Biomarker Testing Mandate
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Defines medical necessity, coverage, and prior authorization requirements for biomarker testing for Blue Cross Blue Shield - Rhode Island, addressing Commercial Products and Medicare Advantage Plans and implementation of a state-mandated biomarker testing coverage statute.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
General medical necessity
Covered when ANY of the following category-specific criteria are met (or when specific criteria in the online authorization tool or related policies apply):
First- and second-degree relatives are defined in policy (first-degree: biological parent, brother, sister, or child; second-degree: grandparent, aunt, uncle, niece, nephew, grandchild, half‑sibling).
Applies when no more specific policy criteria or online authorization tool criteria are present.
Test must provide clinical utility per FDA labeling, CMS NCDs/LCDs, or nationally recognized guidelines.
InterQual criteria are commonly used in the online authorization tool.
Panel testing
Panel tests covered only when individual components demonstrate clinical utility:
If a panel is represented by specific CPT codes, refer to the Coding section for coverage of each code; when a panel is represented by multiple CPT codes, prior authorization is required for each component/CPT code and each code must be entered into the online authorization tool independently.
Some genetic testing services may be excluded from coverage when a self-funded group contract has a specific exclusion for expanded biomarker testing related to the state mandate (R.I.G.L. §27-19-81). For members in those self-funded groups, coverage, prior authorization requirements, and lists of services that are considered covered, not medically necessary, or not covered because of the contract exclusion are identified in the Coding section and in the Genetic Testing Services and Proprietary Laboratory Analyses policies. Always consult the member's Benefit Booklet to confirm whether the member's plan includes such a contract exclusion.
Only the ordering physician may initiate or participate in the clinical prior authorization, appeals, or other administrative processes related to biomarker testing. Laboratories are prohibited from obtaining clinical authorization or otherwise participating in the authorization process on behalf of the ordering physician; use of laboratory representatives or third parties to obtain authorization or to support appeals is a violation and may result in corrective action, including termination from the BCBSRI provider network.
Coverage determinations in this policy do not replace the member's subscriber agreement or employer agreement. Medically necessary as defined in this policy may still be a non-covered benefit for a particular member if their plan documents exclude the service. For member-specific benefits or eligibility questions, contact the provider call center and refer to the member's Benefit Booklet or subscriber/employer agreement.
Tests are considered not medically necessary when there is insufficient clinical evidence or strength of recommendation, when test results would not reasonably be used in patient management, or when the service is unlikely to impact therapeutic decision-making. In particular, multigene panels or genomic sequencing procedures that include genes or variants lacking demonstrated clinical utility render the entire panel not medically necessary for Commercial Products and not covered for Medicare Advantage Plans unless individual components meet accepted clinical utility criteria.
Covered Indications
Diagnosis, treatment, appropriate management, or ongoing monitoring when test provides clinical utility (per FDA labels, CMS NCDs/LCDs, or nationally recognized guidelines).
Covered when the test provides clinical utility for diagnosis, treatment, appropriate management, or ongoing monitoring as demonstrated by one or more of the following:
Clinical utility must be demonstrated by medical and scientific evidence in accordance with the Biomarker Testing Mandate.
Coding and Service Codes
| PLA codes | Proprietary Laboratory Analyses (PLA) codes for proprietary clinical laboratory analyses, ADLTs and CDLTs; when available PLA codes take precedence and should not be reported with other CPT codes. |
| GSP / NGS panel CPTs | Genomic sequencing procedures and multigene panels (codes selected based on genes analyzed; panels may be represented by multiple CPT codes). |
Prior Authorization, Ordering, and Billing Actions
Prior authorization required (Medicare Advantage); recommended for Commercial
Prior authorization is required for services indicated in the attached code grids for Medicare Advantage Plans and is recommended for Commercial Products. For panel testing represented by multiple CPT codes, prior authorization is required for each component/CPT code and each individual CPT code must be entered and processed through the online authorization tool independently. Effective 10/1/2025, fully‑funded Commercial Products may exempt BCBSRI‑contracted primary care providers from prior authorization.
- Prior authorization required for services indicated in attached code grids (Medicare Advantage).
- For panels represented by multiple CPT codes, submit prior authorization for each individual CPT code separately via the online tool.
