DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Biomarker Testing Mandate

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This draft policy governs coverage, medical necessity, and prior authorization for biomarker testing, including genetic, molecular, genomic, panel, proprietary laboratory, and multianalyte assay services for Commercial Products and Medicare Advantage Plans.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBiomarker Testing Mandate

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJanuary 1, 2027

Last ReviewSep 16, 2026

Next Review DateN/A

Key ActionSubmit required biomarker-testing authorization requests through the BCBSRI online prior authorization tool.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CommercialProducts under Rhode Island biomarker mandate

2Lines of business addressed

3General genetic testing categories

6Primary care specialties in exemption

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DraftBlue Cross Blue Shield - Rhode IslandPolicy N/A

Biomarker Testing Mandate

Customize your policy alerts

Sign up for all Blue Cross Blue Shield - Rhode Island policy alerts

Know when Blue Cross Blue Shield - Rhode Island releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBiomarker Testing Mandate

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJanuary 1, 2027

Last ReviewSep 16, 2026

Next Review DateN/A

Key ActionSubmit required biomarker-testing authorization requests through the BCBSRI online prior authorization tool.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CommercialProducts under Rhode Island biomarker mandate

2Lines of business addressed

3General genetic testing categories

6Primary care specialties in exemption

Coverage grids referenced

7Genetic testing limitations

Coverage Criteria

Carrier Screening

Carrier screening is medically necessary when ALL of the following criteria are met:

ALL of the following

One or both individuals have a first- or second-degree relative who is affected by the genetic disease.
One individual is known to be a carrier.
One or both individuals are members of a population known to have a carrier rate that exceeds a threshold considered appropriate for testing for the particular condition.
Previous carrier screening or individual targeted gene testing for the gene variant(s) of interest has not been performed.

First-degree relatives include a biological parent, brother, sister, or child. Second-degree relatives include a biologic grandparent, aunt, uncle, niece, nephew, grandchild, or half-sibling.

Genetic or Hereditary Condition Testing

Genetic screening or testing for genetic or hereditary conditions is medically necessary when ALL of the following are met:

ALL of the following

The diagnostic test of the individual's germline will benefit the individual.
ONE of the following
- Testing is performed to confirm a suspected diagnosis in a patient with signs and/or symptoms of the condition.
- Testing is performed to identify a causative etiology for a clinical syndrome for which there are multiple possible underlying conditions.
- Testing is performed in an asymptomatic individual to determine future risk of disease.

Genetic Testing for Cancer

Genetic testing for cancer is medically necessary when ANY of the following criteria is met:

ANY of the following

Testing is performed in an asymptomatic patient to determine future risk of cancer.
Therapeutic testing of cancer cells from an affected individual is performed to benefit the individual by directing targeted treatment based on specific somatic variants.

General Biomarker Testing

Biomarker testing may be considered medically necessary for Commercial Products and Medicare Advantage Plans when ALL applicable criteria are met:

ALL applicable criteria

The testing is performed for diagnosis, treatment, appropriate management, or ongoing monitoring of a member's disease or condition to guide treatment decisions.
The test provides clinical utility as demonstrated by medical and scientific evidence.
The clinical utility and coverage basis is supported by ONE or more of the following
- The labeled indication for an FDA-approved or FDA-cleared test, or an indicated test for an FDA-approved drug.
- A Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) or Medicare Administrative Contractor (MAC) Local Coverage Determination (LCD).

Genetic Panel Testing

Genetic panel testing is subject to additional clinical-utility requirements. Coverage requires that the evidence support the panel and its individual genes or variants as useful for patient management and improvement of net health outcomes:

ALL of the following

Research is sufficient to show that the genetic panel can lead to better health outcomes for patients.
For each gene and/or gene variant included in the panel, evidence is sufficient to show that it may be useful for guiding patient management.
The panel's use is supported by evidence demonstrating improvement in net health outcomes.

Tests Lacking Demonstrated Clinical Utility

The following tests are not medically necessary:

When ALL of the following evidence limitations apply

The test has extremely limited published data and/or insufficient evidence demonstrating clinical validity.
The available evidence is insufficient to determine the effect of the technology on health outcomes.

