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1 PROPOSED/DRAFT Local Coverage Determination (LCD): Virtual Colonoscopy (CT Colonography) (DL33452) Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. Please note: This is a Proposed/Draft policy. Proposed/Draft LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed/Draft LCDs are not necessarily a reflection of the current policies or practices of the contractor. Contractor Information Contractor Name Contract Type Contract Number Jurisdiction State(s) Palmetto GBA A and B and HHH MAC MAC B J - M South Carolina Palmetto GBA A and B and HHH MAC MAC B J - M Virginia Palmetto GBA A and B and HHH MAC MAC B J - M West Virginia Palmetto GBA A and B and HHH MAC MAC B J - M North Carolina Back to Top Proposed/Draft LCD Information Document Information Source LCD ID L33452 Proposed LCD ID DL33452 Proposed LCD Title Virtual Colonoscopy (CT Colonography) AMA CPT / ADA CDT / AHA NUBC Copyright Statement CPT only copyright American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright American Dental Association. All rights reserved. CDT and CDT-2016 are trademarks of the American Dental Association. Printed on 1/18/2017. Page 1 of 7

2 UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ( AHA ), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. CMS National Coverage Policy Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, 1861(pp) provides coverage for colorectal cancer screening tests. Title XVIII of the Social Security Act, 1833(e) prohibits Medicare payment for any claim lacking the necessary documentation to process the claim. 42 CFR (a) Ordering Diagnostic Tests 42 CFR (k)(1) Particular services excluded from coverage due to not being reasonable and necessary CMS Internet-Only Manual, Pub , Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 210.3, Colorectal Cancer Screening Tests. CMS Internet-Only Manual, Pub , Medicare Claims Processing Manual, Chapter 13, 30, Computerized Axial Tomography (CT) Procedures CMS Internet-Only Manuals, Pub , Medicare Program Integrity Manual, Chapter 3, , states each claim submitted "shall include the appropriate diagnosis code (or codes)"... Coverage Guidance Coverage Indications, Limitations, and/or Medical Necessity Indications Computed Tomography (CT) colonography, also known as virtual colonoscopy, utilizes helical computed tomography of the abdomen and pelvis along with 2D or 3D reconstruction to visualize the colon lumen. The test requires colonic preparation similar to that required for instrument (fiberoptic, video) colonoscopy, as well as air insufflation to achieve colonic distention. Virtual colonoscopy is only indicated in those patients in whom a diagnostic or surveillance instrument colonoscopy of the entire colon is incomplete due to an inability to fully pass the colonoscope proximally, and a repeat attempt is not indicated. Incomplete colonoscopy must be due to one of the following: 1. An obstructing neoplasm. 2. Intrinsic scarring, stricture, aberrant anatomy, or obstruction from prior surgery, radiation, or diverticular disease. 3. Extrinsic compression. There are few absolute contraindications to instrument colonoscopy. Relative contraindications do not create medical necessity for using CT colonography as a screening procedure, and the above indications must still be met. The following relative contraindications to instrument colonoscopy may be indications for CT colonography if well documented in the medical record and the patient's primary physician and the colonoscopist agree on the increased risk to the patient: Severe coagulopathy Printed on 1/18/2017. Page 2 of 7

3 Long-term anticoagulation Increased sedation risk (such as from severe COPD or previous anesthesia adverse reaction). Limitations CPT Computed tomographic (CT) colonography (ie, virtual colonoscopy) screening is never covered. CT colonography is not covered when used for screening, or in the absence of signs or symptoms of disease, regardless of family history or other risk factors for the development of colonic disease. CT colonography is not covered when used as an alternative to instrument colonoscopy for screening or in the absence of signs or symptoms of disease. CT colonography is not covered following incomplete colonoscopy if the reason for the colonoscopy is other than one of those described above. CT colonography is intended for use in pre-operative planning when imaging of the non-visualized colon proximal to the obstruction is necessary in making decisions involving the approach to the patient. Back to Top Proposed/Draft Process Information Synopsis of Changes Changes Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted ICD-10 code Z09. Associated Information Documentation Requirements Fields Changed ICD-10 Codes that Support Medical Necessity Documentation must be legible, relevant and sufficient to justify the services performed for each date of service billed. This documentation must be made available to the A/B MAC upon request. 1. The results of an incomplete instrument colonoscopy that resulted in the order for the CT colonography (virtual colonoscopy) must be retained in the patient's medical record. Similarly, documentation of the presence and severity of a relative contraindication as justification for a CT colonographic examination must be retained in the medical record. 2. The order/prescription from the referring physician must be retained in the patient's medical record. Utilization Guidelines Services performed for excessive frequency are not medically necessary. Frequency is considered excessive when services are performed more frequently than generally accepted by peers and the reason for additional services is not justified by documentation. Sources of Information and Basis for Decision 1. Blue Cross Blue Shield Association Technology Evaluation Center. Radiology( Virtual Colonoscopy/CT Colonography ) Assessment Program Issue 5:2012, Updated 5/10/ Cotton PB, Durkalski VL, Pineau BC, et al. Computed Tomographic Colonography (Virtual Colonoscopy): A Multicenter Comparison with Standard Colonoscopy for Detection of Colorectal Neoplasia. JAMA. 2004; 291(14): Fenlon HM, McAneny DB, Nunes DP, Clarke PD, Ferrucci JT. Occlusive Colon Carcinoma: Virtual Colonoscopy in the Preoperative Evaluation of the Proximal Colon. Radiology. 1999;210(2): Gluecker TM, Johnson CD, Harmsen WS, et al. Colorectal Cancer Screening with CT Colonography, Printed on 1/18/2017. Page 3 of 7

