On April 30, 2015, CMS opened a 30-day comment period for aNational Coverage Analysis (NCA) on Stem Cell Transplantation. Currently, CMS has a National Coverage Determination (NCD) for Stem Cell Transplantation for certain covered and non-covered clinical indications. At the request of the American Society for Blood and Marrow Transplantation (ASBMT), CMS is considering expanding coverage for stem cell transplantation for other indications, specifically in patients with sickle cell disease and myelofibrosis.
CMS defines stem cell transplantation as 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 to the patient by intravenous infusion. In its request letter, ASBMT asked CMS for reconsideration and expansion of the current stem cell transplantation NCD. Specifically, ASBMT asked for (1) explicit coverage for sickle cell disease, myelofibrosis, and lymphoma and (2) reconsideration of the negative coverage status for multiple myeloma. CMS stated in its announcement that its analysis will be limited to determining if national coverage is warranted for stem cell transplantation only in patients with sickle cell disease and patients with myelofibrosis, however. That said, we expect that some commenters may address the coverage of stem cell transplantation more broadly.
The current Stem Cell Transplantation NCD is silent on coverage for sickle cell disease and myelofibrosis. This leaves the decision of coverage to individual Medicare contractors, which can create non-uniform coverage across the country. An expanded NCD would lead to Medicare coverage for these indications by all contractors.
In determining whether to expand coverage of stem cell transplantation to patients with sickle cell disease and myelofibrosis, CMS is particularly interested in clinical studies and other scientific information relevant to stem cell transplantation for these indications. CMS must consider all submitted comments, which are publicly posted here.
The 30-day comment period will end on May 30, 2015. A proposed decision memo is expected by October 30, 2015. Once CMS issues the proposed decision memo, there will be another opportunity to comment. The final NCD is expected by January 28, 2016.