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CurrentBlue Cross Blue Shield - South DakotaPolicy N/A

Hematopoietic Stem Cell Transplantation (HSCT) — Autologous and Allogeneic

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Coverage criteria for autologous and allogeneic hematopoietic stem cell transplantation across multiple non-malignant and malignant indications, including specified immunodeficiencies, inherited metabolic disorders, CNS and other solid tumors, and blood cancers. Applies to Blue Cross Blue Shield - South Dakota members and providers submitting transplant requests.

Policy Summary

PayerBlue Cross Blue Shield - South Dakota

PolicyHematopoietic Stem Cell Transplantation (HSCT) — Autologous and Allogeneic

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2018

Last ReviewApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting indication, prior therapies and response, donor match and transplant type before HSCT is approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Part 12Document segment

2–4Engraftment timeframe (weeks)

1–2Immune recovery (yrs)

ManyInvestigational areas

35+References in section

Coverage Criteria and Indication-Specific Rules

inv-01: Non-cancer disorders: medically necessary vs investigational

Allogeneic HSCT indications for selected non‑cancer inherited immunodeficiencies and metabolic disorders are classified below. Investigational statements apply when criteria are not met.

Immunodeficiency indications (Allogeneic HSCT medically necessary): Allogeneic HSCT is considered medically necessary for a range of inherited immunodeficiencies including (but not limited to) adenosine deaminase deficiency; Artemis deficiency; CD40 ligand deficiency; common gamma chain deficiency; DiGeorge syndrome; DNA ligase IV deficiency; interleukin-7 receptor alpha deficiency; JAK3 deficiency; major histocompatibility class II deficiency; Omenn syndrome; purine nucleoside phosphorylase deficiency; RAG1/2 deficiency; reticular dysgenesis; Wiskott-Aldrich syndrome; X-linked lymphoproliferative disease; ZAP-70 deficiency; and phagocytic disorders such as Chédiak-Higashi, chronic granulomatous disease, Griscelli syndrome type 2, severe congenital neutropenias, and related listed disorders.

Chunks 18-19

Inherited metabolic disorders — proven effective (Allogeneic HSCT medically necessary): Allogeneic HSCT has been proven effective for selected inherited metabolic disorders including Hurler syndrome, Maroteaux-Lamy syndrome, Sly syndrome, childhood-onset cerebral X-linked adrenoleukodystrophy, globoid cell leukodystrophy (Krabbe), metachromatic leukodystrophy, alpha-mannosidosis, and aspartylglucosaminuria.

Policy Summary

PayerBlue Cross Blue Shield - South Dakota

PolicyHematopoietic Stem Cell Transplantation (HSCT) — Autologous and Allogeneic

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2018

Last ReviewApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting indication, prior therapies and response, donor match and transplant type before HSCT is approved.

SourceLink

On This Page

Inherited metabolic disorders — possibly effective: Allogeneic HSCT is possibly effective for additional metabolic disorders listed in policy (examples include fucosidosis; Gaucher disease types 1 and 3; Farber lipogranulomatosis; galactosialidosis; GM1 gangliosidosis; mucolipidosis II; multiple sulfatase deficiency; Niemann-Pick disease; neuronal ceroid lipofuscinosis; sialidosis; Wolman disease).

Chunk 19

Investigational metabolic indications (Allogeneic HSCT not effective): Allogeneic HSCT has not been effective for certain disorders (explicitly Hunter, Sanfilippo, and Morquio syndromes) and HSCT is considered investigational for genetic diseases not listed as effective above.

Chunk 20

inv-02: CNS and other solid tumors: covered vs investigational

Autologous HSCT and tandem HSCT coverage for CNS and other solid tumors is specified by indication; many adult solid tumor uses remain investigational.

Autologous HSCT — CNS tumors (medically necessary): Autologous HSCT may be considered medically necessary for primary CNS lymphoma as consolidation after a complete response, for relapsed or refractory PCNSL, and for embryonal CNS tumors (e.g., medulloblastoma and related embryonal tumors) as consolidation when there is response to induction chemotherapy or for recurrent disease responding to therapy. Tandem autologous HSCT for CNS tumors is considered investigational unless specifically indicated.

Chunks 21-22

Autologous HSCT — Germ cell tumors (medically necessary): Single autologous HSCT is medically necessary for testicular germ cell tumors after prior conventional chemotherapy as second-line therapy and as third-line salvage when prior lines have failed and no prior autologous transplant was given; tandem autologous HSCT may be medically necessary for platinum-refractory or salvage testicular tumors per policy.

Chunk 24

Autologous HSCT — Ovarian metastatic germ cell tumors (medically necessary): Single autologous HSCT may be medically necessary for recurrent metastatic ovarian germ cell tumors following complete response to induction chemotherapy or for residual disease after induction chemotherapy.

Chunk 24

SCCOHT (small cell carcinoma ovary hypercalcemic type): Single autologous HSCT may be considered medically necessary for SCCOHT when there are persistently elevated tumor markers and residual disease after induction therapy; other uses are investigational.

Chunk 27

Pediatric solid tumors (selected) — autologous/tandem HSCT: In children, single autologous HSCT may be medically necessary for high-risk Ewing sarcoma, high-risk or relapsed high-risk neuroblastoma, and metastatic retinoblastoma; tandem autologous HSCT (up to three planned tandem transplants) may be medically necessary for high-risk neuroblastoma per policy criteria.

Chunks 28-30

Adult solid tumors (generally investigational): Autologous or allogeneic HSCT is considered investigational for a broad list of adult solid tumors (including lung, colorectal, pancreatic, breast, renal, gynecologic, prostate, neuroendocrine, soft tissue sarcomas, melanoma, and others) because evidence is insufficient to demonstrate improved net health outcomes.

Chunk 28

inv-03: Blood cancers — ALL: medically necessary conditions and limits

Coverage for adult acute lymphoblastic leukemia (ALL) distinguishes autologous use when an allogeneic donor is unavailable and allogeneic use per standard indications.

Autologous HSCT — Adult ALL (medically necessary): Autologous HSCT may be considered medically necessary to treat adult ALL in first complete remission when no suitable allogeneic donor is available; and to treat relapsed or refractory adult ALL if complete remission is achieved following subsequent therapy and no suitable allogeneic donor is available.

Chunk 34

Allogeneic HSCT — Adult ALL (medically necessary): Allogeneic HSCT may be considered medically necessary for adult ALL in first complete remission (any risk), in second or greater complete remission for relapsed/refractory ALL, and for relapsed/refractory disease after prior autologous HSCT; reduced-intensity conditioning may be used for candidates unable to tolerate myeloablative regimens.

Chunk 35

Investigational HSCT — ALL: Autologous or allogeneic HSCT is considered investigational for ALL indications that do not meet the specific medically necessary criteria above.

Chunks 34-35

inv-04: Pediatric ALL HSCT coverage

Pediatric ALL coverage rules specify autologous versus allogeneic candidacy and investigational uses.

Autologous HSCT — medically necessary when ALL of the following apply: Autologous HSCT may be considered medically necessary for childhood ALL only when there is no suitable allogeneic donor available AND one of these clinical states is present: first complete remission (CR1); following induction failure; relapsed disease achieving second or greater complete remission after subsequent therapy; multiple relapses responsive to subsequent therapy achieving complete remission; or refractory disease achieving complete remission following subsequent therapy.

Chunks 45-46

Autologous HSCT — investigational: Autologous HSCT is considered investigational for pediatric ALL when it does not meet the medically necessary criteria above.

Chunk 48

Allogeneic HSCT — medically necessary: Allogeneic HSCT may be considered medically necessary for childhood ALL in first complete remission, following induction failure, for relapsed disease achieving second or greater complete remission after subsequent therapy, and for relapse or refractory disease after prior autologous HSCT.

Chunks 47-48

Allogeneic HSCT — investigational: Allogeneic HSCT is investigational for pediatric ALL when labeled investigational or when the specific medically necessary criteria are not met.

Chunk 48

inv-05: AML autologous HSCT coverage

Autologous HSCT for AML is described with specific donor-availability and response conditions; other uses are investigational.

Autologous HSCT — medically necessary for AML when ANY of the following apply: Autologous HSCT may be considered medically necessary for AML when an allogeneic donor is unavailable and the patient is in first complete remission (CR1) or beyond; OR for relapsed AML responsive to intensified induction chemotherapy in individuals who are not candidates for allogeneic HSCT.

Chunk 54

Autologous HSCT — investigational for AML: Autologous HSCT is considered investigational for AML indications that do not meet the above criteria because evidence is insufficient to demonstrate improved net health outcomes.

Chunk 55

inv-06: Autologous HSCT — AML

Autologous HSCT may be considered medically necessary for AML when ALL of the following are met:

Autologous HSCT for AML - criteria: Patient has acute myeloid leukemia (AML) and a suitable allogeneic donor is unavailable; AND one of the following applies: the patient is in first complete remission (CR1) or beyond; OR the patient has relapsed AML that is responsive to intensified induction chemotherapy and is not a candidate for allogeneic HSCT.

Chunks 54-55

inv-07: Autologous HSCT — investigational

Autologous HSCT investigational: Autologous HSCT is investigational for treatment of AML that does not meet the specified medically necessary criteria.

Chunk 55

inv-08: Allogeneic HSCT — myeloablative and reduced-intensity for AML

Allogeneic HSCT (myeloablative) is medically necessary for defined AML scenarios; reduced‑intensity regimens allowed when myeloablation is not tolerated.

