Fidelis Care pediatric allogeneic HSCT Coverage Update

Coverage Criteria — Pediatric Allogeneic HSCT

Fanconi Anemia

Covered when ALL of the following are met for Fanconi anemia:

Fanconi Anemia criteria: 1. Age < 18; 2. Performance status - ONE of: Lansky >= 50% OR Karnofsky >= 70% OR ECOG 0-2; 3. No active infection, or infection controlled; 4. No drug or alcohol misuse by history or drug and alcohol free period >= 4 weeks; 5. Patient or caregiver understanding of procedural risk and post procedure compliance and follow-up; 6. Patient has adequate social or family support.

Acute lymphocytic leukemia (ALL)

Covered when ALL of the following are met for Acute lymphocytic leukemia (ALL):

ALL criteria: 1. Age < 18; 2. Treatment response - ONE of: Remission OR Relapsed disease OR Induction failure; 3. Performance status - ONE of: Lansky >= 50% OR Karnofsky >= 70% OR ECOG 0-2; 4. No active infection, or infection controlled; 5. No drug or alcohol misuse by history or drug and alcohol free period >= 4 weeks; 6. Patient or caregiver understanding of procedural risk and post procedure compliance and follow-up; 7. Patient has adequate social or family support; 8. Central nervous system disease - ONE of: Normal cytology by lumbar puncture (LP) OR Abnormal cytology by LP and CNS disease treated.

Acute myeloid leukemia (AML)

Covered when ALL of the following are met for Acute myeloid leukemia (AML):

AML criteria: 1. Age < 18; 2. Treatment response - ONE of: First remission in intermediate or high-risk patient OR Second remission OR Relapsed disease OR Induction failure; 3. Performance status - ONE of: Lansky >= 50% OR Karnofsky >= 70% OR ECOG 0-2; 4. No active infection, or infection controlled; 5. No drug or alcohol misuse by history or drug and alcohol free period >= 4 weeks; 6. Patient or caregiver understanding of procedural risk and post procedure compliance and follow-up; 7. Patient has adequate social or family support; 8. Central nervous system disease - ONE of: Normal cytology by lumbar puncture (LP) OR Abnormal cytology by LP and CNS disease treated.

Aplastic anemia

Covered when ALL of the following are met for Aplastic anemia:

Aplastic anemia criteria: 1. Age < 18; 2. Severe aplastic anemia or very severe aplastic anemia diagnosed by bone marrow biopsy; 3. Performance status - ONE of: Lansky >= 50% OR Karnofsky >= 70% OR ECOG 0-2; 4. No active infection, or infection controlled; 5. No drug or alcohol misuse by history or drug and alcohol free period >= 4 weeks; 6. Patient or caregiver understanding of procedural risk and post procedure compliance and follow-up; 7. Patient has adequate social or family support.

Juvenile myelomonocytic leukemia (JMML)

Covered when ALL of the following are met for Juvenile myelomonocytic leukemia (JMML):

JMML criteria: 1. Age < 18; 2. Performance status - ONE of: Lansky >= 50% OR Karnofsky >= 70% OR ECOG 0-2; 3. No active infection, or infection controlled; 4. No drug or alcohol misuse by history or drug and alcohol free period >= 4 weeks; 5. Patient or caregiver understanding of procedural risk and post procedure compliance and follow-up; 6. Patient has adequate social or family support.

Medical Necessity Criteria (excerpt)

Policy contains medical necessity criteria for pediatric allogeneic HSCT; specific criteria text not included in this document excerpt.

criteria_change: Removed requirement for 'HLA suitable donor or umbilical cord blood donor available' from all medical necessity criteria

Change recorded across multiple annual reviews

The excerpt of this clinical policy does not list any additional, document-level exclusions beyond the disease-specific medical necessity criteria. The available text records that explicit exclusion language is not present in this portion of the policy and that prior revisions removed donor-availability language from the criteria set; for full exclusion details reviewers should consult the complete policy and member coverage documents.

Coverage determinations described in this policy are subject to the terms, conditions, exclusions, and limitations of the member's specific coverage documents and applicable Health Plan administrative policies. Where applicable, state Medicaid provisions or Medicare NCDs/LCDs take precedence; providers should verify plan-specific prior authorization and coverage rules before proceeding.

