Fidelis Care allogeneic stem cell Coverage

Medical necessity criteria by indication

Covered when ALL specified, disease-specific criteria are met (age, disease/response status, performance status, infection control, substance-use history, patient understanding/compliance, and social support). Each disease indication includes its own nested requirements.

General prerequisites: All indications require: Age ≥ 18; performance status meeting Karnofsky ≥ 70% or ECOG 0–2; no active infection or infection controlled; no drug or alcohol misuse by history or drug/alcohol free period ≥ 4 weeks; documented patient understanding of procedural risk and willingness/ability to comply with post-procedure follow-up; and adequate social or family support.

Applies across indications (see disease-specific nodes)

Non-Hodgkin lymphoma (I) — disease-specific nodes

Burkitt, chemosensitive relapsed disease: Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse by history or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up plan; Adequate social/family support; Neurological screen: normal exam OR history of CNS disease with CT/MRI negative OR positive neurologic exam with CT/MRI negative AND (normal LP cytology OR abnormal LP cytology with CNS disease treated).
Peripheral T-cell lymphoma — ALK positive: Disease status: chemosensitive relapsed disease OR induction failure; Disease response: complete OR partial response to second-line therapy; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.
Other Peripheral T-cell lymphoma (ALK negative, NOS, angioimmunoblastic): Cell type specified AND chemosensitive relapsed disease or induction failure with complete OR partial response to second-line therapy; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.
Follicular lymphoma — second or third relapse: Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.
Mantle cell — second remission: Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.
Diffuse large B-cell lymphoma: Disease status: chemoresistant relapsed disease OR relapsed disease post autologous SCT; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.
Mycosis fungoides or Sézary syndrome: Stage I–III: relapsed disease or induction failure; Stage IV/Sézary: induction failure; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.

Hodgkin lymphoma (II): Age ≥ 18; Therapeutic response: relapsed disease post autologous SCT OR induction failure; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.

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Aplastic anemia (III): Severe or very severe aplastic anemia diagnosed by bone marrow biopsy AND one of the following: Age > 40 with incomplete or no response to immunosuppressive therapy OR Age 18–40 (per policy) — in either case performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.

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Myelofibrosis (IV): Age ≥ 18 AND one of: (1) IPSS intermediate-1 with blood product dependency plus at least one of transfusion-dependent anemia OR peripheral blasts >2% OR adverse cytogenetics; OR (2) IPSS intermediate-2 or high-risk. In all cases performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.

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Myelodysplastic syndrome (V): Age ≥ 18 AND risk status one of: IPSS intermediate-1 with blood product dependency; OR IPSS intermediate-2 or high-risk; OR IPSS-R intermediate with score > 3.5; OR IPSS-R high/very high. Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.IPSS-R > 3.5

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Chronic myelogenous leukemia (VI): Age ≥ 18; Disease stage: chronic phase, accelerated phase, or blast crisis; Response status: incomplete or no response to initial TKI AND incomplete or no response to second-generation TKI; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.

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Chronic lymphocytic leukemia (VII): Age ≥ 18; Therapeutic response: first remission in high-risk patient OR first relapse in high-risk patient OR second relapse OR induction failure; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.

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Acute myeloid leukemia (VIII): Age ≥ 18; Therapeutic response: first remission in intermediate or high-risk patient OR second remission OR relapsed disease OR induction failure; Neurological screen: normal neurologic exam OR neurologic exam with positive findings and CT/MRI negative AND (normal LP cytology OR abnormal LP cytology with CNS disease treated) OR history of CNS disease with CT/MRI negative; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.

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Acute lymphocytic leukemia (IX): Age ≥ 18; Remission; Cytology: normal LP cytology OR abnormal LP cytology with CNS disease treated; Performance status: Karnofsky ≥ 70% OR ECOG 0–2; No active infection or infection controlled; No drug or alcohol misuse or drug/alcohol free ≥ 4 weeks; Patient understanding and follow-up; Adequate social/family support.

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Pre-transplant medical necessity criteria

Covered when ALL of the following pre-transplant evaluation and patient readiness criteria are met:

Comprehensive pre-transplant evaluation: Assessment of major organ systems including hepatic, pulmonary, cardiac, and renal function to determine reserve and optimize management prior to transplantation.see individual tests

Includes hepatic function (risk of sinusoidal obstruction syndrome), pulmonary tests (baseline DLCO, FEV, FVC), cardiac testing (ECG and 2-D echocardiogram or MUGA), and renal function assessment.

