Washington Scene: New TAVR NCD Changes Volume Requirements, Endorses Heart Team Approach

STS News, Summer 2019 — Patient access to transcatheter aortic valve replacement (TAVR) will be expanded while patient safety requirements are maintained with the recent publication of a new national coverage determination (NCD) for TAVR.

The Centers for Medicare & Medicaid Services (CMS) has made several important changes to existing Medicare coverage terms for this procedure. Over the past year, STS worked in collaboration with the American College of Cardiology (ACC), the American Association for Thoracic Surgery, and the Society for Cardiovascular Angiography and Interventions to actively petition CMS for high-quality standards that would ensure TAVR is performed safely and in the right patient populations. 

The new NCD changes minimum procedure volume requirements to open and maintain a TAVR program. Although the volume requirements have presented concerns to some centers currently performing TAVR, as access to TAVR is expanded in low-risk populations, volume goals should become more easily attainable.

As access to TAVR is expanded in low-risk populations, volume goals should become more easily attainable.

Details on specific volume requirements can be seen in the chart below. While the societies would have preferred CMS replace volume requirements with quality assessment measures from the STS/ACC TVT Registry™, the timing of the NCD made it difficult to codify that change. However, CMS agreed that "validated outcome measures may be an appropriate alternative to procedural volume requirements when establishing quality standards for TAVR programs" and will consider updating the NCD in the future. For information on how STS and ACC are working with CMS to develop quality metrics, see page 6.

Another way the new NCD addresses concerns about access to care is by modifying the previous requirement that two surgeons independently evaluate patients to determine whether they are candidates for TAVR. CMS now requires that a cardiothoracic surgeon and an interventional cardiologist each examine patients face-to-face and evaluate their suitability for surgical aortic valve replacement (SAVR). CMS made this change to recognize "the accumulated experience of the TAVR surgeons and interventionalists, the wide acceptance of the heart team approach, and concern for improving access while maintaining quality of care."

Finally, the NCD specifically requires continued monitoring of TAVR outcomes using a prospective, national, audited registry. Data from the TVT Registry will be used to answer several research questions associated with the NCD and shape the future of treatment for patients with aortic stenosis.

Although there is still progress to be made in Medicare coverage and reimbursement, keeping careful controls on TAVR while focusing on patient access is a win for cardiothoracic surgeons and their patients.

Requirements to Begin a TAVR Program for Hospitals without TAVR Experience
  • ≥ 50 open heart surgeries in the previous year prior to TAVR program initiation
  • ≥ 20 aortic valve related procedures in the 2 years prior to TAVR program initiation
  • ≥ 2 physicians with cardiac surgery privileges
  • ≥ 1 physician with interventional cardiology privileges
  • ≥ 300 percutaneous coronary interventions per year
Requirements to Begin a TAVR Program for Heart Teams without TAVR Experience
  • The heart team must include:
    • Cardiovascular surgeon with ≥ 100 career open heart surgeries, of which ≥ 25 are aortic valve related
    • Interventional cardiologist with: 
      • Professional experience of ≥ 100 career structural heart disease procedures or ≥ 30 left-sided structural procedures per year
      • Device-specific training as required by the manufacturer
Requirements to Maintain an Existing TAVR Program
  • ≥ 50 AVRs (TAVR or SAVR) per year, including ≥ 20 TAVR procedures in the prior year, or ≥ 100 AVRs (TAVR or SAVR) every 2 years, including ≥ 40 TAVR procedures in the prior 2 years 
  • ≥ 2 physicians with cardiac surgery privileges
  • ≥ 1 physician with interventional cardiology privileges 
  • ≥ 300 percutaneous coronary interventions per year