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DESCRIPTIONHematopoietic Stem-Cell Transplantation
Hematopoietic stem-cell transplantation (HSCT) refers to a procedure in which hematopoietic stem cells are infused to restore bone marrow function in cancer patients who receive bone marrow toxic doses of cytotoxic drugs with or without whole body radiotherapy. Bone marrow stem cells may be obtained from the transplant recipient (autologous HSCT) or from a donor (allogeneic HSCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood and placenta shortly after delivery of neonates. Although cord blood is an allogeneic source, the stem cells in it are antigenically “naïve” and thus are associated with a lower incidence of rejection or graft-versus-host disease. Cord blood is discussed in greater detail in the Placental and Umbilical Cord Blood as a Source of Stem Cells policy.
HSCT is an established treatment for certain hematologic malignancies; however, its use in solid tumors in adults continues to be largely experimental. Initial enthusiasm for the use of autologous transplantation with the use of high-dose chemotherapy for solid tumors has waned with the realization that dose intensification often fails to improve survival, even in tumors with a linear-dose response to chemotherapy. With the advent of reduced-intensity conditioning (RIC) allogeneic transplant, interest has shifted to exploring the generation of alloreactivity to metastatic solid tumors via a graft-versus-tumor effect of donor-derived T cells.
Epithelial Ovarian Cancer
Several different types of malignancies can arise in the ovary; epithelial carcinoma is the most common. Epithelial ovarian cancer is the fifth most common cause of cancer death in women. New cases and deaths from ovarian cancer in the United States in 2014 are estimated at 21,980 and 14,270, respectively. Most ovarian cancer patients present with widespread disease, and yearly mortality is approximately 65% of the incidence rate.
The current management of advanced epithelial ovarian cancer is cytoreductive surgery followed by combination chemotherapy. Approximately 75% of patients present with International Federation of Gynecology and Obstetrics stage III or IV ovarian cancer, and treated with the combination of paclitaxel and a platinum analog being the preferred regimen for newly diagnosed advanced disease. The use of platinum and taxanes has improved progression-free survival (PFS) and overall survival (OS) rates in advanced disease to 16–21 months and 32–57 months, respectively. However, most of these women develop recurrences and die of their disease, as chemotherapy drug resistance leads to uncontrolled cancer growth.
High-dose chemotherapy has been investigated as a way to overcome drug resistance. However, limited data exist on this treatment approach, and the ideal patient population and best treatment regimen remain to be established. Hematopoietic stem-cell transplantation has been studied in a variety of patient groups with ovarian cancer as follows:
HDC with stem-cell support is a procedure and, therefore, is not subject to U.S. Food and Drug Administration (FDA) regulations. However, cytotoxic drugs used in HDC do require, and generally have received, FDA approval. HDC is an off-label use of approved drugs.
See Hematopoietic Stem-Cell Tranplantation in the Treatment of Germ-Cell Tumors medical policy for germ cell tumors of the ovary.
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.
Autologous or allogeneic hematopoietic stem-cell transplantation is considered investigational to treat epithelial ovarian cancer.
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.
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 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 # 8.01.23 per approval by Medical Policy Advisory Committee (MPAC)
7/14/2004: Code Reference section completed
11/18/2004: Reviewed by MPAC, no changes
10/26/2005: Code Reference section updated; CPT-4 code 38230 added; HCPCS code G0355, G0356, G0357, G0358, G0359, G0360, G0361, G0362, G0363, G0364 added; J9000-J9999 deleted
3/14/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy
12/21/2006: Policy reviewed, no changes
12/19/2007: Coding updated per 2008 CPT/HCPCS revisions
1/06/2009: Policy reviewed. No changes.
4/26/2010: Policy title updated to remove “High-Dose Chemotherapy” and to change “Stem-Cell Support” to “Stem-Cell Transplantation.” “High-dose chemotherapy” removed from policy statement; intent unchanged. Policy description updated regarding prevalence of disease and treatment approaches. FEP verbiage added to the Policy Exceptions section. Added new CPT codes 86825 and 86826. Deleted HCPCS G0265, G0266, and G0267 from the code section as these codes were deleted on 12/31/2007. Added HCPCS S2140 and S2142 to the non-covered table.
12/28/2010: Policy reviewed; no changes.
01/17/2012: Policy reviewed; no changes.
02/20/2013: Policy reviewed; no changes.
03/10/2014: Policy reviewed; description updated. Policy statement unchanged.
12/19/2014: Policy reviewed; description updated. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association Policy # 8.01.23
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.