Summary & Overview

CPT 0586U: RNA Salah Targeted Expression Panel, 216-Gene mRNA Tumor Profile

CPT code 0586U is a Proprietary Laboratory Analyses (PLA) code reserved for the RNA Salah Targeted Expression Panel from Moffitt Cancer Center Advanced Diagnostics Laboratory. The assay quantifies messenger RNA (mRNA) expression for 216 genes in formalin–fixed, paraffin–embedded (FFPE) tumor tissue and reports results as log2 ratios. As a PLA code, 0586U identifies a single proprietary test and is critical for accurate billing and tracking of novel, lab-specific molecular diagnostics nationwide.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication provides a national overview useful to hospital billing teams, clinical laboratories, and policy analysts seeking clarity on coverage patterns and coding practice for proprietary tumor gene-expression assays.

Readers will learn the clinical context of the assay, typical sites of service, and the role of PLA coding in distinguishing manufacturer- or lab-specific tests. The report summarizes benchmarks where available, highlights relevant policy considerations for proprietary laboratory codes, and outlines operational details that affect billing and claims submission. Data not available in the input is noted explicitly where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0586UCPTProprietary Laboratory AnalysesmRNA expressiontumor profilingFFPEmolecular diagnosticsgene expression paneloncology testing

Billing Code Overview

CPT code 0586U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the RNA Salah Targeted Expression Panel from Moffitt Cancer Center Advanced Diagnostics Laboratory. The test measures messenger RNA (mRNA) expression across 216 genes in tumor tissue and reports results as log2 ratios, providing a quantitative gene-expression profile relevant to cancer biology.

Service type: Tumor tissue gene-expression profiling (mRNA panel)

Typical site of service: Clinical laboratory using formalin–fixed, paraffin–embedded (FFPE) tumor tissue samples

Clinical & Coding Specifications

Clinical Context

A 62-year-old patient with a history of invasive breast carcinoma undergoes surgical resection of a tumor. The oncology team requests tumor profiling to guide prognosis and potential targeted therapies. A formalin–fixed, paraffin–embedded (FFPE) block from the resected tumor is sent to Moffitt Cancer Center Advanced Diagnostics Laboratory. The laboratory performs the RNA Salah Targeted Expression Panel, which measures messenger RNA (mRNA) levels across 216 genes and reports results as log2 ratios to provide a quantitative gene-expression profile of the tumor.

The clinical workflow: the surgical or pathology team identifies and documents tumor tissue, prepares an FFPE block, completes the laboratory requisition with clinical history and relevant ICD-10 diagnosis codes, and ships the specimen to the reference lab. The reference lab performs RNA extraction, targeted gene-expression analysis, data quality control, and bioinformatic normalization to log2 ratios. Results are returned to the ordering provider and integrated into the oncology care plan for multidisciplinary discussion.

Coding Specifications

Modifier	Description	When to Use
`00`	Standard technical and professional components included	Use when billing the PLA code without any special circumstances modifying payment or reporting.
`22`	Increased procedural services	Use when the laboratory documents substantially greater work or complexity for the test (rare for PLA but applicable if extensive analytic or interpretive work documented).
`52`	Reduced services	Use when the test is partially completed or limited compared with the full descriptor (for example, limited analysis due to insufficient RNA quantity).
`53`	Discontinued procedure	Use when specimen processing is started but the procedure is discontinued for valid clinical reasons.
`76`	Repeat procedure by same provider	Use when the same laboratory performs the identical test again for the same patient during the same encounter (if applicable under payer rules).
`77`	Repeat procedure by another provider	Use when a different certified laboratory repeats the test for confirmation.
`90`	Reference (outside) laboratory	Use when the ordering provider bills and the test was performed by an outside reference laboratory (billing arrangements permitting).
`91`	Repeat clinical diagnostic laboratory test	Use for repeated measurements to obtain serial comparison when the payer allows repeat testing billing.
`59`	Distinct procedural service	Use when a separate unrelated laboratory test is performed on the same day and requires distinct reporting (ensure clinical documentation supports distinctness).
`96`	Habilitative services modifier (laboratory-specific use varies)	Use only if payer-specific guidance recognizes this modifier for lab services (rare).

