ModifiedPremera BluecrossPolicy 8.01.25

Hematopoietic Cell Transplantation for Autoimmune Diseases

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Defines medical necessity, investigational determinations, documentation, and coding for autologous and allogeneic hematopoietic cell transplantation (HCT) as treatments for specific autoimmune diseases for Premera Bluecross members and providers.

Policy Summary

PayerPremera Bluecross

PolicyHematopoietic Cell Transplantation for Autoimmune Diseases

Policy CodePolicy 8.01.25

Change TypeMaterial coverage change: MS updated from investigational to medically necessary

Effective DateAug 1, 2026

Last ReviewJul 14, 2026

Next Review DateAug 1, 2026

Key ActionObtain prior authorization and submit documentation that the individual meets the policy's medical necessity criteria before proceeding with HCT.

SourceLink

POLICY UPDATE CHANGES

Policy statement for multiple sclerosis was changed from investigational to medically necessary with criteria.

HCPCS code S2142 was added to align with policy criteria.

Wording standardized from 'patient' to 'individual' throughout the policy.

1Policy statements changed

S2142HCPCS code added

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ModifiedPremera BluecrossPolicy 8.01.25

Hematopoietic Cell Transplantation for Autoimmune Diseases

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Sign up for Premera Bluecross Policy 8.01.25 alerts

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Policy Summary

PayerPremera Bluecross

PolicyHematopoietic Cell Transplantation for Autoimmune Diseases

Policy CodePolicy 8.01.25

Change TypeMaterial coverage change: MS updated from investigational to medically necessary

Effective DateAug 1, 2026

Last ReviewJul 14, 2026

Next Review DateAug 1, 2026

Key ActionObtain prior authorization and submit documentation that the individual meets the policy's medical necessity criteria before proceeding with HCT.

SourceLink

POLICY UPDATE CHANGES

Policy statement for multiple sclerosis was changed from investigational to medically necessary with criteria.

HCPCS code S2142 was added to align with policy criteria.

Wording standardized from 'patient' to 'individual' throughout the policy.

1Policy statements changed

S2142HCPCS code added

18–55; <60Age limits

Autologous & AllogeneicCoverage types

Coverage Criteria and Determinations

Systemic sclerosis — Medically Necessary

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

Age and disease duration: Adult individuals aged less than 60 years AND maximum duration of condition of 5 years.

From trial-based candidate selection.

Skin involvement: Modified Rodnan Skin Score greater than or equal to 15.>= 15

Organ involvement: Internal organ involvement as noted in Related Information and not meeting exclusion thresholds (see exclusions for cardiac, pulmonary, and renal measurements).

Refer to Related Information for organ-specific thresholds (eg, LVEF, DLCo, FVC, creatinine clearance).

Prior cyclophosphamide exposure: History of less than 6 months of treatment with cyclophosphamide.< 6 months

Gastrointestinal bleeding: No active gastric antral vascular ectasia (no ongoing upper gastrointestinal bleeding).

Exclusions absent: Does not have any exclusion criteria as noted in Related Information (eg, severe, irreversible internal organ involvement per policy measurements).

See exclusion criteria for specific cardiac, pulmonary, and renal thresholds that would preclude consideration.

Multiple sclerosis — Medically Necessary

Autologous HCT is considered medically necessary for multiple sclerosis when ALL of the following are met (relapsing or secondary progressive with inflammatory activity):

MS disease phenotype: Relapsing-remitting multiple sclerosis (RRMS) OR secondary progressive multiple sclerosis with evidence of ongoing inflammatory disease activity defined by any of: two or more clinical relapses in the previous 12 months; OR one or more clinical relapses in the previous 24 months AND MRI evidence of disease activity (new/enlarging T2 lesions or gadolinium-enhancing lesions) at a different time point; OR confirmed EDSS worsening >=1 point over the preceding 12 months.

EDSS definition provided in Related Information.

Disease progression despite therapy: Disease progression or continued activity despite treatment for at least 12 months AND disease-modifying therapy (DMT) exposure as evidenced by failure of >=1 DMT at therapeutic doses for adequate duration or documented intolerance to DMT; AND evidence of treatment failure (continued relapses on DMT, new/enlarging MRI lesions on DMT, or confirmed disability progression EDSS increase >=1 while on DMT).12 months

DMT examples and definition of high-efficacy DMT listed in policy.

