CurrentAlliance HealthPolicy 11A-16

Hematopoietic Stem Cell Transplantation for CLL/SLL

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Clinical coverage criteria for hematopoietic stem cell transplantation (HSCT), including allogeneic HSCT and donor lymphocyte infusion (DLI), for beneficiaries with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) under NC Medicaid.

Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem Cell Transplantation for CLL/SLL

Policy CodePolicy 11A-16

Change TypeNo material change

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify Medicaid eligibility and follow NCTracks prior approval guidance when required.

SourceLink

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CurrentAlliance HealthPolicy 11A-16

Hematopoietic Stem Cell Transplantation for CLL/SLL

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Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem Cell Transplantation for CLL/SLL

Policy CodePolicy 11A-16

Change TypeNo material change

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify Medicaid eligibility and follow NCTracks prior approval guidance when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CoveredAllogeneic HSCT stance

CoveredDLI post‑transplant

Not coveredAutologous HSCT

Not requiredPrior approval

Beneficiary billedDonor billing rule

Coverage Criteria for HSCT in CLL/SLL

inv-01: Allogeneic HSCT — CLL/SLL — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Allogeneic HSCT for CLL/SLL: Allogeneic hematopoietic stem cell transplantation (myeloablative or reduced-intensity conditioning) is covered to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in beneficiaries with markers of poor-risk disease.N/A

Refer to Policy Guidelines Subsection 3.2.4 for definition of poor-risk markers.

inv-03: Allogeneic HSCT for poor-risk CLL/SLL — Covered when ALL of the following are met

Covered when ALL of the following are met

Allogeneic HSCT coverage for poor-risk CLL/SLL: Allogeneic HSCT for CLL or SLL using either a myeloablative or reduced-intensity pretransplant conditioning regimen is covered for beneficiaries with markers of poor-risk disease.N/A

Refer to Policy Guidelines Subsection 3.2.4 for markers of poor-risk disease.

inv-02: Donor Lymphocyte Infusion (DLI) — Covered when ANY of the following post‑transplant conditions are present:

Covered when ANY of the following post‑transplant conditions are present:

DLI Indications: Donor lymphocyte infusion (DLI) is covered following a medically necessary allogeneic HSCT for CLL when: the disease has relapsed or is refractory; to prevent relapse in the setting of high relapse risk; or to convert an individual from mixed to full donor chimerism.N/A

See Section 1.1 for DLI description and Policy Guidelines for additional details.

inv-04: Donor lymphocyte infusion (DLI) — Covered when ANY of the following apply after allogeneic HSCT

Covered when ANY of the following apply after allogeneic HSCT

Donor lymphocyte infusion (DLI): DLI is medically necessary and covered following allogeneic HSCT that was medically necessary for CLL when disease has relapsed or is refractory, when used to prevent relapse in high relapse-risk settings, or when used to convert mixed to full donor chimerism.N/A

Refer to Section 1.1 and Policy Guidelines for additional DLI details.

Under the federal EPSDT special provision for beneficiaries under 21 years of age, medically necessary services must be provided when needed to correct or ameliorate a health problem. However, EPSDT does not require coverage of services that are unsafe, ineffective, experimental, or investigational, nor services that are not medical in nature or not generally accepted as medical practice. Providers should apply these EPSDT limits when considering coverage requests for HSCT-related services for beneficiaries under 21.

Autologous hematopoietic stem‑cell transplantation (autologous HSCT) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) is specifically excluded from coverage under this policy. Allogeneic HSCT is addressed separately and is covered only as noted in the policy's eligibility and criteria sections.

Medicaid requires that donor transplant‑related medical expenses be billed on the transplant beneficiary's claim using the beneficiary's Medicaid identification number. Medicaid does not reimburse for unsuccessful donor searches, and only actual donor transplant‑related medical expenses are reimbursable.

Services are not covered when the beneficiary fails to meet the eligibility requirements in Section 2.0 or the clinical criteria in Section 3.0, when the service duplicates another provider's service, or when the service is experimental, investigational, or part of a clinical trial. In addition, EPSDT does not override these exclusions: services that are unsafe, ineffective, experimental, or investigational remain non‑covered even for beneficiaries under 21.

