Cologuard^TM Multitarget Stool DNA Test

Insufficient Documentation Causes Most Improper Payments. Insufficient documentation means that something was missing from the medical records. Below is a list of the most common reasons CERT determined there was insufficient documentation that caused improper payments for Cologuard^TM (81528).

• Missing laboratory results
• Missing the referring provider order
• Missing electronic signature or legible signature of the referring provider
• Missing medical notes from the referring provider supporting the patient is asymptomatic or at average risk of developing colorectal cancer, or the medical notes received do not support the patient is asymptomatic or at average risk of developing colorectal cancer.

Laboratory results: The signed laboratory results must be submitted.

Referring order: Must be signed and dated.

Signature: An electronic signature or legible signature is required on medical records.

Documentation from the referring provider: Medical documentation from the referring provider (e.g. previous office visit notes or a consultation report) must be submitted that supports the patient is asymptomatic or at average risk of developing colorectal cancer.

NCD 210.3 Guidelines for Colorectal Cancer Screening Tests for the Cologuard^TM Test

The test is covered once every three years for Medicare beneficiaries who meet all of the following criteria

• Age 50 to 85 years, and,
• Asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test (gFOBT) or fecal immunochemical test (iFOBT) and
• at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).

Related Content

• Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 210.3 B2  (Colorectal Cancer Screening Tests)
• National Coverage Determination (NCD) for Colorectal Cancer Screening Tests (210.3)
• Centers for Medicare & Medicaid Services Internet-Only Manual, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4 (Signature Requirements)

Reviewed 11/14/2024