There are many definitions for the word “crazy,” and here's another. Crazy is when you want to get out of Medicare and save the government and the taxpayer money, but the government won't let you. Recent reports indicate that a group of five senior citizens, including former Texas Republican congressman Dick Armey, are okay with their Social Security benefits, but that the law is forcing them to enroll in Medicare Part A if they want to stay on Social Security. The case made it to the Court of Appeals for the District...

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...

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...

Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me. I was concerned, at first, that my lack of a medical or scientific background would hinder my ability to cover the space adequately. But I learned quickly and before I knew it I was well-versed on the differences between a drug-eluting stent and its bare-metal cousin, the pathway...

MONTREAL ‑ At this week’s American Society for Human Genetics annual meeting, where there is a whole genome sequence there is somebody bringing up privacy concerns. Do you really want your genome data to be laid bare? Will it start in a research database, move to your doctor’s office, and soon enough be found floating around on the Internet? Most of those privacy concerns focus on medical issues, which makes a lot of sense. Certainly, most people would not feel warm and fuzzy about having their insurance companies know that, like Craig Venter, they have a higher-than-average risk of developing...

  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...

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...

Healthcare reform has as a million audiences, and it's interesting to see what some of them are reading about the Patient Protection and Affordable Care Act (ACA). Let's look at an opinion piece appearing recently in the New England Journal of Medicine penned by a trio including Michael Chernew, PhD, perhaps the most influential healthcare economist in Washington. Chernew and his co-authors remind that calculations of Medicare costs typically consists of a comparison of the world with and without the ACA, stating that the ACA has to do better than healthcare inflation of about 5.5% in order to impress the...

This week’s report of remissions in three advanced leukemia patients after immunotherapy has generated quite a lot of excitement in the media – which, in turn, has led to some backlash amongst the twitterati and in the blogosphere, noting that two complete remissions plus a partial one don’t make a blockbuster. Or anything, really, that will be broadly useful within the next few years. Mainly, when I look at these controversies, I am grateful that I write for such a smart audience. If you are reading this blog, chances are that you work in the biopharmaceutical industry – and if...

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....