For self-funded groups with a contract exclusion for expanded biomarker testing related to the state mandate under R.I.G.L. §27-19-81, some genetic testing services are not covered. For these groups, covered genetic testing services requiring prior authorization, services that are not medically necessary, and services excluded by contract are identified in the Coding sections of the Genetic Testing Services and Proprietary Laboratory Analyses policies. The member's Benefit Booklet determines whether the plan has customized benefit coverage; see the Related Policies section for additional information.

For Medicare Advantage Plans, biomarker testing services are not covered when there is insufficient clinical evidence or strength of recommendation, when results would not reasonably be used in management of the patient, or when services are unlikely to impact therapeutic decision-making in the clinical management of the patient.

For services requiring prior authorization, the ordering physician must obtain authorization and participate in any appeal or related administrative process. Laboratories may not obtain authorization or participate in the authorization process on behalf of the ordering physician. A laboratory or third party may not prepare documentation or otherwise facilitate authorization or an appeal on behalf of the ordering physician. Violations may result in action up to and including termination from the BCBSRI provider network. An unauthorized laboratory service will be denied as the financial liability of the participating laboratory and may not be billed to the member. Diagnosis-code requirements may apply to certain biomarker services; consult the applicable coding grid and Related Policy.

Biomarker testing services are not medically necessary or not covered, as applicable to the member's product, when there is insufficient clinical evidence or strength of recommendation, results would not reasonably be used in management of the patient, or the service is unlikely to impact therapeutic decision-making in the clinical management of the patient.

For Medicare Advantage Plans, the entire genetic panel test is not covered when research is insufficient to show that a gene and/or gene variant alone in the panel may be useful for guiding patient management and improving net health outcomes. For Commercial Products, the entire panel is not medically necessary under the same circumstances. For a panel test filed with a specific individual CPT code, refer to the Coding section.

Testing may not detect all variants that occur in a gene; may identify variants of uncertain significance; may not determine the clinical outcome; and is subject to laboratory error. Different genes may cause the same disease, a variant in a gene may cause different phenotypes, and some disease-causing genes may not yet be identified. Tests supported by extremely limited published data or insufficient evidence of clinical validity or utility are considered not medically necessary because the evidence is insufficient to determine their effect on health outcomes.

Authorization, Documentation, and Billing Requirements

Prior Authorization

Submit Authorization Through BCBSRI

Submit prior authorization requests for biomarker testing through the BCBSRI online prior authorization tool when available. Providers who cannot use the tool, and providers who cannot find the test in the tool, should fax the request to Utilization Management at (401) 272-8885.

Prior authorization is required for Medicare Advantage services identified in the applicable code grid.
For Commercial Products, prior authorization may be recommended when indicated in the applicable code grid.

Prior Authorization

Authorize Each Panel Component Separately

When a genetic panel is represented by multiple CPT codes, obtain authorization separately for each panel component and/or gene or gene variant. Enter and process each CPT code independently through the online authorization tool.

Biomarker Testing Overview

Biomarker testing analyzes tissue, blood, or another biospecimen for characteristics that may indicate normal biological processes, pathogenic processes, or pharmacologic response. Testing may include single-analyte tests, multiplex panels, whole-genome sequencing, germline or somatic molecular testing, genomic sequencing, proprietary laboratory analyses, and multianalyte assays with algorithmic analysis. Coverage is intended for testing that supports diagnosis, treatment, appropriate management, or ongoing monitoring when the result has clinical utility and can guide a clinical decision.

Policy Definitions

Biomarker

DefinitionA characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a specific therapeutic intervention.

ExamplesBiomarkers include gene mutations and protein expression.

Biomarker testing

DefinitionAnalysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker.

Included test typesBiomarker testing includes single-analyte tests, multiplex panel tests, and whole genome sequencing.

