ModifiedUnitedHealthcarePolicy CS160TN.M

Preimplantation Genetic Testing and Related Services (for Tennessee Only)

This Tennessee-only UnitedHealthcare medical policy governs coverage and medical necessity criteria for preimplantation genetic testing (PGT) and related services for Medicaid and CoverKids members in Tennessee, including which indications are covered and which are considered unproven or not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyPreimplantation Genetic Testing and Related Services (for Tennessee Only)

Policy CodePolicy CS160TN.M

Change TypeCoverage narrowingdocumentation added

Effective DateJun 1, 2026

Next Review Date

Key ActionOrder PGT only after documented genetic counseling and provide medical records to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Replaced language to state that Preimplantation Genetic Testing (PGT) is proven and medically necessary only for monogenic/single-gene defects (PGT-M) or inherited structural chromosome rearrangements (PGT-SR) using PCR, NGS, or chromosomal microarray for the listed indications.

Added explicit statements about medical records documentation requirements to support medical necessity determinations.

Added reference link to the Medical Policy titled 'Whole Exome and Whole Genome Sequencing (Non-Oncology Conditions) (for Tennessee Only)'.

Removed reference link to the Clinical Guideline titled 'Fertility Solutions Medical Necessity Clinical Guideline: Infertility Coverage Rationale'.

Replaced reference to 'gender' with 'sex'.

Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information.

PGT-M & PGT-SRProven indications

PGT-A / PGT-P

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Coverage and Medical Necessity Criteria

Medically necessary coverage (PGT-M and PGT-SR)

Covered when ALL of the following are met

PGT-M or PGT-SR indication: Preimplantation Genetic Testing (PGT) is proven and medically necessary only for monogenic/single-gene defects (PGT-M) or inherited structural chromosome rearrangements (PGT-SR).

Supported testing methods include polymerase chain reaction (PCR), next-generation sequencing (NGS), or chromosomal microarray.

Embryo at increased risk: The embryo must be at increased risk of a recognized inherited disorder because: each intended parent is a carrier of the same autosomal recessive disease; or 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.

The medical 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).

Ordering requirement: PGT must be ordered after genetic counseling.

Genetic counseling is strongly recommended prior to PGT to inform persons being tested about advantages and limitations.

Not medically necessary / Unproven indications

Not covered (unproven and not medically necessary)

PGT-A: Aneuploidy screening (PGT-A) is unproven and not medically necessary for coverage under this policy.

Sex determination: Determining sex when the embryo is not at risk for a sex-linked disorder is unproven and not medically necessary.

PGT-P: Predicting risk of polygenic disorders (PGT-P) and/or embryo selection based on polygenic scores is unproven and not medically necessary.

HLA typing for sibling treatment

Covered when ALL of the following are met

HLA typing for sibling therapy: PGT for human leukocyte antigen (HLA) typing on an embryo is proven and medically necessary when intended to enable the future child to provide bone marrow or blood to treat an affected sibling.

Clinical success is influenced by maternal age, oocyte yield, and genetic chance; diagnostic efficacy reported in multicenter data was approximately 78.5%.

Evidence-informed documentation and clinical considerations

Consider PGT medically appropriate when ALL applicable clinical considerations are met (evidence-based factors for clinician and reviewer):

Core considerations: Patients should have an indication consistent with the specific PGT modality (e.g., known single-gene disorder for PGT-M, known structural chromosomal rearrangement for PGT-SR, or HLA necessity for PGD-HLA).

Supported by clinical outcome data for PGT-M, PGT-SR, and PGD-HLA.

Prognostic embryo/cycle metrics: Provide documentation of oocyte yield, number of embryos/blastocysts available for biopsy, and number of suitable embryos for transfer because these metrics correlate with live birth likelihood.

Evidence linking these metrics to outcomes is summarized in pooled and multicenter analyses.

Methodologic transparency: Specify biopsy stage (day 3 vs day 5), biopsy type (blastomere vs trophectoderm), and genetic testing methodology (e.g., aCGH, NGS, PCR) because outcomes and diagnostic concordance vary by technique.

Method details affect diagnostic accuracy and concordance (see evidence summaries).

Evidence summaries relevant to coverage decisions

Evidence-based findings and subgroup effects reported in the cited studies:

PGT-A overall population: Randomized trials and meta-analyses report inconsistent benefit of PGT-A on live birth rates in the overall IVF population; some analyses show no improvement in ongoing pregnancy or live birth but a reduction in miscarriage rates.

Sources include Taskin 2024, Adamyan 2024, and STAR trial reports.

Advanced maternal age or poor prognosis: Analyses suggest PGT-A may improve implantation and live birth outcomes in individuals of advanced maternal age (>35 years) or with poor prognosis (e.g., recurrent implantation failure or recurrent pregnancy loss).> 35 years

Systematic reviews and cohort analyses report subgroup benefits in older or poor-prognosis populations.

