Local Coverage Determination (LCD)

Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy

L34454

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LCD Information

Document Information

LCD ID
L34454
LCD Title
Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL34454
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 04/29/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
12/13/2018
Notice Period End Date
01/27/2019
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CMS National Coverage Policy

Title XVIII of the Social Security Act §1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

42 CFR §410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, §20.2 Outpatient Defined, §20.3 Encounter Defined, §20.4.1 Diagnostic Services Defined, §20.4.4 Coverage of Outpatient Diagnostic Services Furnished on or After January 1, 2010

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, §30.1B Digestive System - Incomplete Colonoscopies

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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;  

  1. Hematochezia not thought to be from rectum or perianal source
  2. Melena of unknown origin
  3. Presence of fecal occult blood

3. For unexplained iron deficiency anemia;

4. For surveillance of colonic neoplasia;

  1. For examination to evaluate the entire colon for synchronous cancer or polyps in a patient with treatable cancer or polyps.
  2. 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.
  3. 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).
  4. 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.

Summary of Evidence

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

Anatomic abnormalities can be discovered or evaluated by either radiographic techniques, colonoscopy, pathology or surgery where necessary.

An early study of the use of colonoscopy in patients with strictures diagnosed using a barium enema at a time when laparotomy was the only method of confirming and possibly treating the diagnosis, reported results on 160 strictures in 154 patients treated at a single institution.9 The authors noted that in 104 cases in which radiologists were ready to make a probable diagnosis prior to colonoscopy, the diagnosis was proven wrong in 52% of the cases by the colonoscopy. In the 50 patients for whom the radiographic exam did not suggest a clear diagnosis, the colonoscopy was able to establish a diagnosis in all but 2. The authors estimated that surgery was avoided in over half the series through the use of colonoscopy. Diagnoses evaluated included suspected malignancy, polyps, and known or suspected IBD.

Since the publication of this study in 1975, newer imaging techniques have become available including computed tomography (CT). A study of performance characteristics of CT colonography in 300 patients referred for colonscopy (both for screening and because of symptom evaluation) reviewed the diagnostic sensitivity of CT colonography.10 CT colonography was performed prior to the colonoscopy. The sensitivity of CT colonography was found to be 100% for cancerous polyps, though only 77.5% for adenomas and 69.7% for all polyps. For adenomas under 5 mm, the sensitivity of CT was 66.9% and was 59.1% for detection of polyps under 5mm. False positives were also identified on CT scan. Notably, the CT scan did not offer a technique for assessing the nature of polyps seen and the nature of these polyps was determined using colonoscopy.

A subsequent study of CT colonography as compared with colonoscopy for the detection of neoplasia screening compared CT screening in 3120 consecutive patients with colonoscopy screening in 3163 patients.11 Neoplasms under 5 mm were not reported on CT and as such counted as not being detected. For patients with polyps of at least 6 mm detected on CT, patients were offered a same day colonscopy unless medically contraindicated. Among large polyps and polyps with high grade dysplasia, detection rates were similar based on the 2 screening methods. Positive findings detected by CT scan in this study required colonoscopy for further evaluation.

Hematochezia

A study on the use of urgent colonscopy in the diagnosis and treatment of severe hematochezia evaluated 80 consecutive inpatients and found that 74% of the patients examined had bleeding in the colon.12 Of these 80 patients, 64% had an intervention to control bleeding; 39% had a therapeutic endoscopy, 24% had surgery, and 1 had a therapeutic angiography.  A more recent small randomized controlled trial compared urgent colonoscopy for acute lower GI hemorrhage to standard care.13 In this study, consecutive patients were enrolled to a single institution with lower GI bleeding with significant blood loss without upper GI or anorectal bleeding. All patients underwent an upper endoscopy and an anoscopy and were considered for enrollment only if a bleeding source was not identified on these exams. There were 50 patients randomized to each treatment arm. Urgent colonoscopy was performed in the treatment group while the standard care group used a decision tree approach which culminated in either elective colonoscopy or angiographic hemostasis followed by elective colonoscopy. A definite source of bleeding was in a significantly greater percentage of the group treated with urgent colonoscopy than those treated with standard care (which included elective colonoscopy), 42% vs 22% respectively. The most common definitively identified cause was bleeding diverticula, though angioectasias and ischemic colitis were also identified by colonoscopy as causes. In spite of the difference in the rate of definitive diagnosis, there were no significant differences in the outcomes evaluated, including early rebleeding, late rebleeding, mortality, hospital length of stay, transfusion requirements or the need for surgery. Given the similar outcomes, the authors concluded that the choice of treatment approach should be based on local expertise.

Diverticular perforation is a concern in colonoscopy, but the role of colonoscopy in the treatment of hematochezia in the setting of known diverticulosis has been studied in 2 prospective series.14 A total of 121 patients who presented to the hospital with hematochezia and persistent bleeding in the setting of diverticula were followed. The first 73 were treated with medical management, including colonoscopic diagnosis of the bleeding source, and they underwent hemicolectomy if severe bleeding returned or persisted while in the hospital. Of these 73, 17 had diverticular bleeding and were followed for the study. In the second series of 48 patients bleeding was treated endoscopically with colonoscopic epinephrine injections or bipolar probe coagulation for nonbleeding visible vessels. From this second series, 10 were found to have bleeding diverticula and were followed for the study. Among the 17 patients with bleeding diverticula assigned to medical plus surgical treatment if necessary, 6 patients had recurrent bleeding and underwent surgical treatment with hemicolectomy. Of the 10 patients who were treated with colonoscopy, there were no episodes of rebleeding and none required hemicolectomy. With a median follow-up time of 36 months in the medical plus surgical cohort and 30 months in the endoscopically treated cohort there were no episodes of late rebleeding. The authors concluded that surgical treatment of bleeding diverticula should be reserved only for patients who do not respond to medical management and attempted endoscopic control of bleeding.

A clinical guideline from the American College of Gastroenterology (ACG) recommends the use of colonoscopy as the first line diagnostic approach for acute lower GI bleeding.