Allogeneic HSCT (myeloablative) - AML indications: Allogeneic HSCT using a myeloablative conditioning regimen may be considered medically necessary for AML in first complete remission (CR1); for AML refractory to standard induction chemotherapy (failed induction); for relapsed or refractory AML; and for AML relapsed/refractory following prior autologous HSCT when the patient can be brought into complete remission with intensified induction chemotherapy and is medically able to tolerate the procedure.

Chunk 56

Reduced-intensity option: Reduced-intensity (non-myeloablative) allogeneic HSCT is medically necessary when the allogeneic HSCT indications are met but the patient cannot tolerate myeloablative conditioning (examples: age typically >60 years, organ dysfunction, prior intensive chemotherapy, low Karnofsky Performance Status).

Chunk 57

Allogeneic HSCT investigational: Allogeneic HSCT is considered investigational for AML when the specified criteria are not met.

Chunk 58

inv-09: Allogeneic HSCT — investigational

Allogeneic HSCT investigational: Allogeneic HSCT is considered investigational when it does not meet the specified medically necessary criteria because evidence is insufficient to demonstrate improved net health outcomes.

Chunks 58,65,67

inv-10: CLL/SLL and Richter's transformation

Coverage statements for CLL/SLL and Richter's transformation reflect autologous investigational status and selective allogeneic indications.

Autologous HSCT for CLL/SLL: Autologous HSCT is considered investigational for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) for all indications due to insufficient evidence.

Chunk 65

Allogeneic HSCT for CLL/SLL: Allogeneic HSCT may be considered medically necessary for CLL or SLL in individuals with markers of poor risk or in relapsed/refractory disease after prior therapy including BTK inhibitors and venetoclax-based regimens.

Chunk 66

HSCT for Richter's transformation: For chemotherapy-sensitive Richter's transformation (CLL/SLL transformed to DLBCL), either autologous or allogeneic HSCT may be considered medically necessary.

Chunk 68

inv-11: CML coverage

Allogeneic HSCT is an established option for CML under specified conditions.

Allogeneic HSCT for CML (myeloablative): Allogeneic HSCT using a myeloablative conditioning regimen may be considered medically necessary for the treatment of chronic myeloid leukemia (CML).

Chunk 76

inv-12: Reduced-intensity conditioning for CML

Reduced-intensity conditioning is an option when myeloablative regimens are not tolerated.

Reduced intensity option: Allogeneic HSCT using a reduced-intensity (non-myeloablative) conditioning regimen may be considered medically necessary for CML when the individual meets criteria for allogeneic HSCT but is not a candidate for myeloablative conditioning due to age (often >60 years), organ dysfunction, prior intensive therapy, or low performance status.

Chunk 77

inv-13: HL coverage

Hodgkin lymphoma transplant coverage reflects autologous consolidation and selective allogeneic salvage.

Autologous HSCT for HL: Autologous HSCT may be considered medically necessary for individuals with primary refractory or relapsed Hodgkin lymphoma (HL), where primary refractory refers to inability to achieve CR after frontline therapy.

Chunk 81

Allogeneic HSCT for HL: Allogeneic HSCT (myeloablative or reduced-intensity) may be considered medically necessary for primary refractory or relapsed HL and for individuals who relapse after prior autologous HSCT used to treat refractory or relapsed disease.

Chunk 83

inv-14: MM coverage

Multiple myeloma coverage includes autologous, tandem, and allogeneic sequencing rules.

Autologous HSCT for MM: A single autologous HSCT may be considered medically necessary following primary therapy; autologous HSCT is also medically necessary for progressive or relapsed MM in individuals who did not receive autologous HSCT initially; a repeat autologous HSCT may be considered for responsive MM relapsing after CR or VGPR after an initial autologous HSCT.

Chunk 86

Tandem autologous HSCT may be considered medically necessary after primary therapy in selected MM patients; tandem sequences may include an initial autologous HSCT followed by reduced-intensity conditioning and allogeneic HSCT in newly diagnosed MM in selected scenarios; tandem transplantation is a planned second autologous transplant within 6 months and is indicated when the patient fails to achieve at least near CR or VGPR after the first transplant in the sequence.repeat within <=6 months

Chunk 88

Allogeneic HSCT after autologous: Allogeneic HSCT may be considered medically necessary for MM following a single or tandem autologous HSCT for progressive disease; myeloablative conditioning is preferred but reduced-intensity conditioning may be used based on age/comorbidities.

Chunk 90

inv-15: Allogeneic HSCT for Multiple Myeloma

Allogeneic HSCT for multiple myeloma after autologous HSCT is covered when procedural and disease progression criteria are met.

Allogeneic HSCT after autologous HSCT: Allogeneic HSCT may be considered medically necessary for multiple myeloma following a single or tandem autologous HSCT for treatment of progressive disease (PD).

Myeloablative conditioning preferred; reduced-intensity allowable based on age/comorbidity (Chunk 90)

inv-16: Allogeneic HSCT for Myeloid/Lymphoid Neoplasms, MDS/MPN

Allogeneic HSCT is medically necessary for selected myeloid/lymphoid neoplasms and MDS/MPN when disease- and risk-based thresholds are met.

Indications for medically necessary allogeneic HSCT: Allogeneic HSCT may be considered medically necessary for juvenile myelomonocytic leukemia (JMML); chronic myelomonocytic leukemia (CMML); selected myelodysplastic syndromes meeting specified IPSS/IPSS-R/WPSS risk thresholds and lack of response to prior therapy; myelodysplastic disease progressing to advanced-phase AML; myeloproliferative neoplasms (e.g., myelofibrosis) in intermediate/high-risk individuals; and certain myeloid/lymphoid neoplasms with eosinophilia in blast phase or relapsed disease with specified molecular rearrangements (FGFR1, JAK2, FLT3, ABL1, PDGFRA, PDGFRB); reduced-intensity conditioning may be considered when myeloablative conditioning is not tolerated.IPSS/IPSS-R/WPSS thresholds as specified in policy

Chunks 99-104

inv-17: Autologous HSCT — Investigational Indications

Autologous HSCT is investigational for several myeloid/lymphoid neoplasm indications.

Autologous HSCT investigational: Autologous HSCT is considered investigational for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes, and for myelodysplastic syndromes and myeloproliferative neoplasms (including myelofibrosis) because evidence is insufficient to demonstrate improved net health outcomes.

Chunks 99-101

inv-18: Follicular lymphoma with histologic transformation

Follicular lymphoma with histologic transformation to DLBCL has defined consolidation criteria.

Follicular lymphoma with transformation: Autologous HSCT or allogeneic HSCT may be considered medically necessary for individuals with follicular lymphoma that has histologically transformed to diffuse large B-cell lymphoma (DLBCL) when disease is responsive to prior chemotherapy (CR or PR).

Chunk 111

inv-19: Nodal marginal zone lymphoma with histologic transformation

Nodal marginal zone lymphoma with transformation to DLBCL may meet HSCT criteria when responsive.

Nodal marginal zone lymphoma with transformation: Autologous HSCT or allogeneic HSCT may be considered medically necessary for nodal marginal zone lymphoma that has histologically transformed to DLBCL when disease is responsive to prior chemotherapy (CR or PR).

Chunks 112-113

inv-20: Mantle cell lymphoma

Mantle cell lymphoma (MCL) coverage includes autologous consolidation and allogeneic salvage options.

Autologous HSCT consolidation: Autologous HSCT may be considered medically necessary to consolidate a first complete remission following induction therapy for mantle cell lymphoma.

Chunk 114

Autologous HSCT in selected indolent MCL: Autologous HSCT may be medically necessary for individuals with indolent mantle cell lymphoma who are TP53 wild-type and have Stage II bulky noncontiguous, Stage III, or Stage IV disease after induction therapy with complete response.

Chunk 114

Allogeneic HSCT for relapsed/refractory MCL: Allogeneic HSCT may be considered medically necessary for relapsed or refractory mantle cell lymphoma using myeloablative or reduced-intensity conditioning as salvage therapy.

Chunk 114

inv-21: Diffuse large B-cell lymphoma (DLBCL)

DLBCL transplant coverage applies across salvage, chemosensitive relapse consolidation, and select first‑CR high‑risk consolidation scenarios.

DLBCL salvage therapy: Autologous or allogeneic HSCT may be considered medically necessary as salvage therapy for individuals who do not achieve a complete remission after first-line standard chemotherapy.

Chunk 116

DLBCL chemosensitive relapse consolidation: Autologous or allogeneic HSCT may be considered medically necessary to achieve or consolidate a CR for those in a chemosensitive first or subsequent relapse.

Chunk 116

DLBCL first CR consolidation: Autologous or allogeneic HSCT may be considered medically necessary to consolidate first CR in individuals with diffuse large B-cell lymphoma who have an age-adjusted IPI predicting high or high-intermediate risk of relapse.age-adjusted IPI high/high-intermediate

Chunks 116-118

inv-22: Burkitt lymphoma

Burkitt lymphoma consolidation rules for transplant coverage.

Burkitt lymphoma consolidation: Autologous HSCT or allogeneic HSCT may be considered medically necessary for relapsed Burkitt lymphoma that is responsive to second-line therapy (CR or PR) as consolidation therapy.

Chunks 119-120

inv-23: HIV-related B-cell lymphoma

HIV-related B-cell lymphoma transplant coverage in high‑risk first CR scenarios.

HIV-related B-cell lymphoma in high-risk first CR: Autologous HSCT is considered medically necessary for individuals with HIV-related B-cell lymphoma who are in first complete remission and have high-risk features (e.g., age-adjusted IPI >2, MYC rearrangement, TP53 deletion); optimization of HIV control is required.high-risk features as listed

Chunks 121-122

inv-24: Investigational indications

Investigational HSCT indications: Autologous or allogeneic HSCT is considered investigational for the listed lymphoma and related indications when the specific medical necessity criteria are not met (including mantle cell lymphoma not meeting criteria, nodal marginal zone lymphoma not meeting criteria, DLBCL not meeting criteria, Burkitt lymphoma outside criteria, HIV-related B-cell lymphoma outside criteria). Tandem transplants for non-Hodgkin lymphomas are investigational.

