Appropriate Use Criteria for PCI: Making the Best of It

Appropriate use criteria (often referred to as AUC) for various diagnostic tests and procedures are either already in place or being developed across the healthcare industry, with several professional organizations supporting their use. Cardiovascular procedures, including interventional radiology, echocardiography, and stress testing, as well as coronary revascularization, all currently have some guidelines in place for appropriate use with the backing of their respective professional organizations. Well-publicized inappropriate-stenting cases have focused regulatory and media attention on coronary stenting and have garnered support for the criteria use by providers, clinicians, and payors. While the underlying purpose of appropriate use criteria is the good intent to ensure that the right procedure is performed on the right patient at the right time for the right reasons, to achieve the best possible outcome, there are many organizations that struggle to ensure compliance with the criteria. Despite any one factor that makes total compliance somewhat of a struggle, Corazon believes it is always in the best interests of the organization from a clinical, regulatory, and financial perspective to work diligently towards achieving that compliance.

Background on criteria development

Appropriate use criteria for percutaneous coronary intervention (PCI) were developed by a technical panel of physicians who reviewed and scored approximately 180 clinical scenarios as to how likely it would be that revascularization would improve outcomes or survival of the patient. From that review, the determination was made whether the revascularization procedure had the appropriate indications and was medically necessary. Three relevant points to consider when using the criteria were stated in the ACCF/SCAI/AATS/AHA/ASNC 2009 Appropriateness Criteria for Revascularization¹:

• Appropriateness criteria are based on current understanding of the technical capabilities and potential benefits of the procedure;
• Future evidence development will require the criteria to be updated; 
• Appropriateness criteria are intended to assist patients and clinicians, but are NOT intended to replace clinical judgment and experience.

Thus, appropriate use criteria for PCI are a work in progress, as evidenced by the January publication of the 2012 Appropriate Use Criteria for Coronary Revascularization Focused Update² that provides some clarification and additions to the original criteria. The 2012 update reassessed the clinical scenarios against new medical literature and worked to bridge gaps in the previous guidelines. As new information and technology emerges, the guidelines and criteria will require ongoing reassessment to ensure that evidenced-based care is the ultimate goal.

Categories of appropriate use

The AUC place procedures in one of three categories: (1) appropriate, (2) uncertain, or (3) inappropriate. What does placement of a case into one of these three categories mean for the patient, the medical practitioner, the cardiac catheterization laboratory, and the organization? The classifications are as follows:

• “Appropriate” is defined as a procedure that is generally acceptable and is a reasonable approach for the indication cited.
• “Uncertain” is considered generally acceptable and may be a reasonable approach. 
• “Inappropriate” means a case is performed for a procedure that is not generally acceptable and is not a reasonable approach for the indication that is documented. 

The most important issue to note here is that for each of these classifications, there is room to argue a case. That is, not all patient situations are the same, even with very similar coronary anatomy and/or disease. Other patient factors enter the picture and are as diverse as the human race. The classifications are a way to provide an overview of cases performed by a practitioner or an organization, and it is then up to that practitioner and the organization to explain (via documentation) why a case deemed uncertain or inappropriate may, indeed, be appropriate. A case identified as “uncertain” would need to have supportive documentation as to why a revascularization procedure was in fact the right thing to do for the patient, while any procedure that fails to meet the “appropriate” or “uncertain” classification should cause the practitioner to closely scrutinize the decision to perform the procedure. If, after review, the practitioner still feels the patient would have potential benefit from the procedure, it is crucial to scrupulously document all of the factors playing into that decision (be it diagnostic testing results, patient symptoms, patient co-morbidities, history, or any number of other factors).

This leads to a critical issue: documentation. While documentation is often a weakness for healthcare disciplines, the appropriate use criteria provide added motivation to complete supportive documentation for the procedure performed. While that is not to say you can just “talk your way into appropriateness,” it is possible to provide valid arguments, test results, and other indications that can provide convincing evidence that a particular patient may benefit from a procedure that may not be deemed as beneficial to the patient population as a whole. Appropriate use criteria essentially take a standard of care and apply it to the general population. All who work in healthcare realize there are patients and situations that call for an exception or deviation from a standard. Appropriate use criteria require the use of detailed documentation to justify that deviation.

Potential flaws with the current AUC for revascularization

There has been some recent debate regarding the “correctness” of the appropriate use criteria for revascularization (including PCI) and several areas have been identified for future clarification. Organizations must take into account the imperfections of the current appropriate use criteria while working to ensure that the overall intent of the criteria is still achieved. As outlined in Steven Marso’s viewpoint article³, flaws with the AUC have been cited both when the initial guidelines were published and more recently, when the 2012 focused update was released. The composition of the 17-member panel that developed the guidelines is one of the cited concerns. The panel itself, although comprised of interventional cardiologists, cardiovascular surgeons, cardiologists, and other medical physicians or researchers, is believed by many to not adequately represent interventional cardiology, as only four members of the panel represented that subspecialty. Also noted among the panel participants was consistent agreement (94%) on what is considered appropriate, but lesser agreement (70%) on what is considered inappropriate. For example, some believe that too much emphasis is placed on stress testing without specific criteria or requirement for the physician to interpret and document the “risk” identified by the stress test. The assignment of a risk category from a stress test often falls to the data abstractor, thereby leaving this open to the potential for inconsistent interpretation and categorization from abstractor to abstractor, even within a single facility. Other potential points of controversy include over-dependence on stress testing in non-acute PCI, the need for greater emphasis on use of fractional flow reserve in angiographic indeterminate lesions, and concern that only chronic total occlusions are addressed as a complex lesion subset (with no recognition of lesions with excessive tortuosity, calcification, ostial or diffuse disease, and bifurcation lesions).