Anemia and Occult Fecal Blood

GI sources of blood loss have been considered a possibility in patients with iron-deficiency anemia. The diagnostic utility of endoscopy has been studied in this population in a study of 100 patients with iron-deficiency anemia.15 In this study, 100 patients at a single institution who were referred to gastroenterology for evaluation of iron-deficiency anemia were studied. The study included 73 outpatients and 27 inpatients with a mean age of 60 years who had iron-deficiency anemia. Patients underwent upper endoscopy as well as colonoscopy. A significant lesion was found in 62 of the 100 patients, and a likely source of bleeding was found on colonoscopy in 26 of the patients, 1 of whom also had a significant finding on upper endoscopy. Colon cancer was the most common cause, identified in 11 of the 26 patients with a significant colonoscopy finding. Other causes identified in decreasing order of frequency were polyp, vascular ectasia, colitis, cecal ulcer, and parasitic infection. The authors recommended that site-specific symptoms guide diagnostic investigations of GI blood loss sources. Evaluation of GI sources of blood loss should be done first with colonoscopy and followed with upper endoscopy if no colonic source is found in asymptomatic older patients.

In patients who test positive for fecal occult blood sources, the location and cause of the bleeding source is an obvious diagnostic question. The ability of endoscopy to answer this question was addressed in a study of 248 patients who referred to a single institution’s gastroenterology service and who had at least 1 positive test for fecal occult blood.16 Patients with iron deficiency anemia or obvious blood in the stool including melena or hematochezia were excluded from the study. There were 409 patients screened for study inclusion, and 248 were studied, of whom only 7 were hospitalized with the remaining treated as outpatients. All patients underwent a colonoscopy followed by an immediate esophagogastroduodenoscopy (EGD). Using this dual endoscopy approach, 48% of patients had a potential source of bleeding identified endoscopically with 28.6% having a source identified on the EGD and 21.8% having a source identified on the colonoscopy (6 patients had a source on both endoscopic approaches). The most common identified abnormality found with colonoscopy was an adenoma > 1.0 cm, found in 11.7% of patients. Other identified abnormalities, in descending order of frequency, included carcinoma, colitis, vascular ectasia, ulceration and Trichuris trichuria.

S. bovis bacteremia and endocarditis

Early cases series have suggested that S. bovis endocarditis is associated with colonic disease. An early retrospective case series of 14 patients with S. bovis bacteremia found that colon polyps were common in these patients.17 A later prospective study of 29 patients with S. bovis septicemia prospectively completed GI evaluations on 15 and did not complete evaluations on the other 14.18 Of the 15 who had complete evaluations, 8 were found to have colon carcinoma and 2 had esophageal carcinoma. In the 14 who did not have complete evaluations, 1 had stomach carcinoma, 1 had gastric lymphoma and 3 had poorly characterized colonic masses. The majority of the patients had no GI symptoms.  In a subsequent study of 19 patients with S. bovis bacteremia, 14 of whom had endocarditis, found that 2 patients had colon carcinoma and 1 had metastatic gastric cancer.19

A recent study retrospectively reviewed all cases of S. bovis at 2 hospitals in the same city, 1 community and 1 tertiary care.20 They identified 45 patients with S. bovis bacteremia of whom 26 had neoplasia. The most common neoplasm was adenomatous polyps, which were found in 14 patients, but 3 patients had invasive colorectal cancer, and the remaining patients had cancer at other bodily sites.

Treatment of retained colorectal foreign bodies

Retained colorectal foreign bodies may be treated in a number of ways. An early study reviewing a 10 year single institution with ingested foreign bodies found that most ingested foreign bodies that reached the stomach passed spontaneously without intervention, and surgical removal was necessary for those that did not.21 However, numerous case series have reported dealing with colorectal foreign bodies that were retained. Among them an early case series reported on 28 retained foreign bodies, 5 of which caused rectal perforation.22 Of the 23 patients in this series without a perforation, 4 required removal in the endoscopy suite without the need for surgery. In patients without perforation, endoscopic evaluation of the mucosa was performed following removal of the body to assess for mucosal injury. A more recent series reviewed cases of retained colorectal foreign bodies in 86 patients (an 87th patient left against medical advice).23 Of these, 23 patients required treatment in the operating room with 17 examinations under anesthesia and 8 laparotomies.  Bedside extraction was successful in 63 patients (5 patients treated by the emergency room staff and 58 patients treated by the surgical service). A variety of techniques were used in bedside removal including forceps removal, rigid sigmoidoscopy, manipulation with a foley catheter, and enema. As might be expected, an important factor associated with the need for laparotomy was the location of the foreign body, with foreign bodies in the sigmoid colon significantly more likely to require intervention in the operating room as compared with foreign bodies located in the rectum.

No studies have assessed optimal foreign body removal technique, and numerous methods have been described for attempting nonsurgical removal including but not limited to endoscopy as described in several reviews.24-26

Ogilvie’s Syndrome (Colonic Pseudo-Obstruction)

Historically, dangerously large colonic dilation was treated surgically, but with the development of endoscopic techniques, nonsurgical intervention became feasible. Kukora and Dent initially reported the use of colonoscopy in the decompression of massive nonobstructive cecal dilation.27 In this early case series, they report that the surgical endoscopy service at a single institution encountered 6 patients over 3 years with this condition. One of the patients was not successfully decompressed nonoperatively and died following cecostomy. In the other 5 cases, a flexible fiber optic colonoscope was used to successfully decompress the colon without return of dilation in any of the cases. A larger case series was later published which described the outcomes of 22 patients seen for colonic pseudo-obstruction.28 In this later series, the colon was successfully decompressed with a colonoscopy in 19 of the 22 cases and it was unsuccessful in 3 of the cases, of which 1 spontaneously resolved and the other 2 were treated surgically. Of the 19 patients successfully treated, there were 4 patients with recurrence, 2 of which went on to surgical treatment and 2 of whom had resolution spontaneously with repeat colonoscopy.

More recently, neostigmine has been demonstrated to have use in the treatment of colonic pseudo-obstruction. A small controlled trial of 21 patients, 11 of whom were randomized to neostigmine and 10 of whom were randomized to receive a saline control, indicated that neostigmine may be a potential treatment prior to colonoscopy.29 In this study, neostigmine was effective in providing an immediate clinical response in 10 of the 11 neostigmine treated patients; though 2 of the patients had a recurrence and went on to receive a colonoscopy. Additionally, 2 patients who received neostigmine had symptomatic bradycardia which was not experienced in the control group. The authors concluded that neostigmine should be considered before colonoscopy.

