain investigational, including erectile dysfunction, many cardiac uses (autologous bone marrow cells for coronary artery disease, left ventricular dysfunction, heart failure or angina), and other regenerative applications. These uses are excluded from coverage due to limited, heterogeneous, or low‑certainty evidence of safety and effectiveness.

    Autologous HSCT for type 1 diabetes mellitus is not supported because the conditioning regimens carry significant, potentially life‑threatening risks (e.g., bone marrow aplasia, sepsis). Those conditioning‑related risks outweigh currently reported benefits and render autologous HSCT investigational for T1DM.

    The policy explicitly lists the following procedure codes as Not Medically Necessary: 0263T, 0264T, 0265T, and S2150. Claims for these codes may be denied when billed for intramuscular autologous bone marrow cell therapy or the bundled transplant service described.

    In this document fragment there are no newly added items labeled as 'Not Medically Necessary.' Instead, the revision deletes the prior exclusion for persistent or active substance or alcohol abuse and removes the lower age limit for autologous HSCT for multiple sclerosis.

    Patient Candidate Selection Criteria

    Prior Authorization

    Prior Authorization Required

    All bone marrow, peripheral stem cell, or other blood cell transplants must be pre-authorized by Priority Health and performed at a Priority Health–approved facility. Prior authorization is required for autologous hematopoietic stem cell transplantation (AHSCT) in multiple sclerosis (MS), for umbilical cord blood stem cell transplantation (UCBSCT), and for other transplant types per this policy. Prior authorization requests should be submitted on the Bone Marrow/Peripheral Stem Cell or Other Blood Cell Transplant prior authorization form. Prior authorization must reflect the policy's revised exclusions and added criteria; providers should include all required disease-specific and medical documentation (see documentation callouts).

    • Prior Authorization Required: All transplants require pre-authorization from Priority Health.
    • Prior authorization for UCBSCT and CMS alignment: UCBSCT requests require prior authorization and should align with applicable CMS coverage determinations when relevant.
    • Prior authorization for AHSCT in MS: AHSCT for MS requires prior authorization and documentation demonstrating guideline-aligned candidate selection (see criteria groups).
    • Prior authorization must reflect revised exclusions and added criteria; denials may result if exclusionary conditions are present or documentation is insufficient.

    Contraindications

    Contraindications include the presence of psychiatric disease that would interfere with compliance, a significant history of medical noncompliance, or unwillingness/inability to receive or adhere to required post‑transplant therapy (including transfusions or blood products where indicated). These factors may preclude coverage for transplantation.

    Use of nonmyeloablative (reduced‑intensity) allogeneic stem cell transplantation in patients who do not meet selection criteria because of advanced age or significant comorbidities is considered investigational; such age or comorbidity profiles may be treated as contraindications or grounds for noncoverage.

    Increased age, more advanced disease, and significant comorbid conditions raise the risk of treatment‑related morbidity and mortality with HSCT and may constitute contraindications to transplantation. Guideline notes stress individualized decision‑making because risks rise with age and comorbidity burden.

    The policy reiterates that psychiatric disease and medical noncompliance are contraindications to transplant candidacy. Notably, the revision removes the previous explicit exclusion for persistent or active substance or alcohol abuse, so active substance use is no longer listed as an absolute exclusion in the updated text.

    Presence of psychiatric disease that would interfere with compliance, a significant history of medical noncompliance, or unwillingness/inability to adhere to post‑transplant lifestyle restrictions remain contraindications. The document notes the prior exclusion for active substance or alcohol abuse has been deleted in this revision.

    Pre-Transplant Evaluation and Documentation

    Prior Authorization

    Submit one pre‑transplant evaluation using the transplant prior authorization form

    Submit one pre‑transplant evaluation per transplant using the Bone Marrow/Peripheral Stem Cell or Other Blood Cell Transplant prior authorization form; the evaluation initiates prior authorization and pre‑transplant coverage components.

    • One evaluation is required for each transplant
    • Use the specified prior authorization form when submitting the request
    Note

    One pre‑transplant evaluation required (submission reminder)

    (Duplicate) One pre‑transplant evaluation is required per transplant and must be submitted on the Bone Marrow/Peripheral Stem Cell or Other Blood Cell Transplant prior authorization form to initiate authorization.

    • One evaluation required per transplant
    • Submit on the specified prior authorization form

    Provider Actions, Prior Authorization and Documentation

    Prior Authorization

    Obtain prior authorization and use Priority Health approved transplant facilities

    All bone marrow or stem cell transplants must be pre‑authorized by Priority Health and performed at a Priority Health approved facility; referrals should be directed to the Priority Health network or contracted centers.

