While most assume the Food and Drug Administration would serve as the biggest industry obstacle — as the agency approves whether a device can enter the market — many device leaders now view CMS as a larger hurdle to growth and success, according to the report.
Members of the medical device industry feel the time between a device’s approval from the FDA and Medicare’s decision on whether it will cover the product is too long. Gaining CMS coverage for a new medical device is key to the product’s success, the report states, as many private payers base their own coverage rates on CMS’ decision.
The Advanced Medical Technology Association plans to lobby Congress and CMS for an easier, more efficient process of gaining Medicare device coverage, according to Nadim Yared, president and CEO of Minneapolis-based device company CVRX and member of AdvaMed’s board.
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