OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.
ModifiedCignaPolicy 0533
Stem Cell Transplantation: Blood Cancers
Customize your policy alerts
Sign up for Cigna Policy 0533 alerts
Get alerted when Policy 0533 changes without checking for updates manually.
Monitor payer policy activity
Receive email alerts as soon as relevant payer policies are published or updated.
Defines Cigna's coverage stance and medical necessity criteria for hematopoietic stem cell transplantation (autologous, allogeneic, tandem) for blood cancers (e.g., ALL, AML, amyloidosis) and who it affects (members of Cigna-administered health benefit plans).
Policy Summary
PayerCigna
PolicyStem Cell Transplantation: Blood Cancers
Policy CodePolicy 0533
Change TypeAdded and revised disease-specific policy statements
Effective DateAug 15, 2026
Last ReviewAug 15, 2026
Next Review DateAug 15, 2027
Key ActionRequest prior authorization and submit documentation demonstrating the patient meets the disease-specific medical necessity criteria and applicable plan terms.
Added policy statement for mycosis fungoides and Sézary syndrome.
Revised policy statement for recurrent non-Hodgkin lymphoma with chemosensitive disease.
Revised policy statement for primary Central Nervous System lymphoma.
HLA-matchedDonor matching requirement
ANY of 5 criteriaALL coverage triggers
Multiple criteriaAML coverage triggers
ASCT allowedAmyloidosis coverage
Not necessary (AML)Tandem HSCT restriction
Examples listedRelative contraindications
Coverage Criteria for Hematopoietic Stem Cell Transplantation
General coverage statements and donor requirement
General coverage rules: Coverage for HSCT varies across plans; refer to the customer's benefit plan document for coverage details.
Donor matching: All allogeneic transplantations must be from an appropriately matched human leukocyte antigen (HLA) donor.
Acute Lymphoblastic Leukemia (ALL) — Allogeneic HSCT — ANY of the following criteria
Allogeneic HSCT is medically necessary when ANY of the following criteria are met:
ALL allogeneic indications
a: failed induction therapy
Policy Summary
PayerCigna
PolicyStem Cell Transplantation: Blood Cancers
Policy CodePolicy 0533
Change TypeAdded and revised disease-specific policy statements
Effective DateAug 15, 2026
Last ReviewAug 15, 2026
Next Review DateAug 15, 2027
Key ActionRequest prior authorization and submit documentation demonstrating the patient meets the disease-specific medical necessity criteria and applicable plan terms.
c: B-cell lineage ALL with marrow relapse while on treatment or within six months of completing treatment
d: T-cell lineage ALL in first or subsequent remission
e: first remission with poor prognosis or high-risk features (see appendix A)
Second allogeneic HSCT for ALL: A second allogeneic HSCT is medically necessary when relapsed disease occurs more than six months after first allogeneic HSCT.
ALL — Not medically necessary conditions
HSCT for ALL is considered not medically necessary for ANY of the following conditions:
ALL exclusion criteria
active central nervous system (CNS) involvement
b: presence of any significant comorbid medical or psychiatric illness which would significantly compromise clinical care and chances of survival
c: advanced age in an adult
Acute Myeloid Leukemia (AML) — Allogeneic and Autologous HSCT, ANY of multiple criteria
Allogeneic HSCT is medically necessary for AML when ANY of the listed criteria are met; autologous HSCT is an alternative when allogeneic HSCT is not available or appropriate.
AML allogeneic indications
b: second or subsequent remission
c: failed induction
d: no induction treatment and ANY of the following: antecedent hematological disease OR treatment-related secondary AML
Second allogeneic HSCT for AML: A second allogeneic HSCT is medically necessary when BOTH: relapse occurs more than six months after first allogeneic HSCT AND patient is in second or subsequent remission.
AML autologous indications
a: first remission for a favorable/intermediate risk individual when allogeneic HSCT is not available or appropriate (see appendix B)
b: second or subsequent remission
Tandem HSCT for ALL
Tandem HSCT for ALL: A tandem/sequential HSCT for the treatment of ALL is considered medically necessary.
Tandem HSCT for AML — 1 top-level node
Tandem HSCT for AML: Tandem HSCT is considered not medically necessary for the treatment of AML.
Autologous HSCT for amyloidosis: Autologous HSCT is medically necessary for treatment of systemic light-chain amyloidosis in the absence of severe or multiple comorbidities that would increase risk of poor result or death.
Second autologous HSCT for amyloidosis: A second autologous HSCT for the treatment of recurrent or refractory amyloidosis is considered not medically necessary.
Allogeneic HSCT for amyloidosis: Allogeneic HSCT for treatment of systemic light-chain amyloidosis is considered not medically necessary.
Tandem autologous HSCT for amyloidosis: Tandem autologous HSCT for treatment of systemic light-chain amyloidosis is considered not medically necessary.
Amyloidosis — Allogeneic HSCT stance
Allogeneic HSCT is:
Amyloidosis exclusion: Allogeneic HSCT for the treatment of amyloidosis (systemic light-chain) is considered not medically necessary.
Allogeneic HSCT is considered medically necessary when the following condition is met:
CLL requirement: Chronic lymphocytic leukemia (CLL) that is not responsive to standard therapy.
Chronic Myeloid Leukemia (CML) — Allogeneic HSCT when ANY of the following are met
Allogeneic HSCT is considered medically necessary when ANY of the following are met:
CML TKI and disease criteria: a. hematologic remission not reached after three months of tyrosine kinase inhibitor (TKI) therapy; b. no cytogenetic response or cytogenetic relapse at 6, 12, or 18 months after achieving initial hematologic remission after three months of TKI therapy; c. molecular remission not reached by 12 months of TKI therapy; d. disease progression on TKI therapy to accelerated phase or blast crisis; e. individual is not a candidate for TKI therapy.timelines specified
CML - Autologous HSCT stance
Autologous HSCT stance:
Autologous CML: Autologous HSCT for the treatment of CML is considered medically necessary.
Allogeneic CMML: Allogeneic HSCT is considered medically necessary for the treatment of CMML.
Autologous CMML: Autologous HSCT for the treatment of CMML is considered medically necessary.
Hodgkin Lymphoma — HSCT stance for refractory, primary progressive, or recurrent disease
HSCT stance for refractory, primary progressive, or recurrent disease:
Autologous Hodgkin: Autologous HSCT is considered medically necessary for refractory, primary progressive or recurrent Hodgkin lymphoma.
Allogeneic Hodgkin: Allogeneic HSCT is considered medically necessary when the individual is not a candidate for autologous HSCT or in the setting of a failed autologous transplant.
Allogeneic JMML: Allogeneic HSCT is considered medically necessary for the treatment of JMML.
Autologous JMML exclusion: Autologous HSCT for the treatment of JMML is considered not medically necessary.
Multiple Myeloma (MM) — Autologous HSCT guidance
Autologous HSCT for MM:
Autologous MM: Autologous HSCT for the treatment of active (i.e., symptomatic) multiple myeloma is considered medically necessary.
