Non-Covered Genetic Panel Tests
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Defines genetic panel tests considered not medically necessary by Providence Health Plan and the documentation/prior authorization expectations for providers requesting genetic panel testing for Commercial plan members.
No material clinical or coverage changes in this revision.
Coverage criteria and policy scope
Not Medically Necessary (Insufficient Clinical Utility)
Not medically necessary when clinical utility is insufficient; both A and B must be met for each gene/component:
Non-covered panels due to insufficient clinical utility
Not covered when the following applies
Laboratory-performed tests must be FDA-approved and/or performed in a CLIA-accredited laboratory and scientifically validated for the requested indication; FDA approval alone does not establish medical necessity.
This policy excludes certain test types from its scope. It does not address whole exome or whole genome sequencing, nor does it address genetic tests related to reproductive planning or prenatal testing. The list of non-covered panels in this policy is illustrative and not exhaustive, and panel names, gene content, and coding may change over time. When available, condition- or test-specific medical policies should be applied instead of this general non-coverage list.
Laboratories performing genetic panel tests must meet regulatory and validation expectations. Tests should be performed in a CLIA‑accredited laboratory and the offering laboratory must have scientifically validated the panel for the intended indication. FDA approval or informational FDA status alone does not establish medical necessity. At the time of request, providers must identify the performing laboratory and supply documentation demonstrating the test’s validation and intended use.
If an unlisted code is submitted for a service that is non‑covered under this policy, the claim will be denied as not covered. For unlisted codes submitted for potentially covered services, prior authorization is recommended to reduce the risk of post‑service denial. All unlisted codes are reviewed at the claim level for medical necessity, correct coding, and pricing.
Genetic panels and multigene tests for which clinical utility has not been established are considered not medically necessary. This policy provides an extensive (but not exhaustive) illustrative list of proprietary and commercial panels identified as not medically necessary because the panels or components lack demonstrated clinical utility.
Evidence is insufficient for many of the panels and individual panel components listed in this policy. Specifically, there is insufficient evidence that all genes/components in a given panel provide actionable diagnostic, prognostic, or management‑changing information that improves health outcomes; therefore such panels or components are considered not covered.
This policy enumerates a broad set of molecular, genomic and panel testing procedure codes (CPT/PLA/HCPCS and other unique codes) that are addressed as non‑covered or listed for billing guidance. These include DNA methylation panels, mRNA/NGS expression panels, cytogenomic array and optical genome mapping codes, exome and multigene sequence panels, multianalyte algorithmic assays, and related procedure codes used to bill such services.
Billing codes and coding guidance
| 0321U | listed in non-covered panel entries |
| 0549U | listed in non-covered panel entries |
| 0012M | listed in non-covered panel entries |
| 0013M | listed in non-covered panel entries |
| 0363U | listed in non-covered panel entries |
| 0315U | listed in non-covered panel entries |
| 0288U | listed in non-covered panel entries |
| 0565U | listed in non-covered panel entries |
| 0332U | listed in non-covered panel entries |
| 0474U | listed in non-covered panel entries |
| 0012M | Oncology (urothelial), mRNA, gene expression profiling by RT-qPCR of five genes (MDK, HOXA13, CDC2 [CDK1], IGFBP5, and XCR2), urine, algorithm reported as a risk score |
| 0013M | Oncology (urothelial), mRNA, gene expression profiling by RT-qPCR of five genes, urine, algorithm reported as a risk score for recurrent urothelial carcinoma |
| 0087U | Cardiology (heart transplant), mRNA gene expression profiling by microarray of 1283 genes, transplant biopsy tissue, allograft rejection algorithm |
| 0088U | Transplantation medicine (kidney allograft rejection), microarray profiling of 1494 genes, transplant biopsy tissue, probability score for rejection |
| 0134U | Hereditary pan cancer targeted mRNA sequence analysis panel (18 genes) (List separately) |
| 0136U | ATM mRNA sequence analysis (List separately) |
| 0175U | Psychiatry genomic analysis panel, variant analysis of 15 genes |
| 0205U | Ophthalmology (age-related macular degeneration), analysis of 3 gene variants |
| 0258U | Autoimmune (psoriasis), mRNA NGS gene expression profiling of 50-100 genes |
| 0271U | Unexplained constitutional/heritable disorders, tissue-specific gene expression by whole-transcriptome and NGS |
| 0624U | DNA methylation analysis, whole blood, algorithm reported as positive or negative risk (sclerosis) |
| 0625U | DNA methylation analysis of 5,000 sites, whole blood, algorithm reported as positive or negative risk (NASH) |
| 0626U | DNA methylation analysis, whole blood, algorithm reported as positive or negative risk (osteoporosis) |
| 0627U | DNA methylation analysis of >20,000 sites, whole blood, algorithm reported as positive or negative risk (Parkinson disease) |
