CMS to Expand Medicare Coverage for Allogeneic HSCT for High-Risk MDS

The Centers for Medicare and Medicaid Services (CMS) has finalized its analysis on the reconsideration request for National Coverage Determination (NCD) 110.23, allogeneic hematopoietic stem cell transplantation (HSCT) for patients with certain high-risk myelodysplastic syndromes (MDS). This decision, outlined March 6 in a national coverage analysis (NCA), applies to Medicare patients categorized as intermediate-2, high-risk, or very high-risk for developing acute myeloid leukemia, as assessed by designated risk stratification systems.

The new policy replaces the coverage with evidence development (CED) policy that was in place since 2010, which only allowed allogeneic HSCT for Medicare beneficiaries with MDS who were participating in an approved clinical trial. In addition to adding risk stratification criteria, CMS will cover HSCT procedures utilizing bone marrow, peripheral blood stem cells or umbilical cord blood. Additionally, the agency will no longer require patients to participate in a Medicare-approved prospective clinical study to qualify for coverage. For patients who do not meet these criteria, Medicare administrative contractors will determine coverage.