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| Medical Policy: | L-190-004 |
| Topic: | MGMT Testing for Malignant Glioma Alkylating Agent Response |
| Section: | Laboratory |
| Effective Date: | November 13, 2017 |
| Issue Date: | November 13, 2017 |
| Last Reviewed: | June 2017 |
MGMT is the O6-methylguanine- DNA methyltransferase gene, which encodes an essential DNA repair enzyme. MGMT expression in tumors causes resistance to DNA-alkylating drugs. MGMT repairs the damage produced by these DNA cross linking agents. MGMT promoter methylation testing is performed on paraffin embedded tumor tissue. Quantitative methylation-sensitive PCR is used to determine MGMT gene promoter methylation levels. |
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. |
MGMT Testing for Malignant Glioma Alkylating Agent Response may be considered medically necessary when the following criteria are met:
- Diagnosis of glioblastoma (or gliosarcoma); and
- Adjuvant temozolomide chemotherapy is being considered.
| Professional Statements and Societal Positions |
The National Comprehensive Cancer Network (NCCN, 2016 stated that:
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| Place of Service: Outpatient |
MGMT testing for malignant glioma alkylating agent response 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.
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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.
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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
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- Qualified interpreters
- Information written in other languages
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.
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