Second autologous MM: A second autologous HSCT is considered medically necessary when either: a) as a tandem autologous HSCT following autologous HSCT; or b) in an individual with progressive disease following a previous autologous HSCT.
Myelodysplastic Syndromes (MDS) — Allogeneic HSCT when ALL of the following are met
Allogeneic HSCT is considered medically necessary when ALL of the following are met:
MDS IPSS-R: Individual has intermediate- or high-risk myelodysplastic syndrome according to the Revised International Prognostic Scoring System (IPSS-R).IPSS-R intermediate or high
Allogeneic HSCT covered when ALL of the following are met:
Allogeneic HSCT for MDS: Allogeneic HSCT is considered medically necessary for treatment of an individual with intermediate- or high-risk myelodysplastic syndrome as assessed by IPSS-R.IPSS-R intermediate or high
Allogeneic HSCT — Myelofibrosis — coverage when ALL of following met
Allogeneic HSCT covered when ALL of the following are met:
Allogeneic HSCT for myelofibrosis: Allogeneic HSCT is considered medically necessary for myelofibrosis when symptoms persist or worsen despite standard supportive care.symptoms persistent or worsening despite standard supportive care
Autologous HSCT for NHL (adults): Autologous HSCT is medically necessary for adults with stage II-IV or relapsed NHL.stage II-IV or relapsed
Autologous HSCT for pediatric NHL: Autologous HSCT is medically necessary for children with recurrent NHL with chemosensitive disease.recurrent with chemosensitive disease
Autologous HSCT exclusions for NHL: Autologous HSCT is not medically necessary for adults with mycosis fungoides, Sézary syndrome, or stage I disease.mycosis fungoides/Sezary syndrome or stage I disease
Allogeneic HSCT for adult NHL: Allogeneic HSCT is medically necessary for adults with stage II-IV or relapsed NHL who are not candidates for autologous HSCT.stage II-IV or relapsed AND not candidate for autologous HSCT
Allogeneic HSCT for pediatric NHL: Allogeneic HSCT is medically necessary for children with recurrent NHL with chemosensitive disease.recurrent with chemosensitive disease
Allogeneic HSCT exclusions for NHL: Allogeneic HSCT is not medically necessary for stage I disease in adults.stage I disease
Tandem HSCT — Not medically necessary for NHL (1 top-level node)
Tandem HSCT for NHL: Tandem autologous or allogeneic HSCT is considered not medically necessary in an adult or a child for the treatment of NHL.
Autologous HSCT for POEMS: Autologous HSCT is considered medically necessary for treatment of POEMS syndrome.
Autologous HSCT — Primary CNS Lymphoma — medically necessary when EITHER of the following is met
Autologous HSCT is considered medically necessary for primary CNS lymphoma when EITHER of the following is met:
Primary CNS lymphoma criteria: a) relapsed or refractory disease; OR b) first remission as consolidation therapy.relapsed/refractory OR first remission consolidation
Allogeneic HSCT for systemic mastocytosis: Allogeneic HSCT is considered medically necessary for treatment of advanced/aggressive systemic mastocytosis.advanced/aggressive disease
Disease-specific HSCT coverage aligned with society guidance — coverage varies by disease, remission status, risk stratification
Coverage for HSCT varies by disease, remission status, risk stratification, and patient factors; professional society recommendations (ASTCT/ASBMT, NCCN) guide use.
ALL - Pediatrics and Adults: Allogeneic HCT is recommended for selected pediatric and adult patients with high-risk ALL in CR1, for CR2 and later remissions in many settings, and may be considered for non-remission cases with recommendation for clinical trial enrollment; autologous HCT is generally not recommended in many ALL settings.based on ASTCT/NCCN risk categories
AML - Adults and Children: Allogeneic HSCT with myeloablative conditioning confers relapse and survival benefit for intermediate- and poor-risk AML in CR1; autologous HSCT may be an acceptable alternative when allogeneic HSCT is not available or appropriate.risk stratification per ELN/ASTCT
AL amyloidosis: Autologous HCT is preferred for carefully selected patients meeting criteria (single vital organ involvement, <10% marrow plasma cell involvement, good performance status); systemic therapy first may be appropriate for high tumor burden with reassessment for transplant eligibility.organ involvement and marrow plasma cell % thresholds as stated
CLL: Allogeneic HSCT may be curative for select patients with advanced or refractory CLL; consideration is based on limited nonrandomized evidence and guideline recommendations.select high-risk/refractory cases
Disease-specific coverage principles — transplantation recognized as appropriate for selected patients
Coverage is disease- and context-specific; transplantation (autologous or allogeneic) is recognized as appropriate for selected patients based on disease status, prior therapies, and guideline recommendations.
Per-disease guidance: Coverage decisions follow disease-specific guideline-based indications (e.g., CLL: consider allogeneic HCT after BTKi and venetoclax regimens for relapsed/refractory disease in patients without significant comorbidities; CML: allogeneic HCT for TKI-resistant/intolerant or advanced phase disease; CMML/JMML: allogeneic HCT as potentially curative option; Hodgkin lymphoma: HDT/ASCT for relapsed/refractory disease per PET response; Multiple myeloma: autologous HCT is standard consolidation after induction).
Guideline-aligned transplant coverage criteria
Coverage aligns with guideline-based indications; covered when ALL of the following guideline-supported criteria are satisfied for the specific disease context:
General transplant candidate criteria: Patient has a disease and disease-stage/risk status for which HCT is recommended by professional guidelines and society statements (e.g., autologous HCT for eligible newly diagnosed MM; allogeneic HCT for higher-risk MDS or myelofibrosis).
References: NCCN and ASTCT
Organ function and performance status: Sufficient hepatic, renal, pulmonary, and cardiac function and acceptable performance status to tolerate high-dose therapy and HCT; renal dysfunction not an absolute contraindication for some autologous transplants.see clinical thresholds
Autologous HCT specific: Autologous HCT is standard consolidation after induction for eligible newly diagnosed multiple myeloma and may be considered as salvage or repeat transplant per timing criteria.
Allogeneic HCT specific: Allogeneic HCT is considered for higher-risk diseases (e.g., intermediate/high IPSS-R MDS, higher-risk myelofibrosis) and choice of conditioning intensity is guided by age and comorbidity.
ASTCT/NCCN referenced
Disease-specific coverage designations (by transplant type and disease status)
Coverage determinations by disease subtype, remission/relapse status, and transplant type (1 = allogeneic, 2 = autologous).
disease-specific table entries: Each lymphoma subtype and clinical scenario is assigned a designation for allogeneic (1) and autologous (2) HCT (designations: C = covered; S = standard of care; N = not generally recommended/not covered; R = rare/restricted). Example entries: Burkitt relapse sensitive = C for both allogeneic and autologous; Follicular lymphoma CR1 = N for both; mantle cell CR1 = S for both.
Interpretation must follow the detailed table entries.
