Category Archives: CMS

Thank you government!

November is not always a spicy month where federal agencies are concerned, but FDA and CMS have come through to give us something to talk about. Below are a couple of items to mull over as you enjoy a leisurely,…

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The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance….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

The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it’s time to project into the future. Before we head there, however, we should revisit the past. The pivotal event in this story is…

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J.P. Morgan healthcare meeting augurs trends for 2012 and beyond

Hopefully not lost in all the comings and goings of more than 8,500 people at the J.P. Morgan Healthcare Conference in San Francisco last week were some important take-home messages about the future of med-tech, a future that promises many challenges…

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The policy dilemma of prostate cancer screening

  Screening for various diseases is controversial these days thanks to the U.S. Public Services Task Force and similar agencies in other nations, which have suggested a more cautious approach to screening. These suggestions have been blasted by doctors and…

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Medicare’s decision to cover weight-reduction efforts is a good move, but details still matter

By JIM STOMMEN Medical Device Daily Contributing Writer   Talk about eating from the public trough: The folks who run Medicare are putting their money where our collective mouths are. The nation’s largest health insurance plan reported awhile back that…

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Berwick out, but to anyone’s surprise?

Donald Berwick’s tenure at the Center for Medicare & Medicaid Services was brief, but should come as no shock to anyone who knows how the former physician came to the job. What’s stunning is how many believe the Obama administration…

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Buck for the bang: Premium med-tech pricing

By Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group Cook Medical’s Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in…

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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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