CurrentCapital BluecrossPolicy MP 9.053

Hematopoietic Cell Transplantation for Autoimmune Diseases

Defines medical necessity and investigational indications for autologous and allogeneic hematopoietic cell transplantation (HCT) for autoimmune diseases, with detailed criteria for systemic sclerosis/scleroderma and summary evidence for other autoimmune conditions. Applies to Capital Blue Cross products with noted variations.

Policy Summary

PayerCapital Bluecross

PolicyHematopoietic Cell Transplantation for Autoimmune Diseases

Policy CodePolicy MP 9.053

Change TypeNo material change

Effective Date6/1/2026

Next Review Date

Key ActionVerify member eligibility, benefits, and prior authorization requirements; document organ-specific assessments to demonstrate eligibility for autologous HCT in systemic sclerosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MP 9.053Policy identifier

3RCTs cited

<60Age limit

≤5yMax disease duration

>15mRSS threshold

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YesSome codes investigational

Coverage Criteria for Hematopoietic Cell Transplantation (HCT)

Initial therapy — systemic sclerosis (autologous HCT)

Autologous HCT may be considered medically necessary for systemic sclerosis/scleroderma when ALL of the following are met:

Systemic sclerosis eligibility: Adult individuals <60 years of age; maximum duration of condition of five (5) years; modified Rodnan Skin Score (mRSS) >15; internal organ involvement as specified in the Policy Guidelines; history of <6 months treatment with cyclophosphamide; no active gastric antral vascular ectasia; absence of exclusion criteria per Policy Guidelines.

These criteria must all be met concurrently.

Internal organ involvement (one or more required): Cardiac: abnormal electrocardiogram; Pulmonary: DLCo <80% predicted, decline in FVC >10% in last 12 months, pulmonary fibrosis, or ground-glass on high-resolution chest CT; Renal: scleroderma-related renal disease.

At least one qualifying organ involvement measure is required as part of eligibility.

Exclusionary organ dysfunction

Patients with any of the following should not be considered for autologous HCT:

Exclusionary organ dysfunction: Cardiac: left ventricular ejection fraction (LVEF) <50%; tricuspid annular plane systolic excursion (TAPSE) <1.8 cm; pulmonary artery systolic pressure >40 mm Hg; mean pulmonary artery pressure >25 mm Hg; Pulmonary: DLCo <40% predicted; FVC <45% predicted; Renal: creatinine clearance <40 mL/minute.

Presence of any one of these findings excludes consideration for autologous HCT.

Investigational indications

Autologous or allogeneic HCT for other autoimmune diseases:

Investigational indications: HCT (autologous or allogeneic) is considered investigational for autoimmune diseases including, but not limited to, multiple sclerosis; systemic lupus erythematosus; juvenile idiopathic or rheumatoid arthritis; chronic inflammatory demyelinating polyneuropathy; and type 1 diabetes unless within clinical trials or further evidence emerges.

Investigational stance applies broadly to the listed conditions.

Covered when medically necessary

Covered when medically necessary (as stated in the policy):

Covered procedure codes for indicated diagnoses: Procedure codes listed (e.g., 38215, 38232, 38241, S2150) are covered when medically necessary for indicated autoimmune diagnoses such as systemic sclerosis (ICD M34.*).

Coverage of these codes is subject to medical necessity determinations and product-specific prior authorization requirements.

Investigational / Not covered

Not covered:

Investigational procedures (not covered): Procedure codes listed as investigational (e.g., 38204, 38205, 38230, 38240, S2140, S2142) are considered investigational and therefore not covered.

Requests for services billed with these codes will be subject to denial as investigational.

