via Wall Street Journal
As people age, the main valve controlling the flow of blood out of the heart can narrow, causing heart failure, and sometimes death. In the past the only way to repair the damage was risky open-heart surgery. But an ingenious medical device now allows the heart to be repaired using a catheter that introduces a replacement valve through a main artery in the leg—another miracle of modern medicine.
In 2011, more than four years after they hit the European market, the Food and Drug Administration finally approved aortic heart valves for use in the U.S. The total cost of the new procedure is about the same as open-heart surgery. But government bureaucrats feared that the new replacement valve’s lower risks and easier administration would mean that many more elderly patients would seek to fix their failing heart valves, pushing up Medicare’s total spending. To limit their use, regulators created coverage rules based on a set of strained medical criteria. It was a budget prerogative masquerading as clinical reasoning.