Clinical utility

Covered Testing Indications

Preconception or Prenatal Carrier Screening

Preconception or prenatal carrier screening is covered when all of the following requirements are met:

Carrier screening eligibility

Qualifying indication
- Family history: One or both individuals have a first- or second-degree relative affected by the condition
  First-degree relatives include a biological parent, brother, sister, or child. Second-degree relatives include a biologic grandparent, aunt, uncle, niece, nephew, grandchild, or half-sibling.
- Known carrier status: One individual is known to be a carrier
- Population carrier rate:

Carrier Screening Eligibility

For preconception or prenatal carrier screening, one or both individuals must have a first- or second-degree relative affected by the condition, unless another qualifying indication applies. First-degree relatives include a biological parent, brother, sister, or child. Second-degree relatives include a biologic grandparent, aunt, uncle, niece, nephew, grandchild, or half-sibling. Eligibility may also be based on a known carrier in the family or membership in a population with a carrier rate exceeding the threshold appropriate for the condition.

For carrier screening, previous carrier screening or individual targeted gene testing for the gene variant or variants of interest must not have been performed.

Not Covered Services

Genetic panels are not covered when available evidence is insufficient to show that the individual gene or gene variant and the panel as a whole contribute to patient management and improve net health outcomes. This limitation applies to Medicare Advantage coverage and to medical necessity determinations for Commercial Products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyBiomarker Testing Mandate

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJanuary 1, 2027

Last ReviewSep 16, 2026

Next Review DateN/A

Key ActionSubmit required biomarker-testing authorization requests through the BCBSRI online prior authorization tool.

SourceLink

On This Page

Nationally recognized clinical practice guidelines or consensus statements.

For services for which prior authorization is indicated, the criteria in the online authorization tool and/or applicable BCBSRI policy are met.

Prior Authorization

Fully-Funded Commercial Primary Care Exemption

Effective October 1, 2025, prior authorization may not be needed for Fully-Funded Commercial Products when the requesting physician is a BCBSRI Contracted Primary Care Provider in an eligible credentialed specialty. This exemption does not apply to Self-Funded Commercial Products, Medicare Advantage Plans, or other Commercial Products.

Eligible specialties include Internal Medicine, Pediatric Medicine, Family Practice, Obstetrics and Gynecology, Doctor of Osteopathic Medicine, Nurse Practitioner/Primary Care Provider, and Physician Assistant.
The provider must be credentialed as a primary care provider.

Documentation Required

Ordering Physician Owns Authorization and Appeals

The ordering physician is responsible for submitting authorization requests, providing documentation of clinical appropriateness, and managing any authorization or medical-necessity appeal. For services requiring authorization, coverage depends on meeting the criteria in the online authorization tool and/or applicable BCBSRI policy.

Only the ordering physician may perform authorization, appeal, or related administrative functions.
The ordering physician must provide all necessary documentation supporting clinical appropriateness.

Documentation Required

Verify the Applicable Benefit Document

Verify the member’s coverage and cost-sharing responsibility against the applicable Benefit Booklet, Evidence of Coverage, or Subscriber Agreement before ordering or billing testing. Benefits and exclusions may vary by group or contract.

Confirm whether laboratory testing is covered, not medically necessary, or not covered under the member’s plan.

Note

Use the Applicable Coverage Grid

Use the applicable BCBSRI coverage grid to determine code-specific coverage, medical-necessity requirements, and prior authorization status. Refer to the grid corresponding to the service and product line.

Genetic Testing Codes and Coverage grid.
MAAA Codes and Coverage grid.
Pathology and Laboratory Codes and Coverage grid.
PLA Codes and Coverage grid.

Denial Risk

Insufficient Evidence or Clinical Utility May Result in Denial

Testing may be denied as not medically necessary or not covered when clinical evidence, strength of recommendation, or clinical utility is insufficient. Denial risk also exists when results would not reasonably be used in patient management or are unlikely to affect therapeutic decision-making.

For genetic panels, insufficient evidence that an individual gene or variant improves patient management and net health outcomes may result in denial of the entire panel.
Review diagnosis-code requirements and applicable related policies when the code grid specifies them.

Billing Rule

Unauthorized Laboratory Service Cannot Be Billed to the Member

If a participating laboratory performs a laboratory service that was not authorized, the service will be denied as the financial liability of the laboratory. The laboratory may not bill the member for that denied service.

