CurrentAlliance HealthPolicy 11A-1

Hematopoietic Stem-Cell Transplantation for Acute Lymphoblastic Leukemia (ALL)

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Policy governing coverage, eligibility, and requirements for hematopoietic stem-cell transplantation (HSCT) for treatment of acute lymphoblastic leukemia (ALL) for NC Medicaid beneficiaries.

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CurrentAlliance HealthPolicy 11A-1

Hematopoietic Stem-Cell Transplantation for Acute Lymphoblastic Leukemia (ALL)

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Policy governing coverage, eligibility, and requirements for hematopoietic stem-cell transplantation (HSCT) for treatment of acute lymphoblastic leukemia (ALL) for NC Medicaid beneficiaries.

Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem-Cell Transplantation for Acute Lymphoblastic Leukemia (ALL)

Policy CodePolicy 11A-1

Change TypeNo material changes

Effective DateN/A

Last ReviewAug 15, 2023

Next Review DateN/A

Key ActionDocument medical necessity and eligibility, including EPSDT criteria for beneficiaries under 21, when submitting claims and supporting records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Aug 15, 2023Amended date

EPSDTEPSDT applies

Children: listedPediatric indications

Adults: listedAdult indications

Autologous CR2+/refractoryNot-covered scenario

NCState

Coverage Criteria for HSCT in ALL

Coverage criteria overview

Covered when medical necessity and eligibility criteria are met; refer to general and specific criteria sections and EPSDT provisions for beneficiaries under 21.

General eligibility: Beneficiary enrolled in NC Medicaid and provider must verify eligibility at each service

From general provisions

Transplant type and conditioning: Autologous HSCT is typically performed as consolidation when disease is in complete remission; allogeneic HSCT requires appropriate HLA compatibility; reduced-intensity conditioning (RIC) is an alternative for patients who cannot tolerate myeloablative conditioning

Clinical discussion of indications and conditioning intensity

Pediatric HSCT Coverage

Covered when ALL of the following are met for children:

General medical necessity: Procedure is individualized, specific, consistent with symptoms or confirmed diagnosis, not in excess of needs, safely furnished, no equally effective more conservative or less costly option available statewide, and not primarily for convenience.

General criteria from Section 3.1 applies.

High risk in first complete remission: Child in first complete remission (CR1) but at high risk of relapse as indicated by at least one of: poor response to initial therapy including prednisone prophase absolute blast count >=1,000/μL; induction therapy MRD >=1% by flow cytometry at 6 weeks; T‑cell phenotype; or presence of t(9;22) or t(4;11)

Section 3.2.1 Children a.1-4

Second or greater remission or refractory disease: Autologous or allogeneic HSCT may be considered medically necessary for childhood ALL in second or greater remission or with refractory disease.

Section 3.2.1 b.

Relapse after prior autologous HSCT: Allogeneic HSCT is considered medically necessary to treat relapsing ALL after a prior autologous HSCT.

Section 3.2.1 c.

Adult HSCT Coverage

Covered when ALL of the following are met for adults:

General medical necessity: Procedure meets general criteria for medical necessity (see Section 3.1).

General criteria apply.

Autologous HSCT in CR1 with high risk: Autologous HSCT may be considered medically necessary for adult ALL in first complete remission (CR1) but at high risk of relapse as indicated by at least one of: age >35 years; leukocytosis at presentation (B‑cell >30,000/μL; T‑cell >100,000/μL); extramedullary disease (particularly CNS); poor‑prognosis genetics (e.g., t(9;22)); or time to attain CR >4 weeks.

Section 3.2 Adults a.1-5

Allogeneic HSCT in CR1: Allogeneic HSCT may be considered medically necessary for adult ALL in first complete remission for any risk level.

Section 3.2 Adults b.

Allogeneic HSCT in CR2+/relapsed/refractory:

Donor Lymphocyte Infusion (DLI)

Covered when ALL of the following are met:

DLI coverage: Donor lymphocyte infusion (DLI) is considered medically necessary following an allogeneic HSCT that was medically necessary for treatment of relapsed or refractory ALL, when used to prevent relapse in high‑risk settings, or to convert mixed to full donor chimerism.

Section 3.2.1 Adult or Child a.; see definition of DLI in Section 1.1

Under EPSDT, services for beneficiaries under 21 may be provided beyond usual policy limitations when medically necessary to correct or ameliorate a condition; however, EPSDT does not require coverage of services that are unsafe, ineffective, or experimental/investigational.

