The US Centers for Medicare and Medicaid Services (CMS) has updated its national coverage determination (NCD) for transcatheter aortic valve implantation (TAVI), which, amongst other changes, now includes coverage for the treatment of asymptomatic severe aortic stenosis (AS).
In a summary of its new position, which concludes a months-long review process, CMS has determined that the therapy—commonly referred to in the USA as transcatheter aortic valve replacement (TAVR)—will be covered if using a US Food and Drug Administration (FDA)-approved system provided certain patient, physician, heart team, hospital and evidence criteria are met.
Changes to the policy remove hospital procedural volume requirements and coverage with evidence development (CED) requirements for symptomatic severe AS, whilst maintaining CED requirements for coverage indications of asymptomatic severe AS.
Organisations including the American College of Cardiology (ACC), the Society of Thoracic Surgeons (STS), and the Society for Cardiovascular Angiography and Interventions (SCAI), representing the USA’s cardiology and cardiac surgery communities, have been actively involved in efforts to shape the policy through member engagement and consultation.
In a joint statement issued following CMS’s policy determination, ACC, STS and SCAI reiterated the need to enshrine a heart team approach to patient care at the heart of the decision-making process, alongside the need for robust data collection through initiatives such as the Transcatheter Valve Therapy (TVT) Registry—a jointly maintained database from the STS and ACC.
“The American College of Cardiology, the Society of Thoracic Surgeons, and the Society for Cardiovascular Angiography and Interventions appreciate CMS’s efforts to evolve Medicare coverage for TAVR and enhancing access to more patients as the evidence supporting this therapy continues to grow,” the joint statement, signed by each of the presidents of ACC, STS and SCAI—Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, USA), Vinay Badhwar (West Virginia University, Morgantown, USA) and J Dawn Abbott (Brown Medical School, Providence, USA), respectively—states.
“As TAVR expands into new patient populations, it is critical to preserve the quality framework that has contributed to its success. The preservation of the heart team, continued collaboration across specialties, collection of real-world evidence, outcomes monitoring, and continuous quality improvement are the foundation of ensuring and improving outcomes for our patients with severe aortic stenosis.
“Participation in national registries, externally benchmarked quality programmes and rigorous outcomes reporting remain essential to preserving the high standards of care that have defined TAVR’s success. The societies will continue to support the STS/ACC TVT registry and other quality initiatives that promote evidence generation, patient safety, continuous improvement and healthcare value across the cardiovascular community.”
Edwards Lifesciences, whose Sapien 3 platform is US FDA approved for the treatment of severe, asymptomatic AS, currently the only device to hold such an indication, has welcomed the “modernised” policy from CMS.
“Edwards is pleased that this updated policy represents an important step toward improving and expanding patient access to TAVR while reinforcing the value of a multidisciplinary heart team,” the company said in a statement. “Aortic stenosis is a serious, progressive disease, and delays in evaluation, diagnosis and treatment increase the risk of irreversible heart damage and hospitalisation, leading to poorer outcomes and higher healthcare costs, as well as an increased risk of death.
“The modernised policy recognises the importance of timely care by supporting a more streamlined patient care journey and giving heart teams greater flexibility to apply their expertise to both patient evaluation and treatment based on each patient’s clinical needs. Throughout this NCD process, our priority has remained the same: ensuring appropriate access to TAVR, a mature, reproducible procedure backed by an unparalleled body of evidence and support of the Heart Team approach. We appreciate the leadership of CMS and engagement of all stakeholders who contributed evidence, perspectives and expertise to inform this important review of Medicare coverage policy.”