Candidate Selection for Allogeneic HSCT

inv-33: Allogeneic HSCT candidate criteria — Candidate selection for allogeneic HSCT in CLL/SLL

Candidate selection for allogeneic HSCT in CLL/SLL:

Candidate criteria: Beneficiaries with CLL or SLL who have markers of poor-risk disease may be candidates for allogeneic HSCT with either myeloablative or reduced-intensity conditioning.N/A

Policy Guidelines subsection referenced for poor‑risk marker details (Subsection 3.2.4).

inv-34: Allogeneic HSCT candidate criteria — Candidate selection relies on disease risk and staging

Candidate selection relies on disease risk and staging

Candidate for allogeneic HSCT: Beneficiary has CLL or SLL with markers of poor-risk disease as defined in the policy guidelines and appropriate staging (Rai/Binet) and is medically appropriate for allogeneic HSCT.N/A

Coverage After Transplant

Donor lymphocyte infusion (DLI) — Covered post-allogeneic HSCT for relapse, refractory disease, relapse prevention, or chimerism conversion

Coverage indicationDLI is covered following medically necessary allogeneic HSCT for CLL when disease has relapsed or is refractory, to prevent relapse in high‑risk settings, or to convert mixed to full donor chimerism.

Relation to HSCTDLI is performed after an allogeneic hematopoietic stem‑cell transplant from the same donor (infusion of donor lymphocytes).

Reference sectionSee Section 1.1 (DLI definition) and Section 3.2.1 (post‑transplant coverage) for details.

Donor lymphocyte infusion — DLI covered after allogeneic HSCT for relapse prevention, treatment of relapse/refractory disease, or conversion to full donor chimerism

When coveredDLI is considered medically necessary and covered after a medically necessary allogeneic HSCT for CLL to prevent relapse in high‑risk settings, to treat relapse or refractory disease, or to convert mixed to full donor chimerism.

Claims, Codes, and Clinical Thresholds

Claims and coding systemsmixed

CMS-1500/837P	Professional claim form/transaction
UB-04/837I	Institutional claim form/transaction
ICD-10-CM	Diagnosis coding system - report to highest level of specificity
PCS	Procedural Coding System - report to highest level of specificity
CPT	Current Procedural Terminology - use current edition; use unlisted codes with special report when no specific code exists
HCPCS	Health Care Procedure Coding System - use current edition; use unlisted codes with special report when no specific code exists

Lymphocytosis threshold

Threshold> 15 x 10^9/L for 4 weeks

ContextDefined as lymphocytosis for staging and prognosis in CLL/SLL (Rai/Binet classifications).

Use in decisionsApplied alongside staging systems and other prognostic factors when assessing disease risk and treatment options.

Anemia threshold

ThresholdHemoglobin < 110 g/L

Definition roleDefines anemia within staging and prognosis criteria for CLL/SLL.

Clinical use

Provider Responsibilities, Prior Approval, and Documentation

Prior Authorization

Prior Authorization and NCTracks

Prior authorization is not required for Hematopoietic Stem Cell Transplantation (HSCT) for CLL and SLL. Providers should verify current prior authorization rules in NCTracks because prior approval processes and system guidance may change. EPSDT requirements do not eliminate any applicable prior approval requirements for beneficiaries under 21; see NCTracks Provider Claims and Billing Assistance Guide and the EPSDT provider page for details.

Medicaid shall not require prior approval for HSCT for CLL and SLL.
Verify Medicaid eligibility and prior authorization requirements at the time of service via NCTracks.
Beneficiaries under 21 remain subject to prior approval requirements when applicable.

Note

Eligibility Verification and Prior Approval Note

Providers must verify each beneficiary's Medicaid eligibility at the time services are rendered and follow prior approval procedures when a service requires prior approval. For beneficiaries under age 21, EPSDT applies but does not exempt prior approval when it is normally required. Refer to NCTracks and the EPSDT resources for operational guidance.

Pretransplant Evaluation and Testing

Documentation Required

Pretransplant evaluation: HLA compatibility and fitness for conditioning

Pretransplant evaluation must include assessment of HLA compatibility and the beneficiary's fitness to tolerate either myeloablative or reduced‑intensity conditioning; regimen intensity should be tailored to disease and patient condition.

Document HLA typing results and clinical assessment of fitness for conditioning regimen.

Note

See Policy Guidelines for pretransplant markers (3.2.4)

Refer to Policy Guidelines Subsection 3.2.4 for details on pretransplant markers and specific evaluation elements referenced by the coverage criteria.

Policy guidelines subsection contains definitions of poor‑risk markers used for candidate selection.

Note

Provider and Center Qualifications

Documentation Required

Meet provider qualifications and billing eligibility

Provider qualifications, certifications, and billing eligibility requirements are described in the provider sections and must be met prior to billing for HSCT services.