Volvulus

Volvulus is an emergency which has had a high rate of associated mortality for decades.30-31 For decades, volvulus has been managed conservatively with an enema or endoscopy being found as treatment options with technical adequacy, though surgery is required in many cases due to the presence of nonviable bowel in need of resection, inability to achieve decompression with non-operative means, or to resect involved bowel for the treatment of recurrence.32-35

There does not appear to be any large prospective trials comparing the management approaches, though a recent large retrospective cohort study of inpatient admissions in the United States has compared outcomes based on treatment approach.31 This study evaluated data from 63,479 cases from 2002 to 2010 and found that nonsurgical treatment, mostly endoscopy, was used in 16.6% of cases without follow-up surgery and a mortality rate of 6.41%. Surgically managed patients had mortality rates ranging from 3.01% - 17.84% depending on the operative technique. Notably, this was a retrospective data review, and as such management technique may have been selected by the care team in part based on a patient’s pre-procedural health or mortality risk.

Diarrhea

Diarrhea is a nonspecific symptom that may be a presenting symptom in a number of diagnoses that are best evaluated with endoscopy. A number of diagnostic approaches to diarrhea have been applied, colonoscopy among them. Since colonoscopy allows for direct visualization of the colonic mucosa and the ability to obtain tissue samples for histopathologic analysis, it has been studied as a diagnostic tool for diseases where macroscopic or microscopic colonic appearance is suspected to have clinical utility.

A study of 809 patients without human immunodeficiency virus (HIV) who had chronic non-bloody diarrhea, found colonic pathology in 15% of cases with diagnosis from most to least frequent including microscopic colitis, Crohn’s disease, melanosis coli, UC, other forms of colitis, and nodular lymphoid hyperplasia.36 Another study of 167 patients with chronic diarrhea, macroscopically normal colons and terminal ileums on endoscopy reported histologic abnormalities in 68.5% of the cases.37 The majority of these histologic abnormalities were of no importance (67.9%), but a significant minority was of borderline or clear diagnostic importance showing inflammatory changes or infection in 21.6% of the cases and possible inflammatory changes or melanosis coli in 10.5% of the cases. A case series of 228 patients with chronic diarrhea evaluated by colonoscopy, of whom 168 had ileoscopy as well, showed that colonoscopy and biopsy yielded a specific histological diagnosis in 31% of patients, with lymphocytic colitis the most common single diagnosis, and Crohn’s disease and UC 2nd and 3rd most commonly diagnosed.38 An early study of Crohn’s disease found that diarrhea was reported by nearly all patients with this diagnosis.39

Constipation

Constipation is a nonspecific symptom which may be caused by numerous conditions, many of which do not require invasive management.

Constipation as a presenting symptom of abnormal colonoscopy findings has been studied in a large database study.40 This study retrospectively reviewed a Clinical Outcomes Research Initiative (CORI) database containing data from 400 endoscopists in 24 different states. Cases were selected based on presenting symptoms. They identified 41,775 colonoscopies for constipation alone, attributed to another source or for average-risk screening. The final group was used as a control to compare risks of abnormal findings.  A significant colonoscopy finding was defined as a polyp > 9mm and suspected malignant. Patients who had constipation alone had a lower adjusted relative risk of having a significant finding on the colonoscopy as compared with average-risk controls with a relative risk of 0.79. However, constipation accompanied by bleeding or weight loss was associated with a higher relative risk of an abnormal colonoscopy finding than average-risk screening colonoscopy patients: relative risk of 1.57 with anemia, 1.18 with hematochezia, 2.04 with a positive fecal occult blood test (FOBT) and 1.72 with weight loss.

Excision of Polyps

Early histologic evaluations of colon and rectal cancers that were contiguous with benign tumor has for decades suggested that many colon and rectal cancers arise from previously benign polyps or adenomas. It has also been known for decades that incidence of malignancy was highly related to adenoma or polyp size, with tumors > 2 cm in diameter being much more likely to demonstrate malignancy than smaller polyps, and polyps under 1 cm rarely having malignancy.41 This has led to the idea that polyp removal would reduce the rates of colon cancer development.42

The notion that removal of polyps without clear evidence of malignancy would lead to lower rates of colon cancer developing was empirically studied in a cohort of 1418 patients.43 Patients in this cohort underwent colonoscopies with polypectomy if any polyps were found. Patients who had at least 1 adenoma were then followed with subsequent colonoscopies, and rates of colon cancer development in this cohort were compared with 3 reference groups: Mayo Clinic data, St. Mark’s Hospital data, and Surveillance, Epidemiology, and End Results Program (SEER) data. Over the follow-up of up to 7 years, colon cancer development was significantly less common in the cohort who received a polypectomy, supporting the idea that removal of polyps has a therapeutic benefit even prior to the development of malignancy.

IBD

An early study of diagnostic features of IBD reviewed the cases of 357 patients who had 606 endoscopies.44 Histologic or surgical diagnosis was used as the reference against which diagnosis based on macroscopic features on colonoscopy was judged. Colonoscopy was found to show the correct diagnosis in 89% of cases.

Accurately diagnosing a patient’s inflammatory bowel condition may have a role in patients depending on disease severity. While some immunosuppressant’s such as steroids may be effective in the treatment of both illnesses, general approaches to management are to use the mildest and safest medication which adequately controls symptoms. As such, aminosaliclyates, which are recommended as a first line therapy in the treatment of UC have been found to be minimally effective in the management of Crohn’s disease. Alternatively, methotrexate, which may help control disease severity in Crohn’s disease, has not been proven to be effective in UC.45-46

Palliation

Patients with colon cancer that cannot be definitively treated may require palliation of symptoms. Surgical palliation may be needed in many such patients, though emergent surgical treatment of malignant obstruction has been associated with high mortality rates. As such, stenting has been proposed as a potential treatment instead of surgery or as a possible bridge to elective surgery later.

