In its newly released Final Rule for the 2025 Medicare Physician Fee Schedule, the U.S. Centers for Medicare and Medicaid Services (CMS) updated its coverage for a complete colorectal cancer (CRC) screening to include Medicare-covered blood-based biomarker CRC screening tests alongside a follow-on screening colonoscopy.
The final rule now also includes adding coverage of CRC screening with CT colonography (CTC) for the first time while removing coverage for the barium enema procedure.
In 2023, the CMS expanded the regulatory definition of CRC screening to include a complete CRC screening, specifying that it included a follow-on screening colonoscopy after a Medicare-covered noninvasive stool-based CRC screening test returned a positive result.
In the document, the CMS explained that published data showed that patients who didn't receive a follow-up colonoscopy were about twice as likely to die of CRC than patients who had received one.
"Since the overall goal of programmatic cancer screening using any CRC screening test is to prevent cancer, allowing for early detection and treatment and reducing cancer mortality, the follow-up colonoscopy was found to be integral with noninvasive stool-based CRC screening, since improvements in health outcomes would not be possible without the follow-up colonoscopy," the CMS noted.
At the same time, CMS acknowledged the advantages of the noninvasive stool-based CRC screening test as a first step in CRC screening, such as ease of use, its noninvasive nature, and reduced burden of test preparation for both patients and staff. However, while the agency acknowledged requests for the inclusion of blood-based CRC tests as part of the CRC screening procedure, it noted in September 2022 that there were no blood-based CRC screening biomarker tests available that met the coverage requirements. Moreover, the May 2021 USPSTF revised final recommendation statement did not include serum tests.
The CMS wrote that it has since reconsidered, stating that "blood-based biomarker tests for CRC screening may achieve the coverage requirements described in NCD 210.3 within the near term and thereafter quickly become adopted as a noninvasive option within the healthcare system and patient community." It additionally observed that for many patients, the blood-based tests may be preferred, as they can be performed at the same time as other bloodwork, and they may be more accessible to patients in rural and underserved communities. Any blood-based biomarker CRC screening test must have U.S. Food and Drug Administration market authorization with an indication for colorectal cancer screening, CMS noted.
The final rule will be published in the Federal Register on December 9.
