Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Genitourinary/Kidney Disorder: Female Infertility. 
Treatment: Pharmacy/Prescription Drugs. 
The insurer denied Progesterone in ethyl oleate compound for medical necessity. 
The denial was upheld. 

This patient is a female, ordered progesterone in oil for in vitro fertilization treatment due to infertility. The patient was recommended for progesterone in oil but reported a previous allergic reaction at the injection site. The patient was undergoing in vitro fertilization. A compounded progesterone has been ordered which contains Benzyl benzo, ethyl oleate, progesterone powder and benzyl alcohol. The treatment plan would be to use this medication for support of the pregnancy up to 12 weeks gestation. 
A letter from her physician stated the patient cannot take progesterone in oil and a compounded progesterone is needed due to an allergic reaction to progesterone in oil. The patient was noted to experience a rash, swelling that was hot to the touch and itching in the injection site. 
At issue is the medical necessity of Progesterone in ethyl oleate compound.

The health plan's determination of medical necessity is upheld in whole.

The requested health service/treatment of Progesterone in ethyl oleate compound is not medically necessary for this patient.
In this case, the requested health service/treatment of progesterone in ethyl oleate compound would not be considered medically necessary for this patient for the treatment of in vitro fertilization therapy. The recommendations of the American Society for Reproductive Medicine (ASRM) were examined for the use of progesterone for luteal phase support for in vitro fertilization treatment due to infertility.  There are no recommendations for any specific product to perform better than others in the management of the luteal phase or support for in vitro fertilization (IVF) and progesterone compounds can be used that are United States Food and Drug Administration (FDA) approved in this setting.  Progesterone can be administered via oral, vaginal, and intra-muscular routes. The use of progesterone after fertility treatments is distinctly different from using it to supplement the natural menstrual cycle. Although progesterone is beneficial after various therapeutic infertility treatments, there is no evidence that progesterone is beneficial for fertility in natural cycles. Similarly, there is no evidence that progesterone is beneficial for treating luteal phase deficiency (LPD).
There are no randomized controlled trials (RCT) investigating progesterone supplementation for women with LPD. Studies have investigated progesterone supplementation for recurrent pregnancy loss, which theoretically may overlap with LPD due to inadequate progesterone support for early pregnancy. A systematic review and meta-analysis also suggested that progestogen supplementation reduced the miscarriage rate in women with unexplained recurrent miscarriage.  Thus, the proposed progesterone in oil would not be a necessary component of therapy in this case as a compounded agent. 
Therefore, the requested treatment of Progesterone in ethyl oleate compound is not medically necessary.