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High-dose chemotherapy (HDC) with hematopoietic stem cell transplantation (HSCT) has been investigated as a possible therapy in pediatric patients with brain tumors, particularly in patients with disease that is considered high risk. In addition, the use of HSCT has allowed for a reduction in the dose of radiation needed to treat both average and high-risk disease, with preservation of quality of life and intellectual functioning, without compromising survival.
Hematopoietic Stem-Cell Transplantation
Hematopoietic Stem-Cell Transplantation for Brain Tumors
CNS Embryonal Tumors
Medulloblastomas account for 20% of all childhood CNS tumors. The other types of embryonal tumors are rare by comparison. Surgical resection is the mainstay of therapy with the goal being gross total resection with adjuvant radiotherapy, as medulloblastomas are very radiosensitive. Treatment protocols are based on risk stratification, as average or high risk. The average-risk group includes children older than 3 years, without metastatic disease, and with tumors that are totally or near totally resected (<1.5 cm² of residual disease). The high-risk group includes children aged 3 years or younger, or with metastatic disease, and/or subtotal resection (>1.5 cm2 of residual disease).
Current standard treatment regimens for average-risk medulloblastoma (postoperative craniospinal irradiation with boost to the posterior fossa followed by 12 months of chemotherapy) have resulted in 5-year overall survival (OS) rates of 80% or better. For high-risk medulloblastoma treated with conventional doses of chemotherapy and radiotherapy, the average event-free survival at 5 years ranges from 34%–40% across studies. Fewer than 55% of children with high-risk disease survive longer than 5 years. The treatment of newly diagnosed medulloblastoma continues to evolve, and in children under the age of 3, because of the concern of the deleterious effects of craniospinal radiation on the immature nervous system, therapeutic approaches have attempted to delay and sometimes avoid the use of radiation and have included trials of higher-dose chemotherapeutic regimens with autologous HSCT.
Supratentorial PNETs (sPNETs) are most commonly located in the cerebral cortex and pineal region. The prognosis for these tumors is worse than for medulloblastoma, despite identical therapies. After surgery, children are usually treated similarly to children with high-risk medulloblastoma. Three- to 5-year OS rates of 40%–50% have been reported, and for patients with disseminated disease, survival rates at 5 years range from 10%–30%.
Recurrent childhood CNS embryonal tumor is not uncommon, and depending on which type of treatment the patient initially received, autologous HSCT may be an option. For patients who receive high-dose chemotherapy and autologous HSCT for recurrent embryonal tumors, objective response is 50%–75%; however, long-term disease control is obtained in fewer than 30% of patients, and is seen primarily in patients in first relapse with localized disease at the time of relapse.
Note: Other CNS tumors include astrocytoma, oligodendroglioma, and glioblastoma multiforme. However, these tumors arise from glial cells and not neuroepithelial cells. These tumors are considered separately in the Autologous Stem-Cell Transplantation for Malignant Astrocytomas and Gliomas medical policy.
Note: Due to their neuroepithelial origin, peripheral neuroblastoma and Ewing sarcoma may be considered PNETs. However, these peripheral tumors are considered separately in the Hematopoietic Stem-Cell Transplantation for Solid Tumors of Childhood medical policy.
The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation (CFR) title 21, parts 1270 and 1271. Hematopoietic stem cells are included in these regulations.
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.
Embryonal tumors of the CNS
Autologous hematopoietic stem-cell transplantation may be considered medically necessary to treat recurrent embryonal tumors of the CNS.
Autologous hematopoietic stem-cell transplantation may be considered medically necessary as consolidation therapy for previously untreated embryonal tumors of the central nervous system (CNS) that show partial or complete response to induction chemotherapy, or stable disease after induction therapy (see Policy Guidelines).
Tandem autologous hematopoietic stem-cell transplant is investigational to treat embryonal tumors of the CNS.
Allogeneic hematopoietic stem-cell transplantation is investigational to treat embryonal tumors of the CNS.
POLICY EXCEPTIONSFor 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 from the Plan’s Utilization Review Vendor.
POLICY GUIDELINESResidual tumor is defined as a tumor that does not achieve a complete response after initial therapy. This includes partial responses (i.e., those less than complete but greater than or equal to 50% response) and refractory disease (i.e., less than a 50% response).
In general, use of autologous hematopoietic stem-cell transplantation for previously untreated medulloblastoma has shown no survival benefit for those patients considered to be at average risk (i.e., patient age older than 3 years, without metastatic disease, and with total or near total surgical resection [<1.5 cm² residual tumor]) when compared to conventional therapies.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY3/25/2004: See policy "High-Dose Chemotherapy with Hematopoietic Stem Cell Support for Malignancies" prior to 3/25/2004, separate policy developed and aligned with BCBSA policy # 8.01.28 per approval by Medical Policy Advisory Committee (MPAC)
6/25/2004: Code Reference section completed
11/18/2004: Review by MPAC, no changes
10/26/2005: Code Reference section updated, CPT codes 38230, G0355 - G0364 added to the covered table, 38204, 86812 - 86822 added to the non-covered table, J9000 - J9999 deleted, ICD9 procedure codes 41.01, 41.09 added to the covered table, 41.02, 41.03 added to the non-covered table
3/21/2006: Coding updated. CPT4/HCPCS revisions added to policy
5/21/2007: Policy reviewed, description of syngeneic and allogeneic donor types added. No change to policy statements
12/20/2007: Coding updated per 2008 CPT/HCPCS revisions
5/21/2008: Policy reviewed, no changes
04/26/2010: Title changed from “High-Dose Chemotherapy with Autologous Stem-Cell Support for Primitive Neuroectodermal Tumors (PNET) of the CNS and Ependymoma” to “Hematopoietic Stem-Cell Transplantation for CNS Embryonal Tumors and Ependymoma.” The term “PNET” was changed to “embryonal tumors” throughout the policy. Policy description updated. Policy statement changed to state that autologous consolidation therapy in patients with previously untreated embryonal tumors showing complete or partial response to, or stable disease after, induction therapy is now considered medically necessary. Supporting explanation added to the policy guidelines. Policy statement reworded and ependymoma and embryonal CNS tumors are addressed separately. FEP and State and School Employee verbiage added to the Policy Exceptions section. Added new CPT codes 86825 and 86826. Removed CPT codes 86812, 86813, 86816, 86817, 86821, and 86822 from the non-covered table. Added HCPCS S2140 and S2142 to the non-covered table. Deleted HCPCS G0265, G0266, and G0267 from the code section as these codes were deleted on 12/31/2007.
12/28/2010: Policy reviewed; no changes.
01/17/2012: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes.
03/07/2014: Policy reviewed; no changes.
12/11/2014: Policy reviewed; description updated regarding survival rates. Policy statements unchanged.
08/26/2015: Code Reference section updated to add ICD-10 codes, updated the code descriptions for 38240 and 38242; removed deleted code CPT 96445 and replaced with CPT code 96446.
03/21/2016: Policy description updated regarding FDA regulations. Policy statements unchanged.
05/25/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association Policy # 8.01.28
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.