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Pathology/Lab Coding Alert

Reader Question:

Learn 81528 Coverage Requirements

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?

Texas Subscriber

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)