Chunks 112-117,119-125

inv-25: Reduced intensity (non-myeloablative) allogeneic HSCT

Reduced‑intensity (non‑myeloablative) allogeneic HSCT is an alternative for patients who cannot tolerate myeloablative conditioning.

Reduced intensity allogeneic HSCT: Reduced-intensity (non-myeloablative) allogeneic HSCT may be considered medically necessary for non-Hodgkin B-cell lymphomas when the individual meets criteria for allogeneic HSCT but cannot tolerate myeloablative conditioning (e.g., age >60 years, significant comorbidities, low Karnofsky Performance Status).unable to tolerate myeloablative conditioning

Chunk 123

inv-26: Pediatric aggressive NHL transplant coverage

Pediatric aggressive mature B‑cell lymphoma coverage follows NCCN-based mappings for relapsed/refractory disease.

Pediatric aggressive NHL relapsed/refractory: Autologous HSCT or allogeneic HSCT may be considered medically necessary for pediatric aggressive mature B-cell lymphomas (pediatric Burkitt lymphoma or pediatric DLBCL) for relapsed or refractory disease when NCCN criteria are met; choice of autologous vs allogeneic may be individualized where evidence does not favor one approach.NCCN criteria

Chunks 134-136

inv-27: Primary cutaneous and cutaneous T-cell lymphoma transplant coverage

Primary cutaneous lymphomas and cutaneous T‑cell lymphomas have distinct autologous vs allogeneic stances.

Autologous HSCT for primary cutaneous lymphomas: Autologous HSCT is considered investigational for primary cutaneous lymphomas for all indications due to insufficient evidence of improved net health outcomes.

Chunk 139

Allogeneic HSCT for MF/SS and select T-cell lymphomas: Allogeneic HSCT may be considered medically necessary for stage IIB-IV Mycosis fungoides/Sezary Syndrome refractory or relapsed after multiple prior therapies, for MF/SS with large cell transformation, and for selected subcutaneous panniculitis-like T-cell lymphoma (SPTCL) with systemic or high-risk disease; reduced-intensity conditioning may be used if the candidate cannot tolerate myeloablative regimens.refractory/relapsed after multiple prior therapies

Chunks 139-141

inv-28: Tandem transplants

Tandem transplant policy statement.

Tandem transplants for NHL: Tandem transplants are considered investigational for non-Hodgkin lymphomas because evidence is insufficient to demonstrate improved net health outcomes.

Chunk 143

inv-29: Peripheral T‑cell lymphomas

Peripheral T‑cell lymphoma coverage reflects autologous consolidation and allogeneic salvage roles.

Autologous HSCT may be considered medically necessary for peripheral T-cell lymphomas following a complete response (CR; PET negative) and as salvage therapy (including PR or progressive disease) per policy criteria.CR (PET negative) OR salvage setting

Chunk 146

Allogeneic HSCT may be considered medically necessary as salvage therapy for peripheral T-cell lymphomas and may be considered for refractory or relapsed disease after second-line therapy with CR or PR as consolidation; uses outside these criteria are investigational.salvage OR post-second line CR/PR

Chunk 146

inv-30: Adult T‑cell leukemia/lymphoma (ATLL)

Adult T‑cell leukemia/lymphoma (ATLL) coverage rules differentiate autologous investigational status from selective allogeneic indications.

Autologous HSCT is considered investigational for ATLL for all indications.

Chunk 148

Allogeneic HSCT may be considered medically necessary for ATLL in patients responding after two cycles of first-line therapy, or for individuals with no response to first-line therapy who respond to second-line therapy; allogeneic HSCT outside these criteria is investigational.response after 2 cycles OR response to second-line after primary nonresponse

Chunks 149-150

inv-31: T‑cell prolymphocytic leukemia

T‑cell prolymphocytic leukemia coverage when donor availability varies.

Autologous HSCT may be considered medically necessary when no suitable allogeneic donor is available and the individual has achieved a CR or PR to first-line therapy.no suitable donor AND CR or PR to first-line

Chunk 151

Allogeneic HSCT may be considered medically necessary for individuals with CR or PR to first-line therapy.CR or PR to first-line

Chunk 151

inv-32: Extranodal NK/T‑cell lymphoma (nasal and extranasal)

Extranodal NK/T‑cell lymphoma transplant rules by stage.

Stage I-II nasal type relapsed/refractory: Autologous or allogeneic HSCT may be considered medically necessary for Stage I-II nasal type relapsed or refractory disease.relapsed/refractory

Chunk 154

Stage III-IV nasal type: Autologous or allogeneic HSCT may be considered medically necessary for Stage III-IV nasal type disease when achieving CR and biopsy negative after induction therapy OR achieving PR and biopsy negative after induction therapy.CR+biopsy negative OR PR+biopsy negative

Chunk 154

Extranasal Stage I-V: Autologous or allogeneic HSCT may be considered medically necessary for extranasal disease Stage I-V when achieving CR and biopsy negative after induction therapy OR PR and biopsy negative after induction therapy, and for relapsed/refractory extranasal disease.CR+biopsy negative OR PR+biopsy negative OR relapsed/refractory

Chunk 154

inv-33: Hepatosplenic T‑cell lymphoma and other T‑cell lymphoma subtypes

Hepatosplenic and other T‑cell lymphoma subtype coverage statements.

Autologous HSCT for hepatosplenic T-cell lymphoma: Autologous HSCT may be considered medically necessary to consolidate a response when no suitable donor is available and the individual has had CR or PR.no suitable donor AND CR or PR

Chunk 156

Allogeneic HSCT for hepatosplenic T-cell lymphoma: Allogeneic HSCT may be considered medically necessary to consolidate a response for individuals with CR or PR.CR or PR

Chunk 156

inv-34: Reduced intensity conditioning

Reduced‑intensity conditioning may be used when standard myeloablative conditioning is not tolerated.

Reduced intensity (non‑myeloablative) allogeneic HSCT: Reduced-intensity (non-myeloablative) allogeneic HSCT may be considered medically necessary for non-Hodgkin lymphoma/T-cell lymphomas in individuals who meet criteria for allogeneic HSCT but cannot tolerate myeloablative conditioning (e.g., age typically >60 years, comorbidities, low Karnofsky score).unable to tolerate myeloablative conditioning

Chunk 158

inv-35: Autologous HSCT — POEMS

POEMS syndrome transplant coverage.

Autologous HSCT for disseminated POEMS: Autologous HSCT may be considered medically necessary for the treatment of disseminated POEMS syndrome (e.g., diffuse sclerotic lesions or disseminated bone marrow involvement); tandem HSCT for POEMS is investigational.disseminated disease

Chunk 165

inv-36: Allogeneic HSCT — ASM

Allogeneic HSCT indications for Aggressive Systemic Mastocytosis (ASM).

Indications for allogeneic HSCT in ASM: Allogeneic HSCT may be considered medically necessary for ASM after adequate response to first-line treatment, or when there is inadequate response or loss of response evidenced by return/progression of SM-related organ damage, symptomatic or progressive hepatomegaly or splenomegaly, progressive disease-related symptoms, or intolerance to drug therapy.

Chunk 170

inv-37: Allogeneic HSCT — SM-AHN

Allogeneic HSCT criteria for SM-AHN emphasize prioritization of the AHN component and response/progression parameters.

Indications for allogeneic HSCT in SM-AHN: Allogeneic HSCT may be considered medically necessary for SM-AHN when the associated hematologic neoplasm (AHN) requires prioritization, or when there is progression, inadequate response, or loss of response as specified (including return/progression of organ damage, progressive hepatosplenomegaly, progressive symptoms, or drug intolerance), and when WHO-defined AHN criteria are met.

Chunk 171

inv-38: Allogeneic HSCT — MCL

Allogeneic HSCT may be appropriate for Mast Cell Leukemia under defined response/progression circumstances.

Indications for allogeneic HSCT in MCL: Allogeneic HSCT may be considered medically necessary for mast cell leukemia (MCL) with or without associated hematologic neoplasm after adequate response to first-line treatment, for progression of the AHN or transformation to AML, or for inadequate response/loss of response including return/progression of SM-related organ damage.

Chunk 172

inv-39: Investigational

Investigational designations summarized.

Investigational uses: Autologous HSCT is investigational for any subtype of systemic mastocytosis; tandem HSCT is investigational for POEMS syndrome; and allogeneic HSCT is investigational when the specified medically necessary criteria for ASM, SM-AHN, MCL, or other conditions are not met.

Chunks 169,168,173

inv-40: HSCT Coverage Criteria

General HSCT coverage prerequisites and definitions relevant to medical necessity determinations.

General HSCT coverage prerequisites: High-dose chemotherapy and/or radiotherapy precede HSCT; documentation must specify stem cell source (autologous, allogeneic, syngeneic) and conditioning intensity (myeloablative or non-myeloablative).

Chunk 193

Donor types: Donor sources include matched related, matched unrelated, haploidentical, or cord blood depending on clinical context; when allogeneic HSCT is medically necessary the donor must be appropriately HLA matched.

Chunks 193,197

Reduced-intensity conditioning consideration: Reduced-intensity (non-myeloablative) regimens are considered for candidates who would otherwise qualify for myeloablative HSCT but would not tolerate standard conditioning (e.g., age >60, comorbidities, low Karnofsky).

