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Printer Friendly Version High-Dose Chemotherapy with Hematopoietic Stem Cell Support for Malignancies

High-Dose Chemotherapy with Hematopoietic Stem Cell Support for Malignancies

DESCRIPTION

High-Dose Chemotherapy (HDC) involves the administration of cytotoxic agents using doses several times greater than the standard therapeutic dose. In some cases, whole body or localized radiotherapy is also given and is included in the term HDC when applicable. The most significant side effect is marrow ablation and thus HDC is accompanied by a reinfusion of stem cells in order to repopulate the bone marrow.

The 3 potential donors of stem cells are:

Autologous bone marrow cells: bone marrow cells, including stem cells, can be harvested from the patient's own bone marrow prior to the cytotoxic therapy. Peripheral autologous stem cells: Small numbers of stem cells circulate in the peripheral blood and can be harvested via a pheresis procedure. A prior course of chemotherapy or hematopoietic growth factors, or both can increase the number of circulating stem cells. Peripheral stem cells are now the most common source of stem cells used.
Syngeneic stem cells refer to stem cells harvested from an identical twin. The use of syngeneic stem cells is obviously limited by the rarity of identical twins.
Allogeneic stem cell support provides two theoretical advantages; the lack of tumor contamination associated with the use of autologous stem cells, and the possibility of a beneficial graft vs. tumor effect. Blood harvested from the umbilical cord and placenta shortly after delivery of neonates contains stem and progenitor cells. Although cord blood is an allogeneic source, these stem cells are antigenically "naïve" and thus are associated with a lower incidence of rejection or graft vs. host disease.

POLICY

No 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.

High-Dose Chemotherapy with Hematopoietic Stem Cell for Malignancies is considered medically necessary for patients meeting the following:

Acute lymphocytic or myelogenous leukemia (also referred to as acute non-lymphocytic leukemia) – After dates of service 3-24-2004, see Hematopoietic Stem-Cell Support for Acute Lymphocytic Leukemia, Hematopoietic Stem-Cell Support for Acute Myelogenous Leukemia

Allo-BMT or allo-PBSC are considered medically necessary to treat patients in first or subsequent remission, who are at high risk for relapse. Factors associated with high risk of relapse are:
age greater than 15 years;
leukemia count greater than 10 x 109/L;
extramedullary disease (especially central nervous system);
leukemia blasts with chromosomal translocation; and
failure to achieve a complete remission within 6 weeks of the start of induction therapy.
HDC/AuSCS (High Dose Chemotherapy with Autologous Stem Cell Support) is considered medically necessary to treat patients in remission. Factors associated with high risk of relapse are described in the previous paragraph.

Chronic myelogenous leukemia (CML) – After dates of service 3-24-2004, Hematopoietic Stem-Cell Support for Chronic Myelogenous Leukemia

Allo-BMT or allo-PBSC are considered medically necessary to treat patients with CML in either chronic or accelerated phases or blast crisis.
HDC/AuSCS is considered investigational to treat patients with CML in either chronic or accelerated phases or blast crisis.

Hodgkin's disease (lymphoma) – After dates of service 3-24-2004, seeHematopoietic Stem-Cell Support for Hodgkin Lymphoma
Neuroblastoma – After dates of service 3-24-2004, see High-Dose Chemotherapy with Autologous Stem-Cell Support for Primitive Neuroectodermal Tumors (PNET) of the CNS and Ependymoma

HDC/AuSCS and allo-BMT are considered medically necessary to treat patients with stage III or stage IV disease.

Other high-risk solid tumors of childhood – After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Solid Tumors of Childhood

HDC/AuSCS is considered medically necessary to treat children who are too high risk for progression or relapse of disseminated medulloblastoma, peripheral neuroectodermal tumors of stages III or IV, or disseminated Ewing's sarcoma. It is considered investigational for other solid tumors of childhood, including but not limited to, Wilm's tumor, osteosarcoma, retinoblastoma, rhabdomyosarcoma, and hepatoblastoma.

