Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Growth Hormone Deficiency
Treatment: Genotropin
The insurer denied: Genotropin
The denial is overturned.

The patient is a teenage male followed by his pediatric 
endocrinologist for short stature. He presented with linear growth deceleration. Pre-treatment height was less than third percentile. Midparental height is 71.5 inches. The patient underwent growth hormone (GH) stimulation testing using clonidine and arginine which showed a peak of 9.77ng/ml (nanograms per milliliter). He was started on growth hormone treatment a few years ago. He stopped growth hormone therapy for the past six months when his father lost his job and insurance. Of note, he did have excellent response to this treatment with improvement of height to now the 30th percentile. The patient's recent bone age obtained was read as closest to his current age standard. His endocrinologist would like to restart growth hormone therapy.
Coverage for the request was denied by the health plan as not medically necessary, citing height or 1-year growth velocity greater than two standard deviations [2SD] below mean for age and gender; open epiphyses; and two pre-treatment pharmacologic provocative tests for growth hormone deficiency.
An appeal letter from the patient's endocrinologist points out that patient's pre-treatment height was less than third percentile, that bone age means that growth plates are open, and that he did undergo growth hormone stimulation testing using clonidine and arginine, which he failed.

The requested treatment with Genotropin is medically necessary.

The use of growth hormone therapy is considered medically necessary if the criteria for growth hormone therapy is met. The Consensus Guidelines for the Diagnosis and Treatment of Growth Hormone Deficiency (GHD) in Childhood and Adolescence by The GH (Growth Hormone) Research Society state (1): "Diagnosing GHD [Growth Hormone Deficiency] requires a multifaceted process including comprehensive clinical and auxological assessment, combined with biochemical tests of the GH [growth hormone]-insulin-like growth factor (IGF) axis and sometimes radiological evaluation which includes:

A) Clinical and Auxological Criteria: Criteria to initiate immediate investigation include:

1) Severe short stature, defined as a height more than 3 SD (standard deviation) below the mean;
2) Height more than 1.5 SD [standard deviation] below the mid-parental height;
3) Height more than 2 SD [standard deviation] below the mean and a height velocity over 1 year more than 1 SD [standard deviation] below the mean for chronological age, or a decrease in height SD [standard deviation] 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 SD [standard deviation] below the mean over 1 year or more than 1.5 SD [standard deviation] sustained over 2 years; this may occur in GHD [Growth Hormone Deficiency], presenting in infancy, or in organic acquired GHD [Growth Hormone Deficiency];
5) Signs indicative of an intracranial lesion;
6) Signs of multiple pituitary hormone deficiency (MPHD); and
7) Neonatal symptoms and signs of GHD [Growth Hormone Deficiency].

B) Biochemical Assessment of GHD [Growth Hormone Deficiency]:

1) A combination of 2 provocative growth hormone (GH) testing can be used to test for GHD [Growth Hormone Deficiency] and failing both tests has traditionally been used to support the diagnosis. An IGF-1 [insulin-like growth factor 1] value less than -2 SD [standard deviation] suggests an abnormality in the GH [growth hormone] axis.

C)  Radiological Evaluation:

1) Showing evidence of delayed bone age or abnormal pituitary gland."

Based on clinical data submitted, the patient did meet many of the key criteria for the diagnosis of an isolated growth hormone deficiency including the above clinical and biochemical criteria. Although patient's height is currently at the 30th percentile, he did have a pre-treatment height that was less than third percentile, and greater than two standard deviations below his midparental height percentile. He had an excellent response after starting growth hormone treatment with significant improvement in his height percentile. Of note, bone age signifies open growth plates. The patient did fail two growth hormone provocative tests that have traditionally been used to support the diagnosis. These findings are consistent with growth hormone deficiency per the above Consensus Guidelines for the Diagnosis and Treatment of Growth Hormone (GH) Deficiency in Childhood and Adolescence by The GH [growth hormone] Research Society and the referenced medical literature. Hence, growth hormone therapy is medically necessary.