DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Genomic Profiling (Liquid Biopsy) in Solid Tumors

Defines medical necessity and prior authorization requirements for select plasma-based genomic profile (liquid biopsy) tests to guide therapy in solid tumor cancers for BCBSRI Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyGenomic Profiling (Liquid Biopsy) in Solid Tumors

Policy CodePolicy N/A

Change TypeAdded named tests and authorization requirement

Effective DateJan 1, 2026

Next Review DateMar 9, 2025

Key ActionObtain prior authorization via the online authorization tool (required for Medicare Advantage; recommended for Commercial) before ordering Guardant360 or LiquidHALLMARK.

SourceLink

POLICY UPDATE CHANGES

Guardant360 (CPT 0326U) and LiquidHALLMARK (CPT 0409U) are listed as medically necessary when online authorization criteria are met, effective 1/1/2026.

Prior authorization is required for Medicare Advantage and recommended for Commercial products via the online authorization tool for participating providers.

2named liquid biopsy tests listed as medically necessary

2CPT codes added to policy

1/1/2026effective date for coverage changes

Online

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Coverage criteria for plasma-based genomic profile tests

Medically necessary (select plasma-based genomic profile tests)

Effective 1/1/2026, the following tests are considered medically necessary when the medical criteria in the online authorization tool for participating providers are met:

Named tests with authorization: Guardant360 (Guardant Health) (CPT 0326U) AND LiquidHALLMARK (Lucence Health) (CPT 0409U) are listed as medically necessary when the online authorization tool criteria are met.authorization criteria per online tool

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products via the online authorization tool.

Some self-funded employer groups may have contract-level exclusions related to the state Biomarker Testing Mandate (R.I.G.L. §27-19-81). When a group has excluded the expanded biomarker testing coverage, certain genetic testing services that would otherwise be addressed by this policy may be not covered for members of that group. Refer to the Coding sections of the Genetic Testing Services and Proprietary Laboratory Analyses policies and the member’s Benefit Booklet to determine which tests are covered, not medically necessary, or excluded for a particular self-funded group.

Coverage determinations for genetic and molecular testing can vary by group and contract. Benefits and whether a service is considered medically necessary, not medically necessary, or not covered depend on the member’s Evidence of Coverage or Subscriber Agreement. Always consult the member’s plan documents (Evidence of Coverage/Benefit Booklet) for the definitive coverage position for the specific group or contract.

Use as a personalized treatment guide in solid tumor cancers

Use of plasma-based genomic profile testing as a personalized treatment guide in solid tumor cancers is covered when the medical criteria in the online authorization tool for participating providers are met:

Clinical context: Plasma-based genomic profile testing (liquid biopsy) is intended to identify tumor-derived genetic features to guide targeted therapy selection in solid tumors.

Policy addresses medical necessity of select plasma-based genomic profile tests for guiding cancer treatment.

Authorization requirement: Testing is performed only when the patient meets the medical criteria documented in the online authorization tool for participating providers.authorization criteria per online tool

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products.

Applicable tests: Guardant360 (CPT 0326U) OR LiquidHALLMARK (CPT 0409U) may be used as the plasma-based genomic profile test when authorization criteria are met.

Coding and billing

Medically necessary CPT codes when authorization criteria metCPTCovered

0326U	Guardant360 (Guardant Health)
0409U	LiquidHALLMARK (Lucence Health)

Benefits variation (Evidence of Coverage)

Benefits variation by group/contractBenefits may vary between groups/contracts; refer to the member's Evidence of Coverage or Subscriber Agreement for applicable laboratory and not medically necessary/not covered benefits.

Self-funded group exclusionsSome genetic testing services may be not covered for self-funded groups that have contract exclusions per the Biomarker Testing Mandate; check the group's contract.

Where to find specificsSee the Evidence of Coverage or Subscriber Agreement for details on laboratory coverage and not medically necessary/not covered benefits.

Impact on member liabilityCoverage differences by contract determine member benefit and financial responsibility for tests.

Provider actions, authorization, and denial risk

Prior Authorization

Prior Authorization Required

Prior authorization is required for Medicare Advantage Plans and is recommended for Commercial Products. Participating providers must use the BCBSRI online authorization tool and meet the medical criteria there for tests such as Guardant360 (CPT 0326U) and LiquidHALLMARK (CPT 0409U).

Required for Medicare Advantage Plans via online authorization tool
Recommended for Commercial Products via online authorization tool
Affected tests: Guardant360 (CPT 0326U); LiquidHALLMARK (CPT 0409U)

Note

Provider Operational Note

Operational note for providers: consult the online authorization tool for the specific medical criteria and documentation requirements before submitting requests. Refer to the member's Benefit Booklet to confirm plan-specific coverage or contract exclusions.

Check Benefit Booklet for customized benefit coverage

Services not covered / exclusions

For self-funded groups that have a contract exclusion of the Biomarker Testing Mandate, specific genetic testing services may be excluded from coverage. A list of which genetic testing services are covered with prior authorization, which are considered not medically necessary, and which are not covered because of a contract exclusion can be found in the Coding sections of the related Genetic Testing Services or Proprietary Laboratory Analyses policies. Refer to the member’s Benefit Booklet and the related policies for the applicable contract-specific exclusion details.

Background

Plasma-based genomic profiling, commonly called a liquid biopsy, analyzes circulating tumor-derived DNA in a patient’s blood to detect genomic alterations present in solid tumors. These assays can identify actionable mutations and other genomic features that may guide selection of targeted therapies when clinical criteria are met. This policy addresses the medical necessity of select plasma-based genomic profile tests as a personalized treatment guide for patients with solid tumor cancers.

Definitions

Definition: Liquid biopsy / plasma-based genomic profile testing

Definition (Liquid biopsy)Plasma-based genomic profile testing in solid tumors that evaluates circulating tumor-derived genetic material to inform treatment decisions.

Alternate nameAlso called a 'liquid biopsy'.

Clinical purposeUsed to guide treatment plans with drugs based on the genetic features of the cancer.

ScopeApplies to select plasma-based genomic profile tests intended as personalized treatment guides in solid tumor cancers.