Medicare's Upcoming Decision on Transcatheter Aortic Valve Replacement (TAVR) Coverage
By mid-June, Medicare is set to announce its decision on coverage policies for transcatheter aortic valve replacement (TAVR), a procedure that offers a less-invasive alternative for treating aortic stenosis, a prevalent heart valve disease among seniors. This decision could significantly influence access for many beneficiaries, potentially impacting cost savings for Medicare, which estimates a reduction of approximately $10,000 in first-year healthcare expenses per patient.
For the past 14 years, access to TAVR has been constrained by the Centers for Medicare & Medicaid Services (CMS) due to a Coverage with Evidence Development (CED) requirement. These requirements limit Medicare coverage to clinical trials and specified studies, placing limitations on which physicians and hospitals can perform the procedure. CED policies have been applied to over 30 medical treatments and tests, extending to medications as of April 2022.
Organizations such as the Society for Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have significantly influenced TAVR coverage conditions. "The evolution in heart valve treatment since 2011 impacts not only patients but also the ecosystem of hospitals and specialty physicians," noted Joe Grogan, Nonresident Senior Scholar at the USC Schaeffer Institute.
Aortic stenosis affects an estimated 2.5 million individuals over the age of 75. Prior to FDA approval of TAVR in 2011, open-heart surgery was the predominant treatment method. The approval enabled interventional cardiologists to replace aortic valves without opening the chest, transforming patient experiences. However, this shift posed a challenge for thoracic surgeons who viewed it as a threat to their practice.
The STS and ACC have mandated several requirements as part of the CED for TAVR, including dual consultations with a surgeon and cardiologist, and the involvement of specific physicians during procedures. Participation in a clinical study registry is also required, imposing financial burdens on hospitals, particularly impacting smaller and rural facilities.
Research indicates that procedural volume requirements, originally implemented to ensure quality, are not effective indicators of TAVR success. Data from the TVT Registry shows improved outcomes across all volume levels, rendering these thresholds obsolete. Despite these findings, the ACC and STS maintain the necessity of CED policies to monitor evolving transcatheter therapies and ensure data-driven patient safety.
Critics argue that CMS and policymakers need to evaluate whether continued restrictions are justified given the substantial data collected over the past decade. According to Kelly Cleary, a Partner at Akin, it is crucial to determine if maintaining current CED requirements is reasonable, in light of the established efficacy and necessity of TAVR as a standard of care. The delay in Medicare coverage beyond necessary evidence could be considered an oversight that challenges the principles of informed decision-making and fairness to patients.