Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Short Stature
Treatment: Norditropin FlexPro 10mg/1.5ml
The health plan denied Norditropin FlexPro 10mg/1.5ml, as not medically necessary. 
The health plan's determination is overturned.

The patient is a female seeking continuation of growth hormone (GH) treatment for idiopathic short stature (ISS). There is a strong family history of short stature and her mother, sister, and maternal uncle were all treated with GH. Her mother's height is 60 inches and her father's height is 66 inches. She was initially evaluated in the pediatric endocrinology clinic for short stature; however, no clinic note is available for that visit. She was started on GH for ISS, but again no clinical information is available from that visit.
She has been on GH but only one clinic note is available from when she was seen for follow-up. Her height that day was 147.6 centimeters (cm) (19.99%tile:-0.84 standard deviation (SD)). Her bone age was read as 13 years at the chronological age of 12 years and 4 months. She had reached menarche several months prior to this appeal. Continuation of GH was recommended; however, insurance denied continued coverage citing a lack of documentation regarding open epiphysis.
At issue is the medical necessity for the requested medication, Norditropin.

I overturn, on the whole, the health plan's determination of medical necessity.

This patient has been on GH for ISS and her most recent height was at -0.84 SD which is an improvement from -2.66 SD, suggesting that she must have grown at a rate of 8.1 cm since she was started on GH. Her most recent bone age was read as 13 years suggesting that she has not attained near-final height. In the literature, near-final height has been defined as when bone age is >/= 14 years for females and 16 years for males and is used as a criterion for discontinuing GH. At this point, treatment with GH is medically necessary for this patient for at least another year.
In 2003, the US Food and Drug Administration (FDA) approved injectable Somatropin (Humatrope) for the treatment of ISS, also called non-GH-deficient short stature, defined by height standard deviation score (SDS) <=-2.25 and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes of short stature that should be observed or treated by other means.
A carefully examined growth, a detailed family history, and a comprehensive physical exam are critical for the evaluation of any short child. When evaluating growth, a child's height should be assessed in the context of familial background and bone age. If the height (or height for bone age) is within the range of mid-parental target height, further evaluation is usually not necessary except for periodic monitoring of growth.
This patient has been on GH treatment for ISS. No clinical information is available leading to that diagnosis except in the appeal letter that her height was at -2.66 SD. However, neither clinic note, nor growth chart is available to substantiate it. She was started on GH but again no clinical information is available regarding her height SD score or growth velocity. As GH was approved for ISS, I assume that she met the criteria for the diagnosis of ISS, and GH should be continued.
The standard practice is that once GH treatment is started, it is continued until the attainment of adult height. Her most recent bone age was read as 13 years, suggesting that she has not reached adult height.