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The Centers for Medicare and Medicaid Services is in the process of reconsidering its coverage determination for PET radiopharmaceuticals outside of the four it currently reimburses. Stakeholders feel it's important to simplify the process for assessing and approving new PET imaging agents for reimbursement, particularly in light of several new ones coming down the pipeline. Many of these new agents will evaluate myocardial perfusion, as well as the pathophysiology of Alzheimer's disease and Parkinson's disease.

"To go indication by indication on all these new agents we expect to hopefully be approved over the next few years will be a bit cumbersome," said Frederic Fahey, president of the Society of Nuclear Medicine and Molecular Imaging (now SNMMI, formerly SNM).



SNMMI, in conjunction with the Medical Imaging and Technology Alliance, American College of Radiology, Council on Radionuclides and Radiopharmaceuticals, and World Molecular Imaging Society, are backing this request to remove a second layer of approval outside the FDA's. Discussions have been ongoing for the past year with CMS, and a formal letter was sent to the agency at the end of March.

CMS has a national coverage determination in place denying reimbursement for PET agents outside of its approved list.

"Once you've gone through the rather rigorous FDA process including showing efficacy, you've done a pretty decent job of showing the indications that are being recommended for that agent," said Fahey.

The letter that was submitted to CMS from the five agencies goes on to say that recent advances in imaging and CMS' past experience with PET coverage no longer support a clinical rationale for a national noncoverage policy for new PET agents that have undergone FDA review and approval.

"In my mind, the old way may have been reasonable for FDG. FDG is a pretty non-specific agent. It goes a lot of different places and is used for many different things. But I think as we move forward into molecular imaging, more targeted and hopefully more specific imaging for a particular patient, the indications are probably not going to be as broad and wide," said Fahey.

CMS is accepting public comments until Aug. 10 to determine whether to cover remaining uses of PET.