Highmark Commercial Medical Policy - Pennsylvania


 
Printer Friendly Version
Medical Policy: L-177-004
Topic: MUTYH Associated Polyposis Testing
Section: Laboratory
Effective Date: November 13, 2017
Issue Date: November 13, 2017
Last Reviewed: June 2017

MUTYH-associated polyposis (MAP) is an inherited colorectal cancer syndrome caused by mutations in the MUTYH gene (also called MYH).

The identification of two MUTYH mutations is required to make a MAP diagnosis.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

MUTYH associated polyposis testing may be considered medically necessary when the following clinical criteria have been met.

MUTYH Known Familial Mutation Analysis

  • Genetic Counseling:
    • Pre and post-test genetic counseling by an appropriate provider; and
  • Previous Testing:
    • No previous genetic testing for known MUTYH family mutation(s); and
  • Diagnostic or Predisposition Testing:
    • Two (2) known MUTYH mutations in a sibling; or
    • Both parents with one (1) or two (2) known MUTYH mutations.
Procedure Codes
81403


MUTYH Targeted Mutation Analysis for Y179C and G396D Mutations

  • Genetic Counseling
    • Pre and post-test genetic counseling by an appropriate provider; and
  • Previous Testing:
    • No previous MUTYH testing; and
    • No mutation detected on APC gene testing, if performed; and
  • Individual is of Northern European descent; and
  • Diagnostic Testing for Symptomatic Individuals:
    • Clinical findings:
      • Greater than 10 cumulative adenomas; or
      • At least two (2) adenomas; and
        • At least five (5) serrated polyps proximal to the sigmoid colon (2 or more of greater than 10mm); or
        • Greater than 20 serrated polyps of any size, but distributed throughout the colon; and
    • Recessive pattern of inheritance (e.g. family history positive for only an affected sibling); or
  • Testing for Presymptomatic/Asymptomatic Individuals:
    • Reproductive partner of a person with MAP (to determine if children at risk).
Procedure Codes
81401


MUTYH Sequencing

  • Genetic Counseling
    • Pre and post-test genetic counseling by an appropriate provider; and
  • Previous Testing:
    • No previous MUTYH full sequencing; and
    • Two (2) mutations NOT identified through MUTYH targeted mutation analysis (Y179C and G396D) if performed; and
  • Diagnostic Testing for Symptomatic Individuals:
    • Clinical findings:
      • Greater than 10 cumulative adenomas; or
      • At least two adenomas; and
        • At least 5 serrated polyps proximal to the sigmoid colon (2 or more of greater than 10mm); or
        • Greater than 20 serrated polyps of any size, but distributed throughout the colon; and
    • Recessive pattern of inheritance (e.g. family history positive for only an affected sibling); or
  • Testing for Presymptomatic/Asymptomatic Individuals:
    • Reproductive partner of a person with MAP (to determine if children at risk).
Procedure Codes
81406


MUTYH Deletion/Duplication Analysis

  • Genetic Counseling
    • Pre and post-test genetic counseling by an appropriate provider; and
  • Previous Testing:
    • MUTYH full sequencing performed; and
    • No mutations or only one mutation detected in MUTYH through any previous testing (founder mutation panel or full gene sequencing); and
    • No mutation detected on APC gene testing, if performed; and
  • Diagnostic Testing for Symptomatic Individuals:
    • Clinical findings:
      • Greater than 10 cumulative adenomas; or
      • At least two (2) adenomas; and
        • At least 5 serrated polyps proximal to the sigmoid colon (2 or more of greater than 10mm); or
        • Greater than 20 serrated polyps of any size, but distributed throughout the colon; and
    • Recessive pattern of inheritance (e.g. family history positive for only an affected sibling); or
  • Testing for Presymptomatic/Asymptomatic Individuals:
    • Reproductive partner of a person with MAP (to determine if children at risk).
Procedure Codes
81479

Professional Statements and Societal Positions

Guidelines from the National Comprehensive Cancer Network (NCCN, 2016) on High-Risk Colorectal Assessment states the following:

  • MUTYH testing criteria:
    • "Personal history of greater than 10 adenomas
    • Individual meeting criteria 1 or 3 (NCCN, 2016) for Serrated Polyposis Syndrome (SPS) [formerly known as hyperplastic polyposis] with at least some adenomas
    • Known deleterious biallelic MUTYH mutations in the family"
  • SPS clinical diagnostic criteria:
    • “At least 5 serrated polyps (includes hyperplastic polyps, sessile serrated adenomas/polyps, and traditional serrated adenomas) proximal to the sigmoid colon with 2 or more of these being greater than 10mm
    • Any number of serrated polyps proximal to the sigmoid colon in an .individual who has a first-degree relative with serrated polyposis
    • Greater than 20 serrated polyps of any size, but distributed throughout the colon”
  • Footnotes:
    • "When colonic polyposis is present in a single person with a negative family history, consider testing for a de novo APC mutation; if negative, follow with testing of MUTYH (targeted testing for the two (2) common northern European founder mutations c.536A>G and c.1187G>A may be considered first followed by full sequencing if biallelic mutations are not found). When colonic polyposis is present only in siblings, consider recessive inheritance and test for MUTYH first. Order of testing for APC and MUTYH is at the discretion of the clinician."
    • “MUTYH genetic testing is not indicated based on a personal history of desmoid tumor, hepatoblastoma,or cribriform-morular variant of papillary thyroid cancer."
    • “Siblings of a patient with MAP are recommended to have site specific genetic testing for the familial biallelic mutations. Children of an affected parent with MAP are recommended to have site specific genetic testing for the familial mutation/s. If positive for one MUTYH mutation, full sequencing of MUTYH is recommended. Full sequencing of MUTYH also may be considered in an unaffected parent when the other parent has MAP. If the unaffected parent is found to not be heterozygous for a MUTYH mutation, genetic testing in children is not necessary. If he or she is found to have a MUTYH mutation, testing for the familial mutations in the children is recommended.”
    • “It is important to note that de novo mutations can occur in APC or MUTYH. Thus, when colonic polyposis is present in an individual with a negative family history, consideration should be given to genetic testing of APC, followed by testing of MUTYH if no APC mutation is found.”
  • All recommendations are category 2A.

Evidence-based guidelines from the American College of Gastroenterology (ACG, 2009) state: "Patients with classic FAP, in whom genetic testing is negative, should undergo genetic testing for bi-allelic MUTYH mutations. Patients with 10 - 100 adenomas can be considered for genetic testing for attenuated FAP and if negative, MUTYH associated polyposis"[Grade 2C: Weak recommendation, low-quality or very low-quality evidence].


Place of Service: Outpatient

MUTYH associated polyposis testing is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Links




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages
If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



back to top