Infectious disease screening and infection control: Screening for hepatitis A, B, C; cytomegalovirus (CMV); and HIV, plus dental exam/x-rays to identify oral sources of infection; all active infections must be controlled prior to transplantation. Fungal infections may be managed long-term, and transplantation may be considered if the infection is responding to treatment under infectious disease specialist guidance.infection controlled or responding to treatment

Pulmonary and cardiac baseline testing:

This policy covers allogeneic stem cell transplantation for malignant and non‑malignant hematologic disorders in adults and does not address stem cell transplant for solid organ malignancies (for example, neuroblastoma or testicular cancer).

The policy does not enumerate specific absolute exclusions because contraindications are patient‑dependent and protocol‑dependent. Determinations of exclusion should be made in the context of the intended preparative regimen and treating protocol, with consideration of individual organ function, comorbidities, and expected transplant risks.

Prior to transplant, all active infections should be controlled, and patients with active substance abuse should receive counseling and maintain abstinence prior to transplantation. Transplantation is not indicated while uncontrolled infection or unmanaged substance‑use issues persist and should be deferred until these are appropriately addressed and documented.

Candidate Eligibility and Selection

Candidate eligibility

Disease-specific eligibility nodes (age, disease/response status, performance status, infection control, substance-use history, consent, and social support).

General candidate prerequisites: Age ≥ 18; Karnofsky performance score ≥ 70% OR ECOG 0–2; no active infection or infection controlled; no drug or alcohol misuse by history or drug/alcohol free period ≥ 4 weeks; documented patient understanding of procedural risk and post-transplant compliance; and adequate social or family support.

Candidate selection considerations

Candidate selection considerations described in policy background and prerequisites:

Selection based on disease and comprehensive evaluation: Patients with hematologic malignancies should be considered for allogeneic stem cell transplantation after comprehensive evaluation of organ function, comorbidities, infection status, and psychosocial readiness; selection incorporates disease-specific risk (e.g., IPSS/IPSS-R for myelodysplastic syndromes or IPSS for myelofibrosis), prior therapy and response, and multidisciplinary clinical judgment.clinical judgment and protocol-specific criteria

Refer to disease-specific nodes for exact eligibility triggers (e.g., IPSS-R thresholds, prior TKI failure for CML).

Evaluation of comorbidities and organ reserve: Assessment of hepatic, pulmonary (DLCO, FEV, FVC), cardiac (ECG, echocardiogram or MUGA), renal function, and dental health to identify and optimize modifiable risks prior to listing for transplant.see pre-transplant criteria

History of reduced ejection fraction or heart failure increases cardiotoxicity risk and may influence selection.

Psychosocial and support considerations: Documented ability to adhere to complex post-transplant care, evidence of adequate social/family support, and absence or treated substance-use disorder are required; prior noncompliance or ongoing substance misuse should be addressed before selection.documented readiness and support

Social support and understanding are necessary for candidate approval.

Pre-Transplant Evaluation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Obtain prior authorization before scheduling allogeneic stem cell transplantation. Include diagnosis and planned transplant type, anticipated date of transplant, facility, and proposed preparative regimen.

Required codes: include applicable CPT/HCPCS and facility revenue codes on authorization request.
Authorization must be approved prior to admission for transplant-related services.

Denial Risk

Documentation Gaps That May Trigger Denial

Documentation Gaps That May Trigger Denial: Missing or incomplete pre-transplant evaluation records, lack of documented multidisciplinary transplant team assessment, absent infectious disease clearance, no evidence of social/support assessment, or absent documentation of prior therapies and responses.

If organ function testing (hepatic, pulmonary, cardiac, renal) or infectious disease testing results are not included, claim or authorization may be denied.
Lack of documented control or treatment plan for active infections, or missing documentation of substance-abuse counseling/abstinence when indicated, increases denial risk.

Documentation Required

Required Pre-Transplant Documentation

Required Pre-Transplant Documentation: Provide a complete pre-transplant evaluation that demonstrates suitability for transplantation and screens for risks. Include results and interpretations of the following: hepatic function tests, pulmonary function tests (DLCO, FEV1, FVC), cardiac evaluation (ECG and echocardiogram or MUGA), renal function tests, comprehensive infectious disease screening (hepatitis A/B/C, CMV, HIV), dental exam and x-rays, and documentation of patient understanding of procedural risk and post-procedure follow-up. Also include assessment of social/family support and documentation of multidisciplinary team decision.

