What we did and did not learn at AdvaMed 2014

October 10, 2014 – 9:29 AM | By Mark McCarty | No comments yet
Max headroom at McCormick, but little breathing space for industry

Max headroom at McCormick Place

The annual meeting of the Advanced Medical Technology Association, or AdvaMed, doesn’t include a lot of mind-blowing news, but there are often developments worthy of note.

Following are a trio of stories addressing what was (not) said, and a few things to watch for over the next year or so.

Physician payment sunburn?

As reported by Medical Device Daily executive editor Holland Johnson in the Oct. 8 edition of MDD, Covidien’s chief medical officer Michael Tarnoff had a few interesting observations about sustainability. Tarnoff said docs are accustomed to getting what they want, but that the push by payers for more evidence will cut into those wish lists.

On the other hand, the doc payment database mandated by the Physician Payment Sunshine Act has Tarnoff concerned that physicians will kiss device development goodbye. Not a good move, said Tarnoff, because device developers will be “flying blind without healthcare professional input.”

Are Tarnoff’s fears well founded? I guess we’ll see, but AdvaMed did argue a week or so back that CMS was not including all the data supplied by industry and that hence the doc payment sunshine database lacked context. Now we get to wait and see how long it takes for the New York Times to report something outrageous, only to discover later it was much ado about nothing.

Tax inversion introversion

Covidien again appears in this week’s blog, with CEO Joe Almeida appearing at the Oct. 6 AdvaMed presser. The session was replete with the usual stuff about the device tax along with an article about private payers making greater use of financial metrics.

Almeida understandably ducked a question about tax inversion. He’d have to be a prize fool to wade into that one, given how much noise there’s been about inversion and Medtronic’s in-the-works acquisition of Almeida’s employer.

AdvaMed chieftan Steve Ubl did say that the association welcomes the inversion debate to the extent that it shines a light on the corporate tax reform impasse. Looming in the not-too-distant future is the prospect that a slight GOP Senate majority in the 114th Congress might lead to the use of budget reconciliation rules for passage of tax reform.

The 15% non-solution

One really good way to screw up a device clinical trial is to under-enroll, an increasingly conspicuous problem these days at advisory committee hearings. One of the sessions at AdvaMed 2014 tackled the clinical trial problem in the U.S., and Chip Hance of Ireland’s Creganna-Tactx Medical said 15% of trial sites enroll zero patients in the typical clinical trial.

I hate to confess ignorance, but that was news to me. Nearly one in seven? Which administrator at these sites is signing up their doctors for a trial when they’re not going to participate?

Roxanna Mehran of the Cardiovascular Research Foundation said one feature of this dilemma is that study coordinators may be tempted to find reasons not to enroll subjects “because that’s less work for them.” If that’s the case, it suggests that about 10% of the clinical trial sites in the U.S. could disappear and nobody in the device business would be the wiser.

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