Retired Local Coverage Determination (LCD)

MolDX: APC and MUTYH Gene Testing

L36884

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LCD Information

Document Information

LCD ID
L36884
LCD Title
MolDX: APC and MUTYH Gene Testing
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL36884
Original Effective Date
For services performed on or after 05/15/2017
Revision Effective Date
For services performed on or after 04/01/2021
Revision Ending Date
08/20/2022
Retirement Date
08/20/2022
Notice Period Start Date
03/30/2017
Notice Period End Date
05/14/2017
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

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Copyright © 2022, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

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 to be 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 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions

CMS Internet-Only Manual, Pub. 100-02, Chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, §80.1.1 Certification Changes

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This policy provides Medicare coverage for APC and MUTYH gene testing for individuals suspected to have Familial Adenomatous Polyposis (FAP), Attenuated FAP (AFAP) or MYH-associated polyposis (MAP) with a personal history of ≥20 adenomas over a lifetime.

Summary of Evidence

FAP and AFAP are autosomal dominant syndromes caused by a germline mutation in the adenomatous polyposis coli (APC) gene. The distinction between FAP and AFAP is largely based on the number of polyps present. Individuals with >100 are said to have FAP, while those with <100 are said to have AFAP. FAP affected individuals generally develop adenomas throughout the colon beginning in their teens, whereas individuals with AFAP frequently have a right-sided distribution to polyps. The average age of symptomatic FAP diagnosis ranges from 35-45 years of age.1 The clinical expression of AFAP is more variable with adenomas developing at a later age, and some patients with <10 cumulative adenomatous polyps.2 With nearly 100% penetrance of the APC gene, colorectal cancer (CRC) is inevitable in patients with FAP if colectomy is not performed. The cumulative risk of CRC cancer in AFAP is estimated to be nearly 70% at age 80,3 with up to 30% of cancers occurring over age 40.4 The average age of CRC diagnosis is >50 years for AFAP. FAP accounts for up to 1% of colorectal cancers.

Additional findings may be associated with classical FAP including congenital hypertrophy of retinal pigment epithelium (CHRPE); osteomas, supernumerary teeth, and odontomas; desmoids and epidermoid cysts; duodenal and other small bowel adenomas; gastric fundic gland polyps; and increased risk for medulloblastoma, papillary carcinoma of the thyroid and hepatoblastoma; and pancreatic, gastric and duodenal cancers. Although upper gastrointestinal (GI) findings, thyroid and duodenal cancer risks are similar to classical FAP, other extraintestinal manifestations, including CHRPE and desmoids are unusual in AFAP.

Mutations in the MUTYH gene cause MUTYH-Associated Polyposis syndrome (MAP). Affected individuals have large numbers of adenomatous polyp, similar to patient with AFAP, and a high risk for CRC. The average age of patients with MAP-associated CRC is >50 years, with nearly 25% of patients diagnosed after age 60.6 Individuals with MUTYH mutations also may develop extra-colonic findings including duodenal polyps and duodenal cancer.

Treatment and surveillance recommendations for FAP, AFAP and MAP are available in the current National Comprehensive Cancer Network (NCCN) Genetic/Familial High-Risk Assessment: Colorectal guidelines.5

Analysis of Evidence (Rationale for Determination)

Level of Evidence:

Quality – High

Strength – Good

Weight - Good

Based on the results of multiple studies and the surveillance and treatment recommendations of at least one national society guideline, APC and MUTYH gene testing is reasonable and necessary for individuals suspected to have Familial Adenomatous Polyposis (FAP), Attenuated FAP (AFAP) or MYH-associated polyposis (MAP) with a personal history of ≥20 adenomas over a lifetime.

 

General Information

Associated Information

N/A

Sources of Information
N/A
Bibliography

1. Jasperson KW, Burt RW. APC-Associated Polyposis Conditions. 1998 Dec 18 [Updated 2014 Mar 27]. In: Pagon RA, Adam MP, Ardinger HH, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2016. http://www.ncbi.nlm.nih.gov/books/NBK1345/

2. Burt RW, et al. Genetic testing and phenotype in a large kindred with attenuated familial adenomatous polyposis. Gastroenterology. 2004 Aug;127(2):444-51. PubMed PMID: 15300576.

3. Neklason DW, et al. American founder mutation for attenuated familial adenomatous polyposis. Clin Gastroenterol Hepatol. 2008 Jan;6(1):46-52. Epub 2007 Dec 11. PubMed PMID: 18063416.

4. Nielsen M, et al. Germline mutations in APC and MUTYH are responsible for the majority of families with attenuated familial adenomatous polyposis. Clin Genet. 2007 May;71(5):427-33. PubMed PMID: 17489848.

5. NCCN® Clinical Practice Guidelines in Oncology, Genetic/Familial High-Risk Assessment: Colorectal Accessed 02/10/2021.

6. Lubbe SJ, et al. Clinical implications of the colorectal cancer risk associated with MUTYH mutation. J Clin Oncol. 2009 Aug 20;27(24):3975-80. doi: 10.1200/JCO.2008.21.6853. Epub 2009 Jul 20. PubMed PMID: 19620482.

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
08/20/2022 R8

The information in this policy has been incorporated within the MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer LCD L38974.  

  • LCD Being Retired
04/01/2021 R7

Under CMS National Coverage Policy updated descriptions and moved regulation CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5, §60.1.2, §60.2 to the related billing and coding article. Added regulation CMS Internet-Only Manual, Pub. 100-02, Chapter 15, §80 and §80.1.1.

Under Bibliography source #5 deleted “Version 1.2016” as this is no longer accessible and updated hyperlink. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were 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
11/01/2019 R6

The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of 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.

  • Other (The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.
    )
11/01/2019 R5

11/01/2019: 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: MolDX: APC and MUTYH Gene Testing A57353 article.

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.

  • Provider Education/Guidance
11/01/2019 R4

Related Billing and Coding article to LCD

  • Revisions Due To Code Removal
11/01/2019 R3

As required by CR 10901, all billing and coding information has been moved to the companion article, this article is linked to the LCD.

  • Revisions Due To Code Removal
05/15/2017 R2

LCD is revised to add CPT 81401. Note that 81401 was inadvertently left out of the draft and final LCDs.

  • Creation of Uniform LCDs With Other MAC Jurisdiction
05/15/2017 R1

LCD is revised to add ICD-10 code D12.0, effective 5/12/17 and to add the following required fields: Summary of Evidence, Bibliography and Analysis of Evidence.

  • Creation of Uniform LCDs Within a MAC Jurisdiction
  • Revisions Due To ICD-10-CM Code Changes

Associated Documents

Attachments
N/A
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
08/20/2022 04/01/2021 - 08/20/2022 Retired You are here
03/22/2021 04/01/2021 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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