WASHINGTON -- Up to three scans using 18F-fluorodeoxyglucose-enhanced positron emission tomography (FDG-PET) technology can be covered by Medicare for oncology treatment planning, the Centers for Medicare and Medicaid Services (CMS) announced Tuesday.
The agency's final decision expands significantly on its earlier proposal, which would have allowed reimbursement for only a single FDG-PET scan and excluded prostate cancer as a covered indication.
Both limitations were dropped in CMS's final coverage determination. The agency said it now agrees with numerous comments it received on the draft proposal, which argued that FDG-PET scans are valuable in treatment planning in prostate cancer as they are for other tumor types.
Moreover, the final decision to cover up to three scans applies to all Medicare beneficiaries nationwide, whereas the draft proposal had left coverage determinations to local Medicare contractors. CMS also said that coverage of additional FDG-PET scans beyond the initial three can be reimbursed in individual cases at local contractors' discretion.
The scans measure rates of glucose metabolism within tissues. Cancer cells typically metabolize glucose at a higher rate than normal cells. Thus, tumors essentially light up to become visually distinct and quantifiable in FDG-PET imaging.
At issue was the extent to which CMS would allow Medicare coverage of these scans to inform treatment planning decisions after initial surgical or medical anti-tumor therapies, in that the scans are intended to show the presence of residual tumor cells.
Prior to the agency's final decision, FDG-PET scans were covered only under the "coverage with evidence determination" procedure, which pays for services only when provided in rigorous clinical studies.
CMS had received hundreds of comments on the draft memo, most of which complained about the one-scan limit and the exclusion of prostate cancer.
Many of the comments cited published research that documented the value of these scans in planning follow-up treatments in cancer patients, with CMS ultimately agreed.
The agency noted that the research does not yet establish that the scans "meaningfully improve health outcomes." But, because it was satisfied that FDG-PET results can and do make a difference in physicians' treatment plans, CMS decided that was enough to warrant routine coverage.
John Gever
Senior Editor
John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!
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