| 0635U | mRNA NGS gene expression profiling, reported as likelihood of response to therapy (atopic dermatitis / psychiatry references) |
| 81195 | Reported as likelihood of response to therapy |
| 81228 | Cytogenomic (genome-wide) analysis, hematologic malignancy, structural variants and copy number variants, optical genome mapping (OGM) |
| 81229 | Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; comparative genomic hybridization (CGH) microarray analysis |
| 81301 | Cytogenomic analysis for copy number and SNP variants, CGH microarray analysis |
| 81320 | Microsatellite instability analysis (e.g., Lynch syndrome) of markers for mismatch repair deficiency, includes comparison of neoplastic and normal tissue |
| 81400 | Molecular pathology procedure, Level 1 |
| 81401 | Molecular pathology procedure, Level 2 |
| 81404 | Molecular pathology procedure, Level 5 |
| 81405 | Molecular pathology procedure, Level 6 |
| 81406 | Molecular pathology procedure, Level 6 (6-10 exons) |
| 81407 | Molecular pathology procedure, Level 7 |
| 81408 | Molecular pathology procedure, Level 8 |
| 81412 | Molecular pathology, Level 9 (analysis of >50 exons) |
| 81415 | Cardiac panel duplication/deletion analysis example reference |
| 81416 | Exome sequence analysis |
| HCPCS S3844 | DNA analysis of the connexin 26 gene (GJB2) for susceptibility to congenital, profound deafness |
| HCPCS S3870 | Comparative genomic hybridization (CGH) microarray testing for developmental delay, autism spectrum disorder and/or intellectual disability |
| 81599 | Unlisted chemistry procedure |
| 84999 | Unlisted chemistry procedure (paired with 81599 in listing) |
What providers must do — documentation, prior auth, and counseling
Provide required clinical documentation with prior authorization
Requests must include the clinical documentation listed below at the time of prior authorization; include the CPT/PLA codes that will be billed with the request.
- Name of the panel test or the name of the gene(s) and/or components of the test
- Name of laboratory that performed or is performing the test
- Clinical notes: reason for performing test (including suspected condition), relevant signs/symptoms/test results, and family history if applicable
- Description of how test results will impact clinical decision making
- CPT codes billed
Prior authorization / listed CPT/PLA/unique codes
Prior authorization applies to the specific non-covered panels and associated CPT/PLA/unique codes enumerated in the policy's billing and coding section; provide those codes with requests.
- Examples of listed codes include: 0012M, 0013M, 0087U, 0088U, 0134U, 0136U, 0175U, 0205U, 0258U, 0271U, 0288U, 0289U, 0290U, 0291U, 0292U, 0293U, 0294U, 0298U, 0315U, 0319U, 0320U, 0321U, 0323U, 0332U, 0363U, 0366U, 0367U, 0420U, 0423U, 0437U, 0465U, 0474U, 0588U, 0616U, 0617U, 0618U, 0619U, 0620U, 0621U, 0622U, 0623U, 0624U, 0625U, 0626U, 0627U, 0635U, 81195, 81228, 81229, 81301, 81320
- Inclusion on the list does not guarantee coverage; codes are provided as a courtesy.
Obtain prior authorization for unlisted codes (recommended)
Prior authorization is recommended for unlisted codes submitted for potentially covered services to avoid post-service denial; unlisted codes will be reviewed at claim level.
- All unlisted codes are reviewed for medical necessity, correct coding, and pricing at the claim level
- If an unlisted code is for a potentially covered service, obtain prior authorization to reduce risk of post-service denial
Apply condition-specific policies first
When condition- or test-specific policies exist, those policies should be used to review single-gene or genetic panel tests before applying this non-coverage list.
- Refer to condition-specific medical policies (cross references in the policy) for hereditary or oncologic conditions prior to using this general policy
Engage cancer risk assessment experts for complex panels
Involve providers with expertise in cancer risk assessment when ordering or interpreting multigene panels that include genes of uncertain clinical utility, per ASCO guidance.
- Consider targeted gene testing based on personal/family history before ordering broad panels
- Specialist involvement is recommended for ordering and interpretation when panels include genes not suggested by the patient's history
Required documentation to support requests
At the time of request, include the panel name or gene list, the performing laboratory name, and clinical notes describing the reason for testing and how results will affect care.
- Panel name or specific gene list
- Performing laboratory name
- Clinical notes: suspected condition, signs/symptoms/test results, family history if applicable, and impact on clinical decision making
Laboratory accreditation and validation documentation required
Laboratory-performed tests must be FDA-approved and/or performed in a CLIA-accredited laboratory, and the laboratory must have scientifically validated the panel for the requested indication; FDA approval alone does not establish medical necessity.
- Verify CLIA accreditation and scientific validation for the intended indication
- Note that FDA approval is informational and does not by itself establish medical necessity
Unlisted codes are subject to review at claim level
All unlisted codes will be reviewed at claim adjudication for medical necessity, correct coding, and pricing; providers should expect claim-level review.
