Recombinant Human Growth Hormone (rhGH) - MCS a

Clinical Medical Policy Department 

Clinical Affairs Division 

Recombinant Human Growth Hormone (rhGH) 

[For the list of services and procedures that need preauthorization, please refer to www.mcs.com.pr Go to “Comunicados a Proveedores”, 

and click “Cartas Circulares”.] 

Medical Policy: 

MP-RX-11-09 

Original Effective Date: July 9, 2009 

Reviewed: 

Revised: July 9, 2013 

This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, 

Inc. (Classicare) and Medical Card System, Inc., provider’s contract; unless specific contract limitations, exclusions or exceptions 

apply. Please refer to the member’s benefit certification language for benefit availability. Managed care guidelines related to referral 

authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the 

aforementioned exceptions. 

DESCRIPTION 

Human growth hormone, also known as Somatotropin, is essential for normal growth and children 

maturation. This hormone has an important role in controlling metabolism, cardiac function and 

maintenance of corporal composition in adults. Growth hormone deficiency in children produces short 

stature and in severe cases delays skeletal maturation and lineal growth. Other conditions associated 

with growth hormone deficiency and short statures are chronic renal failure and Turner Syndrome. 

Growth hormone deficiency can be acquired as a result of anatomical abnormalities or pituitary tumors 

of pineal or hypothalamic regions. Usually, growth hormone deficiency in adults is secondary to pituitary 

disorders. 

Endogenous growth hormone or Somatotropin is secreted by the anterior lobe of the pituitary gland in 

response to the liberator factor of the growth hormone. The growth hormone regulates, among other 

functions, cellular, lineal, skeletal and organs growth. Recombinant Human Growth Hormone or 

Somatropin produces the same side effects as the endogenous growth hormone Somatotropin. 

Recombinant Human Growth Hormone (rhGH) is administered daily or several times during the week (6- 

7) in individualized dosage by subcutaneous or intramuscular via. The Food and Drug Administration 

indications varies product by product and according with the patient’s age. 

COVERAGE 

Benefits may vary between groups and contracts. Please refer to the appropriate member certificate 

and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, 

benefits and coverage. 

This document is designated for informational purposes only and is not an authorization, or an explanation of benefits (EOB), or a contract. 

Medical technology is constantly changing and we reserves the right to review and update our policies periodically. 

Medical Card System, Inc. 

All Rights Reserved® 

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INDICATIONS 

Medical Card System, Inc. (MCS) will consider recombinant growth hormone medically necessary for 

treatment of members in the following diagnostic categories who meet the criteria set forth below: 

A. Adults: 

1. Adult Members with hypothalamic - pituitary disease 

2. Pituitary tumor 

3. Damage secondary to pituitary surgery 

4. Hypothalamic disease 

5. Radiation 

6. Trauma (e.g. head trauma or central nervous system infection) 

7. Confirmed growth hormone deficiency for either childhood (secondary to congenital, 

genetic, acquired, or idiopathic causes) onset or adult onset (endogenous or associated with 

multiple hormone deficiencies, i.e., hypopituitarism, as a result of pituitary disease, surgery 

or radiation therapy) 

8. For the treatment of short bowel syndrome in patients receiving specialized nutrition 

support as directed by a health care professional. 

9. For the treatment of HIV-associated adipose redistribution syndrome (HARS) †. 

† = Off-label indication 

B. Children and Adolescents: 

1. Children with history of hypothalamic - pituitary disease 

2. Short stature associated with chronic renal insufficiency previous renal transplant 

3. Short stature in patients with Turner Syndrome (TS) i 

4. Short stature in patients with Prader Willis Syndrome (PWS) ii 

5. Short Stature in patients with Noonan’s Syndrome iii 

6. Infants born short for their gestational age (SGA) who have not reach their expected stature at 

two to four years of age or that presented the restriction diagnosis in the intrauterine growth 

(IUGR). GH or IGF-I levels are not needed for this diagnosis. 

7. Trauma (e.g. traumatic delivery in the neonate) 

8. For the long-term treatment of growth failure in children who have growth hormone deficiency 

due to inadequate growth hormone secretion. 

9. For short stature in children with SHOX (short stature homeobox-containing gene) deficiency. 

10. For idiopathic short stature. 

11. For the treatment of HIV-associated failure to thrive in children, AIDS-associated wasting 

syndrome, or cachexia. 





