Growth Hormone Therapy*

Medical Policy: 05.01.04 
Original Effective Date: May 1995 
Reviewed: April 2008 
Revised: September 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 for children with growth hormone deficiency documented by the following:  Submit a prior approval/treatment request now.

  • Height –  ≥ 2 standard deviations below the mean for chronological age and sex,  and growth velocity measured over one year less than 25th percentile for age and sex,

AND one of the following:

  • IGF-1 or IGFBP-3 level below normal.

AND

  • suboptimal response, <10 µg/ml, to ONE of the following provocative tests
    • Insulin, or
    • Arginine, or
    • Clonidine, or
    • Glucagon, or
    • Levodopa

OR

  • Suboptimal response to TWO provocative tests.

OR

  • Panhypopituitarism - Documented presence of at least three other pituitary hormone deficiencies. (i.e., growth hormone stimulation tests are not required in this subgroup of patients.)

Which may be considered medically necessary for children with non-growth hormone deficiency documented by one of the following:

  • Height – ≥ 2.25 standard deviation below the mean for chronological age and sex,

AND

ONE  of the following:

  • Idiopathic short stature
  • Small for gestational age
  • Children with height less than the 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 Turner’s syndrome (defined as 45, XO genotype)
  • Short stature due to Noonan’s syndrome
  • Patients with Prader-Willi Syndrome, a genetic disorder characterized by a microdeletion in the long arm of chromosome 15
  • Prevention of growth delay in children with 3rd degree burns

Prior Approval is recommended for growth hormone replacement therapy, which may be considered medically necessary for the treatment of adult growth hormone deficiency for patients with any of the following:  Submit a prior approval/treatment request now.

  • Documented Growth Hormone Deficiency in childhood;
  • Documented hypopituitarism as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma.
  • Patients with AIDS wasting (defined as a >10% of baseline unexplained wt. loss)
  • Promotion of wound healing in patients with 3rd degree burns
  • 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.

The diagnosis of adult GHD must be confirmed, or reconfirmed, by any the following:

  • A documented subnormal response in adults, to two standard growth hormone stimulation tests (preferred stimulation tests include: insulin-induced hypoglycemia and combined arginine-growth hormone releasing hormone); defined as:
    • Serum GH concentration ≤ 5 µg/ml when using insulin induced hypoglycemia testing; OR
    • Serum GH concentration of ≤ 4.1 µg/ml when using arginine; OR
  • Subnormal response to one stimulation test for adults with documented hypothalamic or pituitary disease and one or more additional pituitary hormone deficits; OR
  • Panhypopituitarism - Documented presence of at least three other pituitary hormone deficiencies in adults (i.e., growth hormone stimulation tests are not required in this subgroup of patients.)

The following FDA-approved indications for growth hormone therapy are considered not medically necessary:

  • Pediatric patients 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  0-2.0 in the absence of a diagnosis of a medically necessary condition.

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
  • Constitutional delay of growth and development
  • 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's syndrome

The following diagnostic test for GH deficiency is considered investigational because it is considered inadequate to document GH deficiency:

  •  24-hour continuous monitoring of GH levels                                


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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- 90772 Therapeutic, prophylactic or diagnostic injection (specify substance or drug); subcutaneous or intramuscular 
  • HCPCS code J2941 (Genotropin, Humatrop, Norditropin, Nutropin, Nutropin Aq, Nutropin Depot, Omnitrope, Saizen, Serostim, Somatropin, Tev-Tropin, Zorbtive)
  • HCPCS code J1675 Injection, histrelin acetate, 10 micrograms
  • HCPCS code S9558 Home injectable therapy; growth hormone, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem  

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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.
  • American Association of Clinical Endocrinologists (AACE) Growth Hormone Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for growth hormone use in adults and children--2003 update. Endocr Pract 2003 Jan-Feb;9(1):64-76. 
  • 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.
  • Molitch ME, Clemmons DR, Malozowski S, Merriam GR, et al. for The Endocrine Society’s Clinical Guidelines Subcommittee. Evaluation and Treatment of Adult Growth Hormone Deficiency: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2006 May;91(5):1621-34. 

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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.

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