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.