Investigational indications

Conditions considered investigational (not covered):

Investigational indications: Autologous or allogeneic hematopoietic cell transplantation for systemic lupus erythematosus, juvenile idiopathic or rheumatoid arthritis, chronic inflammatory demyelinating polyneuropathy, type 1 diabetes, and other autoimmune diseases not specifically listed as covered indications.

These indications are considered investigational per policy and not medically necessary when not meeting specific covered criteria.

Indication-specific evidence summaries

Coverage considerations and evidence summaries by disease

Multiple sclerosis evidence summary: Evidence includes RCTs, systematic reviews, a network meta-analysis, and nonrandomized studies; some trials show imaging and progression benefits and observational studies show clinical improvements, but TRM and adverse events are significant; clinical input supports AHSCT for appropriately selected relapsing-remitting or active secondary progressive MS patients. Overall evidence described as insufficient to determine net health outcome improvement without careful selection.

See policy Summary of Evidence for details.

Systemic sclerosis evidence summary: Three RCTs compared cyclophosphamide plus autologous HCT versus cyclophosphamide alone; trial populations were adults <60 years, disease duration <=5 years, and modified Rodnan skin score >15; trials excluded severe irreversible organ involvement. Short-term TRM higher with HCT but longer-term improvements in mortality and clinical outcomes were reported; evidence considered sufficient to demonstrate improvement in net health outcome for selected patients.

See policy Summary of Evidence for details.

Systemic lupus erythematosus evidence summary: Systematic review and case series heterogeneous in regimens and cell sources; largest series reported 5-year survival 84% and disease-free survival 50%; evidence insufficient to determine net health outcome improvement.

Covered Indications (historical Medicare-based statements)

Policy cites historically covered indications for autologous and allogeneic HCT; certain Medicare-derived criteria apply for specific diseases.

Historical covered indications — autologous HCT: Autologous HCT historically considered reasonable and necessary (Medicare statements) for conditions including acute leukemia in remission with high relapse risk and no HLA-matched donor; resistant non-Hodgkin lymphoma with poor prognostic features after initial response; recurrent/refractory neuroblastoma; advanced Hodgkin disease after failed conventional therapy with no HLA-matched donor; and single autologous HCT for Durie-Salmon Stage II or III multiple myeloma meeting response and organ function criteria.

Based on historical Medicare-based statements cited in policy.

Historical covered indications — allogeneic HCT: Allogeneic HCT historically covered for diseases such as leukemia, leukemia in remission, aplastic anemia, and selected inherited immunodeficiency syndromes (eg, SCID, Wiskott-Aldrich) per historical effective-date statements.

Based on historical Medicare-based statements cited in policy.

Not Covered / Insufficient Evidence

Indications identified as not covered or nationally noncovered.

Nationally noncovered / insufficient evidence: Allogeneic HCT was not covered as treatment for multiple myeloma (effective 1996 through January 26, 2016). Autologous HCT is not considered reasonable and necessary and is not covered under Medicare for conditions where insufficient data exist (eg, acute leukemia not in remission, chronic granulocytic leukemia, most solid tumors other than neuroblastoma, historical tandem transplantation for multiple myeloma, and specified AL amyloidosis scenarios).

Policy lists specific noncovered and insufficient-evidence conditions.

Multiple Sclerosis — coverage status change

Policy statements updated; specific coverage change:

Multiple sclerosis coverage change: Multiple sclerosis policy statement was changed from investigational to medically necessary with defined criteria based on structured clinical input during interim review (approved July 14, 2026).

Refer to the Multiple Sclerosis — Medically Necessary criteria for specific eligibility requirements.

HCT is contraindicated in individuals with severe, irreversible internal organ involvement. The policy specifies objective measurements that should exclude consideration for autologous HCT: cardiac parameters including left ventricular ejection fraction (LVEF) <50% and tricuspid annular plane systolic excursion (TAPSE) <1.8 cm; pulmonary thresholds such as DLCo <40% predicted or FVC <45% predicted; and renal dysfunction with creatinine clearance <40 ml/min. Elevated pulmonary artery pressures (pulmonary artery systolic pressure >40 mm Hg or mean pulmonary artery pressure >25 mm Hg) are also listed as exclusionary cardiac-pulmonary findings.