    • Prior authorization required for all transplants
    • Procedure must occur at a Priority Health approved facility
    • Refer members to Priority Health network or contracted transplant centers
    Prior Authorization

    Show allogeneic eligibility and comply with CMS mandates for UCBSCT requests

    When requesting umbilical cord blood stem cell transplant (UCBSCT), demonstrate that the patient meets the selection criteria for an allogeneic stem cell transplant; follow any applicable federal or state (CMS) coverage determinations.

    • Show patient meets all allogeneic SCT eligibility requirements to request UCBSCT
    • Confirm any applicable CMS/NCD/LCD mandates take precedence

    Facility and Center Requirements

    Prior Authorization

    Route transplants to Priority Health approved/contracted transplant centers

    Transplants must be performed at a Priority Health approved facility and referrals directed to Priority Health's network or contracted centers; ensure referral routing and facility selection comply with Priority Health requirements.

    • Use Priority Health approved transplant facilities
    • Route referrals to Priority Health network/contracted centers
    Note

    Confirm facility approval and route referrals accordingly

    (Duplicate) Priority Health requires transplants be performed at approved facilities and referrals routed to network/contracted centers; confirm facility approval before scheduling procedures.

    • Confirm facility is Priority Health approved prior to scheduling transplant
    • Refer to Provider Manual for network/contract details

    Coding and Billing

    Covered CPT/HCPCS CodesCPT/HCPCSCovered
    38204Management of recipient hematopoietic progenitor cell donor search and cell acquisition
    38205Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic
    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, 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
    1–10 of 51
    1/6
    Not Medically NecessaryCPT/HCPCSNot Covered
    0263TIntramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, 1 leg; complete procedure including harvest
    0264TIntramuscular autologous bone marrow cell therapy; complete procedure excluding bone marrow harvest
    0265TIntramuscular autologous bone marrow cell therapy; unilateral or bilateral bone marrow harvest only
    S2150Bone marrow or blood-derived stem cells, harvesting, transplantation, and related complications; bundled service
    ICD-10 Codes that may support medical necessityICD-10
    C40.00-C40.92Malignant neoplasm of bone and articular cartilage of limbs (Ewing's sarcoma)
    C56.1-C56.9Malignant neoplasm of ovary
    C62.0-C62.92Malignant neoplasm of testis
    C64.1-C64.9Malignant neoplasm of kidney, except renal pelvis (Wilms tumor)
    C69.20-C69.22Malignant neoplasm of retina
    C71.0-C71.9Malignant neoplasm of brain
    C81.00-C81.99Hodgkin lymphoma
    C82.00-C82.99Follicular lymphoma
    C83.00-C83.99Small cell B-cell lymphoma
    C84.60-C84.69Anaplastic large cell lymphoma, ALK-positive
    1–10 of 33
    1/4
    Prior authorization not required for In-Network providers — inv-53
    Policy statementNo prior authorization required for the listed transplant procedure codes when performed by in‑network (Priority Health contracted) providers.
    ScopeApplies to the CPT/HCPCS transplant procedure codes listed in the policy (e.g., 38204–38243 series, HLA typing and chimerism codes, and related transplant procedure codes).
    Operational noteWhen services are provided by non‑contracted facilities, follow-up testing/labs/imaging beyond one year are subject to network restrictions per post‑transplant coverage rules.

    Post-Transplant Coverage and Follow-up

    Follow-up care, testing, labs, imaging — inv-130
    Standard follow‑up periodFollow‑up care and services are covered at the transplant facility for one year following the transplant for both contracted and non‑contracted transplant facilities.
    Beyond one year — contracted facilitiesFollow‑up care beyond one year is covered at contracted transplant facilities.
    Beyond one year — non‑contracted facilitiesFor non‑contracted facilities beyond one year, only physician services are covered; testing, labs, and imaging are covered in network only.
    Repeat autologous or allogeneic HCT — inv-131
    Covered reasons for repeat transplantRepeat autologous or allogeneic hematopoietic cell transplantation is a covered benefit when the first transplant was unsuccessful due to primary graft failure or failure to engraft, or when the member has relapsed after a prior stem cell transplantation.

    Definitions and Terminology

    Relapse — inv-94
    Definition of relapseRelapse is the re‑appearance of disease in regions of prior disease (recurrence) and/or in new regions (extension) after initial therapy and attainment of complete response.
    Context examplesRelapse is referenced in Hodgkin's disease and other malignancy sections to distinguish indications for repeat or further transplantation.
    Policy relevanceRelapse triggers consideration of repeat transplant in several covered indications, while some repeat uses remain investigational depending on disease state.
    Expanded Disability Status Scale (EDSS) — inv-95
    EDSS meaning and useThe Expanded Disability Status Scale (EDSS) is a neurologic scale used to quantify disability in multiple sclerosis and is referenced for transplant eligibility.
    Eligibility range cited

    Background and Evidence Summary

    This policy addresses indications and eligibility for autologous and allogeneic hematopoietic stem cell and bone marrow transplantation across malignant and non‑malignant conditions. It specifies patient selection requirements (adequate organ function, psychiatric stability, social support), facility and pre‑authorization requirements, and condition‑specific coverage stances.

