CMS Raises Questions About New-Technology Payment Candidates
This article was originally published in The Gray Sheet
Boston Scientific’s Watchman stroke device, Medtronic and Bard’s drug-coated balloons, Cardiovascular Systems atherectomy systems and two other devices each come in for criticism in the Medicare agency’s consideration of the next round of inpatient bonus payments for new technologies.
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CMS will consider a national policy for the left atrial appendage closure device in response to a request from Boston Scientific.
Three separate FDA advisory panels examined the clinical data supporting the left-atrial appendage closure device and struggled to identify exactly which patients it benefits. But FDA has finally approved Watchman with an indication that analysts say will support meaningful market action for Boston Scientific. Reimbursement policies, however, remain a question mark.
Medtronic gained FDA approval for its drug-coated balloon for the peripheral artery, as expected, and it is now gunning to take share from first-to-market C.R. Bard with the help of impressive clinical data and a formidable Covidien peripheral vascular device sales force.