Germ cell tumors (e.g., testicular, mediastinal, retroperitoneal, ovarian) – After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support as a Treatment of Germ-Cell Tumors

HDC/AuSCS is considered medically necessary to treat patients with refractory germ cell tumors. Patients with refractory tumors are defined as either:
patients with advanced disease who fail to achieve a complete response to second-line standard-dose platinum chemotherapy; or
patients with minimal or moderate extent disease who fail to achieve a complete response to third-line standard-dose platinum chemotherapy.
It should be noted that ovarian germ cell tumors must be distinguished from the far more common epithelial ovarian cancers. High-dose therapy for ovarian epithelial cancer is considered investigational. – After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Epithelial Ovarian Cancer

Breast cancer – After dates of service 3-24-2004, see High-Dose Chemotherapy with Hematopoietic Stem-Cell Support for Breast Cancer

HDC/AuSCS treatment in patients with breast cancer is considered on a case-by-case basis.

Multiple myeloma

HDC/AuSCS is considered medically necessary to treat patients with multiple myeloma that has been newly diagnosed or is responsive to chemotherapy. It is considered investigational to treat patients with refractory myeloma. Allo-BMT and Allo-PBSC are considered medically necessary to treat any patients with multiple myeloma (i.e., newly diagnosed, responsive, or refractory disease) (added 5/2000). (revised 11-18-2004)

See Single or Tandem Courses of High-Dose Chemotherapy plus Hematopoietic Stem-Cell Support to Treat Multiple Myeloma medical policy after dates of service 1-26-2004 (added 1-27-2004)

Evaluations of HDC with hematopoietic stem-cell support concluded that the TEC criteria were not met for the following cancers. Therefore, HDC/SCS is considered investigational for the following:

Chronic lymphocytic leukemia/small lymphocytic lymphoma - After dates of service 3-24-2004, see High-Dose Chemotherapy with Hematopoietic Stem-Cell Support for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Primary intrinsic tumors of the brain in adults
Epithelial ovarian cancer - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Epithelial Ovarian Cancer
Lung cancer, small cell or non-small-cell - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults Malignant melanoma - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults Tumors of the gastrointestinal tract, including those of the colon, rectum, pancreas, stomach, esophagus, gallbladder, and bile duct - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults
Tumors of the genitourinary system, including testicular cancer, other than germ cell, renal cell carcinoma, and tumors of the cervix, uterus, fallopian tubes, and prostate gland - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults
Tumors of the head and neck, including nasopharyngeal tumors, paranasal sinus neuroendocrine tumors, and tumors of unspecified histology - After dates of service 3-24-2004, seeHigh-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults
Soft tissue sarcomas - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults
Thyroid tumors - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults
Acquired Immunodeficiency Syndrome and Human Immunodeficiency Virus Infection
Tumors of the thymus - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults
Undifferentiated tumors
Tumors of unknown primary origin - After dates of service 3-24-2004, see High-Dose Chemotherapy and Hematopoietic Stem-Cell Support for Miscellaneous Solid Tumors in Adults Autoimmune diseases, including, but not limited to rheumatoid arthritis, systemic lupus erythematosus (SLE) and systemic sclerosis (i.e., scleroderma) – After dates of service 3-24-2004, see High-Dose Chemotherapy and Autologous Stem-Cell Support for Autoimmune Diseases, Including Multiple Scleroses

See Placental and Umbilical Cord Blood as a Source of Stem Cells policy.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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 HISTORY

8/1998: Approved by Medical Policy Advisory Committee (MPAC)

2/2000: Revised; indications for autoimmune diseases, including multiple sclerosis considered investigational

2/17/2000: Note update of DESCRIPTION and POLICY revisions

5/2000: Application for High-Dose Chemotherapy and Radiation Therapy followed by Allogeneic Transplantation for multiple myeloma reviewed by MPAC; investigational status maintained