A large multi-center case series reported data for 201 patients treated for incurable malignant colorectal obstruction.47 There was successful stent placement in 184 patients who were followed for longer term outcomes. Early clinical success with colonic decompression was achieved in 89.7% of these patients. Longer term outcomes were reported based on an average of 115 days of post-procedure follow-up. In this cohort, 77% of patients who had initial clinical success had relief of colonic obstruction until death and 14% were alive with functioning stents at the end of the study period. There were 9% of patients with major late complications, most of which were due to perforations.

A study designed to evaluate the specific role of malignant colon obstruction management strategy on the oncologic management and chemotherapy administration in patients, reported retrospective data obtained from a single institution on 31 patients who received a self-expanding metal stent and 27 patients who underwent surgical treatment.48 The hospital length of stay was 8 days in the stent-treated group as compared to 13.5 days in the surgically treated group. Additionally, hemotherapy was started 14 days following stenting and 28.5 days following surgery. There was no significant difference in mortality between the groups. The authors concluded that use of palliative stenting allows patients to spend less time in the hospital and receive chemotherapy sooner.

A meta-analysis of stent placement reported outcomes of 451 patients, 244 of whom underwent attempted stent placement in 12 studies.49 Studies included considered stent placement in comparison to open surgery. This meta-analysis found that the stent-treated group had lower hospital lengths of stay, mortality, medical complications and the long term need for a stoma. Patients treated with stent placement tended to tolerate an oral diet sooner than those treated with surgery.

A study of Medicare claims with more patients than any single study in the above meta-analysis  compared colon stent placement to colostomy in malignant colon obstructions using the Medical Provider Analysis and Review (MedPAR) data set from 2007-2008. This study evaluated 778 colon stent placements and 5,868 hospitalizations.50 The use of claims data limited the variables that could be examined, so a match case-control study based records from a single institution was also performed to assess clinical outcomes. The case-control study had 12 patients who had colon stent placement and 24 matched patients who had a colostomy. In the MedPAR component of the study, the use of stenting was associated with an 8 day length of stay as compared with a 12 day length of stay in the colostomy group. In the case-control study, they found that both stenting and colostomy were technically successful 100% of the time, but length of stay post-procedure was longer in the surgically treated group and significant hospital complications were more common in the surgically treated group.

For patients with symptomatic bleeding and/or obstruction of the colon, who are not candidates for surgical resection, electrocoagulation and photocoagulation have long ago been shown to be viable treatment options.51-53

Acute Colonic Ischemia

Acute colonic ischemia is associated with unfavorable outcomes and high mortality rates.54 Common presenting signs and symptoms of large bowel ischemia include rectal bleeding, abdominal pain, and diarrhea, clinical features shared with a number of diagnoses above for which colonoscopy is also indicated.55 With the advent of advanced imaging techniques, the diagnosis can sometimes be made with angiography or non-invasive imaging alone when it is clinically suspected, though all imaging techniques have significant diagnostic limitations including demonstrating late findings, a lack of correlation with bowel infarction, and difficulties in demonstrating small vessel occlusion.54,56 As such, colonoscopy is another effective diagnostic approach that may demonstrate milder clinical disease than can be seen in less invasive diagnostic modalities.54,57-58 As reviewed above, colonoscopy also has the ability to demonstrate the presence of other conditions that may present with similar clinical features as large bowel ischemia.

Analysis of Evidence (Rationale for Determination)

Early studies of endoscopy have shown that it is a useful tool where direct visualization of the colonic lumen and mucosa or the need to biopsy/excise tissue in the colon is desired. As such, colonoscopy has generally been applied to the diagnosis and treatment of conditions for which direct visualization of the lumen or mucosa has utility or for which tissue removal is necessary. In summary, colonic endoscopic techniques have been selected for use based on technical considerations, which is largely a matter of device capabilities. As such, the major evidence-based questions for clinical coverage policy relate to the therapeutic utility of endoscopic tissue sampling/excision or diagnostic yield of direct lumen and mucosa visualization in various conditions including IBD. Despite the long history of the use of lower endoscopy, few if any high quality studies exist to answer these questions. However, this long history means that there are decades of clinical experience in addition to the available limited research.

Early studies of large bowel endoscopy showed that it provides better characterization of lesions in the GI tract than imaging does. In spite of the fact that imaging has advanced significantly, research still suggests that endoscopy allows better detection of small lesions and better characterization of lesions than does imaging. Moreover, lesions that are thought to be suspicious on imaging and warrant either biopsy or outright excision require an additional procedure, either surgery or endoscopy. In essence, endoscopy has established itself as a surgery-sparing technique for the evaluation of suspicious lesions. Additionally, while abdominal imaging may help to detect both intra- and extraluminal pathology, specialized imaging to assess intraluminal or epithelial pathology in the colon prior to endoscopy does not clearly add value to the care of patients for whom there is a high pretest probability of an abnormality (e.g., patients getting a colonoscopy to evaluate bothersome symptoms), as endoscopy will be needed regardless to further evaluate or to treat any abnormalities found on imaging.   

Bleeding from the colon suspected based on either rectal blood or occult anemia is a concerning condition, which colonoscopy may help to accurately diagnose and treat. Colonoscopy allows a provider to visualize such bleeding sources and in many cases treat them as well. Evidence has shown in the past that colonoscopy is frequently able to identify a cause of both hematochezia as well as blood loss that is not obvious and may be detected only on FOBT or with iron studies and the diagnosis of iron deficiency anemia. While the studies demonstrating this are of low to moderate quality, the findings among them are consistent, leaving little doubt that colonoscopy is an appropriate intervention in conditions where there is a clear reason to suspect colonic blood loss.

An interesting relationship has been observed between S. bovis bacteremia and endocarditis and colon cancer. While the pathophysiology of this relationship is not well understood, case series of patients with S. bovis suggest that this population has a higher than expected prevalence of colon cancer.

The management of foreign bodies in the colon or rectum is largely a matter of technical feasibility. No specific maneuver or procedure has been shown to be optimal. Rather, published case series have shown that clinicians have at their disposal a number of available treatment options to retrieve foreign bodies which may help achieve successful foreign body removal, endoscopy among them.

Single arm studies of colonoscopy in the treatment of colonic pseudo-obstruction have shown that this therapeutic method is generally effective, though a newer paper reporting results of a small controlled trial provides evidence supporting the use of neostigmine as a preferable first line treatment.

