CMS released its final Medicare National Coverage Determinations for TAVR on Sept. 10.
CMS wants to “streamline and update requirements related to pre-procedural patient assessments, intraoperative requirements and operator and hospital procedural volume requirements,” it said in its June proposal.
Here is what changed.
1. TAVR for patients with symptomatic severe aortic valve stenosis is now covered without the coverage with evidence development (CED) requirements.
2. TAVR coverage has been expanded to asymptomatic severe aortic stenosis with CED requirements.
3. Patient suitability for TAVR, surgery, surveillance or palliative care must be jointly evaluated by cardiac surgery and interventional cardiology, but the initial evaluation can be done asynchronously via medical records. Only one in-person evaluation by a heart team TAVR operator is required.
4. Operators must perform either Operators must perform either ≥20 total transcatheter valve procedures with at least 15 being TAVR annually, or ≥40 such procedures with at least 30 being TAVR every two years. Joint participation by two operators is now optional rather than required even across specialties.
5. Facilities must maintain on-site structural heart/cardiac surgery programs, a post-procedure ICU experienced with open-heart valve patients, and a continuous quality-improvement process.
6. CED studies must be held to AHRQ’s 17-point scientific standards. Previously approved CED studies will now be recognized either under the new NCD’s CED provision or under Investigational Device Exemption regulations. CED studies for asymptomatic patients must address specific evidence gaps including long-term valve re-intervention rates, TAVR vs. SAVR vs. surveillance outcomes, and determine whether outcomes-based measures could replace operator volume criteria.
7. CMS also initiated a national coverage analysis for TAVR for aortic regurgitation due to public comments received on its overall TAVR coverage plan. The agency opened for public comment on Sept 10 and will accept comments for the next 30-days.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
