Description

Colorectal cancer (CRC) screening evaluates the asymptomatic individual to detect cancer that develops in the colon or rectum. Screening tests may identify cancers at an early and potentially more treatable stage.

Some methods such as colonoscopy may detect polyps (precancerous abnormal growths) that can be removed before becoming malignant. Screening differs from diagnostic tests which are used to evaluate an individual who exhibits signs and symptoms of disease.

Laboratory methods for CRC screening include, but may not be limited to:

Colonoscopy and Colorectal Cancer Screening

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0378-029
Page: 2 of 33

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Blood-based biomarker panels are laboratory tests that assess the expression of genes or other biomarkers purportedly associated with increased risk of CRC. Examples include, but may not be limited to:
  1. BeScreened CRC is a multianalyte assay with algorithmic analysis (MAAA) using 3 blood-based biomarkers (carcinoembryonic antigen [CEA], extracellular matrix (ECM) protein and teratocarcinoma-derived growth factor-1 [TGDF-1, Cripto-1]). (Refer to Coverage Limitations section)
  2. GlycoKnow Colon is a laboratory-developed blood test that uses glycoproteomics to pinpoint precursors to colon cancer. (Refer to Coverage Limitations section)
• Stool-based tests are noninvasive laboratory methods to detect blood in stool which may be an early (and sometimes only) symptom of CRC. Examples include, but may not be limited to:
  1. Fecal occult blood test (FOBT) detects occult (hidden) blood in the stool. Blood may come from anywhere along the digestive tract and for that reason, additional types of tests may be ordered. Colonoscopy is performed following an abnormal (positive) FOBT result.
  2. Fecal immunochemical test (FIT) identifies intact human hemoglobin in stool collected by an individual at home then submitted to a laboratory.
  3. Multitarget stool DNA testing (FIT-DNA) (eg, Cologuard) combines FIT with additional testing for altered DNA biomarkers in the stool. An individual with an abnormal (positive) FIT or FIT-DNA test must undergo a definitive test for colon cancer, such as a colonoscopy.
  4. Multitarget stool RNA test (RNA-FIT) (eg, ColoSense) analyzes ribonucleic acid (RNA) biomarkers in the stool and has been proposed as a means for early cancer detection. (Refer to Coverage Limitations section)
• Urine-based testing is a laboratory method that assesses an individual’s urine for biomarkers purportedly associated with CRC. An example includes PolypDx, which is proposed to detect adenomatous polyps (CRC precursor). The assay analyzes urine to detect three metabolites: ascorbic acid, succinic acid and carnitine. It is suggested for those at average to moderate risk for CRC. (Refer to Coverage Limitations section)

Endoscopic visualization

includes methodologies used to view the inside of the large intestine and may be utilized for CRC screening. Examples include, but may not be limited to:

• Colonoscopy is a technique that allows a physician to examine the lining of the entire large intestine by using a colonoscope (flexible, fiberoptic instrument) that is inserted through the anus.

• This test may reveal inflamed tissue, abnormal growths, ulcers or early signs of cancer in the colon or rectum. If needed, special instruments can be passed through the colonoscope to remove polyps.
• Sigmoidoscopy uses a short, flexible fiberoptic tube that provides visualization of the sigmoid (descending) colon and rectum. The tube is inserted through the anus allowing a physician to see abnormal growths, bleeding, inflammation and ulcers. If polyps or cancer are found, then a colonoscopy is performed to screen for polyps or cancer in the remainder of the colon. This procedure may be performed in conjunction with FIT.

Radiologic visualization

is a medical imaging technique to view internal structures in the body and may also be used for CRC screening. This includes, but may not be limited to:

• Computed tomographic colonography (CTC), also known as virtual colonoscopy, is a minimally invasive method to examine the colon and rectum for abnormalities (eg, CRC and polyps). Helical computed tomography (CT) and computer generated images are used to produce high-resolution two- and three-dimensional (3D) images. If suspicious lesions are detected, the individual generally must undergo further testing via conventional colonoscopy.
• Double-contrast barium enema (DCBE), also called a lower gastrointestinal (GI) exam, is an x-ray of the large intestine (colon and rectum). During the procedure, the colon is filled with barium, which enhances the visualization of the outline of the colon. The barium is removed, and the colon is then filled with air. This provides a more detailed view of the inner surface of the colon, making it easier to detect colon polyps and/or other abnormalities (eg, inflammation, strictures). If the test is abnormal (positive), a colonoscopy is needed for further evaluation.
• Magnetic resonance (MR) colonography is a type of magnetic resonance imaging (MRI) that evaluates the entire colon by producing two- and three-dimensional images to detect polyps and cancer without radiation exposure. Studies indicate the test might detect polyps and cancer with high specificity; however, MR colonography is less sensitive than conventional colonoscopy. (Refer to Coverage Limitations section)

