Medical_Policy

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:

An oncology therapy FDA label requires results from the marker test to effectively or safely use the therapy for the member’s AML; or
NCCN guidelines include the tumor marker test in the management algorithm for AML and all other requirements are met (specific pathology findings, staging, etc.); however, the tumor marker must be explicitly included in the guidelines and not simply included in a footnote as an intervention that may be considered; or
The NCCN Biomarker Compendium has a level of evidence of at least 2A for the tumor marker’s application to AML.

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:

Genetic Counseling
- Pre and post-test counseling by an appropriate provider; and
Previous Genetic Testing:
- No previous panel testing for AML; and
Diagnostic Testing for Symptomatic Individuals:
- Member has a diagnosis of AML; and
- The results of the test will directly impact the diagnostic and treatment options that are recommended for the patient.

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.

Links

Link to Provider Resource Center for the Medical Policy Update

05/2018, REMINDER: Molecular and Genomic Testing

Link to References

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.