Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

[Revision log](Revision log)
[Coding Implications](Coding Implications)

CONCERT GENETICS GENETIC TESTING: PREIMPLANTATION GENETIC TESTING

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.

OVERVIEW

Preimplantation genetic testing involves analysis of biopsied cells from an embryo as a part of an assisted reproductive procedure. Preimplantation genetic testing for monogenic disorders (PGT-M) and preimplantation genetic testing for structural rearrangements (PGT-SR) are used to detect a specific inherited disorder in conjunction with in vitro fertilization (IVF) and aims to prevent the birth of affected children to couples at an increased risk of transmitting either a gene mutation(s) or an unbalanced structural chromosomal rearrangement that can be typically targeted in this context. Preimplantation genetic testing for aneuploidy (PGT-A) is used to screen for potential chromosomal or subchromosomal abnormalities (e.g., chromosomal aneuploidy) in conjunction with IVF for couples; in this case testing is untargeted.

Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

POLICY REFERENCE TABLE

Coding Implications

This clinical policy references Current Procedural Terminology (CPT®). CPT is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2023, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

The tests and associated laboratories and CPT codes contained within this document serve only as examples to help users navigate claims and corresponding criteria; as such, they are not comprehensive and are not a guarantee of coverage or non-coverage. Please see the [Concert Genetics Platform](Concert Genetics Platform) for a comprehensive list of registered tests.

Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

OTHER RELATED POLICIES

This policy document provides criteria for preimplantation genetic testing. Please refer to:

• [Genetic Testing: Prenatal and Preconception Carrier Screening](Genetic Testing: Prenatal and Preconception Carrier Screening) for criteria related to carrier screening.
• [Genetic Testing: Prenatal Diagnosis (via amniocentesis, CVS, or PUBS) and Pregnancy Loss](Genetic Testing: Prenatal Diagnosis (via amniocentesis, CVS, or PUBS) and Pregnancy Loss) for coverage related to diagnostic genetic testing during pregnancy or for a pregnancy loss.
• [Genetic Testing: Noninvasive Prenatal Screening (NIPS)](Genetic Testing: Noninvasive Prenatal Screening (NIPS)) for criteria related to prenatal cell-free DNA screening tests.
• [Genetic Testing: Multisystem Inherited Disorders, Intellectual Disability, and Developmental Delay](Genetic Testing: Multisystem Inherited Disorders, Intellectual Disability, and Developmental Delay) for criteria related to diagnostic genetic testing in the postnatal period.
• [Genetic Testing: General Approach to Genetic and Molecular Testing](Genetic Testing: General Approach to Genetic and Molecular Testing) for criteria related to preimplantation genetic testing that is not specifically discussed in this or another non-general policy.

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CRITERIA

It is the policy of health plans affiliated with Centene Corporation® that the specific genetic testing noted below is medically necessary when meeting the related criteria:

PREIMPLANTATION GENETIC TESTING FOR ANEUPLOIDY (PGT-A)

I. Preimplantation genetic testing for aneuploidy (PGT-A) (81229, 81479, 89290, 89291, 0254U) is considered investigational.

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Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

PREIMPLANTATION GENETIC TESTING FOR MONOGENIC DISORDERS (PGT-M)

I. Preimplantation genetic testing for monogenic disorders (PGT-M) (89290, 89291, 81479) may be considered medically necessary when:

A. The embryo is at an elevated risk of a genetic disorder due to one of the following:

1. Both biological parents are known carriers for the same autosomal recessive disorder, OR
2. One biological parent is a known carrier of an autosomal dominant disorder, OR
3. One biological parent is a known carrier of an X-linked recessive disorder.

II. Preimplantation genetic testing for monogenic disorders (PGT-M) (89290, 89291, 81479) is considered investigational for all other indications.

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PREIMPLANTATION GENETIC TESTING FOR STRUCTURAL REARRANGEMENTS (PGT-SR)

I. Preimplantation genetic testing for structural rearrangements (PGT-SR) (81228, 81479, 81229, 89290, 89291) may be considered medically necessary when:

A. The embryo is at an elevated risk of a genetic disorder because one biological parent has a chromosomal rearrangement.

II. Preimplantation genetic testing for structural rearrangements (PGT-SR) (81228, 81229, 81479, 89290, 89291) is considered investigational for all other indications.

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DEFINITIONS

1. Preimplantation genetic testing for monogenic disorders (PGT-M) and Preimplantation genetic testing for structural rearrangements (PGT-SR) are used to

Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

detect a specific single-gene inherited disorder or chromosome rearrangement in conjunction with in vitro fertilization (IVF).

