UnitedHealthcare Preimplantation Genetic Testing Coverage Update

Coverage Criteria and Evidence

PGT-M and PGT-SR (medically necessary)

Covered when ALL of the following are met

PGT-M or PGT-SR coverage: The embryo is at increased risk of a recognized inherited disorder AND the increased risk is due to one of: both intended parents are carriers of the same autosomal recessive disease; at least one parent is a carrier of an autosomal dominant, sex-linked, or mitochondrial condition; or at least one parent is a carrier of a structural chromosome rearrangement.

Condition being prevented must result in Significant Health Problems or Severe Disability and be caused by a single gene (PGT-M) or parental structural chromosome changes (PGT-SR).

HLA typing via PGT (medically necessary)

HLA typing: PGT is proven and medically necessary for HLA typing on an embryo to enable a future child to provide bone marrow or blood to treat an affected sibling.

Clinical series report diagnostic efficacy and live births when used to identify HLA-compatible embryos; outcomes depend on maternal age and oocyte yield.

Unproven / Not Medically Necessary indications

Not covered / unproven

PGT unproven indications: PGT is unproven and not medically necessary for all other populations and conditions due to insufficient evidence, including but not limited to: Aneuploidy screening (PGT-A); determining gender when the embryo is not at risk for a sex-linked disorder; predicting risk of polygenic disorders (PGT-P) and/or embryo selection based on polygenic scores (ESPS).

PGT must be ordered after genetic counseling.

Evidence summaries

Evidence-based findings summarized from systematic reviews and observational studies

PGT vs Spontaneous Conception outcomes: Meta-analyses found higher risks after PGT compared with spontaneously conceived pregnancies for low birth weight, preterm delivery, and hypertensive disorders; no consistent difference in congenital malformations.

Zheng et al. meta-analysis reported increased RR for LBW and preterm delivery versus spontaneous conception.

PGT-M outcomes: Systematic review of PGT-M reported pooled clinical pregnancy rate ~34% per cycle and live birth rate ~29.7% per cycle; concurrent aneuploidy screening (PGT-A) was associated with higher clinical pregnancy and live birth rates in subgroup analyses.

Poulton et al. pooled data of 51 studies with notable heterogeneity.

PGT-SR outcomes: Studies of PGT-SR report variable euploid/normal embryo rates and live birth outcomes; some cohorts demonstrate improved live birth rates and lower miscarriage after PGT-SR compared with prior reproductive history, though pooled analyses are heterogeneous.

Liu et al., Huang et al., and systematic reviews summarized variable euploid proportions and outcomes.

Evidence-based coverage considerations

Evidence summaries and findings for PGT-SR, PGT-HLA, and PGT-A from multiple studies and systematic reviews:

PGT-SR evidence: Studies and systematic reviews show similar live birth rates between natural conception and PGT-SR cohorts; NGS had high concordance with CGH for abnormal results and detected additional de novo segmental aneuploidies and low-level mosaicism.

No large randomized trials; study heterogeneity limits pooled conclusions.

PGT-HLA evidence: A multicenter cohort reported diagnostic efficacy of 78.5% with 136 babies born among 113 couples; success was influenced by maternal age, oocyte yield, and chance.

Kakourou et al. multicenter data support clinical utility in selected couples but with limitations.

PGT-A evidence — mixed: Systematic reviews and RCTs report heterogeneous results for PGT-A: some analyses show no overall increase in live birth rate but benefit in select subgroups (e.g., advanced maternal age) and reduced miscarriage rates; large registry data have reported decreased cumulative live birth rate in some age groups.

Quality of evidence ranges low to moderate; technique, patient selection, and assay type affect outcomes.

Coverage-relevant summary for PGT variants

Summary of coverage-relevant stances drawn from professional society guidance and evidence presented:

PGT-M/PGT-SR: PGT-M and PGT-SR have established clinical utility for appropriate indications; confirmation of PGT-M or PGT-SR results by CVS or amniocentesis should be offered.

ACOG and ASRM recommend confirmatory prenatal diagnostic testing and comprehensive genetic counseling.

