For 14 years, patient access to TAVR has been restricted for Medicare beneficiaries under a Coverage with Evidence Development requirement by CMS. This could change by June 15.
shefkate – stock.adobe.com
By June 15, Medicare is expected to reveal a coverage decision that may affect millions of seniors’ access to a less-invasive procedure for a common heart valve disease. Known as transcatheter aortic valve replacement (TAVR), this procedure is favored by patients because it avoids the need for open-heart surgery, enabling faster treatment and recovery. Additionally, it cuts first-year healthcare costs by approximately $10,000 per patient for Medicare and taxpayers.
This decision is noteworthy because for 14 years, TAVR access for patients has been limited under a Coverage with Evidence Development (CED) requirement by the Centers for Medicare & Medicaid Services (CMS), the federal agency managing Medicare. Under CEDs, Medicare does not cover newer, FDA-approved treatments unless beneficiaries participate in specified clinical trials or studies. The CED policies also impose stringent regulations on which doctors and hospitals qualify for participation, which further restricts access.
Due to these restrictive policies, access to care for millions of beneficiaries is affected each year. Over the past 20 years, CMS has applied CED to more than 30 treatments and tests for conditions like certain cancers, sickle cell disease, and severe hearing loss. In April 2022, Medicare expanded this policy to an entire class of early Alzheimer’s disease medications, marking its first application beyond medical devices and diagnostics to on-label use of FDA-approved drugs. Updated CED guidance in 2024 shows this will not be the last such measure.
While CMS sets these CED policies, especially for TAVR, professional groups like the Society for Thoracic Surgeons and the American College of Cardiology have significantly influenced the coverage conditions and data collection methods. This influence seems to extend beyond clinical concerns and expertise.
“The evolution in heart valve treatment since 2011 not only impacts patients but the ecosystem of hospitals and specialty physicians who make a living treating these conditions,” comments Joe Grogan, Nonresident Senior Scholar at the USC Schaeffer Institute. “The response by the thoracic surgery and cardiology specialty societies to these shifting tides has been to join forces on Medicare coverage determinations for new technologies like TAVR.”
As heart valve disease treatment has evolved, tracking the financial streams within the CED has revealed significant insights.
The Evolution in Heart Valve Treatment and Medicare Coverage
Approximately 2.5 million people over the age of 75 suffer from aortic stenosis, a prevalent form of heart valve disease. Untreated, it can quickly progress to severe AS, with 1 in 10 potentially dying within five weeks after symptoms appear.
Before the FDA approved TAVR in 2011, thoracic surgeons managed AS through open-heart surgery, involving opening the chest, stopping the heart, and sewing in a replacement valve. The risks and fears associated with this procedure deterred many patients, leading to non-survival for some.
The FDA’s approval of TAVR in 2011 altered this scenario. Interventional cardiologists could replace a failing valve via a catheter threaded through a blood vessel, avoiding the need to open the chest.
This was transformative for patients. However, Grogan notes, “For thoracic surgeons about to lose a huge piece of their business to interventional cardiologists, TAVR was an existential threat.”
In 2012, the STS and ACC quickly advocated for Medicare to impose a range of burdensome requirements for TAVR reimbursement. The TAVR CED policy includes several Medicare coverage requirements: patients must have separate, face-to-face appointments with a surgeon and a cardiologist for eligibility assessment, regardless of clinical necessity (e.g., clinical guidelines recommend TAVR as a first choice for patients over 80 years old); surgeons must be paid to be present during the procedure, even if performed by an interventional cardiologist; patients must enroll in the STS-ACC TVT clinical study registry; and hospitals offering TAVR must perform a specified number of surgical and interventional cardiac procedures annually.
The TVT Registry, jointly governed by the ACC and STS, requires hospitals performing TAVR to enroll—$25,000 to get set up and $10,500 per year per facility. With approximately 860 qualified sites, this amounts to roughly $9 million in annual fees, not including what manufacturers and researchers pay for data access. Smaller community hospitals and rural programs often struggle to cover these costs, making TAVR access dependent on location.
