Oscar Colorectal Cancer Screening (CG024) Form

The Plan

The Plan follows the colorectal cancer screening guidelines from the U.S. Preventive Services Task Force and the U.S. Multi-Society Task Force of Colorectal Cancer (MSTF), which represents the American College of Gastroenterology, the American Gastroenterological Association, and The American Society for Gastrointestinal Endoscopy. Colorectal cancer screening is a medically necessary preventive service for men and women aged 50 years and older, and for men and women under the age of 50 with specific risk factors. Depending on individual risk factors, the treating provider may recommend the appropriate screening regimen and intervals. Screening options may be chosen based on individual risk and also by personal preference.

Definitions

Polyps are abnormal tissue growths that most often look like small, flat bumps or tiny mushroom-like stalks.

Endoscopic and Radiologic Screening Examinations include colonoscopy, flexible sigmoidoscopy, double-contrast barium enema, capsule endoscopy and CT colonography and are based on direct or radiographic visualization of the polyp or cancer. Procedures that fall within this definition include:

• Colonoscopy is a procedure that allows a provider to examine the inner lining of the large intestine (rectum and colon) by using a thin, flexible tube called a colonoscope.1
• Flexible Sigmoidoscopy is a procedure that allows the provider to examine the rectum and lower sigmoid colon using a flexible sigmoidoscope or a colonscope that is not inserted all the way
• Double Contrast Barium Enema is a form of contrast radiography in which x-rays of the colon and rectum are taken using barium and air contrast to visualize the internal structures more easily.
• CT Colonography or Virtual Colonoscopy is a procedure that uses specialized CT scan x-ray equipment to examine the large intestine for cancer or polyps.
• Capsule Endoscopy is a procedure where a small ingestible capsule is swallowed. This disposable capsule has small cameras which take video as it moves through the digestive system to visualize the colon for detection of polyps. The video signal is recorded by an external box, then downloaded to a computer so your doctor can visualize the colon for detection of polyps.

Incomplete Colonoscopy refers to a situation when the colon cannot be fully evaluated for a number of reasons, such as patient discomfort, a very twisty colon anatomy, prior surgery, or suboptimal bowel preparation.

Stool-Based Screening Tests include the guaiac-based fecal occult blood test (gFOBT), fecal immunochemical test (FIT), and stool DNA testing (sDNA). While these tests typically cannot detect precancerous polyps, they may detect for other signs of cancer such as blood or cell debris in the stool. Tests that fall within this definition include:

• Guaiac-Based Fecal Occult Blood Test (gFOBT) is a non-invasive screening tool that targets human red blood cell components in stool.This detect bleeding from any part of the gut.
• Fecal Immunochemical Test (FIT) is a non-invasive screening tool that targets human red blood cell components in stool. This detects bleeding predominantly originating in the colon.
• Stool DNA Test (sDNA) is a non-invasive screening tool that targets both human red blood cell components and specific genetic alterations in stool.
• Serum-based testing is a non-invasive blood-based screening tool that looks for evidence of existing colon cancer.

Clinical Indications

General Criteria: Average Risk

Average risk includes persons who meet ALL of the following criteria:

1. ONE of the following age groups:
   • Ages 45 to 75, for which regular screening indicated; or
   • Ages 76 to 85, for which screening is indicated based on individual’s prior screening history and overall health status; and
2. No personal or family history of adenomatous polyps, colorectal cancer, familial adenomatous polyposis (FAP), or hereditary nonpolyposis colorectal cancer (HNPCC); and
3. No personal history of inflammatory bowel disease such as Crohn's Disease or Ulcerative Colitis.

General Criteria: High Risk

People at increased or high-risk of colorectal cancer may begin colorectal cancer screening before age 45 and be screened at more frequent intervals. For individuals defined as high-risk, increased surveillance generally means a specific recommendation for colonoscopy. High-risk includes persons who meet ONE of the following criteria:

1. A personal history of colorectal cancer or adenomatous polyps. This may include individuals up to age 85, for which re-screening is indicated based on individual’s prior screening history and overall health status; or
2. A personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease); or
   • Guidelines recommend screening colonoscopy for these patients 8-10 years after diagnosis, with the interval for further surveillance guided by risk factors and findings at the time of initial colonoscopy
3. A family history of colorectal cancer or polyps; or
   • Persons with a first-degree relative in whom colorectal cancer developed before 60 years of age should undergo a colonoscopy at 40 years of age or an age 10 years younger than the relative’s age when cancer developed, whichever is earlier
4. A known family history of hereditary colorectal cancer syndrome such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC); or
   • Persons with a family history of FAP should undergo their first colonoscopy at the age of 10 to 12 years of age followed by a yearly flexible sigmoidoscopy thereafter
   • Persons with a family history of HNPCC should undergo their first colonoscopy at the age of 20 to 25 years, or 10 years before the youngest case in their immediate family followed by a colonoscopy every 1-2 years thereafter

African-Americans should begin their screening at age 45 due to a higher risk for colorectal cancer than other populations.

