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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.<\/span><\/p>\n shefkate – stock.adobe.com<\/small><\/div>\n<\/div>\n<\/figure>\n By June 15, Medicare is expected to announce a coverage decision<\/a> impacting access for millions of seniors to a less-invasive procedure for a common type of heart valve disease. The procedure, called transcatheter aortic valve replacement, is preferred by patients because it avoids open-heart surgery and allows quicker treatment and recovery. It also reduces first-year health care costs by about $10,000 per patient<\/a> for Medicare and taxpayers.<\/p>\n The decision will be significant because, for 14 years, patient access to TAVR has been restricted under a Coverage with Evidence Development requirement by the Centers for Medicare & Medicaid Services\u2014the federal agency that runs Medicare. Under CEDs<\/a>, Medicare denies coverage for a newer, FDA-approved treatment except when beneficiaries participate in limited clinical trials or other studies. The CED policies also place strict rules on which doctors and hospitals qualify to participate in the CED trials and studies, which further constrain access. <\/p>\n Considering how restrictive these policies are, it\u2019s not surprising that they impact access to care for millions of beneficiaries annually. Over the past two decades, CMS has applied CED to more than 30 treatments and tests<\/a> for certain cancers, sickle cell disease, and severe hearing loss (cochlear implants), among other conditions. In April 2022, Medicare even applied the policy to an entire class of early Alzheimer\u2019s disease medications, which was the first time the program went outside of medical devices and diagnostics and applied CED to on-label use of FDA-approved drugs. Updated CED guidance in 2024<\/a> indicates it will not be the last. <\/p>\n While CMS creates these CED policies, at least in the case of TAVR, the professional societies like the Society for Thoracic Surgeons and American College of Cardiology have played what health policy experts contend is an outsized role in influencing the specific conditions of coverage and data collection. And the reasons for that influence appear to go beyond clinical concerns and expertise. <\/p>\n \u201cThe 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,\u201d says Joe Grogan, Nonresident Senior Scholar at the USC Schaeffer Institute and a former Presidential Assistant and Director of the Domestic Policy Council in President Trump\u2019s first Administration. \u201cThe 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.\u201d<\/p>\n As heart valve disease treatment has evolved over time, following the money streams within the CED has revealed a lot. <\/p>\n The Evolution in Heart Valve Treatment and Medicare Coverage<\/strong><\/p>\n An estimated 2.5 million people over the age of 75 have aortic stenosis, one of the most common types of heart valve disease. Left untreated, it can progress rapidly to severe AS, and once symptoms appear, 1 in 10 may die within five weeks<\/a>. <\/p>\n Before the FDA\u2019s approval of TAVR in 2011, thoracic surgeons had been saving AS patients for decades through open-heart surgery. Replacing a failing aortic valve meant opening the chest by a thoracic surgeon who stopped the heart and sewed in a replacement valve while on bypass. For many patients, the risk and fear of that procedure was decisive. They declined it, and many did not survive. <\/p>\n The FDA approval of transcatheter aortic valve replacement (TAVR) in 2011<\/a> changed that calculus. Interventional cardiologists could now replace a failing valve by threading a catheter through a blood vessel \u2014 no open chest required. <\/p>\n For patients, TAVR was transformative<\/a>. But, according to Grogan, \u201cFor thoracic surgeons about to lose a huge piece of their business to interventional cardiologists, TAVR was an existential threat.\u201d <\/p>\n The STS and ACC acted quickly. In 2012, they advocated for Medicare to condition payment for the procedure<\/a> on a long list of burdensome requirements. The TAVR CED policy<\/a> includes several Medicare coverage requirements: 1) the patient must schedule separate, face-to-face appointments with a surgeon and a cardiologist to determine their eligibility, regardless of clinical necessity (i.e., clinical guidelines recommend TAVR as a first choice for patients >80 years of age), 2) the surgeon must be paid<\/a> to be in the room (62.5% the rate of the interventionalist) while the procedure is performed by the interventional cardiologist, 3) the patient must be enrolled in the STS-ACC TVT clinical study registry under the premise of collecting data, and 4) hospitals that offer TAVR must perform a certain amount of surgical and interventional cardiac procedures per year.<\/p>\n The ACC and STS jointly govern the TVT Registry. Hospitals performing TAVR are required by the NCD to enroll \u2014 $25,000 to get set up and $10,500 per year per facility<\/a>. With approximately 860 qualified sites<\/a>, that translates to roughly $9 million in annual fees before counting what manufacturers and researchers pay for data access. Smaller community hospitals and rural programs often cannot absorb these costs, so TAVR access depends on where you live.<\/p>\n When the original policy was established, hospitals and heart centers had to perform a certain number of annual procedures\u2014assuming volume of open-heart surgery and other cardiac procedures could be used as a surrogate for the quality of its TAVR care.<\/p>\n \u201cThe rationale for the annual procedural volume requirements when the CED started was \u2018if you do more of something you must be better at it\u2019,\u201d says Dr. Peter Pelikan, MD, FACC, FSCAI, Medical Director of the Cardiac Catheterization Laboratory at Saint John\u2019s Hospital and one of three interventional cardiologists who wrote to CMS in 2017 to request reconsideration of the 2012 CED. \u201cBut 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?\u201d <\/p>\n Research now confirms that volume requirements were never true surrogates, and analyses of TVT Registry data<\/a> over time have also shown that outcomes have improved across all center volume levels as TAVR has become routine, and that the performance gap between high- and low-volume programs has narrowed to statistical insignificance for many measures. According to Grogan, \u201cThe procedural volume requirements that the societies advocated for have been invalidated by the TVT registry data that they manage.\u201d<\/p>\n In response to the question of why the STS has supported CED, and believes it is necessary to continue, an email response states, \u201cTranscatheter 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.\u201d<\/p>\n A spokesperson from the ACC said they were unable to provide a quote but instead sent the January 2026 comment letter to CMS their organization coordinated among the specialty societies, which strongly recommends continuation<\/a> of the TAVR national coverage determination under CED.<\/p>\n It\u2019s worth noting that the information in these patient registries is used by CMS in part to determine future coverage policy, yet CMS has no direct access to the data. CMS also has no enforcement mechanism over whether its CED research questions will be answered and shared with the public, 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<\/a> and covers patient data only through 2019. <\/p>\n The Human Costs<\/strong><\/p>\n That financial arrangement has human consequences \u2014 concentrated, predictably, among the patients already hardest to reach. USC Schaeffer Center research<\/a> shows that patients in rural areas are underrepresented at TAVR hospitals and typically can\u2019t access the procedure closer to home. <\/p>\n Delayed care can cost patients both their money and their lives. Those treated more than ninety days after diagnosis<\/a> 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\u2019s onerous requirements add an average of 59 days<\/a> to the timeline between diagnosis and treatment.<\/p>\n Fourteen Years is Long Enough<\/strong><\/p>\n Health policy experts are asking: when will enough be enough? According to Grogan, \u201cThere 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.\u201d The STS and ACC acknowledge the wealth of data generated. They admit<\/a> that TAVR has become integral to patient care. \u201cWhat is left unanswered is the impact that eliminating CED requirements for TAVR could have on their finances by making registry participation optional,\u201d Grogan said. <\/p>\n