The policy excludes individuals with severe or irreversible organ dysfunction from consideration for autologous hematopoietic cell transplantation (HCT). Specific physiologic thresholds that constitute exclusionary dysfunction are listed in the Policy Guidelines and include cardiac, pulmonary, and renal measures. Examples of these exclusionary thresholds are: left ventricular ejection fraction (LVEF) <50%, tricuspid annular plane systolic excursion (TAPSE) <1.8 cm, pulmonary artery systolic pressure >40 mm Hg or mean pulmonary artery pressure >25 mm Hg, DLCo <40% of predicted, FVC <45% of predicted, and creatinine clearance <40 ml/minute. Presence of any one of these findings excludes the individual from autologous HCT under this policy.

Procedures and billing codes that the policy designates as investigational are explicitly excluded from coverage. The investigational code group lists CPT/HCPCS codes that are not covered for autoimmune disease indications and requests for those procedures will be subject to denial per the policy.

Autologous HCT for systemic sclerosis/scleroderma that does not meet all of the policy’s specified eligibility criteria (for example age limit, disease duration, modified Rodnan skin score, documented internal organ involvement, required prior cyclophosphamide exposure, absence of active gastric antral vascular ectasia, and absence of exclusionary organ dysfunction) is considered investigational and therefore not medically necessary under this policy.

Autologous or allogeneic HCT as a treatment for other autoimmune diseases is considered investigational under this policy. The policy lists examples (including but not limited to multiple sclerosis, systemic lupus erythematosus, juvenile idiopathic or rheumatoid arthritis, chronic inflammatory demyelinating polyneuropathy, and type 1 diabetes) for which HCT is investigational unless specific criteria are met in clinical trials or additional evidence emerges.

Coding — Procedure and Diagnosis Codes, Clinical Thresholds

Investigational; therefore not coveredCPTNot Covered

38204	Listed in investigational group
38205	Listed in investigational group
38230	Listed in investigational group
38240	Listed in investigational group
S2140	Listed in investigational group
S2142	Listed in investigational group

Covered when medically necessary (procedure codes)CPT|HCPCSCovered

38215	Listed in covered when medically necessary group
38207	Listed in covered when medically necessary group (paired list formatting in source)
38232	Listed in covered when medically necessary group
38208	Listed in covered when medically necessary group
38241	Listed in covered when medically necessary group
S2150	Listed in covered when medically necessary group

Diagnosis codes associated with covered indicationsICD-10Covered

M34.0	Progressive systemic sclerosis
M34.1	CREST syndrome
M34.2	Systemic sclerosis induced by drug and chemical
M34.81	Systemic sclerosis with lung involvement
M34.82	Systemic sclerosis with myopathy
M34.83	Systemic sclerosis with polyneuropathy
M34.89	Other systemic sclerosis
M34.9	Systemic sclerosis, unspecified

inv-13: DLCo (diffusing capacity of carbon monoxide)

Organ involvement thresholdDLCo <80% of predicted indicates pulmonary involvement qualifying for consideration of autologous HCT

Exclusionary thresholdDLCo <40% of predicted is an exclusion for autologous HCT

Measurement typeDiffusing capacity of carbon monoxide (DLCo) — percent of predicted

inv-14: FVC (forced vital capacity)

Involvement criterionDecline of FVC >10% in the last 12 months indicates pulmonary involvement for consideration of autologous HCT

Exclusionary threshold

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Benefit/Product Variation and Prior Authorization

This policy is applicable only to specific Capital Blue Cross programs and products; benefit coverage and requirements may vary by product. Providers should verify product-specific coverage, benefit limitations, and any FEP (Federal Employee Program) variations prior to submitting authorization requests.

Applicable products may differ; check member’s benefit plan for coverage specifics.
FEP PPO: Refer to FEP Medical Policy Manual at https://www.fepblue.org/benefit-plans/medical-policies-and-utilization-management-guidelines/medical-policies.

Prior Authorization

Covered Codes Require Medical Necessity/Authorization

Certain procedure and diagnosis codes related to hematopoietic cell transplantation are covered when medically necessary; prior authorization or medical necessity review may be required. Submit clinical documentation that supports the member meets the medical necessity criteria listed in the policy.

