CurrentUnitedHealthcarePolicy 2026T0597P

Preimplantation Genetic Testing and Related Services

This policy governs coverage criteria, coding, and related services for preimplantation genetic testing (PGT-M, PGT-SR, and PGT-A) for UnitedHealthcare Commercial and Individual Exchange plans and specifies medical necessity, exclusions, and required documentation for members and providers.

Policy Summary

PayerUnitedHealthcare

PolicyPreimplantation Genetic Testing and Related Services

Policy CodePolicy 2026T0597P

Change TypeTemplate update

Effective DateJan 1, 2026

Next Review Date

Key ActionOrder PGT only after the member has received genetic counseling and verify member-specific benefits prior to scheduling.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CoveredPGT-M / PGT-SR covered

ExcludedPGT-A excluded

RequiredGenetic counseling

<1 yrShort-term storage

>1 yrLong-term storage

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Policy history entry

Coverage Criteria and Medical Necessity

Medically necessary PGT-M and PGT-SR

Covered when ALL of the following are met

Physician order and counseling: PGT must be ordered by a physician after genetic counseling.

Clinical indication: The embryo is at increased risk of a recognized inherited disorder due to one of the following: 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.

Severity requirement: The genetic medical condition being prevented must result in Significant Health Problems or Severe Disability and be caused by a single gene (PGT‑M) or structural changes of a parent's chromosome (PGT‑SR).

Service scope: Benefits are limited to PGT for the specific genetic disorder and related supervised physician services including ovulation induction/controlled ovarian stimulation; egg retrieval, fertilization, and embryo culture; embryo biopsy; embryo transfer; cryopreservation and short‑term embryo storage (less than one year).

Unproven / Not medically necessary uses

Not covered or considered unproven

Unproven indications: PGT is unproven and not medically necessary for all other populations and conditions due to insufficient evidence of efficacy; examples include preimplantation genetic testing for aneuploidy (PGT‑A), determining embryo sex when not at risk for a sex‑linked disorder, and polygenic risk/embryo selection based on polygenic scores (PGT‑P/ESPS).

Evidence-linked clinical contexts where PGT may be considered

Clinical evidence highlights contexts where PGT may impact outcomes:

Recurrent implantation failure (RIF): PGT‑A/PGT‑SR were commonly used for RIF (≈70% of cases in a Japan multi‑center trial) and the study authors concluded PGT‑A/SR may improve pregnancy rates per embryo transfer and reduce miscarriage rates in individuals with RIF, though lack of controls limits definitive conclusions.

Recurrent pregnancy loss (RPL): PGT has been used in people with RPL and some analyses suggest reduced miscarriage rates and improved LBR per transfer in selected studies, but evidence is heterogeneous and further high‑quality trials are needed.

Chromosomal structural rearrangement carriers (CR/CCR): PGT‑SR studies in translocation and complex rearrangement carriers report transferable euploid/normal embryo rates and improved live birth outcomes in many cohorts, indicating PGT‑SR may aid prevention of miscarriage in these couples.

Monogenic disease risk (PGT‑M):

Evidence synthesis and clinical implications

Evidence-based findings and conclusions from studies and reviews

PGT‑SR clinical outcomes: Studies using NGS/CGH/MPS in translocation and complex rearrangement carriers report diagnostic concordance, detection of segmental abnormalities, and often improved proportions of normal live births; however, comparative and randomized data are limited and mosaicism/segmental aneuploidy remain concerns.

PGT‑HLA utility: Multi‑center PGT‑HLA data (704 cycles, 364 couples) demonstrate diagnostic efficacy (≈78.5%) with live births achieved for a subset; success is constrained by maternal age, oocyte yield, and genetic chance and requires multidisciplinary coordination.

PGT‑A evidence synthesis: Systematic reviews, RCTs, and large registry studies show mixed and generally low‑to‑moderate quality evidence for routine PGT‑A: some trials and subgroup analyses report reduced miscarriage or improved outcomes in select populations (e.g., advanced maternal age, blastocyst biopsy), but other data show no improvement or decreased cumulative live birth rate in younger patients.