    Revision History and Policy Changes

    2026-05-?deletion

    Removed explicit exclusion for persistent or active substance or alcohol abuse from the policy exclusions list.

    2026-05-?revision

    Removed the lower age limit of 18 for autologous hematopoietic stem cell transplantation (AHSCT) for multiple sclerosis candidacy criteria.

    2026-05-?additionLatest
    Policy Summary
    Payerpriority health
    PolicySTEM CELL OR BONE MARROW TRANSPLANTATION
    Policy CodePolicy 91066
    Change TypeMaterial changes to exclusions, age limit, and tandem therapy criteria
    Effective DateJun 1, 2026
    Last ReviewMay 1, 2026
    Next Review Date
    Key ActionObtain Priority Health prior authorization and submit required documentation demonstrating medical necessity before scheduling any transplant.
    SourceLink
    On This Page
    Coverage Criteria and IndicationsPatient Candidate Selection CriteriaContraindicationsPre-Transplant Evaluation and DocumentationProvider Actions, Prior Authorization and DocumentationFacility and Center RequirementsCoding and BillingPost-Transplant Coverage and Follow-upDefinitions and TerminologyBackground and Evidence SummaryRevision History and Policy Changes

    See chunk 22

    ALL - tandem: Tandem SCT is considered experimental and not covered.

    See chunk 22

    Within 6 months when member considered high risk

    See chunk 24 and additions re: risk‑adapted tandem criteria (chunk 154)

    MM - allogeneic: Allogeneic SCT from an appropriately matched HLA donor is covered for progressive disease following autologous HSCT.

    See chunk 24

    Note

    Check FDA Device/Product Status

    Providers should verify the FDA approval/status of any devices, cellular products, or biologics used in transplantation. Check the FDA Medical Devices database and other FDA resources (e.g., biologics and BLA/IND listings) for current approval or clearance status prior to submitting prior authorization requests. Documentation of device/product regulatory status may be requested as part of the authorization review.

    • Providers should consult the FDA Medical Devices database and FDA Biologics/BLA/IND listings for product approval or clearance.
    • Document the FDA status of any device, cellular product, or biologic used in the proposed transplant as part of the authorization submission.
    Documentation Required

    Prior authorization for AHSCT in MS

    Priority Health considers AHSCT for MS medically necessary only when documentation supports guideline-aligned candidate selection. Essential documentation must be submitted with the prior authorization request and should include clinical and imaging evidence of disease activity despite appropriate therapy, prior DMT history, functional status (EDSS), disease duration, age, and transplant candidacy assessments (organ function, psychiatric/social support).

    • Required clinical documentation: MS diagnosis, relapsing vs progressive phenotype, EDSS score and functional mobility, disease duration, and age.
    • Disease-specific documentation: Detailed history of disease-modifying therapy (DMT) use including agents, durations, and reasons for discontinuation or failure; documentation of ongoing clinical relapses or new/enhancing MRI lesions despite high-efficacy DMTs when applicable.
    • Guideline-supported documentation: Notes citing guideline recommendations (ASTCT, EBMT, NMSS) that the patient has high inflammatory activity despite one or more lines of approved DMTs, or meets criteria for aggressive disease where earlier AHSCT may be considered.
    • MDS documentation requirements / Essential documentation for AHSCT consideration: Organ function tests (cardiac, pulmonary, hepatic, renal), infectious disease screening, psychosocial evaluation and formal social work assessment, and assessment of ability to tolerate conditioning and post-transplant immunosuppression.
    • Therapy sequencing expectations / Stepwise therapy before AHSCT: Documentation should show sequencing of therapies and rationales; for most candidates, failure of appropriate DMT(s) is expected before AHSCT except in select aggressive presentations per guidelines.
    Denial Risk

    Clinical suitability requirements

    Clinical suitability requirements: Assess and document adequate major organ function (liver, cardiac, pulmonary, renal), predicted ability to tolerate procedure and post-transplant immunosuppression, and emotional/psychiatric stability with demonstrated caregiver/social support. Transplants are not covered for members with psychiatric disease that interferes with compliance, significant history of medical noncompliance, or unwillingness/inability to adhere to post-transplant restrictions.