Recurrent reproductive failure (RPF/RPL/RIF): Systematic reviews and registry analyses report improved implantation, clinical pregnancy, and live-birth rates and reduced miscarriage with PGT-A in populations with recurrent reproductive failure, although heterogeneity and bias limit certainty.

Coverage considerations and clinical criteria

Coverage considerations informed by evidence and professional society guidance:

PGT-A general evidence summary: Randomized trials and systematic reviews show mixed results for routine PGT-A; some trials (e.g., STAR) found no overall improvement in ongoing pregnancy or live birth per intent-to-treat, though subgroup/post-hoc analyses suggest possible benefit in selected age groups.

Routine universal PGT-A is not established as beneficial in all patients.

Technical limitations: Trophectoderm (TE) biopsy may yield discordant results relative to inner cell mass because of mosaicism, producing false positives or false negatives; noninvasive approaches are preliminary and require larger validation studies.

Laboratory methodology (NGS vs CGH vs aCGH vs qPCR) affects diagnostic accuracy.

PGT-P stance: PGT-P lacks evidence of clinical utility for embryo selection and raises ethical concerns; professional organizations advise against routine clinical use outside research settings.

ACMG and other societies recommend PGT-P only in research contexts.

Covered Indications and Methods

Covered when ALL of the following are met:

Coverage conditions: Preimplantation Genetic Testing (PGT) is proven and medically necessary only for monogenic/single-gene defects (PGT-M) or inherited structural chromosome rearrangements (PGT-SR). Testing must use polymerase chain reaction (PCR), next-generation sequencing (NGS), or chromosomal microarray for the listed indications.

Follow methods and indications specified in policy; documentation of medical records may be required to assess whether the member meets clinical criteria.

PGT is considered unproven and not medically necessary for indications and populations other than those explicitly listed as covered. The policy states that Preimplantation Genetic Testing is proven and medically necessary only for monogenic/single-gene defects (PGT‑M) and inherited structural chromosome rearrangements (PGT‑SR); all other uses are unsupported by sufficient evidence and are therefore excluded from coverage under this policy.

If a cycle yields an insufficient number of embryos or a poor embryo yield (documented cycle failure), the inability to perform meaningful diagnostic testing or to obtain transferable embryos may preclude clinical benefit from PGT. Historical surveillance and cohort data highlight that reporting of the number of embryos, biopsy stage, and technique is often incomplete; reviewers should expect documentation of embryo yield and cycle outcomes when assessing medical necessity. The policy also notes that PGT must be ordered after genetic counseling, and lack of adequate prognostic metrics (e.g., oocyte yield, embryos available for biopsy) can limit justification for PGT.

Systematic reviews and randomized trials report heterogeneous and generally low‑quality evidence for routine PGT‑A. Evidence summaries conclude it is uncertain whether PGT‑A increases cumulative live birth rate or live birth after first embryo transfer; some analyses even suggest reductions in clinical pregnancy or ongoing pregnancy rates. Because of inconsistent benefit and methodological limitations (including biopsy timing and testing method variability), routine clinical use of universal PGT‑A is not supported by the cited systematic reviews.

Preimplantation genetic testing for polygenic disorders (PGT‑P) lacks evidence of clinical utility for embryo selection and raises substantive ethical concerns. Professional statements and guideline reviews conclude that PGT‑P is not supported for routine clinical use and should be restricted to research settings; therefore PGT‑P is not considered an established, medically necessary clinical application under this policy.

The policy revision explicitly narrowed coverage language to state that PGT is proven and medically necessary only for PGT‑M and PGT‑SR using specified methods (PCR, NGS, or chromosomal microarray). By replacing broader prior wording with this focused statement, the policy implies that PGT performed for indications other than PGT‑M or PGT‑SR (for example, PGT‑P or elective sex determination) is not covered.

The policy explicitly lists aneuploidy screening (PGT‑A), sex determination when the embryo is not at risk for a sex‑linked disorder, and polygenic risk scoring (PGT‑P) as unproven and not medically necessary. These modalities are identified in the coverage rationale as lacking sufficient evidence of efficacy to support coverage.

The document emphasizes the need for prospective, randomized studies and notes substantial heterogeneity in existing comparative studies. Systematic reviews and reviews of the PGT‑SR literature report variable study designs, differing inclusion criteria, and limited randomized evidence, all of which reduce certainty and underscore the requirement for higher‑quality prospective trials to resolve clinical benefit.

