When Medicare in 2011 agreed to pay for a revolutionary procedure to replace leaky heart valves by snaking a synthetic replacement up through blood vessels, the goal was to offer relief to the tens of thousands of patients too frail to endure open-heart surgery, the gold standard.
To help ensure good results, federal officials limited Medicare payment only to hospitals that serve large numbers of cardiac patients. The strategy worked. In the past seven years, more than 135,000 mostly elderly patients have undergone transcatheter aortic valve replacement, known as TAVR. And TAVR's in-hospital mortality rate has dropped by two-thirds, to 1.5%.
Now, in a campaign motivated by a muddy mix of healthcare and business, smaller hospitals and the medical device industry are arguing that the technique should be more widely deployed.
They note only about half of the nearly 1,100 hospitals offering surgical valve replacement can do TAVR. And they say current limitations discriminate against minorities and people in rural areas, forcing patients to undergo a riskier and significantly more invasive treatment or miss getting a new valve altogether.
Hospitals that already have a TAVR franchise are fighting to stifle new competitors, saying programs that do not do enough procedures would not provide high-quality care. At stake is the care of thousands of patients.
Medicare & Medicaid Services
Half of the more than 250,000 Americans estimated each year to develop severe aortic valve stenosis narrowing of the valve that regulates the flow of blood from the heart to the largest artery of the body die within two years. Getting an artificial heart valve lowers that death rate to as low as 17%, studies show.
Also at stake is the $45,000 Medicare pays hospitals for each TAVR case excluding the doctor's fee. While hospitals typically make only a small profit on the procedure partly because the device costs more than $30,000 they benefit because each TAVR patient typically needs other cardiac services and tests that can boost the hospital's bottom line.
In addition, offering TAVR carries a cachet that helps recruit and retain top specialists, who bring in more patients. At a Medicare advisory committee hearing in Baltimore on July 25, both sides of the debate emphasized how they were seeking to help patients. But the economics of TAVR was ever-present given the horde of the medical device and hospital officials and industry analysts in the audience.
The committee split on the issue, although a majority of members backed the continued use of volume requirements. The Centers for Medicare & Medicaid Services is expected to decide later this year whether to change its patient volume minimum for TAVR.