    • Adequate organ function (labs, cardiac/pulmonary testing, renal/hepatic function).
    • Formal psychosocial evaluation documenting emotional/psychiatric stability and support network.
    • Documented ability to understand risks and comply with pre/post-transplant regimens.
    • Denial triggers: presence of psychiatric disease that would interfere with compliance, significant medical noncompliance, unwillingness or inability to adhere to post-transplant regimen.
    Note

    Guideline-aligned candidate selection for AHSCT in MS

    AHSCT candidate selection for MS should align with current society guidance. Acceptable candidates typically include younger patients (often <45–50 years), disease duration <10 years, ambulatory (EDSS ≤5.5), with high clinical and MRI inflammatory activity despite appropriate DMTs, or patients with aggressive MS where earlier transplant may be justified. Progressive forms (SPMS/PPMS) may be considered only when inflammatory activity is still evident and there is documented disability progression in the prior 12 months.

    • Patients with relapsing forms of MS (RRMS or PPMS with superimposed activity) who have prognostic factors indicating high risk of future disability.
    • Patients with ongoing clinical relapses or MRI lesion activity despite treatment with available DMTs, especially after high-efficacy DMTs.
    • Patients with EDSS ≤5.5, age typically younger than 45–50, and disease duration less than 10 years are preferred candidates.
    • SPMS/PPMS: consider only with documented inflammatory activity and progression in the prior 12 months; preferably in a clinical trial or per guideline indications.
    Denial Risk

    Safety concerns for HSCT in Crohn's disease

    Safety concerns and coverage stance for non-MS autoimmune disorders (example: Crohn's disease) should be documented and considered. Evidence for AHSCT or other HSCT approaches in Crohn's disease remains limited and associated with notable safety concerns; prior authorization requests must include disease-specific trial data, risk/benefit discussion, and rationale for transplant over standard therapies. Experimental, investigational, or unproven transplants are not covered unless an exception is granted per policy.

    • Safety concerns for HSCT in Crohn's disease: include available trial evidence, potential transplant-related morbidity/mortality, and lack of robust long-term benefit in some studies.
    • Denial triggers for ineligible indications: HSCT for indications considered experimental/investigational per policy (including some autoimmune GI disorders) will be denied unless approved under the Experimental/Investigational/Unproven Care Exception policy.
    • Providers should include ASTIClite or relevant trial references when submitting requests for Crohn's disease.
    • Post-transplant coverage considerations: post-transplant care and complications are covered only when the transplant itself was pre-authorized and performed at an approved facility; transportation/lodging are not covered unless specified.
    Documentation Required

    Required clinical documentation

    Required clinical documentation for all transplant authorizations includes disease-specific evidence of medical necessity, prior therapy history, organ function testing, infectious disease and immunologic testing, psychosocial evaluation, and transplant center treatment plans. Incomplete documentation may result in denial. There are no implicit step therapy rules beyond guideline-based expectations for therapy sequencing; however, providers must document prior therapeutic trials and rationale for proceeding to transplant where applicable.

    • Required clinical documentation: diagnosis, disease severity measures (e.g., EDSS for MS), prior treatments with dates and outcomes, objective imaging or laboratory evidence of disease activity, organ function tests, infection screening, and psychosocial evaluation.
    • MDS documentation requirements: formal social work/psychiatric evaluation records as part of transplant candidacy assessment.
    • No explicit authorization or denial triggers beyond those listed: while many denial triggers are stated (psychiatric instability, noncompliance, experimental indications), the policy does not present additional implicit step therapy rules.
    • Denial risk for specific codes: authorization may be denied if submitted codes/procedures correspond to indications excluded as experimental/investigational or lack required documentation.
    Documentation Required

    Document prior therapy response/failure and donor availability in the evaluation

    The pre‑transplant evaluation must document response or failure to prior therapies where applicable and, when relevant (e.g., MDS, allogeneic indications), availability of an appropriately HLA‑matched donor.

    • Document prior therapy response or nonresponse/failure
    • Document donor availability/HLA match for allogeneic transplants when required
    Documentation Required

    Complete comprehensive pre‑transplant evaluation including disease activity and organ function

    Perform a comprehensive pre‑transplant evaluation documenting disease activity, prior therapies tried, major organ function, and an individualized risk–benefit assessment per specialty guidance to support medical necessity.

    • Assess and document clinical relapses and MRI inflammatory activity where applicable
    • Record organ function and predicted ability to tolerate procedure and immunosuppression
    • Provide individualized risk–benefit rationale aligned with guidelines
    Prior Authorization

    Include the pre‑transplant evaluation with prior authorization submission

    Prior authorization requests must include the required evaluation documentation (one evaluation per transplant) submitted on the designated prior authorization form to be processed.

