CMS Declines to Cover NaF-18 PET for Bone Metastases

Alicia Ault

December 16, 2015

The Centers for Medicare & Medicaid Services (CMS) says there is still not enough evidence to support coverage of NaF-18 positron emission tomography to identify bone metastases.

In issuing its final decision, the agency said it would continue to cover the procedure for 2 years for patients enrolled in clinical trials, as part of its coverage with evidence development process. It will reconsider national coverage in 2017.

Medicare has covered NaF-18 positron emission tomography, under the coverage with evidence development process, since 2010. In April 2015, the agency was asked by the National Oncologic PET Registry to take another look at the evidence. The CMS responded in September, posting its opinion that coverage was still not warranted. After that proposed decision was issued, the agency received 221 comments, with the vast majority pleading for full coverage.

According to the CMS, 171 comments "were identical word-for-word submissions, that is form letters," that argued for continued coverage, but "they provided no evidence or supporting studies."

The agency seemed almost miffed at the lack of evidence it found in reviewing the last 5 years' worth of data, including the National Oncologic PET Registry data. The CMS said it recognized the usefulness of publications that "have produced evidence on clinical validity and change in intended patient management," but added, "we are perplexed why additional analyses were not performed and published to confirm actual changes in patient management that improves health outcomes occurred."

In addition, the data included very little analysis by race, sex, or socioeconomic status, said the agency. Going forward, trialists should conduct these kinds of analyses, the CMS said. The agency noted that there is mounting evidence of differences in how different racial and ethnic groups respond to chemotherapy, and that uninsured, low-income, and minority patients are more likely to be diagnosed with cancer at a later stage.

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