Attach lab and imaging reports with dates and values.
Include consult notes (cardiology, pulmonology, infectious disease, dentistry) when abnormalities are present.
Document explicit patient informed consent and social support evaluation.

Note

Required Prior Therapies/Response

Required Prior Therapies and Response: Document prior disease-directed therapies and responses, including lines of chemotherapy, targeted or immunotherapies, and response status (complete/partial/stable/progressive). For infectious or chronic conditions, document treatment regimens and evidence of response or control prior to transplant.

Include dates, agents, dosing, and response assessments (imaging, bone marrow biopsy, laboratory markers).
For fungal or other infections under treatment, provide infectious disease specialist documentation that infection is responding to therapy and transplant is appropriate.
Document history of noncompliance or substance dependence and evidence of counseling/abstinence if applicable.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required with disease‑specific documentation

Obtain prior authorization for allogeneic hematopoietic stem cell transplantation and include documentation showing that all disease‑specific medical necessity criteria are met (age, disease status/response, performance status, infection control, substance‑use history, patient understanding, and social support).

Billing Rule

Include diagnosis and procedure codes with authorization request

When requesting authorization, include the supporting ICD‑10 diagnosis and the relevant CPT/HCPCS procedure codes for the transplant and related services.

Provide supporting diagnosis ICD‑10 codes listed in the policy
Include CPT/HCPCS codes for HSCT and related procedures

Prior Authorization

Document prior therapies and treatment response

For applicable indications, document prior lines of therapy and the patient’s response (for example, failure of tyrosine kinase inhibitors in CML or documented response status in AML/CLL) before transplant is considered.

Record prior therapies and whether there was complete/partial response, relapse, or induction failure as specified by indication

Step Therapy

Step therapy not specified

This policy does not specify any step‑therapy requirements.

Documentation Required

Required documentation elements for authorization

Include core clinical and psychosocial documentation with authorization requests: diagnosis and disease stage/response, performance status (Karnofsky or ECOG), current infection status, substance‑use history, evidence of patient understanding, and social/family support.

Diagnosis and disease stage/response
Karnofsky score or ECOG grade
Active infection status or evidence infection is controlled
Drug/alcohol history and abstinence documentation where applicable
Documentation of patient understanding and social support

Documentation Required

Attach pre‑transplant evaluation results to authorization

Provide the comprehensive pre‑transplant evaluation documentation described in the policy (hepatic, pulmonary, cardiac, renal testing; infectious disease screening; dental exam) as part of the authorization package.

Denial Risk

Documentation gaps can trigger denial

Missing or incomplete evidence of age, disease response/status, performance status, infection control, substance‑use resolution, or documented consent/understanding may result in denial of authorization.

Age and indication‑specific criteria
Therapeutic response/status documentation
Karnofsky ≥70% or ECOG 0–2
Evidence infections are controlled
Documentation of abstinence or substance‑use treatment when applicable
Evidence of informed consent/understanding

Denial Risk

Clinical risk factors that may lead to denial

Active uncontrolled infections, inadequate major‑organ function (e.g., cardiac or pulmonary impairment), or unresolved noncompliance/substance‑use issues are clinical risk factors that may lead to denial of transplant authorization.

Uncontrolled active infection
Significant cardiac dysfunction or reduced ejection fraction
Insufficient pulmonary reserve on baseline PFTs
Ongoing substance abuse or noncompliance

Coding: CPT/HCPCS and Diagnosis Codes

Covered CPT Codes (part 1)CPTCovered

38204	Management of recipient hematopoietic progenitor cell donor search and cell acquisition.
38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic

Additional covered CPT/HCPCS Codes (part 2)mixedCovered

38207-38215	Transplant preparation of hematopoietic progenitor cells (includes codes 38207-38215).
38230	Bone marrow harvesting for transplantation; allogeneic.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor
S2142	Cord blood-derived stem cell transplantation, allogeneic.
S2150	Bone marrow or blood-derived peripheral stem cells (peripheral or umbilical), Autologous 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.

