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Affordable Care Act is here to stay

by Ben Fidler  |  Published November 12, 2012 at 8:26 AM
For companies across the healthcare sector, one thing became clear following last week's election: for better or worse, there is no turning back now.

Indeed, President Obama's re-election hammered home the reality that the Affordable Care Act, and all of its various complexities and repercussions, is here to stay. And while industry watchers believe in the short term the law will be a positive for Big Pharma -- with the more significant maneuvering coming down the road -- there is mixed sentiment regarding how it will affect medical device manufacturers, which are bracing for a tax provision that will squeeze their margins.

For Big Pharma, the greater issues -- those that may shape its attitude toward the ACA -- lie ahead. Currently, drugmakers are in a good position regarding the legislation: Obama's mandate will essentially assure the industry's constituencies a larger market of insured patients that will buy its drugs. And with more and more ways to serve its patients, such as the evolving fields of personalized and preventative medicines, Big Pharma may even be coming out ahead through the ACA.

"Pharma did something on this round that they did not do the last time in healthcare reform, which is they got themselves to the table pretty early," said Kristina Bieker-Brady, a partner at Clark & Elbing LLP. "They took a few hits so they could come out of it in a pretty good place. And in the end, they were very supportive of the legislation."

Big Pharma's biggest concern going forward, on the other hand, is pricing pressure. Glenn Engelmann, a partner at McDermott Will & Emery LLP, explained that the ACA will only continue "and probably accelerate" such pressures, which pharmaceutical and biotech companies have already been dealing with in the marketplace.

One instrument of that pressure will be the as yet unformed Independent Payment Advisory Board, a 15-member panel designed to help keep Medicare costs down.

"Before the election there were rumblings that the industry would try to get that removed from the legislation, and I suspect that effort will continue," Engelmann said. "The industry is concerned that [the board] may be overly focused on the cost of the drugs, and not necessarily the value [they provide]."

Pharmaceutical companies will also have their eye on Washington's attitude toward biosimilars, or generic biologic drugs. The Food and Drug Administration drafted guidelines for the approval pathway for biosimilars this year. The current statute permits 12 years of marketing exclusivity for a biosimilar -- which is far more expensive to produce than a generic drug -- but Engelmann noted there has been some suggestion that the FDA might pull that number back to eight years. Such a move would be bad news for Big Pharma, as several large entities are in an arms race investing hundreds of millions of dollars to create biosimilars and tap into an entirely new healthcare market in the U.S.

"That could be a very contentious issue," Engelmann said.

Still, pharmaceutical companies won't feel the immediate pain facing medical device manufacturers. The reason? The highly controversial, $20 billion medical device tax under the ACA that takes effect in 2013. The provision forces medical device companies to pay a 2.3% levy on sales, regardless of whether they generate a profit. The provision is designed to help make the law revenue-neutral by tapping the windfall device makers are likely to see from the influx of new patients.

"I haven't really seen anybody argue that that's a good thing, especially for small companies," said Thomas Meyers, a partner at Brown Rudnick LLP with more than 20 years experience representing pharmaceutical and biotechnology companies.

Even the big players are having problems with it. St. Jude Medical Inc., for example, expects to pay roughly $60 million to cover the tax and specifically cited the piece of legislation as a factor in its restructuring. St. Jude has announced 800 job cuts since August. Other industry giants such as Zimmer Holdings Inc. and Stryker Corp. have announced job cuts over the past year. Industry group Advanced Medical Devices Association released a study in late 2011 forecasting 43,000 job cuts due to the tax.

"This will have an impact on margins [for smaller companies] making it harder to compete with the big guys," Meyers said.

Bieker-Brady, however, isn't convinced that the tax is a death knell.

"Personally, I think it's kind of an arbitrary tax," she said. "But do I think it's going to kill the medical device world? No."

Bieker-Brady, for example, argued that since the ACA is creating a larger insured patient population, it is increasing the pie for everyone, including medical device makers. As a result, she has seen a "huge uptick" in investments in the sector of late, representing a shift in the model to more of a traditional biotech-VC-pharma paradigm. Namely, a medical device maker gets VC funding, creates technology, and sells itself to an industry powerhouse.

"There's so much that is about to be doable in the medical device field that was previously addressed by things like surgery that the field is just getting so much bigger, and frankly, the model is changing," she said. "I think the ACA is going to catalyze the integration of some very exciting technologies into actual patient healthcare in a way that is faster than it otherwise would have been."

Could medical device makers find a way to get rid of that burdensome tax in the process?

"It'll be interesting to see if that's the one thing that the Democrats actually repeal [from the ACA]," she quipped.

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Tags: ACA | Advanced Medical Devices Association | Affordable Care Act | Big Pharma | biosimilars | biotechnology | FDA | generic biologic drugs | healthcare | Independent Payment Advisory Board | medical device manufacturers | medical device tax | President Obama | St. Jude Medical Inc. | Stryker Corp. | The Food and Drug Administration | venture capital | Zimmer Holdings Inc.

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Ben Fidler

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