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.
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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). |