The CFA Perspective

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

Recent Posts

Could Medicare “Decertify” TAVR Centers?

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

10/22/21 6:30 AM

Decertified image

In the continuing debate linking procedural volume and quality outcomes, recent published research on Transcatheter Aortic Valve Replacement (TAVR) dispersion, center proliferation, volumes and quality outcomes has brought this thorny issue to the forefront.  

Current Research on TAVR Center Dispersion

In August, the Journal of the American College of Cardiology published an original investigation Dissemination of Transcatheter Aortic Valve Replacement (TAVR) in the U.S. based on the Transcatheter ValvularTherapy (TVT) registry to study the influence of TAVR dispersion on patient outcomes.  The outcomes were examined by case volume and site density .  This was accompanied by an editorial titled Rational Dispersion of TAVR:  Failed Expectations and Unintended Consequences.  As always, the overriding issue is access versus quality outcomes, and ultimately, Medicare reimbursement.

The results of the investigation included the fact that TAVR sites in the U.S. increased from 198 in 2011 to 556 in 2018.  In May 2021, the number was about 763.  Median drive time for Medicare beneficiaries decreased from an average of 403 minutes to 26 minutes during the study period.  Higher site density was associated with lower procedural risk as well as an increased hazard of 30-day risk-adjusted mortality.  Over time, increases in site density were associated with a higher hazard of both 30-day and one-year mortality.  Simply put, outcomes are inversely tracking with volume.  One fear expressed in the study was the situation where a low-volume TAVR provider would accept a high-risk patient with multiple co-morbidities to increase their numbers after that patient had been rejected by a more experienced provider’s heart team.

A goal of the Medicare program was to promote “rational dispersion” of TAVR sites, but a conclusion of the research was that “…the well-intended rational dispersion of TAVR has indeed been problematic and has not lived up to expectations.  Thus, irrational dispersion has indeed had unintended negative consequences on quality and outcomes.”  The authors point out that Medicare reimbursement for TAVR has been based on the honor system; that minimum standards and volume requirements – have not been followed.  Thus, these facts reiterate the study conclusion that the unintended consequences of which “… reinforce the volume-quality relationship in TAVR.”  In conclusion, the editorial states that, “If sites in the U.S. do not meet the selection criteria for site selection originally formulated or do not meet the 0ne-year TAVR quality outcome benchmarks, CMS withholding future reimbursement or reimbursement “penalties” should strongly be considered.”

The TVT Registry currently provides in-hospital and 30-day outcome data and soon will report the important one-year alive and “well” endpoint data that can be used as quality benchmarks.  As originally conceived, the one-year endpoints were to be used by CMS to determine which TAVR centers should retain reimbursement.  

Implications for TAVR Providers 

In the future, could Medicare move to end reimbursement (“decertify”) TAVR sites that fail to meet minimum volume, 30-day, one-year mortality rates and/or quality of life measures?  It would be precedent setting, but this is possible, especially in the face of the above referenced findings and recommendations.  CFA has no personal knowledge of any CV-related program that has been “decertified” for failing to meet state or national performance standards through regulation or reimbursement actions.  But that does not mean it can’t happen.

The last figure we saw for underperforming TAVR providers documented that 11% of U.S. TAVR sites had lower than average-level standards of care.  That could be about 80+ hospital TAVR centers in the U.S.  It will be interesting to see the rural/urban dispersion of these CMS-designated “low volume” centers, given the geographic implications for access.  The ramifications for these hospitals are significant and should lead all sites not currently meeting Medicare minimum standards (whether volumes or outcomes) to rethink their program in general, and to evaluate its current patient selection criteria, operating policies, standards and practices.  Obtaining, understanding and addressing one-year “alive and well” statistics could be critical.  Potential decertification could have a devastating effect on any hospitals’ CV program reputation, operations and market position.  

