Biomarker Testing Mandate (Biomarker testing coverage and medical necessity)
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Governs Rhode Island state-mandated coverage and medical necessity determinations for biomarker testing for BCBSRI members, applying to Commercial Products (mandate) and providing guidance for Medicare Advantage Plans; affects ordering providers, laboratories, and claims processing.
No material clinical or coverage changes in this revision.
Coverage Criteria
Carrier screening criteria
Covered when ALL of the following are met for the specified category
First-degree relatives include a biological parent, sibling, or child. Second-degree relatives include a biologic grandparent, aunt/uncle, niece/nephew, grandchild, and half‑sibling.
Genetic/hereditary condition testing
Covered when ANY one of the following is met
Testing applies to analysis of the individual's germline when results will benefit the individual.
Cancer testing criteria
Covered when ANY one of the following is met
Somatic tumor profiling must provide clinical utility as demonstrated by evidence, FDA‑labeled indications, CMS NCDs/LCDs, or recognized guideline recommendations.
Authorization-linked coverage
For services with prior authorization indicated
Requests should be submitted via the BCBSRI online prior authorization tool (or fax to Utilization Management at (401) 272-8885 if unavailable). See attached code grids for test‑specific prior authorization requirements; MA plans require prior authorization for listed codes and Commercial Products are recommended to seek prior authorization.
Evidence-based coverage requirement
Coverage depends on clinical validity and utility specific to condition and test
Assess coverage on a test‑and‑indication specific basis using medical evidence, FDA labeling, CMS NCDs/LCDs, or nationally recognized guidelines (e.g., NCCN).
Some employer self-funded groups may have contract exclusions for expanded biomarker testing under the state mandate. For those self-funded plans, specific genetic testing services may be designated as a contract exclusion and therefore not covered for that sponsor. Refer to the Coding section and the member's Benefit Booklet to confirm whether a member’s plan has such an exclusion and which tests are affected.
Panel tests are addressed separately: when a panel includes one or more genes or variants without demonstrated clinical utility, the panel may be considered not covered for Medicare Advantage and not medically necessary for Commercial Products unless the individual component(s) meet evidence-based criteria. See the Policy Statement, Prior Authorization sections, and attached coding grids for panel-specific rules.
There are specific assays and other tests for which published evidence is extremely limited or absent; when the available literature does not demonstrate clinical validity or utility, BCBSRI considers those tests not medically necessary. The policy explicitly lists that technologies lacking sufficient published data to determine impact on health outcomes will be denied on that basis.
Tests are considered not medically necessary when there is insufficient clinical evidence or a weak strength of recommendation, when results would not reasonably be used to manage the patient, or when the service is unlikely to affect therapeutic decision-making. In addition, laboratories must not seek to obtain authorization on behalf of the ordering clinician; improper authorization practices may lead to denial and sanctions.
Tests that have not demonstrated clinical utility or that lack adequate evidence of clinical validity are considered not medically necessary. This includes situations where panels contain genes of uncertain relevance; because panel composition varies by laboratory and can change over time, the absence of demonstrated utility for constituent genes can render the entire panel noncovered for Medicare Advantage and not medically necessary for Commercial Products.
Covered Indications
Coverage conditional on clinical utility for hereditary disease diagnosis confirmation, causative etiology identification, asymptomatic risk assessment, and somatic tumor profiling
Coverage conditional on clinical utility for the listed clinical purposes
See genetic/hereditary condition testing criteria for specifics.
Clinical utility should be supported by evidence, FDA labeling, CMS coverage determinations, or recognized guidelines (e.g., NCCN).
Diagnosis of hereditary disorders, hereditary cancer syndrome determination, and somatic tumor profiling to identify cancer type/subtype or help select treatment
Diagnosis of hereditary disorders, hereditary cancer syndrome assessment, and somatic profiling are covered when criteria are met
Panel composition is variable by laboratory; include only genes with demonstrated clinical utility to support coverage.
Use recognized guidelines (for example, NCCN) to determine appropriateness.
Evidence of clinical utility and guideline support strengthen coverage decisions; refer to attached coding grids and related policies for specifics.
References that support coverage considerations for carrier screening, hereditary cancer panels, and somatic profiling
References that support coverage considerations for carrier screening, hereditary cancer panels, and somatic profiling
Selected references include ACMG/ACOG statements, systematic reviews of expanded carrier screening, clinical evaluations of multigene panels, and NCCN guidelines for hereditary cancer assessment (see policy References).