See Table of Contents and Section 6.0 for provider qualifications and billing eligibility.

Documentation Required

Maintain Medicaid participation and signed DHHS agreement

Providers must meet Medicaid participation qualifications and have a current, signed DHHS Provider Administrative Participation Agreement to be eligible to bill for HSCT services.

Maintain and present a current DHHS Provider Administrative Participation Agreement when requested.

Background and Definitions

Hematopoietic stem‑cell transplantation (HSCT) is the infusion of hematopoietic stem cells to restore bone marrow function after marrow‑ablative therapy. HSCT may be autologous (patient's own cells) or allogeneic (donor cells). Allogeneic HSCT requires human leukocyte antigen (HLA) compatibility between donor and recipient and may employ either myeloablative or reduced‑intensity conditioning regimens selected according to disease biology and patient fitness.

HSCT definition

DefinitionHematopoietic stem‑cell transplantation (HSCT) is the infusion of hematopoietic stem cells to restore bone marrow function after marrow‑ablative therapy; sources include autologous recipient cells, allogeneic donor cells, or cord blood.

Donor compatibilityAllogeneic HSCT requires assessment of immunologic compatibility (HLA typing) between donor and recipient to optimize outcomes.

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

Reduced-intensity conditioning (RIC) definition

Contraindications

This policy does not list explicit medical contraindications in the Contraindications section. Providers should rely on clinical judgment, institutional transplant center criteria, and referenced policy guidelines for assessment of patient suitability and any contraindications to HSCT.

Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem Cell Transplantation for CLL/SLL

Policy CodePolicy 11A-16

Change TypeNo material change

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify Medicaid eligibility and follow NCTracks prior approval guidance when required.

SourceLink

On This Page

Refer to Rai and Binet staging systems (Table 1) and Policy Guidelines Subsection 3.2.4 for specifics on poor‑risk markers and staging.

Clinical roleUsed to eradicate residual malignant cells and promote conversion to full‑donor chimerism following reduced‑intensity or myeloablative conditioning.

Policy pointersRefer to Section 1.1 for definition and Section 3.2.1 for coverage criteria and context.

Donor transplant-related medical expenses — donor expenses billed on beneficiary's transplant claim using beneficiary ID

Billing ruleDonor transplant‑related medical expenses are billed on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid identification number.

Reimbursement scopeMedicaid reimburses only for the actual donor's transplant‑related medical expenses.

Unsuccessful searchesMedicaid does not reimburse for unsuccessful donor searches.

Considered with other hematologic parameters when determining stage and treatment candidacy for HSCT.

Thrombocytopenia threshold

ThresholdPlatelets < 100 x 10^9/L

Definition roleDefines thrombocytopenia within staging and prognosis criteria for CLL/SLL.

Clinical useUsed with staging systems and other prognostic markers to inform treatment decisions including HSCT candidacy.

Verify eligibility each time a service is rendered.
Follow NCTracks prior approval workflows when prior approval is required.

Note

General Medical Necessity Standards

Coverage is allowed only when services meet general medical necessity standards: individualized, specific, consistent with diagnosis, necessary, and safely furnished. Services that are not individualized, inconsistent with the diagnosis, unsafe, or primarily for convenience may be denied. Additionally, coverage requires that no equally effective and more conservative or less costly statewide option exists.

Services must be individualized, specific, and consistent with symptoms or a confirmed diagnosis.
Services must be safe and not primarily for convenience of beneficiary or provider.
An equally effective, more conservative, or less costly statewide option must not be available.

Denial Risk

General Denial Triggers

Medicaid will not cover services that do not meet eligibility (Section 2.0) or the clinical criteria (Section 3.0), duplicate another provider's services, or are experimental/investigational. Such conditions are common denial triggers — confirm patient eligibility, clinical indications, and that the service is not duplicative or investigational before billing.

Denial triggers include failure to meet Section 2.0 eligibility or Section 3.0 clinical criteria.
Services that duplicate another provider's procedure, product, or service may be denied.
Experimental, investigational services, or those part of a clinical trial are not covered.

Denial Risk

Autologous HSCT Exclusion

Autologous hematopoietic stem cell transplantation (HSCT) to treat CLL or SLL is not covered by Medicaid and will be denied.

Autologous HSCT to treat CLL or SLL is explicitly not covered.

