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Medical Policy: 05.01.04
Original Effective Date: May 1995
Reviewed: April 2008
Revised: April 2008
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
Description:
Human growth hormone (GH), also known as somatotropin, is synthesized in somatotropic cells of the anterior lobe of the pituitary gland. Prior to the development of recombinant human GH in 1985 the only available source of GH was human cadaver pituitary glands. The increased availability of recombinant GH has resulted in an increase in the number of conditions treated with this therapy. GH therapy is given to compensate for the hormonal deficiency in children with proven deficiency of endogenous growth hormones and for various other conditions in adults and children.
Policy:
Prior Approval is recommended for growth hormone replacement therapy, which may be considered medically necessary when any one of the following criteria have been met: Submit a prior approval now.
- Children with proven GH deficiency, in order to increase their adult height
- Adults with proven GH deficiency (For both children and adults, proven GH deficiency is defined as an abnormal response of less than 10 ng/mL to TWO provocative stimulation tests, such as L-dopa clonidine, glucagons, propranolol, arginine, or insulin)
- Children with height less than 3rd percentile for chronologic age with chronic renal insufficiency (Chronic renal insufficiency is defined as a serum creatinine of less than 30 mg/dl or a creatinine clearance between 5 and 75ml/min per 1.73 m²)
- Patients with AIDS wasting (defined as a >10% of baseline unexplained wt. loss)
- Patients with Turner’s syndrome (defined as 45, XO genotype)
- Patients with Prader-Willi Syndrome, a genetic disorder characterized by a microdeletion in the long arm of chromosome 15
- Promotion of wound healing in a patient with 3rd degree burns
- Prevention of growth delay in a child with 3rd degree burns
- Patients who are status post surgical correction of ambiguous genitalia in infancy for the treatment of mixed gonadal dysgenesis resulting in complex endocrinopathies
- Patients with short bowel syndrome receiving specialized nutritional support in conjunction with optimal management of short bowel syndrome. Optimal management may include dietary adjustments, enteral feedings, parenteral nutrition, fluid and micronutrient supplements.
- Patients with Panhypopituitarism and proven growth hormone deficiency
The following FDA-approved indications for growth hormone therapy are considered not medically necessary:
- Pediatric patient born small for gestational age (SGA), in the absence of growth hormone deficiency, who fail to show catch-up growth by age two.
- Children with height standard deviation scores of -2.25 or below.
The off label use of recombinant human GH is considered investigational for all other conditions, including, but not limited to:
- Precocious puberty
- Altered body habitus (eg. buffalo hump) associated with antiviral therapy in HIV-infected patients
- Obesity
- Cystic fibrosis
- Idiopathic dilated cardiomyopathy
- Juvenile idiopathic arthritis
- Constitutional delay
- GH therapy for older adults without proven deficiency
- Anabolic therapy, except for AIDS, provided to counteract acute or chronic catabolic illness (eg. Surgery outcomes, trauma, cancer, chronic hemodialysis) producing catabolic changes in both adult and pediatric patients
- Anabolic therapy to enhance body mass or strength for professional, recreational or social reasons
- Glucocorticoid-induced growth failure
- Intrauterine growth retardation
- Short stature after renal transplantation or
- Short stature due to Down or Noonan syndromes
The following diagnostic tests for GH deficiency are considered investigational because they are considered inadequate to document GH deficiency:
- 24-hour continuous monitoring of GH levels; or
- Serum levels of insulin-like growth factors (IGF) or insulin-like growth factor-binding protein (IGFBP).
In children Growth Hormone replacement therapy is typically discontinued when the growth velocity is less than 2 cm per year, when epiphyseal fusion has occurred, or when the height reaches the 5th percentile of adult height.
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Procedure Codes and Billing
Guidelines:
- To report provider services, use appropriate CPT** codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- CPT- 90782 injection (IM or SubQ), therapeutic
- HCPCS code J2941 (Genotropin, Humatrop, Norditropin, Nutropin, Nutropin Aq, Nutropin Depot, Omnitrope, Saizen, Serostim, Somatropin, Tev-Tropin, Zorbtive)
- HCPCS code J2940 ( Protropin or Somatrem) 1 mg
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Selected References:
- Hintz RL, Attie KM, Baptista, H, Roche, A. Effect of Growth Hormone Treatment on Adult Height of Children with Idiopathic Short Stature. NEJM February 1999, 340(7);p502-507
- Vance ML, Mauras N. Drug Therapy: Growth Hormone Therapy in Adults and Children. NEJM October 1999, 341(16); p1206-1216
- National Guideline Clearinghouse- AACE clinical practice guidelines for growth hormone use in adults and children.
- Cael JC, Ecosse E, Nicolino M, Tauber M, Leger J, Cabrol S, Chaussain JL, Coste J. Adult height after long term treatment with recombinant growth hormone for idiopathic isolated growth hormone deficiency: observational follow up study of the French population based registry. BMJ 2002; 325(7355): 70.
- Pucarelli I, Segni M, et al. Effects of combined gonadotropin-releasing hormone agonist and growth hormone therapy on adult height in precocious puberty: a further contribution. J Pediatr Endocrinal Metab 2003; 16(7):1005-10.
- Adamopoulos S, Parissis JT, Paraskevaidis I et al. Effects of growth hormone on circulating cytokine network, and left ventricular contractile performance and geometry in patients with idiopathic dilated cardiomyopathy. Eur Heart J 2003; 24(24):2186-96.
- Albert SG, Mooradian AD. Low-dose recombinant human growth hormone as adjuvant therapy to lifestyle modifications in the management of obesity. J Clin Endocrinol Metab 2004; 89(2):695-701.
- Darmaun D, Hayes V, et al. Effects of glutamine and recombinant human growth hormone on protein metabolism in prepubertal children with cystic fibrosis. J Clin Endocrinol Metab. 2004 Mar;89(3):1146-52.
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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Prior Approval is recommended for this policy.
**Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
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