4 Colonoscopy, and Double-Contrast Barium Enema Examination: Prospective Assessment of Patient Perceptions and Preferences. Radiology. 2003; 227(2): Isenberg GA, Ginsberg GG, Barkun AN, et al. Virtual colonoscopy. Gastrointest Endosc. 2003;57(4): Laghi A, Iannaccone R, Carbone I, et al. Computed Tomographic Colonography (Virtual Colonoscopy): Blinded Prospective Comparison with Conventional Colonoscopy for the Detection of Colorectal Neoplasia. Endoscopy. 2002;34(6): Laghi A, Iannaccone R, Carbone I, et al. Detection of Colorectal Lesions with Virtual Computed Tomographic Colonography. Am J Surgery. 2002;183(2): Macari M, Bini EJ, Xue X, et al. Colorectal Neoplasms: Prospective Comparison of Thin-Section Low-Dose Multi- Detector Row CT Colonography and Conventional Colonoscopy for Detection. Radiology. 2002; 224(2): Morrin MM, Kruskal JB, Farrell RJ, Goldberg SN, McGee JB, Raptopoulos V. Endoluminal CT Colonography After an Incomplete Endoscopic Colonoscopy. AJR Am J Roentgenol. 1999;172(4): Mulhall BP, Veerappan GR, Jackson JL. Meta-Analysis: Computed Tomographic Colonography. Ann Intern Med. 2005;142(8): Neri E, Giusti P, Battolla L, et al. Colorectal Cancer: Role of CT Colonography in Preoperative Evaluation after Incomplete Colonoscopy. Radiology. 2002;223(3): Pickhardt PJ, Choi JR, Hwang I, et al. Computed Tomographic Virtual Colonoscopy to Screen for Colorectal Neoplasia in Asymptomatic Adults. N Engl J Med. 2003;349(23): Pickhardt PJ. Three-Dimensional Endoluminal CT Colonography (Virtual Colonoscopy): Comparison of Three Commercially Available Systems. AJR Am J Roentgenol. 2003;181(6): Ransohoff DF. Virtual Colonoscopy - What It Can Do vs What It Will Do. JAMA. 2004;291(14): Sun CH, Li ZP, Meng QF, Yu SP, Xu DS. Assessment of Spiral CT Pneumocolon in Preoperative Colorectal Carcinoma. World J Gastroenterol. 2005; 11(25): Open Meetings/Part B MAC Contractor Advisory Committee (CAC) Meetings Meeting Date Meeting Type Meeting State(s) Meeting Information 02/06/2017 Open Meeting South Carolina Columbia 02/06/2017 Carrier Advisory Committee (CAC) Meeting South Carolina Columbia Comment Period Start Date 02/06/2017 Comment Period End Date 03/23/2017 Released to Final LCD Date N/A Reason for Proposed LCD Other (Deleted ICD-10 Code) Provider Education/Guidance Proposed Contact Part B Policy PO Box AG-275 Columbia, SC B.Policy@PalmettoGBA.com Back to Top Printed on 1/18/2017. Page 4 of 7

