Editor's Note: This column was co-authored by Sue Peschin.
At a roundtable in Cleveland, HHS Secretary Kennedy was asked what could be done to improve rural and urban healthcare disparities. The secretary acknowledged such disparities, noting he had spent the day at the Cleveland Clinic observing a robotic-assisted heart surgery. At the Cleveland Clinic, this is just another day. In a rural setting, however, this type of procedure is unheard of.
There are many reasons for disparities in care between urban and rural hospitals–from financial resources to invest in cutting-edge equipment and attract top talent to caseloads that provide the kind of repetition that builds expertise—but for one type of cardiac surgery, a large barrier to rural access stems from financial self-interest and a pliant Medicare agency.
For the half-century before 2012, replacing a failing aortic valve meant open-chest surgery, performed by a thoracic surgeon, stopping the heart and sewing in a replacement valve while on bypass. For many patients, the risk and fear of that procedure were decisive. They declined it, and many did not survive.
An estimated 2.5 million people over the age of 75 have aortic stenosis (AS), one of the most common types of heart valve disease. Left untreated, it can progress rapidly to severe AS, and once symptoms appear, one in 10 may die within five weeks.
The FDA approval of transcatheter aortic valve replacement (TAVR) in 2011 changed that calculus. Interventional cardiologists could now replace a failing valve by threading a catheter through a blood vessel — no open chest required.
For patients, TAVR was transformative. For thoracic surgeons about to lose a huge piece of their business to interventional cardiologists, it was an existential threat.
The Society for Thoracic Surgeons (STS) acted quickly to protect its business. In 2012, they were successful in convincing Medicare to condition payment for the procedure on a long list of burdensome requirements. Under a TAVR Coverage with Evidence Development (CED) policy, hospitals and doctors aren’t paid unless 1) only the highest volume hospitals and experienced doctors perform the procedure; 2) the patient is enrolled in a detailed clinical study registry under the premise of collecting data; 3) the patient must separately see both a surgeon and a cardiologist to determine their eligibility; and 4) the surgeon must be paid to be in the room while TAVR is performed by the interventional cardiologist.
In effect, the STS, the American College of Cardiology (ACC), and larger academic medical centers profit from this arrangement, while access is heavily limited for otherwise eligible patients.
The ACC and STS jointly govern the CED registry, and hospitals performing TAVR are required to enroll and pay $25,000 to set up and then $10,500 per year per facility. With approximately 860 qualified sites, that translates to roughly $9 million in annual fees before counting what manufacturers pay for data access or what researchers pay separately to study it. Smaller community hospitals and rural programs often cannot absorb these costs.
As usual, following the money of special interests reveals a lot. The organizations that want CED are the same organizations profiting from it. The Alliance for Aging Research, joined by 34 patient advocacy groups, put it plainly in January 2026: the framework is “detrimental and unethical,” and the registry fee structure is a direct barrier to equitable access.
That financial arrangement has human consequences — concentrated, predictably, among the patients already hardest to reach. USC Schaeffer Center research shows that patients in rural areas are underrepresented at TAVR hospitals and can’t access the procedure closer to home.
Delayed care can cost patients both their money and their lives. Those treated more than 90 days after diagnosis face a 50 percent higher risk of death over three years and nearly $37,000 in additional health care costs compared to those treated promptly. And even at a TAVR hospital, CED’s onerous requirements add an average of 59 days to the timeline between diagnosis and treatment.
When is enough, enough? There have now been more than 25 TAVR clinical trials and more than 1 million TAVR patients captured in the required registry, with results published in nearly 20,000 articles. The Societies themselves acknowledge the wealth of data generated. They even admit that TAVR has become integral to patient care. What they don’t acknowledge is the impact that eliminating CED requirements for TAVR could have on their finances by making registry participation optional. In fact, they are staging a smoke-and-mirrors campaign to obfuscate the truth.
As many have argued, this arrangement should have ended years ago. It could finally end in June, when Medicare is expected to announce a decision about whether to continue applying CED to TAVR.
Over the past 15 years, enough evidence has been developed to conclusively demonstrate that Americans would benefit from increased access to TAVR. This groundbreaking innovation is a key care option for patients. Medicare should end the TAVR CED without further delay.
Joe Grogan is a senior visiting scholar at the University of Southern California’s Schaeffer Institute. He served as a domestic policy adviser to President Trump, 2019-20. He consults for pharmaceutical and medical technology companies.
Sue Peschin, MHS, serves as president and CEO of the Alliance for Aging Research in Washington, D.C.
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