Some analyses indicate that certain PGT‑A methods (notably older techniques such as FISH) are associated with reduced live births after the first transfer and may lower overall clinical pregnancy or ongoing pregnancy rates in randomized comparisons. These findings support cautious interpretation of PGT‑A outcomes and informed decision‑making about method-specific risks.

Current evidence does not support routine, universal application of PGT‑A for all IVF patients. Professional society guidance and randomized trial summaries cited in the policy conclude that the value of PGT‑A as a universal screening test remains undetermined and that selective use and further prospective research are preferable to routine implementation.

Following the policy revision, the coverage stance is clear: PGT is considered proven and medically necessary only for PGT‑M and PGT‑SR when performed with listed methods (polymerase chain reaction, next‑generation sequencing, or chromosomal microarray). Uses of PGT outside those specified indications are not established as medically necessary under this policy.

Applicable Procedure and Billing Codes

Applicable PGT and related molecular pathology codes (part 1)HCPCS | CPT

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.

Applicable PGT and related molecular pathology codes (part 2)CPT

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.
89291	Biopsy, oocyte polar body or embryo blastomere, microtechnique (for pre-implantation genetic diagnosis); greater than 5 embryos.

Embryology, culture, and related procedure codesCPT

89250	Culture of oocyte(s)/embryo(s), less than 4 days.
89251	Culture of oocyte(s)/embryo(s), less than 4 days; with co-culture of oocyte(s)/embryos.
89253	Assisted embryo hatching, microtechniques (any method).
89254	Oocyte identification from follicular fluid.
89255	Preparation of embryo for transfer (any method).
89257	Sperm Identification from aspiration (other than seminal fluid).
89258	Cryopreservation; embryo(s).
89260	Sperm isolation; simple prep (e.g., sperm wash and swim-up) for insemination or diagnosis with semen analysis.
89261	Sperm isolation; complex prep (e.g., Percoll gradient, albumin gradient) for insemination or diagnosis with semen analysis.
89264	Sperm identification from testis tissue, fresh or cryopreserved.

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Related services and IVF procedure codesCPT | HCPCS

58970	Follicle puncture for oocyte retrieval, any method.
58974	Embryo transfer, intrauterine.
76948	Ultrasonic guidance for aspiration of ova, imaging supervision and interpretation.
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.
S4022	Assisted oocyte fertilization, case rate.
S4037	Cryopreserved embryo transfer, case rate.

Provider Requirements, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization and Ordering Requirement

Prior authorization is required for Preimplantation Genetic Testing (PGT). PGT must be ordered after documented genetic counseling. Provide documentation of the indication for testing and evidence of pretest genetic counseling when requesting authorization. Note that benefit coverage is determined by federal, state, or contractual requirements and this policy may not supersede those terms.

Prior authorization required for requested PGT services
Order PGT only after documented genetic counseling
Attach documentation of indication and counseling to authorization request
Verify member benefit and prior authorization requirements (federal, state, or contractual rules may apply)

Documentation Required

Provide Cycle- and Embryo-Level Metrics with Requests

When submitting requests for PGT, include cycle- and embryo-level metrics to support medical necessity and to aid clinical review. These metrics inform the likelihood of success and are used in clinical assessment and quality reporting.

Definitions and Terminology

Preimplantation genetic testing (PGT) analyzes DNA from oocytes (polar bodies) or embryos (cleavage‑stage or blastocyst) to detect genetic abnormalities or to perform HLA typing. The technology encompasses tests for single‑gene defects (PGT‑M), structural chromosome rearrangements (PGT‑SR), and aneuploidy screening (PGT‑A); genetic counseling is strongly recommended prior to testing and confirmatory prenatal diagnostics are advised when PGT results will affect clinical management.

Preimplantation Genetic Testing (PGT) — definition and test targets

DefinitionPreimplantation Genetic Testing (PGT): A test performed to analyze DNA from oocytes (polar bodies) or embryos (cleavage stage or blastocyst) for human leukocyte antigen typing or for determining genetic abnormalities.

Test targets (PGT-A, PGT-M, PGT-SR)Includes PGT-A (aneuploidy screening), PGT-M (monogenic/single-gene defects), and PGT-SR (chromosomal structural rearrangements).

Specimen sourcesOocytes (polar bodies) or embryos at cleavage stage or blastocyst stage.

Clinical purposeTo identify embryos with or without targeted genetic abnormalities or HLA compatibility prior to embryo transfer.

Prior Authorization

Prior Authorization: Evidence May Guide Review

Clinical evidence, registries, randomized trials, and published outcome data may be reviewed as part of the prior authorization decision. The presence or absence of supportive evidence for the requested indication can affect authorization determinations.

