Device makers are rightly concerned about the viability of Medicare in the coming decades, but there’s a tremendous amount of pressure on the program right now. For instance, budget sequestration will shave 2% off the monies paid out for Medicare by the end of March unless our elected officials can come to some agreement, but we no longer talk about least costly alternative (LCA) because it’s purportedly kaput. The idea that LCA is kaput, however, might not be accurate, and there are a couple of reasons industry should stay...
The new year is in full swing, but just as the Treaty of Versailles left a big mess to be resolved in another bloody conflict a scant 20 years later, the end of 2012 was anything but the end of several contentious issues that could plague the device industry in 2013. As is the case with wedding gifts, this list includes something old, something borrowed, and at least one of these is sure to leave device makers blue. Pre-emption back in play We had discussed previously that a change of...
I come not to praise the effort to repeal the device tax, or even to criticize it. I’m just here to give it a proper burial because it has been one heck of an effort. Industry continues to assert it will do everything it can to peel this tax monkey off its back, but there are a number of reasons I believe it’s just not going to happen. But that doesn’t mean all is lost. The first reason I see the device tax repeal as a goner is...
As discussed previously, a repeal of the device tax faces longish odds. Opponents of the tax have punted to a suspension of the tax as was disclosed by a letter from nearly 20 members of the U.S. Senate, a move purportedly prompted by the short turn-around from the date of the IRS’s final rule to the effective date of the tax. Despite the disclaimers, it’s important to point out that you clearly don’t believe a repeal has any chance in the short term if you’re arguing for a suspension. So let’s ask ourselves what sort of headwinds the device tax...
When I signed up for my first half-marathon, which took place recently on the Las Vegas strip at night, I knew I was in for a tremendous challenge. But I had no idea I would be finishing the 13.1 mile race while battling a small bowel obstruction. While this setback easily could have sidelined me from the race, it made me all the more determined to see it through. The...
The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance. Interesting item #1: The passage stating that CMS is examining the question of “whether local contractors should have the discretion to apply CED in local coverage” is pretty close to an earthquake. I’m assuming that most CED trials will have to span more than one Medicare carrier’s jurisdiction, which suggests a patchwork of CED coverage or a need to get...
Recently, I had the opportunity to interview Pete O'Heeron, CEO of a private company called SpinalCyte, a company developing an application to treat degenerative disc disease using cells derived from human skin for the Nov. 9th edition of Medical Device Daily . O'Heeron was especially enthusiastic about the application, which would promote autologous regrowth of the spinal disc nucleus using human dermal fibroblasts (HDF). If such a technology could garner approval, it could potentially replace implants in patients. Although, this has only been test in animal models - the technology holds great promise. I think this story was right on...
New York may be the town that never sleeps, but Washington is the town that never fails to amaze. We currently have a sex scandal seeming to rival the Bill Clinton-Monica Lewinsky detonation, but the current scandal has more in common with the Profumo affair because a secretary of defense was involved. Obviously the President has a number of distractions. One of those is Benghazi, a story seeming to grow more convoluted every day. Somewhat linked to all that – more or less immediately – are Gen. David...
There’s a saying that elections have consequences, an observation that has special meaning for the highly regulated medical device industry. Here are a few things for device makers to bear in mind as 2012 gives way to 2013. Supreme Court vacancies: Is PMA pre-emption back in play? The last time the U.S. Supreme Court reviewed FDA’s pre-emption of state regulatory mechanisms for PMA devices was Riegel v. Medtronic in 2008, and the decision came out in favor of the defendant. We previously discussed how the election might converge with retirements on the Supreme Court, but industry cannot assume pre-emption is...
If I had to sum up the key take away from Cleveland Clinic's Medical Innovation Summit last week, I would probably say something like this : Innovation is alive and well, but are hospitals and physicians willing to pay for it when capital is so strained? Nearly every panel that I attended seemed to have that as an underlying theme. Everyone from Cleveland Clinic's own Dr. Joseph Iannotti to Medtronic's CEO Omar Ishrak made statements about innovation in healthcare and the importance of having it present in an environment where capital is limited and dollars are few. Iannotti made...
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