Covered procedures: e.g., CPT group that includes codes such as 38215 and related transplant procedure codes as listed in the policy.

Background and Scope

Autoimmune diseases are a heterogeneous group of immune-mediated disorders in which standard management often includes anti-inflammatory, immunosuppressive, or immunomodulatory therapies. Hematopoietic cell transplantation (HCT) is an intensive immune ablation and reconstitution strategy intended to ‘‘reset’’ the immune system. Autologous HCT uses the patient’s own hematopoietic cells, whereas allogeneic HCT uses donor-derived cells; this policy addresses indications, exclusion criteria, and the investigational stance for HCT in various autoimmune conditions.

Definitions and Terminology

inv-29: Autologous HCT

DefinitionAutologous HCT: hematopoietic stem cells are obtained from the transplant recipient and reinfused to restore bone marrow and immune function after cytotoxic treatment

Source of cellsAutologous stem cells may be harvested from bone marrow or peripheral blood

Immunologic considerationImmunologic compatibility is not an issue in autologous HCT (no risk of GVHD from donor cells)

inv-30: Reduced-Intensity Conditioning (RIC)

DefinitionReduced-Intensity Conditioning (RIC): pretransplant use of lower doses of cytotoxic drugs or less intense radiotherapy intended to be nonmyeloablative and balance relapse risk with non-relapse mortality

Purpose

Policy Revision History

2026-02-05Consensus reviewLatest

Consensus review conducted; policy formatting, cross-references, product variations, background, rationale, disclaimer, and references updated; benefit variations removed; no clinical policy statement or coding changes.

2025-01-23Consensus review

Consensus review conducted; references updated and coding reviewed with no coding changes reported.

2024-03-13Consensus review

Policy Summary

PayerCapital Bluecross

PolicyHematopoietic Cell Transplantation for Autoimmune Diseases

Policy CodePolicy MP 9.053

Change TypeNo material change

Effective Date6/1/2026

Next Review Date

Key ActionVerify member eligibility, benefits, and prior authorization requirements; document organ-specific assessments to demonstrate eligibility for autologous HCT in systemic sclerosis.

SourceLink

On This Page

FVC <45% of predicted value is an exclusion for autologous HCT

Measurement typeForced vital capacity (FVC) — percent of predicted and trend over 12 months

inv-15: Left ventricular ejection fraction

Exclusionary thresholdLeft ventricular ejection fraction (LVEF) <50% excludes consideration for autologous HCT

AssessmentCardiac evaluation (e.g., ECG and LVEF) required to document cardiac involvement or exclusion

Measurement typeLeft ventricular ejection fraction — percent

inv-16: Tricuspid annular plane systolic excursion (TAPSE)

Exclusionary thresholdTricuspid annular plane systolic excursion (TAPSE) <1.8 cm excludes consideration for autologous HCT

AssessmentEchocardiographic measurement of TAPSE used to evaluate right ventricular function for transplant eligibility

Measurement typeTAPSE — centimeters (cm)

inv-17: Pulmonary artery pressures

Systolic pressure exclusionPulmonary artery systolic pressure >40 mm Hg excludes consideration for autologous HCT

Mean pressure exclusionMean pulmonary artery pressure >25 mm Hg excludes consideration for autologous HCT

AssessmentRight heart hemodynamics (pulmonary artery pressures) required to document exclusionary pulmonary vascular disease

inv-18: Creatinine clearance

Exclusionary thresholdCreatinine clearance <40 ml/minute excludes consideration for autologous HCT

AssessmentCreatinine clearance should be documented to evaluate scleroderma-related renal involvement before transplant

Measurement typeCreatinine clearance — milliliters per minute (ml/min)

Relevant ICD-10 diagnoses include M34.0, M34.1, M34.2, M34.81, M34.82, M34.83, M34.89, M34.9 (systemic sclerosis variants).

Prior authorization may be required per member’s benefit plan; verify prior authorization requirements before scheduling services.

