Medical Device Daily Washington Editor

WASHINGTON – Gaining control over skyrocketing healthcare costs in the United States is an “economic imperative,” said Mike Leavitt, secretary for the Department of Health and Human Services.

How does he propose we begin to tackle such a directive? More emphasis on healthcare information technology (IT).

In a speech during Tuesday’s opening session of the 11th FDA Science Forum at the Washington Convention Center, Leavitt told a gathering of FDA staff and representatives from industry and academia that the quickest way to drop costs is to improve efficiency and reduce errors through technological improvements.

Healthcare – improvements in healthcare IT and electronic health records (EHRs), in particular – has been as interest of Leavitt’s since served as governor of Utah.

“That is the area where most of us see the promise for substantially reduced costs in years to come,” he said. “Plus, Americans want less hassle in their healthcare.”

According to the secretary’s figures, healthcare spending currently accounts for roughly 15% of gross domestic product in the U.S. In 1960 it was only 5%. By 2014, it will be near 20%.

“When other industrialized nations and allies are at 9% or 10%, it is clear that this is troublesome to our economic equation,” Leavitt said. “This is a significant dilemma for the American people and Americas industry.”

Leavitt likened the current state of EHR adoption to creating of the U.S. intercontinental railroad in the mid-1800s. At that time, three or four major rail lines were competing, and each ran on tracks that were different widths, he said. Eventually, one track standard was chosen and the lines were interoperable.

“I see the same thing happen in our health industry in the U.S.,” he said. “I travel all over the country and see remarkable healthcare IT systems, EHRs with the capacity to collect and mine information for quality for improvement, and systems that allow patients to receive a prescription drug record and not fill out the same form every time they go to their physician’s office.”

But the problem, he said, “is that our tracks don’t line up.”

The secretary said impasses in the widespread adoption of the right kinds of technology – costs and multiple software vendors and systems – has been a “significant barrier.”

Leavitt added: “It has become clear to me that the business of creating standards in health IT is a difficult one because there are only three ways in way standards ultimately will emerge,” he said. “The first way is for the national government to prescribe them. From what I have observed over time, this rarely works.”

Calling the second option “the last vendor standing” approach, he said this exists where different vendors jockey for market size and position, presenting themselves as the best alternative.

“There are many different ways to reach the destination, but there is no synergy,” Leavitt said.

“The third option is good, old-fashioned collaboration,” he said. “Collaboration can be expensive at first, time consuming and messy, but it is absolutely indispensable.”

He predicted that collaboration among the government, private industry, the health community and the public would bring about the best healthcare IT results.

David Kibbe, MD, director of American Academy of Family Physicians’ (Leawood, Kansas) Center for Health Information Technology, recently told Medical Device Daily that collaboration was important to moving the process forward. For government to dictate specific system standards would be a mistake.

“I am a firm believer in the market and consumers with good information making good decisions,” Kibbe said. “I think it is very incumbent upon us to try to create transparency so that the network of physician consumers is informed about price [and] quality, and we are able to continue to put appropriate pressure on the vendors to improve their products.”

He said he believes vendors eventually will standardize their products enough so that EHRs are increasingly interconnected and able to act as the “central nervous systems” for practices, connecting them to pharmacies, laboratories and one another so that information can be shared easily at minimal expense.

“I would hate to see the government come in with too heavy a hand,” he said. “I would like to see the government be very encouraging of the private sector toward the development of interoperability standards and not enforce those standards. I think that’s precisely what is happening right now – and it’s working very well.”

Leavitt said the government plays the role of “convener.” He noted that “roughly 46% of healthcare is paid for by a government agency – Medicare, Medicaid, the Indian Health Service, the VA [Department of Veterans Affairs] – and we can become early adopters of technology,” he said. “We must bring people together.”

Before ending his talk, Leavitt mentioned that increased post-market surveillance of drugs and devices must be a priority for FDA going forward. Leavitt said it was an area where the agency should be more proactive.

“This also is another area where IT can lead to solutions,” he said. “The FDA brand is a trust. A brand is a promise that is kept and will continue to be kept. FDA is going to have to learn to deal with this new environment.”