August 2010

New or updated investigational or medical necessity policy criteria

Surgery

Hematopoietic Stem Cell Transplantation (#45)

Hematopoietic stem cell transplant (HSCT) policies were previously addressed in three separate policies based on transplant type (autologous, allogeneic, tandem). The policies have been reorganized into separate policies by indication, (e.g., multiple myeloma, breast cancer, etc.). New policy TRA-45 is an "index" that provides links to each individual policy.  There were no changes to the criteria in the new separate policies unless identified in this notification.

Hematopoietic Stem-Cell Transplantation for Acute Lymphoblastic Leukemia (#45.36)

Policy criteria expanded: Allogeneic HSCT may be considered medically necessary to treat adult acute lymphocytic leukemia (ALL) in first remission for ANY risk level (criterion III A 1). Previously, this treatment was medically necessary only for HIGH risk patients.

Hematopoietic Stem-Cell Transplantation for CNS Embryonal Tumors and Ependymoma (#45.33)

Criteria clarified for autologous HSCT: May be considered medically necessary as consolidation therapy for previously untreated Central Nervous System (CNS) embryonal tumors.

Hematopoietic Stem-Cell Transplantation in the Treatment of Germ-Cell Tumors (#45.38)

Tandem HSCT
New criteria added: Tandem autologous HSCT may now be considered medically necessary for the treatment of testicular tumors either as salvage therapy or with platinum-refractory disease. Tandem autologous HSCT remains investigational to treat other germ-cell tumors of any stage.

Autologous HSCT
Medical necessity criteria clarified for single autologous hematopoietic stem-cell transplantation which may be considered medically necessary as salvage therapy for germ-cell tumors.

Hematopoietic Stem-Cell Transplantation for Multiple Myeloma (#45.22)

Criteria expanded to consider a single initial or second (salvage) autologous hematopoietic stem-cell transplant medically necessary to treat multiple myeloma.

Hematopoietic Stem-Cell Transplantation in the Treatment of Solid Tumors of Childhood (#45.37)

Autologous HSCT for initial treatment of high-risk Ewing's sarcoma changed from investigational to medically necessary. Added clarification of "high-risk" for Ewing's sarcoma and peripheral neuroblastoma. Clarified medical necessity criteria for autologous HSCT for neuroblastoma.

Placental and Umbilical Cord Blood as a Source of Stem Cells (#45.16)

New, separate policy developed for cord blood stem cell transplant, storage and collection. Policy criteria remains the same: Prophylactic collection and storage for an unspecified future use are considered not medically necessary.

Surgery

Percutaneous Vertebroplasty and Kyphoplasty (#107)

Saturation Biopsy for Diagnosis and Staging of Prostate Cancer (#170)

New investigational policy.

Transplant

Allogeneic Hematopoietic Stem-Cell Transplantation for Genetic Disease and Acquired Anemias (#45.25)

Criteria change: Allogeneic hematopoietic stem cell transplantation (HSCT) is considered medically necessary for the treatment of lysosomal and peroxisomal storage disorders, except Hunter, Sanfilippo and Morquio syndromes. The evidence published to date indicates HSCT fails to alter the disease course favorably or significantly for these indications and the adverse risks of the procedure outweigh the benefits.

Hematopoietic Stem-Cell Transplantation for Breast Cancer (#45.29)

Criteria change from investigational to not medically necessary for autologous and tandem autologous transplants as treatments of breast cancer. This change is based on an accumulation of data, including a meta-analysis involving 15 trials and 6,102 patients that demonstrated no overall survival benefit for autologous hematopoietic stem cell transplant compared to conventional chemotherapy regimens.

Hematopoietic Stem-Cell Transplantation for Multiple Myeloma (#45.22)

More specific criteria added for tandem transplants: Tandem autologous-autologous HSCT may be considered medically necessary to treat multiple myeloma in patients who fail to achieve at least a near-complete or very good partial response after the first transplant.