Taxonomy Code	Specialty	Notes
`208000000X`	Anatomic Pathology	Pathologists oversee tissue handling, specimen adequacy assessment, and interpretation of molecular test results.
`207RI0000X`	Hematopathology	Relevant when the tumor is hematologic or when hematopathologists collaborate on molecular tumor profiling.
`363L00000X`	Clinical Laboratory	Clinical laboratory specialists and laboratory directors manage analytical performance and reporting of PLA tests.
`208000000X`	Molecular Genetic Pathology	Specialists in molecular diagnostics who validate and interpret complex gene-expression profiles.
`282N00000X`	Oncology	Medical oncologists order the test for treatment planning and incorporate results into therapeutic decision-making.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C50.919`	Malignant neoplasm of unspecified site of unspecified breast	Breast cancer is a common indication for tumor gene-expression profiling to inform prognosis and therapy selection.
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Lung cancers frequently undergo molecular profiling, including expression panels, to guide targeted therapy decisions.
`C18.9`	Malignant neoplasm of colon, unspecified	Colorectal tumors may be profiled for gene-expression patterns relevant to prognosis and treatment stratification.
`C71.9`	Malignant neoplasm of brain, unspecified	Primary brain tumors may be evaluated with molecular panels to characterize tumor biology and clinical behavior.
`C61`	Malignant neoplasm of prostate	Prostate cancer can be assessed with RNA expression panels for risk stratification and management planning.
`C80.1`	Malignant (primary) tumor, unspecified	Used when a malignant tumor is known but the primary site or details are not fully specified at the time of testing.
`D49.9`	Neoplasm of uncertain or unknown behavior, unspecified	Applied when a lesion requires molecular profiling to clarify malignant potential or guide further diagnostic steps.
`Z85.3`	Personal history of malignant neoplasm of breast	History codes are relevant when profiling recurrent or new lesions in patients with prior cancer history.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Used by pathology to evaluate the resected tumor and select blocks for molecular testing prior to sending FFPE tissue to the reference lab.
`88104`	Cytopathology, smears or preps—cell blocks and ancillary testing preparation	Relevant when cytology specimens are the source of nucleic acid for molecular panels; preparatory work may precede PLA testing.
`0002M`	Molecular pathology procedure, sequencing-based assay of multiple genes (example panel)	Represents other molecular panel codes that may be ordered in parallel or as alternatives to targeted expression panels (billing depending on payer policies).
`81210`	BRCA1 gene analysis	Example hereditary or somatic single-gene tests that may be ordered adjunctively depending on tumor type; often part of broader molecular workup when indicated.
`0042U`	Another PLA code (example)	Other proprietary laboratory analyses that may be performed alongside or as follow-up tests depending on tumor profile and clinical questions.
`81025`	Urine pregnancy test, qualitative	Administrative pre-procedure test sometimes performed for reproductive-age patients prior to therapy decisions (workflow adjunct rather than directly related).

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Summary & Overview

CPT 0586U: RNA Salah Targeted Expression Panel, 216-Gene mRNA Tumor Profile

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0586UCPTProprietary Laboratory AnalysesmRNA expressiontumor profilingFFPEmolecular diagnosticsgene expression paneloncology testing

Billing Code Overview

Service type: Tumor tissue gene-expression profiling (mRNA panel)

Typical site of service: Clinical laboratory using formalin–fixed, paraffin–embedded (FFPE) tumor tissue samples

