CurrentMass General Brigham Health PlanPolicy 044

Preimplantation Genetic Testing (PGT) — Coverage Criteria for PGT‑M and PGT‑SR

Defines medical necessity criteria and authorization requirements for preimplantation genetic testing (PGT‑M and PGT‑SR) and states that PGT‑A is not covered; applies to Mass General Brigham Health Plan members and variations for Medicare Advantage, MassHealth, OneCare, and SCO plans.

Policy Summary

PayerMass General Brigham Health Plan

PolicyPreimplantation Genetic Testing (PGT) — PGT‑M and PGT‑SR coverage criteria

Policy CodePolicy 044

Change TypeMaterial and operational updates

Effective Date

Next Review Date

Key ActionObtain two authorizations: first from Mass General Brigham Health Plan UM and, if approved, a second authorization from EviCore.

SourceLink

POLICY UPDATE CHANGES

Added variation for OneCare and SCO members and updated prior authorization table.

Added MassHealth variation and clarified Medicare variation.

Added one biological parent having an unbalanced translocation to conditions eligible for PGT-SR and added Retinoblastoma to list of autosomal dominant disorders.

PGT‑M & PGT‑SR covered; PGT‑A not coveredcoverage stance summary

Two‑stepauthorization process

>20enumerated genetic conditions

FSH/AMH/AFC cutoffsfertility reserve thresholds

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Coverage Criteria for Preimplantation Genetic Testing

Covered: PGT-SR and PGT-M

Covered when ALL of the following are met for respective indications

PGT-SR covered indications: PGT-SR is covered to test for unbalanced chromosome rearrangements when one of the genetic parents is known to have an unbalanced translocation, a balanced reciprocal or Robertsonian translocation, or a microdeletion/duplication or other structural chromosomal abnormality associated with the birth of an affected child.

Laboratory documentation of the genetic tests may be required

PGT-M covered indications: PGT-M is covered to detect evidence of specific single-gene disorders in an embryo when one of the following is true: (a) both genetic parents are known carriers of an autosomal recessive disorder, or one genetic parent is a known carrier and they have a child diagnosed with the disorder (examples include Canavan disease; Cystic Fibrosis; Epidermolysis Bullosa Simplex [autosomal recessive type]; Familial dysautonomia; Fanconi's Anemia; Gaucher Disease; Hurler Syndrome; Methylmalonic acidemia; Propionic academia; Sickle Cell Anemia; Spinal Muscular Atrophy Type I; Spinocerebellar Ataxia [autosomal recessive type]; Tay-Sachs Disease; Thalassemia Syndromes); (b) one genetic parent is a known carrier of an autosomal dominant disorder (examples include Epidermolysis Bullosa [autosomal dominant type]; Huntington's Disease; Myotonic Dystrophy; Neurofibromatosis Types I and II; Retinoblastoma; Spinocerebellar Ataxia [autosomal dominant type]; Tuberous sclerosis); or (c) the genetic female parent is a known carrier of an X-linked recessive disorder (examples include Adrenoleukodystrophy; Alport Syndrome; Becker muscular dystrophy; Fabry disease; Choroideremia).

Examples of eligible conditions are enumerated in the policy

Ovarian reserve requirement

Coverage requires demonstration of adequate ovarian reserve for members with ovaries at least 40 years of age when indicated

Ovarian reserve criteria: Members with ovaries at least 40 years must demonstrate adequate ovarian reserve evidenced by either: (1) a Clomiphene Citrate Challenge Test (CCCT) within the past 6 months showing Day 3 FSH < 15 mIU/mL, Day 3 estradiol < 80 pg/mL, and Day 10 FSH < 15 mIU/mL; OR (2) a CCCT within the parameters above performed within the past 12 months plus Day 3 FSH < 15 mIU/mL and Day 3 estradiol < 80 pg/mL performed within the past 6 months; OR (3) anti-Müllerian hormone (AMH) > 1.0 mg/mL or antral follicle count (AFC) > 6 within the past 12 months together with Day 3 FSH < 15 mIU/mL within the past 6 months.FSH <15 mIU/mL; Estradiol <80 pg/mL; AMH >1.0 mg/mL; AFC >6

Applies to members with ovaries who are at least 40 years of age

Preimplantation genetic testing (PGT) is intended to be used as an adjunct to assisted reproductive technologies when testing is medically indicated to prevent transmission of a specific genetic condition. PGT for single-gene disorders (PGT-M) and for structural chromosomal rearrangements (PGT-SR) are covered when the policy’s clinical criteria are met. However, PGT performed solely as an adjunct to infertility services when the member does not meet the PGT clinical coverage criteria is excluded, and PGT is not covered for members who are not expected to be fertile due to age-related decline in fertility (including members with uterus/ovaries ≥44 years or those with FSH ≥15 mIU/ml at any time after their 40th birthday) or for other excluded indications enumerated in the policy.