Coding and Billing
| PLA codes | Proprietary Laboratory Analyses (PLA) proprietary clinical laboratory analyses/ADLTs/CDLTs as defined under PAMA; when available PLA code takes precedence. |
| Molecular pathology / GSP | Molecular pathology and genomic sequencing procedures (GSPs) including NGS; code selection typically based on specific gene(s) analyzed. |
| See attached grids | Genetic Testing Codes and Coverage; HCPCS Codes and Coverage; MAAA Codes and Coverage; Pathology and Laboratory Codes and Coverage; Proprietary Laboratory Analyses (PLA) Codes and Coverage |
| See attached grids | See the attached grid(s) for Medicare Advantage Plans and Commercial Products coverage of Biomarker Testing Codes and indication of which codes may be covered, medically necessary if criteria are met, not medically necessary or not covered. |
| Listed in document | Extensive list of related biomarker, molecular, proteomic, liquid biopsy, sequencing, and other laboratory test topics and policies referenced for coding and coverage determinations |
| Related policies | Assays of Genetic Expression in Tumor Tissue; Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies; and numerous additional molecular and biomarker testing policies listed in the CODING section. |
Provider Actions and Prior Authorization
Prior authorization may be required for MA; recommended for Commercial
Prior authorization may be required for Medicare Advantage Plans and is recommended for Commercial Products; for services listed in the attached code grids prior authorization is required for MA and recommended for Commercial Products. (Effective 10/1/2025: select BCBSRI-contracted PCP specialties may be exempt for fully-funded Commercial Products.)
- Prior authorization required for services indicated in attached code grids for Medicare Advantage Plans.
- Recommended (but not required) for Commercial Products except where noted (exemptions for certain PCP specialties effective 10/1/2025).
See coding grids for which codes require prior authorization
Refer to the attached coding grids to determine which biomarker/genetic testing CPT/HCPCS codes require prior authorization and which codes may be covered when medical necessity criteria are met.
- Coding grids indicate per-code coverage status and prior authorization requirement.
- See the Coding section and attached grids for code-specific criteria and diagnosis coding guidance.
Verify benefits and authorization — policy is informational
This policy is informational and not a guarantee of payment; providers should verify member-specific benefits and prior authorization requirements with BCBSRI before ordering testing.
- Benefits and eligibility are governed by the member's subscriber agreement, member certificate, or employer agreement and supersede this policy.
- For member-specific benefits, contact the provider call center.
Ordering physician must initiate and own authorization process
Ordering physician must initiate prior authorization requests and be the party involved in authorization, appeals, and medical necessity documentation; laboratories may not obtain authorization on behalf of the ordering physician.
- Only the ordering physician shall be involved in authorization, appeal or other administrative processes related to prior authorization/medical necessity.
- Laboratories are not allowed to obtain clinical authorization or participate in the authorization process on behalf of the ordering physician.
Enter each CPT code separately for panel authorizations
For panel tests represented by multiple CPT codes, each individual CPT code must be entered and processed independently through the online authorization tool; prior authorization is required for each component.
- Each component/gene represented by a separate CPT code requires its own authorization entry.
- Enter and process each CPT code independently via the authorization tool.
Confirm authorization requirement before ordering
Confirm whether prior authorization is required for the requested test using the attached code grids and the online authorization tool before ordering to avoid denials or financial liability.
- Use the coding grids to confirm per-code coverage and authorization requirements.
- Check the online authorization tool and verify benefit/authorization status for the member.
How to submit prior authorization
Submit requests for authorization of biomarker testing via the BCBSRI online prior authorization tool (available to BCBSRI-participating providers); all other providers may fax requests to Utilization Management at (401) 272-8885.
- Use the online prior authorization tool if you are a BCBSRI-participating provider.
- If the test is not found in the online tool or you are not a participating provider, fax requests to Utilization Management at (401) 272-8885.
Panel testing: authorization required for each CPT component
When a panel is represented by multiple CPT codes, prior authorization is required for each component — each CPT code must be entered and processed independently through the online authorization tool.
- Prior authorization required for each component/gene when multiple CPT codes represent the panel.
- Enter each CPT code separately in the online tool for authorization.
Refer to attached coding grids for MA and Commercial products
See attached coding grids for Medicare Advantage Plans and Commercial Products for code-specific coverage status, medical necessity criteria, and which codes require prior authorization.
- Attached grids list Biomarker Testing Codes and indicate per-code coverage, medical necessity conditions, and prior authorization status.
Verify member-specific benefits with provider call center
For member-specific benefits and eligibility, contact the provider call center; benefits are governed by the member's subscriber agreement, member certificate, or employer agreement which supersede this policy.
- Call the provider call center for member-specific benefit information.
- Subscriber/member/employer agreements govern benefits and supersede this policy.