PGT-A: The value of PGT-A as universal screening remains undetermined; use may be considered in select populations (for example, advanced maternal age) but evidence is mixed and randomized trials do not show consistent live birth rate benefit across all groups.

ASRM/SART and systematic reviews emphasize need for further research and selective application.

PGT-P (polygenic risk scoring for embryo selection) lacks demonstrated clinical utility and should currently be limited to research settings due to scientific and ethical concerns.

ACMG recommends PGT-P only in research settings and advises caution given ethical implications.

PGT is covered when used to prevent transmission of a recognized inherited condition in embryos at increased risk due to parental carrier status or a parental structural chromosome rearrangement. Covered indications include: PGT-M for single-gene (monogenic) disorders when the condition being prevented causes Significant Health Problems or Severe Disability, PGT-SR for embryos at risk because one parent carries a structural chromosomal rearrangement, and PGT for HLA typing when intended to enable a future child to serve as a hematopoietic or blood donor for an affected sibling. PGT must be ordered after genetic counseling.

The document excerpts provided do not contain separate, explicit exclusion statements beyond the coverage rationale; instead, they describe covered indications and summarize evidence gaps for other uses of PGT, indicating that noncovered or unproven uses are identified in the narrative rather than as a standalone exclusion list.

Evidence for routine use of PGT-A is mixed and of low to moderate quality; systematic reviews and meta-analyses report conflicting results for live birth and cumulative live birth outcomes. Higher-quality studies are heterogeneous, and some RCTs and reviews conclude that current evidence is insufficient to support universal PGT-A as a screening strategy—benefit may be limited to select populations and requires further high-quality randomized trials and validated algorithms to identify those groups.

PGT-P (polygenic risk–based embryo screening) currently lacks demonstrated clinical utility and is associated with substantial ethical and scientific concerns. Professional guidance advises that PGT-P should not be offered routinely in clinical practice and, where considered, be limited to research settings until further evidence and consensus on ethical and social implications are available.

Multiple professional societies and position statements highlight ethical and scientific concerns regarding the use of polygenic risk scores (PRS) for embryo selection. Statements note that PRS are of limited individual predictive value, carry legal and social ramifications, and currently lack sufficient evidence to support clinical use for embryo selection; some societies characterize the practice as ethically controversial or inappropriate for routine clinical application.

Outside the specified covered indications (PGT-M, PGT-SR, and HLA typing), PGT is considered unproven and not medically necessary. Examples of not medically necessary or unproven uses include routine aneuploidy screening (PGT-A) for all IVF patients, elective sex determination when the embryo is not at risk for a sex-linked disorder, and polygenic risk–based embryo selection (PGT-P/ESPS).

A cited Cochrane-style review indicates that current data are insufficient to determine whether biopsy timing (day 3 versus day 5) affects live birth outcomes; prospective randomized studies are needed to resolve questions about optimal biopsy timing and its impact on clinical outcomes.

Systematic reviews and randomized trial data suggest that routine clinical use of some PGT-A methods (for example, FISH-based approaches) is not supported and may reduce live births after the first transfer; overall, routine PGT-A is not supported by current evidence and should not be applied universally without individualized assessment.

Large practice guidelines and joint society opinions conclude that the value of universal PGT-A as a screening test remains undetermined. While some subgroup analyses suggest benefit in certain populations (for example, older patients), overall evidence is inconsistent and does not support routine use of PGT-A for all IVF patients.

PGT-P is described in the literature and society statements as an unproven practice for embryo selection: available evidence is limited to modeling and validation work, there are no studies demonstrating clinical utility for embryo selection, and authoritative groups recommend restricting PGT-P to research contexts while more evidence and ethical consensus are developed.

Indications Considered Medically Necessary

PGT-M for monogenic/single gene defects when embryo at increased risk and condition causes significant health problems or severe disability.

PGT-M eligibility: The embryo must be at increased risk due to parental carrier status (both parents carriers for same autosomal recessive condition, or at least one parent carrier of an autosomal dominant, sex-linked, mitochondrial condition) and the condition must meet the policy definition of Significant Health Problems or Severe Disability.

Policy requires genetic counseling prior to ordering PGT.

PGT-SR for inherited structural chromosome rearrangements when embryo is at increased risk.

