CMS News is Good for Troubled Markets
There was probably no group more relieved than the makers of implantable cardioverter defibrillators (ICDs) to see the Centers for Medicaid and Medicare Services (CMS) in August drastically modify its proposal to slash hospital reimbursement. The change is as a result of effective lobbying from the medical device community as well as the hospital industry, and is welcome news to all high-end device makers.
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The goal of developing a nationwide system of electronic healthcare records (EHRs) for most all Americans is moving at a slower pace than some would like. But now, a group of large and influential employers has entered the picture with a plan that seems poised to change the speed and leadership of the endeavor.
The clinical trials MADIT II and SCD-HeFT definitively proved the benefit of ICDs for preventing the risk of sudden cardiac death and paved the way for reimbursement. But now that the excitement has died down, the confusion has set in. Clinicians aren't entirely sure in which real-world patients to implant devices. The debate about the proper methods of risk stratifying patients for ICD implantation rages on.
Guidant's problems with its ICD business, coming in the midst of its merger negotiations with Johnson & Johnson, highlighted the impact that product recalls and problems can have for companies. Generally speaking, product liability is becoming a bigger issue for medical device companies as consumers grow more skeptical that the government is protecting their interests where product safety is concerned.