The cost of health care continues to rise, with government naturally concerned with expenditures from Medicare and Medicaid disbursements. Cardiovascular disease continues to be the main driver of costs, due to its prevalence, contribution to mortality in developed nations, and the high dollar amount of needed medications, procedures, and devices. Accordingly, coronary interventions have been under scrutiny, particularly given a number of rare but high profile cases of “unnecessary stenting” wherein stents were placed in lesions of marginal significance. While such cases of fraud were easy to identify, it is far more difficult to determine appropriateness of percutaneous coronary intervention (PCI) in cases wherein clinical decision-making can vary as, for example, with complex decisions regarding benefits of an intervention over augmented medical therapy.
It therefore became critical for the cardiovascular community and professional societies to create a mechanism to assist physician decision-making, promote patient education regarding expected benefits from revascularization, and allow for assessment of utilization patterns of revascularization procedures. Recognized throughout was the concept that such a tool would need to be a guide, not a “draconian verdict” of appropriateness. To that end, the first version of the appropriate use criteria (AUC) was created in 2009, focusing on both overuse and underuse of coronary revascularization procedures.1 The AUC document was updated in 2012 and endorsed by ten professional medical societies, including the American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI). This document clearly stated its intention as a quality improvement and shared decision-making tool. It was not intended to be used as a method to determine reimbursement.2 Indeed, the document stated, “it is hoped that payers would use these criteria to ensure that their members receive necessary, beneficial, and cost-effective cardiovascular care, rather than for other purposes.” However, given efforts by policymakers to find creative ways to curb costs, it was only a matter of time before policymakers and payers saw this as an opportunity to use AUC for other purposes, particularly as a “cost-cutting” measure, especially given the widespread adoption of AUC by all relevant professional societies.
The fears of the cardiovascular community that AUC could be used for this ulterior purpose became a reality when the New York State Medicaid Program, in response to a recommendation from the Medicaid Redesign Team Basic Benefit Review Workgroup, announced that it would automatically recoup payments from physicians and hospitals for PCI procedures considered “inappropriate,” according to their own internal evaluation of data in accordance with the 2012 AUC for coronary revascularization. This news was greeted with great concern and frustration by New York cardiologists that the AUC were being misused, and that their patients might lose access to necessary care and individualized, patient-centered, shared decision-making. What followed was a coordinated advocacy effort by SCAI and the ACC, with the goal of educating New York policymakers about the AUC and engaging them to rethink a policy that ultimately could reduce access to medically necessary procedures for the especially vulnerable Medicaid population. This issue is of principal importance to the interventional and cardiovascular community, not merely because of potential financial ramifications. To be sure, the actual amount of dollars to be recouped is quite small, as only ~300-500 Medicaid-insured procedures per year were anticipated to be identified as “inappropriate” by AUC in New York State. Indeed, the more critical issue here is the inappropriate use of a relatively crude tool, that is now being used punitively and retroactively, thereby limiting access to procedures for underserved patients who may lack the ability to advocate for themselves. Furthermore, we fear that this misuse of the AUC may extend into other clinical areas with additional potential for patient harm, including AUC addressing imaging and device implantation.
As the situation in New York illustrates, there is a great potential for the AUC to be misused by policymakers who don’t fully understand the intention behind them or how they were developed. The current AUC for revascularization still uses the term “inappropriate” to describe this minority of procedures, terminology that was adopted directly from the original RAND methodology. The inherent assumption of policymakers that inappropriate procedures are universally “unnecessary” and, therefore, should not be paid for with taxpayers’ dollars is understandable but simply incorrect. Importantly, this terminology will be replaced in future versions by the term “rarely appropriate,” since the implications of the word “inappropriate” are quite different from the new and less definitive phrase “rarely appropriate.”
Furthermore, policymakers and payers need to understand that a procedure that appears inappropriate according to the AUC can be appropriate when the entire clinical picture is considered. We should applaud the AUC task force for boiling down multiple complex clinical scenarios to improve quality of care; however, we must be sure that clinicians, researchers, and policymakers recognize the inherent limitations of the AUC and, therefore, how they should and should not be applied. The current AUC are based on six clinical domains: patient stability varying from stable angina to ST-elevation myocardial infarction; severity of symptoms and functional class; risk assessment based on non-invasive testing; amount of medical therapy; and coronary disease burden (single-vessel to multivessel disease). There are many factors not considered in the AUC that are important in a clinician’s decision. For example, the AUC do not consider age, left ventricular function, lung or kidney comorbidities, ability to take multiple medications and, importantly, patient preference. As estimated by the writing committee, if all clinical factors were to be used to develop the AUC, there would be well over 4000 possible combinations and clinical scenarios.