Adjunctive methods for endoscopic and radiologic visualization

are add-on techniques used in conjunction with real-time endoscopy to purportedly enhance detection and classification of polyps. These include, but may not be limited to:

• Artificial intelligence (AI) software is a type of computer program added to existing colonoscopy systems that has been suggested to improve adenoma detection. Examples include, but may not be limited to, EndoScreener, GI Genius Intelligent Endoscopy Module and MAGENTIQ-COLO. (Refer to Coverage Limitations section)
• Computer-aided detection (CAD) is an automated add-on to real-time endoscopy that purportedly enhances detection and classification of colorectal polyps. It is used as an aid for radiologists to assist in the interpretation and identification of suspicious findings. CAD is not intended to be used in place of a radiologist but rather as a second examination of the images. SKOUT is a US Food & Drug Administration (FDA)-approved system for computer-aided polyp detection. (Refer to Coverage Limitations section)
• G-EYE is a type of colonoscope that uses an integrated balloon purported to improve visibility during the colonoscopy procedure.

(Refer to Coverage Limitations section)

• In vivo analysis is performed as an adjunct to endoscopic procedures, providing real-time additional imaging to purportedly improve examination of in vivo methods including, but may not be limited to:
  • Chromoendoscopy (Refer to Coverage Limitations section)

Colonoscopy and Colorectal Cancer Screening

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0378-029
Page: 5 of 33

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• Confocal laser microscopy (Refer to Coverage Limitations section)
• Confocal miniprobe (eg, Cellvizio) (Refer to Coverage Limitations section)
• Fiberoptic analysis (Refer to Coverage Limitations section)
• Magnification endoscopy (Refer to Coverage Limitations section)
• Narrow band imaging (Refer to Coverage Limitations section)
• Optical coherence tomography (OCT) (Refer to Coverage Limitations section)
• Retrograde imaging/illumination uses additional small cameras with endoscopy to purportedly enhance evaluation of the colon through illumination and continuous retrograde views. Examples of these devices include, but may not be limited to:
  • Third Eye Panoramic can be attached to the distal end of the colonoscope with a flexible clip and provides continuous left- and right-side views of the colon that are displayed simultaneously on monitors. (Refer to Coverage Limitations section)
  • Third Eye Retroscope is a disposable, single-use imaging device that is inserted into the endoscopic working channel and is purported to provide an additional retrograde (backward) view of areas behind folds and colonic flexures. (Refer to Coverage Limitations section)
• Colonic lavage uses 35 or more liters of warmed, gravity-fed water and is purported to prepare and cleanse the bowel prior to colonoscopy or other endoscopy procedures. HygiPrep is an example of a colonic lavage system that is FDA approved. (Refer to Coverage Limitations section)

Diagnostic colonoscopy is performed to confirm or rule out a condition in a symptomatic individual or when a specific condition is suspected. Diagnostic indications include, but may not be limited to, evaluating signs and symptoms suggestive of colonic disease, assessing the response to treatment in an individual with known colonic disease (eg, inflammatory bowel disease [IBD]) or evaluating abnormalities found on imaging studies.

For information regarding proposed colorectal cancer testing not addressed in this policy, please see the following Medical Coverage Policies:

Colonoscopy and Colorectal Cancer Screening

Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0378-029
Page: 6 of 33

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Determination

Any state mandates for colorectal cancer screening and surveillance take precedence over this medical coverage policy.

