FDAnews Device Daily Bulletin

EVIDENCE OF TREATMENT EFFECTIVENESS WILL DETERMINE CMS COVERAGE FOR DEVICES

May 10, 2006
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The clinical benefit to patients from treatments using particular devices must be evident to determine how products will be covered, said a panel of experts May 3.

An initiative called "coverage with evidence development" (CED) will affect how the Centers for Medicare & Medicaid (CMS) determines coverage by assessing device and diagnostics. "This is about evidence transactions," said Cliff Goodman of the Lewin Group, a Maryland-based consulting firm.

The CMS wants to provide the public with better information on how well a particular technology works, said Steve Phurrough, director of the Coverage and Analysis Group at the agency. Developing evidence to better define for the public what technologies are best for them sets the "evidentiary standard," he said.

Presenting poor or preliminary evidence will result in noncoverage, while "persuasive evidence" will lead to coverage, said Phurrough. "There is a threshold we expect to be crossed," but what is considered persuasive evidence "depends on the technology," he said.

"Evidence-based medicine means moving from opinion to fact, and that's what we look for: Evidence to show improved outcomes for particular patient populations," said Phurrough.

The CMS will issue guidance in the near future on what it considers in defining evidentiary standards in product reviews. "We have found a lot of evidence doesn't reach the threshold, so we developed a middle ground called 'promising evidence,'" said Phurrough. This designation means "even though there are some trials that don't produce the evidence we think they should, we will still [cover the technology]." ()a href="http://www.fdanews.com/ddl/33_19/" target=_blank>