Chunks 197,198

Tandem transplant definition and coverage logic: Tandem transplantation refers to a planned second transplant performed within 6 months of the initial transplant; this is distinct from repeat transplantation performed >6 months later and has discrete coverage considerations.<=6 months

Chunk 199

inv-41: Indication classification and coverage logic

Indication classifications (S/C/R/D/N) guide coverage determinations by matching patient disease/status to table entries.

Standard of Care (S): Indications classified as Standard of Care (S) are well defined and generally supported by high-quality trials/observational studies; HCT considered routine care.

Chunk 212

Standard of Care, Clinical Evidence Available (C): Indications with cohort or smaller trials supporting HCT; can be considered after evaluation of risks/benefits.

Chunk 212

Standard of Care, Rare Indication (R): Rare diseases with supportive registry/single-center data where HCT may be an option after individualized assessment.

Chunk 212

Developmental (D): Indications with early-phase/preclinical evidence where HCT is best pursued in clinical trials.

Chunk 212

Not Generally Recommended (N): Indications lacking evidence or where HCT is not supported for routine use; such indications are considered investigational unless in trials.

Chunk 212

inv-42: Pediatric indications mapping (excerpt)

Pediatric indication mapping excerpt demonstrates how disease and remission/status map to coverage categories.

Pediatric AML/ALL/MDS mapping (excerpt): Pediatric indications list per-disease and remission/status codes: examples include CR1 high-risk Allogeneic = S, Autologous = N; CR2+ Allogeneic = S, Autologous = N; MDS low risk Allogeneic = C, Autologous = N; and other specific mappings noted in the pediatric tables.

Chunks 213-217

Pediatric solid tumor mappings (excerpt): Selected pediatric solid tumors have assigned codes: neuroblastoma high risk or relapse Allogeneic = D or N per table entries, autologous designations vary; germ cell tumor relapse/autologous mappings listed.

Chunks 216-217

inv-43: Indication-based coverage classifications

Indication-based coverage classifications are provided per disease and remission/status using letter codes; providers must match the patient to the table entry.

Per-disease indication mapping (adult & pediatric excerpts): Indication tables assign coverage codes (S, C, R, D, N) by disease and remission/status; examples include adult AML CR1 low risk Allogeneic = N, Autologous = C; myeloma initial response autologous = D/ S depending on scenario; lymphoma entries vary by PET status and relapse/resistance; nonmalignant diseases include sickle cell (C/N) and thalassemia (S/N).

Chunks 216-227

Autologous or allogeneic hematopoietic stem cell transplantation (HSCT) described as investigational in the policy (for example, HSCT for certain inherited metabolic disorders such as Hunter, Sanfilippo, and Morquio syndromes, and many adult solid tumors) are excluded from medical necessity coverage because the evidence is insufficient to demonstrate improved net health outcomes.

The policy treats procedures explicitly labeled investigational as not supported for routine coverage. Requests for HSCT in indications classified as investigational (including many adult solid tumors and uses of tandem HSCT outside specified indications) are at risk for denial due to insufficient evidence of improved net health outcomes.

When a transplant indication does not meet the disease‑specific medically necessary criteria laid out in the policy (for autologous or allogeneic HSCT), the procedure is considered investigational and therefore not covered. Examples include autologous HSCT for AML or CLL/SLL when the stated criteria are not satisfied, and allogeneic HSCT outside listed indications.

Autologous HSCT is specifically described as investigational for chronic myeloid leukemia (CML). For CML meeting allogeneic HSCT criteria but who cannot tolerate myeloablative conditioning, a reduced‑intensity (non‑myeloablative) allogeneic regimen may be considered medically necessary.

For Hodgkin and non‑Hodgkin lymphomas, the policy delineates covered scenarios and investigational exclusions. Autologous or allogeneic HSCT that do not meet the specified lymphoma‑subtype and response criteria are considered investigational and may be denied. The policy also notes that individuals who are partial responders to second‑line therapy or have progressive/refractory disease are generally not candidates for transplant and should be managed with alternative therapies.

Allogeneic HSCT for Hodgkin lymphoma is medically necessary for primary refractory or relapsed disease and for relapse after prior autologous HSCT used to treat refractory/relapsed disease. Use of allogeneic HSCT as up‑front consolidation of first complete remission, or autologous HSCT scenarios that do not meet the stated criteria (including certain second autologous or tandem transplants), are labeled investigational.

Allogeneic HSCT coverage requires documentation of appropriate clinical and procedural elements (donor source, conditioning regimen type, and indication). When allogeneic HSCT does not meet the policy's disease‑specific criteria it is considered investigational and therefore not covered.

Tandem transplants and repeat high‑dose transplants for lymphoma are addressed: planned tandem transplants are generally considered investigational for non‑Hodgkin lymphomas and are excluded unless specifically allowed by criteria in the policy.

The policy states that tandem HSCT for non‑Hodgkin lymphoma is investigational. For pediatric aggressive NHL, autologous or allogeneic HSCT may be medically necessary for relapsed/refractory disease per NCCN criteria; outside those scenarios tandem approaches remain investigational.

Autologous HSCT for primary cutaneous lymphomas is considered investigational. For T‑cell and NK‑cell lymphoma subtypes, autologous or allogeneic HSCT is investigational when the policy's specific medically necessary criteria are not met.

Autologous HSCT is considered investigational for systemic mastocytosis of any subtype. Allogeneic HSCT may be considered medically necessary for aggressive systemic mastocytosis (ASM), SM‑AHN, or mast cell leukemia (MCL) only when the detailed disease‑specific criteria in the policy are satisfied.

Reduced‑intensity (non‑myeloablative) conditioning regimens are allowed when candidates meet allogeneic HSCT indications but cannot tolerate myeloablative conditioning (examples include age typically >60 years, organ dysfunction, prior intensive chemotherapy, or low Karnofsky Performance Status). Reduced‑intensity approaches are the preferred alternative rather than outright exclusion when myeloablation is not tolerated.

Across the policy, indications that do not meet the specified medically necessary criteria are treated as investigational and excluded from coverage. Procedural requests for HSCT in these investigational scenarios may be denied for lack of evidence demonstrating improved net health outcomes.

The policy includes indication tables that assign coverage codes; examples of codes used to denote non‑coverage include entries labeled 'N' (not generally recommended/not covered). These table entries illustrate specific disease/remission combinations that are explicit denial examples.

The document provides reference examples and a bibliography supporting clinical statements; these references underpin investigational determinations when evidence is judged insufficient.

The policy gives examples where investigational status equates to not medically necessary. When indications are classified as investigational (e.g., many adult solid tumors and listed genetic/metabolic disorders), they are not considered medically necessary and are excluded from coverage.

Specific investigational examples in the policy include: autologous HSCT for AML or CLL/SLL when criteria are not met; autologous HSCT for myeloid/lymphoid neoplasms with eosinophilia and for MDS/MPN; and many solid tumor indications. These uses are labeled investigational due to insufficient evidence of improved net health outcomes.

Throughout the policy, the terms investigational and not medically necessary are used interchangeably: procedures deemed investigational are treated as not medically necessary and therefore are excluded from coverage.

Autologous HSCT is explicitly not medically necessary for AML or CLL/SLL when the policy's specific autologous HSCT criteria are not satisfied. The policy states autologous HSCT for those conditions outside listed indications is investigational and not covered.

Tandem HSCT is considered investigational for several indications: the policy specifically labels tandem HSCT for POEMS syndrome and many other lymphoma and solid tumor settings as investigational and therefore not medically necessary unless explicit criteria allow it.

Allogeneic HSCT is considered investigational when the detailed coverage criteria for ASM, SM‑AHN, MCL, or other conditions are not met; in such cases allogeneic HSCT is treated as not supported for coverage.

The policy contains explicit examples of not medically necessary scenarios in its tables: multiple disease/remission combinations are assigned an 'N' code indicating non‑coverage for that HCT type and clinical scenario (for example, certain CR1 low‑risk AML and other listed entries).

Transplant Candidate Selection and Donor Matching

inv-169: Candidate and donor matching criteria

Prior authorization should document indication, prior therapies and response, remission status, and donor matching when applicable.

Prior authorization required elements: Prior authorization requests for HSCT must document the clinical indication, prior lines of therapy and response (including relapse status or induction response where applicable), disease remission/response category, and donor HLA matching or lack of suitable donor when allogeneic HSCT is considered.

Chunks 21,24,29,34

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Obtain prior authorization with indication, prior therapy, response, and donor match

Prior authorization must document the clinical indication, prior lines of therapy and treatment response, and donor match when applicable; include remission or relapse status (e.g., for germ cell tumors or CNS lymphoma) and whether a suitable HLA-matched donor is available for allogeneic transplant.

Document the specific indication and disease status (remission/relapse).
List prior systemic therapies and responses (number of lines and best response).
If allogeneic HSCT is requested, document donor type and HLA match status.

Prior Authorization

Prior authorization required for listed HSCT indications

Prior authorization is required when HSCT is requested for the policy’s listed medically necessary indications; the request must show the patient meets the disease‑specific criteria cited in the policy (e.g., pediatric ALL without a suitable allogeneic donor; AML autologous HSCT when no donor is available and in CR1 or responsive relapse).

Attach documentation showing the patient meets the specific medically‑necessary criteria for the requested transplant type.
If criteria are not met, the request may be considered investigational and denied.

Prior Authorization

Submit prior authorization for autologous or allogeneic HSCT

Prior authorization is expected for autologous and allogeneic HSCT; medical necessity determinations will be based on whether the request meets the disease‑specific coverage criteria in the policy (including conditioning intensity decisions and donor availability).

Provide disease‑specific evidence that the patient meets policy criteria.
Specify whether reduced‑intensity conditioning is being requested and why (if patient unable to tolerate myeloablative conditioning).