Humana members may be eligible under the Plan for CRC screening tests for an individual 45 through 85 years of age and at average risk* based on the following recommendations:

• Colonoscopy – Recommended every 10 years; OR
• CTC** – Recommended every 5 years as an alternative to traditional colonoscopy when the CTC Coverage Criteria is met; OR
• FIT** – Recommended every year; OR
• FIT-DNA** (eg, Cologuard) – Recommended every 3 years; OR
• Flexible sigmoidoscopy** – Recommended every 5 years; OR
• Flexible sigmoidoscopy with FIT** – Flexible sigmoidoscopy recommended every 10 years plus FIT every year; OR
• FOBT**– Recommended every year

Average risk individual is defined as the absence of all of the following:

• Family history of CRC
• Hereditary syndrome associated with increased risk (eg, FAP, HNPCC)
• Personal history of any of the following:
• Colorectal polyps
• CRC
• Cystic fibrosis
• Inflammatory bowel disease (IBD) (ulcerative colitis, Crohn’s disease)
• Serrated sessile polyposis (SSP) syndrome

**Abnormal (positive) findings should be followed up with diagnostic colonoscopy

Humana members may be eligible under the Plan for intensive CRC screening for an individual at increased or high risk which includes:

Increased Risk – Abnormal (Positive) Findings on Prior Colonoscopy

• Hyperplastic polyps less than 10 mm in size – Recommend rescreen in 10 years with any modality; OR
• One or 2 small (less than 10 mm) adenomas with low grade dysplasia – Recommend colonoscopy 5 to 10 years after adenoma removal; OR
• Three to 10 adenomas, or 1 large (greater than 10 mm) adenoma or any adenomas with high grade dysplasia or villous features – Recommend colonoscopy within 3 years after initial polypectomy. If rescreen colonoscopy is normal^ or shows only 1 or 2 small (less than 10 mm) adenomas with low grade dysplasia, recommend repeat colonoscopy every 5 years; OR
• Three to 10 adenomatous polyps and/or serrated sessile polyps (SSPs) – Recommend colonoscopy within 3 years after removal; OR
• Three to 10 SSPs – Recommend colonoscopy within 3 years after removal. If rescreen colonoscopy is normal^, recommend repeat colonoscopy in 5 years; OR

Colonoscopy and Colorectal Cancer Screening Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0378-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• More than 10 adenomas on a single exam – Recommend colonoscopy within 1 year after adenoma removal; OR
• SSP that is removed in pieces – Recommend colonoscopy 2 to 6 months after polyp removal; if entire polyp has been removed, repeat colonoscopy is based on physician's judgment

Increased Risk – Childhood Cancer Survivors Who Received Abdominopelvic Radiation

Recommend colonoscopy 5 years after radiation therapy or at 30 years of age,(whichever is applicable first) and every 5 years thereafter

Increased Risk – Personal History of Acromegaly

Recommend colonoscopy at time of diagnosis and then every 10 years with normal initial colonoscopy; follow interval for increased risk – abnormal (positive) prior colonoscopy after abnormal initial screening colonoscopy

Increased Risk – Personal History of CRC

• Diagnosed with colon or rectal cancer – Recommend colonoscopy 3 to 6 months after cancer resection, if no unresectable metastases are found during surgery; OR
• Year after cancer resection (or 1 year after colonoscopy to ensure the rest of the colon/rectum is clear). If normal^, repeat colonoscopy in 3 years. If again normal^, repeat colonoscopy every 5 years. Time between tests may be shorter if polyps are found or there is reason to suspect HNPCC. After low anterior resection for rectal cancer, colonoscopy may be done every 3 to 6 months for the first 2 to 3 years.

Increased Risk – Personal History of Cystic Fibrosis

Recommend colonoscopy beginning at 40 years of age with rescreening in 5 years and then every 3 years thereafter

Increased Risk – Personal History of IBD

IBD (ulcerative colitis, Crohn's disease) – Recommend colonoscopy 8 years after diagnosis and every 1 to 2 years thereafter; OR

Colonoscopy and Colorectal Cancer Screening
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0378-029
Page: 9 of 33

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

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• IBD (ulcerative colitis, Crohn’s disease) with primary sclerosing cholangitis (PSC) – Recommend colonoscopy 8 years after diagnosis and every year thereafter

