The CFA Perspective

While low-dose coronary artery calcium scoring scans (CAC) using CT have been around for some time, their effectiveness and relatively low cost in assessing cardiac risk seems to be taking on a new life.  Accumulated wisdom and several newer studies have added to the body of clinical knowledge about CAC.  These newer studies have done much to further validate its effectiveness in assessing cardiac risk in certain population groups.  Because of this, CAC is being increasingly adopted by the medical community and many hospitals as an excellent screening tool to identify potential patients at moderate to higher risk for coronary artery disease (CAD).  This blog will highlight these new findings and conclusions with links to the published studies.  We also present a case study of a CFA client hospital that has effectively adopted CAC as a means to build public awareness along with offering a low-cost opportunity for the local and regional public to access a well-coordinated cardiac screening program.

Here is a summary of some salient conclusions from past and more recent studies about CAC.

• Low-dose CT calcium scoring tests offer physicians an effective way to address patients whose risk for CAD is the “gray zone” or middle of conventional risk approaches such as the Framingham Risk Score or Pooled Cohort Equations. Calcium scoring allows physicians to have additional risk evidence to be able to convince patients at risk that, for example, statins and aspirin regimens are right for them beyond recommended diet and exercise strategies.  The picture produced by CT scans, showing visible calcium deposits, can be very convincing to patients who may be reluctant to start a drug regimen.
• To date, CAC screening has been studied in 100,000 patients, including large prospective studies with 15-year follow-up. Additionally, there are in excess of 1,000 peer-reviewed articles on CAC from single-site studies, multi-facility cohorts, and randomized trials.
• Data from the PROMISE[i] trial concluded that CT calcium scoring predicted events just as well as functional testing (such as stress testing or nuclear scanning), at a much lower price, and was easier to use.
• Other studies, including MESA[ii] (Multi-Ethnic Study of Atherosclerosis, The Dallas Heart Study, and others have produced similar conclusions as the PROMISE study, and support increased usage of CAC as a viable risk-assessment strategy.
• The newly released ACC/AHA blood cholesterol guideline[iii], for the first time setting specific LDL targets, specifically identifies CAC as a viable and cost-effective method of identifying and tracking calcium deposits and visually incentivizing at-risk patients to aggressively treat high cholesterol levels.
• Many hospitals charge as little as $50 for a CT calcium score study. This is a subsidized price designed to be attractive to the population and reduce barriers to enrollment.  A full CAD screening program is often offered for $99 to $150 (see case study below for components).
• The 2017 Expert Consensus Statement on CAC from the Society of Cardiovascular Computed Tomography summarizes the available data validating CAC in support of the US Preventive Services Task Force Recommendations Statement for Statin Use in the Primary Prevention of Cardiovascular Disease in Adults.[iv]
• Low-dosage CT can be used serially to show changes in calcium over time. Scans have shown the reversal of disease over time to patients who have made an aggressive commitment to diet, exercise and statin use.  Some believe that serial CT scans to document calcium scores and interventional strategies will become common practice (and clinically justifiable to payers for reimbursement) in the near-term future.

A quick, non-scientific review of hospital websites by CFA shows that these types of programs are becoming increasingly common.  The overall design of these programs, required screening components, and overall operation is straightforward and fairly easy to replicate by other facilities.  

A Successful Regional Hospital Screening Program

CFA has been working with a regional hospital cardiac program to re-energize its program.  The hospital has developed and implemented a very successful public awareness and cardiac screening program incorporating CT CAC and promoted through a comprehensive regional marketing program that uses radio and print media. From program inception in May 2018 until November 1, the program screened 724 patients along two tracks – a comprehensive cardiac screen protocol including a CAC scan and a CAC scan-only screening exam.  The table below presents the actual number of patients screened in the 6-month period, their various levels of calcium scores and other vital statistics from the program.  Note that the screening has resulted in a significant (and appropriate!) number of referrals for both physicians and the sponsoring hospital.