For the treatment of volvulus, retrospective studies have demonstrated that endoscopic treatment may be sufficient and offers a good first line treatment for patients so as to avoid or delay surgery.

As the evidence summarized above shows and consistent with a statement by the American Society for Gastrointestinal Endoscopy (ASGE), colonoscopy and biopsies are important for the diagnosis of a number of conditions that could cause chronic diarrhea, including infectious and inflammatory diseases.59 Therefore, colonoscopy is considered reasonable and necessary in the diagnosis of diarrhea that is not self-limited and for which the diagnosis is not known.

In constipation, the available evidence does not suggest that colonoscopy generally has a high diagnostic yield, so colonoscopy is generally appropriate only in the presence of other concerning symptoms as well or as a diagnostic modality when constipation is refractory and a diagnosis remains elusive.

Colonic polyps may be associated with bleeding or anemia, and research has demonstrated that some polyps are precursors to carcinoma, and therefore excision, which can be done endoscopically, reduces the risk of subsequent cancer development.

IBD may be diagnosed by colonoscopy through direct mucosal visualization as well as biopsies, thereby influencing medical therapy.

For patients with colon cancer without definitively treatable causing symptoms, colonoscopy offers a treatment alternative to surgery, which appears to allow patients to spend more time out of the hospital and return to normal activity sooner, which may be particularly important depending on the anticipated life expectancy of the patient.

In acute colonic ischemia, diagnosis can be challenging, especially early on, and endoscopic visualization of the colon may allow a diagnosis of both ischemia as well as severity of the disease so as to guide management in a timely fashion.

General Information

Associated Information

Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD (see Coverage Indications, Limitations and/or Medical Necessity). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Infectious colitis is an acceptable indication in its general form. The medical record should support the medical necessity and frequency of this treatment.

Physicians/providers must maintain adequate information in the patient's medical record in case it is needed by the contractor to document an incomplete colonoscopy.

Documentation supporting medical necessity should be legible, relevant, and sufficient to justify the services billed. This documentation must be made available to the A/B MAC upon request.

Utilization Guidelines

When a diagnostic colonoscopy, sigmoidoscopy or proctosigmoidoscopy is performed and the findings are normal, or did not provide a diagnosis, please report the symptom(s) for which the endoscopy was performed.

Sources of Information

Tekkis PP, Kinsman R, Thompson MR, Stamatakis JD, Association of Coloproctology of Great Britain. The Association of Coloproctology of Great Britain and Ireland study of large bowel obstruction caused by colorectal cancer. Annals of Surgery. 2004;240(1):76-81.

