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US Election 2016

Set Alert for US Election 2016

Medical Innovation Bills On Fast Track In Congress, But Some Barriers Remain

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.

US Election 2016 Policy & Regulation Legislation

Latest From US Election 2016 & Medical Device

Podcast: The Trump Factor – Current And Potential Changes For US Medtech

In this free podcast, In Vivo asks AdvaMed government affairs director JC Scott what the medical technology industry hopes for, expects, and fears from the new Republican US president.

United States US Election 2016

AdvaMed-Chair Exit Interview: Vince Forlenza On Medtech Policy Priorities

BD CEO Vince Forlenza just finished his two-year term as board chairman of AdvaMed. For the most part, his successor will face the same priorities he did during his tenure: repealing the 2.3 percent medical device excise tax and reauthorizing device user fees. Forlenza spoke with Medtech Insight in this podcast interview.

Policy Legislation

Trump's Sights Set On Payers And Pharmas, But Medtechs Must Not Be Complacent

It's been a big month for plans intended to shape the future of health care in the US, with the Trump Administration showcasing its ACA replacement bill and issuing budget proposals. At this stage, it's hard to peg winners and losers and although the focus is squarely on insurance, the medtech sector should guard against complacency, says ZS Associates' Brian Chapman.

Medical Device Regulation

US CMS Nominee Verma Advances To Senate Floor On Narrow Vote

Seema Verma, President Trump's nominee to lead the Medicare agency, was approved by the Senate Finance Committee March 2 on a narrow 13-12 vote; her confirmation will now be taken up by the full Senate. Questions remain about Verma's viewpoints related to replacement of the Affordable Care Act and on promoting alternative Medicare value-based payment models.

Reimbursement Policy

CMS Nominee Seema Verma Urges Caution On Competitive Bidding Program

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.

Policy Reimbursement

US FDA Could Be Mostly Spared From Trump's Regulation-Slashing Order

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.

Regulation FDA
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