On July 27, the ACC partnered with the American Association for Thoracic Surgery (AATS), the Society for Cardiovascular Angiography and Interventions (SCAI) and the Society of Thoracic Surgeons (STS) to respond to the Centers for Medicare and Medicaid Services' (CMS) request for comment on the reconsideration of the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR).

ACC, AATS, SCAI and STS joined together to release an updated Expert Consensus Systems of Care document, presented July 25 at the Medicare Evidence Development and Coverage Advisory Committee meeting, regarding operator and institutional recommendations and requirements for TAVR to serve as the foundation upon which the societies recommend that CMS develop an updated TAVR NCD.

The document specifies criteria for the development and maintenance of TAVR programs in the spirit of optimizing quality outcomes and patient safety for all patients with aortic valve disease, including coordinated care by a multi-disciplinary team that incorporates a shared decision-making process; volume thresholds and external program monitoring to maintain program effectiveness and garner sufficient sample size for quality measurement; and active participation in a prospective, national, audited registry, such as the STS/ACC TVT Registry, to collect data and monitor quality and patient outcomes.

The recommendations also include requirements for minimum performance on quality benchmarks and outcome measurement. Per the recommendations, sites with worse than expected performance for two consecutive reporting periods should enter a remediation process, identify gaps and opportunities for improvement by conducting programmatic assessments and implement corrective action plans.

The societies do not recommend that sites failing to meet all requirements should close their TAVR programs. In the submitted comments, the societies state, "It is essential that all TAVR sites continue reporting data on TAVR procedures to a national registry. Ongoing data collection and analysis enables quality outcome measurement. Sites should review their quarterly outcome reports to assess performance in relationship to national benchmarks."

The comments explain that the U.S. has regions of low population density and thus, access to high quality TAVR may require additional travel time and expense for patients who live farther away from a TAVR program. However, current evidence demonstrates that patient access to TAVR therapy is reasonable and that overall volume growth of TAVR in the U.S. will continue to accelerate, particularly with the expansion of indications to intermediate risk patients and potential expansion to patients at low risk for surgical aortic valve repair.

The ACC recognizes that continued investigation of TAVR therapy accessibility is warranted, and striking the balance between maintenance of high-quality outcomes and providing adequate access to care will need to be continually assessed with evidence. The College will continue to collaborate with CMS and other stakeholders to further advance the field of TAVR therapy.

Keywords: ACC Advocacy, Transcatheter Aortic Valve Replacement, Aortic Valve, Centers for Medicare and Medicaid Services, U.S., Thoracic Surgery, Heart Valve Diseases, Medicaid, Medicare, Heart Valve Prosthesis, Registries, Surgeons, Angiography

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