CurrentAmbetter GeorgiaPolicy CP.MP.101

Donor Lymphocyte Infusion (DLI) Coverage Criteria

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Medical necessity and coverage criteria for donor lymphocyte infusion after allogeneic hematopoietic stem cell transplantation for relapsed or high-risk hematologic malignancies applicable to Ambetter Georgia non‑Medicare plans and Centene-affiliated non‑Medicare plans.

Policy Summary

PayerAmbetter Georgia

PolicyDonor Lymphocyte Infusion (DLI) Coverage Criteria

Policy CodePolicy CP.MP.101

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating prior allogeneic HSCT, evidence of relapse or high relapse risk, and absence of grade ≥2 acute GvHD.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40–60%GvHD after DLI

70–80%CML complete remission

15–20%AML remission (DLI alone)

2–5%Bone marrow aplasia risk

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CurrentAmbetter GeorgiaPolicy CP.MP.101

Donor Lymphocyte Infusion (DLI) Coverage Criteria

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

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Policy Summary

PayerAmbetter Georgia

PolicyDonor Lymphocyte Infusion (DLI) Coverage Criteria

Policy CodePolicy CP.MP.101

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating prior allogeneic HSCT, evidence of relapse or high relapse risk, and absence of grade ≥2 acute GvHD.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40–60%GvHD after DLI

70–80%CML complete remission

15–20%AML remission (DLI alone)

2–5%Bone marrow aplasia risk

Coverage Criteria for Donor Lymphocyte Infusion (DLI)

Medically necessary indications (non‑Medicare plans)

Covered when ALL of the following are met:

Primary coverage criteria: Patient received an allogeneic hematopoietic stem cell transplantation (HSCT).

Applies to non‑Medicare health plans affiliated with Centene Corporation

Primary coverage criteria: DLI is being used to treat relapsed or refractory hematologic malignancy OR to decrease the risk of relapse of a hematologic malignancy following allogeneic HSCT.

Covers therapeutic and preemptive use for high relapse risk (e.g., mixed chimerism or MRD) as described in policy guidance

Primary coverage criteria: DLI is not being used solely to increase donor chimerism without risk of relapse.

Use solely to increase donor chimerism without relapse risk is not recommended due to risk of exacerbating GvHD

Primary coverage criteria: No grade 2 or higher acute graft‑versus‑host disease (GvHD) is present.grade 2 or higher

Presence of grade ≥2 acute GvHD is a contraindication to DLI

Not supported indications / contraindications

Not supported for the following:

Unsupported indications: Genetic modification or ex vivo manipulation of donor lymphocytes (techniques such as graft enrichment, depletion, or activation outside clinical trials).

Current evidence does not support routine use of manipulated donor lymphocyte products; such techniques should be limited to clinical trials.

Unsupported indications: Use of DLI in the presence of grade 2 or higher acute graft‑versus‑host disease (GvHD).grade 2 or higher

Presence of grade ≥2 acute GvHD may trigger denial of coverage.

Unsupported indications: Any other indication not explicitly listed as medically necessary in this policy.

DLI is limited to post‑HSCT treatment of relapse/refractory disease or to decrease relapse risk as specified.

Use of donor lymphocyte infusion (DLI) that involves manipulation of the donor graft (for example, enrichment, depletion, activation, or other ex vivo modification) is not supported outside of a clinical trial setting because benefits versus risks have not been established. Providers proposing manipulated or genetically modified donor lymphocytes should document trial enrollment or provide high-quality evidence demonstrating clinical benefit and safety; absent that, these techniques are considered investigational and not recommended. [[This sentence is supported by source text.]]

Coverage for donor lymphocyte infusion is governed by the member’s applicable coverage documents and Health Plan administrative policies. Determinations about coverage, prior authorization requirements, and benefit administration are subject to the terms, conditions, exclusions and limitations of the evidence of coverage/certificate of coverage/policy or contract, as well as applicable state and federal requirements and Health Plan-level administrative procedures.

DLI performed solely to convert mixed chimerism to full donor chimerism when there is no documented risk of relapse is not recommended and is considered not medically necessary because the procedure exposes the patient to a substantial risk of graft‑versus‑host disease without clear benefit. The policy specifies that DLI should not be used for the sole purpose of increasing donor chimerism in the absence of relapse risk.

