Summary Of Evidence

Indications for diagnostic colonoscopy are based on guidelines from a variety of specialty societies and government organizations. Diagnostic testing is typically done to confirm or rule out a condition in an individual who is symptomatic or who is believed to have a specific condition.

In 2012, the American Society for Gastrointestinal Endoscopy (ASGE) Standards Practice Committee published recommendations for the appropriate use of GI endoscopy.¹ “This is a position statement that discusses the use of GI endoscopy in clinical situations.” “These ASGE recommendations are based on critical review of available information and broad clinical consensus” and recommends diagnostic colonoscopy for individuals with various circumstances and symptoms, in which colonoscopy is required for definitive diagnosis and treatment. Colonoscopy is generally indicated for the evaluation of an abnormality on barium enema or other imaging study that is likely to be clinically significant. Some of these abnormalities may include such abnormalities as a filling defect, an evaluation of unexplained GI bleeding, unexplained iron deficiency anemia, screening and surveillance for colonic neoplasia, for dysplasia and cancer surveillance in select patients with long-standing ulcerative colitis or Crohn’s colitis, evaluation of patients with chronic inflammatory bowel disease if more precise diagnosis or determination of the extent of activity of disease will influence management, and for clinically significant diarrhea of unexplained origin. These are only a few of the clinically significant abnormalities indicated for colonoscopy. However, guidelines are intended to provide information to assist endoscopists in providing care to their patients and varying clinical considerations may require a different course of action that may vary from the guideline.

In 2000, Bond JH and the American Journal of Gastroenterology published the Polyp Guideline: Diagnosis, Treatment, and Surveillance for Patients with Colorectal Polyps.² These practice guidelines were developed to indicate the preferable approaches to the management of patients with colorectal polyps based on the available scientific evidence as colonoscopy is the most accurate method of detecting polyps of all sizes and allows for immediate biopsy or polypectomy. These guidelines indicate patients who have polyps detected by various methods should have a colonoscopy to examine the entire colon, excise the polyp(s) and search for additional neoplasms. Patients who have had excision of a large sessile polyp should have a follow-up colonoscopy in 3-6 months. If residual polyp is present, it should be resected and another 3-6 month follow-up colonoscopy should be performed to check for completeness of resection. If complete resection is not possible after two or three examinations, the patient should be referred for surgical therapy. Patients with polyps detected by barium enema or flexible sigmoidoscopy should undergo colonoscopy to excise the polyp and search for additional neoplasms. After one negative follow-up colonoscopy, subsequent surveillance intervals may be increased to 5 years.

Green et al.³ 2005, is a prospective randomized study consisting of 50 patients with “lower gastrointestinal bleeding but without upper or anorectal bleeding sources.” Patients were randomized into two groups (colonoscopy and standards of care algorithm). According to the findings a definite source of bleeding was found more often in the urgent colonoscopy patients than in the standard care group. There was no difference in outcomes among the two groups with regards to mortality, hospital stay, ICU stay, transfusion requirements, early or late rebleeding. The study demonstrates “patients with substantial lower gastrointestinal hemorrhage, outcomes are similar whether urgent colonoscopy or expectant colonoscopy is performed as part of a standard of care algorithm.” Except for diagnosis, urgent colonoscopy provided no advantage over radiographic intervention. Based on the findings, it is suggested that the type of approach should be based on local expertise and available resources.

Levin et al.⁴ 2008, is a collaborative consensus statement of the American Cancer Society, the U.S. Multi Society Task Force on Colorectal Cancer, and the American College of Radiology. This collaboration developed guidelines for the detection of adenomatous polyps and colorectal cancer in asymptomatic average-risk adults. Screening tests are grouped into those that primarily detect cancer early and those that can detect adenomatous polyps. This provides a greater potential for prevention through polypectomy. “In a case-control study of colonoscopy in the United States Veterans Administration population, colonoscopy in symptomatic patients was associated with a 50% reduction in mortality.” “Overall, the data support the conclusion that colonoscopy with clearing of neoplasms by polypectomy has a significant impact on colorectal cancer (CRC) incidence and, thus, by extension, mortality.”

Regula et al.⁵ 2006, is a cross-sectional analysis from a colonoscopy-based screening program for colorectal cancer in Poland consisting of 50,148 patients aged 40-66. The primary objective was to derive and validate a model for the detection of advanced neoplasia in the large bowel. The secondary objective was to determine the number needed to screen to detect one advanced neoplasia in various age groups and compare these numbers in both men and women. The numbers needed to screen to detect advanced neoplasia are significantly lower in men than in women of similar age and similar family history of colorectal cancer. The findings suggest that screening recommendations should be modified to ensure the maximal diagnostic yield and optimal use of resources.