2. Preimplantation genetic testing for aneuploidy (PGT-A) is used to screen for chromosomal aneuploidy in conjunction with IVF for couples.

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BACKGROUND AND RATIONALE

Preimplantation Genetic Testing for Aneuploidy (PGT-A)

American Society of Reproductive Medicine

The American Society of Reproductive Medicine issued an opinion on the use of preimplantation genetic testing for aneuploidy (2018) which concluded, "Large, prospective, well-controlled studies evaluating the combination of multiple approaches (genomics, time-lapse imaging, transcriptomics, proteomics, metabolomics, etc.) for enhanced embryo selection applicable in a more inclusive IVF population are needed to determine not only the effectiveness, but also the safety and potential risks of these technologies. PGT-A will likely be part of a future multidimensional approach to embryo screening and selection. At present, however, there is insufficient evidence to recommend the routine use of blastocyst biopsy with aneuploidy testing in all infertile patients." (p. 34)

This position was reaffirmed in a 2020 committee opinion regarding clinical management of mosaic results from preimplantation genetic testing for aneuploidy of blastocysts, stating, "It should be recognized that this document does not endorse nor does it suggest that PGT-A is appropriate for all cases of IVF." (p. 253)

American College of Obstetricians and Gynecologists (ACOG)

The American College of Obstetricians and Gynecologists issued Committee Opinion No. 799 (2020, reaffirmed 2023) regarding Preimplantation Genetic Testing. The recommendations include the following:

"The clinical utility of preimplantation genetic testing-monogenic and preimplantation genetic testing-structural rearrangements is firmly established; however, the best use of preimplantation genetic testing-aneuploidy remains to be determined." (p. e133)

Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

Preimplantation Genetic Testing for Monogenic Disorders (PGT-M)

American Society for Reproductive Medicine

The American Society for Reproductive Medicine published an opinion on the use of preimplantation genetic diagnosis (PGD) for serious adult-onset conditions (2013). The statement includes the following:

• "Preimplantation genetic diagnosis (PGD) for adult-onset conditions is ethically justifiable when the conditions are serious and when there are no known interventions for the conditions or the available interventions are either inadequately effective or significantly burdensome."
• "For conditions that are less serious or of lower penetrance, PGD for adult[-]onset conditions is ethically acceptable as a matter of reproductive liberty. It should be discouraged, however, if the risks of PGD are found to be more than merely speculative."

The opinion also stated that physicians and patients should be aware that much remains unknown about the long-term effects of embryo biopsy on the developing fetus and that experienced genetic counselors should be involved in the decision process. (p. 54)

American College of Obstetricians and Gynecologists (ACOG)

The American College of Obstetricians and Gynecologists issued Committee Opinion No. 799 (2020, reaffirmed 2023) regarding Preimplantation Genetic Testing. The recommendations include the following:

"Preimplantation genetic testing comprises a group of genetic assays used to evaluate embryos before transfer to the uterus. Preimplantation genetic testing-monogenic (known as PGT-M) is targeted to single gene disorders. Preimplantation genetic testing-monogenic uses only a few cells from the early embryo, usually at the blastocyst stage, and misdiagnosis is possible but rare with modern techniques. Confirmation of preimplantation genetic testing-monogenic results with chorionic villus sampling (CVS) or amniocentesis should be offered." (p. 133)

Preimplantation Genetic Testing for Structural Rearrangements (PGT-SR)

American College of Obstetricians and Gynecologists (ACOG)

The American College of Obstetricians and Gynecologists issued Committee Opinion No. 799 (2020, reaffirmed 2023) regarding Preimplantation Genetic Testing. The recommendations include the following: "To detect structural chromosomal abnormalities such as translocations, preimplantation genetic testing-structural rearrangements (known as PGT-SR) is used. Confirmation of preimplantation genetic testing-structural rearrangements results with CVS or amniocentesis should be offered." (p. 133)

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Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

Reviews, Revisions, and Approvals

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Important Reminder

Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment, or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment of member/enrollees. This clinical policy is not intended to recommend treatment for member/enrollees. Member/enrollees should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited.

Centene Corporation

Concert Genetics Genetic Testing: Preimplantation Genetic Testing
V2.2024
Date of Last Revision: 04/24

Providers, member/enrollees, and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, member/enrollees to member/enrollees and/or their representatives agree to be bound by such terms and conditions by providing services to member/enrollees and/or submitting claims for payment for such services.

Note: For Medicaid member/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare member/enrollees, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

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