The source material does not present an explicit ‘‘not medically necessary’’ list beyond the specific clinical statements already noted (for example, not recommended use to increase chimerism without relapse risk). Administrative language elsewhere in the document explains that coverage decisions are subject to plan terms and governance but does not enumerate additional clinical not‑medically‑necessary statements in the cited sections.

Clinical Indications and Regimens

Indication	Regimen / Role of DLI	Supporting detail	Coverage
Relapsed chronic myeloid leukemia (CML) after allogeneic HSCT
DLI as monotherapy; often effective as a single‑agent intervention to induce remission
Multiple studies report complete remissions in 70–80% of patients with relapsed CML after DLI; responses are durable in the majority of cases
Covered when policy clinical criteria are met (see Coverage Criteria)

Indication	Regimen / Role of DLI	Supporting detail	Coverage
Relapsed acute myeloid leukemia (AML) after allogeneic HSCT
DLI may be used, commonly combined with chemotherapy rather than as sole therapy
Reported remission induction with DLI alone is approximately 15–20%; combination with chemotherapy is often necessary to elicit an anti‑tumor effect
Covered when policy clinical criteria are met and documentation of combined therapy provided when applicable

Indication	Regimen / Role of DLI	Supporting detail	Coverage
Relapsed multiple myeloma after allogeneic HSCT
DLI may be considered to stimulate a graft‑versus‑myeloma effect or as part of other myeloma therapies (on or off clinical trial)
Reported response rates vary (approximately 22–52% across reports); NCCN notes DLI can be used to stimulate graft‑versus‑myeloma effect or with other therapies
Covered when policy clinical criteria are met and use aligns with guideline recommendations or clinical trial participation where applicable

Line of Therapy and Indications

salvage

Salvage use: DLI as salvage therapy for proven relapse or refractory hematologic malignancy following allogeneic HSCT.

Effectiveness varies by disease (e.g., high remission rates in relapsed CML; lower rates in AML where combination with chemotherapy is often required).

Procedure and Billing Codes

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Obtain prior authorization and follow coding guidance for DLI

Prior authorization is expected for donor lymphocyte infusion (DLI) and related procedures; providers must reference current professional coding guidance and submit clinical documentation supporting medical necessity when requesting authorization for CPT/HCPCS-referenced services (e.g., 38215, 38242, 86950, S2150). Codes in the policy are informational only and do not guarantee coverage.

Reference most up-to-date coding guidance prior to claim submission.
Submit clinical documentation that supports medical necessity with the prior authorization request.
Referenced codes in the policy: 38215, 38242, 86950, S2150 (informational).

Prior Authorization

Follow plan terms for prior authorization and coverage decisions

Prior authorization requirements and medical necessity determinations for DLI are governed by the Health Plan's terms, applicable administrative policies, and the policy criteria, which are used to assist coverage decisions and benefit administration.

Definitions and Key Terms

inv-19: Mixed chimerism — < 90% donor cells detected after HSCT

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

Clinical relevanceIdentifies patients at increased relapse risk who may be considered for pre‑emptive DLI or further monitoring.

ContrastDistinguished from full chimerism (100% donor cells); partial donor engraftment may persist with mixed chimerism.

inv-20: Full chimerism — 100% donor cells detected after HSCT

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

Clinical implicationIndicates complete hematopoietic replacement by donor cells and is associated with lower measurable host hematopoiesis.

Background and Clinical Context

Donor lymphocyte infusion (DLI) delivers donor T lymphocytes from the original allogeneic stem cell donor to produce a graft‑versus‑tumor effect. The therapeutic rationale is twofold: to treat overt relapse of hematologic malignancy following allogeneic HSCT and to preemptively reduce relapse risk in high‑risk patients (for example, those with mixed chimerism or detectable minimal residual disease) by augmenting donor immune surveillance. Clinical outcomes are disease dependent — for example, high complete remission rates have been reported in relapsed CML, whereas response rates are lower in AML — and the treatment carries substantial risks, most notably a high rate of graft‑versus‑host disease and less commonly bone marrow aplasia.

Policy Summary

PayerAmbetter Georgia

PolicyDonor Lymphocyte Infusion (DLI) Coverage Criteria

Policy CodePolicy CP.MP.101

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating prior allogeneic HSCT, evidence of relapse or high relapse risk, and absence of grade ≥2 acute GvHD.

