ModifiedUnitedHealthcarePolicy CS160PA.K

Preimplantation Genetic Testing and Related Services (for Pennsylvania Only)

This policy governs coverage and medical necessity of preimplantation genetic testing (PGT) and related services for members in Pennsylvania; it specifies which PGT indications are considered proven/medically necessary and which are unproven/not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyPreimplantation Genetic Testing and Related Services (for Pennsylvania Only)

Policy CodePolicy CS160PA.K

Change TypeCode list update — Category III codes added

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain preauthorization when billing listed PGT-related procedure codes and document indication and supporting genetic counseling.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable CPT codes to reflect quarterly edits; added 0552U, 0553U, 0554U, and 0555U.

PA-onlyJurisdiction

PGT-M/PGT-SRCovered indications

PGT-A, PGT-P, non–risk-based sex selectionNot covered/unproven

4New Category III codes

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PGT-M and PGT-SR (Medically Necessary)

Covered when ALL of the following are met:

PGT-M or PGT-SR coverage criteria: PGT-M or PGT-SR performed by PCR, NGS, or CMA is proven and medically necessary when: (1) the embryo is at increased risk of a recognized inherited disorder because either 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; AND (2) 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).

PGT for HLA typing (Medically Necessary)

Covered when ALL of the following are met:

HLA typing: 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 (i.e., to enable hematopoietic stem cell transplantation or related therapy).

Evidence summaries relevant to coverage

Key evidence summaries and inferred coverage-relevant findings

PGT-SR evidence summary: Comparative observational studies and method-comparison studies show no consistent improvement in live birth rates with PGT-SR versus natural conception; NGS demonstrates concordance with CGH for abnormal results and can detect additional segmental aneuploidies and low-level mosaicism.

PGT-HLA evidence summary: Multi-center series report modest diagnostic efficacy (~78.5%) for PGT-HLA with pregnancy and live-birth outcomes influenced by maternal age, oocyte yield, and genetic chance; diagnostic efficacy and pregnancy rates are lower than some prior PGD reports.

PGT-A clinical utility — mixed evidence

PGT-A may reduce miscarriage: Several systematic reviews and trials report decreased miscarriage rates with PGT-A.
PGT-A may increase LBR in older patients: Subgroup analyses and some meta-analyses identify improved live birth or ongoing pregnancy for individuals >35 years when blastocyst-stage PGT-A is used.

Evidence summary and society positions

Summarized findings and professional society positions relevant to coverage decisions:

PGT-A general evidence: Randomized and observational studies show mixed results: the STAR RCT found no overall improvement in ongoing pregnancy rate per ET or ITT for PGT-A versus morphology selection, though a post hoc subgroup (age 35-40) suggested higher ongoing pregnancy per ET; other studies and meta-analyses report decreased miscarriage and potential age- or technique-specific benefits, while registry data raise concerns about reduced cumulative live birth in many age groups.

Mosaicism considerations: Mosaic TE biopsy results are associated with variable outcomes; sampling limitations can produce false positives/negatives, and societies recommend counseling, preferential transfer of euploid embryos, and prioritization of mosaics by level of mosaicism (e.g., <40% preferred) and morphology when needed.

PGT-M and PGT-SR utility: Professional societies including ACOG and ASRM consider PGT-M and PGT-SR clinically useful for established indications and recommend offering confirmatory prenatal diagnostic testing (CVS or amniocentesis) after PGT-M/PGT-SR and offering diagnostic testing or screening following PGT-A.

Per Pennsylvania Statute 62, Section 443.6(f), medical services, procedures, or drugs related to infertility therapy are not covered. Within this jurisdictional framework, the policy specifies that PGT-M and PGT-SR are considered proven and medically necessary when performed by PCR, NGS, or CMA and when both of the following conditions are met: (1) the embryo is at increased risk for a recognized inherited disorder because either both intended parents are carriers of the same autosomal recessive disease, at least one parent is a carrier of an autosomal dominant/sex-linked/mitochondrial condition, or at least one parent is a carrier of a structural chromosome rearrangement; AND (2) the medical condition being prevented would result in Significant Health Problems or Severe Disability and is caused by a single gene (PGT-M) or parental structural chromosome changes (PGT-SR).