Randomized controlled trials of autologous HCT in systemic sclerosis explicitly excluded patients with severe and irreversible organ involvement. Because those patients were not studied in the RCTs, the trial-based evidence and resulting coverage determinations do not apply to individuals with irreversible organ dysfunction.

The policy notes that allogeneic HCT was historically not covered for multiple myeloma (effective 1996 through January 26, 2016), reflecting earlier Medicare-derived noncoverage determinations for this indication.

This medical policy is a coverage guideline for Premera Bluecross products and does not apply to Medicare Advantage; member-specific benefit verification is required to determine applicability for a given plan.

Unless an indication is explicitly described as medically necessary in this policy, autologous and allogeneic HCT for most autoimmune diseases are considered investigational and not medically necessary. The policy lists several autoimmune conditions (for example, systemic lupus erythematosus and other listed disorders) for which HCT is investigational when not meeting specific covered criteria.

For many autoimmune conditions (including systemic lupus erythematosus, juvenile idiopathic or rheumatoid arthritis, chronic inflammatory demyelinating polyneuropathy, type 1 diabetes, Crohn disease, and other listed disorders), the evidence base consists largely of observational studies, case series, or limited RCT data. The policy identifies these evidence gaps and states that, for these conditions, HCT has not been shown to improve net health outcome and therefore is not established as routine therapy.

The policy explicitly lists specific conditions for which autologous HCT is identified as having insufficient data to establish efficacy. Examples include acute leukemia not in remission, chronic granulocytic leukemia, most solid tumors (other than neuroblastoma), historical multiple myeloma indications, tandem transplantation for multiple myeloma, and certain AL amyloidosis scenarios; for these conditions autologous HCT was considered not reasonable and necessary under the Medicare-derived statements cited.

Historical investigational determinations and prior editorial statements remain in the policy history unless superseded by a later policy change. The history documents prior noncoverage or investigational classifications for certain transplant indications and records coding and editorial refinements over time.

Billing and Coding

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 peripheral stem cell (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post- transplant care in the global definition.

Historical CPT code changes referenced in HistoryCPT

38220	removed from policy (historical note)
38221	removed from policy (historical note)
38232	added 01/24/12 (historical note)

Added HCPCS CodesHCPCS

S2142

HCPCS code added to align with criteria of the policy

Left ventricular ejection fraction — exclusion threshold LVEF <50%

Exclusion thresholdLeft ventricular ejection fraction (LVEF) <50% — individuals with LVEF <50% should not be considered for autologous HCT.

Related cardiac measuresTricuspid annular plane systolic excursion (TAPSE) <1.8 cm is listed as an exclusion.

Pulmonary pressure limitsPulmonary artery systolic pressure >40 mm Hg or mean pulmonary artery pressure >25 mm Hg are exclusionary cardiac-related measures.

DLCo (diffusing capacity) — exclusion threshold DLCo <40%; values <80% noted

Primary exclusion thresholdDLCo (diffusing capacity of carbon monoxide) <40% of predicted — individuals with DLCo <40% should not be considered for autologous HCT.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior authorization required with supporting clinical records

Prior authorization is required for hematopoietic cell transplantation (HCT). Submit medical records demonstrating that the individual meets the policy’s medical necessity criteria for the specific autoimmune indication.

Include clinical documentation that medical necessity criteria are met (diagnosis, history/physical, severity and duration).
Submit Modified Rodnan Scale scores and length of prior cyclophosphamide treatment when applicable.

Prior Authorization

Identify transplant type and documented indication

When requesting authorization, explicitly state whether the planned transplant is autologous or allogeneic and document the clinical indication that aligns with the nationally referenced covered indications or Medicare-based criteria.

Identify transplant type (autologous vs allogeneic) in the request.
Document the indication consistent with nationally covered indications and Medicare references cited in the policy.

Candidate Selection and Eligibility

Candidate selection

Candidate selection criteria for autologous HCT (by disease):

Systemic sclerosis candidate: Age <60 years; disease duration <=5 years; Modified Rodnan Skin Score >=15; internal organ involvement present but not severe/irreversible per policy thresholds; history of <6 months cyclophosphamide exposure; no active gastric antral vascular ectasia; absence of exclusion criteria.Age <60; disease duration <=5 years; MRSS >=15; cyclophosphamide <6 months

Organ-specific exclusion thresholds in exclusions section (eg, LVEF <50%, DLCo <40%, FVC <45%, creatinine clearance <40 ml/min).

