Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin

Jurisdiction: J15 MAC Part B. States: Kentucky, Ohio. Type: Active LCD

Background Stem cell transplantation is a process in which stem cells are harvested from either a patient’s (autologous) or donor’s (Allogeneic) bone marrow or peripheral blood for intravenous infusion. Autologous stem cell transplantation (AuSCT) is a technique for restoring stem cells using the patient's own previously stored cells. AuSCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies. Allogeneic hematopoietic stem cell transplantation (HSCT) is a procedure in which a portion of a healthy donor's stem cells or bone marrow is obtained and prepared for intravenous infusion. Allogeneic hematopoietic stem cell transplantation (HSCT) is a procedure in which a portion of a healthy donor's stem cells or bone marrow is obtained and prepared for intravenous infusion. Hematopoietic stem cells are multi-potent cells that give rise to all the blood cell types; these stem cells form blood and immune cells. A hematopoietic stem cell is a cell isolated from blood or bone marrow that can renew itself, differentiate to a variety of specialized cells, can mobilize out of the bone marrow into circulating blood, and can undergo programmed cell death, called apoptosis - a process by which cells that are unneeded or detrimental will self-destruct. The Centers for Medicare & Medicaid Services (CMS) has clarified that bone marrow and peripheral blood stem cell transplantation is a process which includes mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells and the administration of high dose chemotherapy or radiotherapy prior to the actual transplant. When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage. NCD 110.23 Stem Cell Transplantation includes for allogenic transplantation: Leukemia Aplastic Anemia Severe Combined Immunodeficiency disease (SCID) Wiskott-Aldrich Syndrome Allogeneic HSCT is covered only for Medicare beneficiaries with the following indications when participating in an approved prospective clinical study meeting specific criteria under the Coverage with Evidence Development (CED) paradigm: Myelodysplastic Syndrome Multiple myeloma only for beneficiaries with Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma Myelofibrosis (MF) only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary MF; or Sickle cell disease (SCD) only for beneficiaries with severe, symptomatic SCD who participate in an approved prospective clinical study meeting specific criteria under the CED paradigm. (Please refer to CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual , Chapter 1, Part 2, §110.23) Per the NCD, “All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion.” Allogeneic hematopoietic cell transplantation, (HCT) has been increasingly used for a variety of hematologic neoplasm and non-malignant marrow disorders. Eligibility for Allogeneic HCT varies among institutions and is usually based on a case-by-case basis dependent upon a risk-benefit assessment, and the needs and wishes of the patient. 1 Although historically allogeneic HCT was offered to patients who had exhausted all other treatment modalities, currently the decision to perform a transplant is dependent upon an assessment if the transplant will offer an outcome superior to other treatment options. 1 The CMS National Coverage Determination (NCD 110.23) for Stem Cell Transplantation describes nationally covered indications for stem cell transplant, the details of which will not be repeated within this policy. This policy describes additional locally covered indications for Allogeneic stem cell for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphoma with B-cell or T-cell origin, for whom there are no other curative intent options, and are medically necessary. Multiple other disorders are under investigation as part of clinical trials and are not covered unless the clinical trial meets the criteria of NCD 310.1 Routine Costs in Clinical Trials. This policy describes additional locally covered indications for Allogeneic stem cell for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphoma with B-cell or T-cell origin, for whom there are no other curative intent options, and are medically necessary. Coverage Indications, Limitations, and/or Medical Necessity Allogenic hematopoietic cell transplant is considered reasonable and necessary when: Patient has primary refractory or relapse of Hodgkin's or non-Hodgkin's lymphoma with B-cell or T-cell origin Pre-transplantation assessment indicates good function status, low-comorbidities and patient is candidate for transplantation based on risk assessment There are no other treatment options available with curative intent