Revising the National Coverage Determination for TAVI: The real barrier to care is not volume requirements

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Scott M Lilly and Satya Shreenivas

Recently the Centers for Medicare and Medicaid Services (CMS) reopened the National Coverage Determination (NCD) for transcatheter aortic valve implantation (TAVI). Much of the discussion has focused on the TAVI and surgical valve volume requirements to start and maintain a TAVI programme. However, in this commentary, Scott M Lilly and Satya Shreenivas argue that the discussion should also review the “two-surgeon” rule as they claim that this is a “more apparent and obstructive barrier” to the care of patients with aortic stenosis than volume requirements.

While volume is one correlate of quality, it is an incomplete one. The extent to which these requirements present a barrier to care is a matter of considerable debate. But as that conversation unfolds, there is a more apparent and obstructive barrier to the care of patients with aortic stenosis within the NCD—namely the two-surgeon rule. Removing this rule immediately would be simpler, occur with the consensus of the care team, and save patient lives.

The original NCD established guidelines for establishing and maintaining TAVI programmes and contained three fundamental elements:

  • The presence of a “heart team” that consists of a cardiovascular surgeon and interventional cardiologist, along with other members that might include specialists in imaging, heart failure, anaesthesia or social work
  • Institutional volume requirements that include the number of surgical valve replacements, percutaneous coronary interventions, and structural heart disease cases (Table 1)
  • Two cardiac surgeons to independently evaluate the patient (face-to-face) and provide assessment of patients’ risk for open surgical valve replacement.
Table 1: Annual requirements for TAVI programmes
Procedures New TAVI programmes Existing TAVI programmes
Surgical aortic valve replacement >50 (>10 high risk) >20 or > 40 per two years
Cardiac catheterisations >1,000 > 1,000
Percutaneous coronary intervention >400 >400

The rationale for these elements was to ensure the appropriate and responsible dispersion of TAVI in a manner that maximised quality and minimised the likelihood of off-label use. These elements revitalised the concept of heart team and were a victory for patient-centred care. These regulations were widely viewed as reasonable and necessary, especially given the environment at the time. TAVI had just been approved for patients deemed high or prohibitive-risk for surgical valve replacement, and concerns about risk-creep necessitated considerable oversight.

While the heart-team approach and the current volume requirements are conventional standards, the requirement for consensus among two surgeons is less defensible. The “two-surgeon” rule often results in an additional clinic evaluation for a patient population that is elderly, often relies on others for transportation, and has a condition with poor short-term outcomes. Additionally, while it may have been important to prevent risk creep as TAVI was being established, we now know that outcomes with TAVI are comparable to surgical aortic valve replacement for the majority of patients with aortic stenosis. Lastly, this rule has no standard—no other approved procedure or medical therapy requires the consensus of two providers from the same specialty; whether it be organ transplantation, percutaneous ventricular support, or chemotherapy.

To view “access to care” as simply as a function of geographical proximity is short-sighted; it involves the delivery of appropriate, quality care in a timely manner. The delay invoked by current volume requirements can be measured in the travel time to a TAVI centre, which is measured in hours. The two surgeon rule often requires a second clinic visit—a delay that is measured in days. While the quality implications of TAVI in lower volume centres are established, a geographical hindrance would seem to be less important than a temporal delay.

We should aim to maximise opportunities for timely, high quality care that benefits patients independent of health systems. By removing the two surgeon rule we mitigate the greatest access to care issue for TAVI in the USA and improve the care of patients. This should be the primary focus of the NCD revision, and occur now, even before quality indices for TAVI are vetted for lower volume centres.

Scott M Lilly is at Department of Medicine, Division of Cardiology, Ohio State University Wexner Medical Center, Columbus, USA; and Satya Shreenivas is at The Christ Hospital Heart and Vascular Center/The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, USA. 

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