National Medical Policy Subject:

Colonoscopy

Policy Number:

NMP105

Effective Date:

February 2004

Updated:

February 2016

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use X

X

Source National Coverage Determination (NCD)

National Coverage Manual Citation Local Coverage Determination (LCD)*

Reference/Website Link Colorectal Cancer Screening Tests:

http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx

Colonoscopy and Sigmoidoscopy-Diagnostic; Diagnostic Colonoscopy:

http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx

X

Article (Local)* Other

Medicare Claims Processing Manual, Chapter 18 Preventive and Screening Services: http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/clm104c18.p df

Medicare Learning Matters Network. MLN Matters Number: MM7012 Revised. Related Change Request (CR) #: 7012. Release Date: March 2, 2011. Waiver of Coinsurance and Deductible for Preventive

Colonoscopy Feb 16

1

Services, Section 4104 of The Affordable Care Act, Removal of Barriers to Preventive Services in Medicare: http://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNMattersArticles/downloads/mm7012.pdf

Medicare Learning Matters Network. MLN Matters Number: SE0613. Updated October 2012. Colorectal Cancer: Preventable, Treatable, and Beatable: Medicare Coverage and Billing for Colorectal Cancer Screening: http://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNMattersArticles/downloads/SE0613.pdf

None

Use Health Net Policy

Instructions  Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.  Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)

 

If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement Health Net, Inc. considers colonoscopy medically necessary according to the guidelines set forth by the American Gastroenterological Association, the American Society of Colon & Rectal Surgeons, the American Cancer Society, the U.S. MultiSociety Task Force on Colorectal Cancer, the American College of Radiology, the National Comprehensive Cancer Network, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy for patients who meet any of the following indications: Diagnostic Colonoscopy 1. Evaluation of an abnormality on barium enema or other imaging study, which is likely to be clinically significant, such as a filling defect or stricture. 2. Evaluation of unexplained gastrointestinal bleeding, such as: 

Hematochezia not thought to be from rectum or perianal source, especially if the patient is > 40 years old.



Melena of unknown origin after an upper GI source has been excluded.

Colonoscopy Feb 16

2



Presence of fecal occult blood.

3. Unexplained iron deficiency anemia. 4. Chronic inflammatory bowel disease of the colon if more precise diagnosis or determination of the extent of activity of disease will influence immediate management. 5. Clinically significant diarrhea of unexplained origin with additional symptoms (e.g., dehydration, weight loss). 6. Evaluation of acute colonic ischemia/ischemic bowel disease. 7. Evaluation of cytomegaloviral colitis in a patient with HIV infection 8. Evaluation of patient with Streptococcus bovis endocarditis. 9. Intraoperative identification of the site of a lesion that cannot be detected by palpation or gross inspection at surgery (e.g., polypectomy site or location of a bleeding source). 10. Marking a neoplasm for surgical localization. 11. Constipation with involuntary weight loss of > 10 lbs within 12 weeks, or continued constipation following 2 weeks of treatment with fiber, hyperosmotic agents or stool softeners. Therapeutic Colonoscopy 1. Excision of colonic polyp(s). 2. Treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site (e.g., electrocoagulation, heater probe, laser or injection therapy). 3. Foreign body removal. 4. Decompression of pseudo-obstruction of the colon (Ogilvie's syndrome). 5. Decompression of acute nontoxic megacolon. 6. Treatment of sigmoid volvulus. 7. Balloon dilation of stenotic lesions (e.g., anastomotic strictures). 8. Palliative treatment of stenosing or bleeding neoplasms (e.g., laser, electrocoagulation, stenting). Screening Colonoscopy Initial screening colonoscopy for colorectal cancer at 50 years of age for asymptomatic, average risk men and women. If negative, rescreen with any accepted modality1 in 10 years. Note: Screening may begin age 45 for African Americans because of the higher incidence of colorectal cancer. Surveillance Colonoscopy Low-risk Patients With No Family History of Colorectal Cancer Removal of small (5 mm occurring proximal to sigmoid colon

A 5 year colonoscopic screening interval is recommended

Four or more hyperplastic polyps of any size found proximal to sigmoid colon

A 5 year colonoscopic screening interval is recommended

Complete removal of 1 or 2 small tubular adenomas or SSPs (< 1 cm) in low risk patients with no family history of colorectal cancer.

Colonoscopy within 5-10 years after the initial polypectomy - if the next exam is normal, then the colonoscopy will be in 10 years, the patient can thereafter be screened as per average risk guidelines.

