CurrentCapital BluecrossPolicy MP 9.045

Hematopoietic Cell Transplantation for Primary Amyloidosis

Medical coverage policy describing when autologous and allogeneic hematopoietic cell transplantation (HCT) are considered medically necessary or investigational for treatment of primary systemic (light‑chain) amyloidosis; applies to Capital BlueCross‑administered products with program‑specific variations.

Policy Summary

PayerCapital Bluecross

PolicyHematopoietic Cell Transplantation for Primary Amyloidosis

Policy CodePolicy MP 9.045

Change TypeNo material clinical or coverage changes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionVerify member benefits and submit required prior authorization with corresponding diagnosis and procedure codes when requesting autologous HCT.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

coveredAutologous HCT status

investigationalAllogeneic HCT status

up to 77%5‑yr survival (responders)

E85.81Diagnosis code

Coverage Criteria for Hematopoietic Cell Transplantation

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Coverage stance for HCT types

Coverage determinations:

Autologous HCT - coverage stance: Autologous hematopoietic cell transplantation may be considered medically necessary to treat primary systemic (light‑chain) amyloidosis.

Supported by randomized trials, comparative studies, and large case series reporting improved response rates and prolonged survival (e.g., up to 77% 5‑year survival in responders); transplant‑related mortality has declined in recent studies.

Allogeneic HCT - coverage stance: Allogeneic hematopoietic cell transplantation is considered investigational to treat primary systemic (light‑chain) amyloidosis and is not covered.

Evidence is limited to case reports and has shown high treatment‑related mortality; insufficient evidence to demonstrate net health benefit.

Coverage by transplant type

Policy coverage statements as presented:

Autologous HCT: Autologous hematopoietic cell transplantation to treat primary systemic (light‑chain) amyloidosis is covered when medically necessary.

Specific autologous procedure codes supporting coverage are listed in the coding section.

Allogeneic HCT: Allogeneic hematopoietic cell transplantation to treat primary systemic (light‑chain) amyloidosis is investigational and therefore not covered.

Specific allogeneic procedure codes are listed in the coding section and are designated investigational/not covered.

Allogeneic hematopoietic cell transplantation (HCT) to treat primary systemic (light-chain, AL) amyloidosis is considered investigational and is not covered under this policy. The coding section lists the allogeneic procedure codes associated with this investigational stance, and claims for these procedures may be denied.

Allogeneic hematopoietic cell transplantation for primary systemic (light-chain, AL) amyloidosis is designated investigational and therefore excluded from coverage. Providers should note the corresponding investigational procedure codes in the coding section when submitting claims.

Candidate selection considerations

Clinical considerations for candidate selection referenced in evidence summary and treatment background:

Response and eligibility: Autologous HCT is an important treatment option for patients who are deemed eligible; selection should consider underlying organ dysfunction and the therapeutic index of proposed chemotherapy/HCT regimens.

Eligibility specifics (e.g., performance status, organ‑specific function thresholds) are not enumerated in this document segment; decisions should account for cardiac, renal, and other organ involvement common in AL amyloidosis.

Coding — Procedure and Diagnosis Codes

Not Covered — Allogeneic HCT (Investigational)CPTNot Covered

38205	Hematopoietic progenitor cell (HPC); allogeneic transplantation
38230	Bone marrow harvest for transplantation; allogeneic
38240	Hematopoietic progenitor cell (HPC); allogeneic, peripheral blood
38242	Collection of progenitor cells by apheresis; allogeneic
S2142	Bone marrow or stem cell transplant related procedure, allogeneic
S2150	Hematopoietic progenitor cell collection for transplant

Covered — Autologous HCT (Medically Necessary)CPTCovered

38213	Hematopoietic progenitor cell (HPC); autologous transplantation
38206	Bone marrow harvest for transplantation; autologous
38214	Hematopoietic progenitor cell (HPC); autologous, peripheral blood
38207	Collection of progenitor cells by apheresis; autologous
38215	Collection of progenitor cells; autologous, peripheral blood
38232	Stem cell processing for transplantation
38241	Peripheral blood stem cell transplantation-related procedure
S2150	Hematopoietic progenitor cell collection for transplant