Medicaid will not cover the procedure, product, or service when the beneficiary fails to meet eligibility in Section 2.0, does not meet the clinical criteria in Section 3.0, when the service duplicates another provider's procedure, or when the service is experimental, investigational, or part of a clinical trial. Additionally, autologous HSCT for adult ALL in second or greater remission or refractory disease is not covered, and coverage may be denied when psychosocial issues or current noncompliance make adherence to required pre- and post-transplant care improbable.

For the additional requirements sections identified as 5.2.1 (General) and 5.2.2 (Specific), the policy states "None Apply", indicating there are no supplementary general or specific additional requirements beyond those already specified in the policy.

Donor transplant-related medical expenses must be billed on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid identification number. Medicaid will only reimburse actual donor transplant-related medical expenses and does not reimburse for unsuccessful donor searches.

The policy identifies specific not-covered scenarios: notably, autologous HSCT is not covered for adults with ALL in second or greater remission or with refractory disease. In general, services are also not covered if the beneficiary does not meet eligibility, does not meet the clinical criteria in Section 3.0, the service duplicates another provider's service, or the service is experimental/investigational or part of a clinical trial. Coverage is also precluded when psychosocial history or current noncompliance would render required pre- or post-transplant care improbable.

Coding, Modifiers and Billing Units

Coding guidance and use of unlisted codesmixed

CPT/HCPCS/ICD-10	Policy directs use of current CPT, HCPCS, and ICD-10 codes at highest specificity; exact codes not listed in this excerpt.
Unlisted Procedure or Service (CPT/HCPCS)	If no specific code exists, report using appropriate unlisted procedure or service code and follow CPT/HCPCS instructions and Special Report requirements.

ModifiersModifier

Modifiers

Use applicable modifier guidelines.

Billing unitsRevenue

Billing units per code

Report the appropriate code(s) which determine the billing units.

inv-13: Blast count threshold for prednisone poor response

Prednisone poor response blast count>= 1,000/μL (absolute blast count)

ContextUsed to identify children with poor response to initial therapy for high relapse risk

Source measurementAbsolute peripheral blood blast count reported in μL

inv-14: Minimal residual disease threshold (children)

MRD threshold (children)>= 1% minimal residual disease by flow cytometry at 6 weeks

TimingMeasured at 6 weeks after induction therapy

Provider Actions, Prior Authorization, and Billing Instructions

Prior Authorization

Prior Authorization Requirement

Medicaid shall not require prior approval for Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia (ALL).

Note

Prior authorization status

Although prior approval is not required for HSCT for ALL, if a service requires prior approval under other policies or circumstances (including EPSDT for beneficiaries under 21), prior approval rules remain applicable. Verify any remaining PA requirements in other sections or related payer guidance.

If the beneficiary is under 21, EPSDT does not eliminate prior approval requirements for services that otherwise require PA.
Review NCTracks Provider Claims and Billing Assistance Guide and EPSDT provider page for additional PA guidance.

Candidate Selection and Evaluation

Candidate selection considerations

Disease‑ and patient‑specific factors influence transplant candidacy.

Age and disease context: Childhood ALL: very high CR rates with chemotherapy; risk stratification by age and WBC at diagnosis guides need for HSCT. Adult ALL: lower long‑term survival compared with children; adverse prognostic factors include age >35 years, poor performance status, male sex, and leukocytosis thresholds (B‑cell >30,000/μL; T‑cell >100,000/μL).

Clinical prognostic factors inform candidacy

Candidate Selection

Clinical candidate criteria for HSCT in ALL are risk‑ and remission‑status based.

Pediatric CR1 high risk: Child in CR1 with at least one high‑risk feature: prednisone poor response (absolute blast count >=1,000/μL), MRD >=1% by flow cytometry at 6 weeks, T‑cell phenotype, or t(9;22) or t(4;11).

Section 3.2.1 Children a.1-4

Evaluation and Testing Requirements

Documentation Required

Obtain HLA typing and document donor matching and donor option considered

HLA typing and donor matching are required for allogeneic HSCT; provider evaluation must include appropriate donor selection such as matched sibling, matched unrelated donor, or haploidentical donor options.

Perform HLA typing using cellular, serologic, or molecular techniques.
Document donor selection considerations and matching results.

