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Home » Topics » Regulatory » CMS

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The policy dilemma of prostate cancer screening

Jan. 10, 2012
By Mark McCarty
  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 patient groups for obvious reasons. Former Medical Device Daily executive editor Jim Stommen took up prostate cancer screening in a posting at this blog a few weeks back, and while I agree with Jim on a lot of things, I felt one perspective was missing; that of the federal budget. The problem is that no national economy can support indiscriminate...
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Medicare’s decision to cover weight-reduction efforts is a good move, but details still matter

Jan. 3, 2012
By Jim Stommen
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 it will pay for screenings and preventive services aimed at helping recipients battle obesity and its attendant medical ailments. For those who screen positive for obesity, the newly covered benefits include initial weekly counseling for the first month, followed by five months of every-other-week appointments. Presuming weight loss continues, another six months of once-monthly sessions may follow. My initial response...
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Berwick out, but to anyone's surprise?

Dec. 12, 2011
By Mark McCarty
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 and House and Senate Democrats bear no responsibility for the brevity of his stint at CMS. Let's take things in chronological order. First, President Obama and Democrats in Congress drafted what is probably the largest piece of legislation ever to pass without any input from the legislative minority. They then rammed the vote through Congress with only feeble support...
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Buck for the bang: Premium med-tech pricing

Oct. 31, 2011
By Mark McCarty
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 favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies. I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had...
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Parallel review: Still not a big deal?

Oct. 11, 2011
By Mark McCarty
  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 very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...
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The Good, the Bad and the Ugly: Third-party coverage requests

Sep. 30, 2011
By Mark McCarty
As a member of the trade press, I get a kick out of how routinely some people in the mainstream media and the population at large routinely assume that device makers are driven by greed and that doctors are morally flawless creatures who spend all their spare time pondering the public weal and woe, continuously devising ways to ensure their passage through the Pearly Gates with constant acts of selflessness. And then I see the parties weighing in on the question of Medicare coverage for the Sapien aortic valve made by...
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The future of healthcare spending: Will ROI be King?

Aug. 10, 2011
By Mark McCarty
Most of us had to take a course or two in economics to get a bachelor’s degree, but few of us remember very much from those lessons. I can't say for certain that Econ 101 is where I first heard the expression “return on investment,” or ROI, but it's an expression that has stuck with me ever since. The notion may gain greater prominence where healthcare payers are concerned in the years to come, thanks to the well-publicized Medicare crunch, but it's tough to imagine that the congressional Gang of 12, charged with finding further ways to close the U.S....
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ReGen v. FDA: A test of government's reach that's sure to bloody noses

June 12, 2011
By Mark McCarty
ReGen Biologics (Hackensack, New Jersey) has filed suit against FDA over the agency's rescission of the firm's Menaflex application, a slugfest that is certain to draw intense interest everywhere, from Capitol Hill to the boondocks of the medical device industry. This might be a lawsuit that wends its way quietly into history, but it could also rupture whatever cohesiveness there might be at the agency's Center for Devices and Radiological Health. At the very least, it will serve as a huge distraction for CDRH officials and impose yet more drag on operations...
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Doc fix awaiting another patch

June 1, 2011
By Mark McCarty
Now that the U.S. House of Representatives has voted down a higher debt ceiling for the U.S. government, Congress can go back the drawing board on deciding how many Medicare spending cuts the voters and stakeholders can stomach, but as always, there are pockets of concern within the larger picture. The picture for device makers is somewhat complicated in part because the Medicare Part B “doc fix” is a $30 billion-a-year overhang that will be tough to resolve, not just because of the positions taken up on each side of Capitol Hill. On the Senate side, Kent Conrad (D-North...
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Forget the naysayers: interventional cardiology's outlook is great

May 5, 2011
By Mark McCarty
Top 10 reasons interventional cardiologists should be happy By MARK McCARTY Medical Device Daily Washington Editor Dear Interventional Cardiologist, Worried about Medicare reimbursement for the Next Great Stent? Concerned that FDA's massive regulatory girth will squash your drug-eluting balloon groove? Not to worry. Here are the top 10 reasons you should be thrilled with your choice of specialty. Number 10: PCI numbers are flat of late, but just watch that Baby Boom fill your waiting room in the years to come. Number 9: The transradial (through the wrist) route is gaining acceptance as an approach to coronary intervention. Number 8:...
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