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BioWorld - Thursday, February 25, 2021
Home » Blogs » BioWorld MedTech Perspectives » Med tech in the Land of Oz

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Med tech in the Land of Oz

Sep. 24, 2014
By Mark McCarty
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Yellow brick roads don't always end where you want
Yellow brick roads don't always go where you want

Sometimes when I think about policy and regulatory matters in the world of med tech, I feel like I’m no longer in Kansas. Here are three stories of interest to device makers that might make one wonder who’s behind the curtain, and an icon of sorts for each.

Jobs legislation; the Cowardly Lion

The U.S. House of Representatives has passed H.R. 4, a bill that deals principally with jobs, but carries with it a repeal of the 2.3% medical device tax. So why is this bill a problem for the Senate?

Besides the repeated opposition to a device tax repeal voiced by the Obama administration, we have two nay votes by Reps. Nancy Pelosi and Henry Waxman, both of whom have served as proxies to the administration’s views on lots of legislation. If they’re opposed to H.R. 4, what are the chances it’ll pass in the Senate?

There’s no need to ask what the Senate vote count would be. Senate majority leader Harry Reid is not going to let it come up for a vote, I guarantee it. Thus the King of the Senate jungle does what he does best, which is to prevent votes that could embarrass his party.

The new CED; the Munchkins

The Centers for Medicare & Medicaid Services has been looking at an overhaul of the coverage with evidence development program since November 2011 and held a public meeting in 2012, turning out a draft guidance for the program in November that year. But there has been nothing since then.

Just like the Munchkins, there are a lot of moving parts to the CED draft, and there are a lot of stakeholders. There are thousands of drug and device makers, and more than 800,000 doctors and hospitals. And there are those 535 Medicare micromanagers on the Hill who want to tell CMS what to do about specific coverage decisions.

Is it just too much trouble to get all those adorable Munchkins to work together?

The only thing we can say for certain is that the draft CED is out there somewhere and that it’s tough to spot. Maybe there’s a wicked witch cruising around overhead on her broom, and that’s why it’s still hiding.

The Watchman device; Dorothy

They say there’s no place like home, and Boston Scientific might believe the FDA circulatory systems advisory committee is a second home for the Watchman left atrial appendage device. The device will appear a third time at an advisory committee Oct. 8, and who knows what will happen? FDA is concerned about ischemic stroke numbers, so it’s anyone’s guess. How ironic that one of the trials used to support the application returned better-than-expected numbers for those on medical management.

When in doubt, just click your heels three times, little Watchman. It might not get you and Toto back to Natick, Massachusetts, but it couldn’t hurt.

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