Increased Risk – Positive Family History

• CRC or adenomatous polyps in first-degree relative less than 50 years of age – Recommend colonoscopy every 3 to 5 years beginning at 40 years of age or 10 years before the youngest affected relative was diagnosed with CRC, whichever is earlier; OR
• CRC or adenomatous polyps in first-degree relative at least 50 years of age but less than 60 years of age – Recommend colonoscopy every 5 years beginning at 40 years of age; OR
• CRC or adenomatous polyps in first-degree relative at 60 years of age or older – Recommend colonoscopy every 5 years beginning at 45 years of age; OR
• CRC or adenomatous polyps in two or more first-degree relatives (on the same side of the family) at any age – Recommend colonoscopy every 5 years beginning at 40 years of age or 10 years before the youngest affected relative was diagnosed with CRC, whichever is earlier; OR
• CRC or adenomatous polyps in two second-degree relatives (on the same side of the family) at any age – Recommend colonoscopy every 5 years beginning at 45 years of age; OR
• CRC or adenomatous polyps in one second-degree relative, or third-degree relative(s) or first-degree relative with nonadvanced adenoma(s) – Recommend screening beginning at 45 years of age; rescreen in 10 years with any modality (colonoscopy is preferred)

High Risk – Familial or Personal History of Hereditary Syndrome Associated with Increased Risk (HNPCC [Lynch Syndrome] and Polyposis Syndromes)

• AFAP in first-degree relative or second-degree relative; AND
• Colonoscopy and Colorectal Cancer Screening Effective Date: 12/14/2023
• Revision Date: 12/14/2023
• Review Date: 12/14/2023
• Policy Number: HUM-0378-029
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• Negative genetic test result– Recommend screening beginning at 45 years of age; rescreen in 10 years with any modality; OR
• Positive or inconclusive genetic test result or no genetic testing – Recommend colonoscopy beginning in late teens, then every 2 to 3 years thereafter; OR
• Personal history of AFAP – Recommend colonoscopy every 1 to 2 years beginning at 18 to 20 years of age; OR
• FAP in first-degree relative or second-degree relative; AND
• Negative genetic test result – Recommend screening beginning at 45 years of age; rescreen in 10 years with any modality; OR
• Positive genetic test result – Recommend flexible sigmoidoscopy or colonoscopy every year beginning at 10 to 15 years of age; OR
• Inconclusive genetic test result or no genetic testing – Recommend flexible sigmoidoscopy or colonoscopy beginning at 10 to 15 years of age, every year until 24 years of age, then every 2 years until 34 years of age, then every 3 years until 44 years of age, then every 3 to 5 years thereafter.

• Consider substituting colonoscopy every 5 years beginning at 20 years of age; OR
• Personal history of FAP (postcolectomy) – Recommend sigmoidoscopy every year; OR
• MAP in first-degree relative or second-degree relative – Recommend colonoscopy beginning at 25 to 30 years of age and every 2 to 3 years if normal^ (consider shorter intervals between colonoscopy exams with advancing age); OR
• Personal history of MAP – Recommend colonoscopy every 1 to 2 years beginning at 20 years of age or 10 years before the youngest relative was diagnosed with CRC (whichever is earlier); OR
• Personal or family history (first-degree relative or second-degree relative) of HNPCC (Lynch syndrome) or positive genetic test result – Recommend colonoscopy every 1 to 3 years beginning at 20 to 25 years of age or 10 years before the youngest affected relative was diagnosed with CRC, whichever is earlier; OR
• Bloom syndrome – Recommend annual colonoscopy beginning at 10 years of age; OR
• Juvenile polyposis syndrome – Recommend colonoscopy, beginning at 12 years of age, yearly if polyps are found; every 2 to 3 years if no polyps are found; OR
• Personal or family history (first-degree relative or second-degree relative) of Li-Fraumeni syndrome – Recommend colonoscopy beginning at 25 years of age or 5 years before the youngest affected relative was diagnosed with CRC (whichever is earlier) and every 2 years; OR
• Personal or family history (first-degree relative or second-degree relative) of PTEN hamartoma tumor syndrome (PHTS) – Recommend colonoscopy beginning at 35 years of age or 5 to 10 years before the youngest affected relative was diagnosed with CRC (whichever is earlier) and every 5 years if normal^; more frequently if symptomatic or polyps are found; OR
• Personal or family history (first-degree relative) of serrated polyposis syndrome (SPS) (also known as hyperplastic polyposis syndrome) – Recommend colonoscopy beginning at 40 years of age or 10 years before the youngest affected relative was diagnosed with CRC (whichever is earlier) and every 1 to 3 years; OR
• Peutz-Jeghers syndrome (PJS) – Recommend colonoscopy every 2 to 3 years, beginning in late teens; OR

^Normal colonoscopy is defined as absence of all of the following:

