CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Investigational Genetic and Molecular Laboratory Tests Coverage Criteria

Defines coverage stance for a list of proprietary and emerging genetic and molecular laboratory tests for Medicare Advantage and Commercial products offered by Blue Cross Blue Shield of Rhode Island; applies to ordering providers and participating laboratories regarding authorization and billing.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyInvestigational Genetic and Molecular Laboratory Tests Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionOrdering physicians must handle authorization and laboratories may not obtain authorization on behalf of the ordering physician.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11named tests listed as investigational / not covered

0355U–0415UPLA codes cited

RequiredPrior auth for unlisted CPT

Medicare & CommercialProducts affected

Coverage Criteria — Investigational / Not Covered Tests

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Not covered / Not medically necessary

Listed tests are considered investigational due to insufficient evidence of clinical validity or utility.

Not covered / Not medically necessary list: The following tests are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products because evidence is insufficient to determine improvement in net health outcome: Polygenic Risk Score; Thyroid GuidePx (Protean Biodiagnostics); Apolipoprotein L1 (APOL1) Renal Risk Variant Genotyping (Quest Diagnostics); Oncuria Detect (DiaCarta Clinical Lab); Oncuria Monitor (DiaCarta Clinical Lab); Oncuria Predict (DiaCarta Clinical Lab); CyPath Lung (Precision Pathology Services / bioAffinity Technologies); BTG Early Detection of Pancreatic Cancer (Breakthrough Genomics); Avantect Pancreatic Cancer Test (ClearNote Health); SmartVascular DX (SmartHealth DX).

This is a blanket investigational stance for the named tests in this policy.

Some genetic test services may be subject to plan-level contract exclusions for self-funded employer groups. For Commercial Products, coverage can vary by the member’s Benefit Booklet; if an employer group has specifically excluded expanded biomarker or proprietary genetic testing related to the state biomarker mandate, those tests may be listed as contract exclusions. Refer to the member’s Benefit Booklet and related policy sections for the Genetic Test Services or Proprietary Laboratory Analyses policies to determine whether a particular test is covered, not medically necessary, or contractually excluded.

Specific PLA codes are referenced in this policy for named tests and are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products. Examples include PLA codes such as 0355U (APOL1 Renal Risk Variant Genotyping), 0362U (Thyroid GuidePx gene-expression profiling), 0365U/0366U/0367U (Oncuria Detect/Monitor/Predict protein biomarker panels), and additional PLA codes listed in the coding section of this policy. Use of these PLA codes for the named tests will follow the not-covered / not medically necessary determinations in this policy.

Coding — PLA and CPT Codes

PLA / relevant CPT codes citedmixed

0355U	APOLL (apolipoprotein L1) (eg, chronic kidney disease), risk variants (G1, G2)
81479	Polygenic Risk Score (Many) — unlisted or miscellaneous molecular pathology code
0362U	Oncology (papillary thyroid cancer), gene-expression profiling via targeted hybrid capture enrichment RNA sequencing of 82 content genes and 10 housekeeping genes
0365U	Oncuria Detect — immunoassays, urine, algorithm reported as probability of harboring urothelial cancer
0366U	Oncuria Monitor — analysis of 10 protein biomarkers, urine, algorithm reported as a probability of recurrent bladder cancer
0367U	Oncuria Predict — analysis of 10 protein biomarkers, urine, diagnostic algorithm reported as risk score for rapid recurrence
0405U	BTG Early Detection of Pancreatic Cancer — 59 methylation haplotype block markers, NGS, plasma
0406U	CyPath Lung — flow cytometry, sputum, 5 markers, algorithm reported as likelihood of lung cancer
0410U	Avantect Pancreatic Cancer Test — DNA whole genome sequencing with 5-hydroxymethylcytosine enrichment, whole blood or plasma
0415U	SmartVascular DX — immunoassay panel combined with demographic/clinical data, reported as 5-year risk score for acute coronary syndrome

Unlisted proceduresCPT

Unlisted CPT

Used when no specific CPT exists for the service; authorization required

Provider Actions — Authorization, Billing, and Denial Risks

Prior Authorization

Prior Authorization Required

All Unlisted genetic testing CPT codes and PLA (proprietary lab analyte) genetic tests require prior authorization. Authorization is required to determine the exact service being rendered and whether it is covered or medically necessary.