High-risk Patients with a Personal History of Colorectal Cancer This refers to patients with colon or rectal cancer that has been resected with curative intent. These patients should undergo high quality perioperative clearing. At the time of diagnosis of colon cancer

After resection of colorectal cancer or neoplastic polyp

Follow-Up

Colonoscopy should be done around the time of initial diagnosis to rule out synchronous2 neoplasms, or synchronous disease. It is recommended to mark the polyp site during colonoscopy or within 2 weeks of polypectomy if deemed necessary by the surgeon Presurgical evaluation for additional synchronous cancer or neoplastic polyps – if not possible due to obstruction from the carcinoma or for other technical reasons, options include intraoperative colonoscopy or colonoscopy within 3 - 6 months of resection. If abnormal repeat in 1 year. Post treatment surveillance: For stage I disease, colonoscopy at 1 year. Repeat at 3 years, and then at 5 years thereafter, unless advanced adenoma (villous polyp, polyp >1 cm or high-grade dysplasia) is found. In this case, repeat colonoscopy in 1 year. Post treatment surveillance stage II/III disease with no known residual disease, colonoscopy 1 year after resection, or 3-6 months post resection if not performed preoperatively due to obstructing lesion. Repeat in 3 years and then every 5 years thereafter, follow-up colonoscopy indicated advanced adenoma (villous polyp, polyp >1 cm or high-grade dysplasia) is found. In this case, repeat colonoscopy in 1 year. More frequent colonoscopies may be

Colonoscopy Feb 16

4

indicated in patients with colon cancer before 50 years of age. Pedunculated polyp containing invasive carcinoma

High-risk Patients 

  

Adenoma with high grade dysplasia or sessile serrated adenomas with cytologic dysplasia (SSP-cd) Adenoma/sessile serrated adenomas (SSP) >1 cm Polyp with villous or tubulovillous histology Presence of multiple (3-10) adenomatous polyps and/or (SSP’s).

Note: SSP’s are managed like tubular adenomas, whereas SSP-cds are managed like high risk adenomas but may need even more frequent surveillance. Any serrated lesion proximal to the sigmoid colon should be followed similarly to adenomatous polyps because of their significant risk of neoplastic progression.

It is recommended to mark the polyp site during colonoscopy or within 2 weeks of polypectomy if deemed necessary by the surgeon. No additional surgery is required if the polyp has been completely resected with favorable histologic features.3

Follow-Up Individuals with advanced or multiple adenomatous polyps should have repeat colonoscopy within 3 years. Subsequent surveillance colonoscopies are recommended within 5 years, depending on colonoscopic finding. Longer intervals are recommended for persons with normal follow-up colonoscopies. Shorter intervals may be necessary when there is uncertainty about completeness of removal of large and/or sessile polyps or if the colonic preparation was suboptimal and for SSPcds. Some authorities recommend surveillance at 1-3 year intervals for SSPcds because they are thought to rapidly progress to CRC. The recommendations for a shorter interval should included a discussion with the individual based on assessment of individual risk, including age, family history, co-morbidity, and the results of previous colonoscopies.

Individuals with more than 10 cumulative adenomatous polyps

Individual management. Consider a polyposis syndrome.

Individual with a personal history of attenuated familial adenomatous polyposis (AFAP) or MUTYHAssociated Polyposis (MAP)

Varies depending on the individual’s age and adenoma burden. For young patients under the age of 21 with small adenoma burden5, colonoscopy and polypectomy are recommended every 1-2 years with appropriate surgical evaluation and counseling. Age 21 and older with small adenomatous polyp burden, colectomy and ileorectal anastamosis (IRA) are alternative treatment options to colonoscopy and polypectomy. When polposis is too significant to be managed by polypectomy, (i.e., polyps >20 at any individual exam, when polyps have been previously ablated or when polyp have reached a size > 1 cm,

Colonoscopy Feb 16

5

or when advanced histology is encountered in any polyp), surgery should be considered. Juvenile Polyposis Syndrome (JPS) Clinical diagnosis is considered in individuals with at least one of the following:  At least 3-5 juvenile polyps of the colon  Multiple juvenile polyps found throughout the GI tract  Any number of juvenile polyps in an individual with a family history of JPS Peutz-Jeghers Syndrome (PJS)

