CurrentBlue Cross Blue Shield - MassachusettsPolicy 192

Hematopoietic Cell Transplantation for Autoimmune Diseases (Coverage Criteria)

This policy governs coverage and prior authorization requirements for autologous and allogeneic hematopoietic cell transplantation (HCT) when used to treat autoimmune diseases for BCBS Massachusetts members across commercial and Medicare products.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyHematopoietic Cell Transplantation for Autoimmune Diseases (Coverage Criteria)

Policy CodePolicy 192

Change TypeAnnual review — literature update

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests via Authorization Manager with facility and servicing provider NPIs and supporting clinical documentation that criteria for systemic sclerosis are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CoveredSystemic sclerosis covered (with criteria)

MultipleInvestigational indications

RequiredPrior authorization required

38241 / S2150Key codes cited

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Coverage Criteria for Hematopoietic Cell Transplantation

Autologous HCT for systemic sclerosis/scleroderma (medically necessary criteria)

Covered when ALL of the following are met:

Age: Adult individuals <60 years of age<60 years

Disease duration: Maximum duration of condition of 5 years<=5 years since diagnosis

Skin score: Modified Rodnan skin score (mRSS) >15>15

Internal organ involvement: Evidence of internal organ involvement (cardiac, pulmonary, or renal) as defined by clinical measurementssee organ-specific thresholds

Patients with severe and irreversible organ involvement were excluded from trials

Prior cyclophosphamide: History of <6 months treatment with cyclophosphamide<6 months

GAVE: No active gastric antral vascular ectasia (GAVE)absent

Exclusion criteria: Does not meet any exclusion thresholds for severe/irreversible organ involvement (eg, cardiac, pulmonary, renal)See exclusion thresholds (LVEF <50%; TAPSE <1.8 cm; PASP >40 mm Hg; mean PAP >25 mm Hg; DLCo <40% predicted; FVC <45% predicted; creatinine clearance <40 ml/min)

Individuals with severe and irreversible internal organ involvement should not be considered for autologous HCT.

Investigational indications

Considered investigational for the following autoimmune diseases (not covered):

Investigational conditions: Multiple sclerosis; systemic lupus erythematosus; juvenile idiopathic or rheumatoid arthritis; chronic inflammatory demyelinating polyneuropathy (CIDP); type 1 diabetes mellitus; and other autoimmune diseases not meeting criteria for systemic sclerosis

Autologous or allogeneic HCT is considered investigational for these indications

Coverage conclusions by indication

Summary coverage stance by indication based on evidence presented in this document portion:

systemic sclerosis: Evidence (systematic reviews, 3 RCTs, observational studies) shows autologous HCT improves long-term outcomes (mRSS, FVC, overall survival) versus cyclophosphamide alone in appropriately selected adults; short-term increased adverse events and treatment-related mortality observed; evidence sufficient to support benefit when selection criteria are met.adults <60 years, disease duration <=5 years, mRSS >15, internal organ involvement; patients with severe irreversible organ involvement were excluded from trials

Based on RCTs summarized in the policy.

systemic lupus erythematosus: Data (systematic review, case series) are heterogeneous in regimens and cell sources; largest series reported 5-year survival 84% and disease-free survival 50%; controlled data lacking—evidence insufficient to determine net health benefit.heterogeneous conditioning and cell sources

Additional controlled studies needed.

Individuals with severe and irreversible internal organ involvement should not be considered for autologous HCT. Examples of exclusionary cardiac measurements include a left ventricular ejection fraction (LVEF) <50%, tricuspid annular plane systolic excursion (TAPSE) <1.8 cm, pulmonary artery systolic pressure (PASP) >40 mm Hg, or a mean pulmonary artery pressure >25 mm Hg. Pulmonary exclusion thresholds include diffusing capacity for carbon monoxide (DLCo) <40% of predicted or forced vital capacity (FVC) <45% of predicted. Renal exclusion examples include creatinine clearance <40 ml/min. These measurements are intended to identify severe, irreversible organ dysfunction that would contraindicate autologous HCT.

