Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Hypogonadotropic Hypogonadism
Treatment: human chorionic gonadotropin (hCG) for hypogonadotropic hypogonadism
The insurer denied coverage for human chorionic gonadotropin (hCG) for hypogonadotropic hypogonadism
The denial is upheld.

According to the medical records, the patient is an adult male with a medical history of hypogonadism, azoospermia, and failure to conceive. There is also a history of bilateral varicocelectomy and bilateral Microsurgical Testicular Extraction (TESE).

The patient returned for consultation due to persistent failure to conceive. Due to sub optimal response with Clomid 50 milligrams and Arimidex 1 milligram with testosterone levels persistent at a low level. Human Chorionic Gonadotropin (hCG) intramuscular injection was then prescribed to help improve the patient's testosterone level. The patient reported improvements while being on the medication; however, the medication was denied by the insurance due to insufficient data for coverage.

The insurer denied coverage for human chorionic gonadotropin (hCG) for hypogonadotropic hypogonadism as not medically necessary. The current plan-approved criteria only allowed coverage of hCG if the patient had a low or low-normal follicle stimulating hormone (FSH) or luteinizing hormone (LH) level. The patient's LH and FSH levels were markedly elevated.

HCG is utilized for secondary hypogonadism, also known as (AKA) hypogonadotropic hypogonadism only (wherein LH is low, FSH is low and testosterone is low). HCG has the biologic activity of LH and stimulates testicles to make testosterone (non-defective testicles or Leydig cells).

Madhusoodanan, V., et al. (2019) write, "Our study indicated that hCG monotherapy is a safe and efficacious treatment option for patients with symptoms of hypogonadism who do not desire fertility or may not have initial testosterone levels greater than 300 ng/dL, significantly improving testosterone levels with no associated reports of complications or side effects."

And per Sizar O, Schwartz J. (2022), "Male hypogonadism, acquired or congenital, can be caused by defects that interfere with the hypothalamic-pituitary-testicular axis. It is essential to distinguish between primary hypogonadism (which originates in the testes) and secondary hypogonadism (which originates in the hypothalamus or pituitary gland). Symptoms highly suggestive of hypogonadism include decreased spontaneous erections, decreased nocturnal penile tumescence, decreased libido, and reduced testicular volume."

This patient has primary hypogonadism, AKA hypergonadotropic hypogonadism, as proven by labs showing an FSH of 19, LH of 12 and total testosterone of 117. This means that the defect is in the testicles, and that the LH and FSH pulses are trying to stimulate the testicles, but to no avail. If the patient receives hCG it will not work, presumably as he has hypergonadotropic hypogonadism. Human chorionic gonadotropin (hCG) for hypogonadotropic hypogonadism is not considered medically necessary for this patient.

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

The insurer's denial of coverage for the human chorionic gonadotropin (hCG) for hypogonadotropic hypogonadism is upheld. Medical necessity is not substantiated.