Bibliography
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  3. Wolff WI, Shinya H. Colonofiberoscopy. Jama. 1971;217(11):1509-1512.
  4. Wolff WI, Shinya H. Polypectomy via the fiberoptic colonoscope: Removal of neoplasms beyond reach of the sigmoidoscope. New England Journal of Medicine. 1973;288(7):329-332.
  5. Nivatvongs S, Forde KA. Diagnostic Evaluations Endoscopy: Rigid, Flexible Complications. In: Wolff B.G. et al. (eds) The ASCRS Textbook of Colon and Rectal Surgery. Springer, New York, NY; 2007:57-68.
  6. Piscatelli N, Hyman N, Osler T. Localizing colorectal cancer by colonoscopy. Archives of Surgery. 2005;140(10):932-935.
  7. Schoellhammer HF, Gregorian AC, Sarkisyan GG, Petrie BA. How important is rigid proctosigmoidoscopy in localizing rectal cancer. The American Journal of Surgery. 2008;196(6):904-908.
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  9. Hunt RH, Teague RH, Swarbrich ET, Williams CB. Colonoscopy in management of colonic strictures. Br Med J. 1975;3:360.
  10. Yee J, Akerkar GA, Hung RK, Steinauer-Gebauer AM, Wall SD, McQuaid KR. Colorectal neoplasia: Performance characteristics of CT colonography for detection in 300 patients. Radiology. 2001;219(3):685-692.
  11. Kim DH, Pickhardt PJ, Taylor AJ, Leung WK, Winter TC, Hinshaw JL, et al. CT colonography versus colonoscopy for the detection of advanced neoplasia. New England Journal of Medicine. 2007;357(14):1403-1412.
  12. Jensen DM, Machicado GA. Diagnosis and treatment of severe hematochezia: The role of urgent colonoscopy after purge. Gastroenterology. 1988;95(6):1569-1574.
  13. Green BT, Rockey DC, Portwood G, Tarnasky PR, Guarisco S, Branch MS, et al. Urgent colonoscopy for evaluation and management of acute lower gastrointestinal hemorrhage: A randomized controlled trial. The American Journal of Gastroenterology. 2005;100(11):2395-2402.
  14. Jensen DM, Machicado GA, Jutabha R, Kovacs TO. Urgent colonoscopy for the diagnosis and treatment of severe diverticular hemorrhage. New England Journal of Medicine. 2000;342(2):78-82.
  15. Rockey DC, Cello JP. Evaluation of the gastrointestinal tract in patients with iron-deficiency anemia. New England Journal of Medicine. 1993;329(23):1691-1695.
  16. Rockey DC, Koch J, Cello JP, Sanders LL, McQuaid K. Relative frequency of upper gastrointestinal and colonic lesions in patients with positive fecal occult-blood tests. New England Journal of Medicine. 1998;339(3):153-159.
  17. Hoppes WL, Lerner PI. Nonenterococcal group-d streptococcal endocarditis caused by streptococcus bovis. Annals of Internal Medicine. 1974;81(5):588-593.
  18. Klein RS, Catalano MT, Edberg SC, Casey JI, Steigbigel NH. Streptococcus bovis septicemia and carcinoma of the colon. Annals of Internal Medicine. 1979;91(4):560-562.
  19. Reynolds JG, Silva E, McCormack WM. Association of streptococcus bovis bacteremia with bowel disease. Journal of Clinical Microbiology. 1983;17(4):696-697.
  20. Gold JS, Bayar S, Salem RR. Association of streptococcus bovis bacteremia with colonic neoplasia and extracolonic malignancy. Archives of Surgery. 2004;139(7):760-765.
  21. Selivanov V, Sheldon GF, Cello JP, Crass RA. Management of foreign body ingestion. Annals of Surgery. 1984;199(2):187-191.
  22. Barone JE, Sohn N, Nealon TF. Perforations and foreign bodies of the rectum: Report of 28 cases. Annals of Surgery. 1976;184(5):601-604.
  23. Lake JP, Essani R, Petrone P, Kaiser AM, Asensio J, Beart RW. Management of retained colorectal foreign bodies: Predictors of operative intervention. Diseases of the Colon & Rectum. 2004;47(10):1694-1698.
  24. Anderson KL, Dean AJ. Foreign bodies in the gastrointestinal tract and anorectal emergencies. Emergency Medicine Clinics. 2011;29(2):369-400.
  25. Goldberg JE, Steele SR. Rectal foreign bodies. Surgical Clinics. 2010;90(1):173-184.
  26. Kann BR, Hicks TC. Anorectal foreign bodies: Evaluation and treatment. Elsevier. 2004;15(2):119-124.
  27. Kukora JS, Dent TL. Colonoscopic decompression of massive nonobstructive cecal dilation. Arch Surg. 1977;112(4):512-517.
  28. Nivatvongs S, Vermeulen FD, Fang DT. Colonoscopic decompression of acute pseudo-obstruction of the colon. Annals of Surgery. 1982;196(5):598-600.
  29. Ponec RJ, Saunders MD, Kimmey MB. Neostigmine for the treatment of acute colonic pseudo-obstruction. New England Journal of Medicine. 1999;341(3):137-141.
  30. Ballantyne GH, Brandner MD, Beart RW, Ilstrup DM. Volvulus of the colon. Annals of Surgery. 1985;202(1):83-92.
  31. Halabi WJ, Jafari MD, Kang CY, Nguyen VQ, Carmichael JC, Mills S, et al. Colonic volvulus in the United States: Trends, outcomes, and predictors of mortality. Annals of Surgery. 2014;259(2):293-301.
  32. Hendrick JW. Treatment of volvulus of the cecum and right colon: A report of six acute and thirteen recurrent cases. Archives of Surgery. 1964;88(3):364-373.
  33. Shepherd JJ. Treatment of volvulus of sigmoid colon: A review of 425 cases. British Medical Journal. 1968;1(5587):280-283.
  34. Ghazi A, Shinya H, Wolfe WI. Treatment of volvulus of the colon by colonoscopy. Annals of Surgery. 1976;183(3):263-265.
  35. Brothers TE, Strodel WE, Eckhauser FE. Endoscopy in colonic volvulus. Annals of Surgery. 1987;206(1):1-4.
  36. Fine KD, Seidel RH, Do K. The prevalence, anatomic distribution, and diagnosis of colonic causes of chronic diarrhea. Gastrointestinal Endoscopy. 2000;51(3):318-326.
  37. Da Silva JG, De Brito T, Cintra Damiao AO, Laudanna AA, Sipahi AM. Histologic study of colonic mucosa in patients with chronic diarrhea and normal colonoscopic findings. J Clin Gastroenterology. 2006;40(1):44-48.
  38. Shah RJ, Fenoglio-Preiser C, Bleau BL, Giannella RA. Usefulness of colonoscopy with biopsy in the evaluation of patients with chronic diarrhea. The American Journal of Gastroenterology. 2001;96(4):1091-1095.
  39. Farmer RG, Hawk WA, Turnbull RB. Clinical patterns in crohn's disease: A statistical study of 615 cases. Gastroenterology. 1975;68(4):627-635.
  40. Gupta M, Holub J, Knigge K, Eisen G. Constipation is not associated with an increased rate of findings on colonoscopy: Results from a national endoscopy consortium. Endoscopy. 2010;42(3):208-212.
  41. Morson B. The polyp-cancer sequence in the large bowel. Proc R Soc Med. 1974; 67(6 Pt 1):451-457.
  42. Muto T, Bussey HJR, Morson BC. The evolution of cancer of the colon and rectum. Cancer. 1975;36(6):2251-2270.
  43. Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, et al. Prevention of colorectal cancer by colonoscopic polypectomy. New England Journal of Medicine. 1993;329(27):1977-1981.
  44. Pera A, Bellando P, Caldera D, Ponti V, Astegiano M, Barletti C, et al. Colonoscopy in inflammatory bowel disease: Diagnostic accuracy and proposal of an endoscopic score. Gastroenterology. 1987;92(1):181-185.
  45. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. The American Journal of Gastroenterology. 2010;105(3):501-523.
  46. Lichtenstein GR, Loftus EV, Isaacs KL, Regueiro, MD, Gerson LB, Sands BE. ACG clinical guideline: Management of crohn’s disease in adults. The American Journal of Gastroenterology. 2018;113(4):481.
  47. Manes G, de Bellis M, Fuccio L, Repici A, Masci E, Ardizzone S, et al. Endoscopic palliation in patients with incurable malignant colorectal obstruction by means of self-expanding metal stent: Analysis of results and predictors of outcomes in a large multicenter series. Archives of Surgery. 2011;146(10):1157-1162.
  48. Karoui M, Charachon A, Delbaldo C, Loriau J, Laurent A, Sobhani I, et al. Stents for palliation of obstructive metastatic colon cancer: Impact on management and chemotherapy administration. Archives of Surgery. 2007;142(7):619-623.
  49. Tilney HS, Lovegrove RE, Purkayastha S, Sains PS, Weston-Petrides GK, Darzi AW, et al. Comparison of colonic stenting and open surgery for malignant large bowel obstruction. Surgical Endoscopy. 2007;21(2):225-233.
  50. Varadarajulu S, Roy A, Lopes T, Drelichman ER, Kim M. Endoscopic stenting versus surgical colostomy for the management of malignant colonic obstruction: Comparison of hospital costs and clinical outcomes. Surgical Endoscopy. 2011;25(7):2203-2209.
  51. Brunetaud JM, Maunoury V, Ducrotte P, Cochelard D, Cortot A, Paris J C. Palliative treatment of rectosigmoid carcinoma by laser endoscopic photoablation. Gastroenterology. 1987;92(3):663-668.
  52. Hoekstra HJ, Verschueren RC, Oldhoff J, Ploeg EVD. Palliative and curative electrocoagulation for rectal cancer. Cancer. 1985;55(1):210-213.
  53. Mathus-Vliegen ME, Tytgat NG. Laser photocoagulation in the palliation of colorectal malignancies. Cancer. 1986;57(11):2212-2216.
  54. Washington C, Carmichael JC. Management of ischemic colitis. Clinics in Colon and Rectal Surgery. 2012;25(4):228-235.
  55. Longstreth GF, Yao JF. Epidemiology, clinical features, high-risk factors, and outcome of acute large bowel ischemia. Clinical Gastroenterology and Hepatology. 2009;7(10):1075-1080.
  56. Brandt LJ, Boley SJ. AGA technical review on intestinal ischemia. Gastroenterology. 2000;118(5):954-968.
  57. Brandt LJ, Feuerstadt P, Longstreth GF, Boley SJ. ACG clinical guideline: Epidemiology, risk factors, patterns of presentation, diagnosis, and management of colon ischemia (CI). The American Journal of Gastroenterology. 2015;110(1):18-44.
  58. Zuckerman GR, Prakash C, Merriman RB, Sawhney MS, DeSchryver-Kecskemeti K, Clouse RE. The colon single-stripe sign and its relationship to ischemic colitis. The American Journal of Gastroenterology. 2003; 98(9):2018-2022.
  59. Shen B, Khan K, Ikenberry SO, Anderson MA, Banerjee S, Baron T, et al. The role of endoscopy in the management of patients with diarrhea. Gastrointestinal Endoscopy. 2010;71(6):887-892.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
04/29/2021 R21

