Highmark Commercial Medical Policy - Pennsylvania

Medical Policy: L-228-001
Topic: Acute Myeloid Leukemia Genetic Testing
Section: Laboratory
Effective Date: July 1, 2018
Issue Date: July 2, 2018
Last Reviewed: March 2018

Acute myeloid leukemia (AML) is a neoplasm resulting from the clonal expansion of myeloid blasts in the peripheral blood (PB), bone marrow (BM), or other tissues. It is a heterogeneous disease clinically, morphologically and genetically.

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.

Single gene testing for AML may be considered medically necessary when the individual has AML and will benefit from information provided by the requested molecular marker test based on at least ONE of the following:

Procedure Codes
81120, 81121, 81245, 81246, 81272, 81400, 81401, 81402, 81403, 81404, 81406, 81407, 81408, 81450, 81455, 81479, 88271, 0046U, 0049U

Gene panels for AML that are specific to hematological cancers, and include the following genes, NPM1, FLT3, CEBPA, IDH1, IDH2, DNMT3A, KIT and TP53, may be considered medically necessary when ALL of the following are met:

Gene panels of over 50 genes are not covered for individuals with AML.

Procedure Codes
81450, 81455, 0050U

Professional Statements and Societal Positions

  • The National Comprehensive Cancer Network (NCCN, 2017) states the following in regards to genetic testing in individuals with AML:

    • “The ability to identify mutations that carry prognostic impact is increasing with the use of molecular profiling. Thus, in addition to basic cytogenetic analysis, new molecular markers can help refine prognostic groups, particularly in patients with a normal karyotype. These markers include NPM1, FMS-like tyrosine kinase 3 (FLT3), CEBPA, isocitrate dehydrogenase 1 and 2 (IDH1/2), DNA (cytosine-5)-methyltransferase 3A (DNMT3A), and KIT gene mutations.

  • Tests for these molecular markers are becoming more common in commercial reference laboratories and in referral centers. Therefore, it is important for physicians to confer with the local pathologists on how to optimize sample collection from the time of diagnosis for subsequent molecular diagnostic tests. Testing for additional mutations may also be recommended.”

  • Some FDA labels require results from molecular marker tests to effectively or safely use the therapy for a specific cancer type.

  • Whereas the above mentioned biomarkers constitute established evaluation pathways for AML, there are many emerging mutations that might have clinical relevance to various types of AML that are not yet considered standard of care.

Place of Service: Outpatient

Genetic testing for AML 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.

A network provider cannot bill the member for the non-covered service.


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: 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.

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