Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1: The patient is a 50-year-old female with a history of hyperlipidemia and low levels of HDL treated with gemfibrozil and Pravachol.  She had a baseline EBCT in 2003 and a second imaging study in June 2005. The Health Plan denied the patients request for reimbursement of the follow-up study based upon their determination that EBCT is considered experimental/ investigational for evaluation of coronary artery disease. In adults at low risk for coronary heart disease (CHD) events, the United States Preventive Services Task Force (USPSTF) now recommends against routine screening for either the presence of severe coronary artery stenosis (CAS) or the prediction of CHD events with resting electrocardiography (ECG), exercise treadmill test (ETT), or electron-beam computed tomography (EBCT) scanning for coronary calcium. The panel concluded that the potential harm of routine screening for CHD in this patient group exceeds the potential benefit. Although there is at least fair evidence that ECG or ETT can detect some asymptomatic adults at increased risk for CHD events independent of conventional CHD risk factors, and that ETT can detect severe CAS in a small percentage of asymptomatic adults, there is little such evidence for EBCT. More importantly, there is no evidence that detection of CAS or of increased CHD risk ultimately results in improved health outcomes. Potential harms of false-positive tests include unnecessary invasive procedures, over treatment, and patient labeling. Limited sensitivity of these tests could also result in false-negative screening. Negative tests do not rule out severe CAS or the risk of a future CHD event.In adults at increased risk for CHD events, the USPSTF found insufficient evidence to recommend for or against routine screening with ECG, ETT, or EBCT for coronary calcium for either the presence of severe CAS or the prediction of CHD events. EBCT has not been recommended by any major society (ACC, AHA or USPTF) as an initial screening test for CAD. It is not recommended as a diagnostic tool to clinically measure progression or regression of CAD in the general population. Other diagnostic modalities (ETT, cardiac catheterization) are recommended as indicated when symptoms are present. In this particular case, EBCT is being used to measure progression of CAD given treatment of a low HDL syndrome. Standard of care practices would be to treat the patients dyslipidemia and other risk factors medically, and to perform a stress test if symptoms of ischemia were suspected. It is unclear why standard treatments and diagnostic measures have not been used first.Based upon the information set forth above, I have determined that the diagnostic procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2: The patient is a 50-year-old female requesting reimbursement for an EBCT that was performed to determine the effectiveness of dyslipidemia therapy.  The record indicates she has been treated with gemfibrozil and Pravachol since 2002 and her last recorded LDL was 78. The Health Plan denied her request on the basis that EBCT is an investigational diagnostic procedure.There is scientific consensus that LDL reduction achieved with dyslipidemia therapy is a predictive factor for the reduction of coronary artery disease (CAD) risk.  EBCT has not been shown to be superior to direct LDL measurement in predicting CAD risk.  The EBCT process is similar to components of the Framingham coronary prediction algorithm and the weight of scientific evidence suggests that it is a useful tool in prognosticating future coronary events.  There is not yet however, a scientific consensus that it is superior to traditional risk factor assessment.   Although there is promise that EBCT may evolve into a useful tool for gauging the effectiveness of therapy, it is still experimental at this time.Based upon the information set forth above, I have determined that the diagnostic procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3:The patient is a 50-year-old female with a history of dyslipidemia and excess weight (209 pounds). The record contained no indications of current cardiac symptoms and no history of heart disease. An EBCT was performed to evaluate coronary artery calcium progression and the efficacy of treatment with gemfibrozil and Pravachol for hyperlipidemia. The Health Plan denied the patients request for reimbursement due to their determination that the procedure was experimental/investigational in this clinical circumstance. Based on the records provided for review, the patient has at least one cardiac risk factor (dyslipidemia) and no current cardiac symptoms or known coronary disease.  In this setting, there are established guidelines written by expert national committees such as the National Cholesterol Education Panel (NCEP) that provide recommendations for risk factor modification. These guidelines do not incorporate the routine use of EBCT.  In addition, EBCT procedures have not been shown to add incremental value to the predictive benefits of established risk factor indices and conventional noninvasive testing when used in combination.  Therefore, I have determined that the diagnostic procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.