Updating appropriate use criteria, enforcing False Claims Act may reduce inappropriate PCI
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Updating current appropriate use criteria for PCI in patients with stable ischemic heart disease to include findings from the ISCHEMIA trial may reclassify a significant number of PCIs to rarely appropriate, researchers found.
Another study found that the False Claims Act suits may have occurred more in high-volume hospitals compared with other hospitals, and that these cases may have led to a decline in PCI use.
Both of these research letters were published in JAMA Internal Medicine.
Appropriate use criteria for PCI
Ali Malik, MD, cardiovascular fellow at St. Luke’s Mid America Heart Institute in Kansas City, Missouri, and colleagues analyzed data from 352,376 patients (mean age, 68 years; 30% women) enrolled in the CathPCI registry with stable ischemic heart disease. PCIs classified as appropriate, maybe appropriate or rarely appropriate based on current definitions of appropriate use criteria were compared with modified ratings based on findings from the ISCHEMIA trial, which recategorized PCIs in asymptomatic patients without left ventricular dysfunction and/or left main CAD as rarely appropriate.
As Healio previously reported, an invasive strategy and a conservative strategy of optimal medical therapy yielded similar long-term CV outcomes in stable patients with moderate or severe ischemia.
Of the patients in this study, 17.5% were asymptomatic or had nonanginal chest pain when undergoing PCI.
Using current appropriate use criteria, 56.2% of PCIs were appropriate, 40.5% were maybe appropriate and 3.3% were considered rarely appropriate. The modified appropriate use criteria ratings considered 50.8% of PCIs as appropriate, 26.9% as maybe appropriate and 22.3% were considered rarely appropriate.
“The appropriate use criteria for PCI are an evolving metric to assess how aligned decision-making for PCI is with evidence-based medicine and/or expert opinion,” Paul S. Chan, MD, MSc, professor of medicine at the University of Missouri-Kansas City and the Saint Luke’s Mid America Heart Institute, told Healio. “However, as they are only updated periodically, our study highlights how emerging trial evidence (such as from ISCHEMIA) may dramatically reshape the landscape of procedural appropriateness for PCI. Thus, our study provides a theoretical framework in understanding the appropriateness of PCI [if] the [appropriate use criteria] were to be updated in real time."
Ratings for appropriateness could not be designated for 39.3% of PCIs with the current criteria and 32.9% of PCIs with the modified criteria. Missing stress test results or lack of stress testing altogether accounted for 81.2% of unclassified PCIs with the current appropriate use criteria and 74.7% of unclassified PCIs with the modified criteria.
The increase in the number of rarely appropriate PCIs resulted from a reclassification of 45,442 asymptomatic patients who underwent PCIs initially classified as maybe appropriate (50.4%), unable to be classified (49.6%) or appropriate (0.03%) using the current criteria to a rarely appropriate rating based on the modified criteria.
Researchers also performed a sensitivity analysis and found that excluding patients with LV dysfunction and left main coronary CAD had a minimal association with the proportion of patients who underwent PCIs that were considered rarely appropriate, maybe appropriate and appropriate.
“We still need to clarify as to the role of risk stratification with stress testing for nonacute patients undergoing PCI,” Chan said in an interview. “To be eligible for ISCHEMIA, patients were required to have at least moderate ischemia on some modality of stress testing. These tests are used ubiquitously across U.S. hospitals, but their role in risk stratification and decision-making remains unclear. Except for symptom relief, does stress testing identify patients who would have ‘hard’ clinical endpoint benefit from coronary revascularization? With ISCHEMIA, we are left with more questions than answers.”
False Claims Act cases
In another research letter published in JAMA Internal Medicine, David H. Howard, PhD, professor in the department of health policy and management at Emory University, and Nihar R. Desai, MD, MPH, associate professor of medicine in the section of cardiovascular medicine at Yale School of Medicine, identified 16 hospitals that were investigated for performing unnecessary PCIs according to the U.S. False Claims Act.
“Application of the False Claims Act to medically unnecessary care is controversial both in the courts and in the Department of Justice,” Howard told Healio. “We wanted to better understand the impact of [False Claims Act] suits. Also, use of percutaneous coronary intervention has declined. It is important for the cardiology community to understand why the decline has occurred. [False Claims Act] suits may have contributed.”
