CurrentUnitedHealthcarePolicy CS16OOH.E

Preimplantation Genetic Testing and Related Services (for Ohio Only)

UnitedHealthcare medical policy (Ohio only) defining medical necessity criteria, covered indications, unproven uses, recommended pre-test counseling, descriptions of PGT types (PGT-M, PGT-A, PGT-SR), and applicable procedure codes for preimplantation genetic testing and related IVF services. This part (1 of 2) includes coverage rationale, definitions, detailed clinical evidence discussion, and applicable CPT/HCPCS and other procedure codes.

Policy Summary

PayerUnitedHealthcare

PolicyPreimplantation Genetic Testing and Related Services (for Ohio Only)

Policy CodePolicy CS16OOH.E

Change TypeCodes added; supporting info archived

Effective DateSep 1, 2025

Next Review Date

Key ActionPGT must be ordered after genetic counseling; provider should document genetic counseling in the medical record prior to ordering PGT.

POLICY UPDATE CHANGES

Applicable Codes Added CPT codes 0552U, 0553U, 0554U, and 0555U

Supporting Information Archived previous policy version CS16OOHD

3PGT coverage categories (medically necessary / HLA typing / unproven)

40+Listed genetic conditions referenced via InterQual

4CPT/Proprietary Codes Added

Coverage Summary

Policy CS16OOH.E (effective September 1, 2025) defines UnitedHealthcare (Ohio only) medical necessity criteria for Preimplantation Genetic Testing (PGT). The policy takes a mixed coverage stance: PGT-M and PGT-SR are covered when specified medical necessity criteria are met (e.g., parental carrier status or structural chromosomal rearrangement and the condition results in Significant Health Problems or Severe Disability), and HLA typing by PGT is covered to enable treatment of an affected sibling. Other uses, including routine aneuploidy screening (PGT-A), gender selection without risk of a sex-linked disorder, and polygenic/embryo selection based on polygenic scores (PGT-P/ESPS), are labeled unproven/not medically necessary due to insufficient evidence.

Key facts

Referenced genetic conditions40+

CPT/Proprietary codes added4

Coverage categories3

Medical-Necessity Criteria

Ordering Requirement

PGT must be ordered after genetic counseling

Provider should document genetic counseling in the medical record prior to ordering PGT.

Unproven / Not Medically Necessary Indications

Systematic reviews, registry analyses, and randomized trials provide inconsistent evidence for routine use of PGT-A. Multiple meta-analyses and Cochrane reviews report heterogeneity and low-to-moderate quality evidence with mixed findings: some analyses suggest reduced miscarriage rates or benefit in selected older age groups, while others show no overall increase in live birth rate. Large registry analyses (SART CORS) observed decreased cumulative live birth rate with PGT-A in many age groups but possible benefit for those >40 years. The STAR randomized trial found no overall improvement in outcomes with PGT-A, with only limited subgroup benefit on per-transfer analyses. Because of these conflicting results, methodological limitations, and variable generalizability across studies, the policy classifies PGT-A and other non‑specified uses as unproven/not medically necessary and advises individualized counseling.

Applicable Procedure and Molecular Pathology Codes

Applicable CPT / Proprietary Molecular Pathology Codes AddedCPT

0552U	Proprietary code added to policy (exact assay not specified in this part)
0553U	Proprietary code added to policy (exact assay not specified in this part)
0554U	Proprietary code added to policy (exact assay not specified in this part)
0555U	Proprietary code added to policy (exact assay not specified in this part)

Provider Actions & Billing Rules

Documentation Required

Genetic counseling required prior to PGT

Document that genetic counseling occurred in the medical record prior to ordering PGT. Genetic counseling should inform the patient about the advantages and limitations of PGT and be recorded as part of the ordering requirement.

Documentation Required

Use InterQual Molecular Diagnostics criteria

Refer to InterQual CP: Molecular Diagnostics for medical necessity determinations for listed single-gene and hereditary conditions. Document the applicable InterQual indication(s) in the medical record when using this policy for coverage decisions.

Documentation Required

Follow federal/state/contractual requirements

Check and follow applicable federal, state (for example, Ohio Administrative Code), or contractual benefit plan requirements before applying this policy, since those requirements govern if there is a conflict with the policy.

Documentation Required

Use InterQual or UnitedHealthcare criteria for medical necessity

UnitedHealthcare uses InterQual for primary medical necessity criteria. If InterQual does not provide applicable criteria, UnitedHealthcare medical policies, Coverage Determination Guidelines, or Utilization Review Guidelines (as approved by the Ohio Department of Medicaid Services) may be used. Document which criteria source was used for the medical necessity determination.

Billing Rule

Report new CPT/proprietary codes

Bill using the newly added CPT/proprietary molecular pathology codes (0552U–0555U) where appropriate per the policy revision effective date.

0552U
0553U
0554U
0555U
Effective date: 2025-09-01

Background and Evidence Summary

Background: Preimplantation Genetic Testing (PGT) encompasses testing of oocytes or embryos to evaluate genetic abnormalities or HLA type before transfer. The policy defines PGT-M (single‑gene/monogenic testing), PGT-A (aneuploidy screening), and PGT-SR (structural rearrangement testing). PGT is performed using laboratory methods such as PCR, chromosomal microarray (CMA), and next‑generation sequencing (NGS), and may be applied at polar body, cleavage, or blastocyst stages.