Guideline-based criteria influencing coverage
Guideline-informed coverage considerations.
guideline recommendations: Professional society statements (ASTCT, ASTCT/EBMT, NCCN) inform when autologous or allogeneic HCT is recommended or not (e.g., autologous HCT as consolidation in newly diagnosed MCL in CR/PR; recommendations inform expected documentation of prior lines and response).
MF/SS transplant candidacy and disease-status requirements
Disease- and status-specific transplant candidacy guidance for Cutaneous T-cell lymphoma / Mycosis Fungoides and Sézary Syndrome (MF/SS).
MF/SS referral and disease status: Refer MF/SS patients for consideration of allogeneic HCT if stage IIB or higher AND refractory disease or progression after at least two lines of systemic therapy; ideal transplant disease status is CR (preferred) or at least PR in relevant compartments; allo-HCT is not recommended for progressive disease in any compartment.
Grading = C
POEMS syndrome — Autologous HCT when ALL of the following apply
POEMS syndrome — Autologous HCT when ALL of the following apply:
POEMS-ASCT-criteria: Confirmed diagnosis of POEMS syndrome AND patient clinically eligible for autologous HCT AND ASCT used as frontline therapy or consolidation after induction therapy (or as clinically indicated).
RT alone appropriate for isolated bone lesions <3 sites in patients without clonal bone marrow plasma cells.
Primary CNS lymphoma — Autologous HSCT (consolidation and relapse) per guideline language
Autologous HSCT for primary CNS lymphoma per guideline language:
PCNSL-consolidation: For newly diagnosed PCNSL with complete or unconfirmed complete response to induction high-dose methotrexate-based therapy, consolidation options include high-dose chemotherapy with stem cell rescue or low-dose whole brain radiotherapy.
NCCN guidance.
PCNSL-relapse-requirement: For relapsed/refractory PCNSL, high-dose chemotherapy with stem cell rescue may be considered only if there is a complete or partial response to reinduction high-dose chemotherapy and the patient did not previously receive this treatment.
NCCN category 2B.
PCNSL-retreatment-timeframe: Retreatment with high-dose chemotherapy and stem cell rescue may be considered when prior benefit was documented and time to relapse was at least one year.>=1 year
NCCN guidance.
Systemic Mastocytosis — Allogeneic HCT in advanced disease when the following apply
Systemic Mastocytosis — Allogeneic HCT in advanced disease when the following apply:
SM-allo-consideration: Patients with advanced systemic mastocytosis (ASM), SM with an associated aggressive myeloid neoplasm (SM-AHN), or mast cell leukemia may be considered for allogeneic HCT, particularly when there is inadequate response to prior treatment or progressive AHN component.
Evaluation for allo-HCT is a consideration; role requires further prospective determination.
SM-allo-initial-treatment: For SM-AHN where the AHN component requires HCT, allogeneic HCT should be considered as part of initial treatment when appropriate.
Per NCCN guidance.
AML risk categories (Appendix A) — cytogenetic/molecular risk list
AML risk categories (Appendix A) — cytogenetic/molecular risk list informs transplant decisions:
Concurrent KIT and/or FLT3 mutations do not alter favorable risk categorization for listed core-binding factor abnormalities.
Intermediate risk examples: Mutated NPM1 with FLT3-ITD; wild-type NPM1 with FLT3-ITD without adverse lesions; t(9;11)/MLLT3::KMT2A; other non-classified abnormalities.
Adverse risk examples: t(6;9)/DEK::NUP214; KMT2A-rearranged; t(9;22)/BCR::ABL1; inv(3)/t(3;3)/GATA2,MECOM; monosomies/del(5q)/del(7); complex or monosomal karyotype; specified gene mutations including TP53 (VAF ≥10%).
This policy identifies specific clinical scenarios in which hematopoietic stem cell transplantation (HSCT) is considered not medically necessary and describes examples of contraindications that may preclude transplantation. Not medically necessary determinations include disease-specific exclusions (e.g., certain HSCT approaches for amyloidosis and JMML) and clinical situations where procedural risk or futility is high (for example, HSCT for ALL with active CNS involvement, significant comorbidities, or advanced age). Evaluation for transplant candidacy should reference guideline-based indications and documented assessment of organ function and performance status prior to authorization decisions.
Allogeneic HSCT for systemic light-chain (AL) amyloidosis is explicitly designated not medically necessary. The policy also states that tandem autologous approaches and allogeneic transplant for AL amyloidosis are considered not medically necessary, and candidates should instead be managed with guideline-recommended systemic therapy and transplant evaluation when autologous HSCT is being considered.
Autologous HSCT for juvenile myelomonocytic leukemia (JMML) is specified as not medically necessary. JMML is considered a disease for which allogeneic HSCT is the appropriate transplant modality; autologous approaches are excluded by the policy.
The policy lists several autologous HSCT scenarios that are considered not medically necessary. These include autologous HSCT for myelofibrosis and for adults with mycosis fungoides or Sézary syndrome, and autologous HSCT for adults with stage I non-Hodgkin lymphoma. In addition, planned tandem (sequential) autologous or allogeneic HSCT is considered not medically necessary for non-Hodgkin lymphoma in adults and children. These exclusions reflect the policy's disease- and stage-specific coverage designations.
Significant comorbid conditions that would substantially compromise treatment tolerance or survival are considered contraindications and may preclude coverage. Examples listed include ejection fraction <35%, bilirubin >2.0 mg/dL (with transaminases >2× normal unless disease-related), creatinine clearance <50 mL/min, DLCO <50% predicted, uncontrolled HIV or active viral hepatitis/HTLV-1, and poor functional status (Karnofsky <60% or ECOG >2). Active CNS involvement is also cited as a not medically necessary scenario for ALL.
The policy notes that the role of autologous HSCT is limited or not established for certain diseases per the literature and society guidance. Examples include a limited role for autologous HSCT in chronic myeloid leukemia (CML) and recommendations from ASTCT/NCCN that autologous or allogeneic transplantation is not generally recommended as consolidation after first-line therapy for some indolent lymphomas. Where autologous HSCT is not the guideline-supported strategy, the policy designates those uses as not medically necessary or of restricted indication.
Billing Codes and Clinical Thresholds
Considered Medically Necessary CPT CodesCPTCovered
Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post- transplant care in the global definition.