Prior Authorization

Document disease status and prior transplant/therapy response for prior auth

Prior authorization must include documentation of disease status (e.g., primary refractory, relapsed disease, prior transplant history) and the patient’s response to prior therapies to justify the requested HSCT.

Include pathology/imaging and response assessments supporting current disease status.
Report prior transplant history and responses to prior salvage or induction therapies.

Prior Authorization

Document prior autologous HSCT and conditioning justification for allogeneic requests

When requesting allogeneic HSCT after prior autologous HSCT (e.g., for progressive multiple myeloma), prior authorization must document the prior autologous transplant and justify the need for allogeneic HSCT; indicate rationale for reduced‑intensity conditioning if myeloablative conditioning is not tolerated.

Provide records of prior autologous HSCT and evidence of progressive disease.
If reduced‑intensity conditioning is proposed, document age/comorbidities or other reasons the patient cannot tolerate myeloablative conditioning.

Prior Authorization

Prior authorization for lymphoma HSCT and reduced‑intensity conditioning

Prior authorization is required for HSCT in indicated lymphoma subtypes and for use of reduced‑intensity conditioning in patients unable to tolerate myeloablative regimens; requests must show the patient meets the policy’s lymphoma‑specific criteria.

For lymphoma indications, include staging, histology, and response to induction/salvage therapy.
If requesting reduced‑intensity conditioning, document reasons (e.g., age >60, comorbidities, low Karnofsky).

Prior Authorization

Show NCCN‑based criteria met for pediatric aggressive NHL or cutaneous T‑cell lymphoma prior auth

For relapsed or refractory pediatric aggressive NHL or advanced cutaneous T‑cell lymphomas, prior authorization should demonstrate that HSCT is being considered per NCCN‑based criteria and that the individual meets the policy’s disease‑specific requirements.

Provide NCCN‑aligned disease stage/response documentation for pediatric aggressive NHL.
For cutaneous T‑cell lymphomas, include prior therapies and evidence of refractory/relapsed disease after multiple treatments.

Prior Authorization

Confirm policy criteria and conditioning need in prior authorization

Prior authorization must confirm the individual meets the medically necessary criteria in the policy (disease subtype/stage and response status) and whether reduced‑intensity conditioning is indicated due to age or comorbidities.

Map the patient’s disease/subtype and remission/status to the policy criteria.
If reduced‑intensity conditioning is planned, include clinical rationale (age, organ dysfunction, low Karnofsky).

Prior Authorization

Specify transplant type, conditioning intensity, and donor source in authorization

Prior authorization must specify the transplant type (autologous, allogeneic, syngeneic), the planned conditioning intensity (myeloablative versus reduced‑intensity/non‑myeloablative), and the donor source when applicable.

State whether the transplant is autologous, allogeneic, syngeneic, or planned tandem.
Specify conditioning intensity and the clinical justification for that intensity.

Prior Authorization

Include transplant type, tandem plan, and indication classification on authorization

Authorization requests should identify whether the transplant is autologous or allogeneic, indicate if a planned tandem transplant is intended (repeat infusion within 6 months), and include the indication classification per the policy’s guideline categories to justify medical necessity.

If tandem transplant is planned, document timing (repeat infusion ≤6 months) and rationale.
Map the indication to the policy classification (S, C, R, D, or N) to support the coverage stance.

Prior Authorization

Match patient’s clinical scenario to policy indication codes for authorization

Prior authorization approvals depend on mapping the patient’s disease, remission status, and prior therapies to the policy’s indication‑specific categorizations (codes such as S, C, R, D, N); include those mappings and supporting documentation in the request.

Document disease, remission/status, and prior therapies to match a favorable policy code.
If no favorable code applies, expect potential denial as investigational or not recommended.

Note

Bibliography/reference lists do not provide prior authorization details

Reference sections in the bibliography do not list prior authorization codes or operational authorization requirements; do not rely on reference‑only chunks for authorization criteria.

Use the policy’s prior authorization modules and clinical criteria rather than reference lists to prepare authorization requests.

Note

Reference‑only chunks contain no prior authorization rules

The reference sections of the policy do not specify prior authorization procedures or codes; ensure authorization requests rely on the policy’s prior_auth/documentation sections rather than reference‑only chunks.

Do not assume authorization criteria are present in the cited references—use the policy text that defines prior authorization requirements.

Step Therapy

Document prior systemic therapy and failures for tumor indications

For certain tumor types (for example, testicular germ cell tumors and neuroblastoma), HSCT is considered after failure of conventional chemotherapy lines; document prior systemic therapy attempts and responses when requesting HSCT.

List prior chemotherapy lines (first, second, etc.) and the response achieved.
For tandem transplant requests (where applicable), document prior therapy failures that justify tandem sequencing.

Step Therapy

Document donor‑of‑choice sequencing and donor availability

When an allogeneic donor is preferred but unavailable, document donor‑of‑choice sequencing and donor availability; autologous HSCT may be considered when a suitable allogeneic donor is not available.

State whether a suitable HLA‑matched related or unrelated donor was sought and unavailable.
If autologous HSCT is proposed because no allogeneic donor exists, include documentation of the unavailability of a matched donor.

Step Therapy

Document prior CLL/SLL therapies before considering allogeneic HSCT

For CLL/SLL, document prior therapies (including BTK inhibitors and venetoclax‑based regimens) and disease status; allogeneic HSCT is considered an option for relapsed/refractory disease after these therapies.

List prior targeted agents and regimens tried and the best response.
Attach evidence of relapsed/refractory status after guideline‑recommended systemic therapies.

Step Therapy

Document transplant sequencing and prior therapies for multiple myeloma

For multiple myeloma, document sequencing of transplants and prior therapies: autologous HSCT is positioned after primary therapy, tandem HSCT has timing and indication limits (planned second transplant within 6 months), and allogeneic HSCT is considered after autologous HSCT for progressive disease.

Document whether the patient had prior autologous HSCT and the response interval.
If proposing a tandem transplant, document rationale and planned timing (≤6 months).
For allogeneic HSCT after autologous HSCT, provide evidence of progressive disease.

Prior Authorization

Document prior autologous HSCT and progression if requesting allogeneic HSCT for MM

Prior authorization should document sequencing considerations when proposing allogeneic HSCT after autologous HSCT for multiple myeloma — include prior autologous transplant details and evidence of progressive disease to support the request.

Provide prior autologous HSCT operative and outcome notes and evidence showing progression after that transplant.
If proposing allogeneic HSCT, justify conditioning choice and donor source.

Step Therapy

Document prior therapies and alternatives before further transplant in multiply relapsed lymphoma

Before additional transplants in multiply relapsed B‑cell lymphomas, the policy recommends considering anti‑CD19 CAR T‑cell therapy (if not previously given), clinical trials, or alternative second‑line therapy; document prior conventional therapy attempts and reasons these alternatives are not appropriate when requesting further HSCT.

Show whether CAR T therapy was given or considered and why it was not appropriate.
Document prior conventional therapies and failures to support HSCT candidacy.

Documentation Required

Provide evidence of prior salvage therapies and conditioning tolerance for reduced‑intensity requests

Document evidence of prior salvage therapies or intolerance to myeloablative conditioning when requesting reduced‑intensity (non‑myeloablative) conditioning; include age, comorbidities, prior intensive chemotherapy, and Karnofsky Performance Status.

Provide objective measures (age, organ function tests, comorbidity list) supporting inability to tolerate myeloablative conditioning.
Include Karnofsky or ECOG performance status scores.

Documentation Required

Document prior lines of therapy and response (line‑of‑therapy documentation)

Document the prior lines of therapy and the line‑of‑therapy status (salvage vs consolidation) and the patient’s response; the policy distinguishes consolidation after response to second‑line therapy versus salvage therapy and requires documentation of prior lines and responses.

List each prior systemic therapy line, dates, and best response.
Classify whether HSCT is proposed as consolidation or salvage and attach supporting treatment records.

Prior Authorization

Document prior medical therapy response for mast cell disorders and MCL before HSCT

For ASM, SM‑AHN, and MCL, HSCT is considered after adequate response to first‑line treatment or when there is inadequate response or loss of response with progression or organ damage; prior authorization must document prior medical therapy response and the specific criteria that are met.

Provide records of initial therapy and objective evidence of response or progression.
Document specific events (organ damage, hepatosplenomegaly progression, AHN progression) that trigger consideration of HSCT.

Documentation Required

Record prior/conventional therapy attempts and reasons HSCT is next

Document prior conventional therapy attempts and failures to support HSCT requests; evidence‑based guideline categories in the policy imply stepwise consideration of standard therapies before HSCT.

Attach records showing failure, intolerance, or ineligibility for conventional therapies when relevant.
If a guideline‑recommended alternative exists (e.g., CAR T for relapse), document why it is not suitable.

Note

Reference entries contain no additional step therapy rules

No step therapy rules are specified in the policy reference entries; do not assume additional administrative step therapy requirements beyond the documented prior therapy expectations in the clinical criteria.

Follow the policy’s specific clinical step/sequence statements rather than reference lists for step therapy expectations.

Documentation Required

Document donor HLA matching and disease status for allogeneic HSCT requests

When allogeneic transplantation is considered medically necessary, document donor HLA matching (matched related, unrelated matched, cord blood, or haploidentical) and provide the candidate’s remission/disease status and suitability for myeloablative versus reduced‑intensity conditioning.

Include HLA matching report and donor type.
Provide remission status and rationale for chosen conditioning intensity.

Documentation Required

Provide clinical response documentation including CR/CRi/CRh, counts, and MRD

Include objective clinical response documentation in the authorization request: response category (CR/CRi/CRh/MLFS), marrow and blood counts (ANC, platelets), and MRD assessment where applicable (note MRD should be obtained as it is not part of morphologic assessment).

