Medical Device Daily Washington Editor

WASHINGTON — The comparative effectiveness (CE) question got a good shaking up on the second day of the Medical Device Manufacturers Association (MDMA; Washington) annual meeting, and if there was any common theme heard in the comments, it was that CE data will not by itself do much to "bend the cost curve," as the saying now goes. The underlying question was how quickly CE will help contain costs, and how long does healthcare have to show some success in cost containment before reforms begin to boomerang on policymakers.

Carolyn Clancy, MD, director of the Agency for Healthcare Research and Quality (AHRQ), addressed the concerns of the audience with the statement that any CE effort "has to include under-use of very effective treatments."

"What we are trying to do at AHRQ is to expand the evidence curve," Clancy remarked, which means that the agency seeks to establish which treatment strategies yield the best effect. "We know that for devices this has to be done in a very timely fashion," she said in acknowledgement of the iterative nature of devices, but said that the position that CE has no role in device selection made her uncomfortable.

Despite the hype, comparative effectiveness has one thing in common with healthcare information technology: it is "necessary but not sufficient" to reform healthcare and bring costs under control. CE studies do not "make policy or healthcare decisions," but rather "is about weighing the evidence," Clancy said.

Guy Clifton, MD, professor of neurosurgery at the University of Texas Health Science Center (Houston), gave his own take on how CE data might infiltrate the cost dynamic, and he sounded a tone that was less than enthusiastic about the prospects.

Clifton, who penned the recently published book Flatlined, said "I think there's a 50% chance that what's coming out of the Senate Finance committee will have any positive impact on costs." He made the case that the real question of comparative effectiveness is not so much "which is the best device?" as it is "when is the procedure warranted?"

By his reckoning, Clifton said, unnecessary surgery and unevaluated surgery probably adds at least 6% to the nation's healthcare tab. "Poorly managed chronic disease adds 30%," he remarked, adding that hospital inefficiency may add as much as 40% to the cost of care, and administrative waste another 8%.

As an example, he cited the use of percutaneous intervention for patients with stable angina, which he said "does not decrease the future rate of heart attacks compared to good medical management." The trick, he said, is to find that area – between patients who demonstrate only a marginal benefit from the procedure and those who derive a proven benefit – where PCI should be avoided in favor of medical management.

In the end, however, Clifton remarked that "if healthcare costs have to come down and they don't come down," care will be rationed.

Medical Device Daily posed to the panel the question of how Capitol Hill will react to extended periods during which healthcare consumes 20% of gross domestic product as a consequence of expanded coverage without concomitant cost containment.

Clancy's response was "a few years ago, Nancy Ann DeParle said that the portion of GDP was not the issue," a reference to the Obama administration's healthcare reform czar. "I think a decade is probably right" to see some cost control, Clancy said, but made the argument that "to imagine that CE by itself is going to bend the cost curve" is unrealistic.

Clifton saw it differently, predicting that after "eight years, maybe six, we'll hit the wall. We have to have results in eight years or we're facing drastic action, such as massive price cuts" for drugs and devices.