November 5th, 2009

Reports the New York Times:

When makers of heart defibrillators wanted Medicare to vastly expand the types of patients eligible to receive the devices, which can cost upward of $25,000, agency officials were skeptical. It was not clear how many of those patients would actually need a defibrillator, a device that can deliver a life-saving shock to restore a faltering heart to normal rhythm.

So government and industry struck a deal back in 2004. Medicare agreed to expand the device’s use, nearly doubling the number of patients who qualified for one. The companies, in return, agreed to pay for a study to see which patients really benefited.

Five years later, Medicare underwrites more than half of the $4 billion the nation now spends annually on defibrillators, but the agency is no closer to knowing how many lives that big investment is saving. That is because the device companies did not finance the study beyond their initial $4 million commitment, and Medicare did not pick up the slack. As a result, researchers still cannot gather data that would identify the types of patients who would most benefit from a defibrillator.

And so, doctors keep implanting costly defibrillators in patients who may not benefit from them. And doctors and patients have no way of knowing whether one producer’s model performs better than a competitor’s.

The picture is no clearer for the many other types of medical devices that taxpayers, through government-run programs like Medicare, underwrite. Every year, for instance, doctors give patients tens of thousands of artificial hips and knees, without having the data to indicate how long they will last or which ones work best, and Medicare picks up the bills.

As Congress seeks to revamp the nation’s health care system, medical devices might seem an inviting target to better control Medicare spending. Outlays on implanted devices stand at about $76 billion annually in this country and are rising at a rate faster than the cost of drugs, according to a recent study by the McKinsey Global Institute, a consulting group. With an aging population in America, Medicare is picking up more of those costs.

But legislation pending in the House and Senate may not help, some experts say, because the proposals do not require device makers to compete on the same ground as other manufacturers — product performance and price.

Get all the details at the NYT.