PGT-SR eligibility: PGT-SR is indicated when one or both parents carry a structural chromosomal rearrangement (e.g., reciprocal translocation, inversion, or complex rearrangement) and the embryo is at increased risk of unbalanced chromosomal inheritance; the testing method must be capable of detecting the expected unbalanced forms.

Studies show variable euploid embryo proportions; NGS demonstrated high concordance with CGH for abnormal results.

Applicable Procedure and Service Codes

Applicable PGT molecular procedure codesCPT

0254U	Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using embryonic DNA genomic sequence analysis for aneuploidy, and a mitochondrial DNA score in euploid embryos, results reported as normal (euploidy), monosomy, trisomy, or partial deletion/duplications, mosaicism, and segmental aneuploidy, per embryo tested.
0552U	Reproductive medicine (preimplantation genetic assessment), analysis for known genetic disorders from trophectoderm biopsy, linkage analysis of disease-causing locus, and when possible, targeted mutation analysis for known familial variant, reported as low-risk or high-risk for familial genetic disorder.
0553U	Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using DNA genomic sequence analysis from embryonic trophectoderm for structural rearrangements, aneuploidy, and a mitochondrial DNA score, results reported as normal/balanced (euploidy/balanced), unbalanced structural rearrangement, monosomy, trisomy, segmental aneuploidy, or mosaic, per embryo tested.
0554U	Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using DNA genomic sequence analysis from trophectoderm biopsy for aneuploidy, ploidy, a mitochondrial DNA score, and embryo quality control, results reported as normal (euploidy), monosomy, trisomy, segmental aneuploidy, triploid, haploid, or mosaic, with quality control results reported as contamination detected or inconsistent cohort when applicable, per embryo tested.
0555U	Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using DNA genomic sequence analysis from embryonic trophectoderm for structural rearrangements, aneuploidy, ploidy, a mitochondrial DNA score, and embryo quality control, results reported as normal/balanced (euploidy/balanced), unbalanced structural rearrangement, monosomy, trisomy, segmental aneuploidy, triploid, haploid, or mosaic, with quality control results reported as contamination detected or inconsistent cohort when applicable, per embryo tested.

Cytogenomic microarray codesCPT

81228	Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation of genomic regions for copy number variants, comparative genomic hybridization [CGH] microarray analysis.
81229	Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants, comparative genomic hybridization (CGH) microarray analysis.

Low-pass sequencing codeCPT

81349

Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation of genomic regions for copy number and loss-of-heterozygosity variants, low-pass sequencing analysis.

Biopsy and unlisted molecular codesCPT

81479	Unlisted molecular pathology procedure.
89290	Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); less than or equal to 5 embryos.
89291	Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); greater than 5 embryos.

Related services and procedure codesmixed

58970	Follicle puncture for oocyte retrieval, any method.
58974	Embryo transfer, intrauterine.
89258	Cryopreservation; embryo(s).
89342	Storage (per year); embryo(s).
89352	Thawing of cryopreserved: embryos(s).
S4011	In vitro fertilization; including but not limited to identification and incubation of mature oocytes, fertilization with sperm, incubation of embryo(s), and subsequent visualization for determination of development.
S4015	Complete in vitro fertilization cycle, not otherwise specified, case rate.
S4016	Frozen in vitro fertilization cycle, case rate.

No codes providedmixed

No codes listed

Applicable CPT/HCPCS Codes (updated)CPT

0552U	Added CPT Category I/III code referenced in summary of changes
0553U	Added CPT Category I/III code referenced in summary of changes
0554U	Added CPT Category I/III code referenced in summary of changes
0555U	Added CPT Category I/III code referenced in summary of changes

inv-24: Significant Health Problems or Severe Disability — key definition used for coverage thresholds

DefinitionA disability or impairment that substantially limits one or more major life activities; the impairment is expected to last at least 12 months or result in death.

Source contextUsed as the coverage threshold for PGT-M and PGT-SR: the condition being prevented must result in significant health problems or severe disability.

