Preimplantation Genetic Testing (PGT) Coverage Criteria
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Defines medical necessity, coverage limits, prior authorization requirements, and coding for preimplantation genetic testing (diagnosis and screening) when used as an adjunct to in vitro fertilization (IVF) for BCBSRI Medicare Advantage and Commercial products.
No material clinical or coverage changes in this revision.
Coverage Criteria for Preimplantation Genetic Testing (PGT)
Medically Necessary Indications
Preimplantation genetic diagnosis (PGT-M/PGT-SR) may be considered medically necessary as an adjunct to IVF when ANY one of the following conditions is met:
Supports testing to detect embryos affected by autosomal recessive single-gene disorders
Applies when prior child is affected by the same recessive disorder
Supports deselection of embryos harboring dominant pathogenic variants
Includes scenarios where sex selection or molecular diagnosis is used to avoid affected offspring (eg, fragile X)
PGT-SR to deselect embryos carrying translocations to reduce risk of implantation failure or recurrent pregnancy loss
Not Medically Necessary / Insufficient Evidence
Preimplantation genetic screening (PGT-A) for individuals without an identified elevated genetic risk is not covered/considered not medically necessary in general due to insufficient evidence; evidence is mixed for newer methods and limited to subgroups:
Applies to Medicare Advantage and Commercial Products as stated
Current data are mixed; further RCTs required before changing coverage stance
Preimplantation genetic screening (PGT-A), whether performed alone or as an adjunct to in vitro fertilization (IVF), is not covered for individuals or couples who do not meet the specific medical criteria described for diagnostic testing (PGT‑M/PGT‑SR). The evidence is insufficient to demonstrate that routine use of PGT‑A improves net health outcomes, and results from randomized controlled trials and meta-analyses of earlier screening methods have shown similar or lower ongoing pregnancy and live birth rates compared with IVF without PGT‑A. Although some newer methods have suggested possible benefit in certain subgroups (for example, advanced maternal age), the data are limited and larger, well‑designed trials are needed before coverage can be expanded.
PGT performed solely as a means of improving general IVF success (screening for aneuploidy in patients without an identified elevated genetic risk) is therefore considered not medically necessary for the majority of patients. Diagnostic PGT (PGT‑M or PGT‑SR) remains the appropriate covered approach when the documented medical criteria for known single‑gene disorders or structural chromosome rearrangements are met.
If a requested or performed preimplantation genetic testing service is determined to be not medically necessary or is a non‑covered benefit under the member’s plan, the service may be denied. Denials may arise when prior authorization requirements are not met or when the testing falls outside the policy’s specified medical indications.
Providers and laboratories should verify member benefits and prior authorization requirements before delivering services. If a laboratory provides a service that was not authorized, that service will be denied as the financial liability of the participating laboratory and may not be billed to the member.
The policy reiterates that PGT‑A is considered not medically necessary / not covered in all situations for patients without an identified elevated genetic risk because current evidence does not establish an improvement in net health outcomes. While some newer screening technologies may show benefit in limited subgroups, these findings are insufficient to change the overall coverage stance at this time.
Coverage for preimplantation genetic testing is therefore limited to diagnostic indications (PGT‑M and PGT‑SR) when the specific medical criteria described in this policy are satisfied.
When a service is determined to be not medically necessary or is a non‑covered benefit, providers may not charge the member for that service unless the member was informed in advance and provided written agreement to accept financial responsibility. Providers should confirm benefits and obtain any required prior authorization and, when applicable, obtain the member’s written consent to accept financial liability before proceeding.
Refer to the member’s subscriber agreement, certificate, or employer agreement for plan‑specific obligations. For member‑specific benefit questions contact the provider call center prior to delivering services.
Coding and Billing
| 0396U | Obstetrics (pre-implantation genetic testing), evaluation of 300000 DNA single-nucleotide polymorphisms (SNPs) by microarray, embryonic tissue, algorithm reported as a probability for single-gene germline conditions (Code Deleted Effective 9/30/2024) |
Provider Actions, Authorization, and Billing Rules
Prior Authorization Required
Prior authorization is required for Medicare Advantage plans and recommended for Commercial products. Providers must obtain prior authorization via the online portal for participating providers before performing preimplantation genetic diagnosis (PGD) as an adjunct to in vitro fertilization (IVF).
- Prior authorization required for Medicare Advantage.
- Prior authorization recommended for Commercial products via the online portal.
Verify Member Benefits and Prior Authorization
Providers must verify member benefits and eligibility prior to providing services. Benefits and eligibility are determined by the member’s subscriber agreement, member certificate, and/or employer agreement; those documents supersede this medical policy. For member-specific benefits or questions, contact the provider call center.
- Verify benefits/eligibility before scheduling or performing services.
- Contact the provider call center for member-specific information.
Authorization Ownership and Prohibited Actions
Only the ordering physician shall be involved in authorization, appeal, or other administrative processes related to prior authorization or medical necessity. Laboratories, laboratory representatives, or third parties may not obtain clinical authorization or participate in the authorization process on behalf of the ordering physician. Use of a laboratory or third party to obtain authorization, facilitate the authorization process, or support appeals is a violation and may result in denial, sanctions, or termination from the BCBSRI provider network.
- Ordering physician must handle authorization and appeals.
- Laboratories or third parties are prohibited from obtaining authorizations on behalf of the ordering physician.
- Violations may result in denial of services, financial liability for the laboratory, or termination from the provider network.
Unauthorized Services and Member Financial Liability
If a laboratory provides a laboratory service that has not been authorized, the service will be denied and may be the financial liability of the participating laboratory; such services may not be billed to the member. If services are determined not to be medically necessary or are non-covered, providers may not charge the member unless the member was informed and agreed in writing in advance to pay.
- Unauthorized laboratory services will be denied and financially liable to the laboratory.
- Providers cannot bill members for non-covered or not medically necessary services unless the member provided written agreement in advance.
Background
Preimplantation genetic testing (PGT) is a laboratory procedure performed in association with assisted reproductive techniques to evaluate embryonic or oocyte genetic material prior to implantation. PGT may be used for diagnostic purposes (PGT‑M for single‑gene disorders; PGT‑SR for structural chromosomal rearrangements) or for screening (PGT‑A for aneuploidy).
Biopsy of oocytes or embryos can be performed at multiple stages (polar body, cleavage-stage blastomere, or blastocyst) and analyzed using a range of methods from targeted assays to array‑based or next‑generation sequencing platforms. Diagnostic PGT is indicated when there is a known elevated genetic risk in the parents (for example, known carriers or a parent with a translocation), whereas screening PGT‑A for individuals without identified elevated risk is limited by insufficient evidence of benefit.
Definitions
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