Cologuard denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Cologuard stool testing for evaluation of the enrollee, who underwent routine colon cancer screening. Findings: 2/3 of the physician reviewers found that the physician reviewer found colorectal neoplasms shed DNA in the stool. The DNA can be isolated and tested for the presence of mutations and epigenetic changes acquired during carcinogenesis. Cologuard is a second generation stool DNA test. Cologuard has been approved by the U.S. Food and Drug Administration as a screening test for colorectal carcinoma to be followed, when abnormal, by diagnostic colonoscopy. This test may be appropriate for asymptomatic patients, 50 to 84 years of age, who are at average risk for colorectal cancer. This patient is a high risk for sedated colonoscopy due to her extensive neurologic history.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Cologuard screening for evaluation of the enrollee’s risk of colon cancer. Findings: The physician reviewer found that the request for Cologuard screening is medically necessary for evaluation of the patient’s medical condition. Cologuard is U.S. Food and Drug Administration (FDA)-approved to test for colon cancer in average-risk patients such as this patient, proved 92% sensitive for detection of colon cancer, and can detect most adenomas if they have high-grade dysplasia (Imperiale, et al). The test is recommended by the American Cancer Society guidelines. Although colonoscopy has the highest recommendation from the U.S. Preventive Services Task Force, the patient has provided a valid relative contraindication to colonoscopy.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Cologuard test. Findings: The physician reviewers found that evidence on impact or on healthcare outcomes of Cologuard versus standard medical care is lacking at this time. Cologuard is not standard of care. Cologuard is U.S. Food and Drug Administration approved to test for colon cancer. However, the limited evidence for Cologuard reports that 154 persons would have to be screened to find one cancer using colonoscopy, versus 166 persons using Cologuard, raising concern that Cologuard may miss cancer. The evidence of the impact of Cologuard on patient care or health outcomes is also lacking.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Cologuard fecal testing performed for evaluation of the enrollee, who has a history of colon polyps. Findings: Three physician reviewers have found that Cologuard is not standard of care at this time. Cologuard is U.S. Food and Drug Administration (FDA) approved to test for colon cancer, proved 92% sensitive for detection of colon cancer, and can detect most (but not all) adenomas if they have high-grade dysplasia. However, the limited evidence for Cologuard reports that 154 persons would have to be screened to find one cancer using colonoscopy, versus 166 persons using Cologuard, raising concern that Cologuard may have missed cancer. The evidence of the impact of Cologuard on patient care or health outcomes is lacking.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Cologuard, then check the rights and deadlines that apply to your plan.