L28770-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Computed Tomographic Colonography (L28770)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28770

LCD Title Computed Tomographic Colonography

Contractor's Determination Number A74261

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 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-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 06/14/2011

Revision Ending Date

CMS National Coverage Policy

Title XVIII of the Social Security Act, Section 1862(a)(7). Excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A). Allows coverage and payment for only those services considered medically reasonable and necessary.

Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Code of Federal Regualtions (CFR), Title 42, part 410.37, subpart B. This section designates the tests approved for coverage of colorectal cancer screening.

Change Request (CR) 3586. January 2005 Update to the Hospital Outpatient Perspective Payment System (OPPS).

CMS Manual System, Pub. 100-08, Program Integrity Manual, Chapter 13, Section 5.1

Indications and Limitations of Coverage and/or Medical Necessity

Computed tomographic colonography (CT colonography) also known as virtual colonoscopy is a technique used for the detection of colorectal polyps. There are two approaches currently utilized for CT colonography. The first approach uses 2-D images with direct 3-D reconstruction for problem areas. The second approach utilizes 3-D endoscopic navigation of the colon with the 2-D images used for confirmation and problem solving.

Medicare will consider CT colonography medically reasonable and necessary:

• When an instrument colonoscopy of the entire colon is incomplete due to an obstructing lesion suspected of being an obstructing neoplasm;

• When the intent of the study is to identify a lesion suspected of being an obstructing neoplasm, even if the final diagnosis suggests that the lesion is due to scarring from previous surgery, extrinsic compression aberrant anatomy, or unsuspected diverticulitis.

• When the patient has an uncorrectable coagulopathy or is on anticoagulant therapy that cannot be safely discontinued and the primary physician and the colonographer agree that there is an increased risk. When performing CT colonography for this indication, one of the previous two indications must also be documented.

• When utilizing equipment which will provide optimal performance such as a CT scanner which includes a multi- detector scanner with a maximum collimation of 5mm, 2.5mm reconstruction interval and a scan time that should not produce a breath hold interval over 25 seconds.

• When performed only by providers of gastroenterology and radiology services or other providers who have specialized training and expertise in performing CT colonography.

The CMS Manual System, Pub. 100-08, Program Integrity Manual, Chapter 13, Section 5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf outlines that “reasonable and necessary" services are "ordered and/or furnished by qualified personnel."

A qualified physician for this service/procedure is defined as follows: A) Physician is properly enrolled in Medicare.

B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

CT colonography will not be covered for the following:

• When CT colonography is performed without a prior incomplete colonscopy due to the indications as outlined in this LCD;

• When used as an alternative to fiberoptic colonoscopy, for screening or in the absence of signs or symptoms of disease;

• When used as an alternative to fiberoptic colonoscopy, even though performed for signs or symptoms of disease; or

• When used for screening, in the absence of signs or symptoms of disease, regardless of family history or other risk factors for the development of colonic disease.

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.

013x Hospital Outpatient 085x Critical Access Hospital

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.

032X Radiology - Diagnostic - General Classification

CPT/HCPCS Codes

74261 COMPUTED TOMOGRAPHIC (CT) COLONOGRAPHY, DIAGNOSTIC, INCLUDING IMAGE POSTPROCESSING; WITHOUT CONTRAST MATERIAL

74262 COMPUTED TOMOGRAPHIC (CT) COLONOGRAPHY, DIAGNOSTIC, INCLUDING IMAGE POSTPROCESSING; WITH CONTRAST MATERIAL(S) INCLUDING NON-CONTRAST IMAGES, IF PERFORMED

ICD-9 Codes that Support Medical Necessity

153.1 MALIGNANT NEOPLASM OF HEPATIC FLEXURE

153.2 MALIGNANT NEOPLASM OF TRANSVERSE COLON

153.3 MALIGNANT NEOPLASM OF DESCENDING COLON

153.4 MALIGNANT NEOPLASM OF SIGMOID COLON

153.6 MALIGNANT NEOPLASM OF ASCENDING COLON

153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE

154.0 - 154.8 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

211.3 BENIGN NEOPLASM OF COLON

211.4 BENIGN NEOPLASM OF RECTUM AND ANAL CANAL

560.0 INTUSSUSCEPTION

560.2 VOLVULUS

560.81 - 560.89 INTESTINAL OR PERITONEAL ADHESIONS WITH OBSTRUCTION (POSTOPERATIVE) (POSTINFECTION) - OTHER SPECIFIED INTESTINAL OBSTRUCTION

560.9 UNSPECIFIED INTESTINAL OBSTRUCTION

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

The documentation of the study requires a formal written report, with clear identifying demographics, the name of the interpreting provider, reason for the test, and interpretive report and copies of all images obtained. The computerized data with image reconstruction should also be maintained.

The medical record must contain documentation, including a written or electronic request for the procedure which fully supports the medical necessity of the procedure performed. This documentation includes, but is not limited to relevant medical history, physical examination, diagnosis (if known), pertinent signs and symptoms and results of pertinent diagnostic tests and/or procedures. This entire documentation-not just the test report or the findings/diagnosis on the order, must be made available to Medicare upon request.

• Documentation must be made available to Medicare upon request.

• The order/prescription form of the referring physician must be retained in the medical record.

• The results of a fiberoptic colonoscopy performed prior to the CT colonography, which was incomplete due to obstruction must be retained in the medical record.