If the required medical necessity criteria are not met, the transplant request is not authorized. Common denial triggers reflected in the criteria include age outside the pediatric range (<18 required), inadequate performance status (e.g., < Lansky 50% / Karnofsky 70% / ECOG 0-2 thresholds), active or uncontrolled infection, and ongoing substance misuse without an adequate drug/alcohol free period (typically ≥ 4 weeks where a history exists). Lack of demonstrated caregiver understanding or insufficient social support are additional reasons authorization may be denied.

This document excerpt does not provide a separate, enumerated list labeled 'not medically necessary.' Instead, the policy conveys that services are covered only when the specified medical necessity criteria are met and that failure to meet those criteria results in non-authorization.

Candidate Selection Criteria

General candidate criteria

Candidate selection criteria by diagnosis (pediatric):

General candidate requirements: Age <18; adequate performance status (Lansky >=50% OR Karnofsky >=70% OR ECOG 0-2); no active/uncontrolled infection; drug/alcohol free >=4 weeks if history of misuse; patient/caregiver understanding and ability to comply; adequate social/family support.

Candidate selection (excerpt)

The policy addresses pediatric allogeneic hematopoietic stem cell transplant candidates; full candidate criteria are not included in this excerpt.

candidate_criteria: Detailed candidate selection criteria not available in provided text

See full policy for explicit candidate criteria

Coding — Procedure and Diagnosis Codes

CPT codes that support coverage criteriaCPTCovered

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38230	Bone marrow harvesting for transplantation; allogeneic.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor.
38242	Allogeneic lymphocyte infusions.

HCPCS codes that support coverage criteriaHCPCSCovered

S2142

Cord blood-derived stem cell transplantation, allogeneic.

S2150

Bone marrow or blood-derived peripheral 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 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.

ICD-10-CM Diagnosis Codes that Support Coverage Criteria (partial list)ICD-10Covered

C91.00	Acute lymphoblastic leukemia not having achieved remission.
C91.01	Acute lymphoblastic leukemia, in remission.
C91.02	Acute lymphoblastic leukemia, in relapse.
C92.00	Acute myeloblastic leukemia, not having achieved remission.
C92.01	Acute myeloblastic leukemia, in remission.
C92.02	Acute myeloblastic leukemia, in relapse.
C93.30	Juvenile myelomonocytic leukemia, not having achieved remission.
C93.31	Juvenile myelomonocytic leukemia, in remission.
D61.09	Other constitutional aplastic anemia (includes Fanconi's anemia).

CPT codesCPT

No codes listed

ICD-10 diagnosis codesICD-10

No codes listed

Blast percentage for AML diagnosis - key values

AML diagnostic blast percentage>= 20% blasts in peripheral blood or bone marrow (WHO diagnostic threshold)

Diagnostic basisWHO classification incorporates morphology, cytogenetics, molecular genetics, and immunologic markers to determine AML; uses blast percentage as diagnostic criterion

Therapeutic response categoriesRemission, relapsed disease, or induction failure (used in coverage criteria)

Aplastic anemia severity lab thresholds - key values

Aplastic anemia diagnostic criteria (any 2)Hemoglobin < 10,000 mm3 OR Platelet count < 50,000 mm3 OR Neutrophil count < 1,500 mm3

Provider Actions — Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required per the payer process for allogeneic hematopoietic stem cell transplant procedures and related services. Providers should obtain authorization before scheduling transplant-related procedures and reference supporting CPT/HCPCS codes when submitting requests.

Prior authorization required for allogeneic stem cell transplant procedures and related inpatient/outpatient services
Include relevant CPT/HCPCS codes and clinical documentation with the authorization request

Note

Prior Authorization / Medical Necessity Review (Implied)

Transplant services are subject to medical necessity review under the Health Plan's coverage framework. Even when authorization is obtained, coverage is determined against the clinical criteria in this policy and the member's specific coverage documents.

All requests are reviewed for medical necessity per Fidelis Care policy CP.FC.32 and applicable coverage rules
Authorization does not guarantee payment — final coverage depends on member benefits and plan terms

Pre-Transplant Evaluation Requirements

Documentation Required

EVALUATION: complete required pre‑transplant workup

Pre‑transplant evaluation must include hepatic testing, pulmonary testing (DLCO, FEV, FVC), cardiac testing (ECG and echocardiogram or MUGA), renal function assessment, infectious disease screening, dental exam, and other baseline evaluations as part of readiness assessment.