Note

No additional evaluation requirements beyond Sections 3.0 and 3.2

No additional evaluation requirements are specified beyond the general and specific clinical criteria in Sections 3.0 and 3.2.

Documentation Required

Apply EPSDT exception and documentation for beneficiaries under 21

Refer to the EPSDT exception (Subsection 2.2.1) when evaluating Medicaid beneficiaries under 21 years of age; documentation requirements for EPSDT apply.

Contraindications and Exclusion Criteria

Patients with significant medical comorbidities or those unable to tolerate conventional myeloablative conditioning may be unsuitable candidates for standard allogeneic HSCT. For such patients, the policy recognizes alternatives such as reduced-intensity conditioning (RIC) regimens, which are intended to minimize treatment-related morbidity and non-relapse mortality while relying more on graft-versus-malignancy effects.

A beneficiary's psychosocial history or evidence of current noncompliance by the beneficiary or caregiver that would make adherence to required pre- and post-transplant medical care improbable is a contraindication to HSCT and may result in denial of coverage. The policy explicitly lists noncompliance and psychosocial limitations as reasons coverage is not appropriate.

Definitions and Key Terms

inv-34: Donor Lymphocyte Infusion (DLI)

DefinitionInfusion of donor lymphocytes to a recipient who previously received a stem cell transplant from the same donor

PurposeDonor lymphocytes may eradicate residual malignant cells after prior allogeneic transplant

Context of useDefined as a therapy given after prior stem cell transplant from same donor

inv-35: High risk of relapse (children/adults)

Children — poor response to initial therapyPrednisone prophase absolute blast count >=1,000/μL

Children — MRD>= 1% minimal residual disease by flow cytometry at 6 weeks

Post-Transplant Coverage (DLI and Reimbursement)

inv-49: Donor lymphocyte infusion (DLI)

Coverage indicationCovered post-allogeneic HSCT when used for relapse, prevention in high relapse-risk settings, or to convert mixed to full donor chimerism

EligibilityDLI covered only following an allogeneic HSCT that was medically necessary for treatment of ALL

PurposeApplies to treatment of relapsed/refractory ALL and prevention of relapse in high-risk scenarios

inv-50: Reimbursement and billing

Billing instructionProviders shall bill their usual and customary charges

Rate referenceFor schedule of rates refer to the Medicaid website: https://medicaid.ncdhhs.gov/

Center and Provider Qualifications

Note

Provider billing eligibility and qualification sections included (see TOC/Section 6.0)

The policy includes sections on providers eligible to bill, provider qualifications, and certifications; see the Table of Contents and Section 6.0 for details.

See Table of Contents and Section 6.0 for billing eligibility and qualification details.

Note

Meet Medicaid participation qualifications to be eligible to bill

Meet Medicaid qualifications for participation to be eligible to bill; no additional center‑specific requirements are specified in this section.

Ensure compliance with Medicaid participation requirements.

Note

No center‑specific requirements specified — follow general Medicaid qualifications

No additional center‑specific requirements are specified in this section; providers must meet general Medicaid qualifications to participate.

Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem-Cell Transplantation for Acute Lymphoblastic Leukemia (ALL)

Policy CodePolicy 11A-1

Change TypeNo material changes

Effective DateN/A

Last ReviewAug 15, 2023

Next Review DateN/A

Key ActionDocument medical necessity and eligibility, including EPSDT criteria for beneficiaries under 21, when submitting claims and supporting records.

SourceLink

On This Page

Allogeneic HSCT may be considered medically necessary for adult ALL in second or greater remission, or in relapsed or refractory disease.

Section 3.2 Adults c.

Reduced‑intensity conditioning (RIC): RIC allogeneic HSCT may be considered for patients in complete marrow and extramedullary first or second remission who cannot tolerate myeloablative conditioning due to factors such as advanced age (typically >60) or comorbidities (e.g., liver/kidney dysfunction, debility, prior intensive chemotherapy, low Karnofsky Performance Status).

Section 3.2 Adults d.

High‑dose chemo with allogeneic support: High‑dose chemotherapy with allogeneic stem cell support may be considered medically necessary in adults with Progenitor‑B cell ALL.

Section 3.2 Adults e.

Relapse after prior autologous HSCT: Allogeneic HSCT is considered medically necessary to treat relapsing ALL after a prior autologous HSCT.

Section 3.2 Adults f.

