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After surgeries moved to ambulatory surgery centers during the pandemic's upending of non-emergency care, experts and industry believe some procedures may never go back.
The policy would automatically OK Medicare reimbursement for devices with FDA breakthrough status, but critics contend the rule would undermine CMS authority to consider the clinical evidence backing new technologies.
The agency is asking users who suspect their systems are suffering from either issue identified by the Swiss medtech giant to stop running tests on them and contact the company.
The company will initially provide 50 million of its point-of-care diagnostics to HHS for use in Florida and Maine, with the potential for up to $766 million under the eight-month deal.
The agency has released details of how medtechs have used RWE, such as registries and medical records, to support filings including 510(k) submissions and premarket approval applications.
"If this [Novitas Solutions] rate is not adjusted, these companies don't make money and will be unlikely to provide the service," Baird analyst Mike Polark said.
"What you saw under the prior administration was this concept of a kinder, softer FDA to industry," said Dennis Gucciardo, partner at Morgan Lewis. Experts now expect a shift, including more enforcement activity.
The U.S. appears to have reached a new phase in its battle against the coronavirus with vaccinations taking precedence over tests. Whether testing will return to earlier levels is an open question.
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