Is Exercise a Cure?
In the September 12/September 19th issue of Time Magazine (available to Time subscribers), there is...
Over the last few years, we have continued to blog to keep readers up to date on the evolving state of cardiac valve surgery and the development of transcatheter aortic valve replacement (TAVR) specifically.
As both clinical research results and regulatory changes push TAVR for all into the forefront, hospitals on the cusp of entering this market will need to reevaluate their positions before deciding to move forward.
On March 16, 2019, the NEJM published online the results of two TAVR versus surgical AVR (SAVR) trials in low-risk patients, which effectively ended the debate. At the ACC meeting in March 2019, one of the principal investigators stated that “TAVR is no longer just an alternative therapy, it is the preferred therapy.” [i]
On the heels of these and other similar results, everyone is waiting for CMS to issue its final, updated national coverage determination (NCD), proposed on March 26, 2019. The pending updated TAVR NCD is predicted to reset minimum volume requirements and effectively lower the threshold for entering into and maintaining a TAVR program (see the proposed CMS decision memo). These changes alone, will induce many more hospitals to enter this market. CFA has a number of clients on the verge of making their decision to move forward. Should the volume threshold be lowered by CMS, as proposed, we offer the following summary of critical considerations for implementing TAVR as Part One of a two-part blog post
It is important to recognize that while AVR represents about 75% of all cardiac valve surgeries, transcatheter mitral valve procedures are now in active clinical trials and, if ultimately proven successful, will have similar impact (and generate the same issues) as those found with TAVR; further increasing the importance of transcatheter technologies on cardiac programs in general, and the overall importance of this market segment.
Some lower-volume cardiac surgery programs can be expected to benefit from the decreases in required volumes for combined SAVR, overall catheterization procedures, PCIs and going-forward TAVRs under the proposed NCD. If adapted, these changes will significantly impact entry into this new market.
Structural heart services[ii] including TAVR (and also transcatheter mitral valve repair and 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, payer mix/procedural cost/reimbursement, capital investment, operational capabilities, competition within the marketplace, physician leadership and capabilities, and other pertinent questions similar to those raised above.
In Part Two of this blog post, we will address in more detail many of the issues raised above, including program planning, development and implementation needs; assessing prospective financial performance, physician and staff training, infrastructure needs and other related topics.
If you are interested in learning more about low-volume cardiac surgery programs strategies, please download our updated and expanded white paper (please see Low-Volume Cardiac Surgery Programs: Grow, Consolidate or Divest: Self-Preservation Strategies and Excellence Expectations). 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 email@example.com.
[i] Allar, Daniel, Cardiovascular Business, May/June 2019, page 32, quoting Michael J. Reardon, MD, Houston Methodist Hospital, ACC19.