Highmark Commercial Medical Policy - Pennsylvania

Medical Policy: L-113-009
Topic: Investigational and Experimental Molecular/Genomic Testing
Section: Laboratory
Effective Date: July 1, 2018
Issue Date: July 2, 2018
Last Reviewed: March 2018

Molecular and genomic (MolGen) tests are routinely released to market that make use of novel technologies or have a novel clinical application. These tests are often available on a clinical basis long before the evidence base required to support clinical validity and utility is established. Because these tests are often proprietary, there may be no independent test evaluation data available in the early stages to support the laboratory's claims regarding test performance and utility.

An experimental or investigational procedure is generally defined as the use of a service, supply, drug or device that is not recognized as standard medical care for the condition, disease, illness or injury being treated as determined by the health plan based on independent review of peer reviewed literature and scientific data. Investigational and experimental (I&E) MolGen tests refer to assays involving chromosomes, DNA, RNA, or gene products that have insufficient data to determine the net health impact, which typically means there is insufficient data to support that a test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinical utility), and/or performs better than an existing standard of care medical management option. Such tests are also not generally accepted as standard of care in the evaluation or management of a particular condition. In the case of MolGen testing, FDA clearance is not a reliable standard given the number of laboratory developed tests that currently fall outside of FDA oversight and FDA clearance often does not assess clinical utility.

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.

Molecular and genomic tests are only eligible for reimbursement when ALL of the following conditions are met:

Novel Oncology Molecular/Genomic Tests
The following tests used in the screening, diagnosis, prognostication, and/or treatment decision-making for various neoplasms do not meet the above criteria and are considered experimental/investigational and therefore non-covered.
Gene Expression Assays:

Procedure Codes
0005U, 0019U, 81455, 81479, 81599, 84999, 0053U, 0057U

Other Novel Assays:

Procedure Codes
0009U, 0013U, 0014U, 81500, 81535, 81536, 0056U

Cardiovascular Molecular/Genomic Tests
The following tests used to predict cardiovascular disease and/or direct therapy do not meet the above criteria and are considered experimental/investigational and therefore non-covered.

Procedure Codes
81291, 81328, 0055U

Gene Variant or Marker Risk Assessment Tests

The following tests that make use of inherited genomic information to assess disease risk, prognosis, or subtyping do not meet the above criteria and are considered experimental/investigational and therefore non-covered.

Pharmacogenomic Panels are considered experimental/investigational and therefore non-covered.

Non-cancer Gene Expression Assays are considered experimental/investigational and therefore non-covered.

Procedure Codes
81490, 0060U

Infectious Disease Assays are considered experimental/investigational and therefore non-covered.

Procedure Codes
0008U, 0010U

Note: A single CPT/HCPCS code may describe more than one MolGen test. Some tests under a single code may be covered while others are determined to be experimental/investigational.

Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Experimental/investigational Molecular/Genomic Testing 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 be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.


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.