CMS Issues Allogeneic Stem Cell Transplantation for MDS NCA

The Centers for Medicare & Medicaid Services (CMS) has initiated a national coverage analysis (NCA) for the use of allogeneic hematopoietic stem cell transplantation (HSCT) for Medicare patients with myelodysplastic syndrome (MDS).

MDS refers to a heterogeneous group of acquired bone marrow disorders characterized by dysplastic growth of hematopoietic progenitors and a hypercellular bone marrow with peripheral cytopenia. Medicare patients age 65 and older represent 80 percent of the total population receiving an MDS diagnosis. One potential therapy for MDS is allogeneic HSCT.

This analysis is in response to an NCA request letter industry stakeholders composed and sent to CMS.

Currently, allogeneic HSCT for MDS is neither a covered or non-covered indication under the national coverage determination (NCD) for Stem Cell Transplantation (110.8.1). As it is not in either of these two categories, it may be covered at local contractor discretion. National Government Services (NGS), jurisdiction 13 Part A/Part B Medicare Administrative Contractor (A/B MAC), recently developed a local coverage determination (LCD) for stem cell transplantation that includes MDS and myelofibrosis with myeloid metaplasia.

CMS is seeking public comment on this topic and says it is particularly interested in any additional recent clinical studies and other scientific information related to the outcomes of this treatment. “If the evidence is determined to be inadequate for coverage, we are especially interested in what types of studies are needed,” CMS states in the tracking sheet.

Public comment may be submitted until Dec. 10. The proposed decision memo is due out May 10, 2010 and the NCA is expected to be completed by Aug. 8, 2010.

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