CHICAGO—Recent CMS decisions related to oncologic use of FDG and amyloid imaging have already left their mark on the radiopharmaceutical industry, according to major market stakeholders at this year's Radiological Society of North America (RSNA) meeting. 

One of the major changes in the radiopharmaceutical industry was the decision by CMS to allow limited coverage of oncologic FDG in March. It may sound counter-intuitive, but the allowance has had a depressing effect on the market.

"FDG study volumes have been down 5-10 percent," remarked Peter Burke, vice president of sales and marketing for IBA Molecular at the meeting. FDG is IBA's bread and butter and the impact of changing regulatory policy has already been seen in contracted numbers of procedures and reluctance by clinicians to follow through on the leg work now required by CMS to approve the three instances of oncologic FDG-PET that are now covered nationally.

"CMS is only going to cover three doses," added Burke. "I think that has scared a lot of people. They're saying, 'I only get three bullets. I have to save them.'"

The decision also disregarded FDG coverage for neurologic and cardiac applications, which will still need to be addressed at some point.

In another area of focus, amyloid imaging has also slowed, says Burke, a trend reinforced by the September decision to allow Amyloid imaging under CED, or coverage with evidence development, which requires imaging to be in the context of mandated clinical trials.

"It used to be that amyloid imaging was done once a week, and then once a month. The CMS decision is not favorable and has led to unnecessary barriers in clinical practice." Burke believed that once dedicated clinical trials were in place, amyloid imaging would begin to see more movement.

One area of renewed promise for the industry is sodium fluoride bone imaging, which has gotten a boost from new therapeutics Xofigo and Provenge, both of which now treat advanced metastatic cancer. The addition of these treatments in turn has created demand for bone imaging, and CMS will no doubt take notice.