Premera Bluecross Autologous HCT Coverage Update

Coverage Criteria for Hematopoietic Cell Transplantation in Primary (AL) Amyloidosis

inv-01: Autologous HCT — Medical Necessity

Covered when ALL of the following apply

Autologous HCT coverage: Autologous hematopoietic cell transplantation may be considered medically necessary to treat primary systemic (AL) amyloidosis.

Statement of coverage for autologous HCT

inv-02: Allogeneic HCT — Investigational

Allogeneic HCT investigational: Allogeneic hematopoietic cell transplantation is considered investigational to treat primary systemic (AL) amyloidosis.

Insufficient evidence; high treatment-related mortality reported

inv-03: Autologous HCT - Medical Necessity

Covered when ALL of the following are met:

Autologous HCT coverage criteria: 1) Diagnosis of primary (AL) amyloidosis; 2) Amyloid deposition in 2 or fewer organs; 3) Cardiac left ventricular ejection fraction >45%; 4) Individual evaluated and selected based on recognized clinical risk factors for transplantation (per CMS NCD and transplant center assessment).see nodes

Reflects CMS NCD requirements and guideline-based evaluation

inv-04: Allogeneic HCT - Professional Society Stance

Not generally recommended:

Allogeneic HCT stance: ASTCT rates allogeneic HCT as 'N' (not generally recommended) for treatment of primary amyloidosis in adults; considered investigational/unproven in this context.

Clinical guideline recommendation

Allogeneic hematopoietic cell transplantation for primary systemic (AL) amyloidosis is classified as investigational and is therefore excluded from coverage. The policy states that allogeneic HCT is considered investigational to treat primary systemic (AL) amyloidosis and may be denied for this indication.

The American Society for Transplantation and Cellular Therapy (ASTCT) rates allogeneic HCT for primary amyloidosis as N (not generally recommended). Consistent with that professional-society rating, this policy classifies allogeneic HCT for primary (AL) amyloidosis as investigational.

ASTCT guidance states that allogeneic HCT is not generally recommended (rating N) for treatment of primary amyloidosis in adults. The evidence supporting allogeneic HCT is sparse and reported series show high treatment‑related mortality, whereas autologous HCT has stronger evidence and improved outcomes in selected patients.

Coding and Billing

Covered CPT CodesCPTCovered

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

Covered HCPCS CodesHCPCSCovered

S2142

Cord blood-derived stem-cell transplantation, allogeneic

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 out-patient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care or the global definition

Historically removed CPT codesCPT

38242

CPT code previously removed from policy (does not match criteria)

Historically removed HCPCS codesHCPCS

S2140

HCPCS code removed from policy (coding update)

inv-12: Number of organs with amyloid deposition

Number of organs with amyloid deposition≤ 2 organs

inv-13: Left ventricular ejection fraction (LVEF)

Left ventricular ejection fraction (LVEF)> 45%

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for hematopoietic cell transplantation (HCT). Submit a prior authorization request before scheduling autologous HCT for primary systemic (AL) amyloidosis.

Prior authorization required for autologous HCT for primary systemic (AL) amyloidosis.
Include documentation of transplant candidacy and selection criteria per CMS NCD and NCCN guidance.

Denial Risk

Allogeneic HCT Investigational / Denial Risk

Autologous HCT may be considered medically necessary when selection criteria are met. Allogeneic HCT is considered investigational for primary systemic (AL) amyloidosis and requests are at high risk for denial.

Autologous HCT: may be covered when medical necessity criteria and selection criteria are documented.
Allogeneic HCT: investigational — likely denial.

Definitions and Key Terms

inv-26: Allogeneic HCT — ASTCT stance summarized

ASTCT stance (summary)ASTCT rates allogeneic HCT as 'N' (not generally recommended) for treatment of primary amyloidosis in adults; autologous HCT received an 'S' rating.

Transplant Candidate Evaluation and Selection Criteria

inv-27: Transplant candidate evaluation — guideline-based organ assessment and consideration of disease control prior to HCT

Evaluation for transplant candidacy should follow guideline-based organ involvement assessment and consider disease control prior to HCT.

General candidate assessment: Individuals should be evaluated for stem cell transplant candidacy with assessment of organ involvement using amyloidosis consensus criteria and consideration of disease status after systemic therapy (e.g., daratumumab-based regimens).

