CurrentPremera BluecrossPolicy 8.01.531

MEDICAL POLICY 8.01.531 Hematopoietic Cell Transplantation for Waldenstrom Macroglobulinemia

Defines medical necessity and investigational indications for autologous and allogeneic hematopoietic cell transplantation (HCT) in individuals with Waldenstrom macroglobulinemia (WM), documentation requirements, and applicable procedure codes.

Policy Summary

PayerPremera Bluecross

PolicyMEDICAL POLICY 8.01.531 Hematopoietic Cell Transplantation for Waldenstrom Macroglobulinemia

Policy CodePolicy 8.01.531

Change TypeMinor wording clarifications; coding addition

Effective DateOct 1, 2025

Next Review Date

Key ActionSubmit medical records documenting diagnosis, history and physical, and prior treatments to demonstrate that medical necessity criteria are met.

POLICY UPDATE CHANGES

Policy moved from 8.01.54 to 8.01.531 and annual review approved September 8, 2025 with minor wording clarifications.

HCPCS code S2150 was added to match policy criteria (effective 10/01/24 previous history).

1Covered procedure (autologous HCT)

1Investigational procedure (allogeneic HCT)

5Academic inputs referenced

Coverage Summary

Policy 8.01.531 (Effective 2025-10-01, last reviewed 2025-09-08) addresses hematopoietic cell transplantation (HCT) for Waldenstrom macroglobulinemia (WM). The policy defines that autologous HCT may be considered medically necessary as salvage therapy for chemosensitive WM when criteria are met, whereas allogeneic HCT is considered investigational to treat WM outside of clinical trials due to higher nonrelapse mortality and insufficient evidence.

Policy Number8.01.531

Policy TitleHematopoietic Cell Transplantation for Waldenstrom Macroglobulinemia

Effective Date2025-10-01

Last Review2025-09-08

StatusCURRENT

Scope SummaryDefines medical necessity and investigational indications for autologous and allogeneic hematopoietic cell transplantation (HCT) in individuals with Waldenstrom macroglobulinemia (WM), documentation requirements, and applicable procedure codes.

Medical-Necessity Criteria

Medically Necessary

Autologous hematopoietic cell transplantation may be considered medically necessary when ALL of the following are met:

Medically Necessary - Autologous HCT for WM

Procedure is autologous hematopoietic cell transplantation
Indication is salvage therapy for Waldenstrom macroglobulinemia
Disease status: Disease is chemosensitive
Documentation submitted demonstrating medical necessity (see Documentation Requirements)

ref

Investigational / Not Medically Necessary

Allogeneic hematopoietic cell transplantation is considered investigational when used to treat WM:

Investigational / Not Medically Necessary - Allogeneic HCT for WM

Procedure is allogeneic hematopoietic cell transplantation
Indication is treatment of Waldenstrom macroglobulinemia (outside a clinical trial or other qualifying investigational context)

ref

The policy requires submission of medical records that document that the medical necessity criteria are met; see the 'Documentation Requirements' section for required elements (diagnosis/condition, history and physical, and prior treatments). Provider-specific prior authorization and documentation expectations are described in the provider_actions/prior authorization sections of the policy.

Provider Actions & Authorization

Prior Authorization

Prior authorization / medical necessity review required

Coverage determination requires review of medical necessity criteria; autologous HCT considered only when criteria are documented. (Implied requirement based on policy review process.)

38232
38241
S2150

Documentation Required

Submit documentation of medical necessity

Medical records submitted for review must document diagnosis/condition, history and physical exam documenting severity, and prior treatments to demonstrate criteria are met.

Diagnosis
History & physical documenting severity
Prior treatments

Background & Evidence

Waldenstrom macroglobulinemia (WM) is a rare lymphoplasmacytic lymphoma (about 1%–2% of hematologic malignancies) that can cause symptomatic hyperviscosity and other complications and for which treatment is indicated only in symptomatic individuals. Autologous HCT uses the patient's own harvested stem cells after high-dose chemotherapy and is an option as salvage therapy for chemosensitive disease; it avoids graft-versus-host disease but carries chemotherapy- and infection-related risks. Allogeneic HCT uses donor cells and can provide a graft-versus-malignancy effect but is associated with higher nonrelapse mortality and treatment-related morbidity; per the policy, allogeneic HCT is considered investigational for WM outside clinical trials.

Evidence item	Value
Registry 5-year overall survival - autologous HCT	68.5% (reported)
Registry 5-year overall survival - allogeneic HCT	52% (reported)
Quality of evidence	Case series and small retrospective series; insufficient controlled studies

ChemosensitiveDisease that demonstrates response to chemotherapy; used as a requirement for considering autologous HCT.

Autologous HCTHematopoietic cell transplantation using the individual's own stem cells.

Allogeneic HCTHematopoietic cell transplantation using stem cells from a donor.

Revision History

2024-10-01added