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

Wake Up Call:  UnityPoint Sues to Stop ASC from Adding Two Cardiac Cath Labs

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

9/14/21 6:00 AM

Medical active staff in hospital

This is an incredibly timely and probably inevitable situation. West Des Moines, Iowa-based UnityPoint Health sued to block a large physician group, the Iowa Clinic, from opening two cardiac cath labs in its ambulatory surgery center (ASC). (See: UnityPoint sues to stop ASC from adding 2 cardiac cath labs, Becker’s ASC Review, Thursday, August 12th, 2021.) The Iowa Department of Health had previously granted the project a certificate of need (CON) for low-risk cases. The Iowa Clinic cardiologists have privileges and currently perform procedures at UnityPoint hospitals. If approved, the physicians would transfer a significant number of patient procedures to the ASC. UnityPoint made the argument that the area was over-saturated with cath labs, that this would cause a decrease in its volume and revenue. UnityPoint Health also put forth the issue of patient safety in the ASC cath lab environment. So far, the State is not buying their arguments, noting that CMS, private insurers, and the American College of Cardiology believe ASC-based cardiac cath labs are safe for selected patients.

Inevitability of the Threat

Other than the few states that require cardiac cath labs to be in the acute care setting, this situation is not unique to Iowa, whether or not other states have CON regulations. ASCs are increasing in number and popularity, adding services as regulations and reimbursement permit, including cardiac cath labs for interventional cardiology and vascular procedures. Physicians and physician groups will continue to look for investment opportunities, including ASC’s, despite the pushback from hospitals. Is this trend inevitable? Unless (or until) hospitals directly employ their market-based cardiologists and vascular physicians (thus controlling referrals), they face the prospect of competing organizations (primarily ASCs and office-based labs [OBL]) siphoning off select patients that can be served within the ASC/OBL environment. This leaves the hospital with sicker patients, less volume and revenue. Additionally, these types of competitive situations will inevitably lead to a potentially contentious political environment. Yes, the number of physicians employed by hospitals and health systems (particularly cardiologists) is high and increasing, but this factor does not preclude the trend towards physician-owned ASCs, it only mitigates the issue to a degree.

Considering Alternative Strategies

CFA proposes that hospitals need to carefully consider a series of issues relating to both their overall ASC strategy and, specifically their long-term CV strategy. As the environment continues to support the growth of a bifurcated CV patient population – sicker, more complex patients needing services most appropriate for the hospital environment, and increasing proportions of outpatient-based procedures that do not necessarily require hospital-level infrastructure – there will be both opportunities and challenges. Here are some thoughts one should consider going forward.

What is the Local Competitive Environment? – Most, but certainly not all, hospitals will have an outpatient strategy in place that may include an ASC. Understanding what your competitors are doing and inventorying their competitive activities is an important first step. What is the local, state-level regulatory environment? Who is providing ASC-services? Who owns them (hospital, individual physician or physician group, joint venture, etc.)? What services are provided? How have existing services impacted hospital business and influenced managed care contracting practices? Is anyone providing CV services in an ASC or OBL? Could they? Even if the state restricts cardiac cath services, can ASC or OBL outpatient peripheral vascular procedures be done in your area? The answer to these questions will inform decision making going forward.

What is Our ASC Strategy? – Each hospital needs to develop its own unique ASC strategy in light of the overall regulatory and competitive environment, physician alignment strategy, and managed care and reimbursement environment. In general, lower acuity procedures should be (and will be where they can) performed in the matching environment that both facilitates optimal patient care, produces the greatest patient satisfaction, at the lowest possible cost. This situation additionally facilitates the hospital’s ability to be price competitive in an increasingly price sensitive world. At worst, it might be thought of as cannibalizing services for the sake of reimbursement/payment pressures, but it is not. It is instead a legitimate, and frankly, necessary strategy to remain as competitive as possible.

