Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Infertility.
Treatment:  Second in vitro fertilization (IVF) cycle and sperm injection with embryo biopsy and freezing.

The insurer denied coverage for second in vitro fertilization (IVF) cycle and sperm injection with embryo biopsy and freezing.  The denial is upheld.
 
The patient is an adult female with a diagnosis of unexplained infertility. She has failed 3 intrauterine insemination (IUI) cycles and has undergone 1 in vitro fertilization (IVF) cycle that resulted in a euploid embryo. The patient has also been diagnosed with Asherman syndrome that was treated. The patient is requesting coverage for additional IVF cycles with intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing for aneuploidies (PGT-A).

According to the American Society for Reproductive Medicine (ASRM), ICSI for unexplained infertility has been associated with increased fertilization rates and decreased risk of failed fertilization in some studies but has not been shown to improve live-birth outcomes.  There are no studies addressing whether ICSI of poor quality oocytes improves live-birth rates.

The diagnosis of embryo aneuploidies in IVF cycles should be considered as a research tool, and systematic implementation in clinical practice may appear unjustified. 

It is important to note that PGS/PGT (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%. 

The American Society for Reproductive Medicine (ASRM) issued an opinion on the use of preimplantation genetic testing (PGS) for aneuploidy in 2018 which was informed by literature search or relevant trials. The committee concluded that "the value of preimplantation genetic testing for aneuploidy as a universal screening test for all IVF patients has yet to be determined."

As per the American College of Obstetrics and Gynecology (ACOG) Committee Opinion #799, "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. Future research is necessary to establish the overall clinical utility for preimplantation genetic testing-aneuploidy, the subset of patients that may benefit from preimplantation genetic testing-aneuploidy, the clinical significance of mosaicism, and residual risk for aneuploidy in preimplantation genetic testing-aneuploidy screened embryos." 

According to ASRM's recommendations about the number of embryos to transfer, it is advised given this patient's age, to transfer a single euploid embryo. The reason for that recommendation is because the odds of a successful cycle and live birth are very good, estimated at more than 65%.

Since the aim of this patient is to conceive a healthy child (rather than to collect embryos) and since with the availability of 1 euploid embryo, the odds of conception and live birth are excellent, additional IVF cycles are not medically necessary. The patient should proceed with the transfer of one embryo. If she does not conceive, then she will undergo a second IVF cycle. 

Note that if transfer of this embryo fails, this will only lead to a delay of 2-3 months and such a delay should not significantly affect this patient's ovarian reserve. This patient should proceed with an embryo transfer rather than more IVF cycles: This is consistent with the standard of care.

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. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for second IVF (in-vitro fertilization) cycle and sperm injection with embryo biopsy and freezing is not substantiated.