2010-08-16
The Centers
for Medicare and Medicaid Services (CMS) has determined allogeneic hematopoietic stem
cell transplantation (HSCT) for Myelodysplastic Syndrome (MDS) should be
available only through participation in an approved clinical study. Provision
of Medicare services through a research program is referred to as Coverage
with Evidence Development (CED). CMS has chosen this course of action because
it determined that there was inadequate evidence to demonstrate that HSCT improves
outcomes for MDS patients. Because evidence was lacking and potentially this
treatment may benefit MDS patients, CMS chose to provide coverage through a
CED, which will allow for further data accrual and determination of whether or
not the treatment is beneficial. Clinical studies covered by this Medicare CED
must address one or more of the following questions:
- Do Medicare beneficiaries with MDS who receive HSCT have improved
outcomes?
- For Medicare beneficiaries who receive HSCT, does the
International Prognostic Scoring System predict outcomes?
- For Medicare beneficiaries who receive HSCT, what treatment
characteristics predict meaningful clinical improvement?
ASH had requested that CMS develop a national coverage decision that would ensure that
Medicare beneficiaries diagnosed with MDS have access to allogeneic HCT.
back to top
