CPT Code for Cologuard
The CPT code for Cologuard (stool-based DNA test) is 81528.
Background on Cologuard
Cologuard is an FDA-approved multitarget stool DNA (mt-sDNA) test used for colorectal cancer screening. It combines:
- DNA methylation biomarkers (BMP3 and NDRG4)
- KRAS mutation analysis
- A hemoglobin immunoassay component (similar to FIT)
The test was approved by the FDA in August 2014 as the first stool DNA test for primary screening of colorectal cancer 1. It has been included in screening guidelines by organizations including the US Preventive Services Task Force and the American Cancer Society 1.
Clinical Performance of Cologuard
Cologuard offers several advantages over traditional screening methods:
- Higher sensitivity than FIT for detecting colorectal cancer (92.3% vs 73.8%)
- Better detection of advanced precancerous lesions (42.4% vs 23.8%)
- Improved detection of polyps with high-grade dysplasia (69.2% vs 46.2%)
- Superior detection of sessile serrated polyps larger than 1 cm (42.4% vs 5.1%) 1
However, it does have lower specificity compared to FIT (86.6% vs 94.9%), which means more false positives 1.
Billing and Coding Considerations
When billing for Cologuard:
- Use CPT code 81528 for the complete test
- The test is typically performed once every 3 years for average-risk patients
- A positive result requires follow-up with diagnostic colonoscopy
Current Guideline Recommendations
While Cologuard is FDA-approved as a primary screening modality, the NCCN guidelines from 2015 noted that appropriate screening intervals were not well established at that time due to limited data 1. More recent guidelines have incorporated Cologuard as an accepted screening option.
The USPSTF (2021) includes stool DNA-FIT testing as one of the recommended screening options for colorectal cancer in adults aged 45-75 years 1.
Patient Considerations
Cologuard may be particularly appealing to:
- Patients who are reluctant to undergo colonoscopy
- Unscreened patients who prefer non-invasive options
- Younger patients (<60 years) who may prefer at-home testing 2
Limitations and Caveats
- Cologuard has relatively low sensitivity for advanced adenomas, making it less suitable for screening precancerous lesions 1
- Cost-effectiveness analyses suggest that significant increases in sensitivity or substantial decreases in cost would be necessary to make Cologuard more cost-effective relative to other screening modalities 1
- Monthly variations in screening test utilization have been observed, with certain months showing lower rates of Cologuard use 3
In summary, when billing for Cologuard, use CPT code 81528, and be aware of the appropriate screening intervals and follow-up recommendations based on current guidelines.