In this regional patient population, the percentage of patients needing further follow–up and/or study has been trending at 16-17% and those needing an intervention (PCI or CABG) at 3-4% respectively.  A full screen for self-referring patients includes a risk evaluation, body composition/BMI, blood pressure evaluation, CT CAC scan, resting ECG, lipid panel, and hemoglobin A1C test, and is offered for $99.  Physician referrals are accepted for CT heart scans only and is offered for $50.  The CT scan is administered by Radiology and the non-cardiac portion of the scan read by radiologists.  The CAC study is read by qualified hospital cardiologists.  Critical to the success of any such program is widespread communication and endorsement among physicians and administration on the plans for the program and the role each participant is to fill.  Basic to this premise is the support of the local and regional referring primary care physicians (PCPs) who will need to be educated on the efficacy and effectiveness of CAC.  Communication and cooperation ensure that the maximum number of potential referrals are captured and that important feedback on both individual patient participation and overall program performance is enhanced.

As can be seen, CT calcium screening can be a highly effective screening tool at a very reasonable price.  Virtually any hospital with the technical and clinical capability, involvement of trained and capable physicians and the will to succeed can develop a successful program that will enhance public awareness of coronary artery disease and the importance of early detection.  One interesting finding emerging in some recent CAC studies is the ability of CAC to identify a sub-population of asymptomatic, low CHD risk individuals who have exceptionally high coronary calcium and, therefore, are at greater risk for serious coronary events.  Please see the American Journal of Medicine article on this topic here.

If you are interested in learning more about cardiac screening programs, cardiac services strategic development, clinical service expansion and/or other programmatic needs for your cardiovascular program, please contact CFA at (949) 443-4005 or by e-mail at cfa@charlesfrancassociates.com.  

[i] Matthew J. Budoff, et al., Prognostic Value of Coronary Artery Calcium in the PROMISE Study (Prospective Imaging Study for Evaluation of Chest Pain), Circulation, Vol. 136, No. 21, 2018.

[ii] Silverman, MG, et al., Impact of Coronary Artery Calcium on Coronary Heart Disease Events in Individuals at the Extremes of Traditional Risk Factor Burden; The Multi-Ethnic Study of Atherosclerosis.  European Heart Journal, 2014 Sep 1;35 (33):  2232-41.

[iii] Grundy, Scott M., et al; AHA/ACC/AACVPR/AAPA/ACPM/ADA/AGS/APhA/ASCP/NLA/PCNA Guideline on the Management of Blood Cholesterol, Circulation, 2018; DOI 10.1161.

[iv] Hecht, Harvey, et al. Clinical Indications for Coronary Artery Calcium Scoring in Asymptomatic Patients:  Expert Consensus Statement from the Society of Cardiovascular Computed Tomography; J. of Cardiovascular Computed Tomography, published online 24, January 2017, pgs. 157-158.

Overview

According to the Society for Thoracic Surgeons (STS) Adult Cardiac Surgery Database: 2018 Update on Outcomes and Quality, across the 1,119 participating cardiac surgery programs in the database, the average adult cardiac surgery procedure volume in 2016 was 200.8 cases.   This is virtually 

equal with the STS definition of “low-volume,” defined as 200 cases or less per year.  As we all know, there are several high-volume to very high-volume cardiac surgery centers across the U.S.  This results in a large percentage of the rest of the cardiac surgery programs having well under 200 annual cases with many providing 100 cases or fewer.  In the most recent reporting year, 80% of total number of programs account for just 54 percent of total CABG volumes!

It is extremely burdensome for a single surgeon to cover a cardiac surgery program, even a low-volume program, given the need for 24/7/365 coverage. Therefore, to attract and retain competent second or “back-up” surgeons, low-volume programs often have to pay market competitive compensation, while their available production will most likely be low compared to its peers.  The resulting “math” results in  a higher compensation per wRVU for employed CT surgeons in the low-volume setting. These and other factors have resulted in a challenging dilemma: What is the most equitable and effective way to address this issue?

In Part One of this blog (see Cardiothoracic Surgeon Compensation in a Low Volume Cardiac Surgery (LVCS) Setting: Part 1) we addressed the multidimensional predicate underlying the challenge of CT surgeon compensation in a low volume (LVCS) setting.  We examined the diverse nature and operating performance of LVCS programs across the country, the need to thoroughly understand each programs’ specific market dynamics, and the changing clinical, technologic and financial factors impacting the successful maintenance of a profitable, high quality LVCS program.

Enhancing Baseline Performance in a LVCS Program

We have learned in our consulting practice not all LVCS programs are cut from the same cloth.  In our experience, many LVCS have opportunities to enhance their strategic operating profile/position through:

1. Redirecting/reducing CT volume leakage. We have found thorough market/program analysis that LVCS programs can identify and slow and/or reverse leakage to competing hospital programs including bypass graft, valve and thoracic cases, leading to increased total case volume/revenue.
2. Recognizing cardiac surgery volume, cost, quality and profitability is a multidimensional equation. Depending on the level of well-planned strategic market and business development activities, many programs can improve their case volume and case mix through smarter competitive and growth strategies.  This is often overlooked and/or untapped within many LVCS programs.
3. LVCS programs with exceptional, outcomes driven CT surgeons leading the service experience decreased operating expense – especially over an entire episode of care – as well as increased quality outcomes, and cost-effective post-op care. Consequently, a program doing 100 surgeries a year can be as, if not more, profitable on a per case basis, than many larger volume programs[i].  (CFA has had the honor of assisting a number of the heart programs listed on the current and past Watson Health Top 50 Cardiovascular Programs lists.)
4. High quality, cost-effective cardiac surgery, even in the low volume setting, can drive significant contribution margins and help dilute the cost of additional CT surgeon support! (nearly 30% of those on the top 50 heart program list qualify as LVCS programs under the aforementioned STS definition!)

In Part Two of this blog we will present an approach to second CT surgeon compensation designed to address the value inequities inherent in wRVU based payment methodology.

Driving the Value Equation – CT Surgeon Compensation Beyond the wRVU Standard

In Part Two of this blog we will present an approach to second CT surgeon compensation designed to address the value inequities inherent in wRVU based payment methodology.

As mentioned above and, in part one of this blog, CFA uses the following dual strategy approach to assist LVCS hospitals to address the second CT surgeon compensation dilemma: 

1. Drive customized program optimization
2. Re-define and expand the CT surgeon value equation

Our firm strongly believes the key issue surrounding the second CT surgeon compensation dilemma is to thoroughly understand and develop a measurable “value play” approach.  It is nearly impossible to retain a competent second CT surgeon based on a compensation methodology using wRVU standards alone.  The “math” simply doesn’t work!  So, besides the obvious “cost of doing business” challenge associated with the need to recruit a second CT surgeon, LVCS programs need to identify, quantify and drive the “total value equation.”  We recommend hospitals develop and use another “value standard” other than the wRVU approach alone.

CFA frequently advises and assists our clients to build into their compensation methodology a set of program development/value drivers.  We have found that most CT surgeons are willing and able to help drive business and optimize the overall cardiac service line!  So, using measures that decrease cost, drive operating outcomes and grow the business can create demonstrable “value.”  Meeting to analyze privately and, also with the entire CV service, a defined set of program growth and development metrics driven by the CT surgeons supports the value play approach to CT surgeon compensation.  Along with operating on a scheduled/fill-in basis, experienced, second CT surgeons can and often have great ideas that help address most of the optimization activities mentioned earlier.  One of our clients has built into their compensation agreements with their second surgeon a set of initiatives that drive cost reduction strategies, improve clinical outcomes, assist the business development team identify and re-direct lost volume, and help the hospital to seek and develop new lines of business (e.g., thoracic, valvular, vascular, etc.)

We recommend that during the recruitment process this approach beyond the wRVU standard be presented in the recruitment job postings and discussed during recruitment interviews so that expectations are clearly understood.  It is not uncommon, and we have seen CT surgeons actually augment the hospitals initial set of “value drivers” during the recruitment and contract negotiation period with their own new, fresh ideas.  CFA understands paying for second CT surgeons to sit in the doctors’ lounge is not a good thing.  While having a second surgeon is almost always needed, LVCS programs can create a methodology to justify and dilute some of this “cost of doing business” through bringing greater, more demonstrable value to their cardiovascular program through measuring and increasing the second CT surgeon’s contributions to the LVCS program via a value-driven agreement!

Footnotes

[i] Watson Health  50 Top Cardiovascular Hospitals Study, 2019 20th edition  |  November 5, 2018

Overview

Advances in coronary heart disease (CHD) prevention, diagnosis and treatment has progressed significantly over the past two decades.  From primary prevention, risk factor reduction and effective noninvasive early screening techniques, to pharmacologic and interventional procedures, the overall volume of coronary artery bypass surgery (CABS) in the U.S. as steadily declined for several years.  Coupled with these preventive, clinical and technologic advances, the proliferation of cardiac surgery programs across many U.S. healthcare markets in past decades has distributed and diluted cardiac surgery volumes adding an additional burden to program viability for many full-service cardiovascular providers.

According to the Society for Thoracic Surgeons (STS) registry data, nearly 80 percent of U.S. CABG programs are considered “low volume,” defined as 200 cases or less per year with a large percentage of these having 100 cases or fewer.  In the most recent reporting year. these 80 percent of programs account for just 54 percent of total CABG volumes.  It is extremely burdensome for a single surgeon to cover a cardiac surgery program, even a low-volume program, so there is likely to be a second surgeon, even though the volumes alone would not support this second physician.  To attract and retain competent surgeons, low-volume programs often have to pay market competitive compensation, while their available production will most likely be low compared to peers.  The resulting math is a higher compensation per wRVU for employed CT surgeons in the low-volume setting. These and other factors have resulted in a challenging dilemma:  What is the most equitable way to compensate employed CT surgeon(s) in a low volume cardiac surgery (LVCS) operating environment?

In part 1 of this blog we will address the complex predicate underlying the challenge of CT surgeon compensation in a low volume setting.  We will examine 1.) multi-factorial market dynamics and 2.) clinical and technologic dimensions impacting the successful maintenance of a profitable, high quality LVCS program.  In part 2, we will present customized, innovative strategies designed to help recruit, retain and compensate CT surgeons in the LVCS setting.

Market Dynamics – Optimizing Your LVCSP

Being designated a “low-volume cardiac surgery program” should not be considered a monolithic phrase or situation.  Not all LVCS programs are cut from the same cloth.  Cardiac surgery volume, cost, quality and profitability is a multidimensional thing.  Depending on the level of demonstrable CT surgeon expertise and quality, payer mix and cost-effective post-op care, a program doing 100 surgeries a year can be as, if not more, profitable per case, than many larger volume programs[i].  High quality, cost-effective cardiac surgery can drive significant contribution margins: nationally, according to a recent Advisory Board cardiac surgery profitability study, the average hospital receives a contribution profit per case of approximately $13,700 for cardiac surgery services, and the profit per case can range from $6,700 to $26,350 for Medicare patients.  Particularly for hospitals with limited risk-based contracting, these highly profitable procedures may subsidize less profitable (but still important) work in other areas.

This factor weighs heavily on the LVCS CT surgeon compensation question.  CFA’s internal data show that LVCS CT financial resource allocation can be well tolerated in high quality, lower cost settings when a cost-effective program performance model drives enhanced contribution margins.

The equation becomes more complex when some or all of these factors are limited or declining.  Surprisingly, for many hospitals, CFA has found that through conducting a comprehensive market assessment and program development evaluation incremental volume growth and/or stabilization can occur in many LVCS programs, even in saturated markets. Through the use of robust, multi-factorial market assessments hospitals can: identify reversable volume leakage, strategies for capturing new growth and provide hospitals and cardiac physicians with an open, honest and rigorous CV surgery program cost, quality and program development evaluation. Additionally, developing an operating environment where greater clinical, operational and performance collaboration and incentives help drive improved CV physician and hospital alignment and treatment strategies can help CV surgery volume stabilization, improve financial performance and improve cost-effectiveness.  This coupled with improving contribution margin helps hospitals better absorb the often-needed addition and cost of a back-up surgeon in LVCS programs.

Case in point, CFA is currently assisting a regional hospital in the mid-west grow its cardiovascular market-share, and in a particular CV surgery volume.  This program has experienced an annual CV surgery volume decreas of approximately 40-50 cases over the past 3 years.  Increasing PCI volume was one factor impacting cardiac surgery volume as well as significant out-migrating case volume within the client’s secondary service area.  With outmigration estimates ranging between 75-125 cardiac surgeries per year, the CV surgery program remained a driver of contribution margin during the past 3 years, albeit in a decreased amount, due to consistently posting some of the best clinical, cost-effective and operational outcomes in the state (and in some cases the nation!).  Due to a consistently cost-effective, best practice CT surgery program, the hospital was able to support their primary CT surgeon with a part-time, back-up surgeon for call coverage and time off.  As a result of the CFA market assessment and strategic growth plan, volumes are steadily growing, some of the “volume leakage” has begun to re-direct, and interventional cardiology is working more closely with the CT surgeon to collaborate on patient treatment strategies.  Currently the hospital is actively developing an expanded second CT surgeon support plan.

Clinical and Technologic Impacts – Not a Death Sentence for LVCS Programs

Coronary intervention has continued to grow substantially in the U.S.  In a large portion of full-service cardiovascular programs, the ratio between PCI and CABS is 3:1 or greater. Additionally, for many programs as much as 30-40% of total cardiac surgery volume is cardiac valve surgery or combination valve/CAB cases.  With the growth of structural heart therapies including TAVR and Mitra Clip surgery, surgical aortic valve replacement (SAVR) and, ultimately, mitral valve surgery (MVS) has begun to further erode cardiac valve surgery volumes with further declines into the future.  According to recent published reports CMS TAVR program requirements may change to become less stringent as the national experience increases and safe, high quality outcomes become commonplace.  This too will have a downward volume effect over time on all cardiac surgery programs including LVCS programs.  However, CFA believes the need for CABS and cardiac valve surgery will be needed into the near to longer term future.  CABS still enjoy a best practice status for many patients with multi-vessel CHD[ii]. Not all valve patients are good candidates for TAVR or Mitra clip intervention.  Plus, reimbursement for cardiac valve surgery versus TAVR is higher in nearly all instances due to substantially reduced cost per case.  Hence there is even a greater need to understand, optimize and maximize the operating performance of your LVCS.

Summary

The purpose of part 1 of this blog post was to provide a concise predicate and review some of the key factors impacting the performance and profitability of low-volume cardiac surgery programs (LVCS).  CFA believes understanding this framework provides important, baseline insights when addressing the challenge of compensating primary and secondary surgeons in the low volume setting.  Not all LVCS program are the same strategically, financially and operationally.  Understanding the key internal and external factors impacting your LVCS comprise one part in developing a sound, sustainable compensation model for adding a second CT surgeon in the LVCS setting.

In part two of this blog we will address how to establish CT surgeon value beyond the use of wRVU’s when adding a second CT surgeon and creative ways to craft an equitable and attractive CT compensation in a LVCS setting.

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, CFA’s 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.

Footnotes

[i] https://truvenhealth.com/Portals/0/Assets/2018-50-Top-Cardio-Study.pdf

ⁱⁱ https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1783046

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.

Strategic Implications

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 cfa@charlesfrancassociates.com.  

Footnotes 

[i] Waksman, Ron, et al, Transcatheter Aortic Valve Replacement in Low-Risk Patients with Symptomatic Severe Aortic Stenosis, JACC:  August 2018, DOI: 10.1016/j.jacc.2018.08.1033

[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.

Two recent developments are important for those hospitals monitoring Transcatheter Aortic Valve Replacement (TAVR) developments.  First, on July 25, 2018 CMS held a meeting of its Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss procedural volume requirements for TAVR, Percutaneous Coronary Interventions (PCI) and other relevant structural heart disease procedures.[1]  Second, prior to the CMS meeting on July 18, 2018, JACC released for pre-publication 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement.  While both the MEDCAC meeting and the AATS/ACC/SCAI/STS consensus recommendations focused on requirements for new programs and continued certification of existing programs, we would like to focus specifically on issues facing new programs. 

Could this be the start of reducing, minimum volume requirements for TAVR reimbursement under Medicare?  If that were to happen, how many lower volume (i.e., less than 50 Aortic Valve Replacements per year) cardiac valve surgery programs would enter this market?  Although speculative at best, this prospect does initiate an interesting discussion of the pros and cons of entering a growing market and attempting to capture lost referrals for hospitals currently operating what CMS has defined by regulation as “low-volume” valve surgery programs. 