TKI response timelines for CML
Hematologic responseHematologic remission not reached after 3 months of TKI therapy
Cytogenetic responseNo cytogenetic response or cytogenetic relapse at 6, 12, or 18 months after achieving initial hematologic remission
Molecular responseMolecular remission not reached by 12 months of TKI therapy
ProgressionDisease progression on TKI therapy to accelerated phase or blast crisis
TKI ineligibilityIndividual is not a candidate for TKI therapy
Ejection fraction threshold — example relative contraindication
Ejection fraction thresholdEjection fraction less than 35% is listed as a relative contraindication to transplantation
ContextPoor cardiac function (EF <35%) may substantially compromise treatment tolerance or survival and affect candidacy
Implication for authorizationPresence of EF <35% may trigger denial of transplant coverage without further justification
Bilirubin threshold — example relative contraindication
Bilirubin thresholdTotal bilirubin greater than 2.0 mg/dL (with transaminases >2x normal unless disease-related) is listed as a relative contraindication
ContextPoor liver function may substantially compromise treatment tolerance or survival and affect candidacy
Authorization riskElevated bilirubin as specified may lead to denial of transplantation coverage if not disease-related or mitigated
Creatinine clearance threshold — example relative contraindication
Creatinine clearance thresholdCreatinine clearance less than 50 mL/min is listed as a relative contraindication (not applicable for most autologous transplants)
ContextPoor renal function may substantially compromise treatment tolerance or survival and influence transplant eligibility
NoteSome autologous transplants may be exceptions; verify applicability per transplant type and plan
DLCO threshold — example relative contraindication
DLCO thresholdDiffusion capacity (DLCO) less than 50% of predicted is listed as a relative contraindication to transplantation
Clinical impactPoor pulmonary function increases peri-transplant morbidity and may preclude candidacy
DocumentationPulmonary function testing should be documented during pre-transplant evaluation
Karnofsky / ECOG performance status thresholds — example relative contraindication
Karnofsky thresholdKarnofsky performance status less than 60% is listed as a relative contraindication
ECOG thresholdECOG performance status greater than 2 is listed as a relative contraindication
ImplicationPoor performance status may substantially compromise treatment tolerance or survival and affect transplant coverage decisions
Provider Actions, Prior Authorization, and Documentation
Prior Authorization
Plan-dependent prior authorization
Coverage and prior authorization requirements depend on the member’s specific benefit plan document; providers must verify the applicable plan terms and any plan-specific prior authorization or utilization review requirements before submitting HSCT requests.
Refer to the customer's benefit plan document for coverage details.
In the event of conflict, the plan document supersedes this policy.
Prior Authorization
Medical necessity-based prior authorization
Prior authorization decisions are contingent on meeting the policy’s medical necessity criteria for the indicated disease; submit documentation that the patient satisfies the disease‑specific HSCT criteria referenced in the policy.
Approval requires demonstration that the patient meets the listed medical necessity criteria for the specific indication (e.g., CML TKI criteria, MDS IPSS‑R intermediate/high).
Medical directors may exercise clinical judgment when reviewing requests.
Prior Authorization
Prior authorization with listed procedure codes
When requesting authorization, include the applicable CPT and HCPCS procedure codes listed in the policy for the HSCT and related collection/preparation services.
Ensure codes are current and appropriate for the date of service.
Prior Authorization
Prior authorization and early transplant evaluation recommended
Initiate transplant referral and HLA typing early (for example, at diagnosis for ALL) and document that the patient has been referred for HCT center evaluation to facilitate donor identification and timely transplant planning.
HLA typing and transplant center referral should be considered for all newly diagnosed ALL patients and relapsed patients who have not yet undergone transplant.
Document plans for donor search and timing of evaluation.
Prior Authorization
Prior authorization expectations
Prior authorization review will confirm prior lines of therapy and that the indication aligns with guideline-concordant indications; include evidence of prior systemic regimens and response status when applicable.
Confirm and document prior therapies (e.g., BTKi/venetoclax for CLL; TKI trials for CML) and guideline‑recommended indications.
Include comorbidity assessment (HCT‑CI) and center expertise referral documentation when relevant.
Prior Authorization
HCT evaluation and collection requirement
Authorization requires documentation that the patient was referred for HCT center evaluation and that plans for stem cell collection are in place (collect for at least one HCT; consider collection for two in younger patients).
Document HCT center evaluation and the planned stem cell collection strategy.
For younger candidates, document consideration of collection for two transplants if clinically indicated.
Prior Authorization
Prior authorization required based on disease-specific table
Prior authorization adjudication is based on the disease subtype, remission/status, and the disease‑specific table designations (covered/standard/not recommended/rare-restricted); provide documentation matching the clinical scenario to the table entry.
Cite the disease‑specific table entry and show how the patient’s disease stage/remission status corresponds to the policy designation (C/S/N/R).
Provide supporting documentation of remission status, response, and prior treatments.
Prior Authorization
Prior authorization for HSCT
When requesting authorization for HSCT in POEMS, PCNSL, or advanced systemic mastocytosis, document the confirmed diagnosis, prior induction therapies and response, and whether HSCT is planned as consolidation or salvage per guideline recommendations.
For POEMS, document diagnosis and eligibility for autologous HCT and prior induction/consolidation plans.
For PCNSL, document response to induction or reinduction high‑dose chemotherapy when applicable.
For systemic mastocytosis, document subtype, response to prior therapy, and indication for allogeneic HCT.
Note
Prior authorization: none specified
No additional specific prior authorization procedures or affected billing codes are provided in these final chunks beyond the general requirements noted elsewhere in the policy.
Refer to the policy code lists and the member’s benefit plan document for exact administrative steps.
Policy statements were revised and added for select indications; providers should review the updated policy language as prior authorization or coverage requirements may have changed.
Check the policy effective date and revision history when preparing authorization requests.
Step Therapy
Step therapy
This policy does not define formal step‑therapy requirements; step therapy is not specified in the policy sections provided.
Coverage decisions are based on disease‑specific medical necessity criteria rather than a formal step‑therapy algorithm in these chunks.
Step Therapy
CML TKI step requirement
For CML, document prior treatment with TKIs and the recommended response timelines (hematologic, cytogenetic, molecular) when requesting allogeneic HSCT authorization; authorization requires evidence the patient meets at least one TKI‑related failure or noncandidacy criterion.
Support documentation for: hematologic remission not reached after 3 months of TKI therapy; lack of cytogenetic response or cytogenetic relapse at 6, 12, or 18 months; molecular remission not reached by 12 months; progression to accelerated/blast phase; or that the patient is not a candidate for TKI therapy.
Step Therapy
Step therapy not specified
The policy does not specify formal step‑therapy sequences for most diseases; authorization is guided by disease‑specific medical necessity criteria and guideline recommendations rather than explicit step therapy rules.
Provide clinical justification per the coverage criteria rather than referencing a policy step‑therapy ladder.
Step Therapy
Consider systemic therapy before autologous HCT in AL amyloidosis
For AL (systemic light‑chain) amyloidosis, document whether the patient has high tumor burden and, if systemic therapy was given first, show reassessment of transplant eligibility after response before requesting autologous HCT authorization.
Document organ involvement, marrow plasma cell percentage (<10% supports eligibility), performance status, and any systemic therapy given prior to HCT consideration.
If systemic therapy was used first for high tumor burden, provide evidence of improved functional status or organ response on reassessment.
Documentation Required
Prior systemic therapy requirements
Document prior systemic therapies and responses where required by the indication (e.g., BTKi and venetoclax regimens for CLL; TKI trials for CML) to support authorization requests for allogeneic HCT.