Covered ICD-10-CM Diagnosis CodesICD-10Covered

C81.00-C81.99	Hodgkin lymphoma.
C82.05-C82.99	Follicular lymphoma.
C83.15-C83.79	Mantle cell lymphoma, Diffuse large B-cell lymphoma, Primary central nervous system lymphoma, Lymphoblastic lymphoma, Burkitt lymphoma.
C84.16-C84.45	Sezary disease, Peripheral T-cell lymphoma.
C85.11-C85.99	B-cell lymphoma, non-Hodgkin lymphoma.
C91.00-C92.A2	Acute myeloblastic leukemia, Acute lymphocytic leukemia, Acute myeloid leukemia, Acute myelomonocytic leukemia, Chronic myeloid leukemia, Myeloid sarcoma, Other myeloid leukemia.
D46.0-D46.Z	Myelodysplastic syndrome.
D61.01-D61.9	Aplastic anemia.
D75.81	Myelofibrosis.

inv-09: IPSS-R score — numeric threshold reference (> 3.5)

IPSS-R thresholdRevised IPSS (IPSS-R) score > 3.5 required for certain MDS risk categories

IPSS categories referencedIPSS intermediate-1 with transfusion dependency; IPSS intermediate-2 or high also listed

Use in eligibilityIPSS/IPSS-R used to define transplant eligibility for MDS and myelofibrosis

inv-10: Pulmonary function testing — DLCO, FEV, FVC baseline measures required (cutoffs not specified)

Required baseline testsDLCO, FEV, and FVC baseline pulmonary function tests required as part of pre-transplant evaluation

PurposeAssess respiratory reserve and identify risk of pulmonary toxicity from pre-transplant regimens

ActionInclude pulmonary function test results in pre-transplant documentation for authorization

Definitions and Clinical Scales

inv-20: Karnofsky Performance Scale — scale 0–100%; policy threshold ≥70%

Scale rangeKarnofsky Performance Scale ranges 0%–100% assessing patient's performance status

Policy thresholdPolicy requires Karnofsky score ≥ 70% for transplant eligibility

InterpretationScore of 70% indicates patient can care for self but may have limitations in work or strenuous activities

inv-21: ECOG Performance Status — grades 0–5; policy accepts grades 0–2

Scale gradesECOG grades 0–5 where 0 = fully active and 5 = dead

Policy acceptancePolicy accepts ECOG performance grades 0–2 for transplant eligibility

Clinical interpretationGrades 0–2 indicate ambulatory and capable of self-care with varying activity restrictions

inv-22: IPSS / IPSS-R — prognostic scoring systems for MDS/myelofibrosis used to define transplant eligibility

DefinitionIPSS and revised IPSS (IPSS-R) are prognostic scoring systems for MDS and myelofibrosis based on marrow blasts, cytogenetics, and cytopenias

Use in policyUsed to define transplant eligibility and risk categories (e.g., IPSS intermediate-1 with transfusion dependency; IPSS-R thresholds)

Specific thresholdsPolicy references IPSS intermediate-2/high and IPSS-R score > 3.5 for eligibility in selected indications

inv-23: Baseline pulmonary function tests — DLCO, FEV, FVC definitions and usage

Test componentsBaseline pulmonary function tests include DLCO, FEV, and FVC to assess respiratory reserve prior to transplant

Clinical rationalePre-transplant regimens may be toxic to the lungs and result in post-transplant respiratory impairment

DocumentationInclude PFT results in pre-transplant workup and authorization documentation

inv-24: Cardiac assessment — ECG and 2D echocardiogram or MUGA to evaluate ejection fraction and cardiotoxicity risk

Required assessmentsCardiac assessment should include electrocardiogram (ECG) and two-dimensional echocardiogram or MUGA scan

PurposeEvaluate ejection fraction and identify cardiotoxicity risk prior to transplantation

Clinical relevanceHistory of reduced ejection fraction or heart failure increases post-transplant cardiotoxicity risk and may affect eligibility

OpenPayer

Allogeneic Stem Cell Transplantation (Adults)

Coverage Criteria for Allogeneic Stem Cell Transplantation

Candidate Eligibility and Selection

Pre-Transplant Evaluation Requirements

Contraindications and High-Risk Factors

Provider Requirements, Prior Authorization, and Documentation

Coding: CPT/HCPCS and Diagnosis Codes

Transplant Center and Facility Considerations

Post-Transplant Hospitalization and Follow-up

Definitions and Clinical Scales

Background on Allogeneic Stem Cell Transplantation