The topic of inappropriate use of stenting has been a hot topic this past year in several states including Maryland. As Immediate Past President Ralph Brindis, MD, MPH, MACC wrote in a previous blog entry, “To be perfectly clear, the ACC does not condone inappropriate use of coronary stenting, overuse or misuse of any cardiovascular technology or therapy. That said, what’s happening in Maryland is a prime example of how a negative situation can be turned into a positive opportunity to improve quality and appropriateness of care.”

Over the past year, the Maryland Chapter, along with the Society of Cardiovascular Angiography and Interventions (SCAI), have been advocating for oversight guidelines for cath labs performing percutaneous coronary intervention (PCI).

The Maryland Chapter has been diligently working to implement internal and external peer review, but as MedPage Today recently reported: “a Maryland plan to regulate stent procedures has elicited a push-back from local chapters of the American College of Cardiology and the Society of Cardiovascular Angiography and Interventions (SCAI).” The “public outcry over” allegations of over-stenting have “spurred a technical advisory group to the Maryland Health Commission to recommend giving the commission the authority to regulate stent procedures as well as continuing evaluation of hospitals with stent programs.” However, “both the Maryland Chapter of ACC and the Maryland SCAI chapter said a better plan would be a two-tiered system of checks that includes an internal review that meets specific standards and an external peer review as an auditing mechanism.”

Although the battle in Maryland continues, their gallant efforts have not gone unnoticed, and this past week at Leadership Forum BOG Chair-Elect Dipti Itchhaporia and I presented Sam Goldberg, MD, FACC, governor of the Maryland Chapter with the ACC Chapter award for Advocacy.

As the famous Robert Frost saying goes, “Two roads diverged in a wood, and I - I took the one less traveled by, and that has made all the difference.” I applaud the amazing efforts of the Maryland Chapter who is working to do something more effective to prevent inappropriate uses.

Another cardiologist, this time in Tennessee, is being accused of unnecessary stenting, theheart.org reported last week. The Department of Justice is investigating accusations brought by a Jackson, Tennessee cardiologist against another Jackson cardiologist, Jackson-Madison County General Hospital, Regional Hospital of Jackson and a Jackson radiologist. The allegations state that the cardiologist overused cardiac services, including cardiac sonography, scintigraphic stress imaging, angiography, angioplasty and stenting, to defraud Medicare. The two hospitals and the radiologist condoned or assisted the cardiologist’s inappropriate use, according to the allegations.

This is one of a series of reports about abuse of cardiac services across the country. Hospitals and physicians in both Maryland and Pennsylvania have come under fire under similar claims. The abuse of services brings a bad name upon cardiology, sullying the reputation of the whole profession.

We need to prevent these abuses from happening. One way in which the ACC is doing so is by supporting the Society for Angiography and Interventions’ (SCAI) Accreditation for Cardiovascular Excellence (ACE). ACE offers formal, objective, and independent evaluation and monitoring of cardiac and endovascular interventional facilities to ensure that they meet the highest possible standards for patient care and safety. The purpose of this program is to ensure the removal of any perceived or real conflicts of interest in oversight of hospital and physician quality performance. ACE accreditation criteria also calls for use of registries like the National Cardiovascular Data Registry (NCDR) and adherence to appropriate use criteria (AUC) -- both of which are already widely accepted and respected by professional and regulatory communities nationwide. Last month, ACE accredited its first hospital – Bon Secours St. Francis Health System in South Carolina – for cardiac catheterization and angioplasty/stenting. Review of other hospitals’ lab programs is underway.

However, ACE alone would not have prevented the abuses alleged in Tennessee. Additional quality tools – such as appropriate use criteria, practice guidelines and other clinical documents – are needed. These quality tools can provide states, payers and purchasers of care with critical, transparent metrics with which to evaluate quality of care, especially necessary as the health care community shifts from a fee-for-service reimbursement model to one more focused on outcomes-based care and commensurate reimbursement.

