Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Evaluation for elective oocyte cryopreservation

Treatment: Gonal-F for oocyte cryopreservation

The insurer denied coverage for Gonal-F for oocyte cryopreservation. The denial upheld.

This patient is a female who consulted a Reproductive Endocrinologist seeking elective oocyte cryopreservation. Gonal-F treatment has been prescribed. The medical records and medical literature were thoroughly reviewed.  The patient consulted a Reproductive Endocrinologist to undergo an evaluation for elective oocyte cryopreservation. Elective oocyte cryopreservation is a means to promote a patient's future fertility when delaying childbearing.  

The American Society for Reproductive Medicine, in its Practice Committee Opinion (2013, Reaffirmed 2019) states, "Since there is a progressive loss of oocyte quantity and quality that occurs with female aging, the prevalence of infertility and the incidence of pregnancy loss and chromosomal abnormalities increase steadily up to age 35 and more rapidly thereafter.  Technologies such as oocyte cryopreservation [OC] may allow women to have an opportunity to have biologic children later in life.  While this technology may appear to be an attractive strategy for this purpose, there are no data on the efficacy of oocyte cryopreservation in this population and for this indication.  Data on the safety, efficacyand emotional risks of elective oocyte cryopreservation are insufficient to recommend elective oocyte cryopreservation. Marketing this technology for the purpose of deferring childbearing may give women false hope and encourage women to delay childbearing. In particular, there is concern regarding the success rates in women in the late reproductive years who may be the most interested in this application.  There are not yet sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women."  

Per Practice Committee of the American Society for Reproductive Medicine in collaboration with the Society for Reproductive Endocrinology and Infertility. (2008, Reaffirmed 2019), "Gonadotropin treatment for ovulation induction [OI] is indicated for anovulatory infertile women with hypogonadotropic amenorrhea [HA] and for those with polycystic ovary syndrome [PCOS] who fail to respond to less complicated OI treatment regimens."

Per Gunnala V1, Schattman G. (2017), "In women who delay child bearing, elective oocyte cryopreservation in the mid-30s may be beneficial in terms of live birth rates.  Prospective studies of women who have undergone oocyte cryopreservation and are now attempting conception are needed before official recommendations can be made regarding elective egg freezing."                                                         

Oocytes are harvested for elective oocyte cryopreservation by transvaginal oocyte retrieval following ovarian stimulation with gonadotropins such as Gonal-F in this patient. Elective oocyte cryopreservation is not considered standard of care and it is not considered medically necessary.  Therefore, the proposed medication in support of the procedure is not medically necessary.

Elective oocyte cryopreservation is not currently a standard of care according to the Practice Committee Opinion of the American Society for Reproductive Medicine.  Therefore, the health plan acted reasonably and with sound medical judgment and in the best interest of the patient.      

The carrier's denial of coverage for Gonal-F for oocyte cryopreservation is upheld.  The medical necessity is not substantiated.