Multiple sclerosis candidate: Relapsing-remitting MS or secondary progressive MS with inflammatory activity meeting relapse/MRI/EDSS criteria; disease progression or activity despite >=12 months of treatment and prior DMT exposure (failure of >=1 DMT or intolerance) with evidence of treatment failure; age 18-55 years; disease duration <=15 years; EDSS 2.0-6.5 and ambulatory (with/without assistive device); acceptable comorbidity profile without increased procedural risk.Age 18-55; disease duration <=15 years; EDSS 2.0-6.5

Pre-Approval Evaluation and Testing

Documentation Required

Pre‑approval evaluation: diagnosis, severity, MRSS, cyclophosphamide, organ assessment

Pre‑approval evaluation must document the diagnosis, severity and duration of disease, Modified Rodnan Scale score (when applicable), prior cyclophosphamide exposure, and organ assessments including cardiac, pulmonary, and renal measurements.

Document diagnosis and history including duration and severity.
Provide Modified Rodnan Scale scores and history of cyclophosphamide treatment.
Include cardiac, pulmonary (DLCo, FVC), and renal assessments as applicable.

Documentation Required

HLA typing and donor compatibility required for allo‑HCT

For allogeneic HCT requests, include HLA typing and donor compatibility assessment and document prior therapies and disease duration consistent with trial or policy criteria.

Provide HLA typing results and documentation of donor compatibility.

Contraindications and Exclusions

Absolute and relative contraindications are enumerated for pre-transplant evaluation. Key values that would preclude consideration for HCT include LVEF <50%, TAPSE <1.8 cm, pulmonary artery systolic pressure >40 mm Hg or mean pulmonary artery pressure >25 mm Hg, DLCo <40% predicted, FVC <45% predicted, and creatinine clearance <40 ml/min.

The policy reiterates that severe and irreversible organ involvement was an exclusion criterion in the systemic sclerosis randomized trials, and therefore such patients were not represented in the trial evidence supporting coverage decisions.

Severe and irreversible organ involvement is listed repeatedly as an exclusionary factor for HCT candidacy in the context of systemic sclerosis trial populations and candidate selection guidance; such individuals are generally not considered appropriate candidates for autologous HCT.

The documentation and trial summaries emphasize that patients with severe, irreversible cardiac, pulmonary, or renal dysfunction were excluded from the RCTs of autologous HCT in systemic sclerosis and therefore represent a contraindicated subgroup for consideration of HCT.

Key Definitions

Definition — Autologous hematopoietic cell transplantation

DefinitionAutologous hematopoietic cell transplantation: infusion of the individual's own hematopoietic stem cells to restore bone marrow and immune function after cytotoxic conditioning.

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

Immunologic noteImmunologic compatibility between infused cells and the recipient is not an issue for autologous HCT.

Definition — Allogeneic hematopoietic cell transplantation

DefinitionAllogeneic hematopoietic cell transplantation: infusion of donor hematopoietic stem cells requiring HLA compatibility and often followed by post-transplant immunosuppression.

Compatibility requirement

Transplant Center and Capability Notes

Note

Use transplant centers with appropriate HCT capabilities

Transplant procedures should be performed in centers with appropriate HCT capabilities and expertise consistent with typical transplant practice; the policy is intended for provider readers and assumes appropriate center capabilities.

Ensure the transplant center has appropriate HCT capabilities and expertise.
Although specific accreditation/volume requirements are not listed in this excerpt, perform procedures at experienced transplant centers.

Note

No explicit accreditation or volume requirements stated in this excerpt

The policy text does not specify explicit center accreditation or minimum volume requirements in this excerpt; do not assume additional accreditation criteria beyond standard practice unless communicated by Premera.

No explicit FACT or other accreditation requirement is stated in the provided text.
Confirm any center requirements with Premera if needed during authorization.

Post-Transplant Care and Coverage

Transplant-related global services — HCPCS S2150 global definition referenced

HCPCS S2150 descriptionS2150: Bone marrow or blood-derived peripheral stem cell (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post- transplant care in the global definition.

Global service scopeS2150 represents a comprehensive global definition that includes pre- and post-transplant care elements within its description.

Policy listingThis HCPCS code is listed in the policy coding section but the policy excerpt does not specify coverage duration or limits for the global service.

