CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Proprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA)

Defines coverage, medical necessity, and prior authorization requirements for PLA and MAAA genetic testing services for Blue Cross Blue Shield of Rhode Island members, including distinctions for Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyProprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests via the BCBSRI online prior authorization tool (fax to Utilization Management at (401) 272-8885 if not in the tool).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1PLA & MAAA categories

10/01/2025Effective date

RequiredPrior auth (MA)

Per-component authPanel testing

Coverage Criteria

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Medical necessity and panel testing

Covered when ALL of the following general conditions and indication-specific criteria are met:

General: Test is of the individual's germline or therapeutic somatic testing to benefit the individual; prior testing or clinical context supports testing; carrier screening criteria met when applicable.

General eligibility per policy

Carrier screening: One or both individuals have a first- or second-degree relative who is affected; OR one individual is a known carrier; OR one or both individuals are members of a population with a carrier rate exceeding an appropriate threshold; AND previous carrier screening or targeted testing for the gene variant(s) of interest has not been performed.

First- and second-degree relatives defined in policy

Genetic diagnostic testing: Testing of the individual's germline is intended to confirm a suspected diagnosis in a patient with signs/symptoms; OR to identify a causative etiology for a clinical syndrome with multiple possible underlying conditions; OR testing an asymptomatic individual to determine future risk of disease.

Includes cancer risk assessment

Genetic testing for cancer: Testing an asymptomatic patient to determine future risk of cancer; OR therapeutic testing of tumor (somatic) cells to direct targeted treatment based on specific somatic variants.

Somatic therapeutic testing must benefit the individual

Panel testing authorization: When a panel is represented by multiple CPT codes, prior authorization is required for each component/CPT code and must be entered and processed independently through the online authorization tool.

Panel tests are subject to additional criteria; InterQual criteria used in online tool

Services are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products when: there is insufficient clinical evidence or strength of recommendation; test results would not reasonably be used in patient management; or the services are unlikely to impact therapeutic decision-making in the clinical management of the patient. Laboratories are not permitted to obtain clinical authorization on behalf of the ordering physician; only the ordering physician may participate in prior authorization, appeal, or related administrative processes.

Whole genetic panels are considered not covered for Medicare Advantage Plans and not medically necessary for Commercial Products when there is insufficient evidence that an individual gene or gene variant included in the panel will be used to guide treatment decisions or improve net health outcomes. When evidence is lacking that an individual component of a panel can affect clinical management, the policy treats the entire panel test as not covered/not medically necessary.

Covered Indications

Carrier screening, diagnostic germline testing, asymptomatic risk assessment for cancer, and therapeutic somatic testing to direct targeted cancer treatment when criteria met

Use InterQual criteria in the online authorization tool; panels have additional criteria. For services requiring prior authorization, the online tool determines medical necessity and panels require per-component authorization.

Authorization source: InterQual criteria within BCBSRI's online prior authorization tool is used to determine medical necessity for the majority of genetic testing requests.

See online authorization tool

Panel-specific rules: Panel tests are subject to additional criteria; when a panel is represented by multiple CPT codes each CPT component must be authorized independently through the online tool.

Refer to Policy Statement and Prior Authorization sections before using medical necessity criteria

Coverage limitations: Genetic testing services (including panels) are not covered for Medicare Advantage Plans and are not medically necessary for Commercial Products when there is insufficient clinical evidence, results would not be used in patient management, or services are unlikely to impact therapeutic decision-making.

Whole panels lacking evidence that individual genes/variants impact treatment decisions are not covered

Authorization responsibility: Only the ordering physician may be involved in authorization, appeals, or other administrative processes related to prior authorization/medical necessity; laboratories are not permitted to obtain authorization on behalf of the ordering physician.

Operational requirement

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

For those tests in which prior authorization is indicated in the attached code grid, prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products.

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products.
Requests for authorization should be submitted via the BCBSRI online prior authorization tool by participating providers; non-participating providers may fax to Utilization Management at (401) 272-8885.

Note

Submission Methods

Requests for authorization of genetic testing should be submitted via the BCBSRI online prior authorization tool, which is available to BCBSRI-participating providers. If a genetic test is not found in the online authorization tool, fax the request to Utilization Management at (401) 272-8885.

