The Obama administration has published its budget proposal for fiscal year 2013 and the proposal includes a drop in appropriated funds of $4 million for FDA's Center for Devices and Radiological Health. As expected, the budget also calls for cuts to Medicare that could have an effect on makers of imaging equipment and durable medical equipment as well, giving device makers an incentive to turn out in force on Capitol Hill to blunt the damage in any spending bills Congress might draft.

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...

One of the big points of contention between industry and FDA is the difficulty in getting the agency to approve investigational device exemptions, but the recent guidance on early feasibility studies is intended to ease the logjam at the point of first-in-human (FIH) studies. Several members of the FDA staff appeared at CRT 2012 to discuss the guidance, but the fact that many devices have already been introduced in other nations led to some questions as to why the agency can't be less restrictive without the need for a focused guidance.

The Centers for Medicare & Medicaid Services has proposed conditions for coverage of transcatheter aortic valve replacements that has sparked ire among clinicians at CRT 2012, including one of the most prominent cardiologists in the U.S., Ron Waksman, MD, of the Washington Hospital Center (Washington), who said, "we struggle with reimbursement" for the device as the rules are currently written by CMS.

This year's edition of CRT is underway in Washington, and much of the emphasis is predictably on transcatheter aortic valve replacements (TAVR). While some of the speakers hinted that while they are amenable to using the procedure on lower-risk patients, one of them said the continued emphasis on high-risk patients in trials is making referring cardiologists anxious about referring their patients to the procedure. Underlying some of the problem, however, is some grumbling over the STS risk scoring methodology for this procedure, with one cardiologist describing it as "a very flawed system" for determining risk.