CurrentPremera BluecrossPolicy 8.01.531

Hematopoietic Cell Transplantation for Waldenström Macroglobulinemia

Defines medical necessity and investigational indications for autologous and allogeneic hematopoietic cell transplantation in individuals with Waldenström macroglobulinemia; intended for providers and payers reviewing transplant requests.

Policy Summary

PayerPremera Bluecross

PolicyHematopoietic Cell Transplantation for Waldenström Macroglobulinemia

Policy CodePolicy 8.01.531

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateSep 8, 2025

Key ActionSubmit prior authorization with clinical documentation showing diagnosis, severity, prior treatments, and applicable procedure codes to demonstrate medical necessity for autologous HCT.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

coveredautologous coverage

investigationalallogeneic coverage

5-10 yrsmedian survival

~1,500U.S. cases/yr

allo 52% / auto 68.5%5-yr OS after HCT

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Coverage Criteria for Hematopoietic Cell Transplantation in Waldenström Macroglobulinemia

inv-01: Autologous hematopoietic cell transplantation — Covered when ALL of the following are met

Covered when ALL of the following are met

Autologous HCT medical necessity: Autologous hematopoietic cell transplantation may be considered medically necessary as salvage therapy of chemosensitive Waldenström macroglobulinemia.chemosensitive disease

salvage therapy / consolidation

inv-02: Allogeneic hematopoietic cell transplantation — Not covered / investigational

Not covered / investigational

Allogeneic HCT investigational: Allogeneic hematopoietic cell transplantation is considered investigational to treat Waldenström macroglobulinemia due to high nonrelapse mortality and insufficient evidence of net health benefit.N/A

Consider only in clinical trials; may be associated with high nonrelapse mortality

inv-03: Guideline-based consideration for HCT — Guideline recommendation excerpt cited in policy

Guideline recommendation cited in policy excerpt

Guideline recommendation: Younger individuals with good physical fitness should be considered for autologous and allogeneic stem cell transplantation at first or second relapse and should avoid stem cell-toxic therapies such as fludarabine.

From Myeloma Foundation of Australia practice guidelines (2017).

Treatment of Waldenström macroglobulinemia based solely on serum IgM concentration is explicitly excluded. Therapy, including hematopoietic cell transplantation, is indicated only for symptomatic individuals. Clinical or laboratory findings that indicate the need for therapy include: hemoglobin < 10 g/dL, platelet count < 100,000/µL, significant adenopathy or organomegaly, symptomatic Ig-related hyperviscosity (>50 g/L), severe neuropathy, amyloidosis, cryoglobulinemia, cold‑agglutinin disease, or evidence of disease transformation.

There is no Medicare national coverage determination for hematopoietic cell transplantation to treat Waldenström macroglobulinemia. Providers and reviewers should consult member benefit documents or plan-specific guidance for coverage details relevant to Medicare and other payer programs.

Allogeneic hematopoietic cell transplantation for Waldenström macroglobulinemia is considered investigational and is not medically necessary outside of clinical trials. The policy notes a high risk of nonrelapse mortality and insufficient evidence of net health benefit to support routine use of donor (allogeneic) transplants for WM.

Billing and Procedure Codes

CPT codes referencedCPT

38230	Bone marrow harvesting for transplantation; allogeneic
38232	Bone marrow harvesting for transplantation; autologous
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor
38241	Hematopoietic progenitor cell (HPC); autologous transplantation

HCPCS codes referencedHCPCS

S2150

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 posttransplant care in the global definition

Covered/Referenced HCPCS CodesHCPCS

S2150

HCPCS S2150 (added to match policy criteria)

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for autologous hematopoietic cell transplantation (HCT). Submitted clinical documentation must demonstrate that medical necessity criteria are met and should reference applicable procedure and HCPCS codes. Include information on diagnosis, history and physical, disease severity, prior treatments received, and evidence of chemosensitivity where applicable. Prior authorization determinations will be made in the context of the member's benefit plan.

Affected codes: CPT 38230, 38232, 38240, 38241; HCPCS S2150 may be required per plan benefits.

Documentation Required

Required Clinical Documentation

Medical records submitted for prior authorization and claims review must document: diagnosis/condition, history and physical exam noting severity, prior systemic therapies and dates, response (including chemosensitivity), and any transplant-specific evaluations. Failure to provide adequate documentation may result in denial.

Documentation should support application of the policy's medical necessity criteria and reference the submitted procedure/HCPCS codes.

Denial Risk

Coverage Risk Note

There is no Medicare national coverage determination (NCD) for autologous HCT to treat Waldenström macroglobulinemia. The absence of an NCD may affect coverage for Medicare members; providers should verify Medicare Advantage or fee-for-service applicability with the member's plan.

No Medicare NCD exists for this indication; coverage may vary by plan and product.

Note

Member Benefit Verification

Verify member-specific benefits, eligibility, and any transplant benefit limits prior to scheduling or initiating authorization. Consult the member benefit booklet or contact member services for coverage details, prior authorization requirements, and any financial or service limitations.

Confirm whether HCPCS S2150 requires prior authorization under the member's plan.
Contact member services for transplant benefit applicability and preauthorization phone numbers.