Inappropriate stent use made the news again last week, after a Pennsylvania hospital announced it plans to review two cardiologists accused of implanting 141 stents inappropriately. The article came out just two days after the Maryland State House held hearings on new legislation that underscores the need for accreditation & certification of catheterization labs. The bill, the Maryland Cardiovascular Patient Safety Act, was drafted by the ACC, the Maryland Chapter of the ACC and SCAI following meetings with state policymakers. We have been working to get this bill introduced.

Maryland has been at the forefront of the stenting controversy. Larry Dean, M.D., F.A.C.C., SCAI president, Sam Golderg, M.D., F.A.C.C, Maryland Chapter governor, and Mark Turco, M.D., F.A.C.C., Maryland Chapter governor-elect, and I wrote a President’s Page for the Feb. 17 issue of JACC that addressed how we see the situation of procedure overuse, which is neither confined to the state of Maryland or the field of interventional medicine. To be perfectly clear, the ACC does not condone inappropriate use of coronary stenting, overuse or misuse of any cardiovascular technology or therapy.

That said, what’s happening in Maryland is a prime example of how a negative situation can be turned into a positive opportunity to improve quality and appropriateness of care. Working with Maryland lawmakers, we were able come up with a solution that allowed state officials to feel that quality in cardiovascular care will being ensured, while allowing physicians to determine the specific manner in which that can best be achieved.

“We are all in the same boat in a stormy sea, and we owe each other a terrible loyalty,” wrote English author G.K. Chesterton. How we react to this overutilization storm will determine our future. We must take stewardship for the health care system into our own hands, so that society will view us as true professionals who can be trusted to practice appropriate use of resources because we are basing our treatments on the latest and best scientific evidence.

You can read more about what the ACC, ACC Maryland Chapter and SCAI have been working on in Maryland in this previous blog post; in particular, the comments section offers great insight into the views of ACC members.

Larry Dean, president of SCAI, and I just sent out an e-mail to our memberships regarding a series of articles that have appeared in the mainstream press about overuse of stents and the opportunity this offers for professional associations like the ACC & SCAI to take a proactive approach to quality issues. Please see the full text below, and leave your comments at the end of the article.

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The American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) are deeply disturbed by findings in a new U.S. Senate Finance Committee report concerning the ongoing investigation into alleged inappropriate use of percutaneous coronary intervention (PCI) and overutilization of stents at St. Joseph Medical Center, in Towson, MD. While the ACC and SCAI cannot comment on the merits of ongoing investigations, the use of inappropriate or unnecessary procedures is intolerable and a violation of both organizations strict codes of ethics (.pdf) as well as the Hippocratic Oath.

Over the last several months the Maryland Chapter of the ACC and SCAI, working closely with the national ACC, have been proactively addressing the issues raised by these allegations. ACC and SCAI representatives have met with state policymakers and have, at the request of Maryland officials, drafted comprehensive legislation that would require accreditation for all state hospitals performing PCIs.

Meanwhile, the overarching issue of quality and appropriate use of medical procedures is not just confined to the state of Maryland and the use of stents. In fact the Senate Finance report has generated national media coverage in the New York Times, Wall Street Journal and other papers. The investigations and subsequent media coverage provide an opportunity for professional societies like the ACC and SCAI to take the lead locally, regionally and nationally to ensure patients receive the right care at the right time.

Collectively, these developments underscore the need for internal peer-review that is clear, rigorous and objective. A standardized internal process must be followed by independent external oversight performed by an external body, such as the Accreditation for Cardiovascular Excellence (ACE) program. ACE has an independent governing board, allowing for removal of any perceived or real conflicts of interest in oversight of hospital and physician quality performance. ACE accreditation criteria also calls for use of registries like the National Cardiovascular Data Registry (NCDR) and adherence to appropriate use criteria -- both of which are already widely accepted and respected by professional and regulatory communities nationwide.

