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Donor lymphocyte infusion (DLI), also called donor leukocyte or buffy-coat infusion, is a type of therapy in which T lymphocytes from the blood of a donor are given to a patient who has already received a hematopoietic stem cell transplant (HSCT) from the same donor. The DLI therapeutic effect results from a graft-versus-leukemic or graft-versus-tumor effect due to the recognition of certain antigens on the cancer cells by the donor lymphocytes and the resultant elimination of the tumor cells.
Approximately 40-60% of patients who receive a DLI develop graft-versus-host disease (GVHD), and the development of GVHD predicts a response to the DLI. A Blue Cross and Blue Shield Technology Evaluation Assessment on this subject was published in 1997. Treatment-related mortality after DLI is 5-20%. There does not seem to be a correlation between the type of hematologic malignancy for which the DLI was given and the development of GVHD. The risk of development of GVHD is related, in part, to DLI dose and therapy prior to DLI.
The timing of the use of DLI depends upon the disease indication and may be used in the setting of relapse after an allogeneic HSCT, as a planned strategy to prevent disease relapse in the setting of T cell depleted grafts or non-myeloablative conditioning regimens, or as a method to convert mixed to full donor chimerism. Management of relapse, which occurs in approximately 40% of all hematologic malignancy patients, is the most common indication for DLI.
The literature is heterogeneous for reporting methods of cell collection, timing of infusion (e.g., after chemotherapy, in early relapse), cell dose infused and cell subtype used. In addition, many studies include multiple diseases with little information regarding disease-specific outcomes; however, DLI is used in nearly all hematologic malignancies for which allogeneic HSCT is performed, including chronic myeloid leukemia, acute myeloid and lymphoblastic leukemias, myelodysplastic syndromes, multiple myeloma and Hodgkin’s (HL) and non-Hodgkin’s lymphoma (NHL).
POLICYNo benefits will be provided for a covered transplant procedure or a transplant evaluation unless the Member receives prior authorization through case management from Blue Cross & Blue Shield of Mississippi.
Donor lymphocyte infusion may be considered medically necessary following allogeneic-hematopoietic stem cell transplantation (HSCT) that was originally considered medically necessary for the treatment of a hematologic malignancy that has relapsed or is refractory, to prevent relapse in the setting of a high risk of relapse (see Policy Guidelines), or to convert a patient from mixed to full donor chimerism.
Donor lymphocyte infusion is considered investigational following allogeneic-hematopoietic stem cell transplantation (HSCT) that was originally considered investigational for the treatment of a hematologic malignancy.
Donor lymphocyte infusion is considered investigational as a treatment of nonhematologic malignancies following a prior allogeneic HSCT.
Genetic modification of donor leukocytes is considered investigational.
POLICY GUIDELINESSettings considered high risk for relapse include T cell depleted grafts or nonmyeloablative (reduced-intensity conditioning) allogeneic HSCT.
In patients undergoing allogeneic stem-cell transplant for chronic myelogenous leukemia or acute myelogenous leukemia, donor leukocytes may be collected and stored at the time of the original collection of stem-cells from the donor.
Charges for the leukapheresis procedure for the donor should be considered as recipient expenses and the claims administered accordingly.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY8/1998: Approved by Medical Policy Advisory Committee (MPAC)
2/14/2002: Investigational definition added
4/26/2002: Type of Service and Place of Service deleted
3/25/2004: Policy reviewed and revised to be consistent with BCBSA policy # 2.03.03, policy title “Donor Leukocyte Infusion” renamed “Donor Leukocyte Infusion for Hematologic Malignancies that Relapse after Allogeneic Stem-Cell Transplant,” Sources updated
9/2/2004: Code Reference section updated, CPT code 36511, 86812, 86813, 86817 added, CPT 36520 deletion date added, ICD-9 diagnosis code 205.10-205.11, V59.09 deleted
1/10/2005: Code Reference section updated, CPT code 36511, 36520 deleted, CPT code 38242 added, ICD-9 procedure code 99.72 deleted
08/11/2011: Policy title changed from "Donor Leukocyte Infusion for Hematologic Malignancies that Relapse after Allogeneic Stem-Cell Transplant" to “Donor Lymphocyte Infusion for Malignancies Treated with an Allogeneic Hematopoietic Stem-Cell Transplant.” Policy description re-written. Policy statement revised to indicate that donor lymphocyte infusion would be considered medically necessary following an allogeneic-hematopoietic stem cell transplantation (HSCT) that was considered medically necessary for the treatment of a hematologic malignancy that has relapsed or is refractory, to prevent relapse in the setting of a high risk of relapse, or to convert a patient from mixed to full donor chimerism. Deleted outdated references from Sources section.
06/06/2012: Policy reviewed; no changes.
08/09/2013: Policy reviewed; no changes.
07/10/2014: Policy reviewed; no changes.
08/25/2015: Code Reference section updated to add ICD-10 codes. Updated the code description for 38242.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.03.03
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.