Diagnosis: Idiopathic short stature.
Treatment: Omnitrope.

The insurer denied Omnitrope. The denial is overturned.

The patient is a female with a history of attention deficit hyperactivity disorder (ADHD) and idiopathic short stature. She has had a normal growth hormone stimulation test, with a low insulin-like growth factor (IGF). X-ray for bone age was done that suggested she has additional growth potential. Continuation of growth hormone was recommended.
At issue is the medical necessity of Omnitrope.

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

The requested health service/treatment of Omnitrope is medically necessary for this patient.

Per the peer reviewed literature including consensus clinical guidelines, classic growth hormone (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 deviation (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 more than 1 SD below the mean for chronological age, or a decrease in height SD of more than 0.5 over 1 year (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 Insulin-like Growth Factor 1 (IGF1) or Insulin-like growth factor binding protein 3 (IGFBP3) or GH stimulation testing with a peak GH less than 10 nanograms (ng)/milliliters (ml). The patient did not meet biochemical criteria. Growth hormone stimulation testing peaked at greater than 10.

However, for idiopathic short stature, growth hormone in the treatment of idiopathic short stature (ISS) is supported by randomized controlled trials and consensus guidelines. [4-9] United States Food and Drug Administration (FDA) approval for this indication is for "non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) less than or equal to negative (-) 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 had a pretreatment height less than or equal to -2.25 SD. The patient's height velocity and bone age would not allow the patient to reach a normal adult height. The request therefore meets idiopathic short stature criteria. This request is consistent with generally accepted standards of medical practice and is medically necessary.

Therefore, the requested health service/treatment of Omnitrope is medically necessary for this patient.