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CONTRAINDICATIONS/LIMITATIONS 

Medical Card System, Inc. (MCS) DOES NOT cover Somatropin for the following indications because 

they are considered experimental, investigational or unproven (this list may not be all-inclusive): 

A. Growth Hormone Use in Adults: 

1. Continuation of growth hormone treatment from childhood use once epiphyses are closed 

(except as defined in adult growth hormone coverage conditions) 

2. Obesity 

3. Osteoporosis 

4. Muscular dystrophy 

5. Infertility 

6. Somatopause 

7. Repeat courses of therapy in Short Bowel Syndrome 

8. Crohn’s disease 

B. Growth Hormone Use in Children: 

1. Russell-Silver Syndrome 

2. Skeletal dysplasias, (i.e., acondroplastia) 

3. Osteogenesis imperfecta 

4. Down Syndrome and other syndromes associated with short stature and malignant diathesis 

5. Continuation of growth hormone treatment for growth promotion once epiphyses are closed 

6. Deletion of chromosome 18q 

7. Chromosomal anomalies unless otherwise specified as covered 

8. Precocious puberty 

9. Juvenile rheumatoid arthritis 

10. Crohn’s disease 

11. Repeat courses of therapy in Short Bowel Syndrome 

C. General Contraindications and Warnings: 

1. Somatropin products should not be used in any patient with a known hypersensitivity to 

Somatropin or any of the product excipients. 

2. Hypersensitivity to benzyl alcohol. 

3. Hypersensitivity to metacresol. 

4. Patients with Active Neoplastic Disease. 





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5. Patients with acute critical illness due to complications following open heart or abdominal 

surgery, multiple accidental traumas or to patients having acute respiratory insufficiency. 

6. Somatropin should be used cautiously in patients with diabetes mellitus. Patients with diabetes 

or glucose intolerance and those patients with risk factors for diabetes or glucose intolerance 

should be monitored closely during treatment with Somatropin. 

7. Diabetic retinopathy, active proliferative or severe non-proliferative. 

8. Patients with a history of scoliosis should receive Somatropin with caution. 

9. Somatropin therapy has been reported to cause increased intracranial pressure with 

papilledema, visual changes, headache, and nausea and/or vomiting. 

10. Underlying intracranial tumor, evidence of progression or recurrence. 

11. Patients who develop persistent, severe abdominal pain during Somatropin treatment should be 

evaluated for pancreatitis, especially pediatric patients. 

12. Somatropin is contraindicated for growth promotion in pediatric patients with epiphyseal 

closure. 

13. Somatropin is contraindicated for use in pediatric patients with Prader-Willi syndrome and 

obesity as there have been reports of fatalities. 

14. Hormone replacement therapy should be monitored closely when somatropin therapy is 

administered to patients with hypopituitarism (multiple hormone deficiencies). 

15. Somatropin must be administered with caution during pregnancy and could affect the 

reproduction capacity. 

16. Somatropin must be administered cautiously in breast feeding mothers; it is excreted into 

human breast milk. 

17. During treatment with Somatropin, Turner’s syndrome patients should be evaluated carefully 

for Otitis and other ear disorders since these patients have an increased risk of ear or hearing 

disorders. 

18. Dose selection for an elderly patient should be cautions, usually starting at the low end of the 

dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, 

and of concomitant disease or other drug therapy. 

CODING INFORMATION 

HCPCS CODES (List may not be all inclusive) 

HCPCS® CODES 

DESCRIPTION 

J2941 

Injection, Somatropin, 1mg 

2013 HCPCS LEVEL II Professional Edition® (American Medical Association). 





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ICD-9 CM® Diagnosis Codes (List may not be all inclusive) 