• Adenoma
• CRC
• Hyperplastic polyp 10 mm or less in size
• SSPs
• Traditional serrated adenoma (TSA)

Colonoscopy and Colorectal Cancer Screening Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0378-029
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CTC

Humana members may be eligible under the Plan for CTC as an alternative to traditional colonoscopy when the following criteria are met:

• Colonoscopy cannot be performed due to documented presence of an obstruction; OR
• Individual is on chronic anticoagulant therapy that cannot be discontinued

DCBE

Humana members may be eligible under the Plan for DCBE as an alternative to traditional colonoscopy ONLY when the individual is unable to undergo colonoscopy or when colonoscopy is technically incomplete.

Diagnostic Colonoscopy

Humana members may be eligible under the Plan for diagnostic colonoscopy for the following indications:

• Chronic, clinically significant diarrhea (eg, abdominal pain, bloody diarrhea, dehydration, weight loss) with unknown cause; OR
• Evaluation of abnormality on imaging study (eg, DCBE) likely to be clinically significant (eg, filling defect, stricture); OR
• Gastrointestinal bleeding with unknown source in a hemodynamically stable (eg, stable blood pressure, heart rate) individual;

AND one or more of the following:

• Hematochezia or rectal bleeding; OR
• Iron deficiency (eg, serum ferritin less than 45 ng/ml [mcg/L]) anemia (hemoglobin [Hgb] less than 12 g/dL [120 g/L] in nonpregnant female or Hgb less than 13 g/dL [130 g/L] in male) with no other source of chronic blood loss identified; OR
• Melena and negative esophagogastroduodenoscopy (EGD); OR
• Positive fecal occult blood test (FOBT); OR
• Suspicion of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis) in a symptomatic individual (eg, abdominal pain, diarrhea, fatigue, rectal bleeding and/or weight loss); OR
• Unexplained iron deficiency (eg, serum ferritin less than 45 ng/ml [mcg/L]) anemia (hemoglobin [Hgb] less than 12 g/dL [120 g/L] in nonpregnant female or Hgb less than 13 g/dL [130 g/L] in male)

Note: The criteria for CRC screening and CTC are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for CRC screening for any indications other than those listed above including, but may not be limited to:

• Any of the following for an individual at increased risk for CRC:
  • FIT
  • FIT-DNA
  • FOBT
  These are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for any of the following for CRC screening, including, but may not be limited to:

• Artificial intelligence (AI) software (eg, EndoScreener, GI Genius Intelligent Endoscopy Module, MAGENTIQ-COLO)
• Blood-based biomarker panels (eg, BeScreened CRC biochemical ELISA of plasma and serum proteins, GlycoKnow Colon glycoproteomics analysis)

Colonoscopy and Colorectal Cancer Screening Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0378-029
Page: 14 of 33

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

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• CAD software (eg, SKOUT)
• MR colonography
• Stool-based testing other than those listed above (eg, multitarget stool RNA test [RNA-FIT] [eg, ColoSense])
• Urine-based testing (eg, PolypDx)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for colonic lavage (eg, HygiPrep). This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

The following are considered integral to the primary procedure and not separately reimbursable including, but may not be limited to:

• Integrated balloons or other devices to enhance visualization during colonoscopy (eg, G-EYE)
• In vivo analysis, including but not limited to:
  • Chromoendoscopy
  • Confocal laser endomicroscopy
  • Confocal miniprobe (eg, Cellvizio)
  • Fiberoptic analysis
  • Magnification endoscopy
  • Narrow band imaging
  • Optical coherence tomography (OCT)
• Retrograde imaging/illumination (eg, Third Eye Panoramic Auxiliary Endoscopy, Third Eye Retroscope)

Colonoscopy and Colorectal Cancer Screening
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 12/14/2023
Policy Number: HUM-0378-029
Page: 15 of 33

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for diagnostic colonoscopy for any indications other than those listed above including, but may not be limited to:

• Acute diarrhea; OR
• Chronic, stable, irritable bowel syndrome; OR
• Routine follow-up of inflammatory bowel disease not related to cancer surveillance in Crohn’s disease or ulcerative colitis; OR
• Upper gastrointestinal (GI) bleeding or melena with a demonstrated upper GI source

These are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Background

Additional information about CRC may be found from the following websites:

• American Cancer Society
• National Comprehensive Cancer Network
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS, or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.