For CLL, demonstrate prior BTKi‑based and venetoclax‑containing regimens and lack of alternative options when claiming allogeneic HCT.
For CML, include detailed TKI trial history and response timelines per the policy criteria.
Step Therapy
Sequencing expectations
Autologous HCT for multiple myeloma is typically used as consolidation after induction for eligible patients; document induction response and prior therapies when requesting authorization for consolidation or repeat autologous HCT.
Document the induction regimen, response (e.g., VGPR), and whether a tandem or second autologous HCT is planned or being requested for relapse per timing criteria.
Follow ASTCT/NCCN‑based sequencing expectations in submission documentation.
Step Therapy
Sequencing considerations
Guideline references cited in the policy (e.g., ASTCT, NCCN) recommend sequencing of available cellular therapies (for example, offering CAR‑T before allogeneic transplant in some relapsed mantle cell lymphoma settings); include guideline‑based rationale when sequencing affects the authorization decision.
If CAR‑T or other cellular therapy is available and guideline‑recommended prior to allogeneic HCT, document attempts or reasons why such therapy is not appropriate before requesting transplant coverage.
Cite pertinent guideline statements in the authorization rationale.
Step Therapy
Treatment sequencing considerations for POEMS and PCNSL
For POEMS and PCNSL, document that HSCT is planned after appropriate induction or as consolidation as per guideline recommendations; show prior induction therapy and response status when relevant to authorization.
For POEMS, confirm diagnosis and whether ASCT is used as frontline therapy or consolidation and document eligibility.
For PCNSL, document response to induction or reinduction high‑dose methotrexate‑based therapy when proposing stem cell rescue.
Step Therapy
Step therapy: none specified
No step‑therapy requirements are described in these sections; literature and guideline citations inform clinical decisions but do not establish mandatory step‑therapy steps in the policy.
When sequencing is relevant, include guideline citations and clinical justification rather than citing a step‑therapy rule.
Documentation Required
Required supporting literature/guidelines
The policy lists disease‑ and evidence‑specific guideline references (NCCN, ASTCT) that should be included with clinical justification as applicable when requesting authorization; cite guideline sources in the submission.
Include pertinent guideline or literature citations (NCCN, ASTCT) that support the indication when submitting authorization requests.
Reference the specific guideline version or recommendation used to justify HSCT.
Documentation Required
Coding and documentation expectations
Providers must submit services with the most appropriate procedure and diagnosis codes as of the date of service and documentation sufficient to demonstrate that the patient meets the medical necessity criteria and the terms of the applicable benefit plan.
Use the correct CPT/HCPCS and diagnosis codes effective on the date of service.
Provide clinical documentation that maps to the policy medical necessity criteria.
Documentation Required
CML documentation needs
For CML allogeneic HSCT requests, include documentation that the patient meets one or more of the specified TKI failure or noncandidacy criteria (hematologic, cytogenetic, molecular timelines, progression to advanced phase, or TKI non‑candidacy).
Provide timelineed evidence of TKI therapy and responses (e.g., hematologic response by 3 months, cytogenetic response status at 6/12/18 months, molecular response by 12 months).
If the patient is not a candidate for TKI therapy, document the reason.
Documentation Required
Multiple myeloma second transplant documentation
For a second autologous HSCT in multiple myeloma, include documentation that the request is for a planned tandem transplant or that disease progression occurred after a prior autologous HSCT as specified in the policy.
Document whether the second transplant is part of a planned tandem sequence or is requested for progressive disease following a prior autologous HSCT.
Include timing and response details from the prior transplant.
Billing Rule
Coding documentation
Submit the appropriate CPT and HCPCS codes for the specific HSCT services and preparatory procedures when requesting authorization; ensure codes submitted are effective and not deleted at the time of service.
Include procedure codes for donor search, collection, processing, transplantation, and related services as applicable.
Verify HCPCS S2150 global definition is used appropriately when billing comprehensive transplant services.
Documentation Required
Document organ involvement and marrow burden for AL amyloidosis
For AL amyloidosis, document extent of organ involvement, marrow plasma cell percentage, and performance status to support eligibility for autologous HCT per the policy criteria.
Confirm single vital organ involvement and <10% marrow plasma cell involvement when applicable.
Document performance status and any systemic therapy given prior to HCT consideration.
Documentation Required
Required clinical documentation
Include documentation of prior systemic therapies, disease phase/staging, and comorbidity assessment (HCT‑CI) where required by the indication to support consideration for allogeneic HCT.
Document prior BTKi and venetoclax use for CLL where relevant.
Provide comorbidity assessment (HCT‑CI) and organ function testing results.
Documentation Required
Referral and stem cell collection
Document HCT center evaluation and stem cell collection plans when requesting authorization; indicate whether stem cell collection for one or two transplants was performed or planned per NCCN recommendations.
Provide documentation of referral to an HCT center and the transplant eligibility assessment.
Document collection plan (at least one HCT collection; consider two collections in younger patients).
Documentation Required
Required clinical documentation
When requesting authorization for POEMS, PCNSL, or systemic mastocytosis, include confirmation of diagnosis, prior induction therapies and response, and evidence of eligibility for autologous or allogeneic HCT per guideline recommendations.
For POEMS, include diagnostic confirmation and evidence of eligibility for ASCT.
For PCNSL, include response to induction or reinduction high‑dose methotrexate‑based therapy when applicable.
Documentation Required
Documentation: cite guideline sources
Cite the guideline sources (NCCN, ASTCT) referenced in the policy when documenting the indication for transplant and include relevant guideline recommendations in the authorization rationale.
Reference the specific guideline and version used to support the HSCT indication.
Attach guideline excerpts or citations when they directly support the requested service.
Documentation Required
Required supporting literature/guidelines
Include pertinent guideline and literature citations (NCCN, ASTCT, disease‑specific literature) with clinical justification as applicable when requesting authorization for HSCT.
Provide disease‑specific supporting literature or guideline excerpts that directly support the medical necessity determination.
Use the references listed in the policy where applicable.
Denial Risk
Coding-related denials
Claims submitted without covered codes under this Coverage Policy will be denied as not covered; ensure the billed CPT/HCPCS codes are listed as considered medically necessary in the policy when submitting claims.
Verify that the procedure codes on the claim are included in the policy’s covered code lists.
If services are billed with codes not covered by the policy, expect denial as not covered.
Denial Risk
Amyloidosis exclusion
Allogeneic HSCT for systemic light‑chain (AL) amyloidosis is considered not medically necessary under this policy and would be denied if submitted as the requested transplant type.
Autologous HCT may be considered in selected AL amyloidosis patients, but allogeneic HSCT is labeled not medically necessary in the policy.
Denial Risk
JMML autologous exclusion
Autologous HSCT for juvenile myelomonocytic leukemia (JMML) is considered not medically necessary and would be denied if requested under this policy.
Allogeneic HSCT remains the indicated transplant modality for JMML per the policy.
