ACC NEWS
President’s Page: Appropriateness Criteria: Breaking New Ground
Pamela S. Douglas, MD, FACC, President, American College of Cardiology*,
Michael J. Wolk, MD, MACC, Immediate-Past President, American College of Cardiology,
Ralph Brindis, MD, FACC, Chair, Appropriateness Criteria Working Group and
Robert C. Hendel, MD, FACC, Co-chair, Technical Panel, Appropriateness Criteria Working Group
* Address correspondence to: Dr. Pamela S. Douglas, American College of Cardiology, c/o Cathy Lora, 9111 Old Georgetown Road, Bethesda, Maryland 20814-1699.
Ap·pro·pri·ate adj: suitable for the occasion or circumstances; doing the right thing (1)
During the past two decades, technologic advances in the evaluation and treatment of cardiovascular disease have resulted in dramatic improvement in the quality and duration of life. Clinical guidelines and practice algorithms have elevated care by stimulating adoption of "best practices." However, not all tests and treatments result in obvious improvements in our patients’ lives. As physicians, we practice medicine based on an often-intuitive process of risk-benefit analysis. Economic pressures now mandate that this evaluation of trade-offs be applied on a societal level because resources must be selected based on their individual and global impact.
Within the context of this volatile health care environment, about a year ago health plan members of the American College of Cardiology-sponsored Medical Directors’ Institute requested the College to provide guidance regarding appropriate use of coronary therapeutics. The initial focus on medical imaging was triggered by the 2001 usage statistics which confirm that diagnostic imaging has experienced the fastest growth among all medical services covered by Medicare (2). These data were not easily analyzed, begging the questions of under- as well as over-use and why and when a test was chosen. It was with this charge that the American College of Cardiology Foundation (ACCF) established its Appropriateness Criteria Working Group. In <6 months, this Working Group has: 1) developed methodology to examine procedural appropriateness; 2) convened a broad-based, discipline-diverse technical panel for creating appropriateness criteria for single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI); 3) created and rated 52 clinical indications for SPECT imaging; 4) published a "methods" paper outlining the underlying technique for establishment of the appropriateness criteria (3); and 5) published the SPECT MPI appropriateness criteria (4).
The groundbreaking ACCF/American Society of Nuclear Cardiology (ASNC) SPECT MPI Appropriateness Criteria (4) have the potential to create waves among those who may see the criteria as interfering with their professional judgment and practice of cardiology, thereby threatening their financial well being. However, the ACCF believes that practice patterns that follow the criteria as "appropriate" and "possibly appropriate/uncertain" should be supported by payers, and performing "inappropriate" indications must be altered. Certainly, individual exceptions to the criteria categories are anticipated and justified, and payment exceptions should be requested and well-documented. But the performance of procedures for indications not supported by medical literature, evidence, and/or expert opinion (i.e., "inappropriate") must be curtailed. Working with payers should minimize any jeopardy against our patients and should result in more cost-effective care.
Another concern about the recently published ACCF/ASNC Appropriateness Criteria for SPECT MPI revolves around tests designated as "uncertain/possibly appropriate." Although this definition tracks classic terminology of the criteria RAND/Modified Delphi Method (5), the potential to misinterpret this nomenclature is great. It was the strong feeling of the Appropriateness Criteria Working Group and Technical Panel for SPECT MPI that this intermediate category should be recognized as potentially valuable and, therefore, qualifies for reimbursement. Changing the term to "possibly appropriate" has been advocated for future criteria to more accurately reflect the Working Group’s intent and actual results examining an acceptable range of options. Although the RAND methodology is admittedly imperfect, the Working Group decided it remains the best approach, with some customization. Other groups, including the American College of Radiology, have used the RAND method, but they have not attempted to provide specific information about the appropriateness of specific applications or tied these to evidence. Also, they "forced" consensus opinion, even in the absence of clear agreement. We openly chose to recognize that insufficient information is often present and that differences of opinion do exist and our appropriateness criteria should reflect these differences and the resulting uncertainty of appropriateness.
