CurrentWellCarePolicy MC.CP.MP.101

Donor Lymphocyte Infusion (DLI)

Customize your policy alerts

Sign up for WellCare Policy MC.CP.MP.101 alerts

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

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Medical necessity criteria and coding implications for donor lymphocyte infusion (DLI) after allogeneic hematopoietic stem cell transplantation (HSCT) for Medicare-affiliated Centene Corporation health plans; describes indications, limitations, and referenced evidence.

Policy Summary

PayerWellCare

PolicyDonor Lymphocyte Infusion (DLI)

Policy CodePolicy MC.CP.MP.101

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionVerify prior authorization requirements with the Health Plan before proceeding with donor lymphocyte infusion.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40-60%GvHD incidence after DLI

70-80%CML complete remission rate

15-20%AML remission rate

2-5%Bone marrow aplasia risk

0.01–8.8×10^8Reported effective dose range

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentWellCarePolicy MC.CP.MP.101

Donor Lymphocyte Infusion (DLI)

Customize your policy alerts

Sign up for WellCare Policy MC.CP.MP.101 alerts

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

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerWellCare

PolicyDonor Lymphocyte Infusion (DLI)

Policy CodePolicy MC.CP.MP.101

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionVerify prior authorization requirements with the Health Plan before proceeding with donor lymphocyte infusion.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40-60%GvHD incidence after DLI

70-80%CML complete remission rate

15-20%AML remission rate

2-5%Bone marrow aplasia risk

0.01–8.8×10^8Reported effective dose range

Coverage Criteria for Donor Lymphocyte Infusion (DLI)

Medically necessary indication (Medicare plans)

Covered when ALL of the following are met

Medicare DLI coverage: DLI is medically necessary following an allogeneic HSCT for treatment of relapsed or refractory hematologic malignancy OR to decrease the risk of relapse of a hematologic malignancy.

Sourced to policy statement I for Medicare health plans affiliated with Centene.

Non-medically necessary / Not supported

Not covered / unsupported indications

Unsupported indications: Use of DLI for indications other than post-HSCT to treat relapsed/refractory hematologic malignancy or to decrease relapse risk; genetic modification or ex vivo manipulation of donor lymphocytes; presence of acute GvHD greater than grade 2.

Derived from policy statement II and subitems A-B.

Genetic modification or any ex vivo manipulation of donor lymphocytes is considered investigational and not supported for routine use. The policy explicitly lists genetic modification or ex vivo manipulation of donor lymphocytes among indications for which current evidence does not support DLI (Policy II.A).

Coverage for donor lymphocyte infusion is subject to the member's individual coverage documents and all applicable state and federal requirements. Benefits, exclusions, limitations, and administrative policies in the member's evidence of coverage, certificate of coverage, policy, or contract govern coverage determinations and payment; this clinical policy does not itself constitute a contract or guarantee of payment.

Use of donor lymphocyte infusion is limited to the post-allogeneic HSCT setting for treatment of relapsed or refractory hematologic malignancy or to decrease the risk of relapse. The policy states that DLI is medically necessary only in these contexts (Policy I) and that DLI should not be used solely to increase donor chimerism in the absence of relapse risk.

Covered Regimens and Indications

Indication	Regimen / Rationale	Coverage status
Relapsed chronic myeloid leukemia (CML) after allogeneic HSCT	Donor lymphocyte infusion (DLI); multiple studies report complete remissions in 70–80% of patients and responses are durable in the majority of cases.	Covered

Indication	Regimen / Rationale	Coverage status
Relapsed acute myeloid leukemia (AML) after allogeneic HSCT	Donor lymphocyte infusion (DLI); lower remission rates (approximately 15–20%); DLI is often combined with chemotherapy to elicit an anti‑tumor effect.	Covered with criteria

Indication	Regimen / Rationale	Coverage status
Relapsed multiple myeloma after allogeneic HSCT	Donor lymphocyte infusion (DLI) may be considered to stimulate a graft‑versus‑myeloma effect; reported response rates vary (approximately 22–52%) and outcomes may be influenced by prior transplant type.	Covered with criteria

Indication	Regimen / Rationale	Coverage status
Pre‑emptive DLI for mixed chimerism or measurable residual disease (MRD) after allogeneic HSCT	Donor lymphocyte infusion (DLI) to convert mixed chimerism (<90% donor cells) to full chimerism (100% donor cells) or to address impending relapse; examples report conversion to full chimerism with clinical responses in some patients.	Covered with criteria

Coding and Dose Information

Referenced procedure codes (informational)mixed

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 post-transplant care in the global definition

Reported effective T cell dose range

Reported effective T cell dose range0.01 to 8.8 x 10^8 T cells/kg

Source study (literature review)Deol and Lum review summarized multiple articles reporting this range

Clinical contextDose range referenced as 'effective cellular range' for DLI in background section

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization: DLI covered with criteria (informational codes)

Medically necessary DLI after allogeneic HSCT for treatment of relapsed or refractory hematologic malignancy or to decrease relapse risk is covered for Medicare plans; codes are provided for informational purposes and may be subject to payer prior authorization processes.

Informational CPT/HCPCS codes referenced: 38215, 38242, 86950, S2150
Inclusion of codes does not guarantee coverage; verify payer requirements

Prior Authorization

Verify prior authorization with the Health Plan

This clinical policy is intended to guide medical necessity determinations, but applicability, effective date, and prior authorization requirements are determined by the Health Plan; providers should verify prior authorization requirements with the Health Plan.

