ModifiedUnitedHealthcarePolicy CS160NJ.J

Preimplantation Genetic Testing and Related Services (for New Jersey Only)

This policy governs coverage and medical necessity criteria for Preimplantation Genetic Testing (PGT) services in the state of New Jersey, including PGT-M and PGT-SR, and related procedures and billing codes. It applies to providers and members covered under UnitedHealthcare in New Jersey.

Policy Summary

PayerUnitedHealthcare

PolicyPreimplantation Genetic Testing and Related Services (for New Jersey Only)

Policy CodePolicy CS160NJ.J

Change TypeUpdated applicable codes

Effective DateJul 1, 2025

Next Review Date

Key ActionConfirm prior authorization requirements and coding review reflect the added proprietary codes (0552U–0555U).

SourceLink

POLICY UPDATE CHANGES

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

Archived previous policy version CS160NJ.I.

2clinically supported PGT types

4new CPT/Proprietary codes added

13studies summarized

multipleapplicable procedure codes listed

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Medically necessary indications for PGT-M and PGT-SR

Covered when ALL of the following are met

PGT-M or PGT-SR medical necessity criteria: 1) Embryo is at increased risk of a recognized inherited disorder AND 2) The increased risk is due to one of: each intended parent is a carrier 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 3) The 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).

PGT must be ordered after genetic counseling.

HLA typing for sibling donor

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

Not medically necessary / unproven indications

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

Genetic counseling recommended prior to testing.

Coverage considerations by PGT modality

Coverage is more strongly supported for PGT when used for specific clinical indications rather than routine screening; evidence summaries inform which indications have supportive data.

PGT-M supportive evidence: PGT-M is associated with pooled clinical pregnancy and live birth rates per cycle and per embryo transfer that compare favorably to IVF for other indications; concurrent PGT-A may be associated with improved outcomes in some studies.

see pooled rates and subgroup data

PGT-SR supportive evidence: PGT-SR can identify euploid or balanced embryos in structural rearrangement carriers and studies report improved normal live birth rates post-PGT-SR in some cohorts; euploid embryo proportions may be low (e.g., ~10.8% in CCR analysis).

outcomes variable by carrier type and female age

PGT-HLA utility: PGT-HLA can produce diagnostically suitable embryos and enable births resulting in potential hematopoietic stem cell transplantation donors; diagnostic efficacy and pregnancy rates vary across centers.

diagnostic efficacy reported 78.5% in multicenter series

Coverage considerations and evidence summary

Coverage considerations summarized from cited evidence and guideline positions:

General PGT-A evidence: Overall evidence for routine PGT-A is insufficient and conflicting: systematic reviews and meta-analyses report uncertain effects on live birth rates in the general IVF population, with reductions in some outcomes depending on methodology and heterogeneity across studies.

Multiple systematic reviews and RCT syntheses concluded routine clinical PGT-A not supported.

Potential benefit subgroups: Some high-quality trials and meta-analyses identify possible benefit of PGT-A for individuals of advanced maternal age (for example age >35) and in certain recurrent pregnancy loss/failure populations, including improved live birth rate per transfer and reduced miscarriage in selected analyses.age > 35 years or history of recurrent pregnancy loss/failure as defined in cited studies

Benefits often observed per transfer or subgroup analyses, but not consistently per intention-to-treat or cumulative live birth rate.

Circumstances increasing uncertainty or harm:

Clinical stance: PGT categories and acceptability

Coverage-relevant clinical positions and criteria derived from professional society statements in this section

PGT-M / PGT-SR considered clinically supported: PGT-M should be offered when there is an identified significant reproductive risk; PGT-SR is appropriate for patients at high risk of pregnancy loss or abnormal liveborn births due to structural rearrangements, provided the technique can detect all expected unbalanced forms.

Based on ACOG, ASRM, ASRM/SART, and ESHRE summaries

PGT-A utility debated: Professional societies state that PGT-A has not been established as universally beneficial; large prospective studies are needed and its value as a screening test remains undetermined.

ACOG, ASRM, and ASRM/SART position summaries

PGT-P/PRS not appropriate for clinical embryo selection: Professional organizations (ACMG, ESHRE, ASRM summaries) state that PGT-P/PRS lacks proven clinical utility, raises ethical concerns, and should be limited to research settings or not used clinically for embryo selection at this time.

Multiple society statements recommend against clinical use

PGT is considered unproven and not medically necessary for indications outside of the specific, evidence-supported uses of PGT-M and PGT-SR. Examples of such unproven uses include PGT-A for general aneuploidy screening, determining embryo sex when there is no risk of a sex-linked disorder, and testing intended to predict polygenic disease risk or select embryos based on polygenic scores (PGT-P/ESPS). Genetic counseling is recommended and PGT should be ordered after counseling when applicable.

