As legislation that could determine how CMS is allowed to use "comparative effectiveness research" is being debated, AdvaMed has come out with a series of principles that it would like to see the government adhere to. At their core is that such data, while it can be useful, should not take the place of doctor-patient counseling, and should not in and of itself be used to eliminate treatment options. The full list of principles can be found here. At a press teleconference this afternoon, AdvaMed President Stephen Ubl said the organization has three key points: 1. Comparative effectiveness data can have value, but individual judgements for individual decisions must remain. 2. Any decision-making process that incorporates comparative effectiveness...
October 24th, 2007
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A CMS official told those at TCT 2007 that the agency is unlikely to scale back coverage for drug-eluting stents, even in the wake of safety concerns, the Wall Street Journal reports. In February, CMS said it was considering restricting coverage for off-label uses of the products. But judging from comments by Marcel Salive, director of medical and surgical services in the agency's coverage and analysis group, that's probably not going to happen. Of course, not a whole lot of study of off-label patients has been done. In a few years, when more data is available, we'll see if the agency changes its mind.
October 24th, 2007
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Inverness Medical Innovations Inc. (Waltham, MA) announced it will buy Alere Medical Inc. (Reno, NV) for $302 million, reports Bloomberg News. On the surface it sounds small-potatoes, given the size of some other recent deals. But here's the twist: Inverness is a medical diagnostics company; Alere is a disease management company. Alere manages home care for patients with heart failure. Inverness develops tests for heart disease and stroke. Inverness believes the two services are complementary. If this plays out as Inverness expects, it will be interesting to see if others go down this path.
October 24th, 2007
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Defibtech, LLC (Guilford, CT) has been ranked #7 (and #1 among medical technology companies) in Deloitte...
October 23rd, 2007
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A big reason why sales of drug-eluting stents have declined is negative publicity from studies questioning their safety. If sales are ever to rebound, positive safety results must be obtained and publicized. And that is what is happening at the kickoff of TCT 2007, the world's premier interventional cardiology conference. At the conference's opening yesterday, both Boston Scientific and Johnson...
October 22nd, 2007
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AdvaMed, the Medical Device Manufacturers Association, and other groups have filed a joint amicus brief in a lawsuit against Medtronic in order to argue that FDA should be the sole arbiter of the safety and effectiveness of medical devices. They say that if a product-liability case against Medtronic is allowed to go forward, state courts will have as much say as FDA does over whether a product is safe and effective. That, they say, would undermine FDA's authority and potentially squelch the introduction of new technologies. One of the lawyers behind the filing of the brief is Dan Troy, who argued this position aggressively when he was FDA's Chief Counsel.
October 22nd, 2007
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Having a strong relationship is one of the most important elements of a business partnership. Sometimes this means getting down to celebrating birthdays and holidays, be it via a simple card or going out to dinner, together. During a day-long conference session at MD&M Minneapolis yesterday, outsourcing experts gave attendees insight into the how they can build and maintain successful partnerships with suppliers. When outsourcing, having suppliers that you can trust is critical, because they're an extension of your company. Whether you're outsourcing components or finished devices, don't treat suppliers like vendors, advised Dan Kunst, executive vice president of sales and marketing at Avail. Although the structure of each relationship differs from company to company, fully integrating them into your organization and, more importantly, treating them like one of your own, is essential.
October 19th, 2007
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CMS is launching a clinical laboratory competitive bidding system, and the medical device and clinical laboratory industries are not happy. CMS selected the San Diego area as the first of two locations for a competitive bidding demonstration. The concern from industry is that the program will encourage a focus on cost rather than the benefits of diagnostics. AdvaMed released a statement late yesterday, which says in part that "the clinical laboratory competitive bidding project is focused primarily on cost rather than quality, value and patient benefit. A competitive bidding scheme based primarily on cost may inadvertently sacrifice the value of clinical laboratory services in delivering high quality of care. It may also artificially reduce the number of clinical lab choices...
October 18th, 2007
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CMS has decided to hold off on implementing a controversial policy that would have eliminated automatic Medicare coverage for government-sponsored clinical trials. It would have forced medical device manufacturers involved in government-sponsored trials to certify that their trials met 13 clinical research standards set by CMS. The agency said it will hold off on implementing the policy until it has time to review the FDA Amendments Act of 2007, which grants new authorities to various branches of the Department of Health and Human Services regarding clinical trials. It said it wants to make sure that the new policy does not duplicate or conflict with any of the new FDAAA requirements. Kirk Dobbins, counsel for Washington, DC law firm King...
October 17th, 2007
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Wall Street analysts are predicting that Boston Scientific will lay off 7-12% of its worldwide workforce, which would come to between 2000 and 3400 people, the Boston Globe reports. This would occur because of slumping sales in its biggest markets, stents and implantable cardioverter-defibrillators. Other factors: the debt from its $27 billion acquisition of Guidant, and a "corporate warning letter" from FDA that prevented the firm from introducing certain new products. One analyst expects the cuts to disproportionately affect the stent business. Boston Scientific eliminated about 500 jobs earlier this year and said more cuts were forthcoming. The firm has not confirmed when the cuts will be announced, but some analysts think it could come as early as this week. Third-quarter financial results will be announced Friday. It's always tough to hear about the...
October 16th, 2007
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