Barry A. Siegel, Cochair, National Oncologic PET Registry Working Group

On July 27 and July 28, 2011, the Medical Imaging & Technology Alliance (MITA) convened a workshop in Baltimore to discuss the Centers for Medicare and Medicaid Services (CMS) coverage policy for positron emission tomography (PET) and the existing exclusionary language that precludes coverage for new PET imaging agents without a time-consuming, formal national coverage determination (NCD). The meeting included stakeholders from CMS, the Agency for Healthcare Research and Quality, and industry and professional organizations.

Currently, as Barry A. Siegel, cochair of the National Oncologic PET Registry Working Group, professor of radiology, Washington University, and an attendee at the MITA workshop, explains, any new PET technology that is not explicitly covered by CMS automatically falls under the noncoverage clause. One of the reasons for this policy is because of the status of the PET industry when the first NCD was made by CMS nearly 15 years ago.

“Fifteen years ago, PET had grown up as a cottage industry,” Siegel said. “It’s now much more mature. The drug, FDG, that was principally used, and has been principally used for the last decade, was FDA approved essentially based on a paper review of the scientific literature as opposed to formal clinical trials. The new PET drugs that are coming are all going to go through the standard formal FDA approval process. CMS certainly should have some comfort level in the fact that appropriate clinical trials are used to provide the FDA with adequate and well-controlled evidence of safety and effectiveness.”

The proposal that arose from the MITA workshop would be to allow local Medicare contractors to determine coverage of new PET technologies and radiopharmaceuticals. This would allow new PET products to enter clinical use more quickly and without as much red tape. However, this would not restrict CMS’s ability to later call for a national coverage determination should it decide that one is appropriate.

“If a year or two down the line, CMS finds that the utilization, as it evolved, was broader than appropriate for the Medicare population, it can rein it in and do its own national coverage determination,” Siegel said. “There is a mechanism to try to reach rational coverage policies but without necessarily burdening the sponsor of a new PET radiopharmaceutical with the prospect of no Medicare coverage upon the moment of FDA approval.”

The belief is that this proposal, if it is accepted, would give smaller companies more incentive to introduce new PET radiopharmaceuticals without the fear of noncoverage. According to Siegel, those in attendance at MITA’s workshop felt that the proposed solution is a fair and appropriate fix to a problem that has been of concern to companies for nearly a decade. And perhaps just as importantly, CMS maintains the ultimate authority to undertake a national coverage determination should the new PET procedure warrant one, without new PET products being placed behind the eight ball before they enter the market.

“This is a chance to change the landscape,” Siegel said. “When any new therapy or new diagnostic test is first released, we don’t know everything about how it’s going to be used on day one. We learn a lot of things over time, based on new scientific literature and expert opinion, leading to evolving appropriateness criteria and guidelines from professional societies. And as evidence builds, CMS can adjust the coverage accordingly.”