Summary & Overview
CPT 0462U: Salivary Melatonin Profile (Circadian Phase Assessment)
CPT code 0462U designates a Proprietary Laboratory Analyses (PLA) test for the Salimetrics® Salivary Melatonin Profile (Circadian Phase Assessment), a specialized ELISA-based assay that creates a melatonin profile from seven or nine saliva samples and may include cortisol. This PLA code identifies a single manufacturer-specific test used to assess circadian phase and sleep-wake biology. Nationally, PLA codes like 0462U matter because they standardize reporting for unique commercial assays and influence lab billing, coverage reviews, and claims adjudication for novel diagnostics.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of clinical context for salivary melatonin profiling, guidance on where the service is typically performed, and the practical implications of a PLA-designated CPT code for billing workflows and payer communications. The publication covers benchmarks and reimbursement context where available, common billing and documentation considerations for proprietary assays, and relevant policy updates affecting laboratory diagnostics and PLA codes. Data not available in the input will be explicitly noted in specific sections.
Billing Code Overview
CPT code 0462U is a Proprietary Laboratory Analyses (PLA) code reported exclusively for the Salimetrics® Salivary Melatonin Profile (Circadian Phase Assessment) from Salimetrics® LLC. The test produces a melatonin profile from either seven or nine salivary samples and may include cortisol. The assay method is enzyme–linked immunosorbent assay (ELISA). Melatonin measurements are used to assess circadian phase and are associated with sleep and wakefulness.
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Service type: Proprietary laboratory diagnostic assay (salivary hormone profiling)
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Typical site of service: Clinical laboratory or specialized diagnostic laboratory; specimen collection typically occurs in outpatient or home settings with subsequent laboratory processing.
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult or adolescent referred for evaluation of suspected circadian rhythm sleep–wake disorder, unexplained insomnia, excessive daytime sleepiness, or shift work-related sleep disruption. A primary care physician, sleep medicine specialist, or pediatrician orders the Salimetrics® Salivary Melatonin Profile (0462U) when assessment of endogenous melatonin secretion timing is needed to determine circadian phase or to guide timed melatonin therapy. The patient collects multiple saliva samples at home (seven or nine timed collections) across an evening and night period per the laboratory kit instructions. The specimen is returned to the performing laboratory (Salimetrics®) where the enzyme–linked immunosorbent assay (ELISA) is run to generate a melatonin concentration profile, optionally with cortisol if included. Results are reviewed by the ordering clinician to correlate melatonin onset/offset with reported sleep patterns and to inform treatment planning such as chronotherapy, light therapy scheduling, or medication timing. Typical site of service is an outpatient clinic, specialty sleep center, or home collection with laboratory processing; specimens are analyzed in a reference or proprietary central laboratory.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When reporting only the physician or professional interpretation component separate from the laboratory technical processing (rare for PLA tests when split billing is allowed). |
TC | Technical component | When reporting only the laboratory technical component; used if professional interpretation is billed separately. |
QK | CLIA waived test performed at point of care by laboratory certified under CLIA | If a performing site meets conditions and reports technical component under the CLIA pathway (unlikely for this PLA but included from provided list). |
QX | Service performed by an auxiliary (e.g., non-physician practitioner) under physician supervision | When the specimen handling or test ordering is performed by auxiliary staff under supervision as allowed by payer rules. |
QY | POCT certification exception | When point-of-care testing meets state licensure exemptions per payer guidance (seldom applicable to proprietary centralized assays). |
52 | Reduced services | When fewer samples or an abbreviated panel is processed than originally planned (e.g., fewer collection timepoints completed). |
53 | Discontinued procedure | If testing cannot be completed due to collection failure and the claim reflects a discontinued attempt. |
78 | Unplanned return to operating/procedure room by the same physician/other after initial procedure | Rare; included for completeness when an unplanned repeat specimen collection procedure occurs under the same encounter. |
80 | Assistant surgeon | Not typically applicable but used when an assisting provider performed technical aspects during an in-facility collection procedure. |
62 | Two surgeons | Rarely applicable; used when two providers share responsibility for an invasive specimen collection during the encounter. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207R00000X | Sleep Medicine | Clinicians who commonly order circadian assessments and interpret melatonin profiles. |
| 207L00000X | Pulmonary Disease (Sleep Medicine) | Pulmonologists with sleep specialty involvement in sleep disorder diagnosis and management. |
| 208D00000X | Pediatrics | Pediatricians managing delayed sleep phase or other circadian disorders in adolescents. |
| 207S00000X | Neurology | Neurologists involved when neurologic causes of sleep–wake disturbance are being evaluated. |
| 363L00000X | Clinical Laboratory | Laboratory directors and technologists responsible for performing the ELISA analysis in the reference lab. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
G47.20 | Circadian rhythm sleep disorder, unspecified | Frequently used when assessing circadian phase with melatonin profiling to evaluate timing of endogenous melatonin secretion. |
G47.00 | Insomnia, unspecified | Melatonin profiling may help differentiate circadian-driven insomnia from other causes. |
G47.33 | Obstructive sleep apnea (adult) (pediatric) | Used when sleep disruption from OSA coexists and clinicians evaluate circadian contribution; melatonin testing may be adjunctive. |
F51.11 | Delayed sleep phase disorder | Directly related—melatonin profile documents delayed dim light melatonin onset supporting diagnosis. |
Z72.82 | Shift work sleep disorder | Melatonin profiling helps assess circadian misalignment in shift workers to guide timing interventions. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0362U | Proprietary Laboratory Analyses — (example PLA code) measurement of a salivary analyte (placeholder) | Other PLA codes for salivary or endocrine assays may be ordered alongside 0462U when additional analytes are required. |
99000 | Handling and/or conveyance of a specimen for transport; e.g., courier service | Used when special specimen transport or courier services are billed in association with home-collected saliva kits sent to the central laboratory. |
99001 | Laboratory specimen handling (non-covered) — carrier/transport charge (example) | Administrative or non-covered charges related to specimen processing and kit management may be documented with facility-specific charges. |
84133 | Prolactin; quantitative | Example endocrine assay codes commonly ordered in endocrine workups; may be ordered in parallel panels in sleep-related endocrine assessment. |
84443 | Thyroid stimulating hormone (TSH) | TSH measurement is commonly ordered in evaluation of sleep disorders where hypothyroidism or other endocrine issues may contribute. |