|Highmark Commercial Medical Policy - Pennsylvania|
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.
This policy applies to all molecular tumor marker testing intended for use in solid tumors. This policy does not apply to tumor marker testing for hematologic malignancies. This policy also does not apply to tumor markers found by liquid biopsy. Please see Liquid Biopsy Testing – Solid Tumors. This policy also does not apply when testing for germline (inherited) mutations in genes related to hereditary cancer syndromes (e.g., Hereditary Breast and Ovarian Cancer, Lynch syndrome, etc.). Although some of the same genes may be tested for inherited or acquired mutations, this policy addresses only testing for acquired mutations from tumor tissue.
Coverage criteria differ based on the type of testing being performed (i.e., individual tumor markers separately chosen based on the cancer type versus pre-defined panels of tumor markers) and how that testing will be billed (one or more individual tumor marker-specific procedure codes, specific panel procedure codes, or unlisted procedure codes).
When separate procedure codes will be billed for individual tumor markers (e.g., Tier 1 MoPath codes 81200-81355 or Tier 2 MoPath codes 81400-81408), each individually billed tumor marker test will be evaluated separately.
The following criteria will be applied:
NOTE: If five (5) or more individually billed tumor marker tests are under review together (a panel) and the member either has non-small cell lung cancer (NSCLC) or meets criteria for five (5) or more individual tumor markers, the panel will be approved. However, the laboratory will be redirected to use a panel CPT code for billing purposes (e.g. 81445 or 81455).
When a multi-gene panel is being requested and will be billed with a single panel CPT code (e.g. 81445 or 81455), the panel may be considered medically necessary when the following criteria are met:
NOTE: If the member meets criteria for less than five (5) of the individual tumor markers in the panel, the panel will not be covered. The laboratory will be redirected to billing for individual tests for which the member meets criteria.
Table 1: Common cancer types and associated tumor markers. This list not all inclusive.
* In general, when there is an associated treatment, results from the referenced tumor marker are necessary for the safe or effective use of that therapy (companion diagnostics). The therapies and tumor markers are only included for cancer types approved for treatment according to FDA labeling.
Tumor marker testing-solid tumors 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.
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 can bill the member for the non-covered service.
05/2018, REMINDER: Molecular and Genomic Testing
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 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.