Medicare 'Coverage With Evidence' May Rise With FDA Postmarket Emphasis

As FDA touts plans to shift clinical data requirements when possible to the postmarket phase, a top CMS official highlights the importance of the Medicare coverage with evidence development policy.

As FDA puts more emphasis on the potential of postmarket data collection to supplant premarket studies when possible, it raises the likelihood of more Medicare coverage-with-evidence development policies, CMS officials suggest.

Reimbursement considerations for products with less premarket data will also likely take more time to review and require closer collaboration...

More from Archive

More from Medtech Insight

US FDA Unveils Plans To Consolidate Support Services

 

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

‘UK Must Put Adoption On A Par With Innovation’

 
• By 

Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.