CurrentAmbetter NevadaPolicy CP.MP.101

Donor Lymphocyte Infusion

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Medical necessity criteria for donor lymphocyte infusion following allogeneic hematopoietic stem cell transplantation for relapsed or high-risk hematologic malignancies; applies to non-Medicare Ambetter Nevada/Centene-affiliated health plans.

Policy Summary

PayerAmbetter Nevada

PolicyDonor Lymphocyte Infusion

Policy CodePolicy CP.MP.101

Change TypeNo material change indicated

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating prior allogeneic HSCT and that DLI criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40-60%GvHD incidence

70-80%CML CR rate

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CurrentAmbetter NevadaPolicy CP.MP.101

Donor Lymphocyte Infusion

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Sign up for Ambetter Nevada Policy CP.MP.101 alerts

Get alerted when Policy CP.MP.101 changes without checking for updates manually.

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Policy Summary

PayerAmbetter Nevada

PolicyDonor Lymphocyte Infusion

Policy CodePolicy CP.MP.101

Change TypeNo material change indicated

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating prior allogeneic HSCT and that DLI criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40-60%GvHD incidence

70-80%CML CR rate

Coverage Criteria for Donor Lymphocyte Infusion (DLI)

Medically necessary indications

Covered when ALL of the following are met

DLI coverage criteria: 1) Procedure performed after allogeneic hematopoietic stem cell transplantation (HSCT); 2) Indication is relapsed or refractory hematologic malignancy OR to decrease risk of relapse (including pre-emptive use for mixed chimerism or detectable minimal residual disease [MRD]); 3) Not performed for the sole purpose of increasing donor chimerism without relapse risk; 4) Not in the presence of grade 2 or higher acute graft-versus-host disease (GvHD); 5) Genetic modification or ex vivo manipulation of donor lymphocytes is not allowed outside clinical trials

Based on Centene non-Medicare policy statements

Use of donor lymphocyte infusion (DLI) is limited to the post-allogeneic hematopoietic stem cell transplantation (HSCT) setting for the following clinical purposes: to treat relapsed or refractory hematologic malignancy, or to decrease the risk of relapse of a hematologic malignancy (including pre-emptive use for mixed chimerism or detectable minimal residual disease). Prior authorization is required and clinical documentation must demonstrate that these criteria are met before DLI will be approved.

DLI should not be used for the sole purpose of increasing donor chimerism in patients who already have full/complete chimerism (100% donor cells detected after HSCT), because additional benefit is not expected and the procedure may increase the risk of graft-versus-host disease (GvHD). Requests for DLI solely to raise donor chimerism without evidence of relapse risk will generally be denied.

Any use of DLI outside the specified post-HSCT indications—such as for indications not related to treating relapse or decreasing relapse risk, or involving genetic modification or other ex vivo manipulation of donor lymphocytes—is not supported by current evidence and is considered not medically necessary. Manipulation techniques and genetically modified grafts should only be used within clinical trials.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for donor lymphocyte infusion (DLI) procedures and associated billable services. Providers must submit supporting clinical documentation demonstrating the indication is post-allogeneic HSCT for treatment of relapsed or refractory hematologic malignancy or to decrease risk of relapse. Requests for DLI for any other indication carry a high risk of denial.

Prior authorization required for DLI procedures and associated CPT/HCPCS codes (e.g., 38242, 38215, 86950, S2150).
Submit documentation of prior allogeneic HSCT, current disease status (relapse vs. high risk of relapse), and rationale for DLI.
Requests for indications other than post-allogeneic HSCT to treat relapsed/refractory hematologic malignancy or to decrease relapse risk are likely to be denied.

Documentation Required

Document Combination Therapy When DLI Alone Has Limited Efficacy

When DLI is planned in settings where DLI alone is often of limited efficacy (for example, relapsed acute myeloid leukemia [AML]), documentation should support the planned use of concurrent or prior cytotoxic therapy or other adjunctive treatments intended to augment response.

Procedure and Billing Codes

Referenced procedure and HCPCS/CPT codesmixed

38215	Transplant preparation of hematopoietic progenitor cells; cell concentration in plasma, mononuclear, or buffy coat layer.
38242	Allogeneic lymphocyte infusions.
86950	Leukocyte transfusion
S2150	Bone marrow or blood-derived 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 posttransplant care in the global definition

Line of Therapy / Indication Context

salvage

Line of therapy context: DLI is used as salvage therapy for relapsed disease after allogeneic HSCT or as pre-emptive/prophylactic therapy in high‑risk post‑HSCT patients (e.g., mixed chimerism or detectable MRD).

Specific line (first‑line, second‑line) is not specified; use is contextual to relapse or high relapse risk after HSCT.

Effectiveness by Disease Context

Indication	Regimen / Role of DLI	Coverage status
Relapsed chronic myeloid leukemia (CML)	DLI often effective as single-agent therapy; multiple studies report complete remission rates of 70–80% with durable responses in the majority of cases.	Covered with criteria

Indication	Regimen / Role of DLI	Coverage status
Relapsed acute myeloid leukemia (AML)	DLI has limited single‑agent efficacy (approximately 15–20% chance of inducing remission); often used in combination with chemotherapy to elicit an anti‑tumor effect.	Covered with criteria

Indication	Regimen / Role of DLI	Coverage status
Relapsed multiple myeloma	DLI can be considered post‑allogeneic HSCT; reported response rates vary (approximately 22–52% across reports) and are generally lower than CML; use may be influenced by prior transplant type and trial availability.	Covered with criteria
Relapsed acute lymphoblastic leukemia (ALL)	DLI may be used post‑HSCT but outcomes are less robust than for CML or AML; published series show limited durable disease‑free remissions when combined with chemotherapy.	Covered with criteria

Key Definitions

Mixed chimerism

DefinitionMixed chimerism: < 90% donor cells detected after HSCT.

Clinical relevanceIndicates incomplete donor hematopoietic engraftment and may prompt pre-emptive interventions such as DLI to decrease relapse risk.

Use in coverage criteriaConsidered a high-risk post-HSCT state qualifying as an indication for DLI when other coverage criteria are met.

Full/complete chimerism

DefinitionFull/complete chimerism: 100% donor cells detected after HSCT.

Clinical implicationSuggests complete hematopoietic replacement by donor cells and is not an indication for DLI solely to increase chimerism.

Background and Rationale

Donor lymphocyte infusion (DLI) is the infusion of donor-derived lymphocytes into a patient after an allogeneic hematopoietic stem cell transplantation (HSCT) with the goal of inducing a graft-versus-tumor (GvT) immune response. DLI may be used therapeutically for proven relapse or pre-emptively for high-risk post-HSCT situations (for example, mixed chimerism or detectable minimal residual disease). Major risks include graft-versus-host disease (GvHD) and bone marrow aplasia; efficacy varies by disease, with higher complete remission rates in chronic myeloid leukemia (CML) and lower response rates in acute leukemias and multiple myeloma.