CMS Proposes Updated Medicare Coverage Criteria for Autologous Stem Cell Transplantation in Multiple Myeloma

The Centers for Medicare and Medicaid Services (CMS) has issued a proposed decision memo to update the national coverage determination governing autologous stem cell transplantation (AuSCT) for patients with multiple myeloma. The proposal would revise the disease-staging criteria used to determine a patient's eligibility for the procedure.

Under the proposal, Medicare would continue to cover a single AuSCT for beneficiaries with newly diagnosed or responsive multiple myeloma who meet organ function requirements. CMS proposes expanding the NCD to allow the International Staging System (ISS) and its revisions (R-ISS and R2-ISS) in a patient's risk assessment, updating criteria that currently reference the Durie-Salmon staging system.

CMS said the proposed change is based on a review of 31 studies published between 2010 and 2025, which found that ISS-based staging more accurately predicts progression-free and overall survival in AuSCT candidates than the Durie-Salmon system.

The proposal would not change Medicare's existing noncoverage policy for allogeneic hematopoietic stem cell transplantation in multiple myeloma, or other noncovered indications addressed elsewhere in the NCD.

CMS is accepting public comments on the proposed decision through Aug. 29.