CurrentAmbetter NevadaPolicy CP.MP.101

Donor Lymphocyte Infusion

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

15-20%AML remission rate

2-5%Bone marrow aplasia

Coverage Criteria for Donor Lymphocyte Infusion (DLI)

Medically necessary indications

Covered when ALL of the following are met

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

On This Page

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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

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.

For AML and similar diagnoses, include treatment plan detailing chemotherapy or other therapies given prior to, concurrent with, or following DLI.
Provide evidence supporting that combination therapy is clinically indicated and expected to improve likelihood of response compared with DLI alone.

Documentation Required

Documentation Must Support Prior Allogeneic HSCT and Current Disease Status

Documentation submitted with the DLI request should explicitly support prior allogeneic HSCT, and provide current clinical details such as evidence of relapse, mixed chimerism, or measurable/minimal residual disease (MRD) that justify pre-emptive or therapeutic DLI.

Confirm prior allogeneic HSCT (date, donor type, conditioning regimen if available).
Provide objective evidence of relapse or high risk of relapse (e.g., mixed chimerism assays, MRD testing results, imaging, marrow findings).
Detail prior and planned therapies, current performance status, and absence of contraindications to DLI.

Denial Risk

Contraindication — Active Grade 2+ Acute GvHD

DLI is contraindicated in the presence of grade 2 or higher acute graft-versus-host disease (GvHD). Requests for DLI when grade 2+ acute GvHD is present may be denied.

Do not submit DLI authorization requests if the patient has active grade 2 or higher acute GvHD.
If there is historical GvHD, provide documentation that it has resolved and the current grade is <2 prior to requesting DLI.

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

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.

Policy noteDLI should not be used in patients with full donor chimerism for the sole purpose of increasing donor chimerism due to GvHD risk.

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.

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