• Documentation should clearly indicate cause of obstruction.

• Documentation should support the technology used to perform the CT colonography.

• When performing CT colonoscopy in lieu of conventional colonoscopy due to an uncorrectable coagulopathy or anticoagulant therapy that cannot be safely discontinued, documentation must clearly support that one of the indications as outlined in bullets #1 or #2 in the “Indications and Limitations of Coverage and/or Medical

Necessity” section of this LCD.

Appendices

Utilization Guidelines

It is expected that the physician who performed the failed colonoscopy will order the CT colonography.

It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

It is expected that only trained qualified physicians, as defined in the Indications and Limitations section of this LCD, will perform CT colonography.

CT colonography is never covered for screening.

Sources of Information and Basis for Decision

ACR Practice Guideline for the Performance of Computed Tomography (CT) Colonography in Adults. (Oct. 2005) Retrieved from website August 2, 2006. http://www.acr.org

ACR Practice Guideline for performing and interpreting diagnostic computed tomography (CT) (2006). Retrieved from http://www.acr.org

ACR Practice Guideline for communication of diagnostic imaging findings (2010). Retrieved from http://www.acr.org

Barish, M.A and Rocha, T.C., Multislice CT colonography: current status and limitations. Radiologic Clinics of North America 43; 6.

Cappell, M.S., Koch, S., Lefkovitz, Z., et al. (2005). The emerging role of virtual colonoscopy. Medical Clinic of North America, 89:111-128.

Cotton, P.B., Durkalski, V.L., Pineau, B.C., et al. (2004) Computed tomographic colonography (virtual colonoscopy): a multicenter comparison with standard colonoscopy for detection of colorectal neoplasia. Journal of American Medical Association; 291:1713-1719.

Hara, A.K., Johnson, C.D., et al. (2001) CT Colonography: single – versus multi-detector row imaging. Radiology, 2001; 219: 461-465.

Laghi, A., Iannacone, R., et al. (2002). Detection of colorectal lesions with virtual computed tomographic colonography. American Journal of Surgery 183; 124-131.

Mark, D., Aronson, N., et al. (2004). Executive Summary. CT Colonoscopy (“Virtual colonoscopy”) for colon cancer screening. Technology Evaluation Center. Blue Cross Blue Shield Association.

Orellana, C. (2004) New study supports use of virtual colonoscopy. The Lancet Oncology. 5(1). Retrieved February 22, 2005 from MD Consult database (449871345-Z).

Pickhardt, P.J., Choi, J.R., Hwang, I., Butler, J.A., Puckett, M.L., Hildebrandt, H.A., et al.(2003) Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. New England Journal of Medicine, 349:2131-200

Pickhardt, P.J. (2004) Virtual colonoscopy. Journal of American Medical Association, 292: 431-431 Pickhardt, P.J., Lee, A.D., et al (2005) Linear polyp measurement at CT colonography: in vitro and in vivo

comparison of two-dimensional and three-dimensional displays. Radiology 2005; 236:872-878. Abstract.

Pickhardt, P.J. (2003) Three-dimensional endoluminal CT colonography (virtual colonography): comparison of three commercially available systems. AJR 2003; 181: 1599-1606.

Ransohoff, D.F. (2004) Virtual colonoscopy-what it can do vs what it will do. JAMA 291: 1772-1774.

Wellbery, C., (2005) Virtual colonoscopy vs. routine colonoscopy. Retrieved February 23, 2005, from findarticles data base (ai_n8702969)

Zepf, B. (2004) Is there a wider role for virtual colonoscopy? Retrieved February 23, 2005, from findarticles data base(ai_n6048582)

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from Radiology and Gastroenterology societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 05/01/2011

Revision History Number 3

Revision History Explanation Revision Number:3 Start Date of Comment Period:N/A

Start Date of Notice Period:07/01/2011 Revised Effective Date:06/14/2011

LCR A2011-059

June 2011 Connection

Explanation of Revision: Based on an outside request to clarify our current training statement outlined in this LCD, language under the “Limitations” section of the LCD has been deleted and replaced with a revised statement regarding the qualification and training. Revisions will be effective based on process date.

Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:05/01/2011 Revised Effective Date: 04/05/2011

LCR A2011-042

April 2011 Bulletin

Explanation of Revision: Under the “Documentation Requirements” section of the LCD, verbiage was updated to be in line with the guidelines used to develop the LCD. In addition, references were updated under the “Sources of Information and Basis for Decision” section of the LCD. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/01/2010

LCR A2010-004

December 2009 Bulletin

Explanation of Revision: Annual 2010 HCPCS Update. Deleted CPT code 0067T. Added CPT codes 74261 and 74262. Contractor’s Determination Number was changed to A74261. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Original Effective Date:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28770) replaces LCD L21613 as the policy in notice. This document (L28770) is effective on 02/16/2009.

11/15/2009 - CPT/HCPCS code 0067T was deleted from group 1

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0320 was changed 8/1/2010 - The description for Revenue code 0321 was changed 8/1/2010 - The description for Revenue code 0322 was changed 8/1/2010 - The description for Revenue code 0323 was changed 8/1/2010 - The description for Revenue code 0324 was changed 8/1/2010 - The description for Revenue code 0329 was changed

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

74261 descriptor was changed in Group 1 74262 descriptor was changed in Group 1

Reason for Change