5 Coding Information Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. N/A Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes Not Applicable CPT/HCPCS Codes Group 1 Paragraph: CPT code Group 1 Codes: Ct colonography dx Ct colonography dx w/dye ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: Use of these codes does not guarantee reimbursement. The patient's medical record must document that the coverage criteria in this policy have been met. Group 1 Codes: ICD-10 Codes Description C18.2 Malignant neoplasm of ascending colon C18.3 Malignant neoplasm of hepatic flexure C18.4 Malignant neoplasm of transverse colon C18.6 Malignant neoplasm of descending colon C18.7 Malignant neoplasm of sigmoid colon C18.8 Malignant neoplasm of overlapping sites of colon C19 Malignant neoplasm of rectosigmoid junction C20 Malignant neoplasm of rectum C21.0 Malignant neoplasm of anus, unspecified C21.1 Malignant neoplasm of anal canal C21.2 Malignant neoplasm of cloacogenic zone C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal C49.A0 Gastrointestinal stromal tumor, unspecified site C49.A1 Gastrointestinal stromal tumor of esophagus C49.A2 Gastrointestinal stromal tumor of stomach C49.A3 Gastrointestinal stromal tumor of small intestine C49.A4 Gastrointestinal stromal tumor of large intestine C49.A5 Gastrointestinal stromal tumor of rectum C49.A9 Gastrointestinal stromal tumor of other sites C7B.04 Secondary carcinoid tumors of peritoneum Printed on 1/18/2017. Page 5 of 7

6 ICD-10 Codes Description D12.0 Benign neoplasm of cecum D12.1 Benign neoplasm of appendix D12.2 Benign neoplasm of ascending colon D12.3 Benign neoplasm of transverse colon D12.4 Benign neoplasm of descending colon D12.5 Benign neoplasm of sigmoid colon D12.6 Benign neoplasm of colon, unspecified D12.7 Benign neoplasm of rectosigmoid junction D12.8 Benign neoplasm of rectum D12.9 Benign neoplasm of anus and anal canal K Crohn's disease of small intestine with intestinal obstruction K Crohn's disease of large intestine with intestinal obstruction K Crohn's disease of both small and large intestine with intestinal obstruction K Crohn's disease, unspecified, with intestinal obstruction K Ulcerative (chronic) pancolitis with intestinal obstruction K Ulcerative (chronic) proctitis with intestinal obstruction K Ulcerative (chronic) rectosigmoiditis with intestinal obstruction K Inflammatory polyps of colon with intestinal obstruction K Left sided colitis with intestinal obstruction K Other ulcerative colitis with intestinal obstruction K Ulcerative colitis, unspecified with intestinal obstruction K Diffuse acute (reversible) ischemia of large intestine K Acute (reversible) ischemia of large intestine, extent unspecified K Focal (segmental) acute infarction of large intestine K Diffuse acute infarction of large intestine K Acute infarction of large intestine, extent unspecified K Focal (segmental) acute (reversible) ischemia of intestine, part unspecified K Diffuse acute (reversible) ischemia of intestine, part unspecified K Acute (reversible) ischemia of intestine, part and extent unspecified K Focal (segmental) acute infarction of intestine, part unspecified K Diffuse acute infarction of intestine, part unspecified K Acute infarction of intestine, part and extent unspecified K55.1 Chronic vascular disorders of intestine K56.2 Volvulus K56.5 Intestinal adhesions [bands] with obstruction (postprocedural) (postinfection) K56.60 Unspecified intestinal obstruction K56.69 Other intestinal obstruction K57.30 Diverticulosis of large intestine without perforation or abscess without bleeding K57.33 Diverticulitis of large intestine without perforation or abscess with bleeding K57.50 Diverticulosis of both small and large intestine without perforation or abscess without bleeding K57.53 Diverticulitis of both small and large intestine without perforation or abscess with bleeding K57.90 Diverticulosis of intestine, part unspecified, without perforation or abscess without bleeding K57.93 Diverticulitis of intestine, part unspecified, without perforation or abscess with bleeding K59.31 Toxic megacolon K59.39 Other megacolon K63.5 Polyp of colon Z08 Encounter for follow-up examination after completed treatment for malignant neoplasm ICD-10 Codes that DO NOT Support Medical Necessity Group 1 Paragraph: All other ICD-10 codes not listed under "ICD-10 Codes that Support Medical Necessity" will be denied as not medically necessary. Group 1 Codes: N/A Printed on 1/18/2017. Page 6 of 7

7 ICD-10 Additional Information Back to Top Associated Documents Attachments N/A Related Local Coverage Documents N/A Related National Coverage Documents N/A Back to Top Keywords Colonoscopy Virtual Colonoscopy Back to Top Read the LCD Disclaimer Printed on 1/18/2017. Page 7 of 7