Clinical context and counseling: Use of PGT has been proposed to improve IVF outcomes (for example, reducing time to live birth or enabling single embryo transfer), particularly for people with advanced maternal age, recurrent pregnancy loss, failed IVF, or parental chromosomal rearrangements. However, because benefits vary by indication and test type, the policy emphasizes that genetic counseling is required and that patients should be counseled about the advantages, limitations, and uncertainty in clinical utility prior to ordering PGT.

Study / Source	Key finding
Cochrane / Systematic reviews and meta-analyses (Cornelisse 2020; Cheng 2022; Simopoulou 2021; others)	Multiple high-quality reviews find inconsistent evidence for routine PGT‑A: overall no clear increase in live birth rate (LBR) but potential reduction in miscarriage; some meta‑analyses report benefit in advanced maternal age or improved cumulative LBR in select subgroups; heterogeneity and low–moderate quality of evidence limit conclusions.
SART CORS registry analysis (Kucherov 2023)	Analysis of 133,494 autologous IVF cycles reported decreased cumulative live birth rate (CLBR) associated with PGT‑A for individuals ≤40 years, with possible benefit for those >40; subgroup FET analyses showed high CLBR when only cycles with transferable euploid embryos were considered; retrospective design limits causal inference.
STAR randomized trial (Munne et al. 2019)	Multicenter RCT comparing PGT‑A vs morphology for frozen single‑embryo transfer found no overall improvement in ongoing pregnancy rates (primary outcome); post‑hoc subgroup showed higher ongoing pregnancy per ET in ages 35–40 but not per intent‑to‑treat; no overall benefit across all participants.
Yan et al. (N Engl J Med 2021) and other key RCTs	Large RCTs included in reviews contributed to mixed results: some trials did not show increased LBR with PGT‑A overall, while others contributed to subgroup findings (e.g., advanced maternal age); included in systematic reviews highlighting heterogeneity across studies.
Non‑selection and assay comparison studies (Tiegs 2021; Friedenthal 2018; Huang 2019; Capalbo 2015)	Assay and biopsy timing affect performance: targeted NGS PGT‑A shows prognostic value for aneuploid results (Tiegs non‑selection study); NGS may yield better implantation/LBR vs CGH; noninvasive approaches and differences between methods raise concerns about concordance and mosaicism artifacts.
RCT/meta‑analyses focused on recurrent pregnancy failure / recurrent loss (Liang 2023; Mumusoglu 2025)	Systematic reviews/meta‑analyses suggest PGT‑A may reduce pregnancy loss and may improve LBR per transfer or per participant in populations with recurrent pregnancy failure or unexplained recurrent loss, but evidence limitations and need for high‑quality RCTs are noted.
Retrospective cohort / donor oocyte analyses (Barad 2017; Bhatt 2021)	Some registry and retrospective studies report lower pregnancy/LBR with PGT‑A in donor cycles or mixed findings; others show increased LBR in selected groups (e.g., RPL with FET), illustrating inconsistent real‑world outcomes and potential selection biases.
Meta‑analysis findings summarized (Cornelisse 2020 detailed results)	Cochrane review found uncertainty about CLBR and LBR with PGT‑A across techniques; FISH‑era PGT‑A probably reduced live births after first transfer, and evidence quality varied from low to moderate, leading to conclusion that routine PGT‑A is not supported.
Subgroup and age‑specific analyses (multiple sources)	Across RCTs, meta‑analyses, and registry data, age appears to modify effect: several analyses report potential benefit in older patients (>35 or >40) for certain outcomes (LBR per ET or reduced miscarriage), but results are inconsistent and not definitive.

Definitions (brief)

Preimplantation Genetic Testing (PGT)A test performed to analyze DNA from oocytes or embryos for HLA typing or genetic abnormalities (PGT-M, PGT-A, PGT-SR).

PGT-MTesting for monogenic/single gene defects (formerly PGD).

PGT-ATesting for aneuploidy screening (formerly PGS).

PGT-SRTesting for chromosomal structural rearrangements (formerly chromosomal PGD).

Significant Health Problems or Severe DisabilityA disability or impairment that substantially limits major life activities, expected to last ≥12 months or result in death (Social Security disability definition).

OACOhio Administrative Code (state regulatory code referenced for coverage governance).

Revision History

2025-09-01material_changeLatest

Applicable Codes Added CPT codes 0552U-0555U; Supporting Information Archived previous policy version CS1600HD; policy effective date September 1, 2025.

2025-09-01archival_note

Previous supporting information archived as part of the update (previous policy version CS16OOHD).

Policy Summary

PayerUnitedHealthcare

PolicyPreimplantation Genetic Testing and Related Services (for Ohio Only)

Policy CodePolicy CS16OOH.E

Change TypeCodes added; supporting info archived

Effective DateSep 1, 2025

Next Review Date

Key ActionPGT must be ordered after genetic counseling; provider should document genetic counseling in the medical record prior to ordering PGT.

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