Denial Risk

Investigational Code Denials

Codes and procedures identified as investigational in this policy are not covered. Claims billed with investigational procedure codes are subject to denial.

Investigational / not covered procedure codes include (examples from policy): 38204, 38205, 38230, 38240, S2140, S2142 (see policy coding section for full list).
Autologous or allogeneic HCT for autoimmune diseases such as multiple sclerosis, systemic lupus erythematosus, juvenile idiopathic or rheumatoid arthritis, chronic inflammatory demyelinating polyneuropathy, and type 1 diabetes is investigational and not covered.

Documentation Required

Required Clinical Documentation

Provide complete clinical documentation to support medical necessity for autologous HCT in systemic sclerosis. Documentation should demonstrate internal organ involvement, disease severity, treatment history, and exclusion criteria have been evaluated.

Cardiac assessment: ECG results; left ventricular ejection fraction and tricuspid annular plane systolic excursion when applicable.
Pulmonary assessment: DLCo (% predicted), FVC and trend over the prior 12 months (document any >10% decline), HRCT findings (pulmonary fibrosis or ground glass changes).
Renal assessment: evidence of scleroderma-related renal disease; creatinine clearance if indicated.
Disease severity: Modified Rodnan Skin Score (must be >15 for policy criteria).
Treatment history: documentation of <6 months of prior cyclophosphamide treatment.
Exclusion assessment: documentation that member does not have active gastric antral vascular ectasia and does not meet other policy exclusions.
Operational note: include dates, numeric values, imaging reports, and treating provider rationale supporting HCT consideration.

Note

Eligibility and Benefits Verification

Verify member eligibility and benefits before requesting prior authorization or scheduling services. Policy determinations do not guarantee coverage or payment; final claim payment is subject to the member’s contract, eligibility on the date of service, and demonstration of medical necessity.

Confirm member enrollment and specific benefit coverage for autologous HCT under the member’s plan.
Confirm any required prior authorization processes and timelines with Capital Blue Cross Provider Services.
A medical policy determination is not a guarantee of payment; adjudication occurs at claim submission based on contract terms and eligibility.

Documentation Required

Cyclophosphamide Treatment Requirement

For systemic sclerosis, one of the medical necessity criteria is a history of less than six (6) months of cyclophosphamide treatment prior to considering autologous HCT. Document prior therapies, duration, dosing, and responses to demonstrate this requirement is met.

Record dates and duration of cyclophosphamide therapy and any reasons therapy was stopped or was inadequate.
If cyclophosphamide treatment exceeds six months or documentation is incomplete, the request is at risk for denial based on policy criteria.

RIC aims to reduce disease burden and minimize treatment-related morbidity while allowing graft-versus-malignancy effects to develop

Scope in this documentTerm refers to conditioning regimens intended to be nonmyeloablative

inv-31: Systemic sclerosis (ICD M34.*)

Definition/ICD groupSystemic sclerosis (ICD M34.*) includes progressive systemic sclerosis (M34.0), CREST syndrome (M34.1), drug-induced systemic sclerosis (M34.2), and subcodes for organ involvement (eg, M34.81–M34.83), other/systemic unspecified (M34.89, M34.9)

Covered indication noteICD M34.* codes are listed as diagnoses associated with covered indications when procedure codes are medically necessary

ExamplesM34.81: systemic sclerosis with lung involvement; M34.82: with myopathy; M34.83: with polyneuropathy

Consensus review conducted; references updated and coding reviewed with no coding changes.

2023-02-24Consensus review

Consensus review conducted; references updated and coding reviewed.

2022-02-16Consensus review

Consensus review conducted; references, background, and rationale updated and coding reviewed; no changes to the policy statement.

2021-05-21Consensus review

Consensus review conducted; references and coding reviewed with no change to the policy statement.

2020-04-07Consensus review

Consensus review conducted with minor changes to reflect BCBSA policy; references reviewed and no change to the policy statement or coding.