Screening for aneuploidy (PGT-A) is not covered under this policy and is considered not medically necessary. This exclusion applies regardless of setting, including PGT-A for recurrent miscarriage, repeated implantation failure during IVF, or advanced maternal age.

Coding and Test Identifiers

Informational procedure codesCPT

89290	Biopsy, oocyte polar body or embryo blastomere, micro technique (for pre-implantation genetic diagnosis); less than or equal to 5 embryos.
89291	Biopsy, oocyte polar body or embryo blastomere, micro technique (for pre-implantation genetic diagnosis); greater than 5 embryos.

Ovarian reserve thresholds (CCCT and alternatives)

Day 3 FSH< 15 mIU/mL

Day 3 Estradiol< 80 pg/mL

Day 10 FSH< 15 mIU/mL

AMH> 1.0 mg/mL

Antral Follicle Count (AFC)> 6

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. This is a two-step authorization process: initial authorization must be obtained from Mass General Brigham Health Plan utilization management (UM); if approved, a second authorization must be obtained from EviCore.

Two authorizations required: 1) Mass General Brigham Health Plan UM, and 2) EviCore
Specialist and/or primary care provider must submit all necessary clinical information (medical history of patient and partner or child, where appropriate)
Members/couples must be counseled on alternative testing (e.g., amniocentesis, chorionic villous sampling), risks of PGT-M (embryo arrest, diagnostic uncertainty, unknown long-term effects), and potential need for prenatal diagnostic testing after pregnancy

Documentation Required

Clinical Documentation Required

Clinical documentation must accompany authorization requests. The provider/specialist is responsible for submitting relevant medical records and laboratory documentation to support medical necessity for PGT-M or PGT-SR, including documentation of the genetic diagnosis in the family and any laboratory reports demonstrating parental translocations or pathogenic variant status when applicable.

Definitions

Preimplantation Genetic Testing (PGT) — brief description

DefinitionA test involving an embryo created via assisted reproductive technology (e.g., IVF) in which 5–10 cells are removed from a blastocyst to test for a specific genetic condition.

PurposeUsed to detect single-gene disorders (PGT-M) or structural chromosomal rearrangements (PGT-SR) in embryos prior to transfer.

Clinical noteRequires assisted reproductive techniques (egg retrieval, fertilization, blastocyst culture) and may require genetic counseling and confirmatory prenatal testing.

Autosomal Recessive — definition

DefinitionA disorder characterized by two mutated copies of a gene present in each cell for the disease to develop; affected individuals often have two unaffected carrier parents.

Inheritance requirement

Background

Preimplantation genetic testing includes different test types with distinct clinical purposes: PGT-M (preimplantation genetic testing for monogenic/single-gene disorders) and PGT-SR (preimplantation genetic testing for structural rearrangements) are performed to prevent transmission of known heritable genetic or chromosomal conditions. By contrast, PGT-A is a screening test for aneuploidy and is explicitly excluded from coverage in this policy. PGT is performed on embryos created via assisted reproductive technologies and typically requires genetic counseling and documentation of the specific genetic diagnosis or parental chromosomal abnormality prior to authorization.

Denial Risk

Excluded Indications — Not Covered

The following indications are excluded and are not covered: PGT-A (screening for aneuploidy), carrier-status screening of embryos, HLA typing for donor selection, gender selection without a documented X‑linked disorder, selection for non‑medical traits or against predisposition absent a single causative genetic defect, late‑onset/adult‑onset disorders not listed in coverage criteria, and specific named conditions listed below.

PGT-A (aneuploidy screening), including for recurrent miscarriage, repeated implantation failure, or advanced maternal age
Carrier testing to determine embryo carrier status
HLA typing of an embryo for future transplantation donor suitability
Gender selection without documented X‑linked disorder
Selecting non‑medical traits or selecting against predisposition without a single known causative genetic/chromosomal defect
Late‑onset/adult‑onset disorders not otherwise covered
Specific conditions not covered (examples listed): Duchenne muscular dystrophy; Fragile X syndrome; Hemophilia A & B; Hunter syndrome; Incontinentia pigmenti; Lesch‑Nyhan syndrome; X‑linked intellectual disability
PGT as an adjunct to infertility services for members who do not meet clinical coverage criteria
PGT for members not expected to be fertile due to age‑related decline (e.g., uterus/ovaries ≥44 years or FSH ≥15 mIU/mL after age 40) or unreversed voluntary sterilization