Attach marrow/aspirate reports and peripheral blood counts.
Provide MRD testing results (NGF/NGS) when applicable and imaging reports (FDG‑PET/CT) if relevant.

Documentation Required

Include performance status and hematologic response in documentation

Required documentation should include performance status (Karnofsky or ECOG), explicit response status (CR, CRi, CRh, PR, refractory, relapsed), and bone marrow/blast counts to support medical necessity for HSCT.

Report Karnofsky and/or ECOG performance status scores.
Include bone marrow blast percentage and classification of response category.

Documentation Required

Justify conditioning regimen selection in documentation

Document the clinical rationale for the chosen conditioning regimen (myeloablative vs reduced‑intensity): include age, comorbidities, organ dysfunction, prior intensive chemotherapy, and Karnofsky Performance Status to justify non‑myeloablative approaches.

Describe specific organ dysfunction or comorbidities affecting conditioning tolerance.
Provide prior therapy history that influences conditioning selection.

Documentation Required

Provide IMWG response and MRD/imaging results for MM prior authorization

For multiple myeloma requests, record IMWG response category, MRD results (NGF/NGS with sensitivity ≥1 in 10^5), and imaging findings (FDG‑PET/CT) as applicable to establish disease status prior to HSCT.

Include IMWG response documentation (CR, VGPR, PR, etc.).
Provide MRD testing method and sensitivity and FDG‑PET/CT imaging reports when used.

Documentation Required

Include WHO diagnostic criteria documentation for PV and ET

Diagnostic documentation per WHO 5th Edition is required for PV and ET indications: include laboratory values (hemoglobin/hematocrit for PV; platelet count for ET), bone marrow biopsy findings, and mutation testing (JAK2, CALR, MPL) as specified in the policy.

Attach lab values meeting WHO diagnostic thresholds (e.g., hemoglobin/hematocrit or platelet count).
Provide bone marrow biopsy report and molecular mutation testing results.

Documentation Required

Provide staging, histology, and prognostic indices for lymphoma HSCT requests

Staging and diagnostic documentation must be provided for lymphoma indications: determine extent with PET/CT for PET‑avid lymphomas (CT for non‑avid), and include stage, histology, and relevant prognostic indices (e.g., IPI) to support the transplant indication.

Attach PET/CT or CT staging reports and pathology confirming histologic subtype.
Provide IPI score or other prognostic indices used in decision making.

Documentation Required

Document subtype, stage, treatment response, and donor availability for NK/T‑cell lymphoma HSCT

Documentation to support disease subtype, stage, response to induction/salvage therapy, and donor availability is required for extranodal NK/T‑cell lymphoma and related subtypes when requesting HSCT.

Include biopsy results, stage, and response to induction or salvage therapy.
Document whether a suitable donor is available when autologous vs allogeneic choice is relevant.

Documentation Required

Provide WHO diagnostic documentation for SM and SM‑AHN

Diagnostic documentation for systemic mastocytosis (SM) and SM‑AHN must demonstrate fulfillment of systemic mastocytosis criteria (major + minor or >3 minor) and, for SM‑AHN, WHO‑defined criteria for the associated hematologic neoplasm; include KIT mutation and tryptase/ marrow findings where applicable.

Provide bone marrow pathology showing major/minor SM criteria.
Include mutation testing (KIT p.D816V) and serum tryptase and documentation of AHN criteria if SM‑AHN is claimed.

Documentation Required

Document mobilization/harvest method, conditioning, and engraftment monitoring

Include mobilization and harvest method (bone marrow aspiration vs peripheral blood apheresis), the planned conditioning regimen, and engraftment monitoring plans (blood counts and possible marrow aspiration) in pre‑approval documentation.

State mobilization agents/methods and harvest source.
Describe engraftment monitoring plan and expected timeframes.

Documentation Required

Classify indication and state transplant type/tandem plan in documentation

Document whether the transplant is autologous, allogeneic, or planned tandem (with timing), and align the clinical indication to the policy’s guideline classification (S, C, R, D, N) when submitting authorization requests.

If planning a tandem transplant, state intended interval (repeat infusion within 6 months).
Map the indication to the policy classification and provide supporting evidence.

Documentation Required

Document cord blood banking counseling and informed decision‑making for parents

For expectant parents considering private cord blood banking, provide counseling documentation that parents reviewed contracts, financial responsibilities, quality standards, median nucleated cell dose, and accreditation of the cord blood bank.

Include evidence that parents received information on public donation preference and low likelihood of private use.
Document review of bank accreditation and unit quality metrics if parents choose private banking.

Note

References do not substitute for documentation requirements

The policy’s bibliography provides references only and does not itself list documentation or administrative requirements for authorization; rely on the policy’s documentation requirements rather than reference lists when preparing requests.

Do not use the reference list as a substitute for required clinical documentation in authorization packets.

Denial Risk

Investigational indications may be denied

Requests for HSCT for indications explicitly labeled investigational in the policy (examples include Hunter, Sanfilippo, Morquio syndromes and many listed adult solid tumors) are at risk for denial due to insufficient evidence of improved net health outcomes.

Confirm the proposed indication against the policy’s investigational lists before submitting authorization.
If the indication is investigational, expect denial unless part of an approved clinical trial.

Denial Risk

Investigational procedures are at risk for denial

Procedures described as investigational in the policy (autologous or allogeneic HSCT for investigational indications) may be denied because evidence is insufficient to demonstrate improved net health outcomes.

If the policy labels the procedure investigational for the indication, supply clinical trial enrollment information if applicable.
Be aware that investigational designation generally results in non‑coverage.

Denial Risk

Requests not meeting criteria are investigational and may be denied

When a requested HSCT does not meet the policy’s medically necessary criteria for that indication (e.g., autologous HSCT for AML or CLL/SLL outside specified scenarios, or allogeneic HSCT when criteria are unmet), the procedure will be considered investigational and is at risk for denial.

Ensure the request maps to the policy’s specified medically necessary criteria; otherwise anticipate investigational determination.
Provide compelling evidence if seeking coverage for borderline scenarios.

Denial Risk

Investigational scenarios (repeat/tandem/other) may be denied

Requests for HSCT in scenarios explicitly labeled investigational in the policy (for example, autologous HSCT for CML, second or tandem autologous HSCT when criteria are not met, third autologous HSCT for MM) may be denied as investigational.

Verify whether prior HSCTs, tandem sequencing, or repeat transplants meet the policy’s limited allowable scenarios.
If proposing repeat/tandem transplants, include policy‑specified justifications and timing.

Denial Risk

Allogeneic HSCT requests not meeting criteria may be denied

Allogeneic HSCT is considered investigational and may be denied when the request does not meet the policy’s specified medically necessary criteria for allogeneic transplant.

Confirm the patient meets one of the policy’s allogeneic HSCT indications before submitting for authorization.
If criteria are unmet, consider alternative therapies or clinical trial enrollment.

Denial Risk

Transplant candidacy exclusions: PR to 2nd‑line, progressive/refractory disease, post‑rescue relapse

Individuals with partial response to second‑line therapy, progressive or refractory disease to second‑line therapy, or relapse after prior high‑dose autologous rescue or allogeneic HCT are not candidates for transplant per the policy and such requests may be denied; manage with third‑line systemic therapy, palliative ISRT, or best supportive care instead of HSCT.

If patient has only PR to second‑line therapy or progressive/refractory disease, HSCT candidacy is excluded.
Document alternative management plans when HSCT is not appropriate.

Denial Risk

Investigational cutaneous lymphoma and tandem transplant requests may be denied

Procedures considered investigational for primary cutaneous lymphomas and certain NHL tandem transplants may be denied when they do not meet the policy’s medically necessary criteria.

For primary cutaneous lymphomas, autologous HSCT is investigational for all indications—expect denial.
Tandem transplants for NHL are investigational unless the policy specifies an allowed scenario.

Denial Risk

T‑cell/NK‑cell lymphoma HSCT outside criteria may be denied

Requests for autologous or allogeneic HSCT outside the specified medically necessary criteria for T‑cell and NK‑cell lymphoma subtypes are considered investigational and may be denied; ensure the request documents that the specific policy criteria are met.

Map the patient’s subtype, stage, and response to policy criteria for T‑cell/NK‑cell lymphomas.
If criteria are unmet, discuss alternative options or clinical trials instead of HSCT.

Denial Risk

Allogeneic HSCT for mast cell disorders may be denied if criteria unmet

Allogeneic HSCT for ASM, SM‑AHN, or MCL is considered investigational when the policy’s specific medically necessary criteria are not met; prior authorization must show the listed response or progression criteria are fulfilled to avoid denial.

For ASM/SM‑AHN/MCL, include documentation of prior therapy response, organ damage, AHN prioritization, or progression as specified.
If criteria are not met, the request will be considered investigational.

Denial Risk

Poor HLA match or unavailable donor may affect coverage decisions

Poor or inadequate HLA matching reduces the likelihood of transplant success; absence of an appropriate donor match should be documented and may negatively affect coverage decisions for allogeneic HSCT.

Provide HLA typing and match level; if no suitable match exists, document donor search efforts.
Explain how donor match limitations influenced the choice of transplant type.

Denial Risk

Transplants for indications not meeting policy criteria are investigational and unsupported

Transplants performed for indications that do not meet the policy criteria are considered investigational/insufficient and would not be supported; verify coverage status before scheduling procedures.

Check whether the patient’s scenario maps to a favorable policy code before proceeding.
If considered investigational, discuss alternatives and trial options with the patient.