Post-transplant immunosuppressive management and infection surveillance — allo-HCT vs autologous follow-up differences

Allogeneic follow-up

Background and Evidence Overview

Autologous HCT is performed with the goal of ablating self-reactive lymphocytes and regenerating a self-tolerant immune system. In contrast, allogeneic HCT may offer the potential to eradicate a genetic source of immune dysregulation by replacing the recipient’s immune system with donor-derived hematopoietic cells, but carries distinct risks and limited evidence across many autoimmune indications.

Policy Revision History and Updates

2017-05-01history entry

Policy moved into new format; literature review through June 2, 2017; HSCT terminology changed to HCT; policy statement unchanged.

2018-04-03annual review

Annual review with literature update through November 2017; policy statement unchanged.

2019-04-01annual review

Annual review with literature update through October 2018; policy statement for systemic sclerosis was changed from investigational (note begins in timeline entry).

Policy Summary

PayerPremera Bluecross

PolicyHematopoietic Cell Transplantation for Autoimmune Diseases

Policy CodePolicy 8.01.25

Change TypeMaterial coverage change: MS updated from investigational to medically necessary

Effective DateAug 1, 2026

Last ReviewJul 14, 2026

Next Review DateAug 1, 2026

Key ActionObtain prior authorization and submit documentation that the individual meets the policy's medical necessity criteria before proceeding with HCT.

SourceLink

On This Page

High risk for future disability:

Any of: >=2 relapses per year despite treatment; incomplete recovery from relapses with residual deficits; early accumulation of disability (EDSS increase >=1 point within 12 months); OR high T2 lesion burden on MRI (3 or more T2 lesions).

Additional eligibility and functional status: Individual aged 18 to 55 years AND disease duration <=15 years AND functional status EDSS between 2.0 and 6.5 AND ambulatory (with or without an assistive device) AND absence of medical comorbidities that would increase procedural risk.Age 18-55; EDSS 2.0-6.5

High-efficacy DMT examples include natalizumab, alemtuzumab, ocrelizumab, ofatumumab, cladribine.

Other autoimmune diseases evidence summary: For juvenile idiopathic or rheumatoid arthritis, CIDP, type 1 diabetes, Crohn disease, and other autoimmune conditions, available data (registry, case series, limited RCTs) are heterogeneous and insufficient to conclude consistent net health outcome benefit; additional controlled studies needed.

See respective summaries in policy.

Broader pulmonary noteDLCo less than 80% of predicted is noted in Related Information as a pulmonary measurement of internal organ involvement.

Associated pulmonary findingsPulmonary fibrosis or ground-glass appearance on HRCT are included among pulmonary considerations.

Forced vital capacity (FVC) — exclusion threshold FVC <45%; decline >=10% in 12 months notable

Exclusion thresholdForced vital capacity (FVC) <45% of predicted — individuals with FVC <45% should not be considered for autologous HCT.

Decline alertA decline of FVC ≥10% in the prior 12 months is identified as a notable change in pulmonary status.

Related pulmonary imagingPulmonary fibrosis and ground-glass changes on high-resolution chest CT are cited alongside FVC measures.

Age for MS candidates — 18 to 55 years

Age range (MS candidates)Individuals must be between 18 and 55 years old to meet the policy's medical necessity criteria for autologous HCT for multiple sclerosis.

Disease-duration contextAge requirement is applied alongside disease-duration (≤15 years) and functional status (EDSS 2.0–6.5).

Ambulatory requirementCandidates must be ambulatory (with or without an assistive device) in addition to age criteria.

Age for systemic sclerosis candidates — less than 60 years

Age limit (systemic sclerosis)Adult individuals aged less than 60 years are eligible under the systemic sclerosis autologous HCT criteria.

Concurrent criteriaAge <60 is applied with maximum disease duration ≤5 years and Modified Rodnan Skin Score ≥15.

Exclusion linkageAge criterion is one element; candidates must also lack exclusionary organ-measurement thresholds (see Related Information).

None specified in this excerpt — placeholder

PlaceholderNo specific threshold or item specified in this excerpt.

ContextReferenced inventory slot reserved for items not present in the provided document segment.

ActionRefer to full policy for any additional thresholds or criteria not shown here.

Prior Authorization

Request prior authorization for HCT

Providers should request prior authorization for HCT procedures because coverage distinctions between autologous and allogeneic indications and historical Medicare-derived statements imply authorization is needed.

