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Local Coverage Determination (LCD)

Colonoscopy and Sigmoidoscopy-Diagnostic

L34614

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34614
Original ICD-9 LCD ID
Not Applicable
LCD Title
Colonoscopy and Sigmoidoscopy-Diagnostic
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 08/29/2024
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description

Limited coverage for colonoscopy and sigmoidoscopy procedures as described in the coverage indications of the policy.
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Social Security Act (Title XVIII)

  • Title XVIII of the Social Security Act, § 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.
  • Title XVIII of the SSA, §1833(e), prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
  • Title XVIII of the Social Security Act, § 1862(a)(7). This section excludes routine physical examinations.

CFR, Title 42, Ch. IV, § 410.32, Diagnostic X-Rays, diagnostic laboratory tests, and other diagnostic tests: Conditions. This section describes regulations that apply to performing these tests.

IOM Citations:

  • Pub 100-02, Medicare Benefit Policy Manual, Chapter 15 Covered Medical and Other Health Services:
  • Section 80-Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, Section 280.2 -Colorectal Cancer Screening
  • Pub.100-04 Medicare Claims Processing Manual -Chapter 18 Preventive and Screening Services: Section 60 - Colorectal Cancer Screening

CR 10901 Local Coverage Determinations (LCDs) Implementation date January 8, 2019.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This LCD only applies to diagnostic colonoscopies and sigmoidoscopies. Refer to the Medicare Internet Only Manuals (IOM) for coverage of colorectal cancer screening procedures.

Sigmoidoscopy and colonoscopy testing allows for the direct visualization of the lower gastrointestinal tract. Inspection is performed with an illuminated tube. These procedures are performed to detect polyps, tumors and other lesions of the intestines. The site of pathology can be identified during a colonoscopy and a biopsy can be obtained.

Definitions:

  1. Sigmoidoscopy is the examination of the entire rectum and sigmoid colon, and includes examination of a portion of the descending colon.
  2. Colonoscopy is the examination of the entire colon, from the rectum to the cecum, and may include the examination of the terminal ileum.


Indications and Limitations of Coverage and/or Medical Necessity

A. The following are Medicare-covered indications for diagnostic colonoscopy:

  1. Evaluation of an abnormality on barium enema or other imaging study, which is likely to be clinically significant, such as filling a defect or stricture.
  2. Evaluation of unexplained gastrointestinal bleeding:
    1. Hematochezia not thought to be from rectum or perianal source,
    2. Melena of unknown origin; after an upper GI source has been excluded,
    3. Presence of fecal occult blood,
    4. Positive stool DNA test results. (e.g. guaiac/Fecal immunochemical test {FIT
      Test}/Cologuard).
  3. Unexplained iron deficiency anemia.
  4. Examination to evaluate entire colon for synchronous cancer or polyps in a patient with treatable cancer or polyp.
  5. Chronic inflammatory bowel disease of the colon if more precise diagnosis or determination of the extent of activity of disease will influence immediate management.
  6. Clinically significant diarrhea of unexplained origin with additional symptoms (e.g., with weight loss).
  7. 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. Treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasm, and polypectomy site (e.g., electrocoagulation, heater probe, laser or injection therapy).
  9. Removal of foreign body.
  10. Excision of colonic polyps.
  11. Decompression of acute nontoxic megacolon or sigmoid volvulus, pseudo obstruction of the colon (Ogilvie’s syndrome).
  12. Balloon dilatation of stenotic lesions (e.g., anastomotic strictures).
  13. Palliative treatment of stenosing or bleeding neoplasm.
  14. Marking a neoplasm for localization.
  15. Evaluation of a patient with endocarditis due to streptococcus bovis or any bacterium of enteric origin.
  16. Suspected disease of terminal ileum.
  17. Evaluation of acute colonic ischemia/ischemic bowel disease.
  18. In patients with Crohn’s colitis and chronic ulcerative colitis: colonoscopy every 1 or 2 years with multiple biopsies for detection of cancer and dysplasia in patients with:
    1. Pancolitis of 8 or more years duration; or
    2. Left-sided colitis of 15 or more years duration.
  19. 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, repeat colonoscopy yearly.
  20. Patients undergoing curative resection for colon or rectal cancer should undergo a colonoscopy 1 year after the resection (or 1 year following the performance of the colonoscopy that was performed to clear the colon of synchronous disease).