ICD-9 CM® CODES 

DESCRIPTION 

042 Human immunodeficiency virus (HIV) disease 

194.3 Malignant neoplasm of other endocrine glands and related structures, pituitary 

gland and craniopharyngeal duct 

227.3 Benign neoplasm of other endocrine glands and related structures, pituitary 

gland and craniopharyngeal duct pouch 

253.2 Panhypopituitarism 

253.3 Disorders of the pituitary gland and its hypothalamic control, pituitary dwarfism 

253.7 Iatrogenic pituitary disorders 

259.4 Dwarfism, not elsewhere classified 

579.3 Other and Unspecified postsurgical non-absorption 

579.8 Other specified intestinal malabsorption 

585.1 Chronic Kidney disease, Stage I 

585.2 Chronic Kidney disease, Stage II (mild) 

585.3 Chronic Kidney disease, Stage III (moderate) 

585.4 Chronic Kidney disease, Stage IV (severe) 

585.5 Chronic Kidney disease, Stage V 

585.6 End stage renal disease 

585.9 Chronic kidney disease, unspecified 

588.0 Renal osteodystrophy 

758.6 Chromosomal anomalies, gonadal dysgenesis (Turner’s syndrome) 

759.81 Other specified anomalies, Prader-Willi syndrome 





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759.89 Other specified anomalies, other (Noonan’s syndrome) 

764.90 Unspecified Fetal growth retardation, unspecified (weight) 

764.91 Unspecified Fetal growth retardation, less than 500 grams 

764.92 Unspecified Fetal growth retardation, 500 – 749 grams 

764.93 Unspecified Fetal growth retardation, 750 – 999 grams 

764.94 Unspecified Fetal growth retardation, 1000 –1249 grams 





764.99 Unspecified Fetal growth retardation, 2500 or and over 

799.4 Cachexia 

909.2 Late effect of radiation 

958.4 Certain early complications of trauma, traumatic shock 

958.8 Certain early complications of trauma, other 

990 Effects of radiation, unspecified 

998.89 Other specified complications of procedures, not elsewhere classified, other 

specified complications 

2013 ICD-9-CM®For Physicians, VOLUMES I & II, Professional Edition (American Medical Association) 

REFERENCES 

1. “Administración de seguros de salud de Puerto Rico. Solicitud de autorización para la hormona de 

crecimiento humana recombinante” (Pre-authorization Request for Recombinant Human Growth 

Hormone [rhGH]). Approved Date: 12/19/2005. Revised Date: 8/28/2008. Document not available at 

Internet. Searched July 9, 2013. 





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2. American academy of pediatrics. Considerations Related to the Use of Recombinant Human Growth 

Hormone in Children. Pediatrics Vol. 99 No. 1 January 1, 1997. pp. 122 -129. Accessed July 09, 2013. 

Available at URL: http://pediatrics.aappublications.org/content/99/1/122.full.pdf+html 

3. American Association of Clinical Endocrinologists. AACE Medical Guidelines for Clinical Practice for 

Growth Hormone – New 2009 Update. Endocrine Practice Vol. 15 (Suppl 2) September/October 2009 or 

Guidelines for Use of Growth Hormone in Clinical Practice, Endocr Pract. 2009; 15(Suppl 2). Accessed 

July 05, 2013. Available at URL address: https://www.aace.com/files/growth-hormone-guidelines.pdf 

4. ECRI Institute. Recombinant Human Growth Hormone (rhGH) in Managing Turner’s syndrome. 

Publication Date: 11/09/2004. Searched on July 09, 2013. Document not available at URL address: 

https://members2.ecri.org/Components/Hotline/Pages/8397.aspx. 

5. Gold Standard / Elsevier. Clinical Pharmacology. www.clinicalpharmacology.com. Somatropin. Last 

Revision Date: 4/19/2012. Revision Date: 7/26/2011 Accessed July 02, 2013. Document available at URL 

address: 

https://www.clinicalpharmacology.com/Forms/Monograph/monograph.aspxcpnum=1564&sec=monin 

di&t=0 

6. National Guideline Clearinghouse. Title: Evaluation and treatment of adult growth hormone 

deficiency: an Endocrine Society clinical practice guideline. Released Date: 2006. Document Available at 

URL address http://www.guideline.gov/content.aspxid=9311. This guideline has been replaced by an 

updated version completed June 2011. Accessed July 05, 2013. Document available at URL address: 

http://www.guideline.gov/content.aspxid=34450 

7. Thomson Micromedex® DrugDex. Somatropin - Indications & Contraindications. Retrieved July 02, 

2013. from https://www.thomsonhc.com/micromedex2 

8. www.chromsome18.org. The Chromosome 18 Registry & Research Society. Distal 18q. 2009. 

Accessed July 08, 2013. Available at URL: 

http://www.chromosome18.org/LinkClick.aspxfileticket=hfLGlJST6mk%3d&tabid=127 

POLICY HISTORY 

DATE ACTION COMMENT 

July 9, 2009 

Origination of Policy 

July 9, 2010 Revised I. Under Indications: indication for children added “Short Stature patients 

with Noonan’s Syndrome”. 

