LCD L34454: Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy

This Local Coverage Determination (LCD) addresses the colonoscopies that are NOT performed for colorectal cancer screening. Colorectal cancer screening is a separate benefit with specific guidelines.

Proctosigmoidoscopy is the examination of the rectum and sigmoid colon.

Sigmoidoscopy is the examination of the entire rectum, sigmoid colon and may include examination of a portion of the descending colon.

Colonoscopy is the examination of the entire colon, from the rectum to the cecum, and may include the examination of the terminal ileum or small intestine proximal to an anastomosis. The colonoscope is inserted anally (or through a stoma) and is advanced optimally through the large intestine under direct vision, using the scope's optical system. See the Centers for Medicare and Medicaid Services (CMS) Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, §30.1B Digestive System - Incomplete Colonoscopies for the definition of incomplete colonoscopies.

Covered Indications:

1. For evaluation of an abnormality discovered on barium enema and/or other imaging technique that is likely to be clinically significant, such as a filling defect or stricture or an inadequate examination;

2. For evaluation of unexplained gastrointestinal (GI) bleeding;

• Hematochezia not thought to be from rectum or perianal source

• Melena of unknown origin

• Presence of fecal occult blood

3. For unexplained iron deficiency anemia;

4. For surveillance of colonic neoplasia;

• For examination to evaluate the entire colon for synchronous cancer or polyps in a patient with treatable cancer or polyps.

• For follow-up 1 year after surgery for treatment of colorectal cancer when the patient is identified as being at high-risk for colon cancer and is eligible for continued screenings at 24-month intervals.

• For follow-up at least 3-6 months after colonoscopic removal of a large sessile adenoma (i.e., greater than 2 cm in greatest dimension).

• For patients with Crohn’s colitis, chronic ulcerative colitis (UC), pancolitis of greater than 7 years duration or left-sided colitis of over 15 years duration (no surveillance needed for disease limited to rectosigmoid) may have a colonoscopy every 1-2 years for multiple biopsies to detect cancer and/or dysplasia.

5. For chronic inflammatory bowel disease (IBD) of the colon (if a more precise diagnosis or if a determination of the extent of activity of disease will influence immediate management);

6. For clinically significant diarrhea of unexplained origin with additional findings (e.g., weight loss or negative stool cultures persisting for more than 3 weeks);

7. For 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);

8. For evaluation of acute colonic ischemia/ischemic bowel disease;

9. For evaluation of a patient with Streptococcus bovis (S. bovis) endocarditis or bacteremia;

10. For treatment of bleeding from such lesions as vascular anomalies, ulceration and neoplasia;

11. For removal of a foreign body;

12. For excision of colonic polyps;

13. For decompression of pseudo-obstruction of the colon (Olgilvie’s Syndrome) following a trial of neostigmine or cathartics or a documented reason that this would be either unsafe or inappropriate for the beneficiary;

14. For treatment of colonic volvulus or stricture;

15. For evaluation of an unexplained, new-onset constipation, refractory to medical therapy;

16. For evaluation of an anorectal polyp (adenomatous polyp only); or,

17. For palliative treatment of stenosing, bleeding neoplasms (e.g., laser, electrocoagulation, stenting).

Limitations:

Endoscopy is generally not covered for treating the indications below. Additional documentation should be submitted indicating the medical necessity of the procedure for review.

• Chronic, stable, irritable bowel syndrome (IBS), or chronic abdominal pain. There are unusual exceptions in which colonoscopy may be done to rule out organic disease, especially if symptoms are unresponsive to therapy;

• Acute diarrhea;

• Hemorrhoids;

• Metastatic adenocarcinoma of unknown primary site in the absence of colonic symptoms, when it will not influence management;

• Routine follow-up of IBD (except for cancer surveillance in Crohn’s disease and chronic UC);

• Routine examination of the colon in patients about to undergo elective abdominal surgery for non-colonic disease;

• Upper GI bleeding or melena with a demonstrated upper GI source; or,

• Bright red rectal bleeding with a convincing anorectal source on sigmoidoscopy and no other symptoms suggestive of a more proximal bleeding source.

Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy are generally not covered for:

• Fulminant colitis;

• Possible perforated viscus;

• Acute severe diverticulitis; or,

• Diverticulosis is not usually considered an indication for a diagnostic or therapeutic colonoscopy/sigmoidoscopy/proctosigmoidoscopy but may be reported on the claim when this condition is found to be the final diagnosis.

Other Comments:

Limitation of liability and refund requirements apply when denials are likely, based on either medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing prior to rendering the service if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category, or is rendered for screening purposes.

Background

Rigid endoscopes have been used in medicine since the early 19th century. 1 Around the middle of the 20th century, the diagnosis and treatment of colon diseases started to make significant advancements. The development and improvement of endoscopic tools of the lower GI tract, particularly flexible fiber optic endoscopes of varying lengths (depending on most proximal area of the colon to be visualized), served as an alternative to barium enemas for visualization of colonic abnormalities. The flexible fiber optic endoscopes allowed biopsies and the removal of polyps at proximal colonic locations beyond the reach of rigid endoscopes that could previously only be achieved by surgery. 2-4 Rigid proctosigmoidoscopy has largely been replaced by flexible endoscopy; however, rigid endoscopy may be used to evaluate the distal large bowel and rectum. This allows relatively easy washout of blood in the distal colon for visualization. 5 Rigid proctosigmoidoscopy is believed by some to provide more accurate localization of malignancies than fiber optic endoscopy techniques. 6-7

One of the early studies of colonoscopy suggested not only a therapeutic but potential diagnostic advantage over imaging techniques. The study compared findings on barium contrast enema radiography and colonoscopy for the first 700 patients to undergo a colonoscopy at a single institution. 8 Colonic neoplasia was the most common indication for colonoscopy, being present in 344 of the 700 patients. IBD was the indication in 133 patients. Other indications in decreasing order of frequency included x-ray negative colonic bleeding, IBS, x-ray negative diarrhea and obstruction. In a comparison of Malmo double contrast barium enema findings vs colonoscopy findings, they noted that the barium enema found 97% of polyps > 1 cm detected by colonoscopy, but only 78% of small polyps. Conventional barium enema evaluation was less successful. In cases of UC, they found that barium enema findings agreed with colonoscopy with biopsy findings in 68% of the cases. However, 18% of cases were found to have a substantial underestimate of the extent of disease with the barium enema and the barium enema was normal for 14% of cases while colonoscopy and biopsy revealed total colitis.

Evaluation of Abnormal Findings on Radiography