B. A diagnostic colonoscopy is not considered medically necessary for the following conditions:

  1. Chronic, stable, irritable bowel syndrome 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.
  2. Acute limited diarrhea.
  3. Hemorrhoids.
  4. Metastatic adenocarcinoma of unknown primary site in the absence of colonic symptoms when it will not influence management.
  5. Routine follow-up of inflammatory bowel disease (except for cancer surveillance in Crohn's colitis, chronic ulcerative colitis).
  6. Routine examination of the colon in patients about to undergo elective abdominal surgery for non-colonic disease.
  7. Upper GI bleeding or melena with a demonstrated upper GI source.

C. A diagnostic flexible sigmoidoscopy is covered for the following indications:

  1. Evaluation of suspected distal colonic disease when there is no indication for a colonoscopy.
  2. Evaluation for anastomotic recurrence in rectosigmoid carcinoma.
  3. All of the covered indications listed for a diagnostic colonoscopy.

D. A diagnostic flexible sigmoidoscopy is not indicated when a colonoscopy is indicated.
Summary of Evidence

NA
Analysis of Evidence (Rationale for Determination)

NA

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.
N/A

Revenue Codes

Code Description

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N/A

CPT/HCPCS Codes

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Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements
The medical record should support the medical reasonableness, necessity and frequency of the diagnostic test performed. This documentation should be made available to the Contractor upon request.

Documentation must indicate the precise areas scoped and the depth reached during colonoscopy.

Utilization Guidelines
It is expected that these services would be performed as indicated by current medical literature and/or standards of practice
Sources of Information

Exact Sciences: Cologuard Colon Cancer Resources
https://www.cologuard.com/resources

National Cancer Institute (NIH) Test to Detect Colorectal Cancer and Polyps 2018
https://www.cancer.gov/types/colorectal/screening-fact-sheet

Other Contractors Medicare Policies
Bibliography

Abdulamir AS, Hafidh RR, Abu Bakar F. The association of Streptococcus bovis/gallolyticus with colorectal tumors: the nature and the underlying mechanisms of its etiological role. J Exp Clin Cancer Res. 2011;30(1):11. Published 2011 Jan 20. doi:10.1186/1756-9966-30-11

Farraye FA, Odze RD, Eaden J, et al. AGA medical position statement on the diagnosis and management of colorectal neoplasia in inflammatory bowel disease. Gastroenterology. 2010;138(2):738-745. doi:10.1053/j.gastro.2009.12.037

ASGE Standards of Practice Committee, Early DS, Ben-Menachem T, et al. Appropriate use of GI endoscopy. Gastrointest Endosc. 2012;75(6):1127-1131. doi:10.1016/j.gie.2012.01.011

ASGE Standards of Practice Committee, Pasha SF, Shergill A, et al. The role of endoscopy in the patient with lower GI bleeding. Gastrointest Endosc. 2014;79(6):875-885. doi:10.1016/j.gie.2013.10.039

Laubert T, Bader FG, Oevermann E, Jungbluth T, Unger L, Roblick UJ, Bruch HP, Mirow L. Intensified surveillance after surgery for colorectal cancer significantly improves survival. Eur J Med Res. 2010 Jan 29;15(1):25-30. doi: 10.1186/2047-783x-15-1-25. PMID: 20159668; PMCID: PMC3351844.

Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012;143(3):844-857. doi:10.1053/j.gastro.2012.06.001

Lichtenstein GR, Hanauer SB, Sandborn WJ; Practice Parameters Committee of American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009;104(2):465-484. doi:10.1038/ajg.2008.168

Rex DK, Kahi CJ, Levin B, et al. Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2006;130(6):1865-1871. doi:10.1053/j.gastro.2006.03.013

American Society for Gastrointestinal Endoscopy Standards of Practice Committee, Shergill AK, Lightdale JR, et al. The role of endoscopy in inflammatory bowel disease. Gastrointest Endosc. 2015;81(5):1101-21.e213. doi:10.1016/j.gie.2014.10.030

Stollman NH, Raskin JB. Diagnosis and management of diverticular disease of the colon in adults. Ad Hoc Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1999;94(11):3110-3121. doi:10.1111/j.1572-0241.1999.01501.x

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
08/29/2024 R18

Posted 08/29/2024 Minor typographical errors corrected to AMA formatting throughout. Moved references from Sources of Information to Bibliography and corrected to AMA formatting. Review completed 07/29/2024.
  • Other (Review)
03/28/2024 R17