The American College of Cardiology National Cardiovascular Disease Registry (ACC-NCDR^®) now provides feedback to its participants on appropriateness for PCI. While this will help participating organizations determine where they stand compared to the AUC, it is not without shortcomings as well. Participation in the NCDR is not mandated. Some hospitals elect to submit data, but fail to adequately resource the effort in terms of data entry personnel. Many organizations do not have individual(s) dedicated, which leads to data capture from multiple individuals, most often cardiac catheterization nurses or technologists who may have varied levels of understanding of the data definitions, as well as limited time and interest in the data collection and reporting process. Corazon recommends that individuals be clearly identified and educated about data definitions and the nuances of submission. They should also participate in the evaluation of outcomes data and the related process improvement activities that result.

Optimizing appropriate use criteria

While articles citing the concerns about the AUC have identified valid issues for further exploration and refinement in their use, it remains imperative that organizations move to embrace the AUC, as this is not going away any time soon. Further, CMS, as well as other payors, are looking to use this information to incentivize for full payment versus penalties through withholds. Thus, regardless of some inherent shortcomings, Corazon advocates investing the time and energy necessary to fully develop processes in order to determine that patients are being appropriately evaluated and therefore classified, while appropriately documenting the support of that classification. In order to be positioned to make best use of the AUC guidelines for quality reporting as well as future payment optimization, we recommend:

• Development of a committee or team to spearhead oversight of AUC use for PCI. This team should invest time and energy to ensure that all team members know and understand the AUC guidelines, and should review all cases that are considered either uncertain or inappropriate. Depending on the outcome of case reviews, if the reason for revascularization is not clearly understood, the case should be referred for peer review. As important as individual case reviews are, a review of case trends (specifically “inappropriate” cases by any one individual or group) may be of even more value in identifying either practice or educational needs. This team may also be responsible for identifying and coordinating any education to referring physicians whose documentation of patient symptoms and use of anti-anginal therapies may play a role in the final determination of case appropriateness.
• If participating in the NCDR database, the organization should invest in a consistent data entry resource (an individual or individuals) who has received education and training in the data entry process, as well as the data definitions. If the facility is unable to fully dedicate resources to this position, it is imperative that staff education and training be provided to any/all members of the staff performing data entry that is factored into the AUC scoring.
• Regardless of NCDR data entry, education should be provided to all invasive and interventional cardiologists, as well as all cath lab clinical staff, as to the AUC guidelines, the case classifications, and the recommendations around documentation and supportive documentation. Data is only as good as the person entering it. In this aspect, it is critical that anyone who plays a role in clinical documentation have a clear understanding of the AUC guidelines, as well as NCDR data definitions. 
• Medical staff oversight of NCDR data submission and a review of received quarterly reports is critical. A process should be in place for the medical director to review, comment, report, and drive process improvement plans based on data results. 
• Develop department policy regarding the required use of fractional flow reserve with specific indications and/or lesions. The policy should go on to identify that any lesion intervened upon with a fractional flow reserve ≥ 0.80 (indicating stenting that particular lesion may not be beneficial) should be case reviewed. This does not necessarily indicate that the case was inappropriate, but does demonstrate the organization’s efforts to closely monitor cases that do not fit the criteria. In this manner, patterns or trends related to clinical judgment and practice can be identified and addressed early.
• Develop a process whereby stress results (performed within the organization or from any outside source) are forwarded and clearly captured in the documentation. Also, a defined process to categorize the results as normal, abnormal, or indeterminate is important, followed by applying the risk as low, intermediate, or high. This will involve use of standard definitions and education about these definitions to those who review the stress tests and enter the data. Most advantageous would be a process that directs the responsibility to the physician for assigning the category and risk for the stress test outcome, which removes the data abstractor from this role. Some organizations will not place elective outpatients on the procedure schedule until this documentation is received.
• Where possible, build into documentation forms (checklists, protocols) or into the electronic medical record prompts for documentation of the items that support classification of appropriateness (stress results, symptoms, medication history, etc.). Documentation needs include pre-procedure evaluations and testing, as well as intra-procedure documentation such as use of fractional flow reserve measurement in intermediate (50-70%) lesions to guide revascularization decisions.

Some final thoughts

While it can be acknowledged that there are some inherent flaws, appropriate use criteria for coronary revascularization can still work to the advantage of those who choose to embrace it and take the time to learn it well. By knowing the criteria, developing a process to collect the information required, and closely monitoring adherence to protocols developed in order to meet the criteria, the organization can be assured of doing the right thing for the patient. By doing so, the organization demonstrates support for use of evidenced-based standards of care while producing good clinical outcomes, which can also translate to lower length of stay and appropriate payment for the organization…two strong indicators of a healthy program.

Marsha is a consultant with Corazon, Inc., offering strategic program development for the heart, vascular, neuro, and ortho specialties, as well as consulting, recruitment, interim management and physician practice and alignment services for clients across the US and in Canada. To learn more, visit www.corazoninc.com or call (412) 364-8200. To reach Marsha, email mknapik@corazoninc.com.

References

1. Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA; 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; Heart Failure Society of America; Society of Cardiovascular Computed Tomography. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 appropriate use criteria for coronary revascularization. J Am Coll Cardiol 2009 Feb; 53(6); 530-553.
2. 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. J Am Coll Cardiol 2012 59(9); 857-881.
3. Marso SP, Teirstein PS, Kereiakes DJ, Moses J, Lasala J, Grantham JA. Percutaneous coronary intervention use in the United States: defining measures of appropriateness. JACC Cardiovasc Interv 2012 Feb;5(2):229-235.