The document does not present additional explicit administrative coverage exclusions beyond the statutory infertility-therapy exclusion noted for Pennsylvania; instead, the sections summarize the current evidence base and highlight limitations and the need for further RCTs and prospective data to clarify safety and effectiveness. Systematic reviews cited in the policy emphasize heterogeneity in biopsy stage, study design, and outcomes reporting and recommend more rigorous prospective trials before expanding routine coverage.

Routine clinical use of PGT-A (aneuploidy screening) for all IVF patients is not supported by the available evidence. Systematic reviews and randomized trials report mixed results with low-to-moderate quality evidence and uncertainty about improvement in cumulative live birth rate or live birth after first transfer; the multicenter STAR RCT (Munné et al.) found no overall improvement in ongoing pregnancy or live birth per intention‑to‑treat, though subgroup analyses suggested possible benefit in selected older age groups. Clinical utility depends on patient selection, biopsy timing, and assay method, and current evidence does not justify universal routine application.

Preimplantation genetic testing to predict or select embryos based on polygenic risk (PGT-P) lacks demonstrated clinical utility for embryo selection and is accompanied by significant ethical, social, and regulatory concerns. Professional guidance and recent reviews conclude that PGT-P should not be used in routine clinical practice and, if pursued at all, should be confined to formal research settings with appropriate oversight.

The policy states that information about FDA clearance or approval is provided for informational purposes only and explicitly notes that FDA approval alone is not a basis for coverage. Laboratory regulation under CLIA is described as relevant background but does not by itself determine coverage.

For populations and indications beyond the proven uses described (PGT-M, PGT-SR, and PGT for HLA typing), the policy considers PGT approaches unproven and not medically necessary due to insufficient evidence. This includes, but is not limited to, broad application of PGT-A, non–risk‑based sex determination, and PGT-P/embryo selection based on polygenic scores; the policy relies on the uncertainty and low quality of evidence reported in systematic reviews and trials when reaching this stance.

Although the policy characterizes many PGT uses as unproven or not medically necessary for populations outside established indications, the document sections provided do not formally label any specific PGT indication as universally 'not medically necessary' in isolation; rather, authors emphasize the need for additional randomized controlled trials and prospective outcome data to make definitive determinations about broader clinical use.

Evidence does not support routine use of PGT-A for all IVF patients. Randomized trials, systematic reviews, and registry analyses report conflicting results: some studies note reduced miscarriage or potential benefit in selected older patients, while other analyses—particularly of cumulative live birth—show no improvement or possible reduction in live births in unselected populations. Hence routine universal application across all IVF patients is not supported.

The STAR randomized trial (Munné et al., 2019) enrolling 661 participants did not demonstrate improved overall ongoing pregnancy or live birth rates for universal application of PGT-A versus morphology-based embryo selection when analyzed per intention‑to‑treat. While a post hoc subgroup (ages 35–40) showed higher ongoing pregnancy per embryo transfer after PGT-A, the trial authors concluded that PGT-A did not improve overall pregnancy outcomes across the full study population, underscoring that routine universal use is not supported by this RCT.

Applicable Procedure and Category Codes

Reproductive medicine (new technology) CPT/HCPCSCPT

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.

Applicable CPT/HCPCS and related service codesmixed

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.
58970	Follicle puncture for oocyte retrieval, any method.
58974	Embryo transfer, intrauterine.
76948	Ultrasonic guidance for aspiration of ova, imaging supervision and interpretation.
89250	Culture of oocyte(s)/embryo(s), less than 4 days.

1–10 of 30

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Applicable CPT/Category III codes addedCPT

0552U
0553U
0554U
0555U

Duration threshold for Severe Disability

Duration threshold>= 12 months

Source definitionSignificant Health Problems or Severe Disability is defined as an impairment expected to last at least 12 months or result in death.

Regulatory citationDefinition references Department of Labor; Office of Disability Employment Policy / Social Security Disability Benefits wording.