Due to the rarity of the syndrome and complexities of diagnosing and managing individuals with JPS, Referral to a specialized team is recommended. Limited data exist regarding the efficacy of various screening modalities in JPS. Initiate screening colonoscopy around age 15 years. Repeat annually if polyps are found and if no polyps, repeat every 2-3 years

Clinical diagnosis is made when an individual has two or more of the following features:  Two or more Peutz-Jeghers–type hammertomatous polyps of the small intestine  Mucocutaneous hyperpigmentation of the mouth, lips, nose, eyes, genitalia, or fingers  Family history of PJS Serrated Polyposis Syndrome (SPS), previously known as hyperplastic polyposis

Referral to a specialized team is recommended and participation in clinical trials is encouraged. Initiate screening colonoscopy around late teens and repeat every 2-3 years.

Clinical diagnosis of serrated polyposis is considered in an individual who meets at least one of the following empiric criteria:

Colonoscopy with polypectomy until all polyps >5 mm are removed, then colonoscopy every 1-3 years depending on number and size of polyps. Clearing of all polyps is preferable but not always possible. Consider surgical referral if colonoscopic treatment and/or surveillance is inadequate or if high-grade dysplasia occurs.

1.

At least 5 serrated polyps* proximal to the sigmoid colon with 2 or more of these being > 10 mm 2. Any number of serrated* polyps proximal to the sigmoid colon in an individual who has a firstdegree relative with serrated polyposis 3. Greater than 20 serrated* polyps of any size, but distributed throughout the colon.** *Serrated polyps include hyperplastic polyps, sessile serrated

Colonoscopy Feb 16

6

adenomas/polyps, and traditional serrated adenomas. **Multiple hyperplastic polyps localized to the rectum and sigmoid are unlikely to contribute to SPS. Such distal polyps should not be counted toward the qualifying burden unless they are > 10mm or display additional characteristics of serrated polyps (serrations extending to the base of crypt, with widened or “boot” shaped crypt base. Incomplete or piecemeal polypectomy or polypectomy of large sessile polyps

Personal history of inflammatory bowel disease: Crohn's colitis and chronic ulcerative pancolitis

Repeat colonoscopy at 2 - 6 month (timing depends on endoscopic and pathologic findings) Shorter intervals may be necessary when there is uncertainty about completeness of removal of large and/or sessile polyps or if the colonic preparation was suboptimal. Other factors in determining intervals might include the results of the prior examinations and the presence of co-morbid conditions. The results of the first 2 screening exams may predict the individuals overall colon cancer risk. Screening every 1-2 years should be initiated 8-10 years after onset of symptoms in patients with a personal history of inflammatory bowel disease. If primary sclerosing cholangitis (PSC) is present, annual surveillance colonoscopies should be started independent of the disease activity and extent. Information regarding the value of endoscopic surveillance of long-standing Crohn’s disease is limited. Surveillance is at the discretion of the physician. Risk factors for dysplasia in ulcerative colitis include extensive colitis, colonic stricture, primary sclerosing cholangitis (PSC), family history of CRC, especially aged 100 adenomas

2.

Personal history of >10-10-20 at any individual exam, when polyps have been previously ablated or when polyp have reached a size > 1 cm, or when advanced histology is encountered in any polyp), surgery should be considered. If one MUTYH mutation found or if no APC or MUTYH mutation found – follow recommendations for average risk individual. If positive for familial LS mutation or genetic testing not done, follow recommendations for Lynch Syndrome surveillance: Surveillance for MHL1, MSH2 and EPCAM mutation carriers - Colon Cancer: Colonoscopy at age 20-25 years or 2-5 years younger then the youngest diagnosis age in the family, whichever comes first, to be repeated every 1-2 years. Surveillance for MSH6 and PMS2 Mutation Carriers – Colon Cancer: Colonoscopy at age 25-30 years or 2-5 years prior to the earliest colon cancer if it is diagnosed before age 30 years and repeat every 1-2 years. (There is limited data to suggest definitive recommendations for when to initiate screening. Current data suggests that MSH6 and PMS2 mutation carriers have significantly lower risks for colorectal and certain extracolonic cancers compared to MHL1, MSH2 and EPCAM mutation carriers.

Colonoscopy Feb 16

9

Family history of colonic adenomatous polyposis of unknown etiology Family history of > 100 adenomas diagnosed at age 10 -100 adenomas diagnosed at age >40 in a first degree relative

Family history of serrated polyposis The risk of CRC of individuals with serrated polyposis is still unclear. Pending further data, it is reasonable to screen first-degree relative at the youngest age of onset of serrated polyposis diagnosis, and subsequently per colonoscopic findings.

