CMS Expands Medicare Coverage for Non-Invasive Colorectal Cancer Screening Tests

17 hours ago
3 min read

Healthcare provider explaining colorectal cancer screening options to an older adult

Important Medicare Update for Adults Age 45–85

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

This update gives eligible Medicare beneficiaries more screening options beyond traditional colonoscopy, including certain stool-based DNA/RNA tests and blood-based biomarker tests.

Medicare Colorectal Screening: What the New Coverage Includes

Medicare will cover FDA-authorized non-invasive biomarker colorectal cancer screening tests once every 3 years for eligible individuals at average risk.

Examples of tests that may qualify include:

• Cologuard® and Cologuard® Plus• ColoSense™• Shield™ blood test• Other tests that meet CMS performance standards and FDA requirements

These tests are designed to help detect signs of colorectal cancer through non-invasive sample collection, such as stool or blood testing.

Who Is Eligible?

Medicare coverage applies when all of the following criteria are met:

• The patient is age 45 to 85

• The patient is asymptomatic, meaning they have no signs or symptoms such as gastrointestinal pain, blood in the stool, or unexplained weight loss

• The patient is at average risk for colorectal cancer

• The test is ordered by a physician, physician assistant, nurse practitioner, or clinical nurse specialist

• The healthcare provider will use the results for patient care and management

• The patient has been informed about the test’s performance and the need for follow-up testing if results are positive

A patient may not qualify as average risk if they have a personal history of colorectal cancer, adenomatous polyps, inflammatory bowel disease, or a relevant family history of colorectal cancer or inherited colorectal cancer syndromes.

Key Requirement: Follow-Up Colonoscopy

A positive result on any non-invasive colorectal cancer screening test must be followed by a diagnostic colonoscopy.

This step is important because non-invasive tests are screening tools. A colonoscopy is needed to confirm findings, evaluate the colon, and remove suspicious polyps when appropriate.

Test Performance Standards

To qualify for Medicare coverage, the test must be:

• FDA-authorized for colorectal cancer screening• Processed in a CLIA-certified laboratory• Supported by FDA labeling and required post-approval study standards• Proven to meet CMS performance requirements

CMS requires covered tests to meet one of the following performance thresholds:

• Sensitivity of at least 90% and specificity of at least 87% for colorectal cancer, or• Sensitivity of at least 79% and specificity of at least 90% for colorectal cancer

Why This Medicare Update Matters

Colorectal cancer remains one of the leading causes of cancer-related deaths in the United States. However, early detection through regular screening can greatly improve outcomes.

Many adults delay or avoid screening because of concerns about colonoscopy preparation, transportation, time, or the procedure itself. Expanding coverage for non-invasive colorectal cancer screening tests may help more people get screened earlier and more comfortably.

These tests do not replace colonoscopy when a follow-up is needed, but they may offer an important first step for eligible adults who are due for colorectal cancer screening.

Talk to Your Healthcare Provider

Not every screening test is right for every person. Individuals should speak with their healthcare provider to determine whether a non-invasive colorectal cancer screening test is appropriate based on their age, symptoms, personal medical history, and family history.