Appeal type: Medical necessity
Decision: Overturned

Pregnancy/Childbirth
Infertility Treatment

Diagnosis: Infertility
Treatment: Frozen embryo transfer
The insurer denied the frozen embryo transfer.
The health plan's determination is overturned.

The patient is a female who suffers from epilepsy and migraines. She presented initially for fertility preservation through egg or embryo cryopreservation. Her case is complicated by her medical comorbidities, which require management with medications including Lamotrigine (pregnancy category C), botulinum toxin injections (pregnancy category C), Memantine (pregnancy category B), and Eletriptan (pregnancy category C). Given the risk to the patient of stopping these medications, as well as the risk of teratogenicity to a future fetus with the use of the above listed medications, the patient's Reproductive Endocrinology and Infertility physician recommended that she consider use of a gestational carrier when she was ready to try to conceive.

The patient underwent ovarian stimulation with progestin intrauterine device (IUD) in place; however, none of the embryos were able to develop into viable blastocysts. Due to the poor outcome of the first cycle, it was recommended the patient remove her progestin IUD before a second cycle. Her IUD was removed, and she underwent her second ovarian stimulation with egg retrieval. Eleven oocytes were retrieved; 8 were mature, 7 fertilized appropriately, and 3 developed into blastocysts which were biopsied then frozen. All three frozen embryos were determined to be euploid on preimplantation genetic testing for aneuploidy (PGT-A). The patient's physician submitted a letter to state the patient's intention to attempt pregnancy with the use of a gestational carrier within 3-6 months.

At issue is the medical necessity for the frozen embryo transfer.
I overturn the health plan's determination, in whole.

The frozen embryo transfer is medically necessary.

The patient reported intentions to attempt pregnancy with a gestation carrier within 3-6 months. As such, her medical co-morbidities must be considered. The patient's medical co-morbidities of epilepsy and migraines appear to have been difficult to control, with several emergency room visits and need for titration of multiple medications in order to achieve current control and quality of life. Several of the patient's current medication regimen are pregnancy Category C. As the patient has tried multiple medications in the past, it would be reasonably difficult to attempt to modify her regimen without risking loss of control of her migraine and epilepsy symptoms. As such, each medication must be assessed for its risk to the fetus during pregnancy.

Of the above medications, Lamotrigine is commonly used in management of psychiatric conditions and can be used in pregnancy based on weighing risks and benefits with treating physicians. In fact, the American College of Obstetricians and Gynecologists (ACOG), American Academy of Neurology, and American Epilepsy Society outline how Lamotrigine can be safely be monitored and titrated in pregnancy. [1,2] Botulinum toxin A use in pregnancy has limited retrospective data, but what has been published has been largely reassuring with few adverse events seen in pregnant women who have used botulinum toxin A for neurologic conditions during pregnancy. [3,4] Triptan use in pregnancy has mixed data, but the American Headache Society and recent published meta-analyses have deemed triptan use to not be associated with fetal adverse effects. [5,6] With this review of recent data and guideline recommendations, there is no clear evidence of harm or safety with use of high dose lamotrigine, botulinum toxin, or triptans in human studies during pregnancy. Thus, the assessment of risks and benefits is deferred to the patient's treating neurologist. As the patient's neurologist clearly recommends the use of a gestational carrier, the frozen embryo transfer is deemed medically necessary.