The Centers for Medicare and Medicaid Services is reconsidering its nationwide policy on whether, and under what circumstances, Medicare will pay for a less-invasive heart valve disease treatment called transcatheter aortic valve replacement (TAVR). Heart valve disease impacts an estimated 8.7 to 11.6 million Americans. Aortic stenosis is one of the most common types of heart valve disease, and it can be debilitating, costly, and deadly. Survival rates for severe aortic stenosis, if left untreated, are low at 50 percent at 2 years after symptom onset, and 20 percent at 5 years. Many with the disease are never diagnosed or treated, particularly minorities and underserved individuals.
TAVR uses a catheter inserted in a patient’s artery that is guided into the heart using advanced imaging techniques. Through this catheter, a tissue heart valve is guided into position and placed directly inside the diseased aortic valve. Once the new valve is correctly positioned, the valve is deployed in a matter of minutes, without opening the patient's chest.
When it was first introduced, this procedure was an important advance for older adults who needed an aortic valve replaced, but were too ill or frail to withstand an open-chest surgery. Over the last six years, the success of TAVR has been demonstrated, and the Food and Drug Administration has expanded its approval to include a large percentage of patients with aortic valve disease. Studies comparing TAVR to traditional open-heart surgery found improved outcomes, and those who underwent the less invasive procedure experienced much shorter hospital stays and recovery times, better quality of life measures, and lower incidence of some major complications.
How the Centers for Medicare and Medicaid Services decide to cover and reimburse hospitals for TAVR is important because it will impact how many hospitals and heart centers will be able to offer the procedure. The biggest debate regarding this coverage decision is about whether the government should continue to require a minimum number of annual surgical and interventional cardiac procedures for a hospital to maintain a TAVR program. When the original policy was established in 2012, the number of annual procedures a given hospital or heart center performed was used as a surrogate for the quality of its care.
This requirement made sense when the technology was new, there was limited data, and there was a learning curve. Early studies showed that increased experience from higher volume facilities led to better outcomes in inoperable-risk and high-risk patients. Today, according to data analyzed from the “TVT Registry”™ managed by the Society for Thoracic Surgeons and the American College of Cardiology, enhanced technology, widespread training, and group learning positively impacts outcomes, independent of procedural volume. TAVR health outcomes are now found to be excellent in both high- and low-volume facilities.
Unfortunately, despite this evidence, the Society for Thoracic Surgeons and the American College of Cardiology have suggested increasing annual procedural volume requirements for hospitals to maintain their TAVR programs. This is not only counterintuitive to what the data tell us, but it could threaten to close TAVR facilities and prevent the opening of new ones.
Not surprisingly, studies have shown that proximity to a hospital that offers TAVR impacts access to this minimally-invasive treatment option. Increasing volume requirements will inappropriately restrict access and create inequalities for patients—because their treatment can differ depending on which hospital they visit. We know that significant disparities already exist for those who do get TAVR, based on race, ethnicity, income, and where people live: 94 percent of patients receiving TAVR are white and 78 percent of patients served by these hospitals are in higher income zip codes. Arbitrary volume requirements harm patients, particularly racial and ethnic minorities who are already undertreated.
Volume is no longer a necessary surrogate for health outcomes in hospitals that offer TAVR. There should be more emphasis on: 1) timely intervention, because the longer patients wait to be treated, the more likely they are to die; and, 2) a focus on health outcomes. Additional measures such as quality of life, mobility, and length of stay in the hospital should be added into the mix. Centers for Medicare and Medicaid Services should work with independent partners on survey research to better understand what patients, not just doctors, prefer. And, the Society for Thoracic Surgeons and the American College of Cardiology should provide open access to their registry data, including meaningful information on hospital performance for Medicare’s Hospital Compare website.
Centers for Medicare and Medicaid Service should develop a solid coverage policy that provides all heart valve patients access to all appropriate treatments. This is an important opportunity for the agency to offer hope and better access to more patients and families.
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