Step Therapy

Guideline Treatment Sequencing

Guideline recommendations: autologous HCT is typically reserved for transplant-eligible individuals with chemosensitive disease and is often considered after systemic therapies. Some guidelines (Mayo Clinic; Myeloma Foundation of Australia) recommend considering autologous HCT for first or second relapse in younger, fit individuals, and suggest harvesting stem cells during first remission in eligible patients. Allogeneic HCT is considered investigational for WM.

Consider autologous HCT for transplant-eligible individuals (<70 years in some guidelines) with chemosensitive disease, particularly for first or second relapse or short first remission (<2 years).
Avoid offering autologous HCT to refractory WM without chemosensitivity per guideline recommendations.

Background on Waldenström Macroglobulinemia

Waldenström macroglobulinemia (WM) is a rare lymphoplasmacytic lymphoma characterized by an IgM monoclonal gammopathy. It typically presents in older adults, with a median age at diagnosis in the mid-60s, and reported median overall survival in the range of approximately 5–10 years. The goal of therapy is symptomatic relief and prevention of organ damage; treatment is indicated for manifestations such as anemia, thrombocytopenia, significant adenopathy or organomegaly, symptomatic hyperviscosity, severe neuropathy, amyloidosis, cryoglobulinemia, cold‑agglutinin disease, or transformation. Autologous hematopoietic cell transplantation uses the patient’s own stem cells as consolidation for chemosensitive disease, whereas allogeneic transplantation (donor cells) carries higher nonrelapse mortality and is considered investigational.

Definitions and Regulatory Notes

Autologous hematopoietic cell transplantation — definition (use individual's own cells)

DefinitionAutologous hematopoietic cell transplantation (autologous HCT) = transplant using the individual’s own hematopoietic stem cells collected before high-dose chemotherapy and reinfused after conditioning.

Cell sourceStem cells are collected from the individual and stored; sources include bone marrow or peripheral blood (cord blood is allogeneic).

Clinical roleUsed as consolidation or salvage therapy for chemosensitive disease in Waldenström macroglobulinemia per policy context.

Reduced-intensity conditioning (RIC) — definition and intent to reduce toxicity

DefinitionReduced-intensity conditioning (RIC) = pretransplant regimens using lower doses or less intense cytotoxic drugs or radiotherapy than conventional myeloablative conditioning.

IntentDesigned to reduce treatment-related morbidity and nonrelapse mortality while reducing disease burden so graft-versus-malignancy effects can develop.

ScopeRIC represents a continuum from nearly myeloablative to minimally myeloablative lymphoablative regimens, with intensity tailored to disease and patient condition.

Hematopoietic stem cells (regulatory status) — FDA regulated under 21 CFR parts 1270 and 1271

Regulatory frameworkHematopoietic stem cells are regulated by the US FDA under 21 CFR parts 1270 and 1271 through the Center for Biologics Evaluation and Research.

Product categoryIncludes human cells and tissues intended for implantation, transplantation, or infusion.

ApplicabilityRegulation covers hematopoietic stem cells regardless of source (autologous or allogeneic).

Policy Revision History and References

2014-05-12policy_created

New policy replacing 8.01.54: autologous hematopoietic stem-cell transplantation may be considered medically necessary as salvage therapy for chemosensitive Waldenström macroglobulinemia with qualifying criteria; investigational outside criteria unless in a clinical trial.

2015-02-03related_policies_updated

Updated related policies: removed 8.01.23 and 8.01.28.

2015-04-24annual_review

Annual review with literature update; no change to policy statements.

2016-11-04coding_update

Transplant benefit-related codes removed (coding update).

2016-12-01annual_review

Annual review approved November 8, 2016; no changes to policy statements.

2017-03-01annual_review

Annual review with literature update through October 26, 2016; references 2 and 5 added; policy statements unchanged.

2017-04-01related_policies_updated

Updated titles of related policies.

2017-06-09coding_update

Coding update: updated description for CPT codes 38240 and 38241.

2017-10-17minor_update

Minor update: updated policy title and related policy title(s).

2017-12-01format_migration

Policy moved into new format; no change to policy statements.

2018-07-01annual_review

Annual review approved June 5, 2018; no changes to policy statements.

2019-04-01annual_review

Annual review with literature update through December 2018; reference 4 updated; policy statements unchanged.

2020-04-01coding_update

Coding update: removed CPT code 38242 as it did not match criteria.

2020-06-01annual_review

Annual review approved May 21, 2020 with literature update through November 2019; no references added and policy statements unchanged.

2021-04-01annual_review

Annual review approved March 23, 2021 with literature update through October 19, 2020; policy statements unchanged.

2021-05-01related_policies_updated

Removed related policy 7.01.50 (archived).

2022-12-01annual_review

Annual review approved November 7, 2022; removed outdated Clinical Trial table and standardized wording from 'patient' to 'individual'.

2024-01-01annual_review

Annual review approved December 11, 2023; no changes to policy statements.

2024-04-11related_policies_updated

Minor update to related policies: 8.01.21 replaced by 8.01.539 Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms.

2024-10-01annual_review_and_coding_update

Annual review approved September 23, 2024; added HCPCS code S2150 to match policy criteria.

2025-10-01annual_reviewLatest

Annual review approved September 8, 2025; no changes to policy statements and minor wording clarifications.