Relevant ICD-10 Diagnosis CodesICD-10

E85.0	Non-neuropathic heredofamilial amyloidosis
E85.1	Neuropathic heredofamilial amyloidosis
E85.81	Light chain (AL) amyloidosis
E85.82	Wild-type transthyretin-related (ATTR) amyloidosis
E85.89	Other amyloidosis

Not Covered — Allogeneic HCT (Investigational) — Alternate ListingCPTNot Covered

38205	Hematopoietic progenitor cell (HPC); allogeneic transplantation
38230	Bone marrow harvest for transplantation; allogeneic
38240	Hematopoietic progenitor cell (HPC); allogeneic, peripheral blood
38242	Collection of progenitor cells by apheresis; allogeneic
S2142	Bone marrow or stem cell transplant related procedure, allogeneic
S2150	Hematopoietic progenitor cell collection for transplant

Covered — Autologous HCT (Medically Necessary) — Alternate ListingCPTCovered

38213	Hematopoietic progenitor cell (HPC); autologous transplantation
38206	Bone marrow harvest for transplantation; autologous
38214	Hematopoietic progenitor cell (HPC); autologous, peripheral blood
38207	Collection of progenitor cells by apheresis; autologous
38215	Collection of progenitor cells; autologous, peripheral blood
38232	Stem cell processing for transplantation
38241	Peripheral blood stem cell transplantation-related procedure
S2150	Hematopoietic progenitor cell collection for transplant

Relevant ICD-10 Diagnosis Codes — Alternate ListingICD-10

E85.0	Non-neuropathic heredofamilial amyloidosis
E85.1	Neuropathic heredofamilial amyloidosis
E85.81	Light chain (AL) amyloidosis
E85.82	Wild-type transthyretin-related (ATTR) amyloidosis
E85.89	Other amyloidosis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization for HCT Procedure Codes

Prior Authorization Required. Prior authorization is required for hematopoietic cell transplantation (HCT) procedures. Verify member benefits and eligibility, the date of service, and obtain prior authorization before scheduling HCT. Coverage differs by graft source: autologous HCT may be covered when medically necessary for primary systemic (AL) amyloidosis; allogeneic HCT is investigational and not covered.

Autologous HCT: submit prior authorization for procedure codes supporting autologous transplants (see coding and documentation).
Allogeneic HCT: do not submit for coverage as it is investigational for AL amyloidosis and will be denied.

Documentation Required

Autologous HCT — Prior Authorization and Submission Requirements

Autologous HCT requires prior authorization and clinical documentation supporting medical necessity. Include referral notes, treating physician documentation, and records demonstrating disease characteristics, organ function assessment, prior therapies and responses, and transplant candidacy evaluation (cardiac, renal, hepatic assessments, performance status).

Document prior chemotherapy regimens and responses (e.g., melphalan/prednisone, bortezomib-based regimens, daratumumab combinations).
Provide organ function testing (cardiac biomarkers, echocardiogram, eGFR/creatinine, hepatic panel) and performance status.
Include hematology/oncology consult notes and transplant program evaluation.
Attach the prior authorization reference number on claims when provided.

Note

Treatment Context — Sequencing and Therapies

Treatment context must be documented to support medical necessity for HCT. Describe sequencing of therapies, prior and current chemotherapy regimens, use of novel agents (e.g., immunomodulators, proteasome inhibitors, anti‑CD38 antibodies), and rationale for proceeding to autologous HCT. Note the therapeutic intent (disease control, organ preservation) and balance of transplant risk given organ dysfunction.

List prior systemic therapies (melphalan/prednisone; vincristine/doxorubicin/dexamethasone; bortezomib regimens; daratumumab-based regimens).
Describe response to each therapy and reasons for transplant referral (insufficient response, relapse, or consolidation).
Document evaluation of transplant fitness and organ-specific risk assessments.

Prior Authorization

Benefit and Eligibility Verification

Verify member benefits and eligibility and confirm the date of service prior to authorization and claim submission. Ensure the member’s benefit plan covers HCT and note any program-specific variations (e.g., FEP PPO).

Confirm coverage limitations and exclusions in the member’s contract.
Obtain and document prior authorization approval prior to service.
Check for any product/program exclusions (refer to product variations).

