Weighing Options for Early Detection of Colorectal Cancer

Did you know that approximately 70 percent of medical decisions are being made based on laboratory test results? Considering that colorectal cancer is one of the most common diagnosed cancers in the United States, our laboratory professionals play a critical role in early detection and prevention of colorectal cancers.

Routine screening is the best practice for early detection of pre-cancerous polyps, which, once identified, allows for removal before the polyps become cancerous. Individuals with high-risk factors, such as a personal history of certain types of polyps, a personal history of inflammatory bowel disease, or a family history of colorectal cancer, to name a few, will most commonly be followed up on by their primary care provider, and with consideration of the person’s age, they will be advised of suggested lifestyle changes and guided toward methods for prevention and reduction of risk. 

For most patients, when caught in the early stages, colorectal cancer is treatable. Unfortunately, the problem is that most patients in early stages present no symptoms and are not actively under the care of a healthcare provider. 

For both men and women, age as a risk factor is a point of recognition. In 2021, the U.S. Preventive Services Task Force lowered the recommended age, from 50 to 45 years, to begin preventive screening.  This adjustment, which is now reflected in payor coverage criteria, is intended to help reduce the rise seen in cancer cases among young and middle-aged patients, even though there has been an overall reduction in colorectal cancer rates. 

As alternatives to the instrumented procedures, which can be somewhat uncomfortable and require lengthy, inconvenient pre-procedure prep, there are several laboratory test options available for preventive screening. In coordination with their healthcare provider, patients can select the option best suited for them based on age, race, and other relevant risk factors. 

The fecal occult blood test (FOBT) is an easy, quick test performed in the office during a clinic visit, along with a digital rectal exam. However, a more reliable screening would be an at-home sample collection kit for testing that is analyzed by a clinical laboratory. For home testing, the patient will be given three to six individual cards, with instruction for collection of separate stool samples from sequential bowel movements. Upon completing the collection, the patient will return the cards to the laboratory for testing. The FOBT is considered a single test that may require collection over multiple days. The correct date of service for billing is based on the collection end date. For preventive screening (CPT 82270), the allowed Medically Unlikely Edit (MUE) is one unit of service, and the NCD has a published frequency limit of one test per year.  

Newer modalities offer increased specificity and better sensitivity for detection of occult blood in the stool sample. The fecal immunochemical test (FIT) uses antibodies to detect occult blood. This test may be preferred over the FOBT, as it only detects human blood from the lower intestines, therefore limiting the need for dietary and medication restrictions before testing. For the FIT (G0328), the laboratory will process the patient sample using a cartridge that provides a visual read, which tends to be more accurate and has fewer false-positive results than peroxidase-based FOBT. Medicare’s preventive benefit will pay for only one covered occult blood test per year, either CPT 82270 or HCPCS G0328, but not both.

Patients today also benefit from the availability of DNA-based stool tests. The Cologuard® test detects hemoglobin as well as altered DNA in shed CRC cells isolated from stool samples. The Medicare National Coverage Determination 210.3 provides a detailed description of the Cologuard® test (CPT 81528). This test is not appropriate for patients with high risk for colorectal cancer. A multi-target sDNA test is covered once every three years for Medicare beneficiaries that meet all required criteria.

There is also the Blood-based Biomarker Test (G0237) that is recognized under the preventive services benefit as of Jan. 19, 2021. The Medicare preventive benefit covers a blood-based biomarker test once every three years when performed in a CLIA-certified laboratory, and when the order of the treating physician, along with medical record notes, provide supporting documentation of all required criteria. 

To reduce denials due to frequency edits, coordinate testing with the patient and verify the date a preventive screening procedure was last performed. To determine the allowable testing period, start counting from the month after the month in which a previous test or procedure was performed. For example, if a FIT was performed in January 2022, start counting from February 2022. The next eligible screening procedure could be scheduled in January 2023 (the month after 11 full months have passed).

The laboratory-performed tests will most likely be assigned a CPT code on the chargemaster, and therefore not require procedure coding by health information management (HIM); however, there may be procedure-to-procedure (PTP) edits that present at the time of coding – or at the time of billing. The edits will require review of documentation, and a decision will need to be made as to whether a modifier should be appended, or if a CPT coded charge should be removed from the claim.

In October 2022, the National Correct Coding Initiative (NCCI) added several PTP edits for Cologuard, with screening procedures for sigmoidoscopy, colonoscopy, or barium enema procedures. The edits, when first published, did cause some concern across the healthcare industry due to the NCCI Modifier Indicator of “0,” meaning no NCCI modifier (59, 76, 77, 91) would allow billing the procedures on same date of service. 

The instance should be rare or non-existent for both a DNA-based stool test and a sigmoidoscopy, colonoscopy, or barium enema to be billed by the same provider for the same date of service. The typical sequence of screening procedures would have the patient completing the DNA-based collection, submitting the specimen to the specified laboratory for testing, and then awaiting physician evaluation of results. The consultation between the physician and patient for scheduling of sigmoidoscopy or colonoscopy would most likely not occur until the results of the stool test are known. The bigger question is, why was it necessary for the NCCI contractor (Capitol Bridge) to create and issue this specific set of PTP edits? 

As of Jan. 1, 2023, Medicare allows for colorectal cancer screening by colonoscopy (HCPCS codes G0105, G0121) that follows a non-invasive, stool-based test (HCPCS codes 82270, G0328 and 81528). When the two distinctly separate screening procedures are performed within the allowable frequency, this scenario will require the facility billing for the instrumented procedure to apply the KX modifier on the claim for screening colonoscopy. When all procedures have been appropriately coded and billed, “deductible and coinsurance do not apply to the non-invasive stool-based tests nor the screening colonoscopy, because both tests are specified preventive screening services.”

Chapter 18 §60 (Colorectal Cancer Screening) of the Medicare Claims Processing Manual has received numerous updates over the past few years. The most recent changes, made in February 2023, provide clarification for frequency denial messages outlined in § 60.7 – Medicare Summary Notice (MSN) Messages. Be certain to reference the applicable sections of the MCPM for the available covered diagnosis codes. For the non-invasive, stool-based laboratory tests discussed here, the most common diagnoses would be the following:

• Z12.11 Encounter for screening for malignant neoplasm of colon, or
• Z12.12 Encounter for screening for malignant neoplasm of rectum.