Human Growth Hormone

Policy ID: I-9012-001

Section: Injections

Effective Date: January 01, 2021

Revised Date: November 09, 2020

Last Reviewed: November 19, 2020

Description

Exogenous human growth hormone is a recombinant polypeptide hormone. The amino acid sequence of this product is identical to that of endogenous human growth hormone, and is responsible for stimulating skeletal, connective tissue, muscle, and organ growth in children and adolescents, as well as metabolism in adults.

Recombinant growth hormone products are considered clinically identical, with no evidence that one commercial product is different or more advantageous than another, apart from differences in how the Growth Hormone product is stored, dosed, and administered by device. Therefore, one commercial Growth Hormone product is not recommended over another because there are no prospective head-to-head trials comparing the clinical efficacy of one commercial product with another.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Preferred Agent
Norditropin^® FlexPro^® (somatropin)
Nonpreferred Agents
Genotropin^®, Genotropin^® MiniQuick (somatropin)
Humatrope^®, Humatropen^® (somatropin)
Nutropin AQ^® NuSpin^® (somatropin)
Omnitrope^® (somatropin)
Saizen^®, saizenprep^® (somatropin)
Serostim^® (somatropin)
Zomacton^® (somatropin)
Zorbtive^® (somatropin)

Children – Initial Criteria

Human growth hormone may be considered medically necessary in the treatment of children when ALL of the following are met:

The individual is a child (as defined by the prescriber); and
The individual has ONE of the following diagnoses:
- The individual is a newborn (≤ 4 months of age) with hypoglycemia AND serum growth hormone (GH) concentration ≤ 5 mcg/L AND at least ONE of the following:
  1. Congenital pituitary abnormality (e.g., ectopic posterior pituitary and pituitary hypoplasia with abnormal stalk); or
  2. Deficiency of at least one additional pituitary hormone; or
- The individual is a newborn (≤ 4 months of age) with hypoglycemia AND growth hormone (GH) concentration < 20 mcg/L AND BOTH of the following:
  1. The individual does not have a known metabolic disorder; and
  2. The individual has a reduced IGFBP-3 level (e.g., < -2 SD); or
- The individual has a diagnosis of Turner syndrome; or
- The individual has a diagnosis of Noonan syndrome;or
- The individual has a diagnosis of Prader-Willi syndrome; or
- The individual has a diagnosis of SHOX gene deficiency; or
- The individual has a diagnosis of short bowel syndrome (SBS) AND is receiving specialized nutritional support; or
- The individual has a diagnosis of panhypopituitarism or has deficiencies in at least 3 or more pituitary axes AND serum IGF-I levels below the age- and sex-appropriate reference range when off GH therapy; or
- The individual has a diagnosis of chronic renal insufficiency and BOTH of the following:
  1. The individual’s height velocity (HV) for age is < -1.88 standard deviations (SD) OR HV for age is less than the third percentile; and
  2. Other etiologies for growth impairment have been addressed; or
- The individual has a diagnosis of small for gestational age (SGA) and ALL of the following:
  1. The individual is 2 years of age or older; and
  2. The individual has a documented birth weight and/or birth length that is 2 or more standard deviations (SD) below the mean for gestational age; and
  3. At 24 months of age, the individual failed to manifest catch-up growth evidenced by a height that remains 2 or more standard deviations (SD) below the mean for age and gender; or
- The individual has a diagnosis of growth hormone deficiency (GHD), short stature, or other AND ONE of the following:
  1. The individual has extreme short stature (e.g., height < -3 SD), normal nutrition, significantly reduced IGF-1 and IGFBP-3 (e.g., < -2 SD), and delayed bone age; or
  2. BOTH of the following:
    1. The individual has ONE of the following:
      1. Height more than 2 SD below the mean for age and sex; or
      2. Height more than 1.5 SD below the midparental height; or
      3. A decrease in height SD of more than 0.5 over one year in children > 2 years of age; or
      4. Height velocity (HV) more than 2 SD below the mean over one year or more than 1.5 SD sustained over two years; or
      5. Height-for-age curve that has deviated downward across two major height percentile curves (e.g., from above the 25^th percentile to below the 10^th percentile); or
      6. Age 2-4 years: HV less than 5.5 cm/year (< 2.2 inches/year); or
      7. Age 4-6 years: HV less than 5 cm/year (< 2 inches/year); or
      8. Age 6 years to puberty AND ONE of the following:
        
        The individual is a boy and HV is less than 4 cm/year (< 1.6 inches/year); or
        The individual is a girl and HV is less than 4.5 cm/year (< 1.8 inches/year); and
    2. One of the following:
      1. The individual has failed at least 2 GH stimulation tests (e.g., peak GH value of < 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab); or
      2. The individual has failed at least 1 GH stimulation test (e.g., peak GH value of < 10 mcg/L after stimulation, or otherwise considered abnormal as determined by testing lab) AND ONE of the following:
        
        Pathology of the central nervous system; or
        History of irradiation; or
        Other pituitary hormone defects (e.g., multiple pituitary hormone deficiency [MPHD]); or
        A genetic defect; or
      3. The individual has a pituitary abnormality and a known deficit of at least one other pituitary hormone; and
The individual does NOT have any FDA labeled contraindications to the requested agent; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., endocrinologist) or has consulted with a specialist in the area of the individual’s diagnosis; and
The requested quantity (dose) does not exceed the maximum FDA labeled dose for the requested indication; and
ONE of the following:
- The request is for a preferred agent; or
- The request is for a nonpreferred agent and ONE of the following:
  1. The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to a preferred agent that is not expected to occur with the requested nonpreferred agent (medical record required); or
  2. The prescriