The CFA Perspective

In our continuing series on low-volume cardiac surgery programs (LVCS), we previously discussed structural heart programs and the importance of valve surgery volumes in the overall assessment of potential cases.

(Refer to Low-Volume Cardiac Surgery Programs:  Valve Surgery Trends and Implications, posted 6/28/18).

While the distribution of cardiac surgical cases presented in the The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2018 Update on Outcomes and Quality (based on 2016 data) favors isolated CABG (54% of total), total valve cases – inclusive of combined CABG/valve procedures, aortic valve replacement (AVR), mitral valve repair/replacement and combined aortic/mitral represent a significant total of 24% of the total cardiac surgery cases.[1] 

Increasingly, open-surgical procedures for AVR are being supplanted by transcatheter procedures, applicable to lower risk patient cohorts, which have a direct impact on overall hospital surgical volumes given the current regulatory limitations placed on hospitals to perform such procedures[2]. 

Cardiovascular research literature clearly affirms the use of TAVR will continue to grow.  With a prevalence of 4.5%, an estimated 16.1 million people aged ≥60 years across 37 advanced economies have aortic stenosis.  Of these, there are ≈1.9 million patients eligible for surgical aortic valve replacement and 1.0 million patients eligible for transcatheter aortic valve replacement.[3]

Like transcatheter aortic valve replacement (TAVR), mitral valve surgery, while a minority of total procedures, is being increasingly impacted by transcatheter procedures that, like TAVR, will have an impact on overall hospital volume of cardiac surgery cases either directly (by adding or deleting volume) or indirectly (by leakage or referral to TAVR/TMVR centers). A recent large scale worldwide market assessment conducted by the global research firm Business Communications Company (BCC) showed transcatheter mitral valve repair (TMVR) accounted for just 12 percent of transcatheter aortic or mitral procedures in 2017, according to the report, but are expected to grow faster over the next few years than the more established field of transcatheter aortic valve replacement (TAVR).

In 2023, BBC research predicts TMVR will account for 22 percent of the segment while TAVR will claim the other 78 percent—down from 88 percent in 2017. New interventional technologies, including Abbott’s MitraClip® and potentially Tendyne™ devices, will have the same, potentially profound impact on MVR, as TAVR devices did on AVR.  Therefore, it is important to consider both AVR and MVR strategies in the overall development of cardiac surgical programs, valve programs in particular, and LVCS programs especially.

Mitral Valve Surgery Volume and Distribution

Admittedly, mitral valve procedures currently represent a small total cardiac surgery volumes.  Referring to the STS data for CY 2016 referenced earlier, mitral valve replacement totaled 7,592, repair totaled 8,619 (total 16,211).  In addition, combination CABG plus MV repair/replacements totaled 6,349, for a grand total of 22,560.  These procedures represent approximately 13% of total adult cardiac surgeries during the reporting period.

The Clinical Challenge

Mitral valve disease creates anatomical changes that prevents the flow of blood between the left atrium and left ventricle through leakage or inadequate closure of the valve.  Managing these patients is clinically challenging, especially in frail or elderly patients, where the disease is most prevalent.  MV disease generally falls into three categories:

• Stenosis, or narrowing of the valve opening
• Prolapse (MVP), when the leaflets of the valve bulge or do not close tightly
• Regurgitation (MVR), where significant backwards leakage of blood occurs

Depending upon the diagnosis, anatomical specificity, extent of damage, etc., the definitive treatment has historically relied on surgical repair or replacement with a bioprosthetic (tissue) or mechanical valve through a surgical approach for both MVP and MVR.  Stenosis can be treated with balloon valvuloplasty in many cases and is relatively rare.  Some large surgical centers are using robotics to repair valves.  Clinically, “MV repair is preferred over MV replacement whenever possible.[4] “ Of particular note is the belief that mitral valve replacement, and particularly repair, is a complex, clinical challenging, highly technical procedure heavily dependent upon both individual operator skill and organizational development and capacity to produce quality results.  LVCS programs that commit to valve programs are taking on a considerable challenge.