In addition, quality tools produced by both the ACC and SCAI can provide states, payers and purchasers of care with critical, transparent metrics with which to evaluate quality of care, especially as the health care community adopts a National Quality Strategy and shifts from a fee-for-service reimbursement model to one more focused on outcomes-based care and commensurate reimbursement.

The ACC and SCAI have the knowledge base and expertise as cardiovascular leaders to advise and implement such programs. The efforts under way in Maryland to address quality and appropriate care have far-reaching implications. Addressing them proactively will allow the field of cardiology to remain ahead of the curve and avoid future allegations like those outlined by the Senate Finance Committee. Working together we can ensure our patients receive high quality and effective cardiovascular care delivery driven by physician oversight and leadership.

The New York Times this weekend featured a detailed article on the ongoing investigation into alleged inappropriate use of percutaneous coronary intervention (PCI) and substantial overutilization of stents at St. Joseph Medical Center, in Towson, MD. 

The issue of quality and appropriateness of medical care is not limited to use of stents in the state of Maryland (In fact, the Times article mentions similar cases in Texas and Louisiana), nor is it confined to the field of cardiology. That being said, this current issue provides an opportunity to illustrate how professionals societies, like the ACC, can take a leadership role in ensuring quality care through use of peer-review, accreditation and data management. 

We happen to have over two-thirds of the US angioplasty/stent clinical data in the United States. Applying the currently recognized best evidence for appropriate use to these procedures, our data shows that nearly 70 percent of stents are placed appropriately as life-saving care for persons having heart attacks. Of the 30 percent placed in patients electively, as in the NYT story, we believe about 12 percent may be inappropriate. That's 4 percent of overall stent use, which while not a crisis of mass overuse, is nonetheless unacceptable. The point is: we now have means to give doctors and hospitals continuous data feedback on how their performance compares with best evidence and with their peers. Why don't we use it!

The ACC Interventional Committee and SCAI recommend (which for many medical staff means “require”) that interventional cardiologists who perform angioplasty and stenting (PCI) perform at least 75 interventional procedures annually to qualify to perform PCI interventions on acute myocardial infarctions. Many hospitals do not enforce this, but those that do might be creating a perverse incentive to perform PCIs that are not necessary to reach this "magic" number!

A vigorous on-line conversation among many members is going on about whether this is now an obsolete number to require -- one that many highly qualified interventionalists may not reach. Consumer groups are also likely becoming curious that such “practice targets” could be promoting unnecessary procedures. In view of recent public scrutiny, the question is, should this number be revisited -- because better medication and sustained clinical benefits of PCI already provided to persons with coronary artery disease have created a reduced average number of per capita procedures in many areas? It seems obvious that the Interventional Committee and SCAI should revisit the issue. In terms of workforce consideration, maybe we need to think carefully about whether we are training too many interventionalists at this point?

The ACC last week announced its partnership with the Society for Cardiovascular Angiography and Interventions (SCAI) to provide accreditation of hospitals where invasive cardiac and endovascular procedures happen. The Accreditation for Cardiovascular Excellence (ACE) organization will review hospitals and then accredit those that achieve predetermined benchmarks for quality care that have been shown by the literature to improve patient care. Right now, ACE is providing accreditation for hospitals that do carotid artery stenting, but it plans to expand to other procedures like PCI. The accreditation lasts for two years, and then hospitals must be reviewed again. Several hospitals have already applied for the accreditation. 

SCAI and ACC have formed a board to oversee the project, which SCAI Past President Bonnie Weiner, who has very much championed this project from the beginning of its inception, will chair.

Recent studies have shown accreditation improves patient outcomes and enhances patient safety standards, and ACE is designed to transfer those academic findings into a real-world application. By developing accreditation standards in this area, we are taking further steps toward our goal of providing excellent care in all facilities where invasive cardiac procedures are performed. The ink is just beginning to dry on the Agreement between ACC and SCAI to establish ACE.  You’ll be hearing a lot more about the ACE offerings as we begin to roll out the program. Facilities seeking ACE accreditation can obtain more information and complete the application process at www.cvexcel.org.