How does our ASC Strategy Mesh with our Physician Alignment Strategy? – The hospital’s ASC strategy may or may not be directly related to its physician alignment strategy. If, for example, the hospital employs its CV-specific physicians, it is not in danger of direct competition from them. They will not start their own ASC or join a competitor ASC and establish cardiac catheterization or vascular lab services there. But non-employed, free-market physicians might. Just like in West Des Moines. Many hospitals may have a mix of employed/non-employed physicians that complicates the scenario. The hospital will need to balance the potential threat of loss of patient procedural volume with its own physician alignment situation, its need for ASC access with the need for physician convenience and income opportunities.

If we Own or Joint Venture participation in an ASC, does it Make Sense to Offer CV Services There? – This is the larger question, but must fit into the questions previously posed. Assuming you could offer invasive and interventional CV services in an ASC, should you do it? As with any significant economic investment, hospitals and physicians will need to study this question in detail to produce an appropriate answer. Economic feasibility is vitally important. Establish revenue – who will be referring (source of patients) the number/type of applicable patients, their payment type/amount, etc. Establish expenses – cost of providing services, facilities, staffing, etc. There may be offsetting costs. For example, channeling appropriate patients to an ASC may free up needed space or volume access in existing hospital cath or vascular labs or obviate the need to replace older labs and equipment or build new labs in expensive hospital-based space. Remember, feasibility also encompasses political, operational and strategic considerations as well. Political considerations include physician attitudes/desires and support for such a project, as their utilization will be key to financial performance.

In Conclusion

The ASC trend has been with us for some time and will continue to expand. Adding CV capabilities to ASC facilities is relatively new, but is expanding rapidly. Hospitals and physician groups will need to stay abreast of this overall trend and react proactively to opportunities that changes in regulation or marketplace competition open up. Offensively or defensively, a CV-specific ASC strategy will be needed by virtually every hospital CV program in the coming years.

If you are interested in learning more about cardiovascular-specific ASC strategy, rationalizing and consolidating cardiac service lines or other areas of 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  

Has Consolidation’s Time Come?  80% of Surveyed Health System Execs Think So

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

5/20/21 11:26 AM

Service-line consolidation has always been a challenge – theoretically feasible, strategically supportable, even desirable (particularly from a health system perspective), yet fraught with practical and political roadblocks.  Has the pandemic and the financial stress it has placed on the American health care system made consolidation more likely in the years to come?  Eighty percent of system execs have said so in a new poll.  Nearly 80% of 79 health system, hospital and physician group administrators surveyed in early February said they are more likely to accelerate service rationalization over the next year, according to a poll by Optum’s Advisory Board.  While this opinion focuses on money-losing services and programs, it can apply to whole service lines and its components.  Thus, it would be an oversimplification to say that this opinion is largely driven by financial performance; it goes beyond mere money.

It is demonstrable fact that the overall volume of cardiac surgery has decreased, thus the number of low-volume cardiac surgery programs has concomitantly increased.  Remarkably,  the number of hospitals offering cardiac surgery has continued to increase until recently.  Go figure!

Our Own Experience

Cardiac surgery program consolidation is a hot topic.  In our own consulting practice, we are currently working with two Western U.S. hospitals, both part of larger regional systems, with thriving cardiovascular service lines, that are debating the issue of consolidating their cardiac surgery programs into larger system hospitals.  It would be easier to address the issue of consolidation if both these hospitals (one low volume, one moderate volume) were losing money on cardiac surgery, but even at low volume, that is not the major issue or precipitating event that launched the discussion.  Both hospitals, in different markets, are facing unique challenges (primarily, but not exclusively physician staffing) and subject to corporate pressure to seriously study the issue. 

Why Consider Consolidation?

