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Washington Roundup, November-December 2012

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover the post-election picture, pending reimbursement reductions for interventional cardiologists, and new guidance on PMA and 510(k) submission reviews.

With President Obama’s re-election November 6th, the administration is expected to accelerate implementation of a range of health care policies. At the top of the list are provisions of the 2010 Affordable Care Act, which were directly threatened by Republican candidate Mitt Romney, who had vowed to repeal the law, and are now on more solid ground. But the politics of the election season also tend to cause federal agencies to delay rollout of a range of the other, lower-profile policies. Elections trigger an extended absence of lawmakers on Capitol Hill, and members of Congress are now returning to Washington to address dramatic year-end fiscal issues. Here is a guide to some of the important policies and events to look out for in the short term.

Public suspense is shifting focus from electoral politics to high-stakes congressional negotiations. The lame-duck Congress has returned to Washington to...

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