Unauthorized lab services will be denied as lab's financial liability
If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the participating laboratory will bear the financial liability; the service may not be billed to the member.
- Unauthorized laboratory services will be denied and are the financial liability of the participating laboratory.
- Such services may not be billed to the member.
Labs/third parties must not perform authorization tasks for ordering physicians
If a laboratory or third party supports any portion of the authorization process on behalf of the ordering physician, BCBSRI will consider it a violation and may take severe action up to termination from the provider network.
- Laboratories/third parties may not obtain authorization or facilitate the authorization/appeal process on behalf of the ordering physician.
- Violation may result in severe action, including termination from the BCBSRI provider network.
Tests with insufficient evidence may be denied/not medically necessary
Tests with extremely limited published data or insufficient evidence demonstrating clinical validity are considered not medically necessary and may be denied.
- Several tests lacking demonstrated clinical utility based on limited published data are considered not medically necessary.
- Insufficient evidence of clinical validity can trigger noncoverage.
Noncovered services may create provider financial/billing risk
If services are determined not medically necessary (or are non-covered benefits), the provider may be unable to charge the member unless the member has been informed and has agreed in writing in advance to self-pay; check participation agreement provisions for details.
- Providers may not charge members for noncovered services unless the member provided written advance agreement.
- Refer to participation agreements for applicable provisions.
Provider actions: ordering specialties, submission methods, effective date note
Ordering physician specialties eligible for the 10/1/2025 PCP exemption include Internal Medicine, Pediatric Medicine, Family Practice, Obstetrics and Gynecology, DO, NP/PCP, and PA; ordering physicians must submit prior authorization via the online tool or fax as specified; policy effective date: 07/01/2026.
- Listed PCP specialties are exempt from prior authorization for fully-funded Commercial Products effective 10/1/2025.
- Ordering physician must submit prior authorization via the online tool if participating; otherwise fax to Utilization Management.
- Policy effective date is 07/01/2026 and benefits/eligibility are governed by subscriber agreements.
Eligibility Requirements
Eligibility for carrier screening requires that one or both individuals have a first- or second-degree relative affected by the condition, or that one individual is a known carrier, or that the individual(s) belong to a population with a sufficiently high carrier rate for the condition. Prior targeted testing for the specific variant(s) of interest must not have already been performed.
First-degree relatives include a biological parent, sibling, or child. Second-degree relatives include grandparent, aunt/uncle, niece/nephew, grandchild, and half-sibling. Confirm family history and prior testing before submitting authorization requests.
Carrier testing may be offered when there is a family history of a genetic condition, when family members have been identified as carriers, or when the member is part of an ethnic or racial group with an increased carrier rate for a specific disorder. Documentation of the qualifying family history or population risk should be included with authorization requests.
For carrier screening to be eligible, previous carrier screening or individual targeted gene testing for the variant(s) of interest must not have been performed; verify prior testing in the medical record.
Genetic testing for diagnostic purposes is eligible when used to confirm a suspected hereditary diagnosis, to identify a causative etiology for a syndromic presentation, or to assess asymptomatic individuals for future disease risk. For cancer-related testing, eligibility includes determining hereditary cancer syndrome status or somatic tumor profiling to inform targeted therapy selection.
Because panel composition varies by laboratory and may change over time, eligibility and coverage must be judged on the basis of the test’s demonstrated clinical validity and utility for the specific indication; consult the online authorization tool and coding grids for test-specific eligibility rules.
Not Covered
Genetic panels or multigene tests that include genes or variants without demonstrated clinical utility are not covered for Medicare Advantage. For Commercial Products, such panels are considered not medically necessary. Review the coding grids and attached policy details to determine whether a submitted panel meets evidence-based criteria or is excluded.
Laboratories must ensure individual component validity is documented when requesting coverage for panels; absence of demonstrated utility for constituent genes may trigger noncoverage.
Tests supported only by extremely limited published data or with insufficient evidence of clinical validity are considered not medically necessary and may be denied. The policy emphasizes that when evidence is inadequate to determine the effect on health outcomes, the test is not covered.
Providers should reference the Coding section and related policy grids to confirm whether a specific test has been evaluated and whether existing evidence supports medical necessity for the requested indication.
Definitions
Background
Biomarker testing analyzes tissue, blood, or other biospecimens for biological indicators such as gene mutations or protein expression that can guide diagnosis, treatment, management, or monitoring.
Covered test types include single-analyte tests, multi‑plex panels, genomic sequencing procedures (including NGS/GSP), PLA/proprietary analyses, and multianalyte assays with algorithmic analyses when they meet medical necessity criteria. Panel composition varies by laboratory and may include variants of uncertain significance; clinical utility and impact on management drive coverage decisions.
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