Imaging equipment manufacturers, oncologists and the National Oncologic PET Registry (NOPR) got most of what they were seeking in CMS’ multi-pronged final decision on Medicare coverage of positron emission tomography for solid tumors.

In a final decision memo issued June 11, the agency ended its coverage-with-evidence-development restriction for the procedure, meaning that coverage will no longer be contingent on prospective data collection by NOPR. This part of the decision memo was consistent with CMS’ May 13 proposal, and was widely supported by equipment makers and physicians.

But on two other points where CMS had encountered broad and vehement opposition, the agency changed its original position. Instead of allowing only one F¹⁸ fluorodeoxyglucose PET scan after a patient has completed initial cancer therapy, as first proposed, CMS decided to provide national coverage for three scans when used to guide subsequent antitumor management. And the agency completely reversed itself in the special case of prostate cancer, going from its initial national non-coverage proposal for this one tumor type to a decision to provide national coverage when the procedure is used to guide subsequent treatment strategy.

Professional medical associations, cancer centers, the imaging equipment industry, and individual physicians and patients had waged a vigorous campaign against CMS’ initial proposal to cover only one post-cancer-therapy FDG PET scan, arguing in 175 written comments to the agency that the limit was neither clinically nor scientifically warranted. (See Also see "CMS Proposal To Limit Number Of PET Scans For Cancer Patients Sparks Outcry" - Medtech Insight, 22 April, 2013..)

In its final decision memo, CMS explained that many of the comments cited three scans as a typical number for patients undergoing second- or third-line cancer treatment. “CMS appreciates these comments and will nationally cover at least three additional scans. Coverage of additional scans (that is, more than three) shall be determined by the local MACs,” the agency wrote.

The about-face on prostate cancer resulted from a review of recent evidence, CMS said. Particularly influential, it appears, were findings from a 2012 study of NOPR data indicating that FDG PET scans to determine the effect of prostate cancer treatment led physicians to change their intended therapy in about 40 percent of instances.

The final decision on prostate cancer does not apply to use of FDG PET to guide a physician’s choice of an initial treatment strategy – only to its use in planning subsequent strategy after a patient has completed initial cancer therapy. FDG PET scans for initial planning remain nationally non-covered, CMS noted.

The new national coverage policies went into effect immediately, allowing Medicare to pay claims with dates of service on or after June 11, 2013.

Bending To Overwhelming Feedback, CMS Softens Stance On PET For Solid Tumors

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