Current Required Criteria to Provide TAVR and Receive Reimbursement from CMS 

Medicare’s 2012 national coverage decision lists the following criteria to establish a new TAVR program: 

• At least 50 aortic valve replacements (AVRs) in the year before a TAVR program is launched; including at least 10 AVRs in “high-risk patients.”
• 1,000 catheterization procedures per year, including at least 400 PCIs per year, to start and maintain a program.
• At least two physicians with cardiac surgery capabilities, including one who has performed at least 100 career AVRs, 25 AVRs in one year, or 50 AVRs in two years.
• An interventional cardiologist who has performed at least 100 structural heart disease procedures overall or 30 left-sided structural procedures per year.
• Once a program is started, an interventional cardiologist and a surgeon must perform a combined 20 TAVRs in a single year or 40 over a two-year span to continue the program.
• All participants must submit data to the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry™ (TVT Registry). 

As of 2015, 400+ U.S. hospitals performed 54,782 TAVR procedures according to the Annual Report of the TVT Registry.[2]  The new expert consensus document states that there are more than 580 active TAVR/SAVR sites with over 100,000 TAVR procedures in the TVT Registry.  During 2016, the total number of TAVR and surgical AVRs were about equal.  It is predicted that eventually, TAVR will far exceed SAVR volume.

 Newly Proposed TAVR Requirements from the Consensus Document[3]

 As stated above, JACC recently released a pre-publication version of 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement.  This new consensus document provides detailed recommendations for institutions and individuals to assess their potential for instituting and/or maintaining a high quality TAVR program (the first update since 2012) and reflects the current evolution in practice and quality benchmarks.  At this stage these are multi-societal consensus recommendations and not accepted CMS requirements.

 Of particular note are two findings:

•  In 2017, 204 of 525 TAVR sites (38.9%) performed less than the recommended 50 TAVR’s/year; and
• The Duke Clinical Research Institute has performed a preliminary analysis of the most recent STS-ACC TVT Registry data that shows a clinically meaningful association of higher mortality and other major complications with site annual volume below the recommended threshold of 50 procedures/year.

 In addition, these recommended changes were made to the current recommendations for new programs:

• At least 40 (down from 50) aortic valve replacements in the year before a TAVR program is launched…
• At least 300 PCIs (down from 1,000 cardiac caths and 400 PCI’s) in the previous year …
• Evaluation by one surgeon (down from two surgeons) – although documentation must include both a surgeon and a cardiologist.

 The Natural Progression of Technology

 The roll-out of TAVR technology and its application to an increasingly higher-risk target population has been logical and conservative, following the general path that other new technologies have historically taken.  This is logically demonstrated in the new AATS/ACC/SCAI/STS consensus documents and its focus on clinical outcomes and performance improvement.  We all remember when PCI was introduced in 1977 and how the device evolution (e.g., balloon, bare-metal stent, drug-eluting stent, dissolving stent), patient appropriateness criteria and technological advances evolved to where it is the common go-to procedure today.  While there are ACC/AHA guidelines, and in some states, guideline-derived licensing/certification requirements for operator/provider minimum volumes, both individual operators work load requirements and clinical outcomes for PCI are not the issues they once were.

 TAVR seems to be following a similar evolutionary and somewhat predictable path.  Within this natural evolutionary process, there are always logical concerns of balancing operator skills; minimum proficiency volumes; patient access and selection, appropriateness and risk assessment; clinical and life-style outcomes, and the technological evolution of the procedure, equipment and devices being utilized.  Information from the TVT Registry documents clinical and quality-of-life outcomes from TAVR continue to improve over time[4].  If the past is prologue to the future, then TAVR criteria will also eventually be modified, and perhaps inevitably reclassified from “mandatory” to “recommended” status.  This could change the market for TAVR providers.  The one unanswerable question involves timing – just how long will it take for new guidelines/recommendations to generate new Medicare reimbursement determinations and state-sponsored regulations?