Denial Risk

Denial triggers: indication classification codes (N, C, S, R, D)

Certain scenarios are coded (e.g., N, C, S, R, D) indicating coverage stance; absence of a favorable code for a given indication or status may trigger denial—map the patient’s disease/status to the policy table and include that mapping in the authorization.

Include the relevant policy table row and code in the submission to expedite review.
If the patient’s combination maps to 'N' or 'D', anticipate non‑coverage or requirement for clinical trial enrollment.

Note

Reference lists do not define authorization/denial rules

Reference‑only chunks do not contain authorization or denial criteria; use the policy’s authorization and criteria sections when preparing requests.

Do not cite reference‑only bibliography entries as the basis for authorization—use policy text that defines requirements.

Note

Bibliography entries contain no authorization triggers

This section of references contains literature citations only and includes no authorization triggers or procedural requirements; clinical authorization requests must rely on policy criteria rather than bibliography entries.

Provide clinical documentation required by the policy rather than relying on supporting literature lists for prior authorization content.

Note

Pre-transplant Evaluation, Diagnostics, and Monitoring

Note

Coding and Thresholds

See Codes tablemixed

See Codes table

Policy references a codes table for details; codes not present in this extract.

Hemoglobin / Hematocrit thresholds for PV

Hemoglobin threshold (men)> 16.5 g/dL (also note sustained absolute erythrocytosis if >18.5 g/dL)

Hemoglobin threshold (women)> 16.0 g/dL (sustained absolute erythrocytosis if >16.5 g/dL)

Hematocrit threshold (men)> 49%

Hematocrit threshold (women)> 48%

Actionable diagnostic noteDiagnosis per WHO requires meeting major/minor criteria; sustained absolute erythrocytosis (hemoglobin >18.5 g/dL men or >16.5 g/dL women) may obviate bone marrow biopsy when JAK2 mutation present

Platelet count threshold for ET

Platelet count threshold> 450 x 10^9/L

Diagnostic contextWHO 5th Edition major criterion for Essential Thrombocythemia

Associated requirementsBone marrow biopsy showing proliferation with mature megakaryocytes and exclusion of other myeloid neoplasms

International Prognostic Index (IPI) risk groups

Low risk0–1 points

Low‑intermediate risk2 points

High‑intermediate risk3 points

High risk4–5 points

Serum total tryptase (B-finding threshold)

Serum total tryptase B‑finding threshold> 200 ng/mL

ContextOne of criteria indicating high mast cell burden (B‑finding) in systemic mastocytosis classification

Adjustment noteBaseline tryptase may be adjusted when hereditary alpha‑tryptasemia is present (refer to footnotes)

Bone marrow mast cell percentage (B-finding and MCL)

Bone marrow infiltration (B‑finding)> 30% mast cell infiltration on bone marrow biopsy

Mast cell percentage in aspirate for MCL> 20% mast cells in bone marrow aspirate smears (MCL definition)

Peripheral blood criterion for MCL>10% mast cells in peripheral blood smears for classic MCL

KIT p.D816V variant allele frequency threshold

KIT p.D816V VAF B‑finding threshold> 10% variant allele frequency in bone marrow or peripheral blood leukocytes

Testing sitesKIT p.D816V may be detected in peripheral blood, bone marrow, or other extracutaneous organs

Role in diagnosisKIT mutation is one of minor criteria for systemic mastocytosis diagnosis

Tandem transplant timing

Tandem transplant intervalPlanned repeat infusion performed within 6 months of the initial transplant

DefinitionPlanned administration of two cycles of high‑dose (with or without TBI) chemotherapy each followed by reinfusion of stem cells

Distinguishing noteRepeat transplant >6 months after the first is considered a separate repeat transplantation (not a planned tandem)

Definitions and Response Criteria

Refractory / Relapse / Salvage therapy

RefractoryCancer that does not respond to treatment (resistant disease)

RelapseCancer that recurs after prior complete response

Salvage therapyTreatment given after cancer has not responded to other treatments

Neuroblastoma staging/risk (INSS/INRG)

INSS and INRG systemsINSS and INRG staging described; INRG uses image‑defined risk factors (IDRFs)

Risk determinantsRisk classification depends on stage, age, histology, MYCN status, 11q status, and tumor cell ploidy

High‑risk neuroblastomaCharacterized by age >1 year, disseminated disease, MYCN amplification, and unfavorable histology

Myeloablative vs Non-myeloablative

Myeloablative definitionSevere myelosuppression / marrow‑ablative conditioning prior to transplant

Non‑myeloablative (Reduced intensity) definitionConditioning that does not completely destroy recipient marrow; used when patients cannot tolerate myeloablative regimens

Use caseReduced‑intensity regimens considered for age typically >60 or significant comorbidities or low Karnofsky

CR / CRi / CRh / MLFS definitions

Complete response (CR)No circulating blasts or extramedullary disease; marrow with trilineage hematopoiesis and <5% blasts; ANC >1000/µL and platelets >100,000/µL

CRi / CRhCR with incomplete blood count recovery or partial hematologic recovery (variations of CR)

MLFSMorphologic leukemia‑free state (BM <5% blasts in aspirate with spicules; specified cell count requirements)

Refractory / Relapse

RefractoryCancer that does not respond to treatment

RelapseRecurrence of cancer after prior complete response

Clinical implicationRefractory or relapsed status impacts candidacy and sequencing for HSCT

Karnofsky Performance Status (definition)

Karnofsky Performance Status scale0–100 scale measuring ability to perform ordinary tasks; higher is better

Sample levels100 = normal; 70 = cares for self but unable to work; 50 = requires considerable assistance; 10 = moribund

UseUsed to assess transplant fitness and guide conditioning intensity

Myeloablative (definition)

MyeloablativeConditioning regimen causing severe myelosuppression and marrow ablation prior to allogeneic HSCT

Clinical consequenceRequires patient ability to tolerate profound cytopenias and organ toxicities

AlternativeIf not tolerated, reduced‑intensity (non‑myeloablative) regimens may be used

Non-myeloablative (Reduced intensity conditioning) definition

Non‑myeloablative (Reduced intensity)Conditioning that does not completely destroy the recipient's marrow; relies more on immunosuppression

IndicationsUsed when patients cannot tolerate myeloablative conditioning (age >60, comorbidities, low Karnofsky)

Coverage noteConsidered medically necessary when allogeneic HSCT criteria met but myeloablative conditioning not tolerated

Primary refractory AML definition

Primary refractory AMLAML that fails to achieve complete remission after conventionally dosed intensive chemotherapy

Clinical impactMay be an indication for allogeneic HSCT if other criteria met

Related definitionsRefractory differs from relapsed disease (recurrence after CR)

Karnofsky Performance Status (duplicate scales)

Karnofsky scale overview0–100 scale; higher scores indicate better function; used for prognosis and transplant eligibility

Typical cutpointsLow Karnofsky referenced as reason to consider reduced‑intensity conditioning

ApplicationDocumented in pretransplant evaluation to support conditioning selection

Myeloablative vs Non-myeloablative (conditioning definitions)

Myeloablative vs Non‑myeloablative conditioningMyeloablative causes severe marrow suppression; non‑myeloablative (reduced intensity) does not fully ablate marrow and is used when patients cannot tolerate full myeloablation

Decision driversAge, comorbidities, prior intensive chemotherapy, and Karnofsky score guide choice

Coverage implicationReduced‑intensity regimens may be medically necessary if myeloablative conditioning contraindicated

Myeloablative (definition duplicate)

Myeloablative definition (repeat)Severe myelosuppression with substantial marrow activity decrease used as high‑intensity conditioning

Clinical noteTypically reserved for patients who can tolerate intense therapy

AlternativeReduced‑intensity used when myeloablative not tolerated

Non-myeloablative / Reduced intensity conditioning (definition duplicate)

Non‑myeloablative / Reduced intensity conditioning (duplicate)Less intensive conditioning not destroying marrow completely; used for patients unable to tolerate myeloablative regimens

ExamplesAge >60 years, organ dysfunction, prior intensive chemo, low Karnofsky

Coverage notePermitted when criteria for allogeneic HSCT met but myeloablative is not tolerable

Karnofsky Performance Status (duplicate)

Karnofsky Performance Status (repeat)0–100 scale measuring functional ability; used in transplant candidacy

InterpretationLower scores support selection of reduced‑intensity conditioning

DocumentationRequired in pretransplant evaluation

Myeloablative vs Non-myeloablative (duplicate)

Myeloablative vs Non‑myeloablative (duplicate)Myeloablative: intensive marrow‑ablative conditioning; Non‑myeloablative: reduced intensity conditioning for those who cannot tolerate full ablation

Clinical decision factorsAge, comorbidities, organ dysfunction, prior therapy, Karnofsky

Policy noteReduced‑intensity may be used per policy when myeloablative not tolerated

Chemosensitive relapse definition

Chemosensitive relapseRelapsed non‑Hodgkin lymphoma that does not progress during or immediately after standard‑dose chemotherapy (achieves stable disease or PR)

Clinical relevanceChemosensitive relapse often required for consideration of HSCT consolidation or salvage

ImplicationNon‑chemosensitive relapse (progression) makes transplant less likely to be successful

Complete response definition

Complete response definitionDisappearance of all signs of cancer in response to treatment (CR) — does not always indicate cure)

UsageUsed as response benchmark for transplant candidacy and MRD assessment

Related termsCRi, CRh, MLFS are defined variations relevant to hematologic malignancies

Karnofsky Performance Status (detailed levels)

Karnofsky Performance Status — detailed levels100 normal; 90 minor symptoms; 80 normal activity with effort; 70 cares for self but unable to work; 60 requires occasional assistance; lower levels indicate increasing dependency