6/1/2000: Note POLICY HISTORY update

11/2000: MPAC reviewed HDC/AuSCS treatment in patients with breast cancer; case-by-case review

2/14/2001: ICD-9 procedure code 41.07-41.09 added

2/7/2002: "Its use is promising, the data remains inconclusive and umbilical cord blood is considered investigational as a source of stem cells." has been deleted

4/10/2002: Investigative definition added

5/1/2002: Type of Service and Place of Service deleted

3/18/2003: Code Reference section updated, code ranges 86812-86822, 96400-96450, Q0083-Q0085, J9000-J9999 listed separately

1/27/2004: Hyperlink added for separate policy "Single or Tandem Courses of High-Dose Chemotherapy plus Hematopoietic Stem-Cell Support to Treat Multiple Myeloma"

3/25/2004: Reviewed by MPAC, approval to develop separate medical policy and aligned with BCBSA policy # 8.01.32, 8.01.26, 8.01.30, 8.01.29, 8.01.20, 8.01.28, 8.01.34, 8.01.35, 8.01.23, 8.01.27, 8.01.15, 8.01.24, 8.01.25, 8.01.21, 8.01.31, hyperlinks inserted for appropriate medical policies, Sources updated

7/14/2004: Code Reference section updated, CPT 38230, 38231, 86915 deleted, CPT 38220, 38221, 96520, 96530 added, CPT 38208, 38209 description revised to be consistent with AMA, ICD-9 procedure code 41.01, 41.02, 41.03, 41.06, 41.09 deleted, ICD-9 procedure code 99.25 description revised, HCPCS J9180 deleted code 2004, HCPCS G0265, G0266, J9098, J9178, J9263, J9395, S2150 added

11/18/2004: Reviewed by MPAC, “HDC/AuSCS (High Dose Chemotherapy with Autologous Stem Cell Support) is considered medically necessary to treat adult patients in first remission only, or in pediatric patients in first or subsequent remission, who are high risk for relapse and who do not have an acceptable allogeneic donor available.” changed to “HDC/AuSCS (High Dose Chemotherapy with Autologous Stem Cell Support) is considered medically necessary to treat patients in remission,” “Hodgkin's disease (lymphoma): HDC/AuSCS, allo-BMT, and allo-PBSC are considered medically necessary when used to treat patients with stage III or stage IV of the following International Working Formulation (IWF) classes: including the table AND For IWF classes B-D, HDC/AuSCS and allo-BMT are considered medically necessary only for those patients who have failed primary therapy and have not transformed to a higher grade. These therapies are considered investigational for patients in a first complete remission or for those who have relapsed NHL with transformation.” deleted, “Multiple myeloma: Allo-BMT and Allo-PBSC are considered investigational to treat any patients with multiple myeloma (i.e., newly diagnosed, responsive, or refractory disease) (added 5/2000).” changed to medically necessary

7/15/2005: Code Reference section updated, CPT code 38230 added, HCPCS G0355, G0356, G0357, G0358, G0359, G0360, G0361, G0362, G0363, G0364 added, HCPCS J9000-J9999 statement added to HCPCS and all separately listed codes deleted

10/26/2005: Code Reference section updated; ICD-9 procedure codes 41.01, 41.02, 41.03, 41.09 added

3/21/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.

12/20/2007: Coding updated per 2008 CPT/HCPCS revisions

9/17/2008: Annual ICD-9 updates effective 10-1-2008 applied

SOURCE(S)

A search of the literature was completed through the MEDLINE database for the period of January 1992 through February 1998. The search strategy focused on references containing the following Medical Subject Headings:

Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation (linked with neoplasms or cancer)

Research was limited to English-language journals on humans.