Under CMS National Coverage Policy added CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, §30.1B Digestive System - Incomplete Colonoscopies and consolidated CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, §20.2 Outpatient Defined, §20.3 Encounter Defined, §20.4.1 Diagnostic Services Defined, §20.4.4 Coverage of Outpatient Diagnostic Services Furnished on or After January 1, 2010. Under Coverage Indications, Limitations and/or Medical Necessity revised the last sentence in the fourth paragraph to state “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.” Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were defined and inserted where appropriate throughout the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
10/10/2019 R20

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding articles. Formatting, punctuation and typographical errors were corrected throughout the LCD. 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
06/20/2019 R19

All coding located in the Coding Information section has been moved into the related Billing and Coding: Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy A56632 article and removed from the LCD. 

All verbiage regarding billing and coding under the Coverage Indications, Limitations and/or Medical Necessity section and the Associated Information section has been removed and is included in the related Billing and Coding: Colonoscopy/Sigmoidoscopy/Proctosigmoidoscopy A56632 article. Formatting, punctuation and typographical errors were corrected throughout the LCD. 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
03/14/2019 R18

Under CMS National Coverage Policy removed the first and second paragraph regarding quoted Internet Only Manual (IOM) text. Under Coverage Indications, Limitations and/or Medical Necessity removed quoted IOM text and changed verbiage to read “See the Centers for Medicare and Medicaid Services (CMS) Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 12, §30.1 Digestive System for information on Incomplete Colonoscopies.” Under Summary of Evidence changes were made to citations to reflect AMA citation guidelines. Under subsection Diarrhea the second sentence in the second paragraph verbiage was corrected to state “Another study of 167 patients with chronic diarrhea…”. Under Sources of Information added “The Association of Coloproctology of Great Britain and Ireland study of large bowel obstruction caused by colorectal cancer” source. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were defined and inserted where appropriate throughout the LCD. 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
01/28/2019 R17

No comments were received during the comment period, therefore no additional changes have been made.

  • Provider Education/Guidance
  • Other
10/01/2018 R16

Under ICD-10 Codes That Support Medical Necessity Group 1: Codes deleted ICD-10 code K35.89. This revision is due to the Annual ICD-10 Code Update and becomes effective October 1, 2018.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Revisions Due To ICD-10-CM Code Changes
04/19/2018 R15

Throughout the entire LCD, punctuation was corrected as necessary.  Under CMS National Coverage Policy deleted the second and third sentence in the first paragraph. Under Coverage Indications, Limitations and/or Medical Necessity – Indications corrected lettered bullets throughout the section.  Formatting was changed in the first paragraph and the word “(GI)” was added after the word “gastrointestinal” in number 2. The word “the” was added after the word “evaluate” in number 4.a., the word “in” was deleted after the word “Follow-up” in number 4.b., the word “after” was added before the word “at” and the word “a” was added before the word “large” in number 4.c. The word “a” was added before the word “patient” in number 9. The word “a” was added before the word “foreign” in number 11. The word “an” was added before the word “anorectal” in number 16. Under Coverage Indications, Limitations and/or Medical Necessity – Limitations replaced the words “gastrointestinal (GI)” with the word “GI” in number 7.  The word “a” was added before the word “neoplasm" in the last sentence.  Under Coverage Indications, Limitations and/or Medical Necessity – Other Comments deleted the word “whether” and added the word “either” before the word “medical” in the paragraph. Under Does the CPT 30% Coding Rule Apply? changed “No” to “Yes”. Under ICD-10 Codes that Support Medical Necessity corrected the ICD-10 code descriptions. Under Associated Information – Documentation Requirements deleted the word “the” from the fourth paragraph.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
02/26/2018 R14 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/29/2018 R13 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
10/01/2017 R12

Under ICD-10 Codes that Support Medical Necessity Group1: Codes deleted ICD-10 codes A04.7, K56.5, K56.60 and K56.69. Under ICD-10 Codes that Support Medical Necessity Group1: Codes added ICD-10 codes A04.71, A04.72, K56.50, K56.51, K56.52, K56.600, K56.601, K56.609,  K56.690, K56.691, K56.699, K91.30, K91.31and K91.32. This revision is due to the 2017 Annual ICD-10 Code Updates.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