Documentation Required

Laboratory Participation in Authorization Is Prohibited

Laboratories must not obtain clinical authorization or otherwise participate in the ordering physician’s authorization process. Laboratory representatives, laboratory-affiliated third parties, and other third parties may not prepare clinical-appropriateness documentation, facilitate authorization, or handle related appeals.

Authorization and appeals must be managed by the ordering physician.
Violation may result in severe action, including termination from the BCBSRI provider network.

Denial Risk

Insufficient Clinical Utility or Validity

Do not proceed without adequate evidence supporting the test’s clinical validity and utility. Tests with extremely limited published data or insufficient evidence to determine their effect on health outcomes may be considered not medically necessary.

Genetic testing may have limitations including variants of uncertain significance, laboratory error, and inability to determine clinical outcomes.

Billing Rule

Use the Available PLA Code

When a specific PLA code is available for a proprietary laboratory service, report that PLA code instead of another CPT code. Do not report the service with additional CPT codes or use other CPT codes to represent a service covered by the specific PLA code.

Documentation Required

Ordering Physician Must Manage Authorization and Appeals

Laboratories and third parties may not obtain authorization, prepare authorization documentation, facilitate any portion of the authorization process, or pursue subsequent appeals on behalf of the ordering physician. The ordering physician must manage these functions directly.

This restriction applies to authorization, clinical-appropriateness documentation, medical-necessity reviews, and appeals.

DefinitionThe test result provides information used to formulate a treatment or monitoring strategy that informs the patient's outcome and impacts a clinical decision.

Information includedThe most appropriate test may include both actionable information and information that cannot be immediately used in formulating a clinical decision.

Consensus statements

DevelopmentStatements developed by an independent, multidisciplinary panel of experts using a transparent methodology and reporting structure.

Evidence and safeguardsThe panel uses a conflict-of-interest policy and bases statements on the best available evidence.

PurposeStatements address specific clinical circumstances to optimize clinical-care outcomes.

Nationally recognized clinical practice guidelines

DevelopmentEvidence-based clinical practice guidelines developed by independent organizations or medical professional societies using a transparent methodology and reporting structure.

Evidence reviewGuidelines are informed by systematic review of evidence and assessment of the benefits and costs of alternative care options.

PurposeRecommendations are intended to optimize patient care.

SafeguardThe development process includes a conflict-of-interest policy.

Molecular pathology

DefinitionMedical laboratory procedures involving analysis of nucleic acid, including DNA and RNA.

PurposeProcedures detect gene variants indicative of germline or somatic conditions.

Additional useMolecular pathology may also test for histocompatibility antigens such as HLA.

Code selectionCode selection is typically based on the specific gene or genes analyzed.

Genomic sequencing procedures and other molecular multianalyte assays

DefinitionDNA and/or RNA sequence-analysis methods that simultaneously assay multiple genes or genetic regions relevant to a clinical situation.

ScopeMethods may target specific combinations of genes or genetic material, or assay the exome or genome.

TechnologyThe technology typically used is massively parallel sequencing, including next-generation sequencing, although other technologies may be employed.

SpecimensProcedures are performed on nucleic acids from germline or neoplastic samples.

PLA and MAAA

PLAA proprietary clinical laboratory analysis code describing a sole-source laboratory test or a test licensed or marketed to multiple laboratories, including advanced diagnostic laboratory tests and clinical diagnostic laboratory tests under PAMA.

MAAAA procedure that combines multiple assay results and other patient information, when used, with algorithmic analysis to produce a numeric score or probability.

Assay sourcesMAAA inputs may include molecular pathology, fluorescent in situ hybridization, protein, polypeptide, lipid, or carbohydrate assays.

Genetic Testing

DefinitionAnalysis of chromosomes, DNA, RNA, genes, or gene products to detect genetic variants related to disease or health.

Variant typesGenetic testing detects inherited, or germline, and noninherited, or somatic, variants.

Carrier

DefinitionA person with one abnormal allele for a disorder.