II. New investigational/experimental section added to policy as stated 





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below: MCS does not cover Somatropin for the following indications 

because they are considered experimental, investigational or unproven 

(this list may not be all-inclusive): 

A. Growth Hormone Use in Children: 

• Russell-Silver Syndrome 

• Skeletal dysplasias, (i.e., acondroplastia) 

• Osteogenesis imperfecta 

• Down Syndrome and other syndromes associated with short stature and 

malignant diathesis 

• Continuation of growth hormone treatment for growth promotion once 

epiphyses are closed 

• Deletion of chromosome 18q 

• Chromosomal anomalies unless otherwise specified as covered 

• Precocious puberty 

• Juvenile rheumatoid arthritis 

• Crohn’s disease 

• Repeat courses of therapy in Short Bowel Syndrome 

B.Growth Hormone Use in Adults: 

• Continuation of growth hormone treatment from childhood use once 

epiphyses are closed (except as defined in adult growth hormone 

coverage conditions) 

• Obesity 

• Osteoporosis 

• Muscular dystrophy 

• Infertility 

• Somatopause 

• Repeat courses of therapy in Short Bowel Syndrome 

• Crohn’s disease 

III.Endnote added with definitions on Turner’s syndrome, Prader-Willie 

and Noonan’s Syndrome. 





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July 6, 2011 

Yearly Review 

August 7, 2012 Revised References updated. 

To the Adults’ Indications Section - modified Indication # 7: for either 

childhood (secondary to congenital, genetic, acquired, or idiopathic 

causes) onset or adult onset (endogenous or associated with multiple 

hormone deficiencies, i.e., hypopituitarism, as a result of pituitary 

disease, surgery or radiation therapy). Also, Added New Indications 8-10. 

To the Children and Adolescents’ Indications Section – Added to 

Indication #6: two to four years as a valid age to evaluate gestational age 

in relation to size. 

New Indications 8-11 were added. 

New General Contraindications Section, # 1-11, was added. 

July 9, 2013 Yearly Review 1. References updated. 

2. General Contraindications and Warnings # 12-18 were added 

to the policy. 

3. The ICD#9 section was reviewed. 

i 

Turner’s syndrome is a chromosomal disorder occurring exclusively in girls with an absence or a defect in chromosome 45X. The disorder 

results in lack of sexual development at puberty, short stature, webbed neck and a variety of heart defects. Turner’s syndrome is diagnosed in 

approximately one in 2000 to 3000 live female births. The reason for short stature in nearly all girls with Turner’s syndrome is probably from an 

impaired response to GH rather than a deficiency of the hormone. Treatment with growth hormone, anabolic steroids and estrogen are 

required to improve physical and sexual development. 

ii Prader-Willi syndrome affects multiple systems resulting in infantile hypotonia and failure to thrive, 

Hypogonadism, short stature, learning disabilities and hyperphagia beginning at one to three years of age that leads to obesity. Prader-Willi 

syndrome is rare, occurring in approximately one in 10,000 to 25,000 live births; approximately 17,000 to 22,000 children in the U.S. have 

Prader-Willi syndrome. Sixty percent of children (primarily boys) diagnosed with Prader-Willi syndrome have abnormal chromosomes; either a 

three to four million base-pair deletion of the paternal chromosome 15q11q13, or both fifteenth chromosomes are inherited from the mother. 

iii 

Noonan syndrome is a genetic disorder that causes abnormal development of multiple parts of the body. It used to be called Turner-like 

syndrome because certain signs (webbing of neck and abnormally shaped chest) resembled those seen in Turner syndrome. Management 

focuses on controlling the disease's symptoms and complications. Growth hormone may be used to treat short stature in some people who 

have Noonan syndrome. 

This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of 

benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with 

the terms of the member’s plan in effect as of the date services are rendered. Medical Card System, Inc., (MCS) medical policies are 

developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but 

not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical 

practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical 

Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion. Medical Card System, Inc.; (MCS) 

medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan’s ability to interpret plan language as 

deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, 

quality, and levels of care and treatment they choose to provide. 





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Recombinant Human Growth Hormone (rhGH) - MCS a

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