The draft guidance is woefully lacking. There does not appear to be a well informed structure or process which properly evaluates promising technologies which can save the gov't and patients signficant health care $. One small example are artifical cervical discs which can replace spinal fusions. They are associated with significant long term health care follow up (e.g. Physical therapy, lost work productivity due to missed days of work etc. etc.). There is substantial and significant long term data on the benefit of such discs, yet, they are not covered. So, the government pays for fusions and continues to pay for the long term aftercare that resutls. This example clearly demonstrates that there is no structured of qualified personnel to evaluate such treatments. As a result, the government loses $$$ and then insurance companies follow suit and say they will not cover new promising therapies because the government does not. In turn, why would ANY company invest $ in innovation. It's a lose lose situation. Even if you set forth a guidance, it is meaningless until you get a structure in place with qualified personnel that understand drugs, devices and clinical health care. You could be saving hundreds of millions of dollars (perhaps more) if you knew how to evaluate patients and assure they received cost effective care. The knowledge is out there you just aren't using it. Oncology is riddled with examples of places where you could be saving big $$$ and helping patient.