Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Growth Hormone Deficiency.
Treatment:  Norditropin 5/1.5 mL injections.
The health plan denied the  Norditropin 5/1.5 mL injections. 
The health plan's determination is overturned.

The patient is a female who is seeking growth hormone (GH) treatment for the diagnosis of growth hormone deficiency (GHD). Her mother's height is 4 feet 8 inches, while her father's height is 6 feet 3 inches. Her growth chart shows her height and weight both below 3 percentile since the age of 3.5 years. She has been diagnosed with attention deficit hyperactivity disorder (ADHD) and is on Ritalin. Her blood work by her primary care provider showed a normal complete blood count (CBC), normal comprehensive metabolic panel (CMP), normal thyroid function tests (TFT), normal insulin-like growth factor binding protein-3 (IGFBP-3), and negative celiac screen. Her bone age was read as 6 years 10 months at chronological age 6 years 10 months.
Apparently, she was initially evaluated in the pediatric endocrinology clinic and had a chromosome analysis that showed a normal female karyotype. No clinical information is available from that visit. At a follow up visit, her height was 111.9 centimeters (cm), and her weight was 15.8 kilograms (kg). She had grown 1.1 cm and gained 0.8 kg since the last visit, both of which were less than expected. She underwent growth hormone stimulation testing, and the peak GH response was 8.23 nanograms/milliliter (ng/ml) after Arginine and 4.46 ng/ml after Clonidine. Magnetic resonance imaging (MRI) of the pituitary gland was normal.

At a most recent follow up visit, her height was 113.8 cm, while her weight was 17.1 kg. Her evaluation showed a normal CMP, normal TFT's, and normal insulin-like growth factor -1 (IGF-1). Her bone age was read as 7 years 10 months at chronological age 7 years 10 months. Based on her bone age, her adult height prediction was calculated as 57 inches, and treatment with GH was recommended.

At issue is the medical necessity of the requested health service/treatment of Norditropin 5/1.5mL injections.

The health plan's determination of medical necessity is overturned in whole.
Diagnosis of GHD involves clinical history (with primary consideration given to genetic background, degree of short stature, and growth velocity), physical examination, auxologic data, bone age determination, measurement of IGF- and IGFBP-3, provocative GH testing, and an MRI of the pituitary.

This patient is quite short for her age and not growing well. Her mother is quite short, while her father is very tall, and her mid parental height +/-1 SD (standard deviation) is 63+/-2 inches; however, with so much difference in parents' height, midparental height may not be very reliable. Her most recent height was 2.38 SD below the mean for age and 1.86 SD below her midparental height. Her weight is affected even more than her height, and her most recent weight was 2.9 SD below the mean for her age suggesting undernutrition. She is on a stimulant for ADHD, which may be affecting her appetite and growth. However, her growth chart shows her height and weight below the chart since the age of 3.5 years when she was probably not on a stimulant.

Based on her bone age, her adult height prediction is 57.3+/-2 inches, which is quite short. She underwent GH stimulation testing, and her peak GH response was less than 10. At this point, it is worthwhile to give her a trial of GH for at least 1 year to see if her growth improves with that.

Usually, bone age is delayed in patients with GHD, but it is not required for the diagnosis of growth hormone deficiency. Nowhere in the consensus guidelines is delayed bone age considered mandatory for the diagnosis. Therefore, the requested health service/treatment of Norditropin 5/1.5 mL injections are medically necessary for this patient.