SourceLink

On This Page

The policy guides medical necessity determinations but plan-level prior authorization rules are controlled by the Health Plan's terms and administrative policies.
Effective dates, legal/regulatory requirements, and plan contracts may affect applicability.

Step Therapy

Document prior or concurrent chemotherapy for combination regimens

When DLI is used in combination with chemotherapy (for example in relapsed AML), document prior and/or concurrent systemic therapies and the clinical rationale for combination treatment in the authorization and medical record.

Document the diagnosis (e.g., relapsed AML) and why DLI is being combined with chemotherapy.
Include treatment timelines showing prior or concurrent chemotherapy relative to DLI administration.

Note

No explicit step therapy specified

No explicit step therapy requirements for DLI are specified in this policy; do not assume additional step edits beyond plan-specific prior authorization rules unless the Health Plan specifies otherwise.

Confirm with the member's Health Plan whether any plan-specific step edits apply before treatment.

Documentation Required

Submit required clinical documentation with authorization and claims

Include definitive clinical documentation in the medical record and with any prior authorization request: evidence of prior allogeneic HSCT, documentation of relapse or high relapse risk (e.g., mixed chimerism or molecular minimal residual disease), and assessment demonstrating absence of grade ≥2 acute graft‑versus‑host disease.

Document date and details of the prior allogeneic HSCT.
Provide objective evidence of relapse or high relapse risk (e.g., chimerism studies, MRD results).
Include clinical assessment confirming no grade 2 or higher acute GvHD at time of DLI request.

Documentation Required

Follow evidence of coverage, contract, and Health Plan administrative rules

Providers must comply with all applicable coverage documents and Health Plan administrative policies when submitting claims or seeking authorization for DLI; the policy itself does not guarantee payment and coverage decisions are subject to the terms and exclusions of the member’s contract.

Follow the member's evidence of coverage, certificate of coverage, policy, and contract provisions.
Adhere to Health Plan-level administrative rules and any applicable state/federal requirements.

Denial Risk

Do not seek coverage for unsupported indications (e.g., graft manipulation)

Do not request authorization or submit claims for DLI when the indication is outside the policy's supported uses (e.g., genetic modification or ex vivo manipulation of donor lymphocytes); such uses are not supported and may be denied.

Unsupported examples include graft manipulation techniques for enhancement of GvT or reduction of GvHD outside a clinical trial.
Only the policy-listed indications (post‑HSCT relapse/refractory disease or to decrease relapse risk) are supported.

Denial Risk

Do not proceed with DLI if grade ≥2 acute GvHD is present

Presence of grade 2 or higher acute graft‑versus‑host disease at the time of request is a contraindication to DLI and may lead to denial of coverage.

Assess and document GvHD grade; if grade ≥2 acute GvHD is present, DLI is not supported per policy.

Denial Risk

Coverage subject to contract terms, exclusions, and limitations

Coverage decisions and administration of benefits for DLI are subject to all terms, conditions, exclusions and limitations in the member’s coverage documents and applicable plan-level administrative policies; these contractual terms may affect authorization and payment.

Verify contract exclusions, limitations, and member-specific coverage before providing DLI.
Policy language assists medical necessity determinations but does not override contract or plan exclusions.

Note

Check state Medicaid provisions (Medicaid precedence may alter coverage)

For Medicaid members/enrollees, state Medicaid coverage provisions take precedence over this clinical policy; providers must follow state Medicaid manual provisions where conflicts exist and confirm applicable state rules when requesting authorization.

Consult the state Medicaid manual for coverage provisions specific to DLI prior to authorization or claim submission for Medicaid members.

Relation to DLIConversion to full chimerism after DLI has been associated with disease response in some patients.

inv-21: Donor Lymphocyte Infusion (DLI) — definition of the therapy

Therapy descriptionDonor Lymphocyte Infusion (DLI): an adoptive cellular therapy in which T lymphocytes (donor leukocytes/lymphocytes) from the original HSCT donor are infused post‑allogeneic HSCT to induce graft‑versus‑tumor effects and convert or augment donor chimerism.

Indications notedUsed therapeutically for proven relapse of hematologic malignancy or preemptively in patients at high relapse risk (e.g., mixed chimerism or MRD positive).

RisksAssociated risks include graft‑versus‑host disease (high rates reported) and, less commonly, bone marrow aplasia.

Evidence/examplesConversions to full donor chimerism after DLI have been reported with clinical responses (e.g., multiple myeloma case series).