Healthcare reform is the law of the land — for now.
But with Republicans — who retook the House in part via a vigorous campaign against the Patient Protection and Affordable Care Act — leading the U.S. House of Representatives again, challenges to the law are sure to mount. But the 112th Congress will also be forced to deal with a number of issues that will affect the landscape for the medical device industry, not least the Food & Drug Administration’s 510(k) and user fee programs.
To get a sense of how that landscape might evolve over the next two years, MassDevice spoke with Brett Loper, senior vice president and director of government affairs for AdvaMed, the Advanced Medical Technology Assn., and Wanda Moebius, vice president of policy communication for the trade council.
Loper said the new Republican leadership is likely to begin with a full frontal assault on the healthcare reform act.
"Clearly the leadership in the House believes that the mandate from the voters is to attempt to repeal [healthcare reform]," Loper told us. "But it doesn’t take a legislative genius to realize that it takes a two-thirds majority to overturn a veto and President Obama is unlikely to veto a law he views as one of his signature achievements."
The game then will resemble "legislative Jenga," Moebius said, with Republicans seeking to pick on individual aspects of the law, looking to undermine it piece by piece until the entire edifice collapses. And a number of factors will determine what the act actually looks like as it’s implemented, Loper said.
Much of the act’s provisions aren’t slated to kick in until after 2012, he noted, meaning we’re in for a diet of political jockeying during the run to the 2012 elections.
"Court challenges could have such a dramatic change on the law’s operational capacity that Congress is forced to go back in and deal with the law," Loper said. "External events could force people back to the table."
And the battle between the states and the feds could intensify, will potentially 30 states opposing the law outright or — because they’ll be charged with much of its implementation — using their leverage to changes aspects of the bill.
"There is going to be a tug of war between more states and the administration," Loper said. "That could force the Congress to go back in and look at this."
Another factor is the federal budget, which could change the dynamics of the debate if healthcare reform winds up being more expensive than promised.
"[Republicans’] view is that the spending issue is part of what convinced a coalition of voters to vote Democrats out," Loper said. "You’ll see a desire to crank down on spending. Discretionary spending, which in part funds the FDA, is going to be under enormous pressure. That’s going to be a tricky issue to handle.
"More discretionary funding of the FDA is necessary and it’s a good thing," he added. "A robust and capable FDA is in our industry’s best interest."
The 112th Congress will have to address reauthorizing the user fee program, Loper said, with Congressional leaders looking to tack other FDA-related bills onto it. With Republicans in the ascendancy, the Medical Device Safety Act will likely stay on the shelf, Loper said.
The tension between the House and the Obama Administration could help the industry, he added.
"When the same party is in charge of Congress and the executive branch, there tends to be much less oversight of what federal agencies are doing, in large part because they see them as allies and want to give them the runway to implement their agendas," Loper explained. "Tension, in our view, is generally good because its helps moderate things.
"Any agency that’s forced to explain how it operates, it’s helpful to better policy creation and it will be generally helpful to the industry. I suspect that next year the FDA will be called before the House Energy and Commerce Committee," he said. "You’ll see Energy and Commerce become more focused on what the FDA is doing, including 510(k), and I think that’s a healthy thing."