Posted 03/28/2024 Corrected broken hyperlink for Exact Sciences Cologuard resources.
  • Other (Review)
10/01/2022 R16

Posted 09/29/2022-Reformatted CMS National Coverage Policy bullet points without change in coverage. Review completed 08/16/2022.
  • Other (Review)
10/01/2020 R15

10/01/2020 Reformatted CMS National Coverage Policy to bullet points without change in coverage. Review completed 09/02/2020.
  • Other (Review)
11/01/2019 R14

Content has been moved to the new template.
  • Revisions Due To Code Removal
03/28/2019 R13

03/28/2019: Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT & ICD-10 codes have been removed from this LCD and placed into the associated billing & coding article linked to this LCD. There will not be a lapse in coverage.
  • Provider Education/Guidance
11/01/2018 R12

11/01/2018: Annual review completed 10/10/2018. Updated NIH link. No change in coverage.
  • Other (Annual Review )
12/01/2017 R11

 

12/01/2017: Annual review completed 11/03/2017. Grammatical corrections completed. No change in coverage.

 
  • Other (Annual Review)
10/01/2017 R10

10/01/2017: ICD-10 CM Code Updates: Group 1 Deleted: A04.7, K56.5, K56.60, K56.69.  Group 1 Added: A04.71, A04.72, K56.50, K56.51, K56.52, K56.600, K56.601, K56.609, K56.690, K56.691, K56.699, K91.30, K91.31, K91.32. 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
05/01/2017 R9 05/01/2017: Added to A. 2. d. Positive stool DNA test results.(e.g. guaiac/Fecal immunochemical test{FIT Test}/Cologuard); Updated Sources of Information.
  • Provider Education/Guidance
01/01/2017 R8 01/01/2017: Annual review completed 12/02/2016
  • Other (Annual review)
10/01/2016 R7 10/01/2016-ICD 10-CM Code update: deleted K52.2, K55.0, K59.3; added C49.A3, C49.A4, C49.A5, K52.21, K52.22, K52.29, K52.3, K52.831, K52.832, K52.838, K52.9, K55.011,
K55.012, K55.019, K55.021, K55.022, K55.029, K55.031, K55.032, K55.039, K55.041, K55.042, K55.049, K55.051, K55.052, K55.061, K55.062, K55.30, K55.31, K55.32, K55.33, K58.1, K58.2, K58.8, K59.03, K59.04, K59.31, K59.39 and description change: D3A.096. Effective 10/01/2016
  • Revisions Due To ICD-10-CM Code Changes
02/15/2016 R6 01/01/2016 – code update, removed deleted codes G6019, G6020, G6022-G6025 & added 44401-44408 effective 01/01/2016. Removed inappropriate dx codes D00.00-D00.08 - effective 02/15/2016, 45 day notice given. Annual Review-12/03/2015, removed CAC info.
  • Revisions Due To CPT/HCPCS Code Changes
  • Other (CPT/HCPCs code changes & Annual Review )
10/01/2015 R5 10/06/2015 - Due to CMS guidance, we have removed the Jurisdiction 8 Notice and corresponding table from the CMS National Coverage Policy section. No other changes to policy or coverage.
  • Other
10/01/2015 R4 05/29/2015 – Annual updates to the Bill Type Codes and Revenue Codes have been reviewed by the Policy Department and are being Approved for public display. No other changes to policy or coverage.
  • Other (Annual Bill Type Code and Revenue Code updates.)
10/01/2015 R3 04/01/2015- Removed codes 45346, 45347, 45349 from LCD; these codes have an “I “indicator, invalid for Medicare, on the MPFSDB.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R2 01/01/2015-Added new codes 45346, 45347, 45349, G6019, G6020, G6022-G6025; removed deleted codes 44393, 44397, 45339, 45345, 45355, 45383, 45387, Description change 44388-44392, 45330, 45332, 45333, 45334, 45337, 45340, 45378, 45379, 45380-45382, 45384-45386, 45391, 45392 & removed CPT codes from the indications section of the policy & annual review 12/03/2014-updated sources of information.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2015 R1 11/01/2014- Removed underlining from Journals listed in the source of information section; changed Carrier to Contractor. No change in coverage.
  • Other
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Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
08/21/2024 08/29/2024 - N/A Currently in Effect You are here
03/20/2024 03/28/2024 - 08/28/2024 Superseded View
09/20/2022 10/01/2022 - 03/27/2024 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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