Authorization is implied given differing coverage rules for autologous versus allogeneic HCT.
Verify authorization requirements during submission for HCT.

Billing Rule

Coding update and authorization depends on member benefits

HCPCS code S2142 was added to the policy’s coding list; whether prior authorization is required and how the service is authorized depends on the member’s benefit and Premera processes.

Coding updated to add HCPCS S2142 per the policy history.
Prior authorization requirements are determined by member benefit and standard Premera verification processes.

Step Therapy

Document failure or intolerance to disease‑modifying therapy (MS)

For multiple sclerosis, prior DMT exposure must be documented and the member must have failed or been intolerant to disease-modifying therapy (DMT) before HCT is considered.

Document prior DMT exposure and either failure of ≥1 DMT at therapeutic dose for adequate duration or documented intolerance.
Provide evidence of treatment failure (continued relapses, new/enlarging MRI lesions, or confirmed EDSS progression while on DMT).

Documentation Required

Provide comprehensive prior therapy history

Document the patient’s prior therapy history showing failure of or inadequate response to standard disease-specific therapies; the evidence base and policy expect prior treatment history before considering HCT.

Include records of prior disease-modifying therapies and outcomes.
For MS, show duration of treatment (≥12 months) and specific measures of treatment failure per policy criteria.

Note

Apply stated candidate selection criteria (example: multiple myeloma)

Follow the candidate selection elements in the policy when applicable; for example, single autologous HCT for multiple myeloma is covered only for Durie‑Salmon Stage II or III patients who meet prior treatment/response and organ function criteria.

Confirm Durie‑Salmon Stage II or III status and documented partial response (≥50% decrease in paraprotein or marrow infiltration sustained ≥1 month) or responsive relapse.
Verify adequate cardiac, renal, pulmonary, and hepatic function per historical coverage criteria.

Documentation Required

Submit clinical records: diagnosis, history/physical, MRSS, cyclophosphamide exposure

Include medical records that document diagnosis, history and physical examination with severity and duration, Modified Rodnan Scale scores (when applicable), and length of prior cyclophosphamide exposure.

History and physical documenting severity and duration of condition.
Modified Rodnan Scale scores and length of cyclophosphamide treatment.

Documentation Required

Document conditioning regimen, stem cell source, and HLA matching

Provide details of the conditioning regimen type, source of hematopoietic stem cells, and HLA matching for allogeneic HCT in the authorization and medical record submission.

Specify conditioning intensity (myeloablative vs reduced‑intensity) and agents used.
For allo‑HCT, include HLA typing and donor compatibility assessment and the stem-cell source (bone marrow, peripheral blood, cord blood).

Documentation Required

Provide indication‑specific clinical documentation for coverage

Ensure submitted documentation supports the applicable covered indication—for example, remission status for acute leukemia, Durie‑Salmon stage for multiple myeloma, or organ‑specific measures for systemic sclerosis—as referenced by the policy’s historical coverage statements.

Include disease‑specific staging or remission documentation referenced in the policy.
Provide organ function measures used to justify coverage under historical Medicare‑based criteria.

Note

Confirm coverage by checking member benefits

Verify member benefits and any plan‑specific limits before submission by consulting the member benefit booklet or contacting a member service representative.

Member contracts differ; coverage is subject to limits and conditions of the member benefit plan.
Contact member services or review the member benefit booklet to confirm coverage for the specific service or supply.

Denial Risk

Exclusion measurements that may preclude approval

Patients with severe or irreversible organ involvement should not be considered for autologous HCT and these measurements may lead to denial if present: LVEF <50%; DLCo <40%; FVC <45%; creatinine clearance <40 ml/min.

Cardiac exclusion: left ventricular ejection fraction <50%.
Pulmonary exclusions: DLCo <40% predicted; FVC <45% predicted.
Renal exclusion: creatinine clearance <40 ml/min.

Denial Risk

Severe irreversible organ involvement increases risk of denial

Randomized trials for systemic sclerosis excluded individuals with severe, irreversible organ involvement; presence of such organ dysfunction may therefore preclude clinical trial–like eligibility and support for HCT in that subgroup.

Trials enrolled adults <60 years with disease duration ≤5 years and excluded those with severe irreversible organ involvement.
Documented severe irreversible organ dysfunction lacks trial-based support and may result in denial.