Routine use of PGT-A for broad population aneuploidy screening is not supported by current evidence and may be excluded or limited absent a specific clinical indication. High-quality studies and systematic reviews report conflicting results and uncertainty about effects on cumulative live birth rate and other key outcomes, indicating that PGT-A should not be applied routinely to all IVF patients without documented rationale.

Preimplantation genetic testing intended to select embryos based on polygenic risk scoring (PGT-P) is not considered appropriate for routine clinical embryo selection. Professional guidance (including ACMG) advises that PGT-P lacks proven clinical utility and should be limited to research settings until evidence on benefits, harms, and ethical implications is available.

Use of PGT-P/PRS for embryo selection is not supported for clinical use at this time and raises important ethical, legal, and social concerns. Professional societies (ACMG, ESHRE/ESHG) state that predictive performance for individuals is unreliable and recommend restricting PGT-P to research or not offering it clinically until further evidence and guidance exist.

This Medical Policy is informational and is intended to assist interpretation of UnitedHealthcare standard benefit plans. Federal, state, or contractual benefit language governs if it differs from this policy, so plan-specific terms may supersede the policy when making coverage determinations.

PGT is considered unproven and not medically necessary for indications outside the established uses of PGT-M, PGT-SR, and embryo HLA typing. Examples include routine PGT-A, non–risk-based gender selection, and predictive polygenic testing (PGT-P/ESPS), all of which lack demonstrated clinical benefit.

Evidence does not support PGT-A as an effective broad population screening tool. Systematic reviews and recent analyses report conflicting findings and insufficient high-quality data to demonstrate consistent improvement in cumulative live birth rate or other population-level outcomes, so PGT-A cannot be recommended for universal screening.

Routine, non–indication-based use of PGT-A (for example, as a standard addition to every IVF cycle) is not supported by the evidence and may be considered not medically necessary in the absence of documented clinical indications such as advanced maternal age or recurrent pregnancy loss where subgroup data suggest possible benefit.

Preimplantation genetic testing using polygenic risk scores (PGT-P/PRS) for embryo selection is considered not medically necessary / unproven. Societal guidance emphasizes the lack of validated clinical utility and the presence of significant ethical concerns, therefore PGT-P should not be used clinically for embryo selection outside research.

Applicable Procedure, Molecular, and Proprietary Codes

Listed proprietary/temporary molecular pathology codesHCPCS

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, 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.
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, per embryo tested.
0554U	Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using DNA genomic sequence analysis from trophectoderm biopsy for aneuploidy, ploidy, mitochondrial DNA score, and embryo quality control, 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, mitochondrial DNA score, and embryo quality control, per embryo tested.

Cytogenomic and molecular pathology codesCPT | HCPCS | mixed

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 SNP variants, comparative genomic hybridization (CGH) microarray analysis.
81349	Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation for copy number and loss-of-heterozygosity variants, low-pass sequencing analysis.
81479	Unlisted molecular pathology procedure.

Procedure and related service codesCPT | HCPCS

89290	Biopsy, oocyte polar body or embryo blastomere, microtechnique; less than or equal to 5 embryos.
89291	Biopsy, oocyte polar body or embryo blastomere, microtechnique; 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.
89251	Culture of oocyte(s)/embryo(s), less than 4 days; with co-culture.
89253	Assisted embryo hatching, microtechniques.
89254	Oocyte identification from follicular fluid.
89255	Preparation of embryo for transfer (any method).

1–10 of 26

1/3

Covered/Referenced Codesmixed

No codes listed

Updated/Added Applicable CodesCPTCovered

0552U	newly added proprietary molecular pathology code
0553U	newly added proprietary molecular pathology code
0554U	newly added proprietary molecular pathology code
0555U	newly added proprietary molecular pathology code

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for selected indications of preimplantation genetic testing for aneuploidy (PGT-A). When requesting authorization, provide clear clinical indication (age, recurrent pregnancy loss [RPL], prior IVF failure, diminished ovarian reserve, or concurrent PGT-M/PGT-SR) and cycle characteristics (number of embryos available, embryo stage, prior treatment history). Prior authorization decisions must reflect applicable federal, state, and contractual benefit language.

Prior authorization required for PGT-A in select indications (age-related diminished ovarian reserve, recurrent pregnancy loss, IVF failure)
Document clinical indication, cycle characteristics, and whether PGT-A is requested concurrently with PGT-M or PGT-SR

Documentation Required

Genetic Counseling and Confirmatory Testing

Genetic counseling is strongly recommended prior to ordering any PGT (PGT-M, PGT-SR, PGT-A, PGT-P). Counseling should explain benefits, limitations, and alternatives. For PGT-M and PGT-SR, offer prenatal diagnostic confirmation (CVS or amniocentesis) when pregnancy is achieved; document that patients were counseled about confirmatory testing and shared decision-making.

