Expert says CMS panel approach to PET coverage expansion was incomplete
Barry Siegel, MD, co-chair of the NOPR Working Group.  
A question mark still remains as to whether the Centers for Medicare & Medicaid Services (CMS) will broaden reimbursement for new cancer types based on data from the National Oncologic PET Registry (NOPR) released this spring.

The Medicare Evidence Development and Coverage Advisory Committee (MedCAC) met Aug. 20 in response to NOPR's March request that CMS—based on NOPR findings—broaden PET reimbursement across all cancer indications, including the nine cancers for which Medicare is currently reimbursing. Since 2006, Medicare has only covered patients with other cancers, including brain, cervical, bladder, small-cell lung, ovarian, testicular, prostate, kidney and pancreatic cancers, if they were enrolled in the registry.

The MedCAC panel consisted of eight members ranging from radiation oncologists to independent medical consultants. However, while there was reasonable representation, inclusion of a surgical oncologist, like a GYN oncologist or urologist, might have been relevant, Barry Siegel, MD, professor of radiology at Washington University School of Medicine in St. Louis and co-chair of the NOPR Working Group, told Health Imaging News.

“The panel had only had one imaging person, who was a non-voting member,” Siegel said. “The rest were evidence-based medicine experts.”

Siegel gave one of several presentations showing the clinical utility of PET in cancer diagnosis and treatment. NOPR Working Group Chair Bruce Hillner, MD, presented the conclusions of the NOPR registry data, showing that FDG-PET is associated with a 36.5 percent change in the intended management of patients.

Siegel noted that there were a few limitations to the approach for the meeting, one of which is related to the technology assessment for PET. “Some cancers, such as bladder and prostate cancer were not included in the previous technology assessment, they were not included in the list,” he said. “So the technology assessment this time—by reaching back only to 2003—ignored the literature from 2003 backward, for those isolated cancers.”

Given the nature of the published literature for the large number of other cancers, the data are very thin, he added.

“If you start to drill down to the level of individual cancers based on what has been able to be published in the literature, absent any sort of really reliable funding source to do robust clinical trials, not surprisingly, you come up with very thin data,” said Siegel.

“At some point, you have to take credence of the biologic arguments about the effectiveness of PET as an imaging agent for cancer; the fact that increased glucose metabolism is a fundamental characteristic of cancer and generalizes the result, instead of drilling down to the cancer by cancer, indication by indication level.”

One of the outcomes of the meeting was for the MedCAC panel to vote on a series of five predetermined questions regarding the evidence for expanding FDG-PET coverage. Siegel said that if CMS has simply framed the question as follows, instead of a grid of nine individual cancers by four questions, the panelists might have answered things differently.

“Given the previous technology assessment, given the subsequent published literature validating the utility of PET for the currently covered cancers, given the new technology assessment and given the results of the NOPR, do you think PET leads to a change in physician decision making for diagnosis, staging and restaging of patients with cancer?”

Siegel added that he shares CMS’ concern about the potential for abuse and overuse, but PET should not be the “imaging whipping boy” when there is a lot of overuse of CT and MRI.

“They seem to be trying to hold back the flood gates by restricting the use of PET,” he said. PET is a small fraction of the total Medicare imaging budget, he noted, that even if broad coverage were given tomorrow for PET imaging of cancer, the NOPR does not expect Medicare coverage of PET to grow by more than 15 percent based on numbers in the registry.

CMS is expected to release a proposed decision memo by January 2009, with an expected completion date in April 2009.