Tag Archives: CMS

Meet the New CED

The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance.

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The implications and future of TAVR

The story of the transcatheter aortic valve implant is well underway thanks to the fact that the Sapien valve, made by Edwards Lifesciences, is on the market, but there is more to this story. Following are three aspects of the…

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TAVR: What it says about FDA and CMS

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Berwick out, but to anyone’s surprise?

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Buck for the bang: Premium med-tech pricing

By Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group

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A whole new world

Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new…

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Parallel review: Still not a big deal?

  Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they’ve tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a…

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What docs are hearing about healthcare reform’s finances

Healthcare reform has as a million audiences, and it’s interesting to see what some of them are reading about the Patient Protection and Affordable Care Act (ACA). Let’s look at an opinion piece appearing recently in the New England Journal…

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ReGen v. FDA: A test of government’s reach that’s sure to bloody noses

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Berwick nomination stymied by poisonous partisan politics

 By most objective accounts, Donald Berwick is doing a pretty decent job as chief administrator of the Centers for Medicare & Medicaid Services, giving CMS a much-needed shot in the arm and kick in the . . . well, you…

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