Billing Rule

Provider Eligibility and Compliance

Providers must meet Medicaid participation qualifications and maintain required agreements, licenses, and compliance with applicable laws and NC Medicaid policies at the time services are rendered.

Meet Medicaid qualifications for participation and maintain a current signed DHHS Provider Administrative Participation Agreement.
Bill only for procedures within the scope of your clinical practice.
Comply with all applicable federal, state, and NC Medicaid policies, laws, and record retention requirements.

Documentation Required

Coding and Documentation Specificity

Report diagnosis and procedure codes to the highest level of specificity supporting medical necessity. Use the current ICD-10-CM/PCS, CPT, HCPCS, and UB-04 revenue codes in effect at the time of service. If no specific CPT/HCPCS code exists, report the appropriate unlisted procedure or service code.

Report ICD-10-CM and PCS to the highest specificity that supports medical necessity.
Use current CPT, HCPCS, and UB-04 revenue codes and editions in effect at time of service.
When no specific code exists, use the appropriate unlisted procedure or service code.

Policy Guidelines (3.2.4) contain detailed evaluation requirements

Refer to Policy Guidelines Subsection 3.2.4 for additional pretransplant marker details and evaluation requirements; supporting documentation and lab panels referenced in prior revisions should be included as applicable.

Include referenced lab results and documentation per policy guidelines.

Billing Rule

Billing eligibility and compliance for providers

To bill under this policy, providers must meet Medicaid participation qualifications, have a signed DHHS Provider Administrative Participation Agreement, bill only within their licensed scope, and follow NCTracks and National Uniform Billing Guidelines for institutional claims.

Bill institutional claims per UB‑04/837I and NCTracks guidance.
Ensure services billed are within scope of clinical practice.

Note

Maintain participation qualifications and regulatory compliance

Providers must meet Medicaid participation qualifications, maintain required agreements, and comply with all applicable agreements, laws, and NC Medicaid clinical policies to remain eligible to furnish and bill for HSCT services.

Adhere to record retention, HIPAA, and NC Medicaid policy requirements.

DefinitionReduced‑intensity conditioning (RIC) refers to pretransplant regimens of lower cytotoxic intensity intended to reduce non‑relapse mortality while permitting graft‑versus‑malignancy effects and eventual donor chimerism.

SpectrumRIC regimens exist on a continuum from nearly myeloablative to minimally myeloablative with lymphoablation; intensity is tailored to disease and patient condition.

DLI relationPatients undergoing RIC often show mixed chimerism initially and may convert to full‑donor chimerism, sometimes supplemented with DLI.

DLI definition

DefinitionDonor Lymphocyte Infusion (DLI) is a therapy in which lymphocytes from the blood of the donor are given to a beneficiary who has previously received a stem cell transplant from the same donor; donor lymphocytes may kill remaining cancer cells.

IndicationsUsed after allogeneic HSCT to treat relapse or refractory disease, to prevent relapse in high‑risk settings, or to convert mixed to full donor chimerism (policy‑specified coverage conditions).

Policy historyDLI definition and coverage criteria were added to the policy in prior revisions (see revision history).

Lymphocytosis / anemia / thrombocytopenia definitions

Lymphocytosis> 15 x 10^9/L for 4 weeks

AnemiaHemoglobin < 110 g/L

ThrombocytopeniaPlatelets < 100 x 10^9/L

Adverse and favorable prognostic factors

Adverse prognostic factorsDiffuse marrow involvement; advanced age; deletions of parts of chromosomes 17 or 11; trisomy 12; high beta‑2‑microglobulin; lymphocyte doubling time <1 year; increased prolymphocytes; high ZAP‑70 (≥20%) or CD38 (≥30%); unmutated IGHV.

Favorable prognostic factorsNon‑diffuse (nodular or interstitial) marrow pattern; del(13q) alone; low ZAP‑70 (<20%) or CD38 (<30%); mutated IGHV.

UsePrognostic markers are considered alongside staging when determining treatment options and HSCT candidacy.

Donor lymphocyte infusion (DLI) — revision history note about addition of DLI criteria

Revision noteDonor lymphocyte infusion definition and DLI coverage criteria were added to the policy in the 10/01/2019 revision; subsequent notes reference DLI criteria in Section 3.2.1.

Prior approval historyRevision history notes that if prior approval was given for allogeneic HSCT and DLI is later indicated, a separate PA may not be required (historical note from 2019 revisions).

DocumentationSee revision history for dates and sections amended related to DLI addition and criteria updates.