Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: L-170-005
Topic: BCR-ABL Testing for Chronic Myeloid Leukemia
Section: Laboratory
Effective Date: November 13, 2017
Issue Date: November 13, 2017
Last Reviewed: June 2017

Chronic myelogenous leukemia (CML) is a hematopoietic stem cell disease that results in overgrowth of white blood cells in the bone marrow. It is defined by the presence of the Philadelphia chromosome (Ph), a translocation between chromosomes 9 and 22 that results in the fusion of two genes known as BCR and ABL.

Test Information:
qPCR for BCR-ABL transcript levels: Bone marrow cytogenetics and measurement of BCR-ABL transcript levels by quantitative polymerase chain reaction is recommended before initiation of treatment as well as for assessing response to therapy.

FISH for t(9;22) BCR-ABL: If collection of bone marrow is not feasible, fluorescence in situ hybridization (FISH) on peripheral blood specimen using dual probes for the BCR and ABL genes is an acceptable method of confirming the diagnosis of CML.

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.

BCR-ABL transcript level testing is indicated in individuals at the initiation of treatment and at regular intervals (ranges from every month to once every 3-6 months) during treatment and may be considered medically necessary with ANY of the following drug therapies:

Procedure Codes
81206, 81207, 81208, 88271

Professional Statements and Societal Positions

The National Comprehensive Cancer Network (NCCN, 2016) recommends bone marrow cytogenetics to confirm a diagnosis of CML. If bone marrow is not available, FISH on a peripheral blood specimen using probes for both BCR and ABL can confirm the diagnosis.

  • NCCN recommends BCR-ABL transcript levels be obtained by quantitative RT-PCR:
    • At diagnosis.
    • Every three months after initiating treatment. After a patient reaches complete cytogenetic response, every 3 months for two years and every 3-6 months thereafter.
    • If a patient has a rising level of BCR-ABL transcripts (1 log increase), repeat testing in 1 – 3 months.

These recommendations are category 2A: "based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate."

 


Place of Service: Outpatient

BCR-ABL testing for CML 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.

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.

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.