Warning: Medicare May Be Bad for Your Heart
Aortic valve replacements are superior to open-heart surgery and less risky. So why are they hard to get?
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.
A transcatheter aortic valve replacement, which can be used as a minimally invasive alternative to open heart surgery. PHOTO:ASSOCIATED PRESS
This episode is a vivid example of the government’s increasing practice to regulate medicine and ration care. A series of landmark studies published earlier this month in theLancet and the New England Journal of Medicine, and presented at the annual meeting of the American College of Cardiology in Chicago, makes clear how contrived the original Medicare guidelines were.
For a patient to be qualified for the aortic valve device, Medicare required two cardiac surgeons to certify first that a patient wasn’t a candidate for the open-heart repair. Also mandated was the presence of a cardiothoracic surgeon and an interventional cardiologist in the operating room during the procedure.
While regulators argued that both doctors had to be on site to rescue the patient in case of a botched procedure (which is extremely rare), in reality this costly and redundant condition was a not-so-veiled way to squelch “competition” between the two different medical specialties that might stoke wider use of the valve device. Medicare also confined the procedure to primarily large academic medical centers.
The limits represented an unprecedented collaboration between Medicare and the FDA, which put labeling rules on the valves that enabled the restrictions. Such a clumsy and forceful intrusion into the practice of medicine would never let medical care evolve with the pace of scientific advance.
The studies unveiled in Chicago confirm that many more patients could benefit from noninvasive valve repairs, and with a lower risk of death and other complications associated with open-heart surgery.
Both the Lancet study and the even more rigorously designed New England Journal study showed that the replacement valves were superior to surgery in the patients examined. The Lancet study reported results from an evaluation of device maker Edwards Lifesciences’ newest transcatheter heart valve—the Sapien 3—in patients who were at “intermediate risk” of death from open-heart surgery. This third-generation device proved superior after one year to open-heart surgery on every key measure, including all-cause mortality (7.4% versus 13.0%) and disabling strokes (2.3% versus 5.9%).
Yet most of the patients in each of these studies, having less severe risks of death, aren’t eligible to receive the devices under current Medicare rules. As a result, many patients are opting for riskier open-heart procedures, or no fix at all. Similar benefits were seen in a third study that looked at outcomes in higher-risk patients three years after they received a comparable valve made by Medtronic.
The studies clearly show that more patients should get the devices. But it will take six months or longer for the FDA to update the product labels to reflect the new results, and another six months or more for a recalcitrant Medicare agency to conform its payment rules to the new medical standard.
Aortic valve devices have improved since Medicare first imposed its restrictive policies, as has the expertise in delivering these procedures. Proponents of Medicare’s heavy hand will argue that without the agency’s intervention the evidence unveiled in Chicago may never have been developed—a fair point.
But it isn’t as if the federal regulators discovered the process for scientific inquiry that led to the Chicago results, or invented evidence-based medical practice. Progress would accelerate if doctors were able to practice medicine more freely, based on the latest science and not the restrictive coverage rules advanced by Medicare.
The alternative to this bureaucratic logjam is to leave the decisions to market participants like health systems and insurers who will compete to offer patients good prices and timelier access to the best services. This is much more akin to the private Medicare insurance model advocated by House Speaker Paul Ryan and others. Embracing the current approach, with its clinical standards crafted in Washington, means getting used to more regulation over what patients can choose, and care that evolves at a pace set by government.
Dr. Gottlieb is a physician and resident fellow at the American Enterprise Institute. He consults with and invests in health-care services companies.