Randomized trials of autologous HCT for systemic sclerosis enrolled adults <60 years with disease duration ≤5 years, modified Rodnan skin score (mRSS) >15, and internal organ involvement, but they explicitly excluded patients with severe and irreversible organ involvement. The trial exclusion of patients with advanced cardiac, pulmonary, or renal dysfunction highlights that outcomes and applicability of the evidence pertain to patients without irreversible organ damage.

Autologous hematopoietic cell transplantation for systemic sclerosis/scleroderma that does not meet the policy’s specified criteria (including age, disease duration, mRSS, organ involvement assessments, prior cyclophosphamide exposure, absence of active gastric antral vascular ectasia, and absence of exclusionary organ dysfunction) is considered investigational and therefore not medically necessary.

For multiple other autoimmune indications listed (including multiple sclerosis; systemic lupus erythematosus; juvenile idiopathic or rheumatoid arthritis; chronic inflammatory demyelinating polyneuropathy; type 1 diabetes mellitus; Crohn disease; immune cytopenias; relapsing polychondritis; and other autoimmune disorders), the available evidence is limited to observational studies, registries, case series, meta-analyses with heterogeneous interventions, or single RCTs with inconsistent results. The policy concludes that current evidence is insufficient to determine that autologous or allogeneic HCT improves net health outcomes for these indications, and therefore these uses are considered investigational.

Coding and Billing References

CPT CodesCPT

38241

Bone marrow or blood-derived peripheral stem-cell transplantation; autologous

HCPCS CodesHCPCS

S2150

Bone marrow or blood-derived peripheral stem-cell harvesting and transplantation, allogeneic or autologous, including pheresis, high-dose chemotherapy, and the number of days of post-transplant care in the global definition (including drugs; hospitalization; medical surgical, diagnostic and emergency services)

Coding history notesmixed

No codes listed

Cardiac, Pulmonary, Renal exclusion thresholds

Left ventricular ejection fraction (LVEF)<50%

Tricuspid annular plane systolic excursion (TAPSE)<1.8 cm

Diffusing capacity for carbon monoxide (DLCo)<40% of predicted

Forced vital capacity (FVC)<45% of predicted

Creatinine clearance<40 ml/min

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Preauthorization Required

For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient. Failure to obtain required precertification/prior authorization may result in denial of payment.

Inpatient services: precertification/preauthorization is required for all products if the procedure is performed inpatient.
Outpatient services: prior authorization is required for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity, Medicare HMO Blue SM, and Medicare PPO Blue when performed outpatient.

Prior Authorization

Authorization Submission Requirements

Providers must use Authorization Manager to submit initial authorization requests. Authorization Manager is available 24/7 and is the quickest way to review authorization requirements, request authorizations, submit clinical documentation, check existing case status, and view/print the decision letter.

Enter the facility's NPI or provider ID for the location where services will be performed.
Enter the appropriate surgeon's NPI or provider ID as the servicing provider (not the billing group).

Background on Hematopoietic Cell Transplantation

Hematopoietic cell transplantation (HCT) is a procedure in which hematopoietic stem cells are intravenously infused to restore marrow and immune function after cytotoxic conditioning. Autologous HCT uses the patient’s own hematopoietic stem cells (so immunologic compatibility is not an issue), while allogeneic HCT uses donor cells and requires HLA compatibility to reduce risks of graft failure and graft-versus-host disease. HCT has been investigated as a means to ‘reset’ the immune system in severe, refractory autoimmune diseases when conventional immunosuppressive therapies have failed; in the systemic sclerosis randomized trials, conditioning was typically cyclophosphamide-based.

Key Definitions

Autologous HCT — definition/notes

DefinitionHematopoietic stem cells obtained from the patient (autologous); immunologic compatibility between infused cells and the recipient is not an issue.

Cell sourcesStem cells may be harvested from bone marrow, peripheral blood, or umbilical cord blood.

Clinical useUsed to restore bone marrow and immune function after marrow‑toxic conditioning regimens.

Allogeneic HCT — definition/notes

DefinitionHematopoietic stem cells obtained from a donor (allogeneic); HLA compatibility between donor and patient is a critical factor to reduce graft failure and graft‑versus‑host disease.

CompatibilityEstablished by typing human leukocyte antigens (HLA) at loci such as HLA‑A, ‑B, and ‑DR.