Evidence conclusions and professional society recommendations

Evidence summary and professional recommendations captured in document:

PGT‑A general conclusions: Multiple RCTs and systematic reviews find inconsistent benefits of PGT‑A for improving live birth or cumulative live birth rates; routine clinical use of PGT‑A is not supported by the current evidence base.

Subgroup signals: Some subgroup analyses and trials suggest possible benefit of PGT‑A in selected groups (for example, older individuals or when biopsy is performed at blastocyst stage), but these signals are not definitive and require further study.

PGT‑P stance: PGT‑P lacks demonstrated clinical utility for embryo selection; professional societies advise against routine clinical use and recommend limiting PGT‑P to research contexts pending further evidence and ethical analysis.

Testing platform variability: Different analytic platforms (NGS, CGH, aCGH, qPCR, SNP arrays) show variable concordance and performance; NGS may detect mosaicism and segmental aneuploidy more sensitively and has been associated with higher implantation and live birth rates in some retrospective comparisons.

Benefits for embryo cryopreservation and storage are limited to short-term storage. Costs associated with long-term embryo storage (greater than one year) are not covered.

The excerpt does not list specific additional clinical exclusions beyond the items called out elsewhere in the policy. However, the document emphasizes limitations in the evidence base — including heterogeneous study designs, differences in biopsy stage (cleavage vs blastocyst), and a relative lack of randomized controlled trials — which constrain conclusions about benefit and may affect coverage determinations in individual cases.

Routine use of preimplantation genetic testing for aneuploidy (PGT-A) as a screening strategy for all IVF patients is not supported by the current evidence. Systematic reviews and randomized trials provide low-to-moderate quality, heterogeneous results and do not establish a clear benefit for routine/unselected practice; professional guidance calls for larger prospective studies to define the value of PGT-A.

Preimplantation genetic testing for polygenic risk (PGT-P) is not supported for routine clinical embryo selection. Evidence of clinical utility is lacking, and professional organizations recommend that PGT-P be offered only in research settings pending further validation and ethical review.

FDA clearance or approval of a test or device is provided for informational purposes only. FDA approval alone is not a basis for coverage; clinical coverage decisions are based on the evidence of medical necessity and member benefit plan terms.

Explicit exclusions in this policy excerpt include that PGT-A is unproven and not medically necessary. The policy also indicates that PGT-P and use of PGT to determine gender when a sex-linked disorder is not at risk are not considered medically necessary or are limited by insufficient evidence and ethical concerns.

The policy excerpt does not enumerate a detailed list of conditions labeled ‘not medically necessary’ beyond the general statements provided. It repeatedly notes that further randomized prospective data are needed and that heterogeneity of existing studies limits definitive determinations of clinical benefit.

The policy states that routine or unselected use of PGT-A for all IVF patients is not supported by current evidence. Available randomized trials and systematic reviews are inconsistent and do not demonstrate a clear improvement in cumulative live birth rates to justify universal application.

Routine universal screening with PGT-A for all IVF patients has not been established as beneficial. Professional society opinions and the available trial data recommend individualized counseling and further large prospective studies before routine universal application is adopted.

Applicable Codes and Billing Rules

Applicable CPT/HCPCS and related service codesmixed

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/duplication, 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.
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.
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.
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.

1–10 of 35

1/4

Embryo storage duration — coverage thresholds

Covered storage durationCryopreservation and short-term embryo storage less than one year are included as related services when PGT-M or PGT-SR criteria are met.

Not covered storage durationBenefits are not available for long-term embryo storage costs greater than one year.

Related service requirementStorage coverage applies when services are provided by or under the supervision of a physician as part of PGT for a specific genetic disorder.

Provider Requirements, Documentation, and Authorization

Prior Authorization

Verify benefits and potential prior authorization

PGT must be ordered by a physician after genetic counseling. Verify the member's specific benefit plan and any applicable federal or state mandates before initiating testing; UnitedHealthcare may require prior authorization for PGT services.

Order requirement: physician order required following documented genetic counseling
Benefit verification: confirm member-specific plan and mandates; member plan governs in event of conflict
Prior authorization: may be required by UnitedHealthcare — verify before testing

Prior Authorization

Indication-based prior authorization guidance

Indication-based prior authorization and coverage decisions should be individualized. Prior authorization guidance is not limited to a fixed code list — clinical indication, documented genetic counseling, and medical records are used to determine eligibility for PGT-M and PGT-SR. PGT-A is excluded from benefits and would typically trigger denial if billed as a covered PGT benefit.

