Summary & Overview
CPT 0553U: Preimplantation Genetic Testing (Smart PGT–A Plus)
CPT code 0553U designates a Proprietary Laboratory Analyses (PLA) test — Smart PGT–A Plus — used in preimplantation genetic testing of IVF embryos to detect chromosomal abnormalities across 24 chromosomes and provide a mitochondrial DNA score. This PLA code applies only to the specific test offered by Igenomix®, part of Vitrolife Group™, and Thermo Fisher Scientific, making it uniquely identifiable in claims and coverage reviews. Nationally, PLA codes like 0553U are important because they link reimbursement and coverage determinations to a single manufacturer’s assay, affecting access and fee schedules for fertility clinics and patients seeking embryo aneuploidy assessment.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise clinical context for the assay, expected site-of-service considerations, and an outline of payer relevance. The publication summarizes benchmark issues and policy considerations that commonly arise with PLA tests: single-source code implications, coverage variability among major payers, and how the test’s clinical scope (chromosome copy-number, structural rearrangements, mosaicism, mitochondrial DNA scoring) informs medical necessity discussions.
The report provides a national-level overview useful to billing staff, fertility program administrators, and policy analysts seeking clarity on how CPT code 0553U maps to clinical service, payer attention, and claims processing challenges. Data not available in the input will be noted where applicable.
Billing Code Overview
CPT code 0553U is a Proprietary Laboratory Analyses (PLA) code for the Smart PGT–A Plus test marketed by Igenomix®, part of Vitrolife Group™, and Thermo Fisher Scientific. The test evaluates trophectoderm biopsy samples from in vitro fertilization (IVF) embryos for chromosomal abnormalities across 24 chromosomes and reports chromosome copy-number status, structural rearrangements, mosaicism, and a mitochondrial DNA score. Results identify embryos with normal chromosomal complements or specific abnormalities.
Service Type: Genetic/embryo diagnostic laboratory testing (preimplantation genetic testing for aneuploidy)
Typical Site of Service: Specialty molecular or reproductive genetics laboratories supporting assisted reproductive technology (ART) centers and fertility clinics
Clinical & Coding Specifications
Clinical Context
A 36-year-old patient undergoing in vitro fertilization (IVF) elects preimplantation genetic testing for aneuploidy using the proprietary Smart PGT–A Plus assay (0553U) offered by Igenomix® (Vitrolife Group™) and Thermo Fisher Scientific. After ovarian stimulation, oocyte retrieval, fertilization and culture to the blastocyst stage (day 5–7), a trophectoderm biopsy is performed by the reproductive endocrinology laboratory. The sampled cells are placed in appropriate transport media and sent to the laboratory performing the Smart PGT–A Plus test.
The laboratory receives the specimen, extracts DNA, and performs comprehensive chromosome screening across 24 chromosomes including assessment for structural rearrangements, whole-chromosome gains or losses, and mosaicism. The assay also reports a mitochondrial DNA score. Results are returned to the ordering reproductive endocrinologist and the patient’s IVF care team to inform embryo selection for transfer or cryopreservation.
Typical site of service: outpatient fertility clinic and specialized molecular genetics laboratory. The service type is specialized molecular diagnostic testing (Proprietary Laboratory Analysis) specific to a manufacturer’s assay. Clinical workflow steps include: embryo biopsy at the IVF clinic, specimen transport to the performing lab, laboratory genomic analysis, and reporting of embryo chromosomal status to the IVF team for transfer planning.
Coding Specifications
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