Diverse opinions were shared in several areas, reflecting concerns within the imaging and health care policy communities, such as with testing asymptomatic individuals, serial testing (i.e., annual testing), and imaging in patients with atrial fibrillation. The appropriateness criteria clarify the role of SPECT MPI for these applications, offering guidance where none had previously existed. This fresh approach demonstrates how the criteria may stretch traditional clinical practice guidelines.
Early in the development of the appropriateness criteria, the College decided to address the appropriateness of specific techniques, rather than define one modality as "more appropriate" than another. Most importantly, the College does not wish to recommend a single modality as the "best test," in recognition of local variations of test quality and availability, as well as regional expertise and the "comfort" of local practitioners with a specific test. Finally, limited, evidence-based comparisons are available among different technologies, even for a common indication, and such data, including subsequent meta-analysis, often suffer from referral bias and other methodological issues that confound retrospective comparisons.
Although we are proud of the bold step the ACCF has taken to develop appropriateness criteria, this is just the beginning. Other procedures are scheduled to be evaluated during the next year, including such emerging imaging areas as cardiac computed tomography and magnetic resonance. Although limited published data are present for many of these relatively immature indications, these new technologies must be allowed to develop and not be deemed "inappropriate" simply due to a relative lack of data at this time. The speed at which additional appropriateness criteria will be created (and revised) will mirror the marketplace need to provide on-the-ground guidance to clinicians and payers, including outlining future steps required to "prove" the value of any one method.
The next phase of this project, if possible, is even more challenging. With the recognition of "possibly appropriate/uncertain" indications comes the mandate for additional research and the development of useful data. We encourage large clinical practices, academic institutions, and health plans to work together in generating the additional data needed to enhance the evidence base that will help us definitively categorize a procedure as "inappropriate" or "appropriate" in the future.
Additionally, research must evaluate the clinical and financial impact of these appropriateness criteria. We are exploring ideas such as creating a data collection instrument that will support the prospective collection of key information, such as a "checklist." The goal of these projects, like the appropriateness criteria themselves, is to improve clinical practice, reduce unnecessary procedures, and enhance overall cost-effectiveness. It is through physician engagement in the collaboration with payers and regulators that these goals may be realized.
Some may suggest that the presence of any "inappropriate" indications is proof that the ACCF has over-reached its boundaries, especially in view of the continued debate in medical imaging. On the contrary, we believe this self-examination is critical, and only those with expertise in clinical cardiology can honestly interpret the patient care impact of the expansion or contraction of diagnostic or therapeutic interventions. The ACCF’s initiative for appropriate criteria is all about "doing the right thing" for contemporary health care—the true meaning of appropriate (6). The beneficiaries of these criteria will be our patients, as well as society at large, and producing them is our professional obligation.
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- Encarta World English Dictionary. Redmond, WA: Microsoft Corp; 1999.
- Medicare Payment Advisory Commission (MedPAC). Report to the Congress: Growth in the volume of physician services 2004. Available at: http://www.medpac.gov/publications/congressional_reports/Mar05_EntireReport.pdf. Accessed October 20, 2005..
- Patel MR, Spertus JA, Brindis RG, et al. ACCF proposed method for evaluating the appropriateness of cardiovascular imaging J Am Coll Cardiol 2005;46:1606-1613.[Free Full Text]
- Brindis RG, Douglas PS, Hendel RC, et al. ACCF/ASNC appropriateness criteria for single-photon-emission computed tomography myocardial perfusion imaging (SPECT MPI)a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology. J Am Coll Cardiol 2005;46:1587-1605.[Free Full Text]
- Finch K, Berstein SJ, Aguilar MD, et al. The RAND/UCLA Appropriate Method User’s Manual. Santa Monica, CA: The RAND Corp; 2001. pp. 4-5.
- Wolk MJ, Peterson E, Brindis R, Eagle A. President’s page: the appropriate cardiologist: responsible stewardship in a golden era of cardiology J Am Coll Cardiol 2004;44:933-935.[Free Full Text]
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R. O. Bonow
Is Appropriateness Appropriate?
J. Am. Coll. Cardiol.,
April 1, 2008;
51(13):
1290 - 1291.
[Full Text]
[PDF]
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