All Unlisted genetic testing CPT codes require authorization.
PLA codes and specific proprietary tests listed in policy require authorization and may be considered not covered or not medically necessary for certain products.

Documentation Required

Ordering Physician Responsible for Authorization

Only the ordering physician may initiate and manage the authorization, appeal, and related administrative processes. Laboratories are not permitted to obtain clinical authorization or otherwise participate in the authorization process on behalf of the ordering physician.

Laboratories may not obtain authorization or act as the ordering physician's representative in authorization or appeals.
If a laboratory provides a service that was not authorized, the service will be denied and the participating laboratory may be held financially liable and may not bill the member.

Denial Risk

Denial and Financial Liability Risk for Unauthorized Lab Services

If an unauthorized laboratory service is provided, the service will be denied and the financial liability will rest with the ordering provider or the submitting laboratory per policy.

Unauthorized lab services will be denied as the financial liability of the ordering provider or participating laboratory.
Use of a laboratory representative or third party to obtain authorization on behalf of the ordering physician is a policy violation and may result in sanctions, up to termination from the BCBSRI provider network.

Billing Rule

Provider Administrative Responsibilities

Providers must handle all authorization and administrative responsibilities; laboratories may not obtain authorization on behalf of the ordering physician or participate in preparing authorization documentation.

The ordering physician must be involved in the authorization, appeal, or any administrative processes related to medical necessity determinations.
Unlisted CPT coding should be used where no specific CPT exists, but authorization is still required to define the service and coverage.

Specific Tests Determined Not Covered

The following proprietary and emerging genetic and molecular tests are designated as not covered for Medicare Advantage Plans and not medically necessary for Commercial Products because the evidence is insufficient to demonstrate an improvement in net health outcomes: Polygenic Risk Score (Many); Thyroid GuidePx (Protean Biodiagnostics); Apolipoprotein L1 (APOL1) Renal Risk Variant Genotyping (Quest Diagnostics); Oncuria Detect, Oncuria Monitor, and Oncuria Predict (DiaCarta Clinical Lab); CyPath Lung (Precision Pathology Services / bioAffinity Technologies); BTG Early Detection of Pancreatic Cancer (Breakthrough Genomics); Avantect Pancreatic Cancer Test (ClearNote Health); and SmartVascular DX (SmartHealth DX).

Background

Scope: This policy applies to laboratory-developed tests (LDTs) and proprietary genetic and molecular assays that are in developmental phases and have limited published evidence on clinical validity and clinical utility. Such tests include, but are not limited to, polygenic risk scores, gene-expression profiling panels (e.g., Thyroid GuidePx), urine protein biomarker panels (Oncuria), methylation-based cfDNA assays for pancreatic cancer (e.g., BTG), flow cytometry sputum assays (e.g., CyPath Lung), whole-genome sequencing with 5-hydroxymethylcytosine enrichment (e.g., Avantect), and combined protein-plus-algorithm cardiovascular risk tests (e.g., SmartVascular DX). The primary rationale for the policy is that many of these proprietary LDTs lack independent evaluation or sufficient evidence that their use improves net health outcomes; when a separate evidence review exists for a specific test, that review supersedes this policy.

Definitions

Laboratory-developed test (LDT) — definition and CLIA-related validation requirements

DefinitionLaboratory-developed test (LDT): a clinical laboratory–developed and -validated test offered as a laboratory service, often proprietary and available clinically before an evidence base is established.

CLIA licensing requirementLaboratories that offer LDTs must be licensed under the Clinical Laboratory Improvement Amendments (CLIA) for high-complexity testing.

Regulatory reviewTo date, the U.S. Food and Drug Administration has chosen not to require routine regulatory review of many LDTs.

Evidence expectationsMany proprietary LDTs lack independent evaluation and have limited published data addressing clinical validity, clinical utility, or the test's role in the clinical pathway.

Implication for coverageBecause evidence of clinical utility is insufficient or non-evaluable for the tests addressed in this policy, they are considered investigational pending further evidence or a separate evidence review.