ApplicabilityApplies when the embryo is at increased risk of a recognized inherited disorder that would cause the defined severe disability or death.

inv-25: gestational age difference (evidence metric)

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Coding Reminder

Prior authorization not specified in the provided excerpts. Providers should verify member-specific benefit terms and any plan or state-specific prior authorization requirements before ordering PGT services.

Applicable CPT/HCPCS code list was updated 08/01/2025 — verify current code set before billing (see Policy History)

Documentation Required

Genetic Counseling and Clinical Evaluation Recommended

Genetic counseling and a comprehensive clinical evaluation are strongly recommended prior to ordering any form of Preimplantation Genetic Testing (PGT), particularly PGT-M and PGT-SR. Counseling should review advantages, limitations, technical limitations (including biopsy type and potential for misdiagnosis), and alternative reproductive options.

PGT must be ordered after genetic counseling (Coverage Rationale, chunk 2).

Not Medically Necessary / Unproven Indications

The policy does not cover PGT-A as a routine service, elective sex determination when no sex-linked risk exists, PGT-P/embryo selection based on polygenic scores, or other indications not listed as covered. PGT-P is specifically identified as not supported for clinical use and ethically controversial; professional guidance recommends limiting PGT-P to research settings.

The excerpts do not enumerate specific laboratory tests that are categorically excluded; rather, they summarize evidence and indicate that noncovered uses are identified based on insufficient evidence rather than by listing named assays in the provided sections.

Routine use of PGT-A for all IVF patients is not supported by current evidence. Randomized trial evidence and systematic reviews report mixed or adverse effects on live birth outcomes with some PGT-A methods, and the overall quality of evidence for improved cumulative live birth rate is poor or inconsistent.

PGT-P and embryo selection based on polygenic risk scores are discouraged for routine clinical use and should be restricted to research settings; professional groups emphasize ethical concerns and lack of demonstrated clinical benefit.

Screening embryos using polygenic risk scores (PGT-P/ESPS) raises significant ethical concerns. Society statements characterize the approach as ethically controversial and recommend caution, education, and broader societal debate before considering clinical implementation.

Definitions and Key Terms

inv-48: Preimplantation Genetic Testing (PGT) — definition

DefinitionA test performed to analyze DNA from oocytes (polar bodies) or embryos (cleavage stage or blastocyst) to determine HLA compatibility or genetic abnormalities; includes PGT-A, PGT-M, and PGT-SR.

Included typesPGT-A (aneuploidy screening), PGT-M (monogenic/single-gene), PGT-SR (structural rearrangements), and related HLA testing.

Clinical roleUsed to identify embryos at risk of genetic disorders or compatible donors (PGT-HLA) within ART workflows.

inv-49: Significant Health Problems or Severe Disability — definition

DefinitionA disability or impairment that substantially limits one or more major life activities; expected to last ≥12 months or result in death.

Use in policy

Evidence Summary and Background

Preimplantation genetic testing (PGT) analyzes DNA from oocytes, polar bodies, or embryos to detect monogenic disorders (PGT-M), structural chromosomal rearrangements (PGT-SR), or aneuploidy (PGT-A). PGT is performed using methods such as PCR, chromosomal microarray, and next-generation sequencing, and genetic counseling is required prior to ordering to discuss indications, limitations, and expected outcomes.

Evidence summaries (duplicated in Coverage Criteria for emphasis)

Evidence-based findings summarized from systematic reviews and observational studies

Zheng et al. meta-analysis summarized increased risk estimates versus spontaneous conception.

PGT-SR and technical accuracy: NGS demonstrates high concordance with CGH for abnormal results in PGT-SR and can detect de novo segmental aneuploidies and low-level mosaicism not found by CGH.

Chow et al. and Zhou et al. reported concordance and detection of additional abnormalities.

Policy Revision History

2025-08-01administrative_updateLatest

Updated applicable CPT code list to add 0552U, 0553U, 0554U, and 0555U; archived previous policy version CS160NE.D.

2025-08-01code_list_update_and_prior_auth_reminder

Added CPT codes 0552U–0555U to the applicable code list and reminded readers to check plan-specific prior authorization and contractual/state/federal requirements when submitting prior authorization requests.

OpenPayer

Preimplantation Genetic Testing and Related Services (for Nebraska Only)