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CMS New Tech Add-On Interpretation Contested By Industry Reps

This article was originally published in The Gray Sheet

Executive Summary

Medtronic will attempt to persuade CMS that the firm's Kinetra deep-brain stimulation device marks a substantial clinical improvement over its predecessor - the dual-implant Soletra - and therefore qualifies for a new technology "add-on" payment

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Spine submission from Medtronic

PMA submission for rhBMP-2 bone growth stimulator in posterior lumbar spinal fusion is announced Sept. 29 at the North American Spine Society meeting in Philadelphia. The recombinant bone morphogenetic protein - to be delivered via the Amplify matrix - is the active component in Medtronic's InFuse bone graft for tibia fractures, which entered the U.S. market in May 2004 (1"The Gray Sheet" May 17, 2004, p. 3). The PMA is supported by a randomized, prospective clinical study that enrolled more than 460 participants, Medtronic says...

Spine submission from Medtronic

PMA submission for rhBMP-2 bone growth stimulator in posterior lumbar spinal fusion is announced Sept. 29 at the North American Spine Society meeting in Philadelphia. The recombinant bone morphogenetic protein - to be delivered via the Amplify matrix - is the active component in Medtronic's InFuse bone graft for tibia fractures, which entered the U.S. market in May 2004 (1"The Gray Sheet" May 17, 2004, p. 3). The PMA is supported by a randomized, prospective clinical study that enrolled more than 460 participants, Medtronic says...

MedPAC Urges Restraint In Granting Add-On Payments For New Technologies

CMS should be selective in awarding new technology add-on payments to promote hospital efficiency, according to the Medicare Payment Advisory Commission

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