Denial Risk
Contraindications may trigger denial
Presence of significant comorbid conditions may represent contraindications and could lead to denial of transplant coverage; include objective organ function and performance status data in authorization requests.
Examples include ejection fraction <35%, bilirubin >2.0 mg/dL (with transaminases >2x normal unless disease‑related), creatinine clearance <50 mL/min (not generally applicable to most autologous transplants), DLCO <50% predicted, uncontrolled HIV or active viral hepatitis/HTLV‑1, Karnofsky <60% or ECOG >2.
Document objective test results and HCT‑CI where applicable.
Denial Risk
Candidate contraindications may lead to denial
Significant comorbidities that substantially compromise treatment tolerance or survival may contraindicate transplantation and could result in non‑coverage; include the HCT‑CI or equivalent assessment to support candidacy.
Provide HCT‑CI scoring or equivalent comorbidity evidence when assessing transplant candidacy.
If comorbidities are present, supply rationale for proceeding and any mitigating clinical factors.
Denial Risk
Therapy sequence and comorbidity considerations
For relapsed/refractory CLL, authorization for allogeneic HCT typically requires prior therapy with BTKi‑based regimens and venetoclax‑containing regimens and absence of significant comorbidities; lack of prior appropriate therapy or major comorbidities may lead to non‑coverage.
Document prior BTKi and venetoclax use and rationale for considering allogeneic HCT.
Include comorbidity assessment (HCT‑CI) to support fitness for transplant.
Denial Risk
TKI failure documentation
For CML, allogeneic HCT is appropriate for patients resistant or intolerant to available TKIs or in advanced phases; absence of documentation of TKI trials, intolerance, or failure may put authorization at risk of denial.
Provide detailed TKI history, documented responses or failures, and timelineed evidence per the CML criteria.
If the patient is TKI‑intolerant or not a candidate for TKIs, include documentation explaining the reason.
Denial Risk
Transplant eligibility evaluation
Patients who have not been evaluated for transplant eligibility or who lack adequate organ function (hepatic, renal, pulmonary, cardiac) documented in the record may not meet HCT candidacy per policy and authorization may be denied.
Provide transplant eligibility evaluation notes, organ function test results, and performance status assessments.
Without documented evaluation and objective test results, requests may not meet policy requirements.
Denial Risk
Denial triggers from disease-stage table
Certain disease‑stage and remission‑status combinations are designated Not covered (N) or Rare/Restricted (R) in the disease‑specific tables; if the clinical scenario corresponds to an 'N' or 'R' designation, coverage may be denied or restricted.
Confirm the patient’s disease stage/remission status and reference the policy table designation in the authorization rationale.
If the scenario is designated N or R, provide exceptional justification or alternative evidence if seeking coverage.
Denial Risk
PCNSL response requirement
Use of stem cell rescue for relapsed/refractory primary CNS lymphoma is contingent on a complete or partial response to reinduction high‑dose chemotherapy; absence of such response would not meet the NCCN‑referenced consideration and may be denied.
Document response to reinduction high‑dose chemotherapy (CR or PR) before requesting stem cell rescue for relapsed/refractory PCNSL.
If prior stem cell rescue was given, document prior response and time to relapse when requesting retreatment.
Candidate Selection and Eligibility Criteria
Candidate criteria by disease — disease-specific candidate criteria for HSCT
Candidate criteria by disease — disease-specific candidate criteria for HSCT:
ALL candidate nodes: Refer to ALL allogeneic indications: failed induction; second+ remission; B-cell marrow relapse on or within 6 months of treatment; T-cell lineage in remission; first remission with poor prognosis/high-risk features.
AML candidate nodes: Refer to AML indications: second+ remission; failed induction; no induction with antecedent hematologic disease or treatment-related secondary AML; blastic plasmacytoid dendritic cell neoplasm after CR.
Amyloidosis candidate node: Autologous HSCT is candidate therapy in absence of severe/multiple comorbidities; allogeneic and tandem approaches are not medically necessary.
Contraindications and Candidate Exclusions
Active central nervous system involvement is listed as a specific not-medically-necessary condition for HSCT in acute lymphoblastic leukemia (ALL). In addition, the policy identifies significant comorbid psychiatric or medical illness that would compromise clinical care and survival, and advanced age in adults, as conditions in which HSCT is not medically necessary for ALL.
The policy does not state additional explicit absolute or relative contraindications beyond the disease-specific not medically necessary indications; instead, it emphasizes individualized assessment of comorbidities and functional status when determining transplant candidacy.
No further absolute or relative contraindications are enumerated in this policy section; clinicians should rely on the documented examples of relative contraindications and guideline-based evaluation to determine eligibility.
The document does not add other explicit contraindication statements in these sections; transplant candidacy is guided by disease-specific coverage rules and comorbidity assessment.
Beyond disease-specific exclusions and the examples of organ- and performance-status thresholds provided, no additional absolute contraindications are listed in this excerpt.
The policy's contraindication discussion focuses on individualized clinical assessment rather than a longer list of absolute exclusions; professional society guidance supplements these considerations.
No separate absolute or relative contraindications are specified in this segment; refer to the provided organ function and performance status examples when assessing candidacy.
The policy reiterates that significant comorbid conditions and inadequate organ function are central to contraindication decisions, with no additional absolute exclusions listed here.
Absent disease-specific exclusions, the policy relies on clinical judgment supported by thresholds for cardiac, hepatic, renal, pulmonary function, and performance status to identify contraindications.
No further contraindication statements appear in these sections; evaluation and documentation of comorbidity burden guide transplant eligibility.
The excerpt does not list additional absolute contraindications beyond those already described; assess each patient against the outlined organ-function and performance criteria.
Clinical contraindication determinations should be grounded in guideline-referenced evaluation and the examples of relative contraindications provided in the policy background.
The policy's approach is to flag disease-specific not medically necessary scenarios and to use organ-function/performance thresholds rather than an extended list of absolute exclusions.
No additional absolute or relative contraindications are enumerated here; ensure documentation addresses the examples given when contraindication concerns arise.
Clinicians should apply the documented contraindication examples and disease-specific exclusions to individual cases; no further explicit contraindications are added in these chunks.
The policy segment provides examples of relative contraindications and advises using guideline-based pretransplant evaluation to identify patients who are not candidates, without enumerating further absolute contraindications.
There are no additional contraindication statements in these portions of the policy; apply established organ-function and performance thresholds in candidate assessment.
The excerpted policy content does not expand the contraindication list beyond disease-specific exclusions and the organ/functional thresholds already provided.
Refer to the policy's background and candidate selection sections for the operative examples of contraindications; no other absolute or relative contraindications are described here.