Provider Responsibilities, Authorization, and Documentation

Prior Authorization

Prior Authorization and Billing Notes

Prior authorization for listed PGT-related procedure codes is not explicitly specified elsewhere in this section of the policy. Providers should be aware that applicable CPT/Category III code lists were updated (quarterly edits) and new Category III codes were added; these coding changes may affect prior authorization workflows. When billing, providers should obtain any required authorizations per UnitedHealthcare administrative processes and the member's plan benefits. If a service does not meet plan-specific administrative requirements or jurisdictional rules (for example, Pennsylvania-specific exclusions for infertility therapy), requests may be evaluated case-by-case and could be denied.

Applicable code updates: 0552U, 0553U, 0554U, 0555U (see policy Applicable Codes)
Obtain prior authorization when required by the member's plan; code list changes may trigger new prior auth requirements

Prior Authorization

PGT-A Prior Authorization: Indication and Embryo Availability

For PGT-A, prior authorization (when required by the plan) should include documentation supporting the medical indication (for example, advanced maternal age, recurrent pregnancy loss, or other documented indication where evidence supports benefit) and documentation of embryo availability when appropriate (e.g., number and stage of embryos available for biopsy, blastocyst availability). The policy indicates insufficient evidence for routine PGT-A and highlights age and embryo-stage considerations in the literature; authorization reviewers may require clinical details to determine medical necessity.

Document clinical indication for PGT-A (e.g., advanced maternal age >35, unexplained RPL with supporting data)
Provide embryo availability: number of blastocysts of adequate quality, biopsy day (day 5 blastocyst preferred when applicable)

Note

Administrative Requirements and Step Therapy

No explicit administrative prior authorization rules, step therapy, or quantity limits are specified directly in the clinical evidence chunks of this section. Providers should follow UnitedHealthcare's standard administrative and prior authorization processes for genetic and reproductive services and reference the member's contract for coverage applicability. Requests for services related to infertility therapy may be excluded under Pennsylvania statute and should be identified up front.

No step therapy requirements described for PGT in this policy
Administrative prior authorization requirements (if any) are plan-specific and not defined in these sections

Documentation Required

Confirmatory Diagnostic Testing and Result Reporting

When reporting PGT results and making clinical decisions based on those results, providers should document whether confirmatory diagnostic testing (chorionic villus sampling or amniocentesis) was offered and whether it was accepted. Professional society recommendations indicate offering confirmatory testing after PGT-M and PGT-SR and offering traditional diagnostic testing or screening following PGT-A. Documentation of any discordant results between PGT and subsequent prenatal testing should be included.

Document that CVS or amniocentesis was offered following PGT-M and PGT-SR
Document acceptance or refusal of confirmatory testing and results of any prenatal diagnostic testing
Document any discordance between PGT findings and prenatal diagnostic results

Documentation Required

Suggested Clinical Documentation Elements

Suggested clinical documentation elements that support review of medical necessity and appropriate coding include details of the ART/IVF cycle and the PGT procedure: number of oocytes retrieved, number of embryos analyzed, embryo stage and biopsy details (day of biopsy, trophectoderm vs cleavage stage), biopsy method, laboratory CLIA status and test authorization, test methodology (PCR, NGS, CMA), and results per embryo. Including these elements in the authorization request and medical record will facilitate timely adjudication.

Number of oocytes retrieved and number of embryos available/analyzed
Embryo stage at biopsy (e.g., blastocyst/day 5) and biopsy type (trophectoderm vs cleavage)
Test method (NGS, PCR, CMA), laboratory CLIA status, and any FDA-cleared/approved test identifiers if available
Results reported per embryo (euploid/aneuploid/mosaic, level of mosaicism if reported)

Documentation Required

Professional Society Recommendations and Counseling

Professional societies recommend offering confirmatory diagnostic testing and genetic counseling: ACOG recommends offering CVS or amniocentesis to all patients after PGT-M and PGT-SR and offering traditional diagnostic testing or screening after PGT-A. ASRM similarly recommends comprehensive genetic counseling before and possibly after PGT-M and encourages clinics to employ genetic counselors. Documenting counseling and the offer of prenatal confirmation supports medical necessity determinations and informed consent.

Document that genetic counseling was provided prior to PGT and whether counseling after results was offered/received
Document that prenatal diagnostic testing (CVS or amniocentesis) was offered following PGT-M and PGT-SR

Note

Laboratory Regulation and Test Authorization

Laboratories performing PGT are regulated under CLIA; FDA approval alone is not a basis for coverage. Providers should include laboratory CLIA certification and relevant test authorization information in requests. Refer to FDA/CLIA guidance for nucleic acid-based tests; lack of CLIA compliance may affect acceptability of test reports for coverage review.

