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Date Printed: August 22, 2017: 07:03 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-82000-27

Original Effective Date: 08/15/03

Reviewed: 10/28/16

Revised: 01/12/17

Next Review: No Longer Scheduled for Routine Review (NLR)

Subject: Analysis of Human DNA in Stool Samples as a Technique for Colorectal Cancer Screening

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

 

 

 

 

 

 

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines

 

 

 

 

 

 

Other References Updates

 

 

 

 

 

 

 

 

DESCRIPTION:

Several genetic alterations have been associated with colorectal cancer. In the proposed multistep model of carcinogenesis, the tumor suppressor gene p53 and the proto-oncogene K-ras are most frequently altered. Mutations in APC (adenomatous polyposis coli) genes and epigenetic markers (e.g., hypermethylation of specific genes) have also been detected. Colorectal cancer is also associated with DNA replication errors in microsatellite sequences (termed microsatellite instability) in patients with Lynch Syndrome and in subgroups of patients with sporadic colon carcinoma. Tumor-associated gene mutations and epigenetic markers can be detected in exfoliated intestinal cells in stool specimens. Since cancer cells are shed into stool, tests have been developed that may detect these genetic alterations in the DNA from shed colorectal cancer cells isolated from stool samples.

POSITION STATEMENT:

The use of an FDA approved fecal DNA test (e.g. Cologuard™) meets the definition of medical necessity once every three years as a screening technique for members 50 - 75 years of age in whom colorectal cancer preventive screening is indicated..

The use of an FDA approved fecal DNA test is considered experimental or investigational for all other indications including post colorectal cancer diagnosis surveillance.

The use of non-FDA approved fecal DNA test and all other methods for the analysis of DNA in stool samples are considered experimental or investigational.

The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

81327

SEPT9 (Septin9) (e.g., colorectal cancer) methylation analysis (Investigational)

81528

Oncology (colorectal) screening, quantitative real-time target and signal amplification of 10 DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Colorectal Cancer Screening Tests (210.3) located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Colorectal Cancer Screening (L36355) located at fcso.com.

DEFINITIONS:

None.

RELATED GUIDELINES:

01-99385-03, Preventive Services

OTHER:

Other names used to report DNA analysis of stool samples:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Cologuard™

ColoVantage (SEPT9)

Epi proColon (SEPT9)