    • Include the pre‑transplant evaluation as part of the authorization submission
    • One evaluation equals one authorization request per transplant
    Prior Authorization

    Check EviCore/InterQual/TurningPoint via Priority Health Prism for authorization criteria

    Use Priority Health Prism authorization lookups (EviCore, InterQual, TurningPoint) to confirm indication‑specific authorization criteria and required documentation before submitting prior authorization requests.

    • Log into Priority Health Prism → Authorizations → Authorization Criteria Lookup to access EviCore, InterQual, or TurningPoint
    Documentation Required

    Align evaluation/documentation with NCCN, EBMT, ASTCT or specialty guidelines

    Ensure evaluation and documentation align with the cited specialty guideline sources (NCCN, EBMT, ASTCT, other relevant guidance) for the specific disease indication prior to authorization.

    • Align clinical rationale and selection criteria with NCCN, EBMT, ASTCT or other specialty guidance as applicable
    • Cite guideline references in the submission to support medical necessity
    Prior Authorization

    Provide guideline/trial‑based documentation with AHSCT prior authorization in MS

    Prior authorization for AHSCT in multiple sclerosis should document trial evidence and guideline‑recommended selection factors, including disease course, prior DMTs, disease activity, and candidate fitness to support medical necessity.

    • Provide clinical trial or guideline rationale (e.g., Burt et al., systematic reviews)
    • Document prior DMT history and objective disease activity measures
    Prior Authorization

    Require evidence of relapsing/high‑inflammatory MS and ambulatory status for AHSCT prior auth

    For AHSCT in MS, prior authorization must include evidence of relapsing MS with high inflammatory activity despite appropriate DMT(s), ambulatory capability (EDSS within recommended range), and age/duration considerations or documentation of 'aggressive' disease if earlier AHSCT is pursued.

    • Document relapsing MS or progressive MS with superimposed inflammatory activity
    • Include EDSS/ambulatory status and age/disease duration or justification for earlier AHSCT in aggressive cases
    Documentation Required

    Verify device regulatory status in FDA databases and document identifiers

    Consult the U.S. FDA Medical Device Databases to verify current regulatory status (PMA, De Novo, 510(k)) of devices used in transplant care and include relevant device identifiers in documentation as needed.

    • Check FDA databases for current 510(k), PMA, or De Novo numbers and notice dates
    • Include device regulatory information in submissions when applicable
    Documentation Required

    Consult FDA device databases for device regulatory information

    When devices are involved in care, providers should consult FDA device databases and record current regulatory information (510(k), PMA, De Novo) to support regulatory compliance and authorization documentation.

    • Use FDA device databases to obtain current regulatory pathway information
    • Record device identifiers and notice dates in the clinical record or submission
    Documentation Required

    Use FDA database records to support device‑related authorization info

    Reference the FDA Medical Device Databases for current premarket approval, De Novo, or 510(k) numbers and notice dates; no specific authorization codes are provided in this policy fragment—use FDA records to support device‑related claims.

    • Obtain PMA/De Novo/510(k) numbers and notice dates from FDA databases as needed for submissions
    Prior Authorization

    Follow Priority Health prior authorization processes and submit medical necessity

    Follow Priority Health prior authorization processes for drugs, devices, services and procedures listed (use Authorization Criteria Lookup and submit medical necessity documentation when required).

    • Follow Priority Health Prism authorization lookup workflow
    • Submit medical necessity documentation when prior authorization is required
    Prior Authorization

    Ensure prior authorization reflects removed substance/alcohol exclusion and new tandem therapy criteria

    Prior authorization submissions must reflect recent policy revisions — do not apply the prior exclusion for persistent or active substance/alcohol abuse and ensure new risk‑adapted tandem therapy criteria (e.g., for multiple myeloma/POEMS) are addressed when relevant.

    • Do not include the removed substance/alcohol abuse exclusion in submissions
    • Address newly added risk‑adapted tandem therapy criteria where applicable
    Billing Rule

    Confirm outpatient Rx coverage for immunosuppressants and 1‑year follow‑up coverage

    Post‑transplant immunosuppressant drug therapy is covered only if the member's group has outpatient prescription drug benefits; follow‑up care at the transplant facility is covered for one year post‑transplant.

    • Confirm outpatient prescription drug coverage for post‑transplant immunosuppressants
    • Follow‑up care/services covered at transplant facility for 1 year after transplant
    Documentation Required

    Document prior therapy sequencing where transplant follows failed/primary therapy

    For many conditions (e.g., intermediate/high‑risk MDS, multiple myeloma), transplantation is indicated after failure of or following response to primary/conservative therapy; document sequencing in the prior authorization.

    • Document prior therapy failure or response when sequencing to transplant is required
    • Include rationale for proceeding to transplant after primary therapy
    Step Therapy

    Document failure or intolerance to approved DMTs before AHSCT in MS (unless aggressive disease)

    Before considering AHSCT for MS, document that the candidate has failed or been intolerant to approved disease‑modifying therapies, consistent with guideline recommendations favoring AHSCT after DMT failure except in aggressive cases.

