Monday, May 13, 2013
Based on advice being given to
the Centers for Medicare & Medicaid Services, it looks like
molecular diagnostics are about to find themselves on the horns of the same
dilemma as therapeutics - the data required for approval may not be sufficient
for reimbursement, and the data payers want may be difficult to obtain even in
the postmarket setting.
In this case, CMS could issue a
National Coverage Determination (NCD) for DNA- and RNA-based tests for cancer
of unknown primary site and use its Coverage with Evidence Development policy
to allow access only to patients enrolled in clinical trials or registries
while the companies collect outcomes data.