 TAVR in Low-Volume Hospitals

 If and when TAVR reimbursement criteria is modified, what impact will it have on the number of TAVR providers?  Will some procedural volume shift from specialty center to lower volume hospital programs?  Is this a positive development?  Hospitals that cannot meet the stringent 2012-issued criteria have inevitably lost perhaps fifty percent of their AVR procedures to competitor programs with higher volumes.  Some lower volume programs may be able to meet new criteria, fundamentally redistributing overall TAVR volume (and the generally adverse financial consequences) between the 500+ providers now in the market across a greater number of providers.  Will the average volume (both TAVR and SAVR) per provider decrease?  Unless or until patient selection criteria evolves to include a higher percentage of TAVR candidates (beyond current low and intermediate risk patients), then the size of the market will stay relatively stable and some existing programs will lose volume to low-volume providers entering the market.

 Complicating this discussion are research findings based on the TVT Registry that TAVR is associated with better outcomes in high-volume centers.  According to Dr. John D. Carroll, “The volume-outcome relationship for TAVR is both statistically significant and clinically important.”[5]  CFA believes the interplay between volume standards, operator skill/proficiency and case acuity stratification are major drivers of outcomes.  This is, as was the case with low-volume cardiovascular surgery program (LVCSP) outcomes, a multi-factorial issue which requires greater assessment.  Today, the clearly documented position in the cardiovascular literature is that cardiac surgery, in the hands of a skilled cardiac surgeon operating in a low volume setting, is as efficacious as those procedures done at larger centers.[6]

 Further complicating the discussion was the debate within the MEDCAC meeting, which appeared to be split on the issue of whether procedural volume requirements should be required to begin and maintain TAVR programs.[7] 

 The Implications of Low-Volume TAVR

 If current reimbursement were to improve and/or licensure criteria were to be relaxed, any hospital contemplating entering the TAVR market on a low-volume basis should think long and hard before deciding.  Optimizing TAVR programs specifically, and valve programs in general, has been challenging even in high-volume situations.  While TAVR reimbursement changed for the better in FY 2015 with dedicated unique MS-DRGs, the cost associated with this procedure typically outstrips the reimbursement.

 In a value-driven world, with an increasing focus on episodes of care, this situation is problematic with infrastructure, overhead, and high device costs.  If your hospital is losing valve surgery cases, and especially TAVR cases, to higher-volume competitors, entering this market may be a viable alternative.  However, there are significant barriers to entry and continuing challenges to going-forward operations and financial viability that make this decision a complex and potentially costly one.  Even now, some hospitals have opted not to pursue TAVR business and have successfully optimized their valve programs by providing expert pre-procedural diagnosis and follow-up for TAVR patients while still referring the patient for the procedure to a center of choice.  CFA will follow CMS’s reconsideration of volume criteria very carefully.  However, a new National Coverage Determination isn’t expected until June 2019. 

 If you are interested in learning more about low-volume cardiac surgery program strategies, please download our updated and expanded whitepaper (see Low-Volume Cardiac Surgery Programs – Grow, Consolidate or Divest:  Self-Preservation Strategies and Excellence Expectations, our newly 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.  

[1] CMS to reconsider TAVR volume requirements, Cardiology Business, accessed online July 02, 2018.

[2] Grover, et al; 2016 Annual Report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, Journal of the American College of Cardiology, December 2016.

[3] Bavaria JE, Tommaso CL, Brindis RG, Carroll JD, Deeb GM, Feldman TE, Gleason TG, Horlick EM, Kavinsky CJ, Kumbhani DJ, Miller DC, Seals AA, Shahian DM, Shemin RJ, Sundt III TM, Thourani VH, 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document:

Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement, Journal of the American College of Cardiology (2018), doi: 10.1016/j.jacc.2018.07.002.

[4] 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.

[5] Carroll JD, et al.  Joint ACC/TCT Late-Breaking Clinical Trials.  Presented at:  American College of Cardiology Scientific Session, April 2-4, 2016; Chicago, IL.

[6] The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2018 Update on Outcomes and Quality

[7] https://www.cardiovascularbusiness.com/topics/structural-congenital-heart-disease/cms-panel-divided-tavr-volume-thresholds