Plasma-Based Genomic Profiling (Liquid Biopsy) in Solid Tumors Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 01|01|2026 POLICY LAST REVIEWED: 09|03|2025 OVERVIEW The use of plasma-based genomic profile testing in solid cancer tumors, also called a “liquid biopsy”, is a newer approach to the medical treatment of cancer. The information obtained from the “liquid biopsy” can be used to guide treatment plans with drugs based on the genetic features of the cancer. This policy is intended to address the medical necessity use of select plasma-based genomic profile tests as a personalized treatment guide in solid cancer tumors. MEDICAL CRITERIA Medicare Advantage Plans and Commercial Products Effective 1/1/2026, the following test(s) are considered medically necessary when the medical criteria in the online authorization tool for participating providers is met: • Guardant360 (Guardant Health) (CPT 0326U) • LiquidHALLMARK (Lucence Health) (CPT 0409U) PRIOR AUTHORIZATION Medicare Advantage Plans and Commercial Products Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online tool for participating providers for the following tests: • Guardant360 (Guardant Health) (CPT 0326U) • LiquidHALLMARK (Lucence Health) (CPT 0409U) POLICY STATEMENT Medicare Advantage Plans and Commercial Products Effective 1/1/2026, the following test(s) may be considered medically necessary when the medical criteria in the online authorization tool for participating providers is met: • Guardant360 (Guardant Health) (CPT 0326U) • LiquidHALLMARK (Lucence Health) (CPT 0409U) Commercial Products Some genetic testing services are not covered and a contract exclusion for any self-funded group that has excluded the expanded coverage of biomarker testing related to the state mandate, R.I.G.L. §27-19-81 described in the Biomarker Testing Mandate policy. For these groups, a list of which genetic testing services are covered with prior authorization, are not medically necessary or are not covered because they are a contract exclusion can be found in the Coding section of the Genetic Testing Services or Proprietary Laboratory Analyses policies. Please refer to the appropriate Benefit Booklet to determine whether the member’s plan has customized benefit coverage. Please refer to the list of Related Policies for more information. Note: Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Only the ordering physician shall be involved in the authorization, appeal or other administrative processes related to prior authorization/medical necessity.
In no circumstance shall a laboratory or a physician/provider use a representative of a laboratory or anyone with a relationship to a laboratory and/or a third party to obtain authorization on behalf of the ordering physician, to facilitate any portion of the authorization process or any subsequent appeal of a claim where the authorization process was not followed and/or a denial for clinical appropriateness was issued, including any Medical Coverage Policy | Plasma-Based Genomic Profiling (Liquid Biopsy) in Solid Tumors

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

element of the preparation of necessary documentation of clinical appropriateness. If a laboratory or a third party is found to be supporting any portion of the authorization process, BCBSRI will deem the action a violation of this policy and severe action will be taken up to and including termination from the BCBSRI provider network. If a laboratory provides a laboratory service that has not been authorized, the service will be denied as the financial liability of the participating laboratory and may not be billed to the member.

COVERAGE Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage or Subscriber Agreement for applicable laboratory and not medically necessary/not covered benefits/coverage.

BACKGROUND Not applicable

CODING Medicare Advantage Plans and Commercial Products Effective 1/1/2026, the following CPT codes may be considered medically necessary for Medicare Advantage Plans and Commercial Products when the medical criteria in the online authorization tool for participating providers is met: • Guardant360 – CPT Code 0326U • LiquidHALLMARK – CPT Code 0409U

RELATED POLICIES Biomarker Testing Mandate Proprietary Laboratory Analysis (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA)

PUBLISHED Provider Update, January/November 2025

REFERENCES Not applicable

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This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.

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