    • Record trials of approved DMTs and reasons for discontinuation
    • If claiming an exception (aggressive disease), include justification per guidelines
    Step Therapy

    Require prior trial of high‑efficacy DMTs or clear justification for earlier AHSCT in RRMS

    Guidelines generally recommend trying approved high‑efficacy DMTs before AHSCT in most relapsing RRMS patients; if AHSCT is requested without such trials, provide documentation that disease is aggressive and justifies earlier transplant.

    • Show trials of high‑efficacy DMTs or document aggressive disease course if proceeding to AHSCT earlier
    Prior Authorization

    Document risk‑adapted tandem therapy sequencing for MM/POEMS in prior authorization

    In multiple myeloma and POEMS, follow newly added risk‑adapted tandem therapy sequencing criteria and document planned sequencing (e.g., timing of 1st and 2nd transplant within 6 months for high‑risk patients) in authorization requests.

    • Document risk‑adapted plan for tandem transplants where applicable
    • Include timing and high‑risk status rationale in submission
    Documentation Required

    Include required clinical documentation: organ function, social work, and risk understanding

    Include documentation that supports organ function, tolerance prediction, social work evaluation, and patient understanding of risks when submitting prior authorization; these are required clinical documentation elements.

    • Organ function test results (liver, cardiac, pulmonary, renal)
    • Formal social work evaluation documenting support
    • Statement of patient understanding of risks
    Prior Authorization

    Use the Bone Marrow/Peripheral Stem Cell prior authorization form and attach evaluation

    Use the Bone Marrow/Peripheral Stem Cell or Other Blood Cell Transplant prior authorization form and include the pre‑transplant evaluation documentation as part of the submission to initiate authorization.

    • Complete and submit the specified prior authorization form
    • Attach the pre‑transplant evaluation documentation
    Prior Authorization

    Show prior therapy failure and HLA‑matched donor availability for MDS requests

    For intermediate‑ or high‑risk MDS, prior authorization must include documentation of prior therapy failure and availability of an HLA‑matched donor for allogeneic transplant.

    • Show prior therapy failure for intermediate/high‑risk MDS
    • Document available HLA‑matched donor
    Documentation Required

    Provide disease‑specific status and response documentation to support necessity

    Provide disease‑specific documentation of disease status (e.g., first complete remission, refractory, relapsed), transfusion dependence for myelofibrosis, and response to prior therapy where required to support medical necessity.

    • State disease status (CR, refractory, relapsed)
    • Document transfusion dependence where applicable
    • Document response to prior therapies
    Documentation Required

    Support requests with guideline‑based documentation and individualized rationale

    Align documentation with guideline‑supported rationales (EBMT/NCCN) and include individualized decision rationale given higher short‑term risks for HSCT; cite guideline sources when relevant.

    • Cite EBMT, NCCN or other specialty guidance to support selection
    • Provide individualized risk–benefit discussion
    Documentation Required

    Include relapses, MRI activity, prior DMT history, and EDSS for AHSCT in MS

    For AHSCT consideration in MS, include documented clinical relapses, MRI inflammatory activity (Gd‑enhancing or new T2 lesions), and a detailed prior DMT history including trials of specific high‑efficacy agents and EDSS/ambulatory status.

    • Document clinical relapses and MRI evidence of activity
    • List prior DMTs tried and outcomes
    • Provide EDSS score and ambulatory status
    Prior Authorization

    Submit medical necessity evidence; investigational treatments require prior plan approval

    When prior authorization is required, submit a request demonstrating medical necessity; individual case review may permit coverage of investigational therapies only with prior plan approval and medical director/pharmacist determination.

    • Submit medical necessity rationale with supporting documentation
    • Requests for investigational treatments require prior plan approval and review by medical director or clinical pharmacist
    Documentation Required

    Ensure documentation aligns with NCCN, EBMT, ASTCT or other cited guidelines

    Align documentation submissions with cited guideline sources (NCCN, EBMT, ASTCT, specialty guidance) relevant to the treated indication to support medical necessity determinations.

    • Reference applicable guideline guidance in the submission
    • Provide evidence that selection aligns with guideline criteria
    Denial Risk

    Clinical suitability: deficiencies may trigger non‑coverage

    Clinical suitability requirements reiteration: inadequate organ function, inability to tolerate transplant/immunosuppression, psychiatric instability, poor social support, medical noncompliance, or unwillingness to adhere to post‑transplant regimen are grounds for non‑coverage.

