Medical Device Daily Staff Writer

Everything changes, yet a lot of things will remain the same. That was the key take home point during an analyst call hosted by Wells Fargo (San Francisco) on Friday, discussing the recent mid-term elections and the impact the results would have on healthcare reform legislation and the med-tech industry.

Vince Ventimiglia, a senior VP with B&D Consulting's (Washington) health and life sciences practice, spoke about what kind of changes the healthcare industry could expect now that Republicans have taken over the House and have gained a bit more steam in the Senate.

Ventimiglia has quite a bit of experience on Capital Hill and prior to his work with BD was at the U.S. Department of Health and Human Services (HHS), where he was Assistant Secretary for Legislation for more than three years.

He noted that the healthcare reform debate is a conversation that would be quickly rekindled.

Already GOP members have gone on record denouncing the Obama administration's healthcare reform plan and calling for an all out repeal of the plan.

"We haven't seen any sign from President Obama yet, that he's really willing to compromise healthcare reform," Ventimiglia said. "My gut says he's not going to be looking [to make] changes."

He added that the administration could feel it's "too early" to start thinking about possible changes. Ventimiglia said that it's very doubtful that there will be an all out repeal of the healthcare reform plan, but added that it will be a strong debate in the coming months.

"Expect a two year period of fighting over no changes or small changes," he said. "An outright repeal and getting the president to sign it ... that isn't going to happen. Republicans have got to find other legislative vehicles."

Questions arose on the effect the increased number of Republican governors would have on health insurance exchanges — an organized marketplace for the purchase of health insurance set up as a governmental or quasi-governmental entity to help insurers comply with consumer protections, compete in cost-efficient ways, and to expand insurance coverage.

"Toward the middle of November, Republican governors are meeting to discuss this issue," he said. "The question they will be asking is do we set these things up in compliance with federal law or do we have an experimental phase to see [how these things work].

He told callers that they should see the first signs of where this issue would go in late November.

Next on the list of topics that Ventimiglia covered was the impact the elections would have on med-tech companies.

He said that med-tech companies shouldn't breathe a sigh of relief when it comes down to the issue of user fees. Ventimiglia pointed out that med-tech companies lost serious support for their protest of the user fee, when Rep. Brad Ellsworth (D-Indiana) and Rep. Baron Hill (D-Indiana) were voted out and Sen. Evan Bayah (D-Indiana) retired.

"The med-tech fees still remain a serious bone of contention," he said. "[But] an across the board reduction is hard to see at this point and so is an all out elimination of the fee."

As for FDA, he told callers that they can expect that the agency would face even more scrutiny and it will probably go through even more oversight (O) and investigation (I) hearings in the near future.

"The O and I threat is very real," he said.

Those hearings, which would require the director to testify in front of a committee regarding the organization's effectiveness, and also provide documentation and paperwork detailing its actions, has the potential to tremendously slow down the operations of the agency.

Ventimiglia said don't expect the FDA to be faster in its operations, or faster with approvals.

"I think they stay as risk averse and go as slow as they have or move even slower," Ventimiglia said.

The biggest casualty he said is the Independent Payment Advisory Board Committee (IPAB), an organization that is tasked with reducing the per capita rate of growth in Medicare spending. IPAB is a U.S. Government agency created in 2010 by sections 3403 and 10320 of the Patient Protection and Affordable Care Act. Funding for the board begins in 2012,and the law requires the board to issue its first proposals in 2014.

"IPAB is a target of both parties," he said. "It's recommendations become law unless legislators act."

He said that group could face the possibility of being eliminated.

"In a way this election has created a donut hole on both sides,"Ventimiglia told callers. "What I mean by that is that there are a lot of those moderates that were sucked out of the middle. Things are going to be more polarized."

Omar Ford, 404-262-5546;

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