You may also contact us at GuidanceA large number of comments that were received described a single clinician’s or a single institution’s anecdotal success with the Corus CAD test without providing specific utilization or outcome data or without an indication that these sources of experience were systematically tracking utilization and outcomes of patients who were or were not tested with the Corus CAD test. 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While the commenters did discuss evidence supporting the diagnostic accuracy of the Corus CAD test, they did not bring to our attention any high quality research suggesting that the Corus CAD test could be used as an alternative to an existing test or that it identified high risk patients who were missed and led to a better long term outcome for stable coronary artery disease.One physician raised the possibility of this test being used in the emergency room.The test has a turnaround time of a couple of days at least and therefore does not provide a timely result in patients with possible acute cardiac ischemia.A representative from CardioDX sent the following comment:The Corus CAD blood test incorporates age, sex, and gene expression to calculate a score reflecting a given symptomatic patient’s current likelihood of obstructive coronary artery disease (oCAD). Clinical utility relates to changing the management of a patient in a way that is beneficial to the patient. None of these commenters presented new data regarding clinical utility in the Medicare population or referenced a study demonstrating this. Some of these comments specifically cited research, which is also reviewed in the draft LCD.The draft LCD is non-covering the Corus CAD test specifically due to a lack of clinical utility of the test in the Medicare population. Systematic tracking of patient characteristics, test results, and patient outcomes are the minimum necessary information to ascertain meaningful information regarding the clinical utility of a test.Numerous providers reported an opinion that the Corus CAD test has good performance characteristics that allow them to confidently use it to stratify a patient’s risk of having coronary artery disease to either reassure the patient or recommend further diagnosis or treatment options.As such, our organization is in the planning phases of a randomized control trial to further support the clinical utility of Corus CAD.Conclusion: We have demonstrated clinical utility in the targeted patient population by showing that use of Corus CAD can reduce unnecessary cardiac testing without a negative impact on patient safety. As an organization, we strive to take a leadership position in the development and commercialization of clinically validated molecular diagnostics. We have attempted to continually update our published evidence with 30 peer reviewed published articles and 70+ abstracts and presentations. Corus CAD reduces the number of downstream procedures, which drives improved patient outcomesAs in indication of the growing acceptance of Corus CAD as a valuable tool in evaluation of symptomatic patients, the American Heart Association Scientific Statement on the Expressed Human Genome in July 2017 referred to Corus CAD as “valid and useful.” CardioDx has, under separate cover, submitted comments directly on the draft policy posted by Palmetto.We appreciate that the level of evidence expected today is different than it was when Corus CAD was launched in 2009.Target population: Patients with symptoms suggestive of obstructive coronary artery disease (oCAD) where the physician is considering what action to take We believe this data is adequate to maintain Medicare coverage of Corus CAD. The Corus CAD test changes the pre-test probability for patients compared to clinical factors.
Profile To Plan View Cad License From TheCorus CAD is associated with higher rates of starting lipid lowering agents and adherence on therapyOutlined below is a description of the published evidence to support the test performance and clinical utility of Corus CAD: Corus CAD decreases the use of unnecessary downstream testing (COMPASS, IMPACT-PCP, PROMISE, IMPACT-CARD, PRESET) Physicians use the likelihood from Corus CAD to change their further diagnostic management leading to fewer unnecessary procedures(IMPACT-CARD, IMPACT-PCP, PRESET) with benefit in vulnerable population (PRESET ELDERLY) Corus CAD changes the pre-test probability for patients and provides information that is not available from other sources (PREDICT,COMPASS, PROMISE) Corus CAD provides an accurate measure of the current likelihood of oCAD (data from: PREDICT, COMPASS, PROMISE) Free version of adobe acrobat 7 for osxObstructive CAD was defined prospectively as ≥1 stenosis ≥50% in a major vessel based on a centralized reading quantitative coronary angiography or coronary computed tomography angiography.
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