Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Pediatric Growth Hormone Deficiency
Treatment: Omnitrope
The insurer denied: Omnitrope
The denial is upheld.

This patient is a teenage male. He is diagnosed with growth hormone deficiency (GHD). This request is for Omnitrope. The patient's growth hormone (GH) stimulation test with arginine and clonidine peaked at 1.03. His magnetic resonance imaging (MRI) scan was normal. His height velocity is reported to be 4.9 centimeters per year. His bone age was 14 years which is close to the chronological age. The patient's testes were 6-8 cubic centimeters bilaterally and pubic hair was at Tanner 2. Last year, his insulin-like growth factor 1 (IGF-1) was 143 (64-508). Recently, the patient's insulin-like growth factor 1 was 302. His height last year was 153.16 centimeters (-1.60 standard deviations) and recently was 160.7 centimeters (-1.22 standard deviations) with height velocity over 1 year 6 months of 9.4 centimeters per year. The patient's mother's height is 167.64 centimeters and father's height is 164.465 centimeters and mid parental height is 172.5525 centimeters (-0.60 standard deviations).

The requested health service is not medically necessary.

The peer-reviewed literature including consensus clinical guidelines and randomized controlled trials are summarized below.
Classic growth hormone (GH) deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of growth hormone deficiency published by the Growth Hormone 
Research Society (1), the Lawson Wilkins Pediatric Endocrinology Society (2,3), and the medical guidelines for growth hormone use provided by the American Association of Clinical Endocrinologists (4). These guidelines are the latest available guidelines from these respective societies. The diagnosis is based on height, height velocity, biochemical, and sometimes radiological findings. 
The height and height velocity criteria based on consensus guidelines upon which a biochemical evaluation is to be initiated are 1) severe short stature, defined as a height more than 3.0 standard deviations below the mean; 2) height more than 1.5 standard deviations below the mid parental height standard deviations; 3) height more than 2.0 standard deviations below the mean and a height velocity over 1 year more than 1.0 standard deviations below the mean for chronological age, or a decrease in height standard deviations of more than 0.5 over 1 year in children over 2 years of age; 4) in the absence of short stature, a height velocity more than 2.0 standard deviations below the mean over 1 year or more than 1.5 standard deviations sustained over 2 year. 
The biochemical criteria include low insulin-like growth factor 1, insulin-like growth factor binding protein 3, or growth hormone stimulation testing with a peak growth hormone less than 
10 nanograms per milliliter.
The patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal. His height last year was 153.16 centimeters (-1.60 standard deviations) and most recently, it was 160.7 centimeters (-1.22 standard deviations) with height velocity over 1 year 6 months of 9.4 centimeters per year. Growth hormone stimulation testing peaked at less than 10 nanograms per milliliter. His growth hormone stimulation test with arginine and clonidine peaked at 1.03. Insulin-like growth factor 1 is normal.
The Pediatric Endocrine Society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing. The patient does not meet growth hormone deficiency criteria. The request is not consistent with generally accepted standards of medical practice and is, therefore, not medically necessary.