Pre-test genetic counseling recommended and should be documented in the prior authorization request
Offer and document post-PGT counseling and offer confirmatory diagnostic testing (CVS or amniocentesis) for PGT-M and PGT-SR results

Denial Risk

PGT-A Evidence Insufficiency and Denial Risk

PGT-A lacks sufficient evidence of routine clinical utility; requests for PGT-A will be reviewed and may be denied when clinical utility is not demonstrated for the individual case. Routine PGT-A for broad populations is unsupported by evidence and may be denied.

PGT-A may trigger denial when submitted for routine/unsupported indications
Provide documentation supporting medical necessity for the specific indication to avoid denial

Denial Risk

PGT-P Considered Investigational / Denial Risk

Preimplantation Genetic Testing for Polygenic Disorders (PGT-P) and embryo selection based on polygenic scores (ESPS) are considered investigational/research-only due to lack of demonstrated clinical utility and unresolved ethical, legal, and social concerns. Coverage may be denied for PGT-P and related services.

PGT-P (polygenic risk/ESPS) considered investigational — clinical use only within approved research settings
Risk of denial for PGT-P claims; provide research protocol documentation if applicable

Step Therapy

Step Approach for Concurrent Testing

When PGT-A is requested concurrently with PGT-M or PGT-SR, a stepwise authorization approach is recommended: clearly indicate the primary clinical purpose (e.g., prevention of a single-gene disorder via PGT-M) and whether concurrent aneuploidy screening is clinically necessary. Provide data on embryos available and reasoning for concurrent testing to facilitate authorization.

State whether PGT-A is concurrent with PGT-M/PGT-SR and justify clinical need
Authorization may be processed with a stepwise review of concurrent testing requests

Note

Consider Non-PGT Options Before Testing

Consider non-PGT management options before authorizing testing when clinically appropriate (e.g., expectant management, traditional prenatal screening/diagnostic options, or alternative fertility strategies). Document counseling about alternatives and rationale for selecting PGT.

Document that non-PGT options were considered and discussed during counseling
Include rationale for selecting PGT over alternative management in the authorization documentation

Billing Rule

Updated Applicable Codes — Confirm Prior Authorization

Confirm that prior authorization and billing reflect the current applicable codes. The policy's applicable codes were updated effective 07/01/2025 to include new CPT/PLA codes (0552U, 0553U, 0554U, 0555U) and other referenced codes; ensure prior authorization systems and claims use the updated code list.

Updated codes added 07/01/2025: 0552U, 0553U, 0554U, 0555U
Verify that prior authorization reflects newly added procedure codes and that coding on claims matches authorized services

Note

Reference Federal/State/Contractual Benefit Requirements

Coverage determinations must reference federal, state, and contractual benefit requirements; when plan language conflicts with this policy, the applicable benefit document governs. Check member federal/state/contractual benefit terms before approving or denying services.

Refer to member-specific benefit language and applicable laws when applying this policy
In event of conflict, federal/state/contractual requirements supersede this policy

Definitions and Terminology

Preimplantation Genetic Testing (PGT) — definition and subtypes

TermPreimplantation Genetic Testing (PGT)

DefinitionA test performed to analyze DNA from oocytes (polar bodies) or embryos (cleavage stage or blastocyst) for HLA typing or for determining genetic abnormalities.

Included subtypesPGT-A (aneuploidy screening), PGT-M (monogenic/single gene defects), PGT-SR (chromosomal structural rearrangements)

Significant Health Problems or Severe Disability — definition used in policy

TermSignificant Health Problems or Severe Disability

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

Source contextFederal Government Definition for Social Security Disability Benefits (Department of Labor; Office of Disability Employment Policy).

PGT-M — definition for monogenic/single gene defects

TermPGT-M

DefinitionPreimplantation genetic testing for monogenic/single gene defects to prevent transmission of inherited single-gene disorders; testing embryos for specific pathogenic germline variants with established clinical utility.

Evidence summarySystematic review pooled data (51 studies): clinical pregnancy rate 34% and live birth rate 29.7% per cycle; concurrent PGT-A may improve outcomes in subgroup analyses.

PGT-SR — definition for structural chromosomal rearrangements

TermPGT-SR

DefinitionPreimplantation genetic testing for chromosomal structural rearrangements to identify balanced or normal embryos in carriers of translocations or complex chromosomal rearrangements, used to reduce risk of unbalanced offspring or pregnancy loss.

