CurrentIndependent HealthPolicy M20210312010

Preimplantation Genetic Testing Policy

Defines Independent Health's medical necessity criteria for preimplantation genetic diagnostic testing as an adjunct to in vitro fertilization (IVF), lists populations and product lines where covered or excluded, and specifies prior authorization and documentation responsibilities.

Policy Summary

PayerIndependent Health

PolicyPreimplantation Genetic Testing Policy

Policy CodePolicy M20210312010

Change TypeFormatting revision (10/1/2025)

Effective DateMay 1, 2021

Next Review Date

Key ActionSecure prior authorization and submit all relevant member-level clinical information to the rendering laboratory before claims; claims without prior authorization will be denied and members must not be billed.

SourceLink

POLICY UPDATE CHANGES

10/1/2025 entry: Revised-Formatting Only.

1Primary Covered Indication Set

3Product Lines Excluding Coverage

1Prior Authorization Required

Coverage Summary

Defines Independent Health's medical necessity criteria for preimplantation genetic diagnostic testing as an adjunct to in vitro fertilization (IVF); coverage stance: mixed; subject: Preimplantation Genetic Testing (PGD/PGT). Effective date: 2021-05-01; Last review: 2025-10-01.

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Key Policy Items

Policy NumberM20210312010

Effective Date5/1/2021

Last Review10/1/2025

Coverage StanceMixed — medically necessary for specific genetic indications; investigational/not covered for other uses and certain product lines

Primary Covered Indication Count1

Major Product Lines Excluding Coverage3 (Medicare Advantage; State Medicaid products; Small & Individual Groups/FEHB)

Prior Authorization RequirementYes — prior authorization required; ordering/rendering lab responsible

Medical-Necessity Criteria

Clinical Indications - Medically Necessary (Covered)

Preimplantation genetic diagnostic testing may be considered medically necessary and a covered benefit when ALL of the following criteria are met:

ALL of the following

ONE or more of
- Both parents are known carriers of a recessive genetic condition, and the specific gene mutation has been identified in each parent
- One parent is affected by or known to be a carrier of a dominant condition, and the specific gene mutation has been identified
- The female contributing the egg is known to be a carrier of an X-linked condition and the specific gene mutation has been identified
- One or both parents are carriers of a structural chromosome rearrangement (e.g., translocation or inversion)
- One or both parents have a known chromosome microdeletion (e.g., 22q11 deletion DiGeorge syndrome, 7q11.23 deletion - Williams syndrome)
The genetic condition is associated with potentially severe disability or has a lethal natural history

Not Medically Necessary / Investigational (Not Covered)

Preimplantation genetic testing is considered investigational and not covered in situations other than the specified covered indications:

ANY of the following

Preimplantation genetic diagnostic testing as an adjunct to in vitro fertilization (IVF) is considered investigational in patients or couples who are undergoing IVF in all situations other than those specified above
Preimplantation genetic screening (PGT-A/PGS) as an adjunct to IVF is considered investigational in all situations
For State product members; preimplantation genetic diagnosis associated with in vitro fertilization services is not covered
For Medicare Advantage members; preimplantation genetic diagnostic testing is not covered

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for preimplantation genetic testing. The ordering/rendering laboratory is responsible for securing prior authorization for medically necessary molecular diagnostic testing; claims received without prior authorization will deny to the rendering laboratory.

The ordering/rendering laboratory is responsible for securing prior authorization for medically necessary molecular diagnostic testing; claims lacking prior authorization will deny to the rendering laboratory.

Documentation Required

Clinical Information Submission

The ordering/referring physician must provide the rendering laboratory with all relevant member-level clinical information to support the prior authorization request for molecular diagnostic testing.

Ordering/referring physician must submit all relevant member-level clinical information to the rendering laboratory to support the prior authorization request.

Denial Risk

Claim Denial and Member Billing Protection

Claims for molecular diagnostic testing received without prior authorization will be denied to the rendering laboratory; Independent Health members shall not be billed for such claims.

Claims for molecular diagnostic testing received without prior authorization will be denied to the rendering laboratory and members shall not be billed.

Background & Definitions

Preimplantation genetic diagnosis (PGD/PGT) involves biopsy of one or two cells from embryos during IVF to perform molecular analysis and detect specific genetic diseases, allowing transfer of embryos without the identified genetic condition. Independent Health evaluated peer-reviewed literature to develop its medical necessity criteria. This policy clarifies that coverage of preimplantation genetic testing does not imply coverage of IVF where IVF is not otherwise provided.

Term	Definition
In vitro fertilization (IVF)	Procedure to treat infertility where ovaries are stimulated, oocytes are aspirated and fertilized in the laboratory and embryos transferred to the uterus.
Preimplantation genetic testing	Testing performed on an embryo for either diagnostic (PGD) or screening (PGS/PGT-A) purposes prior to implantation.
Preimplantation diagnostic testing (PGD)	Testing performed on cells from the developing embryo prior to implantation when one or both parents have a known genetic abnormality.
Preimplantation screening testing (PGS/PGT-A)	Screening an embryo for aneuploidy when both parents are chromosomally normal.

References include: ACOG Committee Opinion Number 799 (March 2020; reaffirmed 2023) cited as a reference.

Not Covered / Investigational

Product-line specific exclusions: For State product members (MediSource, MediSource Connect, Essential Plan/New York Medicaid), preimplantation genetic diagnosis associated with IVF is not covered. For Medicare Advantage members, preimplantation genetic diagnostic testing is not covered. For Small and Individual Groups or FEHB Commercial members, preimplantation genetic diagnostic testing is not covered. Investigational statements: Preimplantation genetic diagnostic testing as an adjunct to IVF is investigational in situations other than the specified medically necessary indications, and preimplantation genetic screening (PGT-A/PGS) as an adjunct to IVF is investigational in all situations. These exclusions and investigational determinations are specified in the 'Not Medically Necessary / Investigational' criteria group above.

Revision History

2025-10-01revisionLatest

Revised-Formatting Only.

2024-10-01review

Reviewed.

2024-01-01revision

Revised.

2023-10-01review

Reviewed.

2022-10-01revision

Revised.

2022-05-01review

Reviewed.

2021-05-01effective

Policy effective date.

Policy Summary

PayerIndependent Health

PolicyPreimplantation Genetic Testing Policy

Policy CodePolicy M20210312010

Change TypeFormatting revision (10/1/2025)

Effective DateMay 1, 2021

Next Review Date

SourceLink

On This Page

OpenPayer

Preimplantation Genetic Testing Policy

Coverage Summary

Medical-Necessity Criteria

Provider Actions

Coding

Background & Definitions

Not Covered / Investigational

Evidence & Guidance

Revision History