  • Revisions Due To ICD-10-CM Code Changes
06/19/2017 R11 Under ICD-10 Codes that Support Medical Necessity – added ICD-10 code Z09 with effective date of 1/1/2017.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
06/19/2017 R10 No revisions were made as there were no comments received from the provider community.
  • Provider Education/Guidance
10/03/2016 R9 Under ICD-10 Codes That Support Medical Necessity Group 1: Paragraph added the following new ICD-10 codes and descriptions: K55.031, K55.032, K55.039, K55.041, K55.042, K55.049, K55.051, K55.052 and K55.059 to the second paragraph and deleted the fourth paragraph. Under ICD-10 Codes That Support Medical Necessity: Group 1 added ICD-10 codes K52.21, K52.22, K52.29, K52.3, K52.831, K52.832, K52.838, K52.839, K55.031, K55.032, K55.039, K55.041, K55.042, K55.049, K55.051, K55.052, K55.059, K55.061, K55.062, K55.069, K90.49, C49.A4, C49.A5, C49.A9, K55.30, K55.31, K55.32, K55.33, K58.1, K58.2, K58.8, K59.03, K59.04, K59.31, K59.39, K91.870, K91.871, K91.872, and K91.873. Under ICD-10 Codes That Support Medical Necessity: Group 1 deleted ICD-10 codes K52.2, K55.0, K59.3, and K90.4. Under ICD-10 Codes That Support Medical Necessity: Group 1 updated the code description for ICD-10 code C7A.096. This revision is due to the Annual ICD-10 Code Update that becomes effective October 1, 2016.
  • Provider Education/Guidance
  • Other
  • Revisions Due To ICD-10-CM Code Changes
10/03/2016 R8 Under Associated Contract Numbers added the contractor numbers for Part B as the Part A LCD was made an A/B MAC LCD.
  • Provider Education/Guidance
  • Other
06/30/2016 R7 Under CMS National Coverage Policy punctuation and capitalization was corrected. Revised the verbiage for 42 CFR Section §410.32 to read “indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).” Revised the verbiage for CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 6, §20.2, to read “Outpatient Defined”. Revised the verbiage for CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 6, §20.4.1 to read “Diagnostic Services Defined”. The verbiage “(Change Request 9317 Transmittal 3368 Dated October 9, 2015)” was removed from CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 12, §30.1 Digestive System. Under Sources of Information and Basis for Decision authors’ names, initials and supplement number were added.
  • Provider Education/Guidance
  • Typographical Error
01/01/2016 R6 Under CPT/HCPCS Codes G6019, G6020, G6022, G6023, G6024, and G6025 were deleted. CPT codes 44401, 44402, 45346, 45347, 45388, and 45389 were added to replace the deleted “G” codes. These revisions are due to the CPT/HCPCS Annual Update for 2016 and become effective 1/1/16. Under ICD-10 Codes That Support Medical Necessity-Paragraph corrected ICD-10 D17.71 to now read D17.79 in the second paragraph as this was a typographical error. Under ICD-10 Codes That Support Medical Necessity corrected ICD-10 D17.71 to now read D17.79 as this was a typographical error.
  • Provider Education/Guidance
  • Revisions Due To CPT/HCPCS Code Changes
  • Typographical Error
01/01/2016 R5 Under CMS National Coverage Policy added CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 12, §30.1 Digestive System (Change Request 9317 Transmittal 3368 Dated October 9, 2015)

Under Coverage Indications, Limitations and/or Medical Necessity Incomplete colonoscopies are defined as the inability to advance the colonoscope to the cecum or colon-small intestine anastomosis due to unforeseen circumstances.
  • Provider Education/Guidance
  • Public Education/Guidance
  • Other (Change Request 9317 Transmittal 3368)
10/01/2015 R4 Under CMS National Coverage Policy removed citations for CMS Internet-Only Manual 100-04, Chapter 4 and Chapter 18 as they are not related to the intent of this policy.
Under Coverage Indications, Limitations and/or Medical Necessity made a few punctuation corrections.
Under ICD-9 Codes that Support Medical Necessity Group I Paragraph: removed redundant sigmoidoscopy from 4th paragraph and made a few punctuation corrections.
Under Associated Information in the second paragraph removed the word “However”.
Under Sources of Information and Basis for Decision corrected all source citations to AMA formatting.
  • Provider Education/Guidance
  • Typographical Error
  • Other (Annual Validation)
10/01/2015 R3 Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.
  • Other (Bill type and/or revenue code removal)
10/01/2015 R2 Under Coverage Indication, Limitations and/or Medical Necessity-Abstract the definition of colonoscopy was revised as per the CPT manual.
Under CPT/HCPCS Codes the following codes were added: 45349, G6019, G6020, G6022, G6023, G6024 and G6025. The following codes were deleted: 44393, 44397, 45339, 45345, 45355, 45383 and 45387.
Revisions were made to the description for the following codes: 44388, 44390, 44391, 44392, 45330, 45332, 45333, 45334, 45337, 45340, 45378, 45379, 45380, 45381, 45382, 45384, 45385, 45386, 45391, and 45392.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R1 Under CMS National Coverage Policy deleted the following citations: Pub 100-04, Medicare Claims Processing Manual , Chapter 12, §§30.1.B and 20.4.6. The following manual citations were added: Pub 100-02, Medicare Benefit Policy Manual, Chapter 6, §§20.2, 20.3, 20.4.1, 20.4.4 and Pub 100-04, Medicare Claims Processing Manual, Chapter 4, §250.2. Throughout LCD, any reference to ICD-9 was changed to now read ICD-10. Under Revenue Codes added second paragraph related to revenue codes 096X, 097X and 098X. Under Associated Information – Documentation Requirements corrected the cited section in paragraph 1 to now read “Coverage Indications, Limitations and/or Medical Necessity”. Under Sources of Information and Basis for Decision sources were listed in alphabetical order. Added author names to number 2. The 2003 cited reference was deleted and updated with the 2011 reference to now read “Fisher DA, Maple JT, Ben-Menachem T, et al. Complications of colonoscopy. Gastrointest Endosc. 2011;74(4):745-752.” The following reference was deleted: The role of colonoscopy in the management of patients with inflammatory bowel disease. American Society for Gastrointestinal Endoscopy. Gastrointest Endosc. 1998;48:689-690.
  • Provider Education/Guidance
  • Other (Maintenance
    Annual Validation)

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Keywords

  • Colonoscopy
  • Sigmoidoscopy
  • Proctosigmoidoscopy

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