When makers of heart defibrillators wanted Medicare to vastly expand the types of patients eligible to receive the devices, which can cost upwards 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 in 2004. Medicare agreed to expand the device's use, nearly doubling the number of patients who qualified. The companies, in return, agreed to pay for a study to see which patients benefited.
Five years later, Medicare underwrites more than half of the $4 billion the nation spends annually on defibrillators but is no closer to knowing how many lives that investment is saving. The device companies did not finance the study beyond their initial $4 million commitment, and Medicare did not pick up the slack. So researchers still cannot gather data that would identify those types of patients who would most benefit from a defibrillator.
There is still no way to track which types of defibrillator patients have received life-saving shocks and which ones have not needed their devices.
So doctors keep implanting defibrillators in patients who may not benefit. 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 other devices taxpayers underwrite through government-run programs like Medicare. Every year doctors give patients tens of thousands of artificial hips and knees without having data to indicate how long they will last or which work best.
As Congress seeks to revamp the nation's health care system, medical devices might seem an inviting target. Outlays on implanted devices stand at $76 billion annually in this country and are rising at a rate faster than the cost of drugs, according to a study by the McKinsey Global Institute, a consulting group.
Legislation 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.