- PCP exemption effective 10/1/2025 applies to fully‑funded Commercial Products for BCBSRI‑contracted primary care specialties listed in policy.
No explicit CPT/HCPCS code list in policy text — see code grids
This policy segment does not enumerate a standalone list of specific CPT/HCPCS codes requiring prior authorization within the body text; providers must refer to the attached code grids in the Coding section for the codes and authorization indicators.
- Refer to the attached code grids in the Coding section for which services/CPT codes require prior authorization.
Ordering physician must handle authorizations — labs may not act on physician's behalf
Only the ordering physician may be involved in authorization, appeals, or other administrative processes related to prior authorization and medical necessity; laboratories may not obtain authorization on behalf of ordering physicians or participate in the authorization process.
- Laboratories and lab representatives are prohibited from obtaining or facilitating prior authorization or appeals on behalf of the ordering physician.
- Violations (use of lab/third‑party representatives) may result in termination from the BCBSRI provider network.
Unauthorized laboratory services will be denied and lab liable
If a laboratory provides a laboratory service that has not been authorized, the service will be denied and the financial liability will rest with the participating laboratory; such services may not be billed to the member.
- Unauthorized laboratory services are denied and billed liability rests with the participating laboratory.
- BCBSRI may take severe action for improper authorization practices.
How to submit prior authorization requests
Submit prior authorization requests for biomarker testing via the BCBSRI online prior authorization tool (available to BCBSRI‑participating providers). Providers who are not BCBSRI participating providers should fax requests to Utilization Management at (401) 272‑8885. If a biomarker test is not found in the online tool, fax the request to Utilization Management at (401) 272‑8885.
- Use the BCBSRI online prior authorization tool for participating providers.
- Non‑participating providers and requests for tests not listed in the tool: fax to Utilization Management at (401) 272‑8885.
Verify member benefits/eligibility with provider call center
For member‑specific benefits or eligibility questions, contact the provider call center because benefits and eligibility are determined by the member's subscriber agreement or employer agreement.
- Benefits and eligibility are determined by subscriber/member certificate or employer agreement and may supersede this medical policy.
- Call the provider call center for member‑specific benefit verification.
Unauthorized lab services denied — lab financial liability
If a laboratory performs a service that has not been authorized, BCBSRI will deny the service and hold the participating laboratory financially liable; the laboratory may not bill the member for unauthorized services.
- Unauthorized services will be denied as the financial liability of the participating laboratory.
- Laboratories may not bill the member for unauthorized lab services.
Billing and denial risk for non‑covered or not medically necessary services
Services determined to be not medically necessary—or medically necessary but non‑covered under the member's plan—may result in the provider being unable to charge the member unless the member provided written agreement in advance; refer to participation agreements for applicable provisions.
- If services are not medically necessary or are non‑covered benefits, the provider may not charge the member unless prior written agreement is obtained.
- Verify plan documents and participation agreement provisions.
Ordering and Authorization Requirements
Only ordering physician may manage authorizations and appeals
Only the ordering physician shall be involved in authorization, appeals, or other administrative processes related to prior authorization/medical necessity; laboratories may not participate in authorization on behalf of the ordering physician.
- Any use of a laboratory representative or third party to obtain authorization is a violation and may result in termination from the BCBSRI provider network.
Not Covered Services
If a laboratory performs a biomarker or genetic testing service that was not authorized through the required prior authorization process, the service will be denied and the financial liability for that unauthorized laboratory-performed service rests with the participating laboratory; such services may not be billed to the member.
Laboratories may not obtain prior authorization on behalf of ordering physicians or otherwise participate in the authorization process for biomarker testing. Use of laboratory representatives, third parties, or any party with a relationship to the laboratory to obtain authorizations or facilitate appeals is a policy violation and may result in disciplinary action up to and including termination from the BCBSRI provider network.
Definitions
Background
Biomarker testing includes analysis of tissue, blood, or other biospecimens to detect biomarkers such as gene mutations or protein expression. These tests range from single-analyte assays to multiplex panels and genomic sequencing procedures (eg, next-generation sequencing). The goal of biomarker testing is to provide information with clinical utility that can guide diagnosis, treatment, management, or monitoring decisions; however, some tests may yield variants of uncertain significance and therefore require careful interpretation in the clinical context.
Frequency Limits
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