Hematopoietic Cell Transplantation

Hematopoietic cell transplantation (HCT) 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 radiation therapy. Hematopoietic stem cells may be obtained from the transplant recipient (autologous HCT) or from a donor (allogeneic HCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood 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 (GVHD).

Conventional Preparative Conditioning for HCT

The conventional (classical) practice of allogeneic HCT involves administration of cytotoxic agents (e.g., cyclophosphamide, busulfan) with or without total body irradiation at doses sufficient to destroy endogenous hematopoietic capability in the recipient. The beneficial treatment effect in this procedure is due to a combination of initial eradication of malignant cells and subsequent graft-versus-malignancy (GVM) effect mediated by non-self immunologic effector cells that develop after engraftment of allogeneic stem cells within the patient’s bone marrow space. While the slower GVM effect is considered to be the potentially curative component, it may be overwhelmed by extant disease without the use of pretransplant conditioning. However, intense conditioning regimens are limited to patients who are sufficiently fit medically to tolerate substantial adverse effects that include pre-engraftment opportunistic infections secondary to loss of endogenous bone marrow function and organ damage and failure caused by the cytotoxic drugs. Furthermore, in any allogeneic HCT, immune suppressant drugs are required to minimize graft rejection and GVHD, which also increases susceptibility of the patient to opportunistic infections.

Reduced-Intensity Conditioning for Allogeneic HCT

Reduced-intensity conditioning (RIC) refers to the pretransplant use of lower doses or less intense regimens of cytotoxic drugs or radiation than are used in traditional full-dose myeloablative conditioning treatments. The goal of RIC is to reduce disease burden, but also to minimize as much as possible associated treatment-related morbidity and nonrelapse mortality (NRM) in the period during which the beneficial GVM effect of allogeneic transplantation develops.

For the purposes of this Policy, the term reduced-intensity conditioning will refer to all conditioning regimens intended to be non-myeloablative, as opposed to fully myeloablative (traditional) regimens.

Germ-Cell Tumors

Germ-cell tumors are composed primarily of testicular neoplasms (seminomas or nonseminomatous tumors) but also include ovarian and extragonadal germ-cell tumors (e.g., retroperitoneal or mediastinal tumors). Germ-cell tumors are classified according to their histology, stage, prognosis, and response to chemotherapy.

Single autologous HCT may be considered medically necessary as salvage therapy for germ-cell tumors for ONE of the following conditions:

• Individuals with favorable prognostic factors that have failed a previous course of conventional-dose salvage chemotherapy; or
• Individuals with unfavorable prognostic factors as initial treatment of first relapse (i.e., without a course of conventional-dose salvage chemotherapy) and in patients with platinum-refractory disease.

Note: Individuals with favorable prognostic factors include those with a testis or retroperitoneal primary site, a complete response to initial chemotherapy, low levels of serum markers and low volume disease.

Note: Individuals with unfavorable prognostic factors are those with an incomplete response to initial therapy or relapsing mediastinal nonseminomatous germ-cell tumors.

Tandem or sequential autologous HCT may be considered medically necessary for the treatment of testicular tumors either as salvage therapy or with platinum-refractory disease.

Autologous HCT is considered experimental/investigational and, therefore, non-covered as a component of first-line treatment for germ-cell tumors. Peer reviewed literature indicates that autologous HCT does not improve health outcomes.

Procedure Codes

Allogeneic HCT is considered experimental/investigational and, therefore, non-covered to treat germ-cell tumors, including, but not limited to its use as therapy after prior failed autologous HCT. Available scientific evidence does not permit conclusions concerning the effect of allogeneic HCT used to treat germ-cell tumors on health outcomes.

Procedure Codes

Diagnosis Codes

Diagnosis Codes Covered for Procedure Codes 38206, 38220, 38221, 38222, 38241 and S2150

Non-covered Diagnosis Codes for Procedure Codes 38205, 38240, S2140, S2142 and S2150