The Health Plan determines the effective date and applicability of this clinical policy
Verify any prior authorization and submission requirements with the member's Health Plan

Line of Therapy and Indication Context

salvage

Post-HSCT salvage or pre-emptive use: DLI is used after allogeneic HSCT as salvage therapy for proven relapse or as pre-emptive/prophylactic therapy in high-risk patients (e.g., mixed chimerism or measurable residual disease).

Background and line-of-therapy statement describing salvage and pre-emptive roles.

Background and Rationale

Donor lymphocyte infusion (DLI) is an adoptive immunotherapy in which lymphocytes from the original allogeneic HSCT donor are infused into the recipient to induce a graft‑versus‑tumor effect. DLI may be used as salvage therapy for proven relapse after HSCT or pre‑emptively in high‑risk situations such as mixed chimerism or measurable residual disease, with response rates that vary by disease (for example, relatively high complete remission rates in relapsed CML and lower rates in AML/ALL). Important risks include graft‑versus‑host disease, reported in the literature at approximately 40–60%, and bone marrow aplasia (2–5%), along with infection and bleeding. Techniques that involve genetic modification or other ex vivo manipulation of donor lymphocytes remain investigational and are not supported outside of clinical trials.

Definitions and Key Terms

Mixed chimerism

DefinitionMixed chimerism is defined when less than 90% donor cells are detected after HSCT.

Clinical implicationMay indicate incipient relapse and be an indication for pre-emptive DLI in high-risk patients

MeasurementDetermined by chimerism testing (molecular or immunophenotypic methods)

Full / complete chimerism

DefinitionFull/complete chimerism is defined as 100% donor cells detected, indicating complete hematopoietic replacement.

Clinical implicationConversion from mixed to full chimerism can reflect a graft-versus-tumor response after DLI

Revision History and Policy Metadata

This clinical policy is the property of the Health Plan and is protected by copyright; unauthorized copying, use, or distribution is prohibited. The policy is intended to guide medical necessity determinations but does not replace contract language—applicability, effective date, and payment are determined by the Health Plan and the member's coverage documents. Internal identifiers and copyright information for administrative use include policy number MC.CP.MP.101 and the document ownership year noted in the policy materials.

Internal policy identifiers and ownership

Internal policy identifierPolicy MC.CP.MP.101

Related policyRead with CP.MP.101 (Donor Lymphocyte Infusion - non-Medicare criteria)

Policy Summary

PayerWellCare

PolicyDonor Lymphocyte Infusion (DLI)

Policy CodePolicy MC.CP.MP.101

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionVerify prior authorization requirements with the Health Plan before proceeding with donor lymphocyte infusion.

SourceLink

On This Page

Note

Provider action: Adhere to policy medical necessity statements

Providers should use professional judgment and follow the clinical criteria when requesting coverage; DLI is medically necessary only as specified in this policy (post-allogeneic HSCT for relapsed/refractory disease or to decrease relapse risk).

Do not request DLI for indications outside those specified in the policy without documented justification
Follow the policy's medical necessity statements when preparing authorization requests

Denial Risk

Provider alert: Unsupported indications and contraindications

Do not use DLI for indications explicitly described as unsupported (including genetic modification/ex vivo manipulation or in presence of acute GvHD > grade 2); such uses may be denied.

Do not submit authorization requests for genetic modification or ex vivo manipulated donor lymphocytes outside clinical trials
Avoid DLI in patients with acute GvHD greater than grade 2 per policy guidance

Billing Rule

Coding and documentation guidance — codes are informational

Codes listed in this policy are informational only; providers must reference the most current professional coding resources prior to claim submission because inclusion or exclusion of codes here does not guarantee coverage.

Referenced procedure codes: 38215, 38242, 86950, S2150 (informational)
Confirm current CPT/HCPCS descriptions and payer-specific billing rules before submitting claims

Documentation Required

Plan documentation requirements for coverage requests

When requesting coverage for DLI, providers must follow the member's coverage documents and applicable Health Plan administrative policies and procedures.

Include required documentation per the Health Plan's evidence of coverage, policy, contract, and administrative procedures
Comply with any Health Plan-specific prior authorization submission requirements

Denial Risk

Unsupported indications — risk of denial

Use of donor lymphocyte infusion for any indication other than post-HSCT treatment of relapsed/refractory hematologic malignancy or to decrease relapse risk is not supported by current evidence and may be denied.

Do not pursue coverage for DLI for non–post-HSCT indications without evidence of medical necessity aligned with the policy
Genetic modification or ex vivo manipulation of donor lymphocytes is investigational and unsupported

Denial Risk

Denial risk from plan terms, exclusions, and limitations

Coverage and administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements; adherence to these terms affects payment decisions.

Verify member-specific coverage terms (e.g., evidence of coverage, contract exclusions) before providing DLI
Health Plan-level administrative policies may further limit coverage or require additional documentation

Orisini report: clinical responses with complete hematopoietic conversion after DLI in multiple myeloma patients

Health Plan (definition)

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates.

Policy applicabilityThis clinical policy guides medical necessity determinations for Health Plans that adopt it

DisclaimerHealth Plan makes no representations and accepts no liability for external information used in developing the policy