Background and Context

Preimplantation genetic testing (PGT) refers to analysis of DNA from oocytes or embryos to detect genetic abnormalities. The primary clinical purposes include identification of single-gene defects (PGT-M), structural chromosome rearrangements (PGT-SR), and aneuploidy (PGT-A), with PGT-M and PGT-SR intended to prevent transmission of disorders that cause Significant Health Problems or Severe Disability.

Definitions and Key Terms

Preimplantation Genetic Testing (PGT) — overview

DefinitionPreimplantation Genetic Testing (PGT) is analysis of DNA from oocytes (polar bodies) or embryos (cleavage stage or blastocyst) for HLA typing or to determine genetic abnormalities including PGT-A, PGT-M, and PGT-SR.

PurposeTo identify and help prevent transmission of genetic medical conditions to offspring when clinically indicated.

ComponentsMay include embryo biopsy, laboratory genetic analysis, and reporting of results to guide embryo transfer decisions.

Significant Health Problems or Severe Disability — definition

DefinitionSignificant Health Problems or Severe Disability: a physical or mental impairment that substantially limits one or more major life activities, expected to last at least 12 months or result in death.

Severity requirement for PGT-M/PGT-SR

Policy Revision History

2026-01-01policy_revisionLatest

Template update and creation of shared policy version; archived previous policy version 2025T0597O and LABORATORY 026.14.

Policy Summary

PayerUnitedHealthcare

PolicyPreimplantation Genetic Testing and Related Services

Policy CodePolicy 2026T0597P

Change TypeTemplate update

Effective DateJan 1, 2026

Next Review Date

Key ActionOrder PGT only after the member has received genetic counseling and verify member-specific benefits prior to scheduling.

SourceLink

On This Page

Systematic reviews of PGT‑M report pooled clinical pregnancy and live birth rates per cycle/transfer and suggest favorable outcomes for appropriately indicated PGT‑M, with some data indicating higher rates when combined with aneuploidy screening.

Safety and perinatal outcomes: Registry and meta‑analytic data show mixed findings for obstetric and neonatal outcomes (e.g., PTB, LBW, hypertensive disorders); comparisons versus spontaneous conception or IVF/ICSI vary by analysis and are limited by heterogeneity.

Laboratory and technical considerations: NGS‑based assays, whole genome amplification methods, and TE biopsy at blastocyst stage have technical advantages but concordance and mosaicism/segmental aneuploidy remain important limitations requiring assay validation.

Technical limitations and validation needs:

TE biopsy may yield false positives/negatives due to discordance with the inner cell mass; noninvasive PGT‑A (niPGT‑A) has promising early data but requires larger validation and non‑selection studies are recommended for new assays.

Mosaic embryo management: Recommendations emphasize prioritizing euploid embryos; if mosaic embryos are considered for transfer prioritize by level/percentage of mosaicism and embryo morphology, with comprehensive counseling and consideration of additional cycles to obtain euploid embryos.

Confirmation testing after PGT: Professional guidance (ACOG/ASRM) recommends offering confirmatory prenatal diagnostic testing (chorionic villus sampling or amniocentesis) after PGT‑M or PGT‑SR and offering traditional aneuploidy screening/diagnostic testing after PGT‑A due to technical limitations and potential for misdiagnosis.

Indication-based review: decisions driven by clinical indication (e.g., risk of transmitting a single-gene disorder or structural rearrangement) and documentation

Documentation required: medical records and genetic counseling notes may be requested to assess eligibility

PGT-A exclusion: PGT-A is not a covered benefit under this policy

Prior Authorization

Prior authorization recommended for selective PGT-A use

Prior authorization is recommended for selective use of PGT-A in populations where evidence suggests potential benefit (for example advanced maternal age or recurrent implantation failure), but use should be individualized following counseling. Routine PGT-A is not supported by high-quality evidence for all populations.