Billing Rule

Coding and Documentation

Coding and documentation on claims must include the appropriate procedure and diagnosis codes that support medical necessity for autologous HCT. Use accurate CPT/HCPCS procedure codes for autologous transplantation and the relevant ICD-10 diagnosis code for AL amyloidosis.

Autologous (covered when medically necessary): procedure codes include autologous HCT harvest/infusion and related codes (see coding list).
Diagnosis: use E85.81 (Light chain (AL) amyloidosis) when applicable.
Claims for allogeneic HCT risk denial as the service is investigational; do not code/submit expecting coverage for allogeneic HCT for AL amyloidosis.

Denial Risk

Investigational Allogeneic HCT — Denial Risk

Investigational allogeneic HCT for primary systemic (AL) amyloidosis is not covered. Submissions for allogeneic transplantation are at high risk for denial and claim rejection.

Do not submit prior authorization requests for allogeneic HCT for AL amyloidosis as a covered benefit.
If allogeneic HCT is submitted, include full clinical rationale — expect denial based on investigational status.

Background and Clinical Context

Primary (light-chain, AL) amyloidosis is a systemic disorder caused by a clonal plasma cell population producing amyloidogenic immunoglobulin light chains that deposit in organs (commonly kidney, heart, and liver), leading to organ dysfunction. Incidence is uncommon (approximately 9–14 cases per million person‑years) with typical age at diagnosis in the 50–65 year range. Treatment aims to reduce or eliminate the clonal plasma cells and light‑chain production; chemotherapy regimens and autologous hematopoietic cell transplantation have improved outcomes compared with historical expectations.

Autologous HCT is used to rapidly eradicate the underlying plasma cell clone and can produce durable hematologic responses; selected patients who respond to therapy may achieve substantially improved survival (reported 5‑year survival rates in responders up to about 77% in some series). By contrast, evidence for allogeneic HCT in primary AL amyloidosis is limited to case reports and is associated with high treatment‑related mortality, which supports the policy distinction between autologous (covered when medically necessary) and allogeneic (investigational) transplant approaches.

Definitions and Code Mapping

Primary amyloidosis (AL) — definition key/value

DefinitionPrimary (light-chain, AL) amyloidosis: systemic disease caused by a clonal plasma cell population producing immunoglobulin light chains that form extracellular beta-pleated sheet fibrils demonstrated by Congo red staining; commonly causes organ dysfunction (kidney, heart, liver).

IncidenceApproximately 9–14 cases per million person‑years (≈4,000 new US cases/year).

Typical age at diagnosisAbout 50–65 years.

Pathognomonic findingExtracellular insoluble fibrils with red‑green birefringence on Congo red stain under polarized light.

Hematopoietic cell transplantation (HCT), autologous and allogeneic — definition key/value

DefinitionHematopoietic cell transplantation (HCT): infusion of hematopoietic stem cells to restore bone marrow function after myeloablative or reduced‑intensity conditioning; cells may be autologous (patient's own) or allogeneic (donor).

Autologous HCT (key point)Uses the patient’s own harvested hematopoietic stem cells; immunologic compatibility is not an issue; typically performed as consolidation after disease response.

Allogeneic HCT (key point)Uses donor stem cells and requires HLA compatibility; involves immunosuppression to prevent graft rejection and GVHD and carries higher infection risk and treatment‑related mortality.

Sources of stem cellsBone marrow, peripheral blood, or umbilical cord blood (cord blood is allogeneic but antigenically ‘naive’ with lower rejection/GVHD risk).

E85.81 — ICD-10 code mapping for Light chain (AL) amyloidosis

ICD-10 codeE85.81

DescriptionLight chain (AL) amyloidosis.

Related ICD-10 codes listedE85.0 (non-neuropathic heredofamilial), E85.1 (neuropathic heredofamilial), E85.82 (wild-type ATTR), E85.89 (other amyloidosis).

OpenPayer

Hematopoietic Cell Transplantation for Primary Amyloidosis

Coverage Criteria for Hematopoietic Cell Transplantation

Coding — Procedure and Diagnosis Codes

Provider Actions, Prior Authorization, and Documentation

Background and Clinical Context

Definitions and Code Mapping

Candidate Selection and Eligibility Considerations

Contraindications

Pretransplant Evaluation Requirements

Center and Program Requirements

Post-Transplant Supportive Care and Coverage