Nonmyeloablative Allogeneic Transplants of Hematopoietic Stem-Cells for Treatment of Malignancy

POLICY NUMBER

L.8.01.406

DESCRIPTION

Transplantation of allogeneic hematopoietic stem cells derived from bone marrow or peripheral blood, in conjunction with myeloablative chemotherapy is an established therapy for various malignancies, including acute and chronic leukemias, Hodgkin's disease, and non-Hodgkin's lymphomas. The treatment effect results from chemotherapeutic ablation of the malignant cells, as well as associated immune-mediated graft versus malignancy effect. The conventional practice of allogeneic stem-cell transplants (allo-SCT) involves administration of myelotoxic agents (e.g., cyclophosphamide, busulfan) with or without total body irradiation at high enough doses to cause bone marrow failure in most patients. While such treatment may eradicate the malignant cells, patients are as likely to die from opportunistic infections, graft-versus-host disease, and organ failure as from the underlying malignancy.

Recently, regimens have been developed that seek to reduce treatment-related adverse effects while retaining beneficial (i.e., graft versus malignancy) effects. So-called nonmyeloablative regimens have been tentatively defined as those that do not eradicate the patient's hematopoietic ability, allowing for relatively prompt hematopoietic recovery (e.g., 28 days or less) without a transplant. Examples of such regimens include fludarabine-cyclophosphamide and fludarabine-idarubicin-cytarabine combinations. On engraftment, patients treated with nonmyeloablative regimens will demonstrate mixed chimerism initially. Most will subsequently convert to full-donor chimerism and may be supplemented with donor lymphocyte infusions to further eradicate malignant cells. Nonmyeloablative chemotherapy is now commonly referred to as reduced-intensity conditioning (RIC), with patients also receiving allogeneic stem-cell support. This procedure also has been called "mini-transplant."

Two general categories of patients that have been considered candidates for nonmyeloablative transplants: those who would otherwise be considered candidates for a conventional myeloablative allotransplant, and those who would not. In the former category, nonmyeloablative allotransplants could be considered as a variant of a standard chemotherapy conditioning regimen. In the latter category, nonmyeloablative transplants would be considered a novel approach, either for patients whose comorbidities preclude a standard myeloablative conditioning regimen, or in those with malignancies that have not been shown to be effectively treated with conventional myeloablative allogeneic transplants.

Note: Donor leukocyte infusions may be administered as part of the above therapy. However, donor leukocyte infusions used as a salvage regimen at relapse following a conventional myeloablative allogeneic stem cell transplant are considered separately. See policy Donor Lymphocyte Infusion for Malignancies Treated with an Allogeneic Hematopoietic Stem-Cell Transplant .

POLICY

No benefits will be provided for a covered transplant procedure or a transplant evaluation unless the Member receives prior authorizationthrough Case Management from Blue Cross & Blue Shield of Mississippi.

Nonmyeloablative allogeneic stem cell transplantation may be considered medically necessary in patients who would otherwise meet patient selection criteria for high-dose chemotherapy and allogeneic stem cell transplantation. These criteria are addressed in the following policies:

• Hematopoietic Stem-Cell Transplantation for Non-Hodgkin's Lymphomas

• Allogeneic Stem-Cell Transplantation for Myelodysplastic and Myeloproliferative Diseases

• Hematopoietic Cell Transplantation for Acute Myeloid Leukemia

• Hematopoietic Stem-Cell Transplantation for Hodgkin's Lymphoma

• Hematopoietic Stem-Cell Transplantation for Chronic Myeloid Leukemia

• Hematopoietic Cell Transplantation for Acute Lymphoblastic Leukemia

Other applications of nonmyeloablative allogeneic stem cell transplantation are considered investigational, including its use in patients who do not meet criteria for high-dose chemotherapy and allogeneic stem cell transplantation due to either age or co-morbidities, or as a treatment of other malignancies, including but not limited to, multiple myeloma, renal cell carcinoma, other solid tumors, or autoimmune disease.

POLICY EXCEPTIONS

For Federal Employee Program (FEP) Subscribers, the Service Benefit Plan includes specific conditions in which autologous or allogeneic blood or marrow stem cell transplants would be considered eligible for coverage.

