There are times when we in the private sector think you have to be crazy to want to work at FDA or CMS, but the true unemployment rate is still in excess of 10%. Who in their right mind is going to turn down a steady paycheck in this economy? Still, working at these agencies is a lot like being an offensive lineman in the NFL: Nobody who's watching the game knows you're there at all unless someone on the other team knocks the stuffing out of the quarterback. Following are...

Continuous glucose monitors have been around for a few years, but the Centers for Medicare & Medicaid Services has had little to say about them to date. NHIC, a Medicare administrative contractor that seems to serve as the agency's point for durable medical equipment, has declared that CGMs are not coverable, and the coverage debate is getting noisier every day. Some argue that nearly all private carriers cover CGMs for Type 1 diabetes, but it would appear that the evidence in support of coverage seems less than overwhelmingly convincing, a...

It seems almost tragic that the acronym "SGR" has disappeared from the news, but there are still lots of stories that never get old. Even the ones that don't age well tend to pop up without warning, though, including questions about the viability of China as a med tech market and a new twist on  interoperability. Asian dragon or a snake in the grass? Sometimes paper is just paper, a comment that might aptly be directed at mainland China's yuan. Some saw the recent move to pull down the yuan's...

Five years ago during Cleveland Clinic's 2010 Medical Innovation Summit, a panel audience was asked, by a show of hands, if they considered obesity a disease. Only about half the audience raised their hand. The other half raised their hand when asked if obesity was a lifestyle choice. Keep in mind, this was a well-educated audience comprised of healthcare executives, clinicians, and investors. And yet, only about half of them were willing, at that time, to call obesity a disease. If the same audience was polled on the topic again today, I'd like to think the outcome would be different....

Everybody thinks they're poor, but Uncle Sam does have an ongoing deficit problem, and these budget issues are showing up in interesting ways of late. Needless to say, these problems are affecting the appropriations process, but there may be an escape hatch, and a couple of items of interest for device makers may be at risk, depending on the outcome. Will user fees cure the Cures problem? It's time for the negotiations for the next round of device user fees, and the first meeting toward this end was a pretty chummy...

  There's no point in pretending that healthcare is a straightforward proposition in the modern world, but it is nonetheless interesting to bear witness to the associated rhetoric, some of which we may be forgiven for thinking is more than a little disingenuous. But ego and self interest are fun ingredients in this healthcare recipe, no? Read on to see what sort of rhetorical flourishes health care has wrought recently. L'etat c'est who? A recent series of Twitter exchanges dealt with the proposition that sugary drinks are creating health care havoc and...

IPOs in the United States may be lagging overall, but in med-tech we have seen a flurry of IPO activity, sparking some long overdue optimism regarding the health of the industry. Most recently, Natera, a California-based company, began trading (NASDAQ: NTRA) this past Thursday at $22.10 after pricing 10 million shares of its common stock at $18, the high end of the expected $17 to $18 range. Natera is a genetic testing company that develops non-invasive methods for analyzing DNA. ConforMIS, a Massachusetts-based company, also received a warm welcome from investors when it began trading last Wednesday (NASDAQ: CFMS) at...

Healthcare IT has generated a lot of press coverage lately, but to hear providers tell it, HIT does not generate enough coverage (or reimbursement) of the Medicare kind. It's fun to speculate that more reimbursement might lead to less media coverage because more jingle should fix the problem, but it hasn't worked out that way to date. When sharing goes horribly wrong Don't tell your school-aged children that sharing doesn't always yield the desired bonhomie, but the latest final rule for shared Medicare savings for accountable care organizations is interesting in several...

We've all heard about the FBI investigation into manufacturers of power morcellators, and much of the coverage comes across as breathlessness in search of a scandal. This story goes back to at least 2006 when Ethicon, the Johnson & Johnson subsidiary that withdrew its morcellators from the market last year, appended product labels to advise physicians of the potential for the spread of uterine neoplasms during morcellation for hysterectomy or fibroid removal. There are a number of moving parts to this saga, but the nagging question is still that of what prompted...

This year’s edition of the Heart Rhythm Society annual scientific sessions is in the can, and there were a number of interesting related developments inside and outside the confines of the Boston Convention and Exhibition Center. While the content was fascinating, there was also a lot about social media that was quite interesting as well. Lead Twitterators have stethoscopes Gatherings like HRS draw an interesting and varied crowd, but when you look at the event’s hashtag (#HRS2015), you have to wonder about the ratio of media tweets to those from...