New Medicare Rules Cover More Colon Cancer Screening Tests for Adults 45–85

Important Medicare Update for Adults Age 45–85

The Centers for Medicare & Medicaid Services (CMS) has finalized a National Coverage Determination that expands coverage for certain non-invasive biomarker tests used for colorectal cancer (CRC) screening.

What the New Coverage Includes

Medicare will cover FDA-authorized non-invasive biomarker tests (such as stool DNA/RNA-based tests and certain blood-based tests) once every 3 years for eligible individuals at average risk.

Examples of covered tests include:

•  Cologuard® and Cologuard® Plus

•  ColoSense™

•  Shield™ (blood test)

•  and other tests meeting CMS performance and FDA requirements

Eligibility Criteria

Coverage applies when all of the following are met:

•  Patient is age 45 to 85

•  Patient is asymptomatic (no signs or symptoms such as gastrointestinal pain, blood in stool, or unexplained weight loss)

•  Patient is at average risk for colorectal cancer (no personal history of adenomatous polyps, CRC, or inflammatory bowel disease; no relevant family history such as CRC, advanced adenomas, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer)

•  The test is ordered by a physician, physician assistant, nurse practitioner, or clinical nurse specialist who will use the results in patient management

•  The patient has been informed about the test’s performance characteristics and the need for follow-up colonoscopy if the test is positive

Key Requirement: A positive result on any non-invasive test must be followed by a diagnostic colonoscopy.

Test Performance Standards

To qualify for Medicare coverage, tests must meet FDA authorization and one of these performance thresholds (based on FDA labeling compared to colonoscopy):

•  Sensitivity ≥90% and Specificity ≥87% for CRC, or

•  Sensitivity ≥79% and Specificity ≥90% for CRC

Tests must be processed in a CLIA-certified laboratory.

Why This Matters

Colorectal cancer remains one of the leading causes of cancer-related deaths, but early detection through screening significantly improves outcomes. Non-invasive options can help increase screening rates among those who may hesitate due to the preparation or invasiveness of traditional colonoscopy.

Official Sources

•  Full CMS Decision Memo: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=319

•  Cologuard Information: https://www.cologuard.com/

•  Medicare Preventive Services Overview: https://www.medicare.gov/coverage/colorectal-cancer-screenings

Individuals should consult their healthcare provider to determine if a non-invasive colorectal cancer screening test is appropriate based on their individual health history and risk factors. Medicare colon cancer screening

If your family is looking for reliable senior home health care in Mount Prospect or surrounding areas, we’re here to help.

Contact OCTIHEALTH HOME HEALTH today at (847) 305-3070 or email octihealth@gmail.com to schedule a free call and check your eligibility.