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Use of hematopoietic stem cell transplantation (HSCT) has been investigated for treatment of patients with epithelial ovarian cancer. Hematopoietic stem cells are infused to restore bone marrow function after cytotoxic doses of chemotherapeutic agents with or without whole body radiotherapy.
Hematopoietic 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 is 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 determinants 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 2016 are estimated at 22,280 and 14,240, respectively. Most ovarian cancer patients present with widespread disease, and yearly mortality is approximately 65% of the incidence rate.
Current management of advanced epithelial ovarian cancer is cytoreductive surgery in addition to combination chemotherapy. Approximately 75% of patients present with International Federation of Gynecology and Obstetrics stage III or IV ovarian cancer and treated with paclitaxel plus a platinum analog, the preferred regimen for newly diagnosed advanced disease. Use of platinum and taxanes has improved progression-free survival and overall survival in advanced disease to between 16–21 months and 32–57 months, respectively. However, cancer recurs in most women and they die of the disease because chemotherapy drug resistance leads to uncontrolled cancer growth.
High-dose chemotherapy has been investigated as a therapy to overcome drug resistance. However, limited data exist on this treatment approach; the ideal patient population and best treatment regimen remain to be established. Hematopoietic stem-cell transplantation has been tested in various patient groups with ovarian cancer:
The U.S. Food and Drug Administration (FDA) 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. Cytotoxic drugs used in high-dose chemotherapy (HDC) 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 and allogeneic hematopoietic stem cell transplantation are 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 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 # 8.01.23 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.
08/26/2015: Code Reference section updated to add ICD-10 codes, updated the code descriptions for 38240, 38241, and 38242; removed deleted HCPCS code G0363, and removed deleted code CPT 96445 and replaced with CPT code 96446.
03/17/2016: Policy description updated regarding estimated data for 2016 and FDA regulations. Policy statement unchanged. Investigative definition updated in policy guidelines section.
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.