Summary & Overview
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.
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
Clinical & Coding Specifications
Clinical Context
A pregnant individual, who tested RhD negative on routine prenatal blood typing, presents at 10–20 weeks' gestation for noninvasive fetal RhD genotyping. A peripheral maternal blood sample is collected and sent to Devyser Genomic Laboratories for the proprietary test reported as 0536U (Prenatal Detect RhD). The laboratory isolates cell‑free fetal DNA from maternal plasma and performs polymerase chain reaction (PCR) targeting exon 4 of the fetal RHD gene with an internal control (GAPDH) to confirm sample adequacy. Results returned as fetal RhD positive or negative guide antenatal management: Rh immune globulin administration decisions, antenatal counseling, and postpartum planning for hemolytic disease of the fetus/newborn surveillance. Typical workflow steps include order by obstetric clinician, phlebotomy at an outpatient prenatal clinic or ambulatory lab, courier to the performing laboratory, testing and reporting, and documentation placed in the maternal chart and communicated to the patient and obstetric care team. Typical site of service: outpatient prenatal clinic, ambulatory phlebotomy center, or hospital outpatient laboratory.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default, no modifier | Use when no special reporting modifier applies to the service. |