August 10th, 2012
Re: National Coverage Analysis (NCA) Tracking Sheet for Positron Emission Tomography (CAG-00065R2)
Dear Dear Dr. Roche and Mr. Caplan:
We provide content, analysis, and studies for the molecular imaging industry. Through our analytical approach to study the problem of PET reimbursement, we have reached to the conclusion that lifting the national non-coverage language for new FDA approved PET diagnostic radiopharmaceuticals would be an appropriate decision.
Our conclusion is based upon the following reasons:
1) CED Process and Uncertainty: Uncertainty gives rise to invoking CED. If there is no uncertainty, the decision, one way or another, is clear. PET has now become an important diagnostic modality and is widely recognized in the medical community. The robust data collection of NOPR clearly shows FDG's superior clinical accuracy and its impact on patient management. The removal of uncertainty eliminates the need for CED.
2) CED Process and Innovation: CED process can enable and spark innovation. The recent report of the Obama Administration's "National Bio-economy Footprint" clearly outlines the need for creative and value creating aspects of the CED program. Since the fundamental clinical value of PET as an imaging modality has been confirmed, it is no longer an innovation suitable for the CED process. Instead it has acquired the status of a standard diagnostic platform. CED process is an incredibly powerful tool and hence its deployment should be restricted to true novel innovations. Using this tool for innovations where no uncertainty exists would be a waste of resources as the financial and human resources needed to drive value can be deployed for true new innovations.
3) FDA Process is Appropriate: The rigorous process employed by FDA in approving new radiopharmaceuticals evaluates and determines not just the safety but also the efficacy of new agents. For innovations that have already been vetted through the CED data collection process, the rigor and discipline of the FDA process should be sufficient to establish ongoing research. As such, reliance on the FDA process demonstrates interagency trust and respect for the other agency. If such a trust factor exists, then there is no need to re-demonstrate what FDA has already vetted.
4) The "Reasonable and Necessary" scope: The reasonable and necessary criteria for the Medicaid population is an important consideration however it should be scoped as such. Since the Medicaid population can benefit most of PET (cardiology, oncology, neurology) - determining the reasonable and necessary criteria can be left to the decision-making of the local contractors - even though a national analysis framework can also be deployed.
In summary, based on the past review of FDG-PET, and now NaF-18, we strongly believe that future FDA approved imaging agents should not be non-covered by Medicare following FDA approval. In the next decade we expect to see the commercialization of a new generation of highly targeted radiopharmaceuticals. Furthermore, we believe that the improvements in the FDA approval process for new radiopharmaceuticals have led to the evolution of significant protocols and rigor to evaluate and determine the safety and efficacy of these new agents. Obviously, the final determination for CMS purposes is whether new FDA approved agents meet the "reasonable and necessary" criteria for coverage of the Medicare specific population. We believe that the most appropriate framework for the next generation of PET tracers in oncology, neurology (Dementia, Alzheimer’s disease), and cardiology would be the elimination of the overly restrictive national non-coverage language. Coverage could be reviewed through the local contractor process and when appropriate through a national coverage analysis framework.-.