US Election 2016
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With an all-Republican House, Senate and administration lined up to lead the government following the 2016 elections, the path is clear for passage of a set of FDA reforms to ease device approvals embedded in a combined House 'Cures' and Senate medical innovation package. It could even happen over the upcoming lame-duck session, before the new administration and Congress take over. But controversy around price-gouging by drug firms still could stymie quick Cures bill passage, an industry attorney predicts. Meanwhile, medtech industry groups plan to seize on the Trump victory as a means to achieve permanent device tax repeal.
Latest From US Election 2016 &Medical Device
Seema Verma, President Trump’s pick to run the US Medicare agency, told the Senate Finance Committee that rural areas should not have to comply with CMS’ medical supplies competitive-bidding program if it is not a good fit. Verma was also questioned on changes she might make to the Affordable Care Act and the Medicare program, but did not offer many specifics.
Even though the executive order that requires regulatory offsets may only have limited application to the agency, industry experts warn that it still could prove to be unwieldly to implement.
Senators voted 52 to 47 to confirm Rep. Tom Price, R-Ga., as Health and Human Services secretary, where he will be a key leader implementing reversals to the Affordable Care Act. Meanwhile, Trump’s pick to lead the Medicare agency, Seema Verma, faces a confirmation hearing in the Senate Feb. 16.
As Obamacare repeal-and-replace plans begin to take shape in the Senate, not all of the legislative proposals include provisions to repeal the medical device tax, and fewer senators in the 2017-2018 Congress have signed on to support repeal of the tax than did in the early days of the prior Congress.
Actions coming out of the Trump administration are important to Medtech Insight readers, but so are detailed coverage of FDA policies not yet specifically impacted by the political change, as our top-10 US regulatory and policy stories in January shows.
The medical device lobby group is targeting lawmakers on the Hill and in key states in a new campaign intended to ensure permanent repeal of the 2.3% device tax is part of a future congressional budget reconciliation bill.
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