ModifiedPremera BluecrossPolicy N/A

8.01.15 Hematopoietic Cell Transplantation for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Defines medical necessity criteria for hematopoietic cell transplantation (allogeneic vs autologous) to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), documentation requirements, coding guidance, related benefit considerations, evidence summary, and guideline concordance.

Policy Summary

PayerPremera Bluecross

Policy8.01.15 Hematopoietic Cell Transplantation for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Policy CodePolicy N/A

Change TypeCoding and policy statement updates

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis, history and physical, and markers of poor‑risk disease when requesting allo‑HCT coverage review.

SourceLink

POLICY UPDATE CHANGES

Policy statements updated for clarity and concordance with current guidelines; coding update added CPT codes 38231 and 38241 and HCPCS codes S2142 and S2150 as they apply to this criteria.

1Covered Indication (allo-HCT for poor-risk CLL/SLL)

1Investigational/Not Covered (auto-HCT for CLL/SLL)

4Poor-risk markers listed (examples)

Coverage Summary

This policy defines medical necessity criteria for hematopoietic cell transplantation in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), distinguishing allogeneic HCT (allo-HCT) as medically necessary for individuals with markers of poor-risk disease and autologous HCT (auto-HCT) as investigational/not covered for CLL/SLL. It outlines required documentation for coverage review and provides coding guidance (including CPT and HCPCS/S-code usage and recent coding updates). The policy summarizes the evidentiary basis and alignment with practice guidelines to inform benefit determinations.

Medical-Necessity Criteria

Medically Necessary

Allogeneic hematopoietic cell transplantation is considered medically necessary when ALL of the following are met:

ALL of the following

Procedure is allogeneic hematopoietic cell transplantation (allo-HCT)
Individual has diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Individual has markers of poor-risk disease (see Table 1 and Policy Guidelines)

Investigational / Not Covered

Autologous hematopoietic cell transplantation is considered investigational for CLL/SLL.

ALL of the following

Procedure is autologous hematopoietic cell transplantation (auto-HCT)
Indication is chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Markers of Poor-Risk Disease (used to determine eligibility for allo-HCT)

Markers of poor-risk disease include the following unfavorable prognostic factors (per NCCN and policy text):

ONE or more of

TP53 aberrations: del(17p) or TP53 mutation
IGHV unmutated status≤2% mutation or ≥98% homology with germline
(in those treated with chemoimmunotherapy-based regimens)
Interphase cytogenetics with del(17p) or deletion of 11q (del11q)
Complex karyotype: ≥3 unrelated chromosome abnormalities in more than 1 cell on karyotype≥3 unrelated chromosome abnormalities in more than 1 cell on karyotype

Coding

Included CPT codes (transplant procedure codes listed in policy)CPT

38230	Bone marrow harvesting for transplantation; allogeneic.
38231	Bone marrow harvesting for transplantation; (added in 2026 history).
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor.
38241	Hematopoietic progenitor cell (HPC); autologous transplantation.

Previously/Related CPT codes (removed or noted in history)CPT

38232	Bone marrow harvesting for transplantation; autologous. (was removed in prior coding updates; referenced in history)
38242	Previously removed effective April 1, 2020; code did not match criteria.

HCPCS / S codes referencedHCPCS

S2142	Cord blood-derived stem-cell transplantation, allogeneic. (applies to criteria; added back in 2026)
S2150	Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; global definition. (applies to criteria; added back in 2026)
S2140	Referenced as previously removed in 2020 history.

Provider Actions

Documentation Required

Medical record documentation for review

Medical records submitted for review must document the diagnosis/condition, a history and physical examination documenting severity, and markers of poor-risk disease (per policy guidelines). Include results of relevant laboratory and genetic testing used to define poor-risk features (for example, TP53 aberrations [del(17p) or TP53 mutation], IGHV mutation status, interphase cytogenetics [del(17p), del(11q)], and karyotype showing complex abnormalities).

Diagnosis/condition
History and physical exam documenting severity
Markers of poor-risk disease (e.g., del(17p) or TP53 mutation, IGHV unmutated status, del(11q), complex karyotype ≥3 unrelated abnormalities)

Billing Rule

Use listed CPT/HCPCS codes for transplant procedures

Report the appropriate CPT and HCPCS S-codes for transplant procedures as applicable. The policy lists specific CPT procedure codes for bone marrow and hematopoietic progenitor cell harvesting/transplantation and HCPCS S-codes for stem-cell transplantation; note that coding history and recent updates (addition/removal of codes) may affect adjudication.

CPT 38230
CPT 38231
CPT 38240
CPT 38241
HCPCS S2142
HCPCS S2150

Background & Evidence

Hematopoietic cell transplantation (HCT) may be used in CLL/SLL as part of risk-adapted therapy; HCT infuses hematopoietic stem cells obtained from bone marrow, peripheral blood, or umbilical cord blood to restore marrow function after marrow-ablative therapy. Allo-HCT uses donor cells and offers a graft‑versus‑malignancy effect that can be potentially curative in poor-risk disease, whereas auto-HCT uses the individual's own cells and is not considered curative for CLL/SLL.

Conventional myeloablative conditioning regimens use cytotoxic agents with or without total body irradiation to ablate marrow before allo-HCT; reduced-intensity conditioning (RIC) uses lower-dose or less intense regimens intended to be non‑myeloablative and may be considered based on age, comorbidities, and disease burden. Donor selection emphasizes HLA matching (ideally HLA‑identical siblings), with matched unrelated donors and haploidentical donors as additional options, each with differing risks such as graft‑versus‑host disease.

The policy's conclusions align with available evidence and current practice guidelines: allo-HCT is supported for selected poor‑risk CLL/SLL based on single‑arm prospective and registry data showing durable disease control, while auto‑HCT is investigational given randomized trials and systematic reviews showing no overall survival benefit. Recent guideline updates (ASTCT and NCCN) refine recommendations for HCT use, including consideration of allo‑HCT in specific refractory or transformed disease settings and acknowledgment of alternatives such as CAR T and small‑molecule therapies.

Evidence strength for transplant types

Strength of evidence for allo-HCTSufficient to determine improvement in net health outcome (single-arm prospective and registry studies)

Strength of evidence for auto-HCTInsufficient to determine improvement in net health outcome (RCTs and systematic review show no overall survival benefit)

Allogeneic hematopoietic cell transplantation (allo‑HCT): Transplantation using hematopoietic stem cells obtained from a donor (bone marrow, peripheral blood, or umbilical cord blood).

Autologous hematopoietic cell transplantation (auto‑HCT): Transplantation using the individual's own harvested hematopoietic stem cells.

Reduced‑intensity conditioning (RIC): Pretransplant regimens using lower doses or less intense cytotoxic drugs or radiation intended to be non‑myeloablative, used to balance disease control with reduced treatment‑related morbidity.