TEC Assessment, 1998, 1997, 1990, 1989, 1986

Hayes Medical Technology Directory

Blue Cross Blue Shield Association policy # 8.01.32, 8.01.26, 8.01.30, 8.01.29, 8.01.20, 8.01.28, 8.01.34, 8.01.35, 8.01.23, 8.01.27, 8.01.15, 8.01.24, 8.01.25, 8.01.21, 8.01.31 (added 3-25-2004)

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some codes may be variable and coverage will be based on the clinical indication for the service.

Covered Codes

Code Number	Description
CPT-4
38204	Management of recipient hematopoietic progenitor cell donor search and cell acquisition (added 3-18-2003)
38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection allogenic (added 3-18-2003)
38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous (added 3-18-2003)
38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215	Transplant preparation of hematopoietic progenitor cells code range (added 3-18-2003)
38220	Bone marrow; aspiration only (added 7-14-2004)
38221	Bone marrow; biopsy, needle or trocar (added 7-14-2004)
38230	Bone marrow harvesting for transplantation (added 7-15-2005)
38240	Bone marrow or blood-derived peripheral stem cell transplantation; allogeneic
38241	Bone marrow or blood-derived peripheral stem cell transplantation; autologous
38242	Bone marrow or blood-derived peripheral stem cell transplantation; allogeneic donor lymphocyte infusions (added 3-18-2003)
86812, 86813, 86816, 86817, 86821, 86822	HLA typing code range
96400	Chemotherapy administration, subcutaneous or intramuscular, with or without local anesthesia (deleted 12-31-2005)
96401	Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic (new 1-1-2006)
96402	Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-neoplastic (new 1-1-2006)
96405	Chemotherapy administration; intralesional, up to and including 7 lesions (revised 1-1-2006)
96406	Chemotherapy administration; intralesional, more than 7 lesions (revised 1-1-2006)
96408	Chemotherapy administration, intravenous; push technique (deleted 12-31-2005)
96409	Chemotherapy administration; intravenous, push technique, single or initial substance/drug (new 1-1-2006)
96410	Chemotherapy administration, intravenous; infusion technique, up to one hour (deleted 12-31-2005)
96411	Chemotherapy administration; intravenous, push technique, each additional substance/drug (List separately in addition to code for primary procedure) (new 1-1-2006)
96412	Chemotherapy administration, intravenous; infusion technique, one to 8 hours, each additional hour (List separately in addition to code for primary procedure) (deleted 12-31-2005)
96413	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug (new 1-1-2006)
96414	Chemotherapy administration, intravenous; infusion technique, initiation of prolonged infusion (more than 8 hours), requiring the use of a portable or implantable pump (deleted 12-31-2005)
96415	Chemotherapy administration, intravenous infusion technique; each additional hour, 1 to 8 hours, (List separately in addition to code for primary procedure) (new 1-1-2006)
96416	Chemotherapy administration, intravenous infusion technique; initiation of prolonged chemotherapy infusion (more than 8 hours), requiring use of a portable or implantable pump (new 1-1-2006)
96417	Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug), up to 1 hour (List separately in addition to code for primary procedure) (new 1-1-2006)
96420	Chemotherapy administration, intra-arterial; push technique
96422	Chemotherapy administration, intra-arterial; infusion technique, up to one hour
96423	Chemotherapy administration, intra-arterial; infusion technique, each additional hour up to 8 hours (List separately in addition to code for pirmary procedure) (revised 1-1-2006)
96425	Chemotherapy administration, intra-arterial; infusion technique, initiation of prolonged infusion (more than 8 hours), requiring the use of a portable or implantable pump
96440	Chemotherapy administration into pleural cavity, requiring and including thoracentesis