Hepatic function assessment
Pulmonary: DLCO, FEV, FVC
Cardiac: ECG and 2D echo or MUGA
Renal function testing
Infectious disease screening (hepatitis A/B/C, CMV, HIV)
Dental exam and other baseline evaluations

Note

No further evaluation details provided

No additional evaluation requirements are specified in this excerpt.

Contraindications and Conditions Requiring Stabilization

The policy identifies active, uncontrolled infection as a contraindication or a condition that must be controlled prior to proceeding with transplant. It also specifies that no drug or alcohol misuse (or a documented drug/alcohol free period of ≥ 4 weeks if there is a history) is required before transplantation is authorized; ongoing substance abuse therefore functions as a contraindication until adequately addressed.

No additional contraindications are specified in this excerpt. The policy notes that contraindications are patient- and protocol-dependent and that full contraindication details and protocol-specific exclusions are available in the complete policy and treatment protocols.

Center and Program Requirements

Note

Center requirement: experienced teams and comprehensive care

Center-level expectations include comprehensive pre‑transplant evaluation and management by experienced transplant teams; specific accreditation (e.g., FACT) is not specified in this excerpt.

Provide comprehensive pre‑ and post‑transplant evaluation and management
Ensure experienced multidisciplinary transplant team involvement

Note

No further center requirements provided

No additional center requirements are detailed in this excerpt.

Post-Transplant Coverage Considerations

Comprehensive transplantation services — HCPCS S2150

HCPCS S2150 descriptionBone marrow or blood-derived peripheral stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; includes comprehensive services and number of days of pre- and post-transplant care in the global definition

Coverage implicationS2150 indicates bundled coverage that includes pre- and post-transplant care per code description

Related HCPCSS2142 — cord blood-derived stem cell transplantation, allogeneic

POST-TRANSPLANT COVERAGE — placeholder

Post-transplant coverage placeholderDetailed post-transplant coverage policy text not included in this excerpt; S2150 indicates bundled services may cover pre- and post-transplant care

Provider action

Background

Allogeneic hematopoietic stem cell transplant (HSCT) uses donor-derived hematopoietic stem cells collected from peripheral blood, umbilical cord blood, or bone marrow and delivered intravenously. In pediatric indications, HSCT is a potentially curative therapy for select malignant and non-malignant hematologic disorders but carries significant risk of complications; therefore, comprehensive pre-transplant evaluation of organ function, infection status, and psychosocial support is essential prior to proceeding.

Definitions and Condition Summaries

Fanconi anemia — definition and testing note

DefinitionFanconi anemia — an autosomal recessive inherited blood disorder causing bone marrow failure with multisystem manifestations; HSCT is the only effective therapy for hematologic manifestations

Definitive testChromosome breakage test using diepoxybutane or mitomycin C

Clinical featuresMay include skin discoloration, skeletal malformations, GI abnormalities, cardiac/renal/vision/hearing/genital malformations

Acute lymphocytic leukemia (ALL) — definition

DefinitionAcute lymphocytic leukemia (ALL) — malignancy of lymphoid precursors; abnormal lymphocytes displace normal marrow cells leading to infection, anemia, and bleeding

Epidemiology noteHigher proportion diagnosed before age 20 (57.2%); relatively rare in older adults

Revision History and Policy Changes

2026-04annual_reviewLatest

Updated CPT codes and references reviewed and updated.

2025-01annual_review

References reviewed and updated.

2024-01annual_review

OpenPayer

Allogeneic Hematopoietic Stem Cell Transplant (Pediatric)

Coverage Criteria — Pediatric Allogeneic HSCT

Candidate Selection Criteria

Coding — Procedure and Diagnosis Codes

Provider Actions — Authorization, Documentation, and Billing

Pre-Transplant Evaluation Requirements

Contraindications and Conditions Requiring Stabilization

Center and Program Requirements

Post-Transplant Coverage Considerations

Background

Definitions and Condition Summaries

Revision History and Policy Changes