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...
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....
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...
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...
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:...
By most objective accounts, Donald Berwick is doing a pretty decent job as chief administrator of the Centers for Medicare & Medicaid Services, giving CMS a much-needed shot in the arm and kick in the . . . well, you know. Unfortunately, that appears to not be enough for him to keep the job beyond the end of the year, as mandated by law for "recess" appointments such as himself. Berwick, who knows the provider side of medicine as a pediatrician, is a health policy expert of some repute. He has been quite the thinker on broader healthcare questions, including...
The recess appointment of Donald Berwick, MD, to the administrator’s position at the Centers for Medicare & Medicaid Services (CMS) last July roiled many members of Congress, and a recent Senate letter to the Obama administration expressing disfavor for Berwick’s continued presence at CMS may have finally lain to rest any chance that he had of a successful confirmation hearing. The letter, whose principal authors include Sen. Mike Enzi (R-Wyoming), the ranking GOP member of the Senate Health, Education, Labor and Pensions Committee, and Orrin Hatch (R-Utah), the ranking GOP member of the Senate Finance Committee, cite Berwick’s “past record...
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