    • Inadequate major organ function
    • Inability to tolerate conditioning or immunosuppression
    • Psychiatric disease interfering with compliance or poor social support
    • Significant history of medical noncompliance
    Prior Authorization

    Do not authorize experimental/investigational transplants without prior approval

    Transplants that are experimental or investigational are not covered unless an exception is granted per the Experimental/Investigational/Unproven Care/Benefit Exceptions policy or via individual case review with prior plan approval.

    • Experimental/investigational indications excluded absent approved exception
    • Refer to policy #91117 or individual case review for exceptions
    Denial Risk

    Risk of denial for UCBSCT if allogeneic eligibility not met

    Requests for UCBSCT where the patient does not meet allogeneic SCT eligibility criteria may be denied; verify allogeneic selection criteria before submitting UCBSCT requests.

    • Confirm patient meets all allogeneic selection criteria before UCBSCT request
    • Do not submit UCBSCT requests for patients ineligible for allogeneic SCT
    Denial Risk

    Crohn's HSCT safety concerns may trigger denial or high‑risk review

    High rates of serious adverse events and treatment‑related deaths reported in HSCT for refractory Crohn's disease (trial halted for safety) may prompt denial or require high‑risk specialist review for such requests.

    • Recognize substantial safety concerns in Crohn's HSCT RCT (multiple serious adverse reactions and deaths)
    • Expect high‑risk review or denial without compelling justification
    Documentation Required

    Consult FDA device databases when device regulatory status affects authorization

    If device regulatory status is relevant to the request, consult FDA device databases for current information prior to submission; the policy fragment provides no explicit authorization triggers for devices.

    • Consult FDA databases for device regulatory status
    • Include device regulatory data if pertinent to the request
    Note

    No explicit device authorization triggers — verify FDA status

    When device regulatory questions arise, consult the FDA Medical Device Databases for current status; this policy section does not specify explicit authorization or denial triggers for devices.

    • Use FDA databases to verify device approval pathway and dates
    • Policy does not provide device‑specific authorization rules in this fragment
    Note
    Denial Risk

    Denial risk: 0263T/0264T/0265T and S2150 billed for investigational therapies

    Claims for intramuscular autologous bone marrow cell therapy codes (0263T, 0264T, 0265T) and S2150 may be denied as Not Medically Necessary under this policy when billed for investigational procedures — do not submit without prior approval and supporting evidence.

    • Avoid billing 0263T, 0264T, 0265T, or S2150 for investigational intramuscular autologous bone marrow cell therapies without prior approval
    Note

    Removed exclusion: do not apply prior substance/alcohol abuse exclusion

    Although the policy previously excluded persistent/active substance or alcohol abuse, that exclusion has been removed; do not rely on the former exclusion when preparing authorization documentation.

    • Do not apply the removed exclusion for substance/alcohol abuse in current submissions
    Billing Rule

    Ensure compliance with applicable federal/state (CMS) coverage mandates

    Any applicable federal or state mandates (including CMS coverage determinations) take precedence over this policy; ensure requests align with relevant CMS NCDs/LCDs when applicable.

    • Verify and comply with applicable CMS NCD/LCD requirements where relevant
    • Federal/state mandates supersede this medical policy
    Note

    Reconfirm facility and referral requirements for transplants

    Reiteration: transplants must be done at a Priority Health approved facility and referrals directed to Priority Health's network or contracted facilities; confirm approval before proceeding.

    • Use approved facilities and contracted networks for referrals
    • Check Provider Manual for details
    Prior Authorization

    Verify facility approval and follow Priority Health referral routing

    Ensure the selected transplant facility is Priority Health approved and that referrals are routed to the network or contracted centers as specified in the Provider Manual prior to authorization and scheduling.

    • Confirm facility approval in advance
    • Route referrals per Provider Manual
    Note

    Confirm Priority Health approved facility for transplant

    (Duplicate) Confirm the transplant will occur at a Priority Health approved facility and route referrals to network/contracted centers to meet coverage requirements.