Services & Criteria

The Plan considers the following tests medically necessary for either average or high-risk patients for the detection of polyps (precancerous lesions) and cancer when the following criteria are met:

1. A preventive screening that results in a therapeutic service done at the same encounter and as an integral part of the preventive service (e.g., polyp removal during a preventive colonoscopy), the therapeutic service would still be considered a preventive service upon screening.
2. A Colonoscopy may be indicated as a preventive measure when ALL of the following are present:
   • General criteria (above) for average risk is met and no colonoscopy within the past 10 years; or
   • General criteria (above) for high risk is met OR MCG Colonoscopy (A-0129) criteria are met for abnormal results of screening, high-risk family history, or high-risk personal history; and
   • Testing frequency is ordered for 1 of the following:
     1. For high risk members, a screening interval appropriate for the individual’s underlying high risk indication and associated degree of risk; or
     2. Accelerated rescreening with optimal preparation is warranted when examination is performed in the setting of limited visualization due to patient factors or occluding colonic contents.
3. A Flexible Sigmoidoscopy may be indicated as a preventive measure when ALL of the following are present:
   • General criteria (above) for average is met; or
   • General criteria (above) for high risk is met OR MCG Sigmoidoscopy, Flexible (A-0128) colorectal cancer screening criteria are met for family history or surveillance for local recurrence (excludes MCG average-risk adult criteria); and
   • Testing frequency is ordered for 1 of the following:
     1. Once every 5 years for average risk patients; or
     2. For high risk members, a screening interval appropriate for the individual’s underlying high risk indication and associated degree of risk.
4. A Double Contrast Barium Enema may be indicated as a preventive measure when ALL of the following are present:
   • General criteria (above) for average risk is met; and
   • Colonoscopy or CT colonography are not available or desired by the member; and
   • Testing frequency is ordered for 1 of the following:
     1. Once every 5 years for average risk patients; or
     2. For high risk members, a screening interval appropriate for the individual’s underlying high risk indication and associated degree of risk.

The Plan considers the following tests medically necessary for average risk patients for the detection of cancer when the following criteria are met:

1. A CT Colonography can detect but not remove polyps and may be indicated as a preventive measure when ALL of the following are present:
   • General criteria (above) for average risk is met; and
   • MCG Colonography, CT (Virtual Colonoscopy) (A-0030) colorectal cancer screening criteria is met; and
   • Testing is ordered once every 5 years. **The patient may also qualify if unable to tolerate a colonoscopy with sedation or has medical conditions (e.g., recent myocardial infarction, recent colonic surgery, bleeding disorders, severe lung and/or heart disease).
2. A Guaiac-Based Fecal Occult Blood Test (gFOBT) cannot adequately screen for precancerous polyps but may be indicated as a preventive measure when ALL of the following are present:
   • General criteria (above) for average risk is met; and
   • No gFOBT within 1 year; and
   • gFOBT is ordered for 3 separate bowel movements yearly; and
   • gFOBT is ordered alone or in conjunction with a sigmoidoscopy; and
   • No positive result from another colorectal cancer screening test in last 6 months; and
   • No signs or symptoms of active colorectal disease (e.g., no lower GI pain, no blood in stool, no positive stool DNA test or fecal immunochemical test); and
   • Testing is ordered once annually.
3. A Fecal Immunochemical Test (FIT) cannot adequately screen for precancerous polyps but may be indicated as a preventive measure when ALL of the following are present:
   • General criteria (above) for average risk is met; and
   • No FIT testing within 1 year; and
   • No positive result from another colorectal cancer screening test in last 6 months; and
   • No signs or symptoms of active colorectal disease (e.g., no lower GI pain, no blood in stool, no positive guaiac fecal blood test or stool DNA test); and
   • Testing is ordered once annually.
4. A Stool DNA Test (sDNA) cannot adequately screen for precancerous polyps but may be indicated as a preventive measure when ALL of the following are present:
   • The stool DNA test is the Cologuard® test; and
   • General criteria (above) for average risk is met; and
   • No stool DNA test within 1 year; and
   • No positive result from another colorectal cancer screening test in last 6 months; and
   • No signs or symptoms of active colorectal disease (e.g., no lower GI pain, no blood in stool, no positive guaiac fecal blood test or FIT test); and
   • Testing is ordered once every three years and in lieu of colonoscopy, unless test results warrant further colonic investigation.

Experimental or Investigational / Not Medically Necessary

Colorectal cancer screening is currently NOT recommended for average risk patients age 85 or older.

The application and clinical utility of the Capsule Endoscopies are considered experimental or investigational:

• Colon capsule endoscopy (e.g., PillCam COLON 2)
• Patency capsule (e.g., PillCam Patency System)

Any colorectal cancer screening tests for which safety and efficacy has not been established and proven is considered experimental, investigational, or unproven, and is therefore not covered by the Plan.

Furthermore, serum-based genetic testing or biomarker testing for the purposes of colorectal cancer routine screening is considered experimental.

(However, testing and monitoring related to the diagnosis of colon cancer may be considered medically necessary as per MCG or NCCN, but is considered outside the scope of this Colorectal Cancer Screening guideline).

Experimental routine screening tests include, but are not limited to, the following:

• Colon Cancer Gene Expression Assay Oncotype DX
• Colon Cancer Gene Expression Assay GeneFx Colon5
• Colon Cancer Gene Expression Assay ColoPrint
• Colorectal Cancer (Hereditary) Gene Panel
• Methylated Septin 9 (ColoVantage, EpiproColon)
• MicroRNA Detection
• Screening Upper Endoscopy
• Chromoendoscopy or Narrow-Band Imaging Optical Colonoscopy
• Other Stool DNA Tests (PreGen-26, PreGen-Plus, ColoSure)
• Serum-based screening test