EFFECTIVE IMMEDIATELY: CMS Publishes New National Coverage Determination for TAVR Reimbursement

CMS announced its long-awaited updated transcatheter aortic valve replacement (TAVR) national coverage determination (NCD) final rules on June 21, 2019. 

 Based upon the proposed changes from its original 2012 coverage determination, the updates, as formally adapted, could be a gift to low-volume cardiac surgery programs — and lower-volume cardiology programs in general — nationwide!  The pressure was on CMS to increase access to and availability of TAVR for more hospitals from the hospital industry by lowering the existing volume requirements.  The counter was the professional societies that believed keeping, or even strengthening the current requirements would help ensure a quality product (the classic volume = quality issue).  It appears the hospital industry has won this debate over balancing access and outcomes.  After a comment period following the release of the proposed changes, CMS adopted the final regulations with no material changes from the proposal published on March 26, 2019.

The final decision specifies hospital infrastructure requirements, such as needing on-site heart valve surgery and interventional cardiology programs, along with a post-procedural intensive care unit experienced in managing patients following open-heart valve procedures.

The heart of the final NCD are the proposed volume requirements, which requires the following for hospitals to begin a program and receive reimbursement for the procedures:

• ≥ 50 open-heart surgeries in the year prior to starting a TAVR program, and;
• ≥ 20 aortic valve-related procedures in the two years before program initiation, and;
• ≥ Two cardiac surgeons, and;
• ≥ One or more interventional cardiologists, and;
• ≥ 300 percutaneous coronary interventions (PCIs) per year.

 In order to maintain reimbursement for a TAVR program, the proposal requires centers to have:

• At least 50 AVRs (TAVR or SAVR) per year annually, including ≥ 20 TAVRs in the prior year, or;
• ≥ 100 AVRs (TAVR or SAVR) every two years; including ≥ 40 TAVR procedures in the two years prior, and;
• Two physicians with cardiac surgery privileges, and;
• One physician with interventional cardiology privileges, and;
• 300 PCIs per year.

The CT surgeon on the team is required to have completed 100 or more open-heart surgeries, of which 25 or more are related to the aortic valve, while the interventional cardiologist must have done 100 or more structural heart disease procedures (or 30 left-sided structural procedures per year), as well as device-specific training by the valve manufacturers.

Requirements for the heart team’s composition and for independent evaluation by both a surgeon and an interventional cardiologist for either a surgical or transcatheter procedure, are included in the final NCD. The prior NCD rule that requires a two-surgeon signoff HAS BEEN REMOVED.

Low-volume cardiac surgery programs could benefit from the decreases in required volumes for combined SAVR, catheterization, PCIs and going-forward TAVRs under the final NCD, effective immediately.  These changes will significantly impact entry into this new market. CFA has several client hospitals that are following these developments closely, on the cusp of making a decision to move forward – unable to meet the strict current requirements, but probably able to meet the proposed changes.  We have blogged extensively about the TAVR question – whether or not to proceed with TAVR under the best of circumstances.  Structural heart services[i] including TAVR (and also transcatheter mitral valve repair/replacement) are complex and demanding services.  Beyond the question of “can we meet the current and/or proposed standards,” comes the larger, more complex question of “should we enter this market?”  With the latter question, each hospital will have to assess its own corporate strategy, internal existing/potential volumes, referral patterns and practices, operational capabilities, competition within the marketplace, physician leadership and capabilities, and other pertinent questions.    

The official NCD can be accessed by clicking here.

If you are interested in learning more about structural heart programs, and/or low-volume cardiac surgery programs strategies, please download our updated and expanded 2019 white paper (see Low-Volume Cardiac Surgery Programs:  Grow, Consolidate or Divest:  Self-Preservation Strategies and Excellence Expectations, our expanded and updated White Paper).  If you are interested in cardiac services strategic development, service expansion and/or other programmatic needs for cardiovascular or other services, please contact CFA at (949) 443-4005 or by e-mail at cfa@charlesfrancassociates.com.

[i] See also Valve Surgery Trends and Implications, posted June 28, 2018, and Mitral Valve Surgery Trends and Implications, posted March 14, 2019.