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CPT 0536U: Prenatal Detect RhD Test by Devyser Genomic Laboratories
CPT code 0536U identifies a single-vendor Proprietary Laboratory Analyses (PLA) test: the Prenatal Detect RhD by Devyser Genomic Laboratories. The assay determines fetal RhD status by PCR analysis of fetal cell-free DNA in maternal blood, targeting exon 4 of the RHD gene and including a GAPDH quality control. Nationally, this code matters for prenatal care pathways where RhD-negative pregnant individuals require non-invasive fetal RHD determination to guide antenatal management.
Key payers examined include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise clinical context for when the test is used (RhD-negative pregnant individuals from 10 weeks’ gestation), the service setting (laboratory processing of outpatient maternal blood samples), and the nature of the PLA designation (single-manufacturer coding). The publication summarizes coverage and payment benchmarks, common billing considerations, and policy implications for incorporating single-source genetic tests into prenatal care. Data not available in the input is noted where applicable, and the report focuses on national implications rather than state-specific policy.
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Billing Code Overview
CPT code 0536U is a Proprietary Laboratory Analyses (PLA) code for the Prenatal Detect RhD test by Devyser Genomic Laboratories. The test determines fetal RhD status by analyzing fetal cell-free DNA in maternal blood using polymerase chain reaction (PCR) targeted to exon 4 of the RHD gene, with a housekeeping gene (GAPDH) assayed to verify sample quality. Report 0536U only for the specific test performed by this manufacturer/laboratory.
Service type: Non-invasive prenatal genetic test (maternal blood, fetal cell-free DNA analysis)
Typical site of service: Clinical laboratory or reference laboratory processing maternal blood samples collected in an outpatient obstetrics setting