Insurance Coverage Age Limits for Cologuard
Insurance will cover Cologuard (multitarget stool DNA testing) for average-risk adults from age 45 through age 85 years. 1
Age-Specific Coverage Guidelines
Starting Age
- Age 45 is the FDA-approved lower age limit for Cologuard use in average-risk adults 1
- The American Cancer Society (2018) supports screening beginning at age 45 with multitarget stool DNA testing as an acceptable option 1
- The U.S. Multi-Society Task Force (2022) recommends offering colorectal cancer screening starting at age 45, with FIT-fecal DNA (Cologuard) every 3 years as a recommended option 1
Upper Age Limit
- Age 85 is the FDA-approved upper age limit for Cologuard 1
- Insurance coverage typically follows FDA approval parameters, meaning coverage extends through age 85 1
Important Coverage Considerations by Age Range
Ages 45-75 Years
- Strong insurance coverage with high certainty of benefit 1
- Cologuard should be performed every 3 years if this modality is chosen 1
- All major guidelines support screening in this age range with multitarget stool DNA testing as an acceptable option 1
Ages 76-85 Years
- Coverage continues but screening decisions should be individualized based on prior screening history, life expectancy, and overall health status 1
- Never-screened individuals in this age range are more likely to benefit and should still be considered for screening 1
- Those with prior negative screening (especially colonoscopy) have smaller benefit 1
- Life expectancy greater than 10 years is a key determinant for whether screening provides benefit 2
Age 86 and Older
- Insurance coverage is not recommended as Cologuard is only FDA-approved through age 85 1
- Guidelines discourage screening after age 85 years 1
Critical Caveats
Positive Cologuard results require follow-up colonoscopy, which must be factored into the decision to use this test, particularly in elderly patients who may not tolerate colonoscopy 1
The test has reduced specificity (87%) compared to FIT (95%), resulting in false-positive rates of 13-40%, meaning many patients will undergo unnecessary colonoscopy 1, 3
Prior screening history matters: In patients with a previously normal colonoscopy within the past 7-10 years, the utility of Cologuard may be questioned, though one study found 30% of such patients with positive Cologuard had advanced adenomas on follow-up 4
Insurance coverage follows FDA labeling and guideline recommendations, so coverage outside the 45-85 age range would require special justification and is unlikely to be approved 1