Selective PGT-A consideration: may be reasonable for individuals >35 years, RIF, or RPL after counseling
Individualized decision-making: counsel patients about uncertain benefit and alternative options
Registry and retrospective data: large studies suggest selective counseling rather than routine use

Documentation Required

Document counseling and offer confirmatory testing

Document that comprehensive genetic counseling was provided before PGT and that patients were informed of the test limitations, potential need for confirmatory prenatal diagnostic testing, and availability of alternative reproductive options. Offer and document the offer of confirmatory testing (CVS or amniocentesis) after PGT-M or PGT-SR results and traditional aneuploidy testing or diagnostic screening for patients after PGT-A in pregnancy.

Counseling documentation: note content of counseling, who provided it, and that informed consent was obtained
Offer confirmatory testing: CVS or amniocentesis should be offered and documented for PGT-M and PGT-SR
PGT-A counseling: offer standard prenatal aneuploidy testing or diagnostic testing in accordance with pregnancy screening recommendations

Note

TE biopsy diagnostic limitation

TE (trophectoderm) biopsy has diagnostic limitations: results may not concord with the inner cell mass and can produce false positives or false negatives due to embryo mosaicism. Consider these limitations in counseling and documentation; emerging noninvasive methods may have different performance characteristics.

TE biopsy discordance: TE cell chromosomal status may not reflect inner cell mass
False results: risk of false positive and false negative aneuploidy calls due to mosaicism
Clinical implication: document counseling about biopsy limitations and impact on transfer decisions

Documentation Required

Reasons planned PGT-A treatment may not proceed

Reasons a planned PGT-A treatment or planned embryo transfer may not proceed should be documented (e.g., no euploid embryos available, thaw failure, patient withdrawal, or protocol deviations). These reasons were observed in randomized trials and registries and may affect outcomes and authorization decisions.

Common causes: lack of euploid embryos, thaw failure, patient withdrawal, deviation from protocol
Age effect: frequency of lack of euploid embryos increases with maternal age
Operational note: document any cycle-specific issues that prevented planned treatment

Documentation Required

Laboratory method and validation details

Laboratory methods and validation details should be documented with submissions: include assay methodology (NGS, SNP arrays, aCGH, WGA approach such as MDA or OmniPlex), laboratory validation, quality metrics, and whether concurrent testing (e.g., linkage analysis, karyotyping) was performed. Method choice should be justified based on downstream analysis needs.

Method details: NGS, aCGH, SNP arrays, whole genome amplification method (MDA, OmniPlex)
Validation: provide laboratory validation and quality control metrics
Supporting analyses: note use of linkage analysis, parental SNP testing, karyotype comparisons when performed

Documentation Required

PGT-HLA data collection documentation

For PGT-HLA cases include detailed documentation of assisted reproductive technology (ART) workflow, PGD/HLA testing results, collaboration across centers (if applicable), and the intended clinical use (e.g., HSCT recipient). Provide outcome and diagnostic efficacy data when available to support medical necessity.

PGT-HLA documentation: ART cycle details, oocyte source, biopsy day, diagnostic efficacy, and embryos analyzed
Cross-center collaboration: document sample flow and responsibilities if testing and clinical care occur at separate centers
Clinical intent: document reason for HLA matching and planned subsequent clinical interventions (e.g., HSCT)

Documentation Required

Benefit verification and policy precedence

Member specific benefit plan documentation must be referenced when making coverage decisions. This policy is informational and does not guarantee payment; in the event of conflict, the member specific benefit plan governs. Medical records may be requested to assess whether criteria are met.

Member benefit reference: always check the member-specific plan and any applicable mandates
Policy precedence: member plan document governs in conflicts
Medical records: documentation may be required for review and determination of coverage

Note

Stage- and age-dependent consideration

Stage- and age-dependent considerations should be documented and discussed during counseling. Evidence suggests potential benefit of PGT-A performed on blastocyst-stage (day 5) biopsies and in individuals older than 35 years, while younger individuals may not derive the same benefit.

Stage: day five (blastocyst) biopsy associated with better outcomes vs day three in some analyses
Age: potential benefit observed in individuals >35 years; limited or no benefit in younger cohorts
Counseling: document discussion of age- and stage-related evidence when considering PGT-A

Documentation Required

Mosaic embryo transfer prioritization

When mosaic embryos are considered for transfer, prioritize euploid embryos first. If only mosaic embryos are available, use the level/percentage of mosaicism to guide prioritization and counseling; include discussion of chromosome(s) involved, embryo morphology, and potential outcomes in the record.

