Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Recurrent miscarriages.
Treatment: In-vitro fertilization (IVF), pre-implantation genetic testing (PGT) for cryopreservation, and storage, codes, S4015, 58970, 58974, 89258, 89280, 89281, 89290, 89291 and 89342.
The insurer denied coverage for IVF, PGT for cryopreservation, and storage, codes, S4015, 58970, 58974, 89258, 89280, 89281, 89290, 89291 and 89342.
The denial is upheld. 

This is a female patient with a medical history of recurrent miscarriages, who conceived spontaneously every 3 months but had 3 miscarriages; one of which showed trisomy 16. The patient's provider would like to follow-up with in-vitro fertilization (IVF) and preimplantation genetic testing for aneuploidies (PGT-A) to minimize the risk of another miscarriage.

As per literature review, embryo aneuploidies may be responsible for implantation failures, miscarriages and affects IVF outcomes.  A variety of technologies have been implemented to evaluate euploid embryos in IVF treatments, {preimplantation genetic testing for aneuploidies (PGT-A)}. According to this strategy, a better embryo selection should increase IVF 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 cycles should be considered as a research tool, and systematic implementation in clinical practice may appear unjustified. 

As per the American College of Obstetricians & Gynecologists (ACOG), PGT-A is not indicated for advanced maternal age or recurrent pregnancy loss or for recurrent implantation failures. The American College of Obstetricians & Gynecologists (ACOG) 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."

The American Society of Reproductive Medicine (ASRM) 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 preimplantation genetic screening (PGS) or PGT-A may lead to damage to the embryo and may have long-lasting health issues for the newborn. Also neither the sensitivity nor the specificity of the test is 100%. 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. Since this patient does not have diagnosis of infertility as she has been able to conceive spontaneously and since PGT-A is not shown to improve live birth rates, this patient does not have any indication for: IVF, pre-implantation genetic testing (PGT) for cryopreservation, and storage, codes, S4015 Complete in vitro fertilization cycle, case rate not otherwise specified.

The health plan acted reasonably with sound medical judgment and in the best interest of the patient.

The carrier's denial of coverage for IVF, PGT for cryopreservation, and storage, codes, S4015, 58970, 58974, 89258, 89280, 89281, 89290, 89291 and 89342 should be upheld.  The medical necessity is not substantiated.