PGT is considered unproven and not medically necessary for populations and clinical situations that are not explicitly listed as medically necessary in this policy. Examples include, but are not limited to, routine aneuploidy screening (PGT-A), determining embryo gender when there is no risk of a sex-linked disorder, and preimplantation prediction or selection using polygenic risk scores (PGT-P/ESPS). PGT testing must be ordered after appropriate genetic counseling and documentation supporting an evidence-based indication is required for coverage consideration.

Assessment of clinical benefit is limited by incomplete and inconsistent reporting of key procedural and population details in the literature. Important data gaps include the specific PGT technique used, biopsy timing/type (day 3 vs day 5 trophectoderm biopsy), protocols for selecting embryos, the number and morphology of embryos available, and disposition of discarded embryos. These documentation and reporting limitations reduce the ability to determine whether observed outcomes are attributable to PGT itself or to underlying patient or laboratory factors.

Current evidence does not support the universal, routine use of PGT-A for all patients undergoing IVF. Systematic reviews and randomized trials show heterogeneous results with respect to cumulative live birth rate and other clinical outcomes, and benefits—when present—appear to be limited to selected subgroups (for example some older patients or specific clinical contexts). Routine application of PGT-A across the general infertility population is not supported without a documented clinical indication and appropriate counseling.

Preimplantation genetic testing using polygenic risk scores (PGT-P) is currently inappropriate for routine clinical use. Professional society statements and evidence reviews identify limited or no demonstrated clinical utility, substantial ethical and social concerns, and recommend that PGT-P be restricted to research settings until further validation and societal guidance are available.

The document references multiple position statements and systematic reviews that question or limit specific PGT practices. Cited guidance emphasizes methodological limitations (for example sampling and mosaicism issues), ethical concerns for embryo selection based on polygenic scores, and the need for laboratory- and assay-specific validation prior to clinical implementation. These professional positions inform the policy's exclusion of certain PGT uses from standard clinical coverage.

Preimplantation testing aimed at aneuploidy screening for unselected populations, non–medically indicated gender determination, and embryo selection based on polygenic risk scores is not supported as medically necessary. The policy explicitly lists PGT-A, gender determination when not at risk for a sex-linked disorder, and PGT-P/ESPS among unproven indications that may be denied as not medically necessary.

Prospective, randomized studies are needed to clarify clinical effectiveness for many PGT uses. Until higher-quality, generalizable RCT evidence is available, routine use of PGT without a clear, documented clinical indication is not supported. Coverage and clinical decisions should therefore prioritize established indications and consider selective use within well-defined patient subgroups.

PGT-A should not be applied indiscriminately as a routine adjunct to IVF across the general infertility population. Randomized and registry data have produced mixed results on cumulative live birth rate and per-transfer outcomes; where benefit has been observed it is subgroup-dependent (for example, select older patients or trials using contemporary blastocyst biopsy and NGS). Prior authorization and counseling should reflect this evidence uncertainty.

Selection of embryos based on polygenic risk scores for common, multifactorial diseases is currently considered not medically necessary. Evidence demonstrating clinical utility for preimplantation polygenic selection is lacking and professional organizations recommend against routine clinical application.

Eligibility statements in this policy are determined by the presence of a documented, evidence-based clinical indication for PGT and by adherence to the policy's coverage criteria. Coverage is limited to PGT indications explicitly described as medically necessary (for example, PGT-M, PGT-SR, and PGT-HLA under specified conditions); other uses are considered unproven or not medically necessary.

Eligibility for PGT-M requires documentation that the embryo is at increased risk due to a known parental pathogenic variant or carrier status. For PGT-HLA, eligibility includes a documented need to produce an HLA-compatible offspring to enable hematopoietic stem cell transplantation for an affected sibling; clinical context and multidisciplinary coordination must be evident in the medical record.

Eligibility for PGT-SR is contingent on parental identification of a structural chromosomal rearrangement and the use of validated testing methods capable of detecting the expected unbalanced products. Clinical documentation should include cytogenetic confirmation in the parents and counseling about expected embryo yield and reproductive alternatives.

For PGT-A, coverage considerations are limited to selected high-risk scenarios where evidence suggests possible benefit (for example, some individuals of advanced maternal age or specific recurrent pregnancy failure/loss cases). Eligibility should be supported by clinical documentation of the indication, expected embryo availability, and counseling regarding limitations.

All services billed under PGT must be accompanied by documentation of pre‑test genetic counseling and relevant prior testing: confirmation of parental pathogenic variants for PGT-M, parental karyotype for PGT-SR, or documentation supporting a medically indicated rationale for PGT-A/PGT-HLA.

Claims or prior authorization requests lacking sufficient clinical detail—such as the specific intended indication, testing method, number and quality of embryos available, and prior genetic test results—may be denied as documentation gaps limit demonstration of medical necessity.

Eligibility decisions should incorporate genetic counseling recommendations from professional societies. For PGT-M and complex indications, an experienced PGT genetic counselor should be involved in case review and documentation to support the clinical necessity of testing.

Where PGT is requested for embryo selection within assisted reproduction, eligibility should consider patient age, prior ART history, and the anticipated number of blastocysts suitable for biopsy; some studies required a minimum number of blastocysts to qualify for enrollment, reflecting that embryo yield influences clinical utility.

Eligibility for PGT-HLA requires documentation of an affected sibling and clear intent to use an HLA-matched offspring as a donor for hematopoietic stem cell transplantation. Multidisciplinary coordination and counseling must be documented.

Ordering of PGT must follow comprehensive pre-test genetic counseling and should be performed by clinicians experienced in assisted reproductive technologies in collaboration with genetic counseling teams. PGT should be ordered only after counseling has been provided and documented.

Services described as not covered in this policy include PGT-A, PGT-P/ESPS, and gender determination when performed in the absence of a documented risk for a sex-linked disorder. These indications are identified as unproven and not medically necessary and may be denied when submitted for coverage without an evidence-based medical indication.

Routine PGT performed without a clearly documented, evidence-based clinical indication lacks sufficient randomized trial support and is not supported as standard of care. Requests for routine or universal PGT should be evaluated in light of the available randomized and high-quality evidence and may be excluded from coverage when no specific indication is present.

The policy explicitly does not support routine, universal application of PGT-A for all patients undergoing IVF because current evidence is mixed and, in some analyses, shows no improvement in cumulative live birth rate. Coverage for PGT-A is limited to indications and patient subgroups where benefit is supported by the evidence.

Preimplantation genetic testing using polygenic risk scores (PGT-P) is not supported for clinical use and should not be offered clinically outside of approved research settings. Professional society guidance emphasizes lack of proven clinical utility and ethical concerns that preclude routine clinical implementation.

The policy references ESHRE, ACMG, and ESHG position statements that caution against embryo selection based on polygenic risk scores. These professional positions are cited to support the exclusion of PGT-P/ESPS from routine clinical coverage pending further research and broader societal and ethical consensus.

Preimplantation genetic testing encompasses different test types with distinct clinical goals: PGT-M for single-gene (monogenic) disorders, PGT-SR for structural chromosome rearrangements, PGT-A for aneuploidy screening, and PGT-HLA for HLA typing to enable sibling donor matching. PGT can prevent transmission of known pathogenic variants or identify HLA-compatible embryos in specific clinical contexts, but clinical effectiveness and safety vary by indication, technique, and population.

This policy was updated effective 07/01/2025 to reflect coding changes. New procedure codes 0552U–0555U were added to the Applicable Codes list; providers should verify and use current codes when requesting prior authorization or submitting claims.