Evidence summaryStudies report low proportions of euploid embryos (overall ~10.8% in CCR analyses) but PGT-SR may improve reproductive outcomes and aid genetic counseling when detection methods identify expected unbalanced forms.

PGT-A — definition for aneuploidy screening; evidence insufficient for routine use

TermPGT-A

DefinitionPreimplantation genetic testing for aneuploidy screening intended to identify chromosomal abnormalities in embryos prior to transfer (formerly PGS / preimplantation genetic screening).

Policy stanceCurrent evidence is insufficient to support routine use of PGT-A for general aneuploidy screening; benefits may be limited to select subgroups and further high-quality studies are needed.

PGT-HLA — definition for combined HLA-typing use

TermPGT-HLA

DefinitionPreimplantation genetic testing combined with HLA typing to identify embryos that are HLA-compatible with an affected sibling for possible hematopoietic stem cell transplantation or other cellular therapies.

Clinical considerationsRequires multidisciplinary collaboration; diagnostic efficacy and success rates vary across centers and published systematic data are limited.

PGT-HLA — clinical use to identify HLA-compatible embryos for sibling treatment

Clinical usePGT-HLA is used to identify HLA-compatible embryos to enable a future child to potentially serve as a donor (e.g., bone marrow or cord blood) for an affected sibling.

Supporting dataMulti-center ESHRE study (Kakourou et al.): diagnostic diagnosis made in 78.5% of embryos analyzed; births and HSCTs documented in cohorts but outcomes vary by maternal age and oocyte/embryo yield.

LimitationsRetrospective data, center variability, and limited systematic data on methodology and long-term outcomes.

PGT-A — restated definition for embryo aneuploidy screening

TermPGT-A (reiteration)

DefinitionPreimplantation genetic testing for aneuploidy screening aimed at selecting euploid embryos for transfer; previously termed PGS.

Policy noteRoutine, non-indication-based PGT-A is not supported by current evidence and may be considered not medically necessary absent documented clinical indication.

PGT-P — definition for polygenic risk scores; lacks evidence

TermPGT-P

DefinitionPreimplantation genetic testing using polygenic risk scores to predict multifactorial disease risk in embryos; provides statistical predictions of increased clinical risk for polygenic conditions.

Policy stanceEvidence for clinical utility of PGT-P for embryo selection is lacking; ethical, legal, and social concerns exist and professional societies recommend limiting clinical use to research settings.

PGT-P / PRS — definition and statistical prediction context

TermPGT-P / PRS

DefinitionGenetic testing that screens embryos for multiple-gene disorders using polygenic risk scores to provide statistical predictions of increased risk; not validated for reliable individual-level embryo selection.

Clinical and ethical contextProfessional statements (ACMG, ESHRE) caution against clinical application due to limited evidence, potential for harm, and unresolved ethical implications; recommend research-only use.

PGT-M — definition reiteration for clinically supported single-gene testing

TermPGT-M (reiteration)

DefinitionPreimplantation genetic testing for monogenic disorders — testing embryos for specific pathogenic germline variants with established clinical utility in many situations.

GuidanceProfessional society guidance (ACOG, ASRM, ESHRE) supports use of PGT-M when an identifiable pathogenic variant or clear inheritance risk is present; confirmatory prenatal diagnostic testing is recommended.

PGT-SR — definition reiteration and recommended use

TermPGT-SR (reiteration)

DefinitionPreimplantation genetic testing for structural chromosomal rearrangements used when there is risk of unbalanced inheritance; recommended when the technique can detect all expected unbalanced forms.

Evidence/guidanceStudies report variable euploidy rates and potential improvements in reproductive outcomes for carriers; professional guidance supports PGT-SR in appropriately selected patients.

Preimplantation genetic testing (PGT) and subtypes — aggregated term references

Aggregated termPGT and subtypes—summary

ContentPGT encompasses testing of oocytes or embryos for HLA typing and genetic abnormalities, including PGT-M (monogenic), PGT-SR (structural rearrangements), PGT-A (aneuploidy), PGT-HLA, and PGT-P/PRS; clinical utility and coverage stance differ by subtype.

Coverage implicationsPGT-M and PGT-SR are considered clinically supported for indicated cases; PGT-A routine use is insufficiently supported; PGT-P is not supported for clinical embryo selection and should be limited to research per professional societies.

OpenPayer

Preimplantation Genetic Testing and Related Services (for New Jersey Only)

Coverage and Medical Necessity Criteria

Applicable Procedure, Molecular, and Proprietary Codes

Provider Requirements, Prior Authorization, and Documentation

Definitions and Terminology

Clinical Background and Evidence Summary

Policy Revision History