If approved, the proposal means that PET providers will no longer have to report data to the National Oncologic PET Registry (NOPR), the registry set up in 2006 to collect data on how PET was being used to manage patient care. CMS had required providers to report data to NOPR as a condition of reimbursement under its coverage with evidence development (CED) requirement.
CMS also approved reimbursement of one FDG-PET scan to evaluate the success of initial cancer therapy treatment for most indications, with the exception of prostate cancer. The decision also applies to PET/CT studies, the agency said. Medicare had already been paying for an FDG-PET scan prior to patient treatment.
In a March 13 decision memo, CMS evaluated a proposal submitted by NOPR in September 2012 that asked the agency to end the CED requirement. In making the request, NOPR said that seven years of data collection has confirmed PET's efficacy in oncology, and has shown that PET is "both reasonable and necessary for subsequent treatment strategy of oncologic indications."
In 2009, CMS eliminated the CED requirement for PET scans to develop an initial treatment strategy for patients with most oncologic indications, but it continued to require data reporting for follow-up scans used to guide treatment strategy for many cancer types. Whether PET was useful in changing health outcomes and guiding patient management after the initial scan was the focus of the agency's new review, the memo said.
In its memo, CMS described how it reviewed the evidence behind follow-up PET scans for multiple types of solid tumors, including brain, pancreas, prostate, small cell lung, soft tissue including the heart, testicular, and thyroid cancers. The agency reviewed public comments received in December 2012 and January 2013, performed a literature review, and reviewed two external technology assessments, one by Blue Cross/Blue Shield and one from the U.K. The agency also reviewed evidence from a number of studies submitted by NOPR.
The agency concluded that its literature search was unable to find direct evidence that FDG-PET improved health outcomes. However, the agency was able to find adequate evidence that the scans guided physician management for all solid tumors it was reviewing except for prostate; therefore, it approved payment for one FDG-PET scan after the initial study when used to evaluate the initial cancer treatment. Coverage decisions for additional scans can be made by local Medicare contractors.
With respect to prostate cancer, CMS said that its review indicated that the available evidence does not support the usefulness of FDG-PET for prostate cancer; instead, most of the literature for this indication focuses on PET scans with the choline-11 radiopharmaceutical. Therefore, CMS did not approve coverage for follow-up PET scans of the prostate, a decision that is in line with the agency's ruling on initial PET scans, which was also denied.