R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

On the Edge of Our Seats

As the government shutdown dragged onward, nobody was watching the outcomes more than medical device manufacturers. For device manufacturers – there was and still is a lot at stake. And make no mistake – the medical device tax is part of the hot debate in Washington right now. Part of the 2010 Affordable Care Act included a 2.3% tax on medical devices. The tax has caught a lot of attention from both Republicans and Democrats – part of the most recent House GOP proposal to end the partial government shutdown actually includes a deal to suspend this medical device tax for two years. The revenue from this tax is to be utilized to help fund the Affordable Care Act.
The tax has not been fully supported by either party – back in 2010, 30 Democrats joined Republicans and opposed the medical device tax. However, there are very worthy arguments against the device tax & defending the device tax, which I will not explore in this article but are referenced on Newsreplubic.com. (Source: News Republic “Is Obamacare’s Medical-Device Tax Up for Negotiation?”)
Why hasn’t the tax been nixed in general you might ask? Mainly, we haven’t found an alternative source of tax revenue that would replace what the medical device tax would provide, as it raises approximately $30 billion over 10 years and is a large part of the funding for the Affordable Care Act.
In most recent news (Late Tuesday, 10/15), the tax has been cut from the latest House Republican offer; meaning the two year delay might be scrapped altogether. However – it has been in and out of several offers from both Republicans and Democrats for the last several months. (Source: The Washington Post “GOP leaders nix medical device tax delay”). As of this most recent news – it is not looking good for device manufacturers as far as delaying the tax; however, as we’ve already found out – a lot can change in a short amount of time. -SJG

Bipartisan Repeal of Medical Device Excise Tax

Bipartisan support, in today’s world of politics, might seem a little hard to believe. However, the U.S. Senate passed an amendment that repeals the medical device tax last month (Thursday, March 21, 2013). The bill was passed by a bipartisan vote of 79 to 20. 1 This impressive bipartisan support may suggest increasing support for industry.

FDA Budget Cuts This Week

This week, the FDA faces between 5.1 to 5.3% of their budget being cut this week ($210 million of a $4.1 billion budget). I’ll be interested to see what areas of the FDA are impacted by these budget cuts, and what that means for medical device manufacturers. Proposed to be included in those cuts are the user fees medical device & pharmaceutical companies pay the FDA for timely reviews of new medical devices & drugs. Zimmer’s CEO and AdvaMed chairman David Dvorak announced during a conference “The fees voluntarily paid by industry in exchange for meeting certain performance goals are not tax payer dollars and should not be considered in the same light as appropriation funding”. March 1st marks the deadline for when or if these budget cuts will be passed.

Medical Devices and Fantasy Football, More in Common Than You Think

I constantly find myself trying to draw parallels between my work life and personal life in almost everything I do and while I work in Quality and Regulatory for medical device manufacturers, I enjoy spending downtime playing fantasy football. Being that this weekend was the Championship round for the NFL I began some reflection. I found myself realizing that fantasy football has similarities to writing a technical file for a medical device.

Lists by Topic

see all