Initially, hospitals and heart centers had to perform a certain number of annual procedures, assuming that the volume of open-heart surgery and other cardiac procedures could indicate TAVR care quality.
“The rationale for the annual procedural volume requirements when the CED started was ‘if you do more of something you must be better at it’,” explains Dr. Peter Pelikan, MD, FACC, FSCAI, Medical Director of the Cardiac Catheterization Laboratory at Saint John’s Hospital. He further questions, “But there is no relationship between performance of surgery or other interventional cardiac procedures and TAVR. The analogy would be if I do 100 hernias on you, does that mean I can replace your hip?”
Research now confirms that volume requirements were never accurate surrogates, and analyses of TVT Registry data show that outcomes have improved across all center volume levels as TAVR has become routine, with the performance gap between high- and low-volume programs narrowing to statistical insignificance for many measures. According to Grogan, “The procedural volume requirements that the societies advocated for have been invalidated by the TVT registry data that they manage.”
When asked why the STS supports CED and believes it is necessary to continue, an email response states, “Transcatheter therapies continue to evolve. New devices, device modifications, and evolving clinical indications are being introduced into practice. As changes occur without robust evidence, it is essential that clinical outcomes data are captured to understand and thoroughly inform treatment decisions supported by a robust functioning heart team. CMS National Coverage Decisions and Coverage with Evidence Development provide a pathway for rational dispersion of new technology and/or indications that emphasize evidence and patient safety. STS is committed to using data-driven evidence to support the highest quality care for patients.”
A spokesperson for the ACC mentioned they could not provide a quote but sent the January 2026 comment letter to CMS, coordinated among the specialty societies, which strongly recommends continuation of the TAVR national coverage determination under CED.
It is noteworthy that the data in these patient registries is used by CMS to determine future coverage policy, yet CMS lacks direct access to the data. CMS also has no enforcement mechanism to ensure its CED research questions are answered and shared publicly as required by law. For example, the last annual report of the aggregate registry data on patient characteristics, trends, and outcomes of TAVR procedures was published six years ago, covering patient data only through 2019.
The Human Costs
This financial structure has significant human implications, especially among patients who are hardest to reach. USC Schaeffer Center research shows that patients in rural areas are underrepresented at TAVR hospitals and typically lack access to the procedure close to home.
Delayed care can be costly both financially and in terms of lives. Patients treated more than 90 days after diagnosis face a 50 percent higher risk of death over three years and nearly $37,000 in additional healthcare costs compared to those treated promptly. Even at a TAVR hospital, CED’s demanding requirements delay treatment by an average of 59 days from diagnosis to treatment.
Fourteen Years is Long Enough
Health policy experts question how much longer this can continue. Grogan states, “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 STS and ACC acknowledge the substantial data generated, and they admit that TAVR has become crucial to patient care. “What remains unanswered is the financial impact of eliminating CED requirements for TAVR by making registry participation optional,” Grogan noted.
In May, the Alliance for Aging Research commissioned a poll of 1,000 U.S. adults on the potential impact of these changes. Overall, 77% of respondents agreed Medicare should cover TAVR “the same way that it covers open-heart surgery,” and 67% said they would be more likely to support a political candidate who “supports requiring Medicare to broaden patient access to TAVR.”
“Given the professional and financial interests at play here, there is one important question for CMS and policymakers,” says Kelly Cleary, Partner at Akin. “Can CMS plausibly say that after 14 years of ‘evidence development’ there is still insufficient evidence that TAVR is reasonable and necessary for Medicare coverage purposes? Data has been collected for over a decade, and TAVR is the standard of care. Willful ignorance of decades of evidence is the very antithesis of the reasoned decision making required of agencies under the Administrative Procedure Act. It is also unfair to patients who must wait six months or more for an FDA-approved procedure their cardiologists have recommended.”
