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CMS Skeptical Of Watchman, CardioMEMS Data For New-Tech Add-Ons

The Medicare agency is questioning whether Boston Scientific’s Watchman stroke device or the CardioMEMS implantable heart failure monitor, championed by St. Jude Medical, can meet the “substantial clinical improvement” threshold to qualify for an inpatient new-technology add-on payment.

CMS suggests it is not satisfied with data supporting two highly anticipated new cardiac technologies, signaling potential reimbursement challenges ahead for both devices.

Boston Scientific’s Watchman left atrial appendage closure device for stroke and CardioMEMS’ Inc.’s CardioMEMS implantable heart failure monitoring system are both candidates for a new-technology add-on payment in the Medicare hospital inpatient system in fiscal year 2015

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