Submit relevant clinical evidence or registry participation information when available
Evidence supporting PGT-M and PGT-SR is well-established; PGT-A and other indications have limited or mixed evidence

Note

Confirmatory Testing and Counseling Recommended

Confirmatory prenatal diagnostic testing (chorionic villus sampling or amniocentesis) and comprehensive counseling are recommended when PGT results will affect prenatal or pregnancy management decisions. Offer confirmatory testing for PGT-M and PGT-SR and traditional diagnostic testing or screening after PGT-A.

Offer chorionic villus sampling or amniocentesis to confirm PGT-M and PGT-SR results
Offer traditional diagnostic testing or screening for patients who had PGT-A
Provide documentation that patients were offered and counseled about confirmatory testing

Denial Risk

Insufficient Clinical Detail May Limit Justification

Insufficient clinical detail in the request may limit the ability to justify medical necessity. Failure to provide technique details, biopsy type, laboratory protocols, or the requested cycle/embryo metrics can result in delays or denial.

Include biopsy type and stage (e.g., day 3 vs blastocyst), laboratory methodology (NGS, aCGH, PCR), and embryo selection protocols
Provide rationale for the specific PGT modality requested (PGT-M, PGT-SR, PGT-A, etc.)

Documentation Required

Documentation-Dependent Coverage

Coverage determinations are documentation-dependent. The patient's medical record must contain legible documentation that fully supports medical necessity, including relevant history, physical examination, and results of pertinent diagnostic tests. Documentation does not guarantee coverage.

Maintain and make available upon request all supporting medical records
Documentation should include history, exam findings, genetic testing results, counseling notes, and lab/embryology reports

Documentation Required

Medical Records Required for Review

The patient's medical record must contain documentation that fully supports the medical necessity for the requested PGT services. This includes, but is not limited to, relevant medical history, physical examination, results of pertinent diagnostic tests or procedures, and genetic counseling notes.

Medical records must be legible, maintained in the patient's chart, and made available upon request
Documentation may be required to assess eligibility but does not guarantee coverage

Documentation Required

Document Oocyte/Embryo and Outcome Metrics

Document oocyte yield, the number of embryos and blastocysts biopsied, diagnostic results for each embryo, subsequent embryo selection/transfer decisions, and downstream treatments and outcomes. These data support medical necessity determinations and are useful for outcome reporting.

Record oocyte yield per retrieval and number of embryos reaching blastocyst stage
Record biopsy results and classification (euploid, aneuploid, mosaic, variant)
Report downstream outcomes: transfers, pregnancies, miscarriages, live births

PGT-M — definition (monogenic/single-gene defects)

DefinitionPGT-M: Preimplantation genetic testing for monogenic/single-gene defects used to identify embryos free of a specific inherited single-gene disorder.

Evidence of clinical utilitySystematic review (Poulton et al., 2025) pooled 5,305 stimulated cycles and reported live-birth rate per cycle 29.7% (95% CI, 28.5%-31.0%).

Policy stancePGT-M is listed as a proven and medically necessary indication when criteria are met; testing methods specified in policy include PCR, NGS, or chromosomal microarray for listed indications.

PGD-HLA — definition and context

DefinitionPGD-HLA: Preimplantation genetic diagnosis combined with human leukocyte antigen (HLA) typing to identify embryos that are HLA-compatible with an affected sibling, typically to enable stem cell or bone marrow transplant therapy.

Clinical contextUsed when the intended child would serve as an HLA match donor to treat an affected sibling; multicenter data report diagnostic efficacy ~78.5% and subsequent ET and live births in select couples.

LimitationsSuccess limited by maternal age, oocyte yield, and genetic chance; many cycles use day 3 biopsy and may include concurrent single-gene exclusion (e.g., β-thalassemia).

TE biopsy — definition (trophectoderm biopsy) and limitation note

DefinitionTE biopsy (trophectoderm biopsy): sampling of trophectoderm cells from a blastocyst (typically day 5–7) for genetic analysis used in PGT procedures.

LimitationTE cell chromosomal constitution may not always reflect the inner cell mass due to mosaicism, potentially causing false-positive or false-negative results relative to the fetus. TE biopsy accuracy varies by method (NGS vs CGH).

ImplicationMethodologic differences and mosaicism risk support counseling and consideration of confirmatory prenatal diagnostic testing when results will affect clinical decisions.

PGT-SR (term repeat) — Preimplantation Genetic Testing for inherited structural chromosome rearrangements

TermPGT-SR: Preimplantation Genetic Testing for inherited structural chromosome rearrangements (repeat/term clarification).

PurposeIdentify balanced or normal embryos in carriers of reciprocal translocations, complex rearrangements, or CCRs to reduce risk of adverse pregnancy outcomes.

Policy notePGT-SR is designated as a proven and medically necessary indication when policy criteria are met; recommended methods include PCR, NGS, or chromosomal microarray for listed indications.