Prioritization: euploid > lower-level mosaic > higher-level mosaic
Mosaicism reporting: document percentage/level of mosaicism and chromosomes involved
Counseling: discuss risks, alternatives, and possibility of repeated PGT or additional cycles

The genetic condition targeted must, if transmitted to offspring, result in Significant Health Problems or Severe Disability to meet medical necessity criteria.

Source referenceBased on Department of Labor / Federal Social Security Disability definitions referenced in policy definitions.

PGT-A / PGT-SR / PGT-M — distinctions

PGT-APreimplantation genetic testing for aneuploidy; used to screen embryos for chromosome number abnormalities.

PGT-SRPreimplantation genetic testing for chromosomal structural rearrangements (e.g., balanced translocations) to prevent transmission of parental rearrangements.

PGT-MPreimplantation genetic testing for monogenic/single gene defects to prevent inheritance of single-gene disorders.

TE biopsy — technical note

Procedure descriptionTrophectoderm (TE) biopsy samples cells from the outer layer of a blastocyst (blastocyst-stage embryo) to obtain material for genetic testing, commonly performed at day 5–6 blastocyst stage.

Laboratory useTE biopsy specimens are commonly analyzed using NGS or other cytogenomic platforms and may be combined with whole genome amplification methods to improve assay performance.

Associated interventionsTE biopsy is typically performed as part of PGT workflows that include embryo culture, biopsy, cryopreservation, and later embryo transfer.

TE biopsy — discordance and limitation

Discordance riskTE biopsy may be discordant with the inner cell mass (ICM) because mosaicism can cause the TE chromosome complement to differ from the ICM, leading to false positive or false negative PGT results.

Mosaicism impactMosaic distribution and sampling limitations mean a TE result may not reliably predict embryo ploidy when only a small number of cells are sampled.

Validation implicationBecause of discordance risk, confirmatory prenatal diagnostic testing (CVS or amniocentesis) is recommended when PGT results are used to guide clinical decisions.

Segmental de novo aneuploidy — definition

DefinitionSegmental de novo aneuploidy: gains or losses of chromosome segments that arise during meiosis or mitosis in embryo development and are detectable by NGS and can be confirmed by FISH in some cases.

Frequency and detectionNGS-based studies have identified hundreds of de novo segmental aneuploidies among thousands of blastocysts, indicating this is a real phenomenon rather than an artifact of amplification.

Clinical relevanceSegmental de novo aneuploidy contributes to discordant TE/ICM findings and may affect transfer decisions and diagnostic concordance between platforms.

PGT-P (polygenic risk) — description

DefinitionPGT-P screens embryos for polygenic disorders by calculating statistical predictions of increased clinical risk based on multiple genes (polygenic risk scores).

Evidence and stanceEvidence for utility of PGT-P for embryo selection is lacking and professional guidance expresses ethical concerns; PGT-P is not supported for routine clinical use.

Recommended contextPGT-P should be limited to research settings pending further validation and ethical/regulatory guidance.

TE biopsy and mosaicism — summary

SummaryTE biopsy samples TE cells at blastocyst stage; because embryos can be mosaic, TE sampling may not reflect inner cell mass and can yield false positive or false negative aneuploid results.

Clinical implicationMosaicism complicates interpretation and transfer decisions; euploid embryos are prioritized and mosaic embryos require counseling on level and type of mosaicism.

Testing/validation noteNoninvasive PGT-A (niPGT-A) shows promise in small studies with potentially higher concordance, but larger validation is needed before routine adoption.

PGT-A / PGT-M / Mosaicism — brief

PGT-APreimplantation genetic testing for aneuploidy (PGT-A) screens embryos for chromosome number abnormalities; routine use is not supported by current evidence and PGT-A is considered unproven/not medically necessary in this policy.

PGT-MPreimplantation genetic testing for monogenic disorders (PGT-M) is intended to prevent transmission of single-gene conditions that cause significant health problems or severe disability and is covered when criteria are met.

Mosaicism considerationMosaic embryos contain mixtures of euploid and aneuploid cells; level/percentage of mosaicism may inform outcomes and transfer prioritization, and confirmatory prenatal testing is recommended when PGT guides transfer.