Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome

CMS has determined that the evidence does not demonstrate that the use of allogeneic hematopoietic stem cell transplantation (HSCT) improves health outcomes in Medicare beneficiaries with myelodysplastic syndrome (MDS). Therefore, we determine that allogeneic HSCT for MDS is not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act (the Act). However, we believe the available evidence shows that allogeneic HSCT for MDS is reasonable and necessary under §1862(a)(1)(E) of the Act through Coverage with Evidence Development (CED). Therefore, we are making the following decision. Allogeneic HSCT for MDS is covered by Medicare only for beneficiaries with MDS participating in an approved clinical study that meets the criteria specified in the decision memorandum (DM). A clinical study seeking Medicare payment for allogeneic hematopoietic stem cell transplantation for myelodysplastic syndrome pursuant to Coverage with Evidence Development (CED) must address one or more aspects of the questions stated in the DM. The criteria that CMS will used to evaluate study protocols submitted by investigators is in an appendix to the DM.

The DM and CMS approved clinical study may be accessed through the urls below.