Denial Risk

Insufficient‑evidence indications likely denied

Autologous HCT for indications listed in the policy as having 'insufficient data' is considered not reasonable and necessary and is not covered under Medicare; requests for those indications risk denial.

Policy lists specific conditions (e.g., acute leukemia not in remission, chronic granulocytic leukemia, most solid tumors) where autologous HCT is not considered reasonable and necessary.
Claims for listed indications with insufficient evidence are likely to be denied.

Note

Verify benefit limits and plan conditions

Coverage is subject to the limits and conditions of the member’s benefit plan; verify whether plan restrictions or exclusions apply before submitting an authorization request.

Member contracts differ and benefits should be confirmed.
Benefits may impose limits or conditions that affect coverage decisions.

High-efficacy DMT examples and definitions provided in policy.

General candidate attributes

Candidate selection aligns with trial inclusion and society guidance

Selection considerations: Systemic sclerosis RCTs enrolled adults <60 years, disease duration <=5 years, modified Rodnan skin score >15, and internal organ involvement but excluded severe irreversible organ damage; ASBMT guidance classifies indications by evidence categories and informs selection of candidates for HCT.

See RCT criteria and ASBMT 2020 guideline summary.

Transplant candidate criteria (historical Medicare-based)

Candidate selection elements referenced in historical coverage statements.

Multiple myeloma single autologous HCT (historical): Patient is Durie-Salmon Stage II or III AND newly diagnosed or responsive disease (including partial response defined as >=50% decrease in measurable paraprotein or bone marrow infiltration sustained at least 1 month) OR in responsive relapse AND adequate cardiac, renal, pulmonary, and hepatic function.Partial response = >=50% decrease sustained >=1 month

Based on historical Medicare coverage statements cited in the policy.

AL amyloidosis autologous HCT (historical): Primary AL amyloidosis patients selected using clinical risk factors with amyloid deposition in 2 or fewer organs AND left ventricular ejection fraction (LVEF) greater than 45% are historically considered reasonable and necessary for high-dose melphalan with autologous HCT.LVEF >45%

Based on historical Medicare coverage criteria.

Candidate criteria — not included here

Policy historical notes and changes relevant to HCT for autoimmune diseases; candidate-specific criteria are not present in this excerpt.

Historical notes: Policy history documents prior changes including earlier evidence reviews and a 2026 interim review that changed the MS statement from investigational to medically necessary; detailed candidate criteria beyond those listed elsewhere in this policy are not included in this document segment.

See full policy for comprehensive candidate eligibility details.

Document prior disease‑modifying therapies and length of disease history as relevant to eligibility.

Documentation Required

Include comprehensive organ‑function assessment and disease status

Assessment of organ function—cardiac, renal, pulmonary, hepatic—must be included in pre‑approval evaluation and documentation of disease response/status is required to meet the historical coverage descriptions for certain indications.

Include cardiac measures (e.g., LVEF), pulmonary function (DLCo, FVC), renal function (creatinine clearance), and hepatic assessment.
Document disease response/status (remission, staging) relevant to the indication.

Documentation Required

Allo‑HCT: donor compatibility and prior therapy documentation

For allo‑HCT, provide HLA typing and donor compatibility assessment plus documentation of prior disease‑modifying therapies and disease duration to support eligibility.

HLA typing and donor compatibility assessments are critical for allo‑HCT.
Document prior therapies and disease duration consistent with trial inclusion where applicable.

Compatibility is established by HLA typing (HLA-A, -B, -DR loci); an acceptable donor will match at all or most loci.

Post-transplant managementAllo-HCT recipients typically require immunosuppressant drugs to minimize graft rejection and graft-versus-host disease.

Definition — Autologous HCT (alternate phrasing)

Alternate phrasingAutologous HCT: hematopoietic stem cells obtained from the transplant recipient and reinfused; compatibility between infused cells and recipient is not an issue.

Use caseTypically performed after high-dose cytotoxic conditioning to allow engraftment and marrow repopulation.

SourcesCells can be harvested from bone marrow, peripheral blood, or umbilical cord blood.

Definition — Allogeneic HCT (allo-HCT) (alternate phrasing)

Alternate phrasingAllogeneic HCT (allo-HCT): hematopoietic stem cells obtained from a donor; immunologic compatibility (HLA matching) between donor and recipient is critical.