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ), Technology Assessment- Cost-Effectiveness of DNA Stool Testing to Screen for Colorectal Cancer, 12/07.
  2. Ahlquist DA, Sargent DJ, Loprinzi CL, et al, Stool DNA and Occult Blood Testing for Screen Detection of Colorectal Neoplasia, Annals of Internal Medicine, 2008; 149: 441-450.
  3. American Cancer Society Recommendations for Colorectal Cancer Early Detection. Last Medical Review: 10/15/2014; Last Revised: 02/01/16. Accessed at cancer.org 03/29/16.
  4. Berger, BM, et al. Screening for Colorectal Cancer Using a Multitarget Stool DNA Test: Modeling the Effect of the Intertest Interval on Clinical Effectiveness; Clin Colorectal Cancer. 2015 Dec 18. Pii: S1533-0028(15)00154-1. Doi: 10.1016/j.clcc.2015.12.003.
  5. Berger B, et al, USPSTF Colorectal Cancer Screening Guidelines: An Extended Look at Multi-Year Interval Testing; Am J Manag Care. 2016;22(2):e77-e81.
  6. Blue Cross Blue Shield Association Medical Policy – Analysis of Human DNA in Stool Samples as a Technique for Colorectal Cancer Screening (2.04.29), 10/16.
  7. Blue Cross Blue Shield Association Special Report – “Fecal DNA Analysis for Colon Cancer Screening” 08/06.
  8. Blue Cross Blue Shield Association. Technology Evaluation Center. Special Report: Fecal DNA Analysis for Colorectal Cancer Screening. September 18, 2014.
  9. Centers for Medicare & Medicaid Services (CMS), National Coverage Analysis (NCA) for Screening for COLORECTAL CANCER – Stool DNA Testing (CAG-00440N), 10/09/14; accessed at cms.hhs.gov 02/11/15.
  10. Centers for Medicare & Medicaid Services (CMS), NCD for Colorectal Cancer Screening Tests (210.3), 10/09/14, accessed at cms.gov 03/29/16.
  11. Cole D, et al. Preferences for Colorectal Screening Tests Among a Previously Unscreened Population. Proceedings of the 80th Annual American College of Gastroenterology; 2015 October 16-21; Honolulu, HI. Am J Gastroenterol. 2015;110:S595-S628.
  12. Diehl F, Schmidt K, Durkee K, et al, Analysis of Mutations in DNA Isolated From Plasma and Stool of Colorectal Cancer Patients, Gastroenterology, 03/08.
  13. ECRI Institute, Emerging Technology Evidence Report, Fecal DNA Testing for Colorectal Cancer Screening, 2011.
  14. ECRI Institute Forecast Report, Colorectal Cancer, 07/12.
  15. First Coast Service Options, Inc. (FCSO), LCD: Colorectal Cancer Screening (L36355), 01/01/16, accessed at fcso.com 03/29/16.
  16. Gellad ZF, et al. Longitudinal adherence to fecal occult blood testing impacts colorectal cancer screening quality; Am J Gastroenterol. 2011 Jun;106(6):1125-34. Doi: 10.1038/ajg.2011.11. Epub 2011 Feb 8.
  17. Hayes, Inc., CMS Coverage Decision on Screening DNA Stool Test for Colorectal Cancer, 05/08.
  18. Hayes, Inc., FDA Warning Letter Regarding DNA Test for Colorectal Cancer, 10/07.
  19. Hayes Technology Assessment-Fecal DNA Testing for Colorectal Cancer Screening and Monitoring, 01/02, updated 10/07.
  20. Hayes, Inc., Medical Technology Directory: Fecal DNA Testing for colorectal Cancer Screening and Monitoring, 02/07/07.
  21. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. Apr 3 2014;370(14):1287-1297.
  22. Inadomi JM, et al. Adherence to Colorectal Cancer Screening, A Randomized Clinical Trial of Competing Strategies; Arch Intern Med. 2012;172(7):575-582.
  23. Itzkowitz S, Brand R, Jandorf L, et al, A Simplified, Noninvasive Stool DNA Test for Colorectal Cancer Detection, AM J Gastroenterology. 2008 Nov; 103(11):2862-70.
  24. Ladabaum U, et al. Colorectal testing utilization and payments in a large cohort of commercially insured US adults; Am J Gastroenterol. 2014 Oct;109(10):1513-25. Doi: 10.1038/ajg.2014.64. Epub 2014 Jul 1.
  25. Levin B, Lieberman D, McFarland B, et al, Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology, CA Cancer j Clin 2008, accessed at amcancersoc.org 02/20/12.
  26. Mayo Clinic, Hope for Patients at Risk for Colon Cancer- Simple Stool Test Could Help in Detection and Prevention, accessed at mayoclinic.com 02/21/12.
  27. Mass High Tech: The Journal of New England Technology, Exact Sciences Gets FDA Word on Colorectal Cancer Trial, 07/10/08.
  28. National Cancer Institute (NCI), Colorectal Cancer Screening-Health Professional Version (PDQ®), Updated: January 15, 2016; accessed at cancer.gov 03/29/16.
  29. National Cancer Institute (NCI), U.S. National Institutes of Health (NIH) – Genetics of Colorectal Cancer PDQ® – 05/06.
  30. National Comprehensive Cancer Network (NCCN), Clinical Practice Guidelines in Oncology- Colorectal Cancer Screening Version 1.2016.
  31. National Guideline Clearinghouse (NGC). Guideline Summary: Screening for Colorectal Cancer: A Guidance Statement form the American College of Physicians,2012. Accessed at guideline.gov 02/05/14.
  32. Parekh M, Fendrick AM, Ladabaum U, As Tests Evolve and Costs of Cancer Care Rise: Reappraising Stool=Based Screening for Colorectal Neoplasia, Aliment Pharmacol Ther. 2008 Apr; 27(8): 697-712.
  33. Redwood DG, et al. Stool DNA Testing for Screening Detection of Colorectal Neoplasia in Alaska Native People. Mayo Clin Proc. 2016;91(1):61-70.
  34. U.S. Food and Drug Administration, Medical Devices: Cologuard – P130017, 08/11/14; accessed at fda.gov 02/11/15.
  35. U. S. Preventive Services Task Force (USPSTF) – Recommendations and Rationale: Screening for Colorectal Cancer, 06/16.
  36. Worldwide Gastroenterology Organization (OMGE) Position Statement: “Colorectal Cancer Screening and Surveillance”, 2002 (06/04 revision).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the Florida Blue Medical Policy & Coverage Committee on 10/27/16.

GUIDELINE UPDATE INFORMATION:

08/15/03

New Medical Coverage Guideline.

07/15/04

Scheduled review. No change in policy statement.

01/01/05

HCPCS update. Added S3890.

08/15/05

Scheduled review. No change in policy statement. Updated references and related Internet links.

08/15/06

Annual review; continue investigational.

07/15/07

Scheduled review; investigational status maintained, guideline reformatted, references updated.

09/15/08

Annual review: position statement maintained, description section and references updated.

07/15/09

Annual review: position statement maintained, description section and references updated.

05/15/10

Annual review: position statement maintained, description section and references updated.

04/15/12

Annual review; position statement maintained and references updated.

04/15/13

Annual review; position statement maintained and references updated.

04/15/14

Annual review; investigational position statement maintained, Medicare program exception and references updated.

01/01/15

Annual HCPCS/CPT update. Added code G0464.

04/15/15

Annual review; position statement maintained; program exception and references updated.

01/01/16

Annual HCPCS/CPT update; code 81528 added, codes G0464 and S3890 deleted.

05/15/16

Annual review; position statement section, description, program exception, and references updated.

08/12/16

Revisions to Position Statement.

12/15/16

Revision; position statement section and references updated.

01/01/17

Annual CPT/HCPCS update. Added 81327.

01/11/17

Revision; position statement section updated.

Date Printed: August 22, 2017: 07:03 AM