Analysis of Evidence

According to the Centers for Disease Control and Prevention (CDC),⁶ colorectal cancer is the second leading cancer killer in the United States. “In 2017, in the United States, 141,425 new cases of colon and rectum cancer were reported, and 52,547 died of colon and rectum cancer”. Colorectal cancer is most often found in individuals aged 50 years and older and affects men and women of all racial and ethnic groups. The literature supports that diagnostic colonoscopy is a safe and important diagnostic tool in the assessment of colon cancer given the prevalence of adenomas, colorectal cancer or other findings requiring medical therapy is higher among individuals referred for diagnostic colonoscopy than those referred for a screening exam.⁷ Based on the clinical literature and guidelines from various specialty societies, Medicare will consider colonoscopy medically necessary, as a diagnostic tool, to confirm or rule out various conditions in symptomatic patients who are believed to have a specific condition as indicated in the indications section of this policy.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Colonoscopy allows direct visual examination of the intestinal tract with a flexible tube containing light transmitting glass fibers that return a magnified image. Colonoscopy can act as both a diagnostic and therapeutic tool in the same procedure. Therapeutic indications include removal of polyps or foreign bodies, hemostasis by coagulation, and removal of tumors.

Covered Indications

A diagnostic colonoscopy will be considered medically reasonable and necessary under any of the following circumstances:

1. Evaluation of an abnormality (e.g barium enema) which is likely to be clinically significant, such as a filling defect or stricture.¹
2. Evaluation and excision of polyps detected by barium enema or flexible sigmoidoscopy, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), and positron emission tomography (PET).²
3. Evaluation of unexplained gastrointestinal bleeding; hematochezia not thought to be from rectum or perianal source, melena of unknown origin, or presence of fecal occult blood.¹
4. Unexplained iron deficiency anemia.¹
5. Examination to evaluate the entire colon for simultaneous cancer or neoplastic polyps in a patient with a treatable cancer or neoplasic polyp.¹ The term treatable cancer may include not only curative intent, but also procedures done to prolong survival, progression free disease, and quality of life/palliative care.
6. Evaluation of a patient with carcinoma of the colon before bowel resection.
• Post-surgical colonoscopy should be conducted at 1 year, if normal then subsequent examination should be at 3 years, if normal then subsequent examination should be at 5 years.^1,4
7. Yearly evaluation with multiple biopsies for detection of cancer and dysplasia in patients with chronic ulcerative colitis who have had pancolitis of greater than seven years duration.⁴
8. Yearly evaluation with multiple biopsies for detection of cancer and dysplasia in patients with chronic ulcerative colitis who have had left-sided colitis of over 15 years duration.⁴
9. Evaluation in patients with chronic inflammatory bowel disease of the colon when more precise diagnosis or determination of the extent of activity of disease will influence immediate management.^1,4
10. Evaluation of clinically significant diarrhea of unexplained origin.¹
11. Evaluation and treatment of bleeding from lesions such as vascular anomalies, ulceration, neoplasia, and polypectomy site (e.g., electrocoagulation, heater probe, laser or injection therapy).^1,3
12. Detection and removal of foreign bodies.¹
13. Evaluation and decompression treatment of acute non-toxic megacolon.¹
14. Evaluation and balloon dilation treatment of stenotic lesions (e.g., anastomotic strictures).¹
15. Evaluation and decompression of colonic volvulus.¹
16. Examination and evaluation when a change in management is probable or is being suspected based on results of the colonoscopy.¹
17. Evaluation within 6 months of the removal of sessile polyps to determine and document total excision.
• If evaluation indicates that residual polyp is present, excision should be done with repeat colonoscopy within 6 months.
• After evidence of total excision without return of the polyp.
18. Unsuccessful colonoscopy preoperatively due to obstructive cancer,
• repeat colonoscopy 3-6 months post-operatively unless unresectable metastases are found at surgery.⁴
19. Evaluation to differentiate between ulcerative and Crohn's colitis.¹
20. Evaluation 3 years after resection of newly diagnosed small (< 5mm diameter) adenomatous polyps when only a single polyp was detected.
• After 1 negative 3-year follow-up examination subsequent surveillance intervals may be increased to 5 years.⁴
21. Evaluation at 1 and 4 year intervals after resection of multiple or large (> 10mm) adenomatous polyps.
• Subsequent surveillance intervals may then be increased to every 5 years.⁴
22. Evaluation in 1 year after the removal of multiple adenomas.
• If examination proves negative then repeat in 3 years.
• After 1 negative 3-year follow-up examination, repeat exam every 5 years.²
23. Evaluation of a patient presenting with signs/symptoms (e.g., rectal bleeding, abdominal pain) of a disorder that appears to be related to the colon.¹

Limitations

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

1. Diagnostic colonoscopy is not indicated in patients with chronic ulcerative colitis who have had left-sided colitis of over 15 years duration when disease is limited to the rectosigmoid colon.