Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Growth Hormone Deficiency. 
Treatment: Genotropin. 
The insurer denied the Genotropin. 
The determination is upheld. 

The patient was diagnosed with growth hormone deficiency (GHD). This request is for Genotropin. His growth hormone (GH) stimulation test with arginine and clonidine peaked at 3.23. His height velocity is reported to be 7.01 centimeters/year (cm/yr). His testes were 5-6 milliliters (ml) bilaterally and pubic hair was at Tanner 3. His Insulin-like Growth Factor 1 (IGF1) was 466 (range 64-508) and previously his IGF1 was 283.
His weight was 44.5 kilograms (kg). His height was 144 cm (-1.07 standard deviation score (SDS)) and 150.7 cm (-0.73 SDS). 

His mother's height is 149.86 cm and father's height is 172.72 cm and mid parental height is 167.79 cm (-1.26 SDS). The provider states his height predicted adult height 65.6-66.8 inches. 

At issue is the medical necessity of Genotropin. 

The Genotropin is not medically necessary. 

The peer reviewed literature including consensus clinical guidelines, randomized controlled trials are summarized below: 

Classic GH deficiency criteria are outlined in the consensus guidelines for the diagnosis and treatment of GH deficiency published by the GH research society [1], the Lawson Wilkins Pediatric Endocrinology Society [2, 3], and the medical guidelines for GH use provided by the American Association of Clinical Endocrinologists [4]. The above referenced 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 standard deviations (SD) below the mean; 2) height more than 1.5 SD below the mid parental height SD; 3) height more than 2 SD below the mean and a height velocity over 1 year (yr) more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 yr in children over 2 yr of age; 4) in the absence of short stature, a height velocity more than 2 SD below the mean over 1 yr or more than 1.5 SD sustained over 2 yr. The biochemical criteria include low IGF1 or Insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 nanograms/milliliter (ng/ml). 
The patient did not meet height and height velocity criteria as pretreatment height and height velocity are normal. IGF-I was normal. GH stimulation testing peaked at less than 10 ng/ml. 
The Pediatric Endocrine Society recommends against making a diagnosis of growth hormone deficiency based solely on failed growth hormone stimulation testing.

Growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines [4-9]. Food and Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height SDS less than or equal to -2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means." [10-13] 
The patient does not have a pretreatment height less than or equal to -2.25 SD. The patient therefore does not meet idiopathic short stature criteria. 

The request does not meet any nationally accepted criteria for use of growth hormone. The request is therefore not medically necessary.