Stem cell transplantation is a process in which hematopoietic stem cells are harvested from the bone marrow or peripheral blood of a patient (autologous) or a donor (allogeneic) and then administered by intravenous infusion. Hematopoietic stem cells are multi-potent stem cells that give rise to all the blood cell types; these stem cells form blood and immune cells. Autologous stem cell transplants are used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy and/or radiotherapy used to treat various malignancies. Allogeneic stem cell transplants may be used to restore function in recipients having an inherited or acquired deficiency or defect.
The NCD (110.8.1) for Stem Cell Transplantation provides covered and non-covered clinical indications.
The requestor is formally asking CMS for reconsideration and expansion of the current NCD.
This NCA will only evaluate the available evidence to determine whether a national coverage determination is warranted for
- allogeneic stem cell transplantation in patients with sickle cell disease,
- allogeneic stem cell transplantation in patients with myelofibrosis, and
- allogeneic stem cell transplantation in patients with multiple myeloma.
CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.
CMS is reorganizing the National Coverage Determination manual for section 110.8.1. This reorganization is an administrative change only to make it easier for the public to read and understand the NCD manual.