CurrentCapital BlueCrossPolicy MP 9.038

Hematopoietic Cell Transplantation for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Defines medical necessity and investigational status for allogeneic and autologous hematopoietic cell transplantation to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) for Capital BlueCross benefit programs.

Policy Summary

PayerCapital BlueCross

PolicyHematopoietic Cell Transplantation for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Policy CodePolicy MP 9.038

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionProviders should document medical necessity for hematopoietic cell transplantation and use the procedure codes listed in the policy when submitting prior authorization requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Medically necessaryAllogeneic stance

InvestigationalAutologous stance

NCCN v2.2026Guideline cited

Insufficient OS benefitEvidence summary

Multiple HSCT codes

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Coverage Criteria for Hematopoietic Cell Transplantation

Allogeneic HCT — medical necessity criteria

Covered when ALL of the following are met

Allogeneic HCT indication: Allogeneic hematopoietic cell transplantation may be considered medically necessary to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in individuals with markers of poor-risk disease (see Policy Guidelines).

Supports use in poor-risk or relapsed/refractory disease per policy text and guideline context.

Poor-risk markers/guideline context: Unfavorable prognostic markers include TP53 mutation or del(17p), del(11q), IGHV mutation ≤2%, or complex karyotype; NCCN states allo-HCT can be considered for relapsed/refractory disease after prior BTKi- and venetoclax-based regimens in patients without significant comorbidities.

Policy Guidelines and NCCN guidance referenced.

Conditioning and donor considerations: Conditioning intensity (myeloablative vs reduced-intensity conditioning) should be individualized based on age, comorbidities, and disease burden; ideal donors are HLA-identical siblings or matched unrelated donors; haploidentical donors have been under investigation and may carry higher GVHD risk.

Includes RIC discussion and donor hierarchy.

ASTCT/CAR T context: Professional society guidance (ASTCT) and guideline summaries reduce routine recommendation for allo-HCT in some settings in favor of cellular therapies; allo-HCT is recommended after relapse/refractory to CAR T when an objective response is present prior to allograft, and may be considered in clonally-related Richter transformation after objective response to frontline chemoimmunotherapy.

Professional society and guideline guidance influences sequencing.

Autologous HCT — investigational

Autologous HCT: Autologous hematopoietic cell transplantation is considered investigational to treat CLL or SLL due to insufficient evidence of benefit; studies have not demonstrated improved overall survival.

Policy explicitly states investigational status and evidence summary.

Transplant Coverage Criteria

Covered when criteria below apply (policy aligns with transplant guideline recommendations):

Allogeneic HCT indications

Relapsed/refractory after CAR T: CLL is relapsed and/or refractory to CAR T-cell therapy when an objective response is demonstrated prior to the allograft.
NCCN/Guideline statement.
Clonally-related Richter transformation: Patients with clonally-related Richter transformation after demonstrating an objective response to frontline chemoimmunotherapy or other treatments.
NCCN/Guideline statement.

Autologous HCT stance: Autologous HCT is feasible in younger patients but has not shown improvement in overall survival in CLL/SLL; evidence is insufficient to determine benefit for health outcomes.

Evidence summary from policy.

NCCN guidance (v.2.2026) notes that the availability of effective targeted therapies—specifically covalent BTK inhibitors and venetoclax—has changed sequencing for hematopoietic cell transplantation in CLL/SLL. The guideline states that allogeneic HCT is not considered a reasonable option for relapsed/refractory CLL after only initial purine-analogue therapy, and that allogeneic HCT may be considered for relapsed/refractory disease following prior BTKi- and venetoclax-based regimens in patients without significant comorbidities. This context should inform consideration of allo-HCT timing and prior therapeutic exposure when assessing medical necessity.

Procedure code 38206 is listed in the policy as investigational and not covered when used to treat chronic lymphocytic leukemia or small lymphocytic lymphoma; providers should not use this code to request coverage for HCT in CLL/SLL under this policy.

Autologous hematopoietic cell transplantation for CLL or SLL is designated investigational (not medically necessary) in this policy. Requests for autologous HCT to treat CLL/SLL will be denied on that basis.

Published evidence, including randomized trials and systematic reviews, indicates that autologous HCT has not demonstrated improvement in overall survival for patients with CLL/SLL. While autologous HCT is technically feasible in younger patients, it is not curative for poor‑risk disease and available studies do not show a survival benefit; therefore the evidence is insufficient to support routine use for improved health outcomes.