MethodFlow cytometry assessment of minimal residual disease (MRD)

inv-15: Age threshold (adult high risk)

Adult high-risk age threshold> 35 years

UseOne of several factors indicating high risk of relapse in adults in CR1

ApplicationMay support consideration of autologous HSCT in adult CR1

inv-16: Leukocytosis thresholds at presentation

Leukocytosis threshold — B-cell lineage>30,000/μL

Leukocytosis threshold — T-cell lineage>100,000/μL

ContextMeasured at presentation; used as a high-risk feature for adult ALL CR1 treatment decisions

Documentation Required

Eligibility verification and restrictions

Providers must verify Medicaid beneficiary eligibility at each encounter. Beneficiaries may be ineligible for this service due to their Medicaid eligibility category or lack of verified eligibility at the time of service.

Verify enrollment in the Medicaid program prior to service.
Confirm the beneficiary's eligibility category allows coverage of this service.

Denial Risk

Triggers for Denial

Claims may be denied when the beneficiary does not meet Section 2.0 eligibility requirements, does not meet the coverage 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.

Denial triggers include failure to meet policy clinical criteria or beneficiary eligibility.
Services that duplicate another provider's billed service may be denied.
Experimental or investigational services and clinical trial services are not covered.

Denial Risk

Provider eligibility denials

Providers must meet Medicaid participation qualifications to bill for the service. Lack of a current, signed DHHS Provider Administrative Participation Agreement or billing services outside the provider's licensed scope may result in denial.

Maintain a current DHHS Provider Administrative Participation Agreement.
Bill only for services within the provider's licensed scope of practice.

Billing Rule

Donor search reimbursement denial risk

Medicaid reimburses only for actual donor transplant-related medical expenses billed on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid ID. Medicaid does not reimburse for unsuccessful donor searches.

Bill donor transplant-related medical expenses on the beneficiary's claim using the beneficiary's Medicaid identification number.
Do not submit claims for unsuccessful donor searches; these are not reimbursed.

Note

Conditioning intensity alternatives

Reduced-intensity conditioning (RIC) is an accepted alternative to myeloablative conditioning for patients who cannot tolerate standard myeloablative regimens (for example, due to advanced age or comorbidities such as liver or kidney dysfunction, prior intensive chemotherapy, or low Karnofsky Performance Status). Document the medical rationale for using RIC in the record.

RIC may be considered for patients typically older than 60 years or with significant comorbidities.
Document inability to tolerate myeloablative conditioning and why RIC is selected.

Documentation Required

Conservative Therapy Consideration

Providers must consider and document that no equally effective, more conservative, or less costly statewide treatment is available before proceeding with the service; the procedure must be individualized, consistent with diagnosis, and not primarily for convenience.

Documentation should demonstrate that the service is specific to the beneficiary's diagnosis and needs.
Show that no equally effective, more conservative, or less costly statewide treatment is available.

Pediatric CR2 or refractory: Child in second or greater remission or with refractory disease may be considered for autologous or allogeneic HSCT.

Adult CR1 high risk (autologous): Adult in CR1 with high‑risk features (e.g., age >35, leukocytosis thresholds, extramedullary disease, poor‑prognosis genetics, time to CR >4 weeks) may be considered for autologous HSCT.

Section 3.2 Adults a.

Adult CR1 any risk (allogeneic): Adult in CR1 of any risk level may be considered for allogeneic HSCT.

Section 3.2 Adults b.

Adult CR2+/relapsed/refractory (allogeneic): Adult in second or greater remission, or with relapsed or refractory disease, may be considered for allogeneic HSCT.

Section 3.2 Adults c.

Adults — composite criteria

Age >35 years or leukocytosis thresholds, extramedullary disease, poor-prognosis genetics, or delayed time to CR

inv-36: Donor Lymphocyte Infusion (DLI)

Revision date addedDefinition of Donor Lymphocyte Infusion (DLI) added 10/01/2019

Scope of revisionDefinition inserted into Section 1.1 and referenced in revision history

ImpactDLI term formally defined within policy text

ApplicabilityApplies to provider reimbursement for covered transplant-related services

Note

Maintain participation agreements and bill within licensed scope

No additional center‑specific requirements are specified in this section; maintain required participation agreements and bill within scope of practice.

Note

Comply with Medicaid provider qualifications; no extra center requirements stated

No additional center‑specific requirements are specified in this section; comply with Medicaid provider qualifications.