Tag Archives: CMS

Coverage of coverage: two recent moves by CMS

When it comes to coverage and reimbursement, there are gatekeepers all over the place, but some keep bigger gates than others. Following are two stories about the Centers for Medicare & Medicaid Services and how it has kept its gate…

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Growing pains: TAVR still in adolescence?

It’s tough to know what’s “normal” for the natural history of a medical device, but it appears the path to maturity for those first-of-a-kind, high-risk circulatory system devices is more drawn out than in times gone by. Now that TCT…

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Government, industry and crossed wires

The playwright George Bernard Shaw is credited with having said, “the single biggest problem in communication is the illusion that it has taken place,” a remark device makers might apply to their interactions with FDA and the Centers for Medicare…

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The difference between good news and bad news

There’s an old story about a farmer who lost a horse, and the neighbor said “such bad news.” Then the horse came back with a bunch more in tow, and the neighbor said “such good news!” Then the farmer’s son…

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5 for Five: Device coverage from the pages of MDD

The merry month of May is just about kaput, so let’s ask ourselves how entertaining the past five months of May have been. Entertaining, that is, if you’re a med tech geek or wonk, and it’s a cinch you’re one…

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The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance….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