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Modifier	Description	When to Use
`00`	Standard technical and professional components included	Use when billing the PLA code without any special circumstances modifying payment or reporting.
`22`	Increased procedural services	Use when the laboratory documents substantially greater work or complexity for the test (rare for PLA but applicable if extensive analytic or interpretive work documented).
`52`	Reduced services	Use when the test is partially completed or limited compared with the full descriptor (for example, limited analysis due to insufficient RNA quantity).
`53`	Discontinued procedure	Use when specimen processing is started but the procedure is discontinued for valid clinical reasons.
`76`	Repeat procedure by same provider	Use when the same laboratory performs the identical test again for the same patient during the same encounter (if applicable under payer rules).
`77`	Repeat procedure by another provider	Use when a different certified laboratory repeats the test for confirmation.
`90`	Reference (outside) laboratory	Use when the ordering provider bills and the test was performed by an outside reference laboratory (billing arrangements permitting).
`91`	Repeat clinical diagnostic laboratory test	Use for repeated measurements to obtain serial comparison when the payer allows repeat testing billing.
`59`	Distinct procedural service	Use when a separate unrelated laboratory test is performed on the same day and requires distinct reporting (ensure clinical documentation supports distinctness).
`96`	Habilitative services modifier (laboratory-specific use varies)	Use only if payer-specific guidance recognizes this modifier for lab services (rare).

Taxonomy Code	Specialty	Notes
`208000000X`	Anatomic Pathology	Pathologists oversee tissue handling, specimen adequacy assessment, and interpretation of molecular test results.
`207RI0000X`	Hematopathology	Relevant when the tumor is hematologic or when hematopathologists collaborate on molecular tumor profiling.
`363L00000X`	Clinical Laboratory	Clinical laboratory specialists and laboratory directors manage analytical performance and reporting of PLA tests.
`208000000X`	Molecular Genetic Pathology	Specialists in molecular diagnostics who validate and interpret complex gene-expression profiles.
`282N00000X`	Oncology	Medical oncologists order the test for treatment planning and incorporate results into therapeutic decision-making.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C50.919`	Malignant neoplasm of unspecified site of unspecified breast	Breast cancer is a common indication for tumor gene-expression profiling to inform prognosis and therapy selection.
`C34.90`	Malignant neoplasm of unspecified part of unspecified bronchus or lung	Lung cancers frequently undergo molecular profiling, including expression panels, to guide targeted therapy decisions.
`C18.9`	Malignant neoplasm of colon, unspecified	Colorectal tumors may be profiled for gene-expression patterns relevant to prognosis and treatment stratification.
`C71.9`	Malignant neoplasm of brain, unspecified	Primary brain tumors may be evaluated with molecular panels to characterize tumor biology and clinical behavior.
`C61`	Malignant neoplasm of prostate	Prostate cancer can be assessed with RNA expression panels for risk stratification and management planning.
`C80.1`	Malignant (primary) tumor, unspecified	Used when a malignant tumor is known but the primary site or details are not fully specified at the time of testing.
`D49.9`	Neoplasm of uncertain or unknown behavior, unspecified	Applied when a lesion requires molecular profiling to clarify malignant potential or guide further diagnostic steps.
`Z85.3`	Personal history of malignant neoplasm of breast	History codes are relevant when profiling recurrent or new lesions in patients with prior cancer history.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Used by pathology to evaluate the resected tumor and select blocks for molecular testing prior to sending FFPE tissue to the reference lab.
`88104`	Cytopathology, smears or preps—cell blocks and ancillary testing preparation	Relevant when cytology specimens are the source of nucleic acid for molecular panels; preparatory work may precede PLA testing.
`0002M`	Molecular pathology procedure, sequencing-based assay of multiple genes (example panel)	Represents other molecular panel codes that may be ordered in parallel or as alternatives to targeted expression panels (billing depending on payer policies).
`81210`	BRCA1 gene analysis	Example hereditary or somatic single-gene tests that may be ordered adjunctively depending on tumor type; often part of broader molecular workup when indicated.
`0042U`	Another PLA code (example)	Other proprietary laboratory analyses that may be performed alongside or as follow-up tests depending on tumor profile and clinical questions.
`81025`	Urine pregnancy test, qualitative	Administrative pre-procedure test sometimes performed for reproductive-age patients prior to therapy decisions (workflow adjunct rather than directly related).