Procedure and Diagnosis Codes

Covered CPT/Procedure Codes (as listed)CPTCovered

38211	Procedure Codes
S2142	Procedure Codes = 38212 (mapping listed)
38212	Procedure Codes
S2150	Procedure Codes = 38213 (mapping listed)
38213	Procedure Codes
38204	Procedure Codes = 38214 (mapping listed)
38214	Procedure Codes
38205	Procedure Codes = 38215 (mapping listed)
38215	Procedure Codes
38207	Procedure Codes = 38230 (mapping listed)

1–10 of 16

1/2

Investigational / Not Covered Procedure CodesCPTNot Covered

38206	Investigational; therefore, not covered when used to treat chronic lymphocytic leukemia, or small lymphocytic lymphoma
38232	Procedure Codes (mapping listed)
38241	Procedure Codes (mapping listed)

Relevant ICD-10 Diagnosis CodesICD-10

C91.10	Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11	Chronic lymphocytic leukemia of B-cell type in remission
C91.12	Chronic lymphocytic leukemia of B-cell type in relapse

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Product-specific prior authorization

This policy may apply only to certain Capital Blue Cross products and programs. Prior authorization requirements and benefit coverage vary by member plan; verify the member's specific benefit plan before proceeding.

Check member benefit plan and product prior to authorization submission.
FEP PPO: Refer to FEP medical policy manual at fepblue.org for FEP-specific guidance.

Denial Risk

Autologous HCT investigational

Requests for autologous hematopoietic cell transplantation (HCT) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are considered investigational and will be denied.

Autologous HCT for CLL/SLL = investigational; do not authorize or bill as covered for this indication.

Line-of-Therapy and Salvage Criteria

salvage

salvage — consider allo-HCT after prior targeted regimens: Consider allogeneic HCT for relapsed/refractory disease after prior therapy including BTKi- and venetoclax-based regimens in patients without significant comorbidities; allo-HCT is not considered reasonable after only initial purine-analogue therapy per NCCN.

Reflects NCCN and ASTCT statements regarding sequencing and exclusions.

salvage

salvage — post-CAR T relapse/refractory: Allogeneic HCT is recommended if CLL is relapsed and/or refractory to CAR T-cell therapy when an objective response is demonstrated prior to the allograft.

Guideline-recommended sequencing after CAR T.

salvage

Biomarker and Genetic Testing Requirements

TP53 mutation/del(17p)

BiomarkerTP53 mutation or deletion of 17p (del(17p)) identifying poor‑risk disease for consideration of allogeneic HCT

PurposeUsed to identify individuals with unfavorable prognosis who may be considered for allo‑HCT

Source guidanceListed among unfavorable prognostic factors in NCCN guidance referenced in policy

IGHV mutation status

BiomarkerIGHV mutation status ≤2% (≤2% immunoglobulin heavy‑chain variable mutation) considered unfavorable

PurposeThreshold (≤2%) used to classify IGHV as unmutated/poor‑risk for transplant consideration

Definitions

CLL/SLL

DefinitionChronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are B‑cell neoplasms characterized by accumulation of mature‑appearing lymphocytes; CLL involves blood, bone marrow, lymph nodes, and spleen while SLL is primarily nodal

RelationshipCLL and SLL are considered a single disease entity (blood and tissue counterparts) with similar treatments and outcomes

Clinical noteBoth are usually indolent but can transform to more aggressive disease (e.g., Richter transformation); median age at diagnosis ~72 years

Hematopoietic cell transplantation (HCT)

DefinitionHematopoietic cell transplantation (HCT) is a procedure in which hematopoietic stem cells are infused to restore bone marrow function after marrow‑toxic therapy

Sources of cells

Background

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are related B‑cell neoplasms characterized by accumulation of mature‑appearing lymphocytes; CLL typically involves blood, bone marrow, lymph nodes, and spleen, while SLL is primarily nodal. These disorders are generally indolent but can transform or progress, and conventional therapies rarely cure CLL/SLL—prompting investigation of hematopoietic cell transplantation as a potentially curative option. The median age at diagnosis is approximately in the early 70s, which influences transplant candidacy and the choice between myeloablative and reduced‑intensity conditioning regimens.

Policy Summary

PayerCapital BlueCross

PolicyHematopoietic Cell Transplantation for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Policy CodePolicy MP 9.038

Change TypeNo material changes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionProviders should document medical necessity for hematopoietic cell transplantation and use the procedure codes listed in the policy when submitting prior authorization requests.