Colonoscopy Feb 16

However, given the limited data and variability in the ages of onset and penetrance among MSH6 and PMS2 carriers, colonoscopies starting at younger or later ages may be considered in some families. Data is limited to suggest definitive recommendations for when to initiate screening or the interval of screening. Consider colonoscopy beginning at age 10— 15 years. Then every year until age 24, every 2 years from 24-34, every 3 years from 24-44 and then every 3-5 years thereafter. If polyposis is detected, follow recommendations for classical FAP Data is limited to suggest definitive recommendations for when to initiate screening or the interval of screening. Consider colonoscopy and polypectomy every 3-5 years starting at the same age as the youngest diagnosis of polyposis in the family if uncomplicated by cancer or by age 40, whichever is earliest. If multiple polyps are found then colonoscopy every 1-3 years depending on type, number, and size of polyps. Data is limited to suggest definitive recommendations for when to initiate screening or the interval of screening. Consider colonoscopy and polypectomy every 2-3 years starting at age 40if uncomplicated by cancer. If multiple polyps are found then colonoscopy every 1-3 years depending on type, number, and size of polyps. First degree relatives are encouraged to have colonoscopy at the earliest of the following:   

Age 40 Same age as youngest diagnosis of serrated polyposis if uncomplicated by cancer Ten years earlier than earliest diagnosis in family of CRC complicating serrated polyposis.

10

A 1st degree relative with CRC diagnosed at age< 60 years or 2 first-degree relatives diagnosed with colorectal cancer at any age

A first-degree relative with CRC ≥ age 60 years One second-degree relative with CRC aged < 50 years First-degree relative with advanced adenoma(s) (i.e., high-grade dysplasia, >1 cm, villous or tubulovillous histology)

Following baseline exam, repeat every 5 years if no polyps are found. If proximal serrated polyps or multiple adenomas are found, consider colonoscopy every 1-3 years Screening colonoscopy recommended every 5 years, beginning 10 years prior to the earliest diagnosis in the family or at age 40 at the latest. If colonoscopy is positive, follow-up colonoscopy should be based on findings. Colonoscopy begining at age 50. Repeat every 5 - 10 years4. If positive, repeat per colonoscopy findings. Colonoscopy beginning at age 50. Repeat every 5 - 10 years4 or repeat per colonoscopy findings. Colonoscopy at the relative’s age of onset of adenoma or by age 50 at the latest, with repeat colonoscopy every 5-10 years or based on findings..

Footnotes 1.

Screening modalities that detect adenomatous polyps and cancer include colonoscopy, flexible sigmoidoscopy, and CT colonography. Screening modalities that primarily detect cancer include stool based screening. NCCN notes that currently there is not a consensus on the use of CT colonography as a primary screening modality, and it is evolving with regards to recommendations/programmatic frequency, polyp size leading to referral for colonoscopy, and protocol for evaluating extra colonic lesions. However, the data available suggests that, if CT colonography is negative/no polyps, then repeat CT colonography in 5 years, and referring patients with identified polyps larger then 5 mm to colonoscopy

2.

Synchronous neoplasms refers to two or more abnormal growths of tissue occurring simultaneously and presumed to be of separate origin. The neoplasms may be histologically the same or different, and may be found in the same or different sites. Preoperative or intraoperative diagnosis of the presence of synchronous colorectal carcinomas is very important because once they are over looked, they present as early metachronous carcinomas with advanced stages and usually require re-operation. Synchronous adenocarcinomas from large bowel could metastasize to the liver.

3.

Favorable prognostic indicators include all of the following:

4.



Complete excision



No vascular or lymphatic invasion



Clear margins



Well-differentiated histology (Grade I or II).

Some combinations of affected first, second and third degree relatives may increase risk sufficiently to alter screening guidelines. Colonoscopy intervals

Colonoscopy Feb 16

11

should be further modified based on personal and family history as well as individual preferences. Factors that modify colonoscopy intervals include specifics of family history, including number and age of onset of affected 2nd and 3rd degree relatives, size of family, completeness of family history; and participation in screening and colonoscopy findings in family members. Multiple (2 or more) negative colonoscopies may support stepwise lengthening in the colonoscopy interval. 5.

Small adenoma burden is defined (somewhat arbitrarily) as fewer than 20 adenomas, all