Include the performing laboratory's CLIA status and any relevant test identifiers in documentation
FDA clearance/approval is informational only and does not by itself establish coverage

Note

Testing Sequence and Biopsy Considerations

Testing sequence and biopsy timing considerations should be documented when relevant to the authorization or medical record. Evidence and professional guidance note that embryo-stage biopsy at the blastocyst (day 5) is commonly preferred for PGT-A and may influence outcomes; patient age (>35) and embryo availability are important factors in selecting whether to perform PGT and when to biopsy.

Document embryo biopsy day (e.g., day 5 blastocyst) and rationale for timing
Document patient age and how it influenced testing/selection strategy

Key Definitions

Preimplantation Genetic Testing (PGT) definition

TermPreimplantation Genetic Testing (PGT)

ScopeAnalysis of DNA from oocytes (polar bodies) or embryos (cleavage stage or blastocyst) for HLA typing or genetic abnormalities.

IncludesPGT-A (aneuploidy), PGT-M (monogenic/single gene), PGT-SR (structural rearrangements).

Significant Health Problems or Severe Disability definition

TermSignificant Health Problems or Severe Disability

DefinitionA physical or mental impairment that substantially limits one or more major life activities.

Duration requirementThe impairment is expected to last at least 12 months or result in death.

PGT-M definition

TermPGT-M (Preimplantation genetic testing for monogenic/single gene defects)

PurposeUsed to avoid transmission of single-gene disorders; can be performed on oocytes or embryos and may be concurrent with aneuploidy screening.

Evidence summarySystematic reviews report clinical pregnancy and live birth rates supportive of utility when indicated (see Poulton et al. 2024).

PGT-SR definition

TermPGT-SR (Preimplantation genetic testing for structural rearrangements)

PurposeUsed for carriers of balanced translocations or complex chromosomal rearrangements to identify transferable embryos and help prevent recurrent miscarriage.

Technical noteNGS is acceptable for PGT-SR and can detect de novo segmental aneuploidies and low-level mosaicism; concordance with CGH is high for abnormal results.

TE biopsy — Trophectoderm biopsy definition and discordance note

TermTrophectoderm (TE) biopsy

DescriptionSampling of TE cells from a blastocyst for genetic analysis (typically blastocyst-stage biopsy).

Discordance noteTE biopsy results may be discordant with the inner cell mass (fetal lineage) due to mosaicism, risking false positives/negatives.

niPGT-A definition

TermniPGT-A (Noninvasive PGT-A)

DescriptionAnalysis of cell-free DNA released into culture media (from TE and ICM) by sequencing as a noninvasive method to assess embryo ploidy.

LimitationsInvestigational data suggest lower false negative rate and higher concordance than TE biopsy in small studies; larger validation studies needed.

PGT-P definition

TermPGT-P (Polygenic testing)

DescriptionTesting that screens an embryo for multiple-gene disorders and provides a statistical prediction of increased clinical risk.

LimitationsClinical utility for embryo selection is lacking; evidence is limited and ethical concerns exist, supporting use only in research settings.

Mosaic embryo definition

TermMosaic embryo

DefinitionAn embryo with cells of differing chromosomal complements detected on trophectoderm biopsy.

ImplicationLevel (percentage) of mosaicism influences outcomes and transfer prioritization; TE sampling can produce false positives/negatives affecting clinical decisions.

CLIA definition

TermCLIA (Clinical Laboratory Improvement Amendments)

DescriptionFederal regulatory standards for laboratories performing testing on human specimens; laboratories performing PGT are regulated under CLIA.

Coverage noteFDA approval alone is not a basis for coverage; CLIA status and laboratory compliance are informational considerations for testing.

OpenPayer

Preimplantation Genetic Testing and Related Services (for Pennsylvania Only)

Coverage Criteria and Evidence Basis

Applicable Procedure and Category Codes

Provider Responsibilities, Authorization, and Documentation

Background and Scope

Key Definitions

Policy Revision History