96445	Chemotherapy administration into peritoneal cavity, requiring and including peritoneocentesis
96450	Chemotherapy administration, into CNS (eg, intrathecal), requiring and including spinal puncture
96520	Refilling and maintenance of portable pump (added 7-14-2004) (deleted 12-31-2005)
96521	Refilling and maintenance of portable pump (new 1-1-2006)
96522	Refilling and maintenance of implantable pump or reservoir for drug delivery, systemic (eg, intravenous, intra-arterial) (new 1-1-2006)
96523	Irrigation of implanted venous access device for drug delivery systems (new 1-1-2006)
96530	Refilling and maintenance of implantable pump or reservoir for drug delivery, systemic (eg, intravenous, intra-arterial) (added 7-14-2004) (deleted 12-31-2005)
96545	Provision of chemotherapy agent (deleted 12-31-2005)
ICD-9 Procedure
41.01, 41.02, 41.03	Bone marrow transplant code range (added 10/26/2005)
41.04, 41.05, 41.07, 41.08	Hematopoietic stem cell transplant code range (Note: 41.07-41.09 added 2-14-2001)
41.09	Autologous bone marrow transplant with purging (added 10/26/2005)
41.91	Aspiration of bone marrow from donor for transplant
99.25	Injection or infusion of cancer chemotherapeutic substance (description revised 7-14-2004)
99.79	Other apheresis (harvest) of stem cells (description changed 10/26/2005)
ICD-9 Diagnosis
140-195	Neuroblastoma, malignant (neoplasm by site)
158.0	Malignant neoplasm of retroperitoneum
160.0	Neuroblastoma, Olfactory
164.2-164.9	Malignant neoplasm of mediastinum code range
174.0-174.8	Malignant neoplasm of female breast
175.0	Malignant neoplasm of male breast
183.0	Malignant neoplasm of ovary (Germ Cell)
186.9	Malignant neoplasm of testis
194.0	Neuroblastoma
200.00-200.88	Lymphosarcoma and reticulosarcoma code range
201.00-201.98	Hodgkin's disease code range
202.00-202.08	Nodular lymphoma code range
202.80-202.88	Non-Hodgkin's lymphoma code range
203.00-203.01	Multiple myeloma
204.01	Acute lymphoid leukemia; in remission
205.01	Acute Myeloid Leukemia; in remission
205.10	Chronic myeloid leukemia, without mention of having achieve remission (description revised 10-1-2008)
205.12	Chronic myeloid leukemia, in relapse (new 10-1-2008)
206.01	Acute Monocytic Leukemia; in remission
207.01	Acute erythremia and erythroleukemia; in remission; leukemia of unspecified cell; in remission
V10.60-V10.69	Personal history of leukemia code range
HCPCS - Note: To report antineoplastic drugs, see code range J9000-J9999 in the HCPCS Level II manual
G0265	Cryopreservation, freezing and storage of cells for therapeutic use, each cell line (added 7-14-2004) (deleted 12-31-2007)
G0266	Thawing and expansion of frozen cells for therapeutic use, each aliquot (added 7-14-2004) (deleted 12-31-2007)
G0267	Bone marrow or peripheral stem cell harvest, modification or treatment to eliminate cell type(s) (e.g. t-cells, metastatic carcinoma) (added 3-18-2003)(deleted 12-31-2007)
G0355, G0356, G0357, G0358, G0359, G0360, G0361, G0362	Chemotherapy administration code range (effective 1-1-2005) (added 7-15-2005) (deleted 12-31-2005)
G0363	Irrigation of implanted venous access device for drug delivery systems (do not report G0363 if an injection or infusion is provided on the same day) (effective 1-1-2005) (added 7-15-2005)
G0364	Bone marrow aspiration performed with bone marrow biopsy through the same incision on the same date of service (effective 1-1-2005) (added 7-15-2005)
Q0083	Chemotherapy administration by other than infusion technique only (eg, subcutaneous, intramuscular, push), per visit
Q0084	Chemotherapy administration by infusion technique only, per visit
Q0085	Chemotherapy administration by both infusion techniques and other techniques(eg, subcutaneous, intramuscular, push), per visit
S2150	Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including pheresis and cell preparation/storage; marrow ablative therapy; drugs; supplies; hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition (added 7-14-2004)

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