There’s rarely a lack of activity on the policy and regulatory fronts in the world of med tech, and the past couple of weeks are no exception. Let’s talk about a few of those developments.
Consequences or tea leaves? President Obama said in 2009 that elections have consequences, and that’s certainly true. But that’s a very different proposition than declining to “read the tea leaves on election results,” isn’t it Mr. President?
(And then there’s MIT’s Jonathan Gruber extolling the virtues of a lack of transparency, not to mention that he was taking in $400,000 of taxpayer money he decided not to disclose while publishing on healthcare reform. Ah, what a great time to be a stupid American!)
The trick for device makers is figuring out just what those electoral consequences will be in 2015. The medical device tax and corporate tax reform are high on the wish list, and some in industry feel the two are twin sides of the same coin.
Joined at the hip? Says who?
The problem with that definition of the device tax repeal problem is that while several members of the GOP have spoken hopefully of repeal in recent days, it’s not clear that a pairing of repeal with corporate tax reform is seen as a natural act by all involved.
Ask yourself how IBM or General Motors feels about exposing corporate tax reform to a potential veto over the device tax. Nothing against Medtronic’s market cap of more than $60 billion, but it’s a punk compared to Apple, which has a market cap of more than $600 billion. Even the Johnson & Johnson colossus is less than half that.
But whose ox will be gored in the corporate tax reform debate? As Paul Van de Water of the Center on Budget and Policy Priorities reminded me, the closed tax loopholes will affect different industries differently, while the reduced tax rates will affect everyone more uniformly.
That’s the debate that will make the corporate tax reform scrum really interesting in 2015 (remember that it took Congress five years to forge a consensus on patent reform). A device tax repeal may fly as a solo legislative venture next year, but I’ll ask only one question about corporate tax reform: Holding your breath yet?
Combo Dx devices
Steering away from elections, it was interesting to see the draft and final guidances on diagnostic systems used for both medical and research purposes. The draft emerged in April 2013, and FDA indicated in the draft that the provisions would not apply to systems used to screen blood and other tissue donors for communicable diseases.
AdvaMed made a different argument in its remarks for the draft, claiming that “consistency and optimal utility” would be enhanced by making the draft’s provisions applicable to those tissue-screening systems as well.
You have to wonder, though; optimal for whom? The manufacturers? Well, sure, but operators of blood and other tissue donor operations might think they’re paying for features they’ll never use. I find myself in the unusual position of applauding FDA for ignoring industry’s pleas.