Tag Archives: Congress

Congress and the doc fix: Is 2013 the year?

A clumsy attempt to address the Medicare Part B physician fee problem has nagged at Washington for a decade, but it appears Congress is ready to put a doc fix in play. Whether it’ll happen depends on politics and, as…

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Five years later: Hays v. Leavitt and the Medicare cost dilemma

Device makers are rightly concerned about the viability of Medicare in the coming decades, but there’s a tremendous amount of pressure on the program right now. For instance, budget sequestration will shave 2% off the monies paid out for Medicare…

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The device tax repeal effort: RIP

I come not to praise the effort to repeal the device tax, or even to criticize it. I’m just here to give it a proper burial because it has been one heck of an effort. Industry continues to assert it…

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Election 2012: What it means for device makers

There’s a saying that elections have consequences, an observation that has special meaning for the highly regulated medical device industry. Here are a few things for device makers to bear in mind as 2012 gives way to 2013. Supreme Court…

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Election 2012: Is Jeff Shuren’s job on the line?

Jeff Shuren, MD, has brought a lot of changes to FDA’s Center for Devices and Radiological Health, but there are those who think Shuren has not gone far enough while others think he’s gone too far. None of this would…

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On This Date in History: Medicare signed into law in 1965

At the risk of becoming mired in the past, we are inclined to glance backward now and then to see where we’ve been and ask what the past says about where we’re going. So let’s examine July 30, 1965, the…

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Counting to 51: The fate of the device tax and the Affordable Care Act

The biggest judicial showdown in quite a while is finally over, and here are a couple of things to consider while we’re playing numerology games in an effort to interpret the scribblings of nine citizens in black robes we all…

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Congress enjoys a rare moment of harmony with passage of FDA user fee act

With all the acrimony between Democrats and Republicans in Congress these days, it was truly edifying to see lawmakers on both sides of the aisle agreeing on a piece of legislation – and in the healthcare sector no less –…

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FDA user fees: A necessary evil?

The FDA medical device review mechanism has come under fire from many quarters for some time now, but one of the criticisms of the 510(k) and PMA programs is that the reviews are funded by user fees, a claim that…

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FDA whistleblowers sue FDA: A big deal?

Fans of pro football may think the matter of whether Peyton Manning will ever play in the NFL again is taking forever to come to a conclusion, but they might want to examine the FDA whistleblower issue as a benchmark…

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