RoleUsed to assess transplant candidacy and guide conditioning intensity

DocumentationShould be included in pretransplant evaluation records

Non-myeloablative (reduced intensity conditioning) definition

Non‑myeloablative (reduced intensity) definitionConditioning regimens relying more on immunosuppression than cytotoxic effects; marrow not completely destroyed prior to donor infusion

Clinical examplesUsed for older or medically infirm patients to permit engraftment while minimizing toxicity

Outcome considerationMay reduce transplant‑related toxicity but relies on graft‑versus‑disease effects

Salvage therapy definition

Salvage therapyTreatment given after cancer has not responded to other treatments (includes refractory or relapsed disease scenarios)

ExamplesMay include high‑dose chemotherapy, CAR T therapy, clinical trials, palliative ISRT, or supportive care depending on disease

Policy impactSalvage therapy intent and response status must be documented for HSCT consideration

Diagnostic criteria for systemic mastocytosis (major/minor)

Diagnostic major criterion (SM)Multifocal dense infiltrates of mast cells (≥15 mast cells in aggregates) in bone marrow or extracutaneous organs

Minor criteria examplesAtypical mast cell morphology (>25% spindle/immature), aberrant antigen expression (CD2, CD25, CD30), KIT mutation, baseline tryptase >20 ng/mL

Diagnostic ruleDiagnosis requires 1 major + 1 minor or >3 minor criteria

B- and C-findings definitions

B‑findingsIndicators of high mast cell burden without organ dysfunction (eg, BM >30% infiltration, serum tryptase >200 ng/mL, KIT VAF >10%)

C‑findingsFindings indicating organ dysfunction (eg, cytopenias, hepatic insufficiency) and determine advanced disease/subclassification

UseNumber and type of B/C findings drive subclassification (ISM, SSM, ASM, MCL)

Autologous stem cells (definition)

Autologous stem cellsStem cells harvested from the individual's own bone marrow or peripheral blood

Allogeneic stem cellsStem cells harvested from a histocompatible donor (matched related, unrelated, or haploidentical)

ImplicationDonor type determines graft‑versus‑host risk and conditioning/coverage considerations

Allogeneic stem cells (definition)

Allogeneic stem cellsStem cells harvested from a histocompatible donor (matched related, unrelated, or haploidentical)

Donor matchingAppropriate HLA matching is required for medically necessary allogeneic transplantation

SourcesIncludes unrelated donor registries and cord blood as applicable

Tandem transplant (definition)

Tandem transplantPlanned repeat infusion of previously harvested stem cells performed within 6 months of the initial transplant

PurposeMultiple cycles intended to eradicate residual tumor cells when used in high‑risk malignancies

DistinctionRepeat transplant beyond 6 months is considered a separate repeat transplantation for salvage, not a planned tandem

Engraftment (definition and timeframe)

Engraftment timeframeTypically occurs within 2–4 weeks after transplantation

Immune recoveryFull immune recovery may take months (autologous) to 1–2 years (allogeneic)

MonitoringEngraftment monitored by blood counts; bone marrow aspiration may be used to assess progress

Autologous HSCT (definition)

Autologous HSCTIndividual receives his or her own previously harvested stem cells after myeloablative therapy

AdvantageReduced toxicity compared with allogeneic HSCT; avoids GVHD

Typical useConsolidation after primary therapy or salvage for responsive relapse in selected tumors

Tandem Transplantation (detailed definition)

Tandem transplantation (detailed)Planned administration of two cycles of high‑dose chemotherapy (with/without TBI), each followed by reinfusion of stem cells, with the second infusion within 6 months

RationaleAimed to enhance eradication of residual tumor cells in advanced malignancies

Coverage noteTandem transplants have specific, limited indications in policy (e.g., neuroblastoma); often investigational in other settings

UCB / CB (umbilical cord blood definition and ASBMT guidance)

Umbilical cord blood (UCB/CB)Source of hematopoietic stem cells; public donation encouraged over routine private storage

Private banking guidanceParents should review contracts, quality standards, median nucleated cell dose, and accreditation if choosing private storage

Family bankingMay be recommended when a sibling has a disease treatable with HSCT or shared HLA suggests parental benefit

Contraindications and Exclusions

Inability to tolerate myeloablative conditioning (for example due to advanced age, significant comorbidities, or low Karnofsky Performance Status) is addressed as a clinical consideration: such individuals may be offered reduced‑intensity conditioning or may be unsuitable for transplant if any conditioning is not tolerable. The policy treats inability to tolerate conditioning as a factor guiding regimen selection and potential contraindication to myeloablative HSCT.

The policy does not list a detailed catalog of absolute contraindications in this extract; instead it emphasizes assessing a candidate's ability to tolerate conditioning and to meet disease‑specific criteria before determining transplant suitability.

Where inability to tolerate myeloablative conditioning exists, the document advises using reduced‑intensity (non‑myeloablative) regimens when medically appropriate rather than excluding the patient from consideration for HSCT altogether.

The policy specifies that individuals with partial response to second‑line therapy, progressive or refractory disease to second‑line therapy, or relapse after prior high‑dose autologous stem cell rescue or allogeneic HCT are not candidates for transplant and should be managed with alternative therapies such as third‑line systemic therapy, palliative ISRT, or best supportive care.

When the policy tables classify an indication/status combination as 'N' (not generally recommended), that assignment functions as a contraindication to coverage for that specific transplant scenario within the policy framework.

Post-Transplant Monitoring and Follow-up Coverage

Clinical response and hematologic monitoring

Post‑transplant monitoringInclude response assessment and blood count recovery parameters (ANC, platelets); MRD assessment when applicable

Engraftment monitoringMonitor blood counts for 2–4 weeks; bone marrow aspiration may be performed if indicated

Long‑term recoveryFull immune recovery may take months to years; follow‑up should include survival and treatment‑related morbidity assessment

Non-myeloablative allogeneic HSCT (post-transplant conditioning note)

Non‑myeloablative allogeneic HSCT noteReduced‑intensity conditioning may be used when patients cannot tolerate myeloablative regimens (examples: age >60, comorbidities, low Karnofsky)

ApplicationApplicable across indications when allogeneic HSCT criteria are met but myeloablative conditioning is contraindicated

DocumentationRationale for reduced intensity should be documented in pretransplant evaluation

allogeneic HSCT after autologous HSCT for MM

Allogeneic HSCT after autologous HSCT for MMMay be considered medically necessary for progressive multiple myeloma following a single or tandem autologous HSCT

Conditioning preferenceMyeloablative allogeneic HSCT preferred; reduced‑intensity acceptable based on age/comorbidities

Prior autologous requirementDocument prior autologous HSCT and progressive disease to support allogeneic consideration

Autologous HSCT may be covered for disseminated POEMS syndrome

Autologous HSCT for disseminated POEMSMay be considered medically necessary for disseminated POEMS syndrome (eg, diffuse sclerotic lesions or disseminated bone marrow involvement)

DocumentationExtent of dissemination should be documented to support medical necessity

Tandem HSCT noteTandem HSCT is investigational for POEMS when criteria not met

salvage systemic therapy / palliative ISRT (post-transplant options)

Post‑transplant options when further transplant not appropriateConsider third‑line systemic therapy, palliative ISRT, clinical trial, or best supportive care

Transplant candidacy exclusionsNot candidates: PR to second‑line therapy, progressive/refractory disease to second‑line therapy, relapse after prior high‑dose autologous or allogeneic HCT

Recommended sequencingConsider CAR T‑cell therapy or clinical trial before further transplant in multiply relapsed B‑cell lymphomas

conditioning regimen selection (repeat)

Conditioning regimen selection (repeat)Reduced‑intensity conditioning may be used for candidates unable to tolerate myeloablative regimens

Clinical rationaleBalances transplant efficacy with lower toxicity in older/comorbid patients

Authorization needsDocument reasons for non‑myeloablative choice in prior authorization

Post-transplant blood count monitoring and bone marrow aspiration timing

Post‑transplant blood count monitoring timeframeMonitor blood counts for engraftment typically for 2–4 weeks; immune recovery may take months to years

Bone marrow aspirationMay be performed to assess engraftment progress when indicated

DocumentationMonitoring plan should be included in post‑transplant care documentation

Long-term outcome monitoring

Long‑term outcome monitoringFollow‑up should assess overall survival, disease‑specific survival, treatment‑related mortality and morbidity over years

ScopeLongitudinal follow‑up may span months to years to capture late effects and immune recovery

PurposeUsed to evaluate net health outcome of HSCT interventions

Cord blood banking guidance and counseling (post-transplant related)

Cord blood banking counselingExpectant parents should receive accurate information about collection, banking, likely utility, and quality metrics

Public donation preferencePublic banking is recommended over routine private storage for general use

Family banking indicationConsider family banking when a sibling has a disease treatable with HSCT or shared HLA suggests parental benefit

Center and Program Considerations

Note

Background and Evidence Context

Background: HSCT (autologous or allogeneic) follows high‑dose chemotherapy and/or radiotherapy with reinfusion of hematopoietic stem cells. Allogeneic HSCT is an established therapy for many congenital immunodeficiencies and selected inherited metabolic disorders; autologous HSCT is used selectively for some solid tumors and hematologic malignancies where evidence supports benefit.

Bibliography and Literature References

References: The policy includes a bibliography of peer‑reviewed studies and guidelines that support the clinical statements and coverage determinations; these references are used to determine when evidence is sufficient or insufficient for coverage decisions.

Selected reference entries in the bibliography include foundational HSCT outcome and disease‑specific studies and society position statements that informed the policy's coverage logic and investigational determinations.

Policy Version and Revision History

2018-04policy_created

Evidence review and policy created (initial literature review period begins April 2018).

2025-04evidence_updateLatest

Most recent literature update to the evidence review (literature searches updated through April 2025).