Conditioning and risksAllo-HCT often involves myeloablative or reduced-intensity conditioning and carries risks of GVHD requiring immunosuppression.

Donor matching methodsHLA typing can be cellular, serologic, or molecular to determine donor suitability.

Definition — Reduced-intensity conditioning (RIC)

DefinitionReduced-intensity conditioning (RIC): pretransplant use of lower-dose cytotoxic drugs or less intense radiotherapy intended to be nonmyeloablative, aiming to reduce treatment-related morbidity while permitting graft-versus-disease effects.

Intensity spectrumRIC regimens range from nearly myeloablative to minimally myeloablative with lymphoablation and are tailored to disease and patient condition.

PurposeSeeks to balance relapse risk from residual disease against non-relapse mortality and toxicity.

Definition — HCT (hematopoietic cell transplantation)

DefinitionHCT (hematopoietic cell transplantation): procedure in which hematopoietic stem cells are intravenously infused to restore bone marrow and immune function; includes autologous and allogeneic stem cell transplant procedures.

Cell sourcesStem cells may be obtained from the recipient (autologous) or a donor (allogeneic) and harvested from marrow, peripheral blood, or umbilical cord blood.

Clinical roleUsed for hematologic malignancies and, in selected cases, severe autoimmune diseases to achieve disease control or remission.

Definition — HCT / HSCT term change noted in history

Terminology changePolicy history notes that 'HSCT' was changed to 'HCT' in the policy format and guidelines (term update recorded in 2017 history).

Historical contextThe term 'Stem' was removed from the title and policy; HSCT references in older history entries were updated to HCT.

ImplicationReaders should interpret older references to HSCT as equivalent to HCT in this policy's history and guidance.

Note

No explicit accreditation or volume requirements (duplicate)

Duplicate statement: no explicit accreditation or volume requirements are provided in the policy excerpt; verify with Premera for any center‑specific requirements during authorization.

Policy excerpt does not list center accreditation/volume thresholds.
Contact Premera for clarification if required.

Note

No explicit accreditation or volume requirements (duplicate)

Repeat: policy excerpt contains no explicit accreditation or volume requirements; providers should confirm any center prerequisites with Premera as part of authorization if needed.

Confirm center prerequisites with Premera during prior authorization if necessary.
Do not assume additional requirements beyond what is in the policy excerpt.

Individuals undergoing allo-HCT require post-transplant immunosuppression and monitoring for infections and graft-versus-host disease.

Autologous follow-upAutologous recipients are susceptible to chemotherapy-related toxicities and opportunistic infections until engraftment, but do not require GVHD immunosuppression.

Management implicationPost-transplant immunosuppressive management and infection surveillance differ substantially between allo-HCT and autologous HCT and must be planned accordingly.

Regulatory oversight of cell/tissue products — FDA 21 CFR 1270/1271 cited

Regulatory citationRegulated human cells and tissues, including hematopoietic stem cells, are subject to FDA regulations under 21 CFR parts 1270 and 1271.

Responsible officeRegulation is through FDA's Center for Biologics Evaluation and Research.

ScopeThese CFR parts apply to human cells and tissues intended for implantation, transplantation, or infusion.

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2020-04-01annual review

Annual review with literature update through November 2019; removed CPT code 38242.

2021-04-01annual review

Annual review with literature update through December 1, 2020; policy statements unchanged and related policy references updated.

2022-04-01annual review

Annual review with literature update through December 1, 2021; policy statements unchanged.

2023-04-01annual review

Annual review with literature update through November 17, 2022; minor editorial refinements including changing 'patient' to 'individual'.

2024-04-01annual review

Annual review with literature update through November 14, 2023; policy statements unchanged.

2025-04-01annual review

Annual review with literature update through November 21, 2024; policy statements unchanged.

2026-04-01annual review

Annual review with literature update through December 2, 2025; coding updated and HCPCS code S2142 was added to align with policy criteria.

2026-07-14interim review (approved)Latest

Interim review approved July 14, 2026: literature update through April 10, 2026, and the policy statement for multiple sclerosis was changed from investigational to medically necessary with defined criteria based on structured clinical input.

The policy history records prior investigational determinations and editorial refinements; recent updates note substantive changes (for example, a coverage-status change for multiple sclerosis) made following clinical input and routine coding updates reflected in the history section.