From Regulation To Reimbursement: Ex-FDA Chief Says CMS Needs New Reimbursement Frameworks
Following his recent talk at the National Press Club on reimbursement issues, former US FDA Commissioner Scott Gottlieb told Medtech Insight a new breakthrough device rule proposed by the Medicare agency CMS is good but will still be economically unfeasible for many hospitals. Instead, he says new frameworks need to be developed for the new kinds of technologies coming to market.
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As digital health becomes more ubiquitous in the medical device space, industry advocacy group AdvaMed has launched a Center for Digital Health to aggregate its resources and coordinate efforts to lobby the government on behalf of digital-health companies.
In an address to the National Press Club on 10 May, former FDA Commissioner Scott Gottlieb pointed to some of the challenges that CMS would face in supplying coverage for new technology, should a "Medicare for All" bill be adopted by Congress and signed by the president. Medtech Insight analyzed provisions that could impact industry in some of the proposed bills, in a comparative chart.
A new proposed rule would give automatic new technology add-on payments to breakthrough devices. While it may affect only a very small sector of the industry, the lobby group AdvaMed says it is a good first step to getting broader coverage for all devices and will incentivize companies to invest in breakthrough device research.