The final decision also lifts the longstanding “coverage with evidence development” (CED) requirement for coverage of the scans. The rule meant Medicare would only cover fluorodeoxyglucose (FDG) PET scans for solid tumors post-treatment if providers provided data and tracked outcomes in the National Oncologic PET Registry, which was established in 2005.
An analysis from consulting firm Avalere Health showed that 97% of public comments—or 195 out of 201 filed—explicitly opposed the CMS' proposal to limit scans. Of those commenters, 170 were from individual providers. America's Health Insurance Plans endorsed the coverage restrictions.
“This is a win for a lot of the commenters because it's better to have the assurance at the national level that more than one is covered rather than leave it at the hands of local contractors,” Jenny Gaffney, a senior manager at Avalere Health, told Modern Healthcare. “This provides assurance that if a patient needs a second or third scan, then they will,” she continued.
Gaffney added that the decision to lift the CED requirement is a big win, too, because the CMS acknowledged that after eight years, enough data had been collected to show that these scans were necessary.
“There is hope for other technologies that find themselves in similar situations where their coverage has been confined to CED,” Gaffney said, adding that if evidence collected is robust, then the CMS might reconsider their CED requirements and potentially lift or remove those requirements.
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