As clinicians, we understand the value of guidelines and the AUC, but we also understand that care must be individualized for each patient. Unfortunately, the limited number of AUC scenarios has led policymakers to believe they can condense complex clinical decision-making into “cook-book” algorithms of right-or-wrong decisions. As the developers of the AUC, we recognized them as a tool for gauging general practice patterns designed to identify both overuse and underuse of procedures and treatments. It is simply inappropriate to extrapolate data on practice patterns to individual patients.
SCAI and ACC support the use of these criteria to identify areas of improvement so that we can deliver the best possible care to our patients. In the ACC-National Cardiovascular Data Registry (NCDR) analysis of 1091 United States hospitals in 2009-2010, 11.6% of elective cases were classified as inappropriate.3 The majority of inappropriate PCIs for stable coronary artery disease were performed in patients with no angina, low-risk ischemia on non-invasive stress testing, or suboptimal (≤1 medication) antianginal therapy. Similarly, an analysis of 2009-2010 New York State data, utilizing a somewhat different AUC algorithm from the one developed by the ACC-NCDR, revealed that when the AUC were applied to mandatory data on all PCIs submitted to the state database, 28% lacked sufficient data to determine appropriateness and, of the rated PCIs, 14.3% were deemed inappropriate.4 The proposal to withhold payments for “inappropriate” PCI assumes that inappropriate PCI are uniformly unnecessary and sets up an unrealistic goal of 0% inappropriate cases. When we met with the New York State Medicaid officials, we stressed the proper way of using the AUC, whereby hospitals or physicians seen as outliers might be targeted for educational and quality improvement efforts. This puts high-quality care and patients first, and is in keeping with the intention and appropriate use of the AUC.
Does this experience with New York policymakers set the precedent for the AUC being used punitively? Will other specialties and their professional societies go forward with creating their own AUC to improve the quality of care, having learned from our experience that they may put themselves at risk? For instance, in the field of orthopaedic surgery, the 2014 AUC for non-arthroplasty (non-replacement) treatment of osteoarthritis of the knee were published by the American Academy of Orthopaedic Surgeons,5 with the AUC for knee and hip replacements soon to follow. The writing panel cautiously used “rarely appropriate” and “may be appropriate” terminology as opposed to “inappropriate.” Interestingly, prior or optimal medical therapy was not considered at all among the indication features. The point of this comparison is not to judge other societies and their AUC, but simply to demonstrate that different criteria may be used by various specialties. Are we being unduly punished for being at the forefront of quality measurement and improvement efforts? Did we make our AUC too strict by defining optimal medical therapy as two or more antianginal classes of therapies? What we do not want to do is hinder the development of future AUC by professional societies, which are intended to improve patient care while understanding and considering the subtleties necessary in making “appropriate” clinical decisions. Unfortunately, events such as those occurring in New York state do push us unintentionally in this direction.
We consider this issue of utmost importance. Working rapidly and effectively together, SCAI and ACC succeeded in educating the New York Department of Health and engaging their policymakers in rethinking and modifying their policy. As a result of the meeting in Albany and continuous dialogue with policymakers:
- The payments will not be recouped immediately (before a medical review);
- Physicians/institutions will have an opportunity to explain and submit supporting data on why the procedure should be payable;
- We have insisted and convinced policymakers that the medical review needs to be performed by physicians with personal expertise in diagnostic and interventional procedures, allowing for an informed clinical judgment when forming a decision regarding appropriateness of PCI.
Although the New York policy is limited to Medicaid patients, the SCAI is very concerned that implementation of such a policy could lead to similar proposals in other states affecting Medicaid, Medicare patients, and those covered by third-party payers. We urge our members to get involved in SCAI and become engaged in this national discussion to help us formulate a strategy of minimizing overuse, but importantly also eliminating underuse of effective interventions. We need to stand up for our patients and against policies that could and would hinder access for patients, particularly disadvantaged ones, to optimal quality cardiovascular care.
- Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 appropriateness criteria for coronary revascularization: a report by the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol. 2009;53(6):530-553.
- Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol. 2012;59(9):857-881.
- Chan PS, Patel MR, Klein LW, et al. Appropriateness of percutaneous coronary intervention. JAMA. 2011;306(1):53-61.
- Hannan EL, Cozzens K, Samadashvili Z, et al. Appropriateness of coronary revascularization for patients without acute coronary syndromes. J Am Coll Cardiol. 2012;59(21):1870-1876.
- Sanders JO, Murray J, Gross L. Non-arthroplasty treatment of osteoarthritis of the knee. J Am Acad Orthop Surg. 2014;22(4):256-260.
From the 1Greenberg Division of Cardiology, New York Presbyterian Hospital, Weill Cornell Medical College, New York, New York; 2SUNY – Stony Brook School of Medicine, Mineola, New York; and 3FirstHealth Moore Regional Hospital, Pinehurst, North Carolina.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Address for correspondence: Dr Srihari S. Naidu, Director, Cardiac Catheterization Laboratory, SUNY – Stony Brook School of Medicine, 120 Mineola Blvd, Suite 500, Mineola, NY 11501. Email: firstname.lastname@example.org