Pre-Transplant Evaluation and Documentation Requirements
Note
Note
Note
Note
Note
Note
Note
Note
Note
Note
Note
Note
Note
Transplant Center and Volume Considerations
Note
Note
Note
Note
Note
Note
Note
Note
Note
Note
Note
Note
Post-Transplant Coverage and Follow-up
Post‑transplant coverage depends on plan terms; not specified here
Plan dependencePost‑transplant coverage and services depend on the customer's benefit plan document; refer to plan terms for specific coverage
Not specified in policyThis policy does not define routine post‑transplant service coverage durations or limits
Prior authorizationPrior authorization/coverage determination for post‑transplant services may be required per plan terms
Post‑transplant coverage — not specified
Coverage detailsSpecific post‑transplant coverage provisions are not specified in the final policy chunks provided
Action for providersVerify post‑transplant benefits and authorization requirements with the member's benefit plan document
Policy revision noteRevision history does not add explicit post‑transplant service rules in these excerpts
Comprehensive harvesting, transplantation, and related complications — HCPCS S2150 global definition
HCPCS S2150 scopeHCPCS S2150 is defined as a global code covering harvesting, transplantation, related complications, and may include pre‑ and post‑transplant care when medically necessary
Included servicesGlobal definition may include pheresis, cell preparation/storage, marrow ablative therapy, drugs, supplies, hospitalization and outpatient follow‑up
ImplicationClaims for bundled services should be reviewed against HCPCS S2150 definition and plan coding rules
Long‑term follow‑up and surveillance — acknowledges need for long‑term follow‑up for HCT survivors
Long‑term follow‑up needAcknowledges need for long‑term follow‑up and surveillance for HCT survivors due to risks such as chronic GVHD, late complications, and secondary cancers
Survivorship careSurveillance should include monitoring for organ dysfunction, infections, secondary malignancies, and psychosocial/late effects
Guideline basisNCCN AYA guidance highlights long‑term surveillance needs for HCT survivors
Post‑transplant therapies and supportive care per guideline recommendations
Guideline‑directed therapiesPost‑transplant therapies and supportive care should follow guideline recommendations (e.g., maintenance therapy after autologous HCT for myeloma, RT when indicated)
ExamplesHDT/ASCR with or without RT, and disease‑specific maintenance regimens referenced in NCCN/ASTCT guidance
DocumentationPost‑transplant management plans should be documented and justified per guideline concordance when seeking coverage
Maintenance systemic therapy after autologous HCT — recommendations referenced
Maintenance after ASCT (myeloma)Maintenance systemic therapy after autologous HCT (e.g., lenalidomide for standard‑risk myeloma; bortezomib±lenalidomide for high‑risk) is referenced as guideline‑recommended
ContextMaintenance decisions should follow ASTCT/NCCN guidance and be documented for authorization or claims review
Plan verificationConfirm benefit coverage for maintenance agents per member's prescription and medical benefits
Post‑transplant considerations when autologous HCT used as consolidation or salvage
Consolidation vs salvageWhen autologous HCT is used as consolidation or salvage (per guideline recommendations, e.g., for certain MCL or DLBCL settings), post‑transplant considerations follow standard‑of‑care protocols
No explicit rulesSpecific post‑transplant coverage rules (durations, limits) are not detailed in these excerpts and depend on plan terms
Provider actionDocument indication (consolidation vs salvage) and guideline concordance when requesting authorization or coverage
Retreatment with high‑dose chemotherapy and stem cell rescue — depends on prior response/time to relapse
Retreatment guidanceRetreatment with high‑dose chemotherapy and stem cell rescue may be considered based on prior response and time to relapse (e.g., retreatment if prior response and time to relapse ≥1 year)
Documentation requirementPrior benefit from HDC and interval to relapse should be documented to support repeat HSCT
Plan variabilityCoverage for repeat HSCT depends on clinical context and member plan terms; verify with benefits and authorization requirements
Post‑transplant coverage durations — none specified in these chunks
Duration not specifiedNo post‑transplant coverage durations or service rules are specified in the policy excerpts provided
Verify by planProviders must consult the customer’s benefit plan document for specific duration or benefit limits for post‑transplant services
Policy revision noteRevision history did not add explicit post‑transplant duration rules in these final chunks
Revision history notes — no explicit post‑transplant coverage rules in final chunks
Revision historyRevision notes provided but no explicit post‑transplant coverage rules are included in these chunks
Effect on coveragePolicy revisions added/revised disease statements (e.g., MF/SS, NHL, PCNSL) but did not specify post‑transplant service rules in the final excerpts
Provider actionReview full updated policy and member benefit plan for any changes affecting post‑transplant authorization requirements
Background and Scope
Hematopoietic stem cell transplantation (HSCT) encompasses both autologous and allogeneic approaches. Conditioning regimens may be myeloablative (high-dose chemotherapy and/or radiation intended to eradicate disease and ablate marrow function) or non‑myeloablative/reduced-intensity (lower-intensity regimens designed to reduce toxicity while preserving graft-versus-tumor effects). Tandem HSCT denotes a planned second high‑dose therapy and transplant within approximately six months of the first procedure. Donor sources for allogeneic HSCT include HLA‑matched sibling donors, matched unrelated donors, haploidentical related donors, and umbilical cord blood.
