Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Z31.83  Encounter for assisted reproductive
fertility procedure cycle
Treatment: Genome -wide Microarray Analysis For Copy Number Variants (CPT 81228).
The insurer denied the Genome -wide Microarray Analysis For Copy Number Variants (CPT 81228).
The denial is upheld.

The patient is a female with a diagnosis of two prior miscarriages. She is the carrier of a Fragile X intermediate allele.

The patient is requesting coverage for PGT-A (Preimplantation Genetic Testing for Aneuploidy): Genome -wide Microarray Analysis For Copy Number Variants (81228).

The requested health service is not medically necessary.
This patient is requesting coverage for PGT-A (preimplantation genetic testing for aneuploidies).

Embryo aneuploidies may be responsible for implantation failures, miscarriages, and affects IVF (in vitro fertilization) outcomes. A variety of technologies have been implemented to evaluate euploid embryos in IVF (in vitro fertilization) treatments, {preimplantation genetic testing for aneuploidies (PGT-A)}.

According to this strategy, a better embryo selection should increase IVF (in vitro fertilization) results. In reality, several issues remain unaddressed including the sampling strategy, involving the test outcomes, and the frequent occurrence of embryo mosaicism, affecting the criteria for selection of supposed viable embryos. Safety issues are in place, including peri-and post-natal consequences of embryo sampling and the epigenetic weaknesses from a prolonged in vitro culture. On the other side, chromosome number mistakes are progressively recognized as physiologic events in the early pre-implantation embryo with many corrective mechanisms in place and their destiny in the post-implantation development is unclear. Accordingly, the increasing precision of the diagnostic tools should be used to investigate the effect of such interventions within rigorous research programs in the sake of improved clinical outcomes.

The diagnosis of embryo aneuploidies in IVF (in vitro fertilization) cycles should be considered as a research tool and systematic implementation in clinical practice may be evidenced to be unjustified.

Note that PGT-A (preimplantation genetic testing for aneuploidies) is not indicated for advanced maternal age or recurrent pregnancy loss or for recurrent implantation failures. ACOG (American College of Obstetricians and Gynecologists) stated the following: "At this time there are no data to support preimplantation genetic screening for recurrent unexplained miscarriage and recurrent implantation failures; its use for these indications should be restricted to research studies with appropriate informed consent."

ASRM (American Society for Reproductive Medicine) also stated the following: "A study of women with recurrent miscarriages found no evidence of benefit of preimplantation genetic screening in women of any age."

It is important to note that PGS/PGT (preimplantation genetic screening/ Preimplantation Genetic Testing) may lead to damage to the embryo and may have long-lasting health issues for the newborn.

Note that neither the sensitivity nor the specificity of the test is 100% (percent).

This patient does not have any genetic anomaly and is not a carrier of a genetic condition or chromosomal anomaly known to cause the birth of a child with a genetic condition. In summary, this patient does not have any indication for Genome -wide Microarray Analysis For Copy Number Variants (81228), and it is therefore not medically necessary.

The health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.
Since the requested test is not medically necessary and is considered unproven for this patient, the health plan acted reasonably.