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

Jurisdiction: JE Part B. States: California, Hawaii, Nevada, American Samoa, Guam, Northern Mariana Islands. Type: Active LCD

Per NCD 110.12 Stem cell transplantation is a process in which s tem cells are harvested from a patient’s (autologous) or donor’s (allogeneic) bone marrow or peripheral blood for intravenous infusion to replace diseased and malignant processes which have undergone therapeutic treatment and ablation. Autologous S tem Cell Transplantation (AuSCT) is a technique for restoring stem cell s using the patient's own previously stored cells. Allogeneic hematopoietic stem cell transplantation (Allo-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 to accomplish the hematopoietic restoration for those individual unable to utilize their own cells. AuSCT must be used to affect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies and disease. The Centers for Medicare & Medicaid Services (CMS) has clarified per NCD 110.23 "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 associated with 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 and reimbursement per Medicare allowed fee schedule. When bone marrow or peripheral blood stem cell transplantation is non-covered, none of the steps are covered.” NCD 110.23 Stem Cell Transplantation includes coverage for allogeneic transplantation when meeting requirement criteria outlined within the Coverage Determination. Please refer to NCD 110.23 for those provisions. Leukemia, leukemia in remission 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. For details pertaining to coverage criteria please refer to NCD 110.23. Myelodysplastic Syndrome Multiple myeloma limited to beneficiaries with Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma Myelofibrosis (MF) limited to beneficiaries with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary MF; or Sickle cell disease (SCD) limited to 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 Manual (NCD) , Chapter 1, Part 2, §110.23) Per the NCD, “Coverage of all other indications for stem cell transplantation not otherwise specified above as covered or non-covered will be made by local Medicare Administrative Contractors under sections 1862(a)(1)(A)." It is the intention of this Local Coverage Determination to formally notify Medicare enrolled providers of Noridian Medicare’s coverage and allowance for reimbursement of services related to Allogeneic Stem Cell Transplantation in compliance with NCD 110.23. Covered indications for allogeneic stem cell transplant of hemopoietic cells extracted from healthy donor matched peripheral blood and/or bone marrow for infusion as treatment of primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphoma, B-cell or T-cell origin, is limited to Medicare beneficiaries for whom the primary disease is refractory to standard-of-care treatment or for those whose disease has relapsed and are without alternative potentially curative options. Documentation to support medical necessity as well as the appropriateness of the choice of therapy must be retained in the patient’s chart and made available to Medicare on request. It must include all elements mandated by NCD 110.23 for Stem Cell Transplantation as well as in-depth patient history and physical exam, the nature and severity of the disease process, previous therapeutic interventions, disease course and response to therapy, rationale for choice of therapy, and evidence of patient (and family) education of risk and benefit inherent to the intervention. Risk assessment as well as documentation of concomitant disease and psychosocial factors affecting outcome are suggested as components of the in-depth patient assessment.