Definitions and Acronyms
Autologous transplant definition
Autologous transplantHematopoietic stem cells are collected from the individual, cryopreserved, and reinfused after high‑dose chemotherapy or radiation
Typical useCommonly used for diseases such as multiple myeloma and relapsed Hodgkin lymphoma
Tandem planningStem cells may be collected for potential tandem or repeat transplant per guideline recommendations
Allogeneic transplant definition
Allogeneic transplantStem cells are obtained from a donor, ideally an HLA‑matched sibling; alternatives include matched unrelated donors, haploidentical related donors, or umbilical cord blood
HLA matching requirementAll allogeneic transplantations must be from an appropriately matched HLA donor per policy
Graft‑versus‑tumor effectAllogeneic HCT may provide graft‑versus‑tumor effects and is used as potentially curative therapy in selected indications
Myeloablative transplant definition
Myeloablative transplantHigh‑dose chemotherapy and/or radiation prior to transplantation to eradicate disease and ablate bone marrow function
IntentUsed to maximize disease eradication but with higher toxicity; candidate selection considers age and comorbidities
AlternativesReduced‑intensity/non‑myeloablative regimens may be considered for patients who cannot tolerate myeloablative conditioning
Non‑myeloablative transplant definition
Non‑myeloablative transplantLower‑intensity conditioning regimens prior to allogeneic transplantation to reduce toxicity while preserving graft‑versus‑tumor effect
Also calledSometimes referred to as reduced‑intensity conditioning
Candidate selectionMay be chosen based on age, comorbidities, and disease characteristics
Tandem HSCT definition
Tandem HSCTA planned second course of high‑dose therapy and HCT within 6 months of the first course
Use casesTandem transplants are considered in selected diseases (policy specifies tandem allowed for ALL but not for AML or NHL in adults)
Collection guidanceCollect stem cells for at least one HCT and consider for two in younger patients if tandem or repeat transplant may be needed
IPSS‑R definition
IPSS‑RRevised International Prognostic Scoring System for Myelodysplastic Syndromes used to define intermediate‑ or high‑risk MDS for transplant consideration
Coverage implicationAllogeneic HSCT is considered medically necessary for intermediate‑ or high‑risk MDS per IPSS‑R
AssessmentCytogenetic/molecular risk stratification elements in Appendix A inform IPSS‑R‑based decisions
HSCT — therapeutic intervention description
HSCT descriptionHSCT is a therapeutic intervention that restores hematopoiesis by transplanting hematopoietic stem cells obtained from bone marrow or peripheral blood
SynonymsAlso referred to as hematopoietic cell transplantation (HCT) or stem cell transplant
PurposeUsed to restore marrow function after disease or cytotoxic therapy
HSCT / HCT term definition
HSCT / HCT termTherapeutic replacement of blood‑forming hematopoietic stem cells (from bone marrow or peripheral blood) to restore hematopoiesis after disease or cytotoxic therapy
Procedure componentsMay include collection/harvesting, conditioning (myeloablative or reduced intensity), infusion, and post‑transplant supportive care
Outcome driversOutcomes influenced by disease status, donor match, conditioning intensity, organ function and performance status
Acute lymphoblastic leukemia (ALL) definition
Acute lymphoblastic leukemia (ALL)An acute leukemia of lymphoid lineage characterized by rapid proliferation of abnormal lymphoblasts in blood and bone marrow that impairs normal hematopoiesis
Clinical relevanceAllogeneic HSCT indications and exclusions for ALL are disease‑stage and risk dependent per policy
Guideline basisNCCN and ASTCT guidance inform transplant indications for ALL
Allogeneic HCT/HSCTTransplantation using hematopoietic stem cells from a donor (related, unrelated, or alternative sources) intended as potentially curative therapy for select hematologic malignancies
Donor optionsIncludes HLA‑matched sibling, matched unrelated donor, haploidentical donors, or cord blood depending on availability
IndicationsUsed based on disease‑specific guideline recommendations and patient risk profiles
Autologous HSCT definition
Autologous HSCTTransplantation using the patient’s own hematopoietic stem cells, commonly used in multiple myeloma and relapsed Hodgkin lymphoma
Not curative for some diseasesAutologous HSCT may improve disease‑free survival but is not curative for many malignancies
Role guidanceGuideline statements define when autologous HCT is standard (e.g., MM consolidation) or not recommended
HCT‑CI definition
HCT‑CIHCT‑specific comorbidity index used to assess comorbidities prior to hematopoietic cell transplantation and to predict risks of non‑relapse mortality and survival
UseRecommended for comorbidity assessment prior to transplant; informs candidacy decisions
Relation to policyPolicy references HCT‑CI when considering comorbidity burden for transplant candidacy
Multiple myeloma (MM) definition
Multiple myeloma (MM)A malignant plasma cell disorder with clonal proliferation in bone marrow, monoclonal immunoglobulin production, and end‑organ damage
Transplant roleAutologous HSCT is standard consolidation for eligible newly diagnosed MM patients per guidelines
MaintenanceMaintenance therapy after ASCT is recommended per guideline risk stratification
Myelodysplastic syndromes (MDS) definition
Myelodysplastic syndromes (MDS)A heterogeneous group of clonal hematopoietic stem cell disorders marked by ineffective hematopoiesis, cytopenias, morphologic dysplasia, and variable risk of progression to AML
Transplant roleAllogeneic HSCT is considered for intermediate/high‑risk disease per IPSS‑R
ManagementRisk‑adapted management includes supportive care and disease‑modifying agents; HCT is potentially curative for selected patients
Myelofibrosis (MF) definition
Myelofibrosis (MF)A chronic myeloproliferative neoplasm with clonal proliferation, marrow fibrosis, cytopenias, splenomegaly, and variable symptom burden; allogeneic HCT is a potential curative option for appropriate candidates
Autologous roleAutologous HSCT is not considered medically necessary for myelofibrosis in adults per policy excerpts
POEMS syndrome definition
POEMS SyndromeA rare multisystem plasma cell disorder (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) for which ASCT is a standard option in selected patients
EvidenceRegistry data show higher CR/VGPR rates with ASCT versus non‑ASCT in selected cohorts
Treatment optionsLocalized RT for isolated bone lesions or systemic therapy and ASCT for disseminated disease per NCCN guidance
Primary CNS lymphoma (PCNSL) definition
Primary CNS lymphoma (PCNSL)An aggressive extranodal non‑Hodgkin lymphoma arising within brain, spinal cord, eye, or leptomeninges; autologous HSCT may be considered for consolidation in CR or for relapsed/refractory disease after response to reinduction
Guideline‑based criteriaStem cell rescue for relapsed/refractory PCNSL should be used only if there is a complete or partial response to reinduction high‑dose chemotherapy
Retreatment considerationRetreatment with HDC and stem cell rescue may be considered if prior response and time to relapse ≥1 year
Systemic mastocytosis (SM) definition
Systemic mastocytosis (SM)A clonal proliferation of abnormal mast cells accumulating in extra‑cutaneous organs with subtypes ranging from indolent to advanced disease; allogeneic HCT may be considered in advanced SM
Allo‑HCT roleEvaluation for allogeneic HCT is considered for advanced SM, SM‑AHN, or mast cell leukemia particularly after inadequate response to prior therapy
Evidence needsRole of allo‑HCT in SM requires prospective determination; guideline‑based consideration recommended
Complex / Monosomal karyotype and TP53 adverse marker definitions
Complex karyotypeDefined as ≥3 unrelated chromosome abnormalities in the absence of other class‑defining recurring genetic abnormalities (excludes certain hyperdiploid patterns)
Monosomal karyotypePresence of two or more distinct monosomies (excluding loss of X or Y), or one autosomal monosomy plus at least one structural abnormality
TP53 mutationTP53 mutation at a variant allele fraction ≥10% is considered an adverse marker associated with AML with complex/monosomal karyotype
ASTCT / NCCN guidance — guideline frameworks
ASTCT / NCCN guidanceProfessional guideline frameworks (ASTCT, NCCN) inform indications, candidate selection, and pre‑transplant evaluation across diseases
Use in coveragePolicy aligns coverage determinations with guideline‑based recommendations and cites these sources for documentation expectations
Provider actionCite guideline recommendations (NCCN/ASTCT) when documenting indications for authorization requests
Policy Revision History
2026-08-15annual_reviewLatest
Annual review with additions and revisions: added policy statement for mycosis fungoides and Sézary syndrome; revised statements for recurrent non-Hodgkin lymphoma with chemosensitive disease and for primary Central Nervous System lymphoma.
2025-12-15annual_review
Annual review noted with no clinical policy statement changes.
2024-08-15annual_review
Annual review noted with no clinical policy statement changes.
2024-01-15focused_review
Focused review: content addressing primary central nervous system lymphoma (PCNSL) was removed from CP 0534 and added to this Coverage Policy.