Medicare receives the lion's share of attention where coverage and reimbursement are concerned, but at least one venture capitalist deeply involved in med-tech says private payers have historically been more stringent, and are becoming more so. Jack Lasersohn of the Vertical Group (Summit, New Jersey) told Medical Device Daily, "I think it is more coverage" than reimbursement that is the issue with regard to private payers. He also said this is no reflexive approach to a slippery coverage slope, stating, "I think this is a very conscious raising of the bar" on the part of private payers.

WASHINGTON The House Ways and Means Committee has passed a medical device tax repeal bill by a sizable margin (see story below), but Rep. Erik Paulsen (R-Minnesota) told industry at a meeting in Washington it is unlikely that a repeal bill would be available for review in the Oval Office until after the November elections. "We have some opportunity to make some headway in the Senate," Paulsen told attendees at the Medical Device Manufacturers Association (Washington) annual meeting, but he acknowledged he does not have a good grasp of the Senate head count as it currently stands.

WASHINGTON The FDA guidance on when to file a new 510(k) to address changes to an existing device is still in force at FDA despite industry blow-back and vocal opposition to the guidance on Capitol Hill, said Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA. Shuren was speaking to device makers at the annual meeting of the Medical Device Manufacturers Association (MDMA), and said that any action on this and other guidances mentioned in device user fee legislation would wait until the House and Senate reconcile the differences in their respective bills. Among the other guidances addressed in draft or final user fee legislation are the guidances for mobile medical applications and de novo device applications.

The story behind the problems with Riata electrophysiology leads made by St. Jude Medical has yet to be fully fleshed out, so it’s only natural that there is still a lot of uncertainty. Here are the top five questions I have. Five: What is the role of the surgeon? I have no idea what it takes to implant these things, but I haven’t seen data on lead fractures by center or implanting physician. We know doctors make mistakes, but how will the specialty societies respond if it turns out that skill and experience play a role? Leaving this question entirely...