Refer to NCCN guidance for detailed organ-assessment criteria.

inv-28: Transplant candidate criteria — candidate selection follows guideline-based organ assessment and transplant candidacy evaluation

Candidate selection should follow guideline-based organ assessment and transplant candidacy evaluation:

Candidate selection: Assess organ involvement per amyloidosis consensus criteria; limit to individuals with deposition in ≤2 organs and adequate cardiac function (LVEF >45%); perform transplant candidacy evaluation including comorbidity and risk-factor assessment.

Contraindications and Not Recommended Situations

This portion of the policy does not list specific contraindications exhaustively; however, allogeneic HCT is characterized as investigational in part because the available evidence is limited and reports high treatment‑related mortality associated with the procedure.

Per the Centers for Medicare & Medicaid Services national coverage determination, a cardiac left ventricular ejection fraction of ≤45% is a contraindication to coverage for autologous stem cell transplantation and is a key selection criterion. The NCD specifies that individuals must have a cardiac LVEF of greater than 45% to meet coverage selection criteria.

Pre-approval Evaluation and Documentation Requirements

Documentation Required

Submit comprehensive pre-approval evaluation records

Pre-approval records should include diagnosis, history and physical documenting severity, prognostic index scores when applicable, and relevant evaluative data supporting transplant candidacy.

Include diagnostic data and H&P with severity assessment.
Provide prognostic indices and treatment response data relevant to candidacy.

Documentation Required

Evaluate organ involvement and document prior systemic therapy

Evaluate organ involvement per amyloidosis consensus criteria and document prior systemic therapy (including daratumumab-based regimens when used) and the assessment of stem cell transplant candidacy.

Document organ assessment findings according to consensus criteria.
List prior systemic therapies and responses as part of the transplant evaluation.

Transplant Center and Outcomes Considerations

Note

Perform HCT at appropriately accredited centers (implied)

The policy does not specify center accreditation details; transplants should be performed at appropriately accredited centers as implied by standard practice and referenced outcomes literature.

Ensure procedures are performed at centers with appropriate transplant experience and accreditation.

Documentation Required

Document center accreditation/experience if relevant

Center accreditation and standards are not explicitly defined in this document; providers should use centers meeting standard accreditation and experience expectations.

Document the center’s experience or accreditation if relevant to support the request.

Note

Center outcomes and experience influence recommendations

Policy references center experience and outcomes literature (e.g., CI-BMTR studies and CMS NCD); center selection and experience influence recommendations and expected outcomes.

Post-Transplant Care and Related Services

inv-36: Post-transplant global care and related services

Global care billing (HCPCS S2150)HCPCS S2150 covers bone marrow or blood-derived stem-cells (allogeneic or autologous) including harvesting, transplantation, related complications, and the number of days of pre- and post-transplant care or the global definition.

inv-37: Hematopoietic reconstitution after high-dose melphalan

Hematopoietic reconstitution requirementAutologous HCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (e.g., high-dose melphalan) per CMS National Coverage Determination.

Background on Primary (AL) Amyloidosis

Primary (AL) amyloidosis is a systemic disorder caused by clonal plasma cell production of immunoglobulin light chains that deposit in tissues and organs (most commonly kidney, heart, and liver), leading to organ dysfunction. Reduction of amyloidogenic light‑chain production is central to therapy; autologous HCT following high‑dose melphalan can rapidly reduce light chains and has shown improved survival in selected responders, while allogeneic HCT has sparse evidence and substantial treatment‑related mortality. Coverage policy reflects these differences: autologous HCT may be medically necessary in eligible individuals, whereas allogeneic HCT is considered investigational.

OpenPayer

Hematopoietic Cell Transplantation for Primary Amyloidosis

Coverage Criteria for Hematopoietic Cell Transplantation in Primary (AL) Amyloidosis

Coding and Billing

Provider Actions, Prior Authorization, and Documentation

Definitions and Key Terms

Transplant Candidate Evaluation and Selection Criteria

Contraindications and Not Recommended Situations

Pre-approval Evaluation and Documentation Requirements

Transplant Center and Outcomes Considerations

Post-Transplant Care and Related Services

Background on Primary (AL) Amyloidosis