PCI volumes at eight hospitals were measured with inpatient and ambulatory surgery data from states, including Kentucky, Florida, New Jersey and Maryland. Investigations at these hospitals became public in 2007, 2008, 2011 and 2015.
Patients with acute MI were excluded. Researchers matched hospitals that were investigated with those from the same state based on PCI volumes from 2006.
Of the cases in this study, 87.5% were resolved with settlement. In addition, the DOJ successfully sought prison terms for individual cardiologists in 18.8% of cases.
During the study period, 676,729 PCIs were performed in patients without acute MI in Kentucky, Florida, New Jersey and Maryland. In these states, 234 hospitals performed at least 25 PCIs in these patients, of which 3.4% of cases became public. Investigated hospitals accounted for 13.5% of PCIs in these states in 2006.
In eight investigated hospitals, the mean annual PCI volume decreased by 81.2% from 2006 to 2017 (1,440 procedures to 271 procedures; P < .001). The total number of procedures also declined during this time (11,520 procedures to 2,172 procedures).
In matched, noninvestigated hospitals, the mean volume declined by 68.4% (1,168 procedures to 369 procedures; P = .003). The null hypothesis of equal trends between groups was eliminated by an F test (F = 20.73; P < .001).
“The results suggest that [False Claims Act] suits have contributed to the national decline in PCI use,” Howard said in an interview. “Although it is controversial, the [False Claims Act] can discourage unnecessary medical treatment, saving Medicare and private payers money in the process.”
Howard added that the False Claims Act is a powerful tool to reduce overuse of PCI. He said, “No amount of utilization review or prior authorization can substitute for the [False Claims Act’s] incentive for insiders — nurses, physicians, administrators — to disclose evidence of wrongdoing at their employers.”
Additional research is needed in this area. “Some of the physicians sued under the [False Claims Act] were accused of miscoding patients’ stenosis to justify performing PCI and avoid scrutiny,” Howard told Healio. “Knowing the extent of miscoding, which probably went on at other hospitals as well, is important for establishing the validity of data in the national PCI registry.”
In an editor’s note addressing both research letters, James W. Salazar, MD, MAS, resident physician at University of California, San Francisco School of Medicine, and Cardiology Today Editorial Board Member Rita F. Redberg, MD, MSc, professor of medicine at University of California, San Francisco School of Medicine and editor-in-chief of JAMA Internal Medicine, wrote” “The work of these authors shows a promising method of reducing unnecessary PCI by combining robust, unambiguous consensus guidelines with enforcement of accurate reporting of indications for PCI. However, these measures are not a cure-all in a health care system propelled by enthusiasm for technology regardless of net benefits and rewarded with fee-for-service payments not associated with the appropriateness of the procedure.”
Editor’s Note: This article was updated on September 29, 2020 to clarify that updating appropriate use criteria may reclassify some PCIs as rarely appropriate, not increase the rates of rarely appropriate PCI. The Editors regret the error.
References:
- Howard DH, et al. JAMA Intern Med. 2020;doi:10.1001/jamainternmed.2020.2812.
- Salazar JW, et al. JAMA Intern Med. 2020;doi:10.1001/jamainternmed.2020.2801.
For more information:
Paul S. Chan, MD, MSc, can be reached at paulchan.mahi@gmail.com.
David H. Howard, PhD, can be reached at david.howard@emory.edu.
Perspective
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Emmanouil S. Brilakis, MD, PhD
The study on the U.S. False Claims Act demonstrates that although infrequent inappropriate PCI did occur, they were punished with severe penalties. The indications for each PCI procedure should be determined by taking into consideration risks and benefits with the patient before making the final decision. There is often uncertainty about what the best course of action may be; however, it is unacceptable for physicians to perform procedures for financial gain knowing that it will not provide benefit to the patient and may expose him or her to risk. This should be punished, as it was in the examples shown in this study.
Regarding the study evaluating the change in procedure appropriateness based on revised appropriate use criteria categorizing patients without symptoms with stable ischemic disease as rarely appropriate, I agree that symptom improvement should be the key determinant of whether PCI is needed in patients with stable ischemic heart disease. This is based both on the COURAGE (Boden WE, et al. N Engl J Med. 2007;doi:10.1056/NEJMoa070829) and ISCHEMIA trials (Maron DJ, et al. N Engl J Med. 2020;doi:10.1056/nejmoa1915922.). Having said that, database-based studies may not always capture the full clinical picture of each patient, which is an important limitation of this study.
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