Autosomal recessive or X-linked disordersCarriers are typically unaffected.

Autosomal dominant disordersA person with one normal copy and one mutated copy may be affected, unaffected but at high risk of developing the disease later, or unaffected because of sex-limited disease expression.

Testing contextsCarrier testing may be offered based on family history, identified carrier relatives, or membership in an ethnic or racial group with a higher carrier rate.

Germline Variant

DefinitionA variant present in the DNA of every cell of the body from the moment of conception.

Gonadal cellsGermline variants include cells in the gonads, such as testes or ova.

InheritanceBecause gonadal cells may carry the variant, it could be passed on to offspring.

Somatic Variant

DefinitionA variation that occurs over time and is restricted to a specific cell or cells derived from it.

InheritanceIf somatic variants are limited to cells that are not in the gonads, they will not be passed on to offspring.

Pharmacogenomics

DefinitionThe study of how a person's genetic makeup affects the body's response to drugs.

Genetic Panel

DefinitionA test that simultaneously evaluates multiple genes rather than sequentially testing individual genes.

Included methodsGenetic panels include panels performed by next-generation sequencing, massive parallel sequencing, and chromosomal microarray analysis.

ScopePanels may focus on a few genes or include a large number of genes.

ExclusionPanels reporting gene-expression profiling are not included when they generally do not directly evaluate genetic variants.

Proprietary Laboratory Analysis (PLA)

DefinitionA proprietary clinical laboratory analysis code.

Laboratory scopeA PLA may describe a sole-source laboratory test or a test licensed or marketed to multiple providing laboratories.

Test categoriesPLA codes include advanced diagnostic laboratory tests and clinical diagnostic laboratory tests defined under PAMA of 2014.

Coding precedenceWhen a PLA code is available for a proprietary laboratory service, it takes precedence and the service should not be reported with another CPT code.

Multianalyte Assay with Algorithmic Analysis (MAAA)

DefinitionA procedure that uses multiple results derived from assays of various types and performs algorithmic analysis to produce a numeric score or probability.

Possible assay inputsInputs may include molecular pathology, fluorescent in situ hybridization, protein, polypeptide, lipid, or carbohydrate assays.

Additional informationOther patient information may also be used in the algorithmic analysis.

Typical providerMAAAs are typically unique to a single clinical laboratory or manufacturer.

One or both individuals belong to a population known to have a carrier rate exceeding the threshold considered appropriate for testing for the particular condition

Carrier-rate threshold appropriate for the particular condition

No prior testing: Previous carrier screening or individual targeted gene testing for the gene variant or variants of interest has not been performed

Germline Testing for Diagnosis, Etiology, or Future Disease Risk

Germline testing is covered when all of the following requirements are met:

Germline testing eligibility

Qualifying indication
- Suspected diagnosis: Testing confirms a suspected diagnosis in a patient with signs and/or symptoms of the condition
- Clinical syndrome etiology: Testing identifies a causative etiology for a clinical syndrome with multiple possible underlying conditions
- Future disease risk: Testing an asymptomatic individual determines future risk of disease

Cancer Genetic Testing for Risk Assessment or Targeted Treatment

Cancer genetic testing is covered when at least one of the following indications is present:

Cancer testing indication

Future cancer-risk assessment: Testing an asymptomatic patient determines future risk of cancer
Targeted treatment selection: Testing cancer cells from an affected individual benefits the individual by directing targeted treatment based on specific somatic variants

Biomarker Testing with Demonstrated Clinical Utility

Biomarker testing is covered when all applicable requirements are met:

Demonstrated clinical utility: Testing is used for diagnosis, treatment, appropriate management, or ongoing monitoring of a member's disease or condition to guide treatment decisions, and the test provides clinical utility demonstrated by medical and scientific evidence

Relevant evidence may include a labeled indication for an FDA-approved or FDA-cleared test, an indicated test for an FDA-approved drug, a CMS National Coverage Determination, a Medicare Administrative Contractor Local Coverage Determination, or nationally recognized clinical practice guidelines and consensus statements.