If a genetic test is not found in the online tool, fax the request to Utilization Management at (401) 272-8885.

Prior Authorization

Panel Testing — Per-Component Authorization

Panel testing requires prior authorization per component. When a panel is represented by multiple CPT codes, each individual CPT code must be entered into and processed through the online authorization tool independently.

Panel testing: prior authorization is required for each component and/or gene/gene variant when represented by multiple CPT codes.
Enter and process each individual CPT code separately in the online authorization tool.

Documentation Required

Provider Authorization Requirements

Only the ordering physician shall be involved in the authorization, appeal, or other administrative processes related to prior authorization. Effective 10/1/2025, for Fully-Funded Commercial Products only, prior authorization requests may not be needed when the requesting physician is a BCBSRI-contracted Primary Care Provider (PCP). This exemption does not apply to Self-Funded Commercial Products or Medicare Advantage Plans.

Effective 10/1/2025 exemption applies only to Fully-Funded Commercial Products and only when the requesting physician is a BCBSRI-contracted PCP.
Prior authorization continues to be required for Self-Funded Commercial Products and Medicare Advantage Plans.

Note

PCP Specialties Included in Exemption

The following specialties, when credentialed as a primary care provider, are included in the Fully-Funded Commercial Products exemption effective 10/1/2025: Internal Medicine; Pediatric Medicine; Family Practice; Obstetrics and Gynecology; Doctor of Osteopathic Medicine; NP (Nurse Practitioner)/PCP; PA (Physician Assistant).

Internal Medicine
Pediatric Medicine
Family Practice
Obstetrics and Gynecology
Doctor of Osteopathic Medicine
NP/PCP
PA

Denial Risk

Improper Authorization Procurement Prohibited

In no circumstance shall a laboratory or a physician/provider use a laboratory representative or any third party to obtain authorization on behalf of the ordering physician, to facilitate any portion of the authorization process, or to prepare documentation of clinical appropriateness. Use of a laboratory representative or third party to obtain authorization is a violation and may result in severe action including termination from the BCBSRI provider network and denial of services.

Use of a laboratory representative or third party to obtain authorization or support the authorization/appeal process is prohibited and will be deemed a violation.
Violations may result in termination from the BCBSRI provider network and denial/penalty.

Denial Risk

Unauthorized Service Denial

If a laboratory provides a laboratory service that has not been authorized, the service will be denied and will be the financial liability of the participating laboratory and may not be billed to the member.

Unauthorized services will be denied and billed to the provider, not the member.

Definitions

Proprietary Laboratory Analyses (PLA)

DefinitionProprietary Laboratory Analyses (PLA) — alpha‑numeric CPT codes describing proprietary clinical laboratory analyses that may be provided by a single (sole‑source) laboratory or licensed/marketed to multiple laboratories (eg, FDA cleared or approved).

Code precedenceWhen a PLA code is available to report a given proprietary laboratory service, that PLA code takes precedence and the service should not be reported with any other CPT code(s).

FDA statusPLA codes may or may not be FDA approved; they do not require adherence to CPT Category I code criteria or AMA review for clinical utility.

Inclusion requirementsTest must be commercially available in the U.S. for use on human specimens and the offering laboratory or manufacturer must request the PLA code.

Multianalyte Assays with Algorithmic Analyses (MAAA)

DefinitionMultianalyte Assays with Algorithmic Analyses (MAAA) — procedures that use multiple analyte results (molecular, FISH, protein, etc.) with algorithmic analysis to produce a numeric score or probability, typically unique to a single clinical laboratory or manufacturer.

Data inputsMay combine molecular pathology assays, FISH, and non–nucleic‑acid assays (eg, proteins, polypeptides, lipids, carbohydrates) and may include other patient information in the algorithm.

ReportingAlgorithmic analysis is reported typically as a numeric score(s) or probability(ies).

UniquenessMAAAs are typically unique to a single clinical laboratory or manufacturer.

OpenPayer

Proprietary Laboratory Analyses (PLA) and Multianalyte Assays with Algorithmic Analyses (MAAA)

Coverage Criteria

Covered Indications

Eligibility Requirements

Coding

Provider Actions & Authorization

Not Covered / Limitations

Background

Definitions