Medical Device Daily Washington Editor

WASHINGTON – The contribution of medical technology to overall healthcare costs has been debated vigorously for the past several years, with critics saying that the value of med-tech is exceeded by the cost and supporters making the opposite argument. The Advanced Medical Technology Association (AdvaMed; Washington) co-hosted a session held here on Tuesday offering another set of perspectives on the topic, but the session included a supportive voice with more than the usual heft in this debate: former CMS administrator and former FDA commissioner Mark McClellan, MD.

The session came on the heels of the announcement made Monday by Senate majority leader Harry Reid (D-Nevada) that the Senate healthcare reform bill will include a public option that states will automatically be required to participate in unless they opt out of the program. What is unclear is whether a state that opts out of the public option would also be able to opt out of paying toward the taxes necessary to subsidize a public option for the other states.

McClellan, now the director of the Engelberg Center for Health Care Reform (Washington), thanked AdvaMed "for putting the focus where it should be," on innovation that saves lives.

The American public is "very concerned about rising costs," McClellan said, but the public also "knows how important healthcare can be in their lives." He observed that "compared to fifty years ago, Americans are living more than seven years longer," thanks in large part to advances in medical technology.

McClellan made a point of casting doubt on worries over the value of the various novel therapeutics that have dotted the medical landscape in the past couple of decades. He said, "while costs have gone up, it has been well worth it," citing Harvard (Cambridge, Massachusetts) healthcare economist David Cutler, PhD, as a source of data that argues that spending on med-tech has "paid off by a factor of more than four to one."

"So the public wants healthcare costs addressed," McClellan said, but the public also wants advances to continue. Americans generally support reform, he noted, unless those reforms impede access or blunt the advances in drugs and devices that residents of the U.S. have come to expect. In that case, "that support goes way down to below 30%," he said.

Overuse, underuse and misuse of drugs and devices all seem to bedevil attempts to streamline the delivery of care, McClellan suggested, and preventive care is also ignored. McClellan also argued that policymakers would do well to put "more of an emphasis on measuring what we really want" from care delivery systems as opposed to paying for individual services.

Reform, McClellan said, "is going to happen" this year and will continue over the next few years even if a reform bill passes this year. "What's missing is the discussion of the impact of reform on innovation," he said, which "needs to be a central part of the debate." Regarding the tax on devices, he said, "hopefully there are better ways to finance the reform efforts," such as savings engendered by preventive care and better outcomes driven by reforms to payment.

Mike Minogue, president/CEO of Abiomed (Danvers, Massachusetts) opened the session with a few remarks about the value of med-tech. "I know that innovation ... saves lives, improves patient outcomes, and reduces overall costs," he said, offering data in support of the position. He noted that advances in cardiovascular treatment "have brought down death rates from heart attack by 47%" and have reduced the mortality due to stroke by double-digit percentages as well.

However, heart disease is still the leading killer in the U.S., Minogue remarked, reminding the audience, "more women die every year of heart attacks than men," and that more women still die of heart disease than of breast cancer. He also said that a heart attack carries a lot of costs even if the patient survives the acute episode. "You may have given up half of your remaining life" due to the effects of an infarct on the myocardium, Minogue stated.

Charles Tillman, a cornerback with the Chicago Bears (Chicago) of the National Football League (New York) told attendees of an experience he had with cardiovascular devices. He said his daughter Tiana was diagnosed in 2007 with an acute form of cardiomyopathy, which required a transplant. "We were just waiting on a heart" as Tiana survived on an extracorporeal membrane oxygenation (Ecmo) machine to sustain her heart. "When you're on the Ecmo, you're completely paralyzed," Tillman noted, adding that his daughter's condition was rapidly deteriorating.

However, a physician from Michigan informed Tiana's parents that she might benefit from what Tillman described as the Berlin Heart, presumably a reference to the Excor pediatric ventricular assist device made by Berlin Heart (The Woodlands, Texas). Berlin recently announced that it had acquired an orphan product development grant from FDA to support its investigational device exemption for the Excor pediatric unit (Medical Device Daily, June 19, 2009).

Tillman said Tiana's first day on the Excor was difficult. "On the first day, she didn't wake up," but the girl's condition improved. "She was on the Berlin heart for two days," which bridged to a transplant, he said. "We were fortunate to have to wait only two days" before a donor heart came available, he noted. Their daughter is now two years old and thriving.

Mark McCarty, 703-268-5690