Reader Question: Learn 81528 Coverage Requirements- Published on Fri, Dec 09, 2016
Question: Our lab performs the Cologuard test for colon cancer screening, but we’re getting denials. Could you please outline the criteria for screening Cologuard test coverage?
Answer: The test you’re asking about is 81528 (Oncology [colorectal] screening, quantitative real-time target and signal amplification of 10 DNA markers [KRAS mutations, promoter methylation of NDRG4 and BMP3] and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result).
Medicare has developed a policy to pay for this test as a screening tool in certain circumstances. The patient must meet these criteria for coverage:
The patient is between 50–85
Patient shows no signs or symptoms of colorectal disease including, but not limited to, lower gastrointestinal pain, blood in stool, positive fecal occult blood test such as guaiac (82270-82271, Blood, occult, by peroxidase activity [e.g., guaiac] »» qualitative …) or immunochemical (82274, Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations)
Patient is not at high risk for developing colorectal cancer, meaning no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease (including Crohn’s Disease and ulcerative colitis)
Patient has no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer.
To get paid for the test as a screening, the clinician must order the test with an accepted diagnosis code indicating the high-risk status of the patient. Most Medicare payers require at least one of the following ICD-10 codes to indicate the use of the 81528 test for screening:
Z12.11 (Encounter for screening for malignant neoplasm of colon)
Z12.12 (Encounter for screening for malignant neoplasm of rectum)