Hospitals with small to medium-sized cardiac valve surgery programs need to know that the era of TAVR for most or all aortic valve replacement cases (AVR) – regardless of overall risk category – is moving ever closer to reality. A recently published clinical trial of low-risk TAVR patients did not find any significant differences in the rate of all-cause mortality between low-risk patients undergoing TAVR and a control group undergoing surgical aortic valve replacement (SAVR).[i] Positive results for high-risk, then medium-risk, and now low-risk patient cohorts would suggest that the clinical appropriateness of TAVR for all or certainly the majority of patients requiring AVR is now one step closer to becoming best practice.
Recognizing that regulatory and reimbursement changes historically lag behind both clinical trial outcomes and professional society guidelines and recommendations, hospitals with cardiac valve surgery programs will need to evaluate their program volume and SAVR/TAVR procedure mix as the dust finally settles on both clinical appropriateness and reimbursement-related issues. Consequently, low-volume cardiac valve surgery programs are rapidly approaching a crossroads where strategic decisions will need to be made if program viability is at stake in those markets where higher-volume TAVR providers take more volume away from existing non-TAVR providers. In the future, a hospital left with only SAVR capability will be at a distinct disadvantage.
The Current State
CFA has blogged extensively on TAVR-related issues and strategy. Here is a recap of important past and current information, followed by strategic implications.
- We have previously made the point that cardiac valves cases can represent a significant portion of the total cardiac surgery population (refer to Low-Volume Cardiac Surgery Programs: Valve Surgery Trends and Implications, posted 6/28/2018). Nationally in CY 2016, 23% of total cardiac surgeries were cardiac valve cases.[ii] Low-volume cardiac surgery programs in particular, cannot afford to lose additional volume of potential surgical cases to hospitals with both TAVR capability and reimbursement approval. While the actual (and potential) number of valve cases performed in individual hospitals varies tremendously, it is a factor that must be considered in assessing both overall program viability and conceptualizing offensive and defensive strategies.
- Currently, Medicare’s 2012 National Coverage Decision spells out specific criteria for TAVR reimbursement and continuing approval. Between 25% and 33% (or roughly 50% of all hospitals doing valve surgery) of all hospital cardiac surgery programs are now approved to perform TAVR. The procedure, and the regulations surrounding it, have become hotly contested. CMS held a July meeting of its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss procedural volume requirements for procedures including TAVR. Under some industry pressure to relax its existing minimum volume requirements, the group produced no consensus specific to this issue (although the majority favor retaining minimum volume requirements). Prior to the meeting, JACC released for prepublication 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care document: Operator and Institutional Recommendations and Requirements for TAVR. Important findings from this consensus document include: 1) that 38.9% of approved centers perform less than the recommended 50 TAVR’s/year; and, 2) that the STS-ACC TVT Registry shows “a clinically meaningful association of higher mortality and other major complications with site annual volume below the recommended threshold of 50 procedures per year.”[iii] Further, the Consensus document recommends some lowering of recommended minimum volumes from 50 to 40 per year.
- Hospitals are actively competing for TAVR market share. Lower volume hospitals and hospitals in geographic areas without ready access to TAVR, and medical device manufacturers are complaining that the current reimbursement criteria are too stringent and needs to be modified. They claim discrimination issues for minorities and rural residents due to lack of access that force SAVR or no surgery at all. As noted in Hospitals Battle For Control Over Fast-Growing Heart-Valve Procedure,[iv] it is all about money and market share of a cachet-carrying service of importance to all full-service cardiovascular program hospitals. The seemingly perpetual battle between the “haves and have-nots,” and the quality outcomes/volume argument goes on.
On the surface, the broadening of clinical indicators for TAVR to include nearly all patients requiring AVR, has the potential to reconfigure local marketplaces. This should allow the average TAVR provider to increase its volume and thus come closer to meeting or exceeding the national minimum volume standards – especially if minimum thresholds are decreased. It may also allow some lower volume providers to establish TAVR programs for the first time. Lowering of the volume standard by Medicare would potentially assist this scenario. Low-volume cardiac valve surgery programs will now be faced with a complete loss of AVR surgery cases, potentially putting an additional strain on overall program volume and forcing them to make hard decisions about program viability and financial performance.
In our last related blog post, we commented on the need for any hospital contemplating entering this market to think long and hard before making a decision. Optimizing TAVR programs specifically, and valve surgery programs in general, has been challenging even in high-volume situations. The potential for virtually all AVR candidates to receive TAVR at approved centers certainly needs to be factored into every hospital’s unique market and circumstances. Increasing the overall surgical volume may very well help some programs achieve a degree of viability, but careful consideration of potential volume, reimbursement, competitive position, cost and associated factors will be needed to make a robust strategic decision going-forward.
If you are interested in learning more about low-volume cardiac surgery program strategies and options, please download our updated and expanded whitepaper (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 email@example.com.
[ii] D’Agostino, et al, The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2018 Update on Outcomes and Quality, Annals of Thoracic Surgery, 2018; 105; 15-23.
[iii] Grover, F. L., and Holmes, D. R., New Insights from the STS/ACC TVT Registry, Cardiac Interventions Today, Vol. 11, No. 2, March/April 2017.
[iv] Galewitz, Phil, Hospitals Battle For Control Over Fast-Growing Heart-Valve Procedure, Kaiser Health News, posted online August 17, 2018.