For State and School Employee Subscribers, all bone marrow / stem cell transplants must be certified as medically necessary by the Plan's Utilization Review Vendor.No benefits will be provided for any transplant procedure unless prior approval for the transplant is obtained.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Nonmyeloablative stem-cell transplant is composed of a collection of donor stem cells, infusion of stem cells into the recipient, collection of donor leukocytes, and infusion of donor leukocytes. The recipient will also undergo preceding nonmyeloablative chemotherapy. The regimens have varied from center to center. (added 3-25-2004)

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/2001: Approved by Medical Policy Advisory Committee (MPAC)

2/15/2002: Investigational definition added

3/6/2002: Prior authorization through case management added

5/2/2002: Type of Service and Place of Service deleted

5/29/2002: Code Reference section completed, CPT code 38231, 38240, 86915 added, ICD-9 procedure code 41.05, 41.08 added, ICD-9 diagnosis code V42.82 added, HCPCS S2142, S2150 added

3/18/2003: Code Reference section updated

3/25/2004: Policy aligned with BCBSA policy # 8.01.38, Policy title "Nonmyeloablative Allogeneic Stem-Cell Transplantation for Treatment of Malignancy" renamed "Nonmyeloablative Allogeneic Transplant of Hematopoietic Stem Cells for Treatment of Malignancy"

8/24/2004: Code Reference section updated, ICD-9 diagnosis code V42.82 deleted

11/18/2004: Reviewed by MPAC, no changes 

7/14/2005: Code Reference section updated, CPT code 38231, 86915 deleted covered codes, CPT code 38230, 86812, 86813, 86816, 86817, 86821, 86822 added covered codes, HCPCS J9000-J9999 statement “See J-code section in the HCPCS Manual for additional chemotherapy drug codes” changed to “To report antineoplastic drugs, see code range J9000-J9999 in the HCPCS Level II manual” and all separately listed codes deleted, HCPCS G0355, G0356, G0357, G0358, G0359, G0360, G0361, G0362, G0363, G0364, S2140 added covered codes, HCPCS S2150 description revised and Note “Only allogeneic stem-cell support is covered. See Policy section.” added

3/9/2006: Coding updated.  CPT-4/HCPCS 2006 revisions added to policy

5/21/2007: Policy reviewed, no changes

12/19/2007: Coding updated per the 2008 CPT/HCPCS revisions

5/28/2010: Description section revised to include "mini-transplant." New CPT codes 86825 and 86826 added to covered table. FEP and State and School Employee verbiage was added to the Policy Exceptions section. Code Reference section was revised to add CPT codes 86825 & 86826 to the covered table. HCPCS codes G0265, G0266 and G0267 were removed from covered table due to codes were deleted as of 12-31-2007.

08/27/2015: Code Reference section updated to add ICD-10 codes, updated the code descriptions for 38240 and 38242, removed deleted HCPCS code G0363, and removed deleted code CPT 96445 and replaced with CPT code 96446.

05/26/2016: Policy number L.8.01.406 added. Policy Guidelines updated to add medically necessary and investigative definitions.

09/30/2016: Code Reference section updated to add the following new ICD-10 procedure codes: 30230Y2, 30233Y2, 30240Y2, 30243Y2, 30230Y3, 30233Y3, 30240Y3, 30243Y3, 30230Y4, 30233Y4, 30240Y4, and 30243Y4.

12/21/2017: Code Reference section updated to add new 2018 CPT code 38222. Revised descriptions for CPT codes 38220 and 38221. Removed deleted ICD-10 procedure codes 30230Y1, 30233Y1, 30240Y1, and 30243Y1.

09/27/2019: Code Reference section updated to add new ICD-10 procedure codes 30230U2, 30233U2, 30240U2, 30243U2, 30230U3, 30233U3, 30240U3, 30243U3, 30230U4, 30233U4, 30240U4, and 30243U4, effective 10/01/2019. Removed deleted CPT code 86822 and HCPCS code G0364.

12/27/2021: Code Reference section updated to make note of deleted ICD-10 procedure codes. Removed deleted ICD-10 procedure codes 30250Y1, 30253Y1, 30260Y1, and 30263Y1 and ICD-9 procedure code 41.05.

09/30/2022: Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

11/22/2022: Code Reference section updated to remove deleted ICD-10 procedure codes 30230U2, 30240U2, 30230U3, 30240U3, 30230U4, 30240U4, 30230Y2, 30240Y2, 30230Y3, 30240Y3, 30230Y4, and 30240Y4.

12/29/2022: Policy reviewed; no changes.

12/08/2023: Policy reviewed; no changes.

03/11/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 8.01.38

CODE REFERENCE

This 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.

Covered Codes

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