SourceLink

On This Page

Documentation Required

Coverage contingent on benefits/medical necessity

Coverage for allogeneic HCT is contingent upon the member's benefits, eligibility, and a determination that the service is medically necessary and appropriate for the member's condition.

Verify member eligibility and benefits on the date of service.
Coverage decisions require documented medical necessity consistent with policy criteria.

Documentation Required

HLA and conditioning documentation

Document donor compatibility (HLA) testing and the conditioning regimen used for allogeneic HCT in the medical record and prior authorization submission.

Include HLA typing results (HLA-A, -B, -DR loci) and donor match level.
Document the chosen conditioning regimen (myeloablative vs reduced-intensity), rationale, and relevant comorbidities.

Note

Use of targeted therapies before allo-HCT

NCCN guidance indicates effective targeted therapies (e.g., BTK inhibitors, venetoclax) can alter the timing and appropriateness of allogeneic HCT; document prior targeted therapy use and response before considering allo‑HCT.

Document prior use and response to targeted agents (BTKi, venetoclax) and reason for proceeding to allo‑HCT.
If patient responded to targeted therapy, include rationale why allo‑HCT is still medically necessary.

Billing Rule

Document medical necessity and use listed codes

Providers must document medical necessity for HCT and submit appropriate procedure codes when requesting authorization or submitting claims; coding lists in policy are informational and do not guarantee coverage.

Include supporting clinical documentation with prior authorization: diagnosis, prior therapies, response, HLA testing, conditioning regimen, and comorbidities.
Use applicable procedure codes for hematopoietic cell transplantation when billing; verify code applicability to the service and member benefit.

salvage — Richter transformation after response: Allogeneic HCT is recommended for patients with clonally-related Richter transformation after demonstrating an objective response to frontline chemoimmunotherapy or other treatments.

Guideline-recommended indication for allo-HCT in RT.

Specifically listed as an unfavorable prognostic factor in NCCN guidance summarized in policy

del(11q); complex karyotype

BiomarkersDeletion of 11q (del(11q)) and complex karyotype (≥3 unrelated chromosome abnormalities in >1 cell)

PurposeClassified as unfavorable prognostic markers to identify poor‑risk CLL/SLL for allo‑HCT consideration

Source guidanceIncluded with other unfavorable prognostic factors per NCCN guidance cited in the policy

Stem cells may be obtained from the recipient (autologous) or a donor (allogeneic) and harvested from bone marrow, peripheral blood, or umbilical cord blood

IndicationUsed in patients receiving bone‑marrow‑toxic doses of drugs with or without whole‑body radiotherapy to reconstitute hematopoiesis

Allogeneic

DefinitionAllogeneic: transplantation using donor cells (different genetic constitution) requiring HLA matching; provides possible graft‑versus‑tumor effect but carries risk of graft‑versus‑host disease (GVHD)

AdvantagesLack of tumor contamination in graft and potential graft‑versus‑tumor activity

RisksIncreased risk of GVHD, which rises with greater HLA disparity and older recipient age

Autologous

DefinitionAutologous: transplantation using the patient’s own harvested stem cells collected prior to myeloablative therapy

Advantage/limitationAvoids GVHD risk but may have tumor cell contamination; policy states autologous HCT is investigational for CLL/SLL

SourcesAutologous stem cells commonly harvested from the patient’s bone marrow or peripheral blood prior to high‑dose therapy

Reduced-intensity allogeneic SCT

DefinitionReduced‑intensity allogeneic stem cell transplantation (RIC): uses lower doses of chemotherapy than standard allogeneic transplant and does not fully ablate the recipient immune system; intended for older or sicker patients

Clinical useConditioning intensity (myeloablative vs reduced‑intensity) should be individualized by age, comorbidity, and disease burden

TradeoffsRIC aims to reduce regimen‑related toxicity but may rely more on graft‑versus‑tumor effects for disease control

Relapsed / Refractory

RelapsedDisease that returned after achieving remission (patients who achieved remission but later have decreased normal blood counts and return of leukemia in marrow)

RefractoryDisease that persists despite intensive treatment (residual leukemia cells in marrow after intensive therapy)

Clinical implicationRelapsed or refractory status influences consideration for salvage therapies including allogeneic HCT per policy and guideline context