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Uncertainty's impact on health-care's success stories

Jan 12, 2012

Recent reports reveal that regulatory uncertainty is discouraging investment in two of America's great engines of economic growth, jobs and health -- the biomedical industry and medical devices. No surprise, really.

From the California Health Institute, "CHI Survey: Lack of Investment, Regulatory Environment Threaten Future Biomedical Growth, Innovation":

SAN FRANCISCO, Jan. 10, 2012 – Access to capital, a burdensome and uncertain regulatory environment and lack of innovation and productivity in research and development are the biggest threats to the biomedical industry’s growth over the next five years, according to biomedical company CEOs surveyed by CHI-California Healthcare Institute, BayBio and PwC US. ...

According to CEOs surveyed, FDA and regulation are the key issues affecting research and development. Eighty-one percent of CEOs also said that coverage and reimbursement issues are extremely important to the industry’s ability to advance biomedical research, innovation and investment in California.

Also on Tuesday, CNBC interviewed three CEOs from leading medical device firms: Omar Ishrak, Medtronic; Michael A. Mussallem, Edwards Lifesciences and Stephen P. MacMillan of Stryker (video), attending the JP Morgan Healthcare Conference. Asked about the implementation of the Affordable Care and Patient Protection Act, Ishrak commented:

I think the uncertainty around its implementation has definitely impacted this industry, and definitely impacted us. In addition, there’s been greater scrutiny -- some of it is good -- into our hospital customers, and that's also caused a bit of a slowdown in the industry. It's definitely impacted our marketplace.

In a timely report, the Mercatus Center at George Mason University examined the regulatory implementation of the health care law. The free-market regulatory think tank is harsh in its conclusions. From "Haste Made Waste: The Health Care Law's Rushed Regulations":

New research out ...from the Mercatus Center looks at the eight major regulations federal agencies issued to implement the Affordable Care Act and finds "ready, fire, aim!" rulemaking at its worst.

Economists Jerry Ellig and Christopher Conover discovered that the rules contain top-driven, low-quality regulatory analysis that reads more like an attempt to justify decisions than to inform them.

The study shows that the low-quality regulatory analysis for the health care law reflects a systemic failing of the federal regulatory process.

Then there's the coming tax increase, a 2.3 percent excise tax, on medical devices, also thanks to the new health care law. Writing for Bloomberg, Ramesh Ponnuru reports the tax, due to hit in 2013, has already prompted layoffs across the industry with more to come.

The sluggish economy is clearly part of the explanation, but the medical-devices industry had been a relative bright spot within U.S. manufacturing, losing only 1.1 percent of its employees during 2007-2008 while manufacturing as a whole lost 4.8 percent. A study done for AdvaMed, a trade association for the industry, claims the tax could ultimately cost more than 45,000 jobs.

Medical-device companies employ more than 400,000 Americans. Their wages are higher than the national average. The U.S. is a net exporter of medical devices.

The tax will change these numbers for the worse. It will be levied at 2.3 percent of sales; on average, profits make up less than 4 percent of sales in the industry. The AdvaMed study concludes, “The new 2.3 percent excise tax will roughly double their total tax bill and raise the average effective corporate income tax rate to one of the highest effective tax rates faced by any industry in the world.”

There's time to fix these problems, the regulatory miscues and excesses and the punitive tax, but meanwhile the uncertainty remains a major economic disincentive.

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