While consolidation considerations are often triggered by low volume, there are a myriad of other interrelated issues that are often present.  These can include the need for greater efficiency, better clinical outcomes, lower costs-per-case, physician and other staffing-related issues, reduction in unnecessary variation, better overall patient experience, appropriate distribution of specialty services within regions, the need to optimize resource management, a leadership or physician staffing crisis, value creation, and overriding corporate strategy.  Increasingly, systems are trying to create optimized “system-ness” and well-integrated service lines to appeal to value-driven payers and referring organizations.  Service line integration and rational distribution can also integrate hospital strategy with physician group strategy for a more coordinated system-wide marketing position.  Many systems with regional hospital assets have adopted a “hub-and-spoke” approach to specialty service lines, with full-service cardiovascular programs based in larger, regional referral facilities with community hospitals relegated to a less-comprehensive array of services.  Physician referral patterns are difficult to shift, and attitudes will often reflect “winners’ and “losers” among hospitals and clinical staff.  Optimizing hub-and-spoke service lines is often particularly challenging without sound leadership and strong centralized program direction and overall development.

The continuing development of both interventional cardiology and electrophysiology as cardiac subspecialties at the community hospital level, have implications when considering divesting lower-volume cardiac surgery programs.  “Complex” PCI is routinely performed in community hospitals and the percentage of complex cases as a percent of total cases continues to rise as the population ages.  While the emergency conversion of all PCIs to surgery remains extremely low, most interventional cardiologists are biased towards performing such procedures in facilities with on-site access to cardiac surgery.  The same holds true for many electrophysiologists performing complex EP ablation procedures, again, an increasing percentage of their work.  Divesting cardiac surgery can have serious consequences and the attitudes, opinions and clinical patient and procedural mix of cardiologists must be seriously considered in any divestiture project.  In one specific low-volume divestiture project we are aware of, corporates’ attitude was that divesting cardiac surgery would have an unacceptably negative impact on both the hospital’s existing and continuing growth of cardiology and electrophysiology business, and was therefore “discouraged” for this sole reason. 

It is important to note that any consideration of consolidation has broader impacts than simply on the program or the service line itself.  Cardiac surgery, for example, impacts many other clinical areas of the hospital, its physician staff and clinical team.  Additionally, it reflects directly in the hospital (and health system) market positioning, value-based managed care considerations, public perception, EMS interface and even philanthropy.  All of these constituent bodies need to be considered when contemplating the addition, and particularly the deletion, of any special program.

Strategizing the Consolidation Decision

Strategizing the consolidation decision is consequential and thus must be thorough, market-driven and fact-based.  With that in mind, it is realized that such decisions go  beyond clinical considerations and can be very political.  Involving all stakeholders, both inside and outside the hospital, will be critical.  Corporate pressure to consolidate is commonplace, as is local system hospitals reluctance to forfeit any service line program or service that it has built, promoted and resourced over long periods.  Alternatives to cardiac surgery such as providing PCI without surgery on site, available in many (but not all) states can be considered a viable alternative in some circumstances.  

The Importance of Process

If a decision is reached to divest, it is critical that the effort be process-driven, all-inclusive, and thoroughly planned through a comprehensive team implementation approach.  A good case study describing the process involving two hospitals consolidating their cardiac surgery programs is featured in (NEJM Catalyst, Cardiac Surgery Consolidation – Improving Value in Care Delivery, Volume 1, Number 2, February 19, 2020).  They emphasize the need to include all affected constituents, including those beyond the institution’s walls, the need for a comprehensive process involving multiple work teams, and the critical need for administrative and physician champions to support a significant change such as this.  Additionally, they strongly emphasize one point – “don’t rush discernment.”  Consolidation issues are rarely time-critical and thus should be given the thoroughness required to mitigate unexpected issues or areas of resistance that will often appear.


In summary, changing markets and continuing financial stress will force hospitals and health care systems to evaluate the optimal, market-based, service line provision of individual services and programs.  Cardiac surgery, in particular, should be strongly considered a potential candidate for divestiture or consolidation under specific/unique circumstances, but will require serious study and understanding of the pros and cons of such a decision.  These decisions can have wide-ranging community repercussions beyond the more obvious inside-the-walls hospital consequences.  Thorough analyses and well-planned implementation of subsequent decisions will be critical.

 If you are interested in learning more about rationalizing and consolidating cardiac service lines or other areas of 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

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  

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