New and Developing Technologies

Transcatheter devices for valve repair and replacement have been approved for MVR since 2013 for the highest risk patients and are steadily supplanting open surgical approaches.  New and evolving technologies are also now in clinical trials.  Two are summarized below.

The MitraClip® for MV Repair

Abbott’s MitraClip technology, approved in 2013, now in its third generation, is a transcatheter-delivered device used to repair leaky mitral valves and has been used in over 65,000 patients worldwide over the last ten years.  Mitral valve regurgitation, or leakage, is the most common mitral valve problem.  MitraClip is appropriate for the patient that would be the highest risk surgical candidate. 

The Investigational Tendyne™ Device for MV Replacement[5]

A new transcatheter device, Tendyne, has been initially studied in Europe, and is has entered clinical evaluation with the SUMMITT trial in the U.S. as of July 2018.  This device is the first and only MR valve replacement that is repositionable and fully retrievable to allow for more precise implantation, with the hope of improving patient outcomes.  The study will enroll up to 1,010 patients in 80 sites in the U.S., Canada, and Europe.  The initial results of the European trial, released in May 2018, were promising.

Strategic Implications

Why should a LVCS program worry about a low-volume procedure such as mitral valve surgery, particularly when these patients tend to be referred (or self-refer) to high-volume, specialized valve surgery programs capable of utilizing the latest transcatheter technology and marketing themselves based on expertise and excellent clinical outcomes?  The answer is straightforward.  LVCS programs must aggressively (but realistically) understand the total market for cardiac surgery, its component clinical procedures, the overall market for these procedures, and their current and potential role in this market.  If there are patients that are being referred or leaking to competing programs, why are they going?  If it is a question of programming, clinical expertise, outcomes and/or technology, can these issues be successfully addressed to the concerned hospital’s advantage?  If so, what specifically would need to change? For most hospitals with a clear market opportunity the key strategic driver will be access to a skilled TMVR Cardiac surgeon with the right training and expertise. If not, are there ways to compensate for a “disadvantaged situation?”  For example, some hospitals without TAVR capability or minimum volume have negotiated arrangements with TAVR providers to do all pre- and post-TAVR diagnosis and follow-up short of the actual TAVR procedure itself.  Thus, they retain at least a portion of the TAVR patient business.  Could mitral valve cases be “retained” in a similar fashion?  It is well worth thinking about.

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CFA has successfully worked with both low- and moderate-volume cardiac surgery programs to assist them in evaluating structural heart program development.  This work has focused on capturing as much available heart valve surgical volume as possible in the hospitals’ situation.  This assistance has included market analyses, strategy development, “readiness” assessment and program implementation tactics aimed at either starting a new program, or building upon an existing program.   It is important to understand the current market, the exact clinical nature of the potential cases that are being lost to competitors, and the existing and required programmatic and clinical capabilities that will be required to re-capture this important market.

If you are interested in learning more about low-volume cardiac surgery programs strategies, please download our updated and expanded 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.  

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Footnotes:

[1] 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; 13-23.  Note that the distribution of procedures by type included in this update is for CY 2016 data.

[2] Whether or not current minimum volume requirements tied to Medicare reimbursement will be changed by CMS in FFY 2019 is open to speculation as it is currently under active consideration.

[3] https://www.ahajournals.org/doi/pdf/10.1161/CIRCOUTCOMES.116.003287

[4] Nishimura R.A., et al, 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guidelines for the Management of Patients with Valvular Heart Disease:  A Report of the ACC/AHA Task Force on Clinical Practice Guidelines, J. Am College of Cardiology 2017; 70:  252-289.

[5] Abbott Begins Tendyne Transcatheter Mitral Valve U.S. Pivotal Trial, Abbott Laboratories press release; July 26, 2018.

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.