    • Confirm Priority Health approved facility status
    • Route referrals to contracted transplant centers
    Not covered/Investigational repeat usesRepeat transplant for persistent or progressive disease is considered experimental and investigational.
    Tandem repeat statement for AMLTandem stem cell transplant for AML is considered investigational and not covered.
    Follow-up assessments — inv-132
    Key follow‑up assessmentsPost‑transplant monitoring should include clinical assessments (relapse status), EDSS where applicable for MS, MRI activity (Gd‑enhancing or new T2 lesions), and hematologic surveillance as clinically indicated.
    Outcome monitoringReported post‑AHSCT outcomes include relapse‑free and progression‑free survival; monitoring supports detection of relapse and hematologic adverse events.
    Documentation to support follow‑upClinical relapses, MRI lesion activity, prior therapy history, and EDSS scores are part of essential documentation for AHSCT consideration and subsequent follow‑up assessments.
    Clinical follow-up and hematologic monitoring — inv-133
    Clinical follow‑up requirementsPost‑AHSCT follow‑up should include clinical visits for relapse‑free/progression‑free outcome assessment and monitoring for transplant‑related complications.
    Hematologic monitoringSurveillance for hematologic adverse events is required after immunoablative conditioning and AHSCT due to increased risk of cytopenias and related complications.
    Outcome metrics citedMeta‑analyses report pooled progression‑free survival (~73%), relapse‑free rates (~81%), and transplant‑related mortality (~4%) after AHSCT, underscoring need for close clinical and hematologic follow‑up.
    Post-transplant aftercare and status coding — inv-134
    Applicable aftercare/status ICD‑10 codesZ48.290 — Encounter for aftercare following bone marrow transplant.
    Transplant status codesZ94.81 — Bone marrow transplant status; Z94.89 — Stem cells transplant status.
    Use caseThese diagnosis/status codes are listed as applicable for documenting post‑transplant aftercare and transplant status in claims and clinical records.
    tandem transplant/therapy sequencing — inv-135
    Policy change — tandem therapy criteriaRisk‑adapted criteria for tandem therapy were added for multiple myeloma (and POEMS), affecting sequencing decisions for peri‑ and post‑transplant care.
    When tandem sequencing is considered medically necessaryTandem autologous transplants or autologous followed by allogeneic transplant may be considered medically necessary for high‑risk members when planned 1st and 2nd transplants are within a 6‑month period (see multiple myeloma section).
    Operational implicationPrior authorization and documentation should reflect risk‑adapted sequencing criteria when tandem therapy is proposed for MM/POEMS.
    Policy specifies EDSS 2.0 to 6.0 as an eligibility criterion for AHSCT in multiple sclerosis.
    Preferred ambulatory thresholdGuidelines and policy favor ambulatory candidates (EDSS ≤5.5 preferred) when considering AHSCT for MS.
    Tandem Transplantation defined — inv-96
    Tandem transplant definitionTandem transplantation is defined as two or more planned courses of high‑dose chemotherapy and stem cell support administered typically at 2–6 month intervals.
    Distinguishing from multiple cyclesTandem transplants differ from multiple cycles of high‑dose chemotherapy with transplantation in the shorter planned interval (2–6 months) contingent on recovery from prior toxicity.
    Policy implicationsTandem transplant coverage is condition‑specific; some indications (e.g., high‑risk neuroblastoma, selected MM) permit tandem transplants up to policy limits, while other uses are investigational.
    Treatment response and disease status definitions — inv-97
    ResponsiveA tumor showing either a complete or partial remission (policy defines partial remission as ≥50% reduction in tumor burden).
    RelapseRecurrence of tumor after a prior complete remission (used to determine eligibility for repeat transplantation).
    RefractoryFailure to attain a complete or partial response to therapy (primary or secondary refractoriness).
    Sources of Stem Cells — inv-98
    AutologousPatient's own stem cells harvested from bone marrow or peripheral blood (pheresis).
    AllogeneicStem cells from a donor (bone marrow, peripheral blood) offering potential graft‑versus‑tumor effect but higher risk of complications.
    Umbilical cord bloodCord blood is an allogeneic source; cells are antigenically naive and associated with lower incidence of rejection/GVHD.
    Autologous HSCT definition — inv-99
    Autologous HSCT definedTransplantation using the patient's own hematopoietic stem cells, commonly harvested from peripheral blood or bone marrow; generally considered safer than allogeneic HSCT.
    Use contextAutologous HSCT is commonly used for autoimmune diseases (e.g., MS) and many hematologic malignancies where donor stem cells are not required.
    Risk profileAlthough autologous HSCT avoids donor‑related GVHD, it carries conditioning‑related risks and hematologic adverse events requiring close monitoring.
    AHSCT (Autologous HSCT) definition — inv-100
    AHSCT descriptionAutologous hematopoietic stem cell transplantation: immune‑ablative or non‑myeloablative conditioning followed by reinfusion of the patient’s collected stem cells to reconstitute the immune system.
    Clinical use in MSUsed in MS to ablate autoreactive immune cells and reconstitute immunity; guideline groups (EBMT, ASTCT, NMSS) recommend AHSCT for selected patients with inflammatory disease activity.
    Monitoring and outcomesRandomized trials and meta‑analyses report improvements in EDSS, relapse rates, and progression‑free survival after AHSCT but with nonzero transplant‑related mortality and hematologic AEs.

    Added risk-adapted tandem therapy criteria for multiple myeloma (and related indications such as amyloidosis and POEMS) specifying when tandem transplants may be applied.