Wednesday, January 24, 2018

CMS to scrap plans for accelerated access to medical Devices

CMS scraps plans to accelerate access to medical devices


The CMS has withdrawn a proposed rule intended to accelerate access to medical devices. Officials put the rule forward to enable earlier Medicare coverage of medical devices, only to withdraw it nine months later.

Details of the plan to create the Expedited Coverage of Innovative Technology (ExCITe) pathway and why it was pulled are sketchy. The fullest publicly available account of what the CMS wanted the rule to achieve comes from the abstract it submitted to the White House unit that helps the president with policy and regulatory objectives.  

“This proposed rule would provide Medicare coverage of certain devices under investigation through a clinical research study and the associated routine care items and services in that research,” the CMS wrote in the abstract for the proposed rule. “The ExCITe pathway would remove the barrier in evidence generation by allowing CMS to provide faster access to new technologies that would have the potential to improve patient health and quality of care.”

From this writer's view, it may be a good thing.  While many medical device manufacturers have rushed to fill the 'hype' . it is largely being promoted by 'startups' and investors.  The devices need to be further vetted to verify their accuracy and worth.  Some have reached the market place and are in use.

The approval process for medical devices and for drugs is a long and expensive process.  Medical devices and pharmaceuticals must be approved first by the FDA. 

The conundrum for CMS is whether they will pay for these services. (devices) 

Details of the plan to create the Expedited Coverage of Innovative Technology (ExCITe) pathway and why it was pulled are sketchy. The fullest publicly available account of what the CMS wanted the rule to achieve comes from the abstract it submitted to the White House unit that helps the president with policy and regulatory objectives.

“This proposed rule would provide Medicare coverage of certain devices under investigation through a clinical research study and the associated routine care items and services in that research,” the CMS wrote in the abstract for the proposed rule. “The ExCITe pathway would remove the barrier in evidence generation by allowing CMS to provide faster access to new technologies that would have the potential to improve patient health and quality of care.”
http://tinyurl.com/yaynrms8

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