- Unlisted codes for services addressed as non-covered will be denied as not covered
- Unlisted codes for potentially covered services may be subject to prior authorization to avoid denial
Denial risk: insufficient clinical utility
Genetic panel testing will be denied as not medically necessary when there is insufficient evidence that the panel or its components provide proven clinical utility to guide management.
- Both criteria A and B in the policy must be met for each gene/component to establish clinical utility
- Panels lacking evidence that components provide actionable diagnostic, prognostic, or management-changing information are non-covered
Denial risk when clinical utility is not demonstrated
Tests or panels lacking evidence that genes/components provide actionable diagnostic, prognostic, or management-changing information are considered non-covered and may be denied.
- Insufficient evidence that all genes/components provide actionable information supports non-coverage
- Laboratory validation and indication-specific evidence are required to demonstrate clinical utility
Unlisted code submission may be denied
If an unlisted code is submitted for services that are non-covered by this policy, it will be denied as not covered; unlisted codes for potentially covered services may be reviewed but prior authorization is recommended to avoid post-service denial.
- Unlisted codes for non-covered services addressed in this policy will be denied
- Obtain prior authorization for unlisted codes for potentially covered services to reduce denial risk
See MP316 for genetic counseling considerations
Refer to related policy MP316 (Genetic Counseling) for counseling considerations; this policy references genetic counseling but does not itself list specific pre/post counseling mandates.
- See MP316 for guidance on genetic counseling considerations
Involve clinicians experienced in cancer risk assessment
Ordering and interpretation of multigene panels that include genes of uncertain clinical utility should involve clinicians experienced in cancer risk assessment, as recommended by ASCO.
- Specialist involvement is recommended for panels containing genes not suggested by the patient's history
Supply clinical rationale and use condition-specific policies when available
Provide a clinical rationale and the required documentation with any request for panel testing; when condition-specific genetic testing policies exist, use those policies first to guide ordering and review.
- Supply clinical rationale (reason for testing, relevant findings, family history) and documentation at time of request
- Use condition-specific policies when available before applying this general non-coverage policy
Require experienced providers for interpretation of uncertain-significance genes
Ordering and interpretation should involve providers experienced in cancer risk assessment when panels include genes of uncertain clinical significance; consider specialist input for interpretation and management.
- Specialist ordering and interpretation recommended for panels that include genes of uncertain clinical utility
- Consider targeted testing guided by personal/family history prior to broad panel testing
Explicitly not medically necessary tests and panels
The document explicitly lists numerous proprietary and commercial panels that are considered not medically necessary due to insufficient evidence of clinical utility. Examples include named tests such as AlloSure Kidney, CancerTYPE ID, CxBladder series, DecisionDx‑SCC, DetermaRx, MindX blood tests, Molecular Microscope (MMDx) assays, Percepta, Prospera, TruDiagnostic tests, and many Invitae and other company panels.
Panels and codes listed in the billing and coding section are identified as lacking demonstrated clinical utility; the policy therefore treats these genetic panels and their component genes as not covered when the individual genes/components are not shown to provide actionable clinical information. Specific components and gene counts tied to certain hereditary condition panels are provided in the coding guidance.
Numerous PLA, CPT and HCPCS codes appear in the billing section and are addressed as non‑covered or listed for this policy. These include DNA methylation analysis codes (for multiple site counts), cytogenomic and MSI testing codes (e.g., 81228, 81229, 81301, 81320), molecular pathology and exome-related CPT codes (e.g., 81400–81412, 81415–81417, 81434), multianalyte algorithm codes (e.g., 81504, 81599), and other unique PLA codes enumerated in the coding tables.
Definitions and key terms
Eligibility and applicability
No top‑level eligibility criteria are defined in this policy; eligibility requirements for specific tests are not specified in the inventory.
There are no additional top‑level eligibility nodes captured in the inventory for this policy.
No further eligibility placeholders were identified in the policy inventory.
Background and rationale
Genetic panel tests analyze multiple genes simultaneously and can improve diagnostic efficiency, but they frequently identify variants of uncertain significance (VUS) that do not alter clinical management and may lead to unnecessary procedures or harm. High‑quality evidence supports clinical utility for only selected panels; many commercially available panels and novel algorithmic tests lack peer‑reviewed evidence demonstrating improved diagnostic yield or improved health outcomes. For a panel to be considered clinically useful under this policy, testing must provide a definitive diagnosis or risk classification and avoid invasive testing when appropriate, and test results must guide clinical management.
Policy revision history
Q3 2026 code set update.
Q2 2026 code set update.
Interim update removing panels from the non-covered panel table.
Annual update revising the 'not medically necessary' list and Q4 2025 code set update.
Q3 2025 code set update; code added.
Q2 2025 code set update.
Q1 2025 code set update; updated 'not medically necessary' list.
Q3 2024 code set update.
Q1 2024 code set update.
Annual update with revisions to the list of non-covered panels.
Denial criteria changed from investigational to not medically necessary and Q4 2023 code set update.
Annual review; panels and codes already addressed by another policy were removed.
Q2 2023 code set update.
Converted to new policy template.
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