CurrentAetnaPolicy 0516

Colonoscopy and Colorectal Cancer Screening

Defines Aetna's medical necessity coverage for colorectal cancer screening, diagnostic testing, surveillance, high-risk testing, and lower GI biopsies; lists experimental/investigational tests and applicable procedure and diagnosis codes. This brief covers Part 1 of 5 of the full policy.

Policy Summary

PayerAetna

PolicyColonoscopy and Colorectal Cancer Screening

Policy CodePolicy 0516

Change TypeNo material change

Effective Date

Next Review Date

Key ActionDocument member age and risk status to justify screening interval and modality.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes — has_material_change=false in brief.

7Routine screening options listed

15Experimental/Investigational modalities listed

~40Covered codes approx.

92.3%Cologuard sensitivity (CRC)

73.8%FIT sensitivity (CRC)

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Overview: This policy defines Aetna’s medical necessity coverage for colorectal cancer (CRC) screening, diagnostic evaluation, surveillance, high‑risk testing, and lower gastrointestinal biopsies. It applies to average‑risk adults and lists covered screening modalities, tests considered medically necessary when recommended by a physician, and experimental/investigational approaches that are not covered.

Headline coverage and thresholds: routine CRC screening for average‑risk members aged 45 years and older is covered when recommended by a physician. Approved screening intervals: colonoscopy every 10 years; CT colonography (virtual colonoscopy), double contrast barium enema (DCBE), or flexible sigmoidoscopy every 5 years; annual guaiac‑ or immunochemical‑based FOBT/FIT; and stool DNA (FIT‑DNA, Cologuard) every 1 to 3 years. Routine screening for members aged 85 years or older is considered not medically necessary unless life expectancy is ≥ 10 years.

Key Screening & Surveillance Intervals - Thresholds

Average-risk screening interval - colonoscopyevery 10 years

Average-risk screening interval - CT colonography/DCBE/sigmoidoscopyevery 5 years

Average-risk screening interval - FOBT/FITevery year

FIT-DNA (Cologuard) intervalevery 1 to 3 years

High-risk testing frequencyas frequently as every 2 years

Surveillance frequency - IBD / personal history of colorectal canceras frequently as every year

Surveillance frequency - personal history of adenomatous polypsas frequently as every 2 years

Medical-Necessity Criteria

Routine Screening - Average Risk

Covered when ANY of the following screening tests are recommended by physician for average-risk members aged 45 years and older:

Colonoscopy every 10 years (medically necessary for average-risk persons)every 10 years

medically necessary for average-risk persons

CT colonography (virtual colonoscopy) every 5 years (medically necessary)every 5 years

medically necessary

Double contrast barium enema (DCBE) every 5 years (medically necessary)every 5 years

medically necessary

Immunohistochemical or guaiac-based FOBT every year (medically necessary)every year

medically necessary

Sigmoidoscopy every 5 years (medically necessary)every 5 years

medically necessary

Sigmoidoscopy every 5 years with annual immunohistochemical or guaiac-based FOBT (medically necessary)sigmoidoscopy every 5 years + FOBT annually

medically necessary

Stool DNA (FIT-DNA, Cologuard) every 1 to 3 years (medically necessary)every 1 to 3 years

medically necessary

Age limitation: Average-risk routine screening is for members aged 45 years and older; routine screening for members 85 years of age or older is considered not medically necessary unless life expectancy is greater than or equal to 10 yearsage >=45; >85 only if life expectancy >=10 years

screening > =85 only if life expectancy >= 10 years

High-Risk Testing

Colorectal cancer testing with sigmoidoscopy, DCBE, or colonoscopy as frequently as every 2 years is medically necessary for members with ANY of the following risk factors:

First-degree relative with colorectal cancer or adenomatous polyps — screening begins at age 40 years, or 10 years younger than the earliest diagnosis in their family, whichever comes firstinitiate at age 40 or 10 years younger than earliest family diagnosis

Family history of familial adenomatous polyposis — screening begins at pubertybegin at puberty

Family history of hereditary non-polyposis colorectal cancer (HNPCC) — screening begins at age 20 yearsbegin at age 20 years

Family history of MYH-associated polyposis in siblings — screening begins at age 25 years

Surveillance

Colorectal cancer surveillance with colonoscopy, flexible sigmoidoscopy or DCBE is medically necessary as frequently as indicated below for members who meet ANY of the following criteria:

Inflammatory bowel disease (including ulcerative colitis or Crohn's disease) — surveillance as frequently as every yearas frequently as every year

Personal history of adenomatous polyps — surveillance as frequently as every 2 yearsas frequently as every 2 years

Personal history of colorectal cancer — surveillance as frequently as every yearas frequently as every year

Annual FOBT, alone or with sigmoidoscopy, is medically necessary for surveillanceannual FOBT

Diagnostic Testing

Covered when medically necessary for evaluation of signs or symptoms:

FOBT, colonoscopy, sigmoidoscopy and/or DCBE for evaluation of members with signs or symptoms of colorectal cancer or other GI diseases (medically necessary)diagnostic as needed

medically necessary for evaluation of signs or symptoms

Diagnostic upper endoscopy for evaluation of persons with signs and symptoms of upper GI disease (medically necessary)diagnostic as needed

medically necessary

Biopsy of the Lower Gastro-Intestinal Tract

Biopsy is medically necessary for the following indications and sample counts:

Microscopic colitis — 8 or more biopsies (2 or more from ascending, transverse, descending, and sigmoid colon)8 or more biopsies (2+ from each: ascending, transverse, descending, sigmoid)

Inflammatory bowel disease diagnosis — 2 or more biopsies from 5 different locations, including the ileum and rectum2+ biopsies from 5 locations incl ileum and rectum

IBD dysplasia screening (targeted plus...)

Pancolitis — biopsies from the 4 quadrants each 10 cm4 quadrant biopsies every 10 cm

Experimental, Investigational, and Not Covered Tests

Experimental and Investigational - Screening / Anal Pap

The following tests are considered experimental and investigational (not covered) because effectiveness not established:

Stool molecular genetic tests other than Cologuard (e.g., ColoCaller Test, ColoSure, PreGen-Plus)not covered (investigational)

Methylated Septin 9 (ColoVantage, Epi proColon)not covered (investigational)

Whole-blood DNA methylation markersnot covered (investigational)

MicroRNAsnot covered (investigational)

Chromoendoscopy or narrow-band imaging optical colonoscopynot covered (investigational)

Plasma/serum biomarkers (CRP, complement C3a, GATA5 and SFRP2 methylation, serum CD26, MMP-7, TIMP-1)not covered (investigational)

PolypDxnot covered (investigational)

CD3 immuno-stainingnot covered (investigational)

Full-spectrum endoscopy (FUSE) colonoscopynot covered (investigational)

Stool-based protein biomarkersnot covered (investigational)

Blood-based protein biomarkers (e.g., BeScreened-CRC)not covered (investigational)

Capsule endoscopynot covered (investigational)

Artificial intelligence-aided colonoscopy (including computer-aided colonoscopy)not covered (investigational)

SimpliPro Colon Testnot covered (investigational)

Fecal volatile organic compoundsnot covered (investigational)

Performance of multiple screening strategies simultaneously in same individual (eg, virtual colonoscopy every 5 years plus stool DNA every 3 years)not covered (investigational)

Screening beginning earlier than standard recommended ages for persons at increased risk due to smoking or obesitynot covered (investigational)

Screening for anal cytological abnormalities (anal Pap) or anal HPV infection — experimental and investigationalnot covered (investigational)

Policy stance — experimental / not covered: Aetna considers a number of emerging and alternative CRC screening modalities to be experimental and investigational because their effectiveness for screening has not been established. Examples explicitly listed as not covered include methylated Septin‑9 (ColoVantage / Epi proColon), capsule endoscopy (colon capsule endoscopy), full‑spectrum endoscopy (FUSE), and artificial intelligence‑aided / computer‑aided colonoscopy (including CADe/CAC/AIC) when proposed as screening replacements. The brief’s evidence summary notes variable test performance (for example, SEPT9 sensitivity reported variably and a USPSTF‑included study sensitivity of ~48%), mixed CCE meta‑analysis results, and promising but not yet validated CADe/CAC data — supporting the policy’s exclusion of these modalities for routine screening.

Codes — Covered, Not Covered, Related

CPT codes covered if selection criteria are metCPTCovered

44401-44408	Colonoscopy through stoma
45330-45350	Sigmoidoscopy, flexible
45378-45398	Colonoscopy, flexible
74263	CT colonography, screening, including image postprocessing
74270	Radiologic exam, colon; contrast enema, with or without KUB
74280	Air contrast with specific high density barium
81528	Oncology (colorectal) screening, FIT-DNA (eg, Cologuard)
82270	Fecal occult blood by guaiac; feces, consecutive collected specimens
82272	Blood, occult, guaiac, 1-3 simultaneous determinations, non-screening
82274	Fecal hemoglobin by immunoassay, qualitative, feces, 1-3

CPT codes not covered for indications listed in the CPBCPTNot Covered

0002U	Oncology (colorectal), quantitative assessment of three urine metabolites
0163U	Oncology (colorectal) screening, ELISA of 3 plasma/serum proteins
0261U	Oncology (colorectal cancer), image analysis with AI assessment of histologic/IHC features
81327	SEPT9 (Septin9) methylation analysis
86140-86141	C-reactive protein
87623	HPV nucleic acid detection, low-risk types
87624	HPV nucleic acid detection, high-risk types
87625	HPV types 16 and 18 only
91113	Gastrointestinal tract imaging, intraluminal capsule endoscopy, colon

Other CPT codes related to CPB (genetic/molecular)CPT

81201-81203	APC gene analysis
81292-81294	MLH1 gene analysis
81295-81297	MSH2 gene analysis
81298-81300	MSH6 gene analysis
81317-81319	PMS2 gene analysis
88271-88275	Molecular cytogenetics

HCPCS codes covered if selection criteria are metHCPCSCovered

G0104	Colorectal cancer screening; flexible sigmoidoscopy
G0105	Colorectal cancer screening; colonoscopy on individual at high risk
G0106	Colorectal cancer screening; alternative to G0104, screening sigmoidoscopy, barium enema
G0120	Colorectal cancer screening; alternative to G0105
G0121	Colorectal cancer screening; colonoscopy on individual not meeting criteria for high risk
G0122	Colorectal cancer screening; barium enema
S0285	Colonoscopy consultation prior to a screening colonoscopy

HCPCS codes not covered for indications listed in the CPBHCPCSNot Covered

G0327	Colorectal cancer screening; blood-based biomarker
G0464	Colorectal cancer screening; stool-based DNA and fecal hemoglobin (eg, KRAS, NDRG4, BMP3)
G0476	Infectious agent detection by nucleic acid; HPV for cervical cancer screening (must be performed with pap)

Other HCPCS related to CPBHCPCS

S3833	Complete APC gene sequence analysis
S3834	Single-mutation analysis for APC

ICD-10 codes covered if selection criteria are metICD-10Covered

C18.0-C21.8	Malignant neoplasm of colon, rectosigmoid junction, rectum, anus and anal canal
C7A.020-C7A.026	Malignant carcinoid tumors of appendix, large intestine, rectum
D12.0-D12.9	Benign neoplasm of colon, rectum, anus and anal canal
D3A.020-D3A.029	Benign carcinoid tumors of appendix, large intestine, rectum
D50.0	Iron deficiency anemia secondary to blood loss (chronic)
D50.9	Iron deficiency anemia, unspecified
D62	Acute posthemorrhagic anemia
K51.00-K55.9	Noninfective enteritis and colitis
K57.20-K57.93	Diverticular disease of intestine
K59.00-K59.09	Constipation

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ICD-10 codes not covered for indications listed in the CPBICD-10Not Covered

B97.7	Papillomavirus as the cause of diseases classified elsewhere
R85.610-R85.619	Abnormal cytologic smear of anus
R85.81-R85.82	Other abnormal findings in specimens from anus
Z11.51	Encounter for screening for human papillomavirus (HPV)

Biopsy CPT codes covered if selection criteria are metCPTCovered

44010	Duodenotomy for exploration, biopsy(s)
44020	Enterotomy, small intestine, for exploration, biopsy(s)
44025	Colotomy for exploration, biopsy(s)
44382	Ileoscopy through stoma; with biopsy
44386	Endoscopic evaluation of small intestinal pouch with biopsy
44389	Colonoscopy through stoma; with biopsy
44361	Small intestinal endoscopy with biopsy
44377	Small intestinal endoscopy including ileum; with biopsy
44407	Colonoscopy through stoma; with transendoscopic ultrasound guided FNA/biopsy
45100	Biopsy of anorectal wall, anal approach

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Provider Actions & Operational Notes

Documentation Required

Age and risk documentation for screening

Document the member's age and specify whether they are average-risk or meet any listed high‑risk criteria (family history, genetic syndromes, personal history of IBD, prior adenomas or colorectal cancer, transplant status, etc.) to justify the chosen screening interval and modality.

Prior Authorization

High-risk and surveillance intervals

If the indication is high‑risk or surveillance, ensure authorizations and claims reflect the more frequent intervals allowed by policy (as frequently as every 1–2 years for specified high‑risk or surveillance indications) so that coverage/authorization decisions align with the listed criteria.

Billing Rule

Use correct CPT/HCPCS for screening vs diagnostic

Use the appropriate screening versus diagnostic CPT/HCPCS and the ICD‑10 diagnosis codes specified in the policy; note that some HCPCS/CPT codes (listed as not covered) should not be billed for CPB‑listed indications.

Denial Risk

Age >85 screening denial risk

Routine screening for members aged 85 years or older is considered not medically necessary unless life expectancy is ≥ 10 years; claims may be denied if documentation of life expectancy or individualized justification is not provided.

Documentation Required

Follow-up for abnormal non-invasive CRC tests

Record and follow up any abnormal non‑colonoscopy screening test (e.g., positive stool DNA/Cologuard, FIT, or blood‑based tests) with diagnostic colonoscopy per the cited recommendations and FDA/CMS guidance.

Documentation Required

Consider earlier screening for specific high-risk groups

Document consideration of earlier screening for specific higher‑risk groups per guidelines (eg, African Americans: begin at age 45; hereditary syndromes: HNPCC surveillance beginning age ~20 and MUTYH biallelic surveillance beginning ~25–30 with 2–3 year intervals if negative).

Documentation Required

Positive non-colonoscopy blood tests require diagnostic follow-up

If a blood‑based screening test (e.g., Septin9/ColoVantage or other whole‑blood DNA methylation assays) is positive, document that diagnostic colonoscopy is recommended and planned; these blood tests are not intended to replace colonoscopy.

Documentation Required

Cystic fibrosis patient screening protocol

For adults with cystic fibrosis, document adherence to Cystic Fibrosis Foundation recommendations: colonoscopy preferred; start screening at age 40 (start at age 30 if post‑transplant); repeat screening every 5 years; if adenomas found, surveillance every 3 years; and note use of intensive bowel preparation.

Documentation Required

Capsule endoscopy role as filter test

When using second‑generation colon capsule endoscopy (CCE) as a filter or alternative for FIT‑positive patients unwilling to undergo colonoscopy, document that CCE is considered a filter test and note variable completion and bowel‑prep adequacy rates (adequate prep 40%–100%; complete transit 57%–100%) which may limit applicability.

Note

Policy review and references available

Refer providers to the full Clinical Policy Bulletin for complete coverage criteria, definitions, references, review history, and operational details; the bulletin contains the full list of supported tests, intervals, and investigational exclusions.

Background, Evidence Summary & Definitions

Background and guideline rationale: Major guideline bodies (USPSTF, ACS, ACG, NCCN and others) support CRC screening because early detection markedly improves outcomes (5‑year survival ~90% for early disease) and screening can identify and remove precancerous polyps. The USPSTF and ACS summarize test options and recommend start/stop ages and individualized decisions in older adults.

Recommended ages and intervals are driven by evidence on benefits and harms: the policy aligns with guideline guidance to initiate routine screening in average‑risk adults (guidelines historically at age 50, with more recent guidance supporting age 45 initiation) and to continue through ages where life expectancy and comorbidity make benefits unlikely. For high‑risk groups and genetic syndromes, guidelines endorse earlier and more frequent surveillance (examples: HNPCC surveillance with colonoscopy to the cecum every 3 years; MUTYH biallelic surveillance beginning at ages ~25–30 every 2–3 years; cystic fibrosis recommendations to start screening at age 40 [or 30 if post‑transplant] and repeat every 5 years).

Source	Key finding
USPSTF summary	Recommends screening starting age 50 (2016/2017) and individualize ages 76-85; found screening reduces CRC mortality
ACS recommendation	Recommends adults 45+ undergo regular screening; positive non-colonoscopy tests should be followed by colonoscopy
CT colonography cost-effectiveness vs optical colonoscopy	CT colonography every 5 years with colonoscopy referral for polyps >6 mm has cost per life-year gained of $630,700 compared with optical colonoscopy every 10 years (study)
ACG recommendation for African Americans	Begin CRC screening at age 45 rather than 50; colonoscopy preferred
Cologuard vs FIT (Imperiale 2014)	Sensitivity for CRC: Cologuard 92.3% vs FIT 73.8%; sensitivity for advanced precancerous lesions: 42.4% vs 23.8%; specificity lower for Cologuard
Cologuard in Alaska Native cohort (Redwood 2016)	MT-sDNA detected SRN 49% vs FIT 28%; sensitivity increased with adenoma size; specificity 93% vs 96% for FIT
FDA & CMS status (as summarized)	Cologuard FDA-approved Aug 2014; CMS covers once every 3 years for asymptomatic Medicare beneficiaries age 50-84 (as of Oct 2014)
miRNA research state	miRNAs are investigational biomarkers; promising but infancy, require further validation
Fecal and urinary VOCs	Pooled urinary VOC fingerprinting sensitivity 84% and specificity 70% for CRC (van Liere 2023); require multi-center validation
Blood-based protein panels	Preliminary biomarker panels show promising AUCs but lack population-level validation and mortality/cost-effectiveness data

Term	Definition
Average-risk	Asymptomatic adults without family history of known high-risk genetic disorders, personal history of IBD, prior adenomatous polyp, or prior colorectal cancer
SRN	Screening-relevant colorectal neoplasia (includes CRC and advanced precancerous lesions)
MT-sDNA	Multi-target stool DNA test (e.g., Cologuard)
Epi proColon / Septin9	Plasma-based assay detecting methylated SEPT9 DNA for CRC detection; FDA-cleared April 14, 2016 for average-risk patients who decline colonoscopy/FIT.
FUSE (Full-Spectrum Endoscopy)	Colonoscope with panoramic view (additional lateral cameras) designed to improve detection behind folds and in blind spots.
CCE (Colonic Capsule Endoscopy)	Second-generation capsule endoscopy capturing images of colon used as noninvasive diagnostic/triage test compared with standard colonoscopy. Colon capsule endoscopy - patient swallows a capsule with video cameras that images the colon; requires bowel preparation, no sedation.
Mt-sDNA	Multi-target stool DNA testing for colorectal cancer screening.
CADe/CAC/AIC	Artificial intelligence/computer-aided detection systems used during colonoscopy to detect polyps.

Effective Date	Name	Number	Type
2014-10	CMS coverage for stool DNA testing (summary)		NCD
2014-10-09	Screening DNA stool test for colorectal cancer	CAG-00440N	NCD
2003-11-04	Screening immunoassay fecal-occult blood test	CAG-00180N	NCD
2008-04-28	Screening DNA stool test for colorectal cancer (earlier)	CAG-00144N	NCD

OpenPayer

Colonoscopy and Colorectal Cancer Screening

Coverage Summary

Medical-Necessity Criteria

Experimental, Investigational, and Not Covered Tests

Codes — Covered, Not Covered, Related

Provider Actions & Operational Notes

Background, Evidence Summary & Definitions

Medicare Determinations

Revision History