The CFA Perspective

John W. Meyer, LFACHE, and Charles W. Franc

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Periodic Cardiovascular News Update and Implications August 2020

Posted by John W. Meyer, LFACHE, and Charles W. Franc

8/26/20 3:01 PM

Periodic News Update and Implications

Periodically, CFA will highlight a few significant news articles on cardiovascular topics -- clinical or organizational.  Reprinted below are four news items we found interesting and worthy to highlight.  For full information, the links to the original news sources are included.  We have included our interpretation of the organizational implications of each item.

Springboard’s Back to Work Survey Results

Springboard, a healthcare staffing and education firm, conducted a Back to Work Survey, between June 18, 2020 and July 6, 2020, to analyze the current state of the Cath/EP/IR industry and the impact the COVID-19 pandemic has had on it.  The national survey, distributed by e-mail to facility managers across a diverse cross-section of rural and urban facilities, was developed in cooperation with managers and director-level professionals who were looking for answers to twelve specific questions related to the current and changing landscape of an industry being shaped by the pandemic.

The survey received 135 responses and provided key insights on these and other critical topics:

  • Methods of disinfection for PPE
  • Factors contributing to operational capacity
  • Caseloads
  • Planning.

See the full, detailed survey results here.

Implications – Without question, hospital CV programs have been adversely impacted by the COVID-19 pandemic – directly and indirectly through the hospitals overall financial health and substantially decreased patient volumes.  This survey documents that fact.  On a going-forward basis, much will have to change to convince many CV patients that have deferred hospital visits and procedures that they will be safe and treated appropriately.  (Also, refer to the following paragraph).  Additionally, assuring availability to timely COVID-19 testing was also an issue raised by a significant number of those surveyed.  Many of those surveyed are unclear on when operations and patient volumes will return to normal.

American Heart Association “Don’t Die of Doubt” Campaign

The American Heart Association has launched a public communication campaign targeting hospital patient safety during the coronavirus pandemic.  Aimed at cardiac and potential stroke patients, the information provided focuses on urging patients to not delay needed or urgent medical care because of fear of going to the hospital.  The program stresses the measures that hospitals utilize to assure patient safety. The Don’t Die of Doubt campaign information can be found here.

Implications – As highlighted in the Springboard Back to Work survey described above, patient fears and concerns regarding visiting the hospital for testing or needed procedures during the coronavirus pandemic continue to suppress cardiac care activity.  It will benefit patients and hospitals throughout the country if hospitals can effectively communicate the patient safety measures they consistently employ during the pandemic and educate their community on the risks of delaying diagnosis and treatment.

SCAI Issues Position Paper on PCI in ASC’s

The Society for Cardiovascular Angiography and Interventions (SCAI) issued a position paper on May 14, 2020 concerning PCI in ambulatory surgical centers (ASCs).  The Centers for Medicare & Medicaid Services began reimbursing for PCI in ASCs in 2020 after data were published supporting same-day discharge after PCI.

ASCs can appropriately perform diagnostic procedures, such as left and right heart catheterization and coronary angiography, as well as intravascular imaging, physiologic assessment, and coronary angioplasty and stenting, according to the document.

But the statement says that only patients who are candidates for same-day discharge should be treated in ASCs, and not all of these patients would be appropriate for the ASC.

“It is crucial that patients in the ASC receive the same quality of care as those in the hospital setting…This paper is a ‘must-read’ for anyone involved with PCI in an ASC.” Lyndon C. Box, MD, chair of the writing group that prepared this document and an interventional cardiologist at West Valley Cardiology Services in Idaho, said in a statement at the release of the position paper.

The Position Paper can be accessed here.  Additionally, a companion statement was issued May 11, 2020 on optimal percutaneous coronary interventional therapy for complex coronary artery disease (available here.)

Implications – Hospitals in markets with competing ASC’s (and not otherwise prohibited by State regulation) have reason to be concerned that they will potentially lose PCI business if cardiologists shift selective business to ASC’s, particularly if they have a financial interest in such facilities.  Notably, CMS has specifically excluded PCI for coronary artery bypass grafts, chronic total occlusions (CTO), myocardial infarction or coronary atherectomy from being reimbursed in an ASC site of service. The implication is that only “clinically easy,” elective cases will be performed in ASC’s, leaving the more difficult cases to be done in-hospital.  The SCAI has published a list of “unfavorable patient conditions,” and “complex or high-risk lesion characteristics” that should be deferred to the hospital setting.  In general, the PCI market is changing, with increasingly complex cases.  The shift in procedural volume from hospitals to ASCs will have financial implications for hospitals that could potentially impact their ability to provide other necessary services, as well as adversely impacting cost per case and clinical outcomes.  Hospitals need to monitor this scenario very seriously.

Key Trends in Cardiac CT at SCCT 2020

Hospitals that are planning or are already pursing advanced imaging programs utilizing CT should be encouraged by the multitude of new and evolving advances highlighted in the Society for Cardiovascular CT (SCCT) 2020 virtual meeting.  Hot topics included quantification of low-attenuation coronary plaque as the next big cardiac risk assessment, coronary artery shear stress as a marker for heart attacks, CT for the assessment of non-STEMI patients, the role of CT in COVID-19, CT's role in structural heart assessments, as well as new CT technologies.   The trial that had many people talking was the SCOT-HEART Trial: LAP (low-attenuation plaque) Burden sub-study.  It showed non low attenuation, noncalcified plaque accurately predicts MI.  The study found there was a five-fold increase in MI if LAP was above 4 percent.  Classifying plaque can be tedious to characterize manually and subject to reader variability, so this study used a semi-automated artificial intelligence (AI)-based plaque quantification software to standardize how the plaque was analyzed.

Other key topics covered at the SCCT 2020 virtual sessions included information on the recent incorporation of calcium scoring into guidelines for primary cardiac risk assessment and cardiac CT increases in uses while reimbursement has been decreased.

For a full review, go to the Diagnostic and Interventional Cardiology website here.  A CFA article titled CT Coronary Artery Calcium Scoring Revisited:  One Hospital’s Successful Cardiac Screening Program, can be found here.

Implications – Advanced imaging continues to rapidly evolve the use of cardiac CT as a diagnostic tool.  Many hospitals have been slow to adapt cardiac CT beyond basic coronary artery calcium scoring for risk-assessment and diagnosis, particularly in light of the dearth of cardiologists truly qualified to use CT to its fullest potential.  While most of the reported developments from SCCT 2020 are not in everyday practice, their future is very positive.  However, reimbursement for existing approved scans has been diminished.  Hospitals need to continually explore advanced imaging technologies, particularly CV CT, as these advancements move into accepted practice.  Recruiting and supporting cardiologists with advanced imaging training and certification will be critical to advance these technologies in the future.  Look for a future blog post from CFA on advanced cardiovascular imaging.

If you are interested in learning more about any of these important issues or 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.  

Cardiovascular News Update and Implications

Posted by John W. Meyer, LFACHE, and Charles W. Franc

3/11/20 10:00 AM

Periodically, CFA will highlight a few significant news articles on cardiovascular topics – clinical or organizational.  Reprinted below are five interesting news items we feel worthy to highlight.  For full information, the links to the original news sources are included.  We have included our comments and interpretation of the organizational implications of each item.

More Than Half of Heart Patients Nonadherent to Multi-drug Regimens

This topic is an important one and has always fascinated me personally, as I am also on a cardiac multi-drug regimen.  A new study in the American Journal of Cardiology Feb. 6, 2020 edition finds that over half of heart patients on a triple-drug regimen of ACE inhibitors, statins and either calcium channel blockers (CCB) or aspirin are nonadherent to their medications.  Polypharmacy is effective, the authors said, …” but it also complicates a person’s medication regimen, making them less likely to stick to their doctor’s treatment plan. Data from the World Health Organization suggest nonadherence to antihypertensive meds in particular is low, ranging from 30% to 50%.”

The research team found that 52.1% of patients were nonadherent to the ACE inhibitor/CCB/statin regimen, and 50.6% reported nonadherence to the ACE inhibitor/statin/aspirin regimen. Men and patients at a higher CV risk were more likely to be adherent to their pills; those with depression and atrial fibrillation were less likely to adhere.

Implications – The implications of this research are significant.  “These results confirm that nonadherence is one of the most important hurdles to achieve effectiveness in preventing CVD,” the authors said.  Developing ways to enhance compliance, designing mitigations to existing barriers to compliance, and overall strategies to promote compliance through methodologies such as those supported by smart technology (e.g., wearables, smartphones, EHRs), are critical.

Do Anti-Smoking Policies Pay Off?

As reported in the January 3, 2020 edition of WebMD, U-Haul Corporation is stopping the hiring tobacco users in 21 states, but workplace wellness programs efficacy is in doubt.  U-Haul, with 30,000 employees nation-wide, will stop new-hires of tobacco users in the 21 states where such practices are legal (interestingly, California isn’t one of them).  This may sound logical, since it has been documented by the CDC that smoking-related medical expenses add nearly $170 billion dollars per year to employer and government medical expenses.  Employers also suffer $156 billion dollars in lost productivity from smoking-related health issues.  Further, a randomized 4,500 patient study published in JAMA in 2019 found that employees enrolled in wellness programs showed no major improvements in healthcare status or spending after 18 months, compared with employees who didn’t participate.[i]  A Rand study further found that wellness programs generated an average savings of $157 per employee, which was wiped out by the programs cost of $144 per person.[ii] 

Implications – Such programs and policies remain controversial.  Firstly, only 21 states allow discrimination against tobacco-users in employment.  The issues being individual rights and the best way to address tobacco addiction.  Smokers tend to be less educated, make less money and have fewer health benefits than non-smokers.  In practice, it may be better for a smoker to work for a company that has a smoke-free workplace, but provides support to quit.  Comprehensive health and wellness programs still have a place in a broader program of health promotion, including incentives for compliance and meeting health goals, but they are not a panacea for all employers or employees.  It will be instructive to see how the U-Haul policy plays out over time.      

World’s First Transcatheter Mitral Valve Approved in Europe

The Abbott Tendyne Transcatheter Mitral Valve Implantation (TMVI) system received European approval In January 2020.  It is the first transcatheter mitral valve replacement (TMVR) technology to gain commercial clearance in the world. It addresses a critical need to eliminate mitral regurgitation when surgery or mitral repair is not an option in high-risk surgical patients. 

Implications – The Tendyne system is an investigational device in the United States.  In July 2018, Abbott initiated the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) clinical study in the U.S. for the TMVR system (primary completion date 2022). Abbott will use the SUMMIT data for a market clearance submission to the U.S. Food and Drug Administration (FDA). The Tendyne device allows repositioning and retrieval, enabling more accurate device placement during implantation for better outcomes. The trial is enrolling up to 1,010 patients at 80 sites in the U.S., Europe and Canada.  The rapid development of transcatheter approaches to valve surgery will continue to evolve the competitive marketplace in the U.S.  Small or low-volume valve surgery providers will continue to attempt to build their programs with the additional support provided by new research (see item to follow), new products and new techniques. Competition will inevitably increase; and consequently, volume per provider will decrease.

CMS PCI Volume Requirements Questioned for TAVR, MitraClip

Investigators have completed research that found that there was no relationship between a hospital’s percutaneous coronary intervention (PCI) volume and patient outcomes after valve replacement, therefore questioning the relevance of setting minimum PCI volume standards for structural heart programs.  These findings (reported in JAMA online) are timely now that the Centers for Medicare and Medicaid Services (CMS) is updating the National Coverage Determination (NCD) for the TMVr, which currently includes PCI volume requirements, according to the study authors. TAVR had its most recent NCD update in June 2019.  National readmissions data showed hospitals with different PCI volumes had nearly identical median rates of risk-adjusted in-hospital mortality or 30-day readmission after transcatheter aortic valve replacement (TAVR) in 2016.

Implications – Barriers to entry into the TAVR market keep falling.  As regulation and reimbursement guidelines keep changing in favor of smaller volume programs, additional hospital programs will continue to enter this market.  The findings that PCI volume requirements have minimal or no impact on TAVR outcomes will likely further this trend.

FDA Approves New Lipid-Lowering Drug

The U.S. Food and Drug Administration has approved bempedoic acid, an oral, once-daily, non-statin LDL cholesterol (LDL-C)-lowering medicine for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C.

Bempedoic acid has been studied four phase III clinical trials representing more than 3,600 patients. The most recent of these was CLEAR Wisdom, presented at the American College of Cardiology (ACC) 2019 Scientific Session, showing that the addition of bempedoic acid to maximally tolerated statin therapy significantly lowered LDL-C by 15.1% at 12 weeks; it also lowered total cholesterol, apolipoprotein B, non-HDL cholesterol, and C-reactive protein levels. While the study wasn’t powered for clinical events, major adverse cardiovascular events were reduced in the patients treated with bempedoic acid.

Implications – This is important news for the subset of patients who continue to struggle with bad cholesterol and have ASCVD or HeFH, even with maximally tolerated statins, which may mean no statin at all, some of these patients can’t achieve their LDL-C goals. This new drug is an important addition to the continuing pharmaceutical approach to preventing and managing CVD.

If you are interested in learning more about any of these important issues or 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://jamanetwork.com/journals/jama/fullarticle/2730614

[ii] http://www.rand.org/content/dam/rand/pubs/research_reports/RR200/RR254/RAND_RR254.pdf

Quarterly Cardiovascular News Update and Implications

Posted by John W. Meyer, LFACHE, and Charles W. Franc

11/21/19 4:07 PM

Occasionally, CFA will highlight a few significant news articles on cardiovascular topics -- clinical or organizational.  Reprinted below are four interesting news items we feel worthy to highlight.  For full information, the links to the original news sources are included.  We have included our interpretation of the organizational implications of each item.

  • ISCHEMIA and ISCHEMIA-CKD Trial Results Presented at AHA

The results of the ISCHEMIA and ISCHEMIA-CKD studies were presented at the American Heart Association Scientific sessions on Saturday, November 16, 2019.  The multicenter, international randomized trial was designed to determine the differences between a conservative medical therapy approach to treating stable ischemia heart disease (SIHD) and an interventional/surgical approach to SIHD patients.

ISCHEMIA Study Design from the ischemiatrial.org website:

Approximately 400 research centers worldwide will participate in ISCHEMIA enrolling 5,000-6,000 patients.

Eligible participants were recruited following clinically indicated stress imaging testing, but before catheterization, and randomized in a 1:1 fashion to one of two groups:

  • Invasive (INV) Management: Study participants in this group will undergo a cardiac catheterization within 30 days of randomization; if significant coronary artery disease is present, coronary revascularization will be performed. In addition, study participants in this group will receive optimal medical therapy (OMT).
  • Conservative (CON) Management: Study participants in this group will receive optimal medical therapy (OMT) alone with catheterization and possibly revascularization if the participant is not responding to therapy.

Quoting from the ISCHEMIA Study results summary:

“The trial showed that heart procedures added to taking medicines and making lifestyle changes did not reduce the overall rate of heart attack or death compared with medicines and lifestyle changes alone. However, for people with chest pain symptoms, heart procedures improved symptoms better than medicines and lifestyle changes alone. The more chest pain to begin with, the more symptoms improved after getting a stent or bypass surgery.

These results apply to people with stable symptoms.
They do not apply to people having a heart attack, when emergency stent procedures save lives.”

You will find a summary of the ISCHEMIA Study on the American College of Cardiology website.

The ISCHEMIA-CKD Trial results were summarized on the ischemiatrial.org website:

“The trial showed that heart procedures added to taking medicines and making lifestyle changes did not result in a reduced rate of heart attack or death compared with medicines and lifestyle changes alone. The trial also showed that heart procedures did not reduce symptoms appreciably or improve the quality of life compared with medicines and lifestyle changes alone. These results do not apply to people having a heart attack or those with severe chest pain symptoms.”

Implications – The results of the ISCHEMIA Trial will assuredly be questioned, dissected and in some quarters possibly argued as flawed in study design.  The study endpoint time period of 3.3 years will potentially be stated by some as not long enough to more fully illuminate the differences in the two distinct forms of treatment.  But with more than 5,000 patients in a two-track, international randomized trial, the ISCHEMIA Study brings forward new information that will generate discussion, reflection and review of protocols that may prospectively identify patient sub-sets that will clearly benefit from one approach or the other.

  • CMS to Reimburse Select Outpatient PCI Procedures in ASC’s in 2020

According to newly finalized rule, CMS will pay for certain angioplasty and stenting procedures performed outside the hospital outpatient setting starting in calendar year 2020.

CMS initially estimated that moving 5% of coronary interventions from the hospital outpatient setting to ASCs would reduce Medicare payments by about $15 million and total beneficiary copays by about $3 million in calendar year 2020.  The agency updated those figures to estimated savings of $20 million and $5 million, respectively, in its final rule.  Reimbursement in ASCs will be available for six specific current procedural terminology (CPT) codes covering percutaneous transluminal coronary angioplasty with or without placement of stents in a single major coronary artery or branch, as well as in each additional branch of a major coronary artery.  The inclusion of these interventions on the CPL comes despite the fact they may involve major blood vessels, which has been considered an exclusion for CMS coverage at ASCs.

“Although the proposed coronary intervention procedures may involve blood vessels that could be considered major, . . . we believe the involvement of major blood vessels is best considered in the context of the clinical characteristics of individual procedures, and we do not believe that it is logically or clinically consistent to exclude certain cardiac procedures from the list of ASC covered surgical procedures on the basis of the involvement of major blood vessels, yet continue to provide ASC payment for similar procedures involving major blood vessels that have a history of safe performance in ASCs,” CMS said.  In support of their decision, CMS cites CPT codes for “mechanochemical destruction of insufficient vein of arm or leg, accessed through the skin using imaging guidance” and “insertion of stents into groin artery, endovascular, accessed through the skin or open procedure.”

Implications – There has been a longstanding interest on the part of some interventional cardiologists in adding invasive and interventional cath lab capabilities to ASC’s in which they have (or could acquire) an ownership interest.  Federal reimbursement policies, as well as state law (for example, it is prohibited in California, among other states) has prevented the proliferation of such services.  This may now change.  Hospitals in markets with competing ASCs should monitor this situation and prepare for potential proliferation of this important service capability.

  • Association Between Aging and Heart Disease Mortality from 2011 to 2017

Was the rapid increase in the number of adults aged 65 years and older from 2011 to 2017 associated with mortality related to heart disease?  A new study published in JAMA online finds the answer to be “yes.”  A deceleration in the rate of decrease of heart disease (HD) mortality between 2011 and 2014 has been reported.  In the context of the rapid increase in the population of adults aged 65 years and older, extending the examination of HD mortality through 2017 has potentially important implications for public health and medical care.  The total size of this population of US adults aged 65 years and older increased 22.9% from 41.4 million to 50.9 million between January 1, 2011, and December 31, 2017, while the population of adults younger than 65 years increased by only 1.7%.  During this period, the age-adjusted mortality rate decreased 5.0% for HD and 14.9% for CHD while increasing 20.7% for heart failure and 8.4% for other HDs.  The number of deaths increased 8.5% for HD, 38.0% for heart failure, and 23.4% for other HDs while decreasing 2.5% for CHD.  A total of 80% of HD deaths occurred in the group of adults aged 65 years and older.  The substantial increase in the growth rate of the group of adults aged 65 years and older who have the highest risk of HD was associated with an increase in the number of HD deaths in this group despite a slowly declining HD mortality rate in the general population.

Implications – The substantial increase in the growth rate of the group of adults aged 65 years and older who have the highest risk of HD was associated with an increase in the number of HD deaths in this group despite a slowly declining HD mortality rate in the general population. With the number of adults aged 65 years and older projected to increase an additional 44% from 2017 to 2030, innovative and effective approaches to prevent and treat HD, particularly the substantially increasing rates of heart failure, are needed.

For your review, you can find this important study in full here.

CMS Confirms Substantial Cuts to Cardiac CT Reimbursement in 2020

The Centers for Medicare & Medicaid Services (CMS) has rendered its final rule regarding 2020 reimbursement rates associated with cardiac computed tomography performed in hospitals, and imagers are not happy.  In July, the agency announced proposed cuts of nearly 30% compared with 2018 rates for the three main billing codes as part of the Hospital Outpatient Prospective Payment System (OPPS). In an addendum to its final rule, CMS cut the reimbursement for all three of the following codes to $182.20, a drop of $19.54 compared with 2019 rates:

  • 75572: Heart CT with contrast for evaluation of cardiac structure and morphology
  • 75573: Heart CT with contrast for evaluation of cardiac structure and morphology in the setting of congenital heart disease
  • 75574: CT angiography of the heart, coronary arteries, and bypass grafts with contrast

The full document has been posted to the federal register, with a formal publication date of November 12, 2019.  The Society of Cardiac CT along with the American College of Cardiology (ACC) and the American College of Radiology (ACR) mounted a concerted effort over the past several months to convince CMS to rethink its suggested cuts, sending letters and encouraging members to submit comments on the proposal as well as establish how much their institutions bill for cardiac CT, but to no avail.

Implications -- SCCT President Ron Blankstein, MD (Brigham and Women’s Hospital, Boston, MA), states that “This is a very big deal for the field of cardiac CT,” he told TCTMD, adding, “The current methodology that CMS is using is vastly underestimating the cost of cardiac CT and therefore the payment rate.” Any negative change in reimbursement for important tests such as cardiac CT could ultimately have a negative impact on overall usage and thus the early diagnosis of CHD.

If you are interested in learning more about any of these important issues or 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.  

Cardiovascular Program Strategy:  TAVR for All Moves Ever Closer

Posted by John W. Meyer, LFACHE, and Charles W. Franc

9/19/18 12:41 PM

Time to PlanHospitals 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.

Could New TAVR Volume Criteria Open the Competitive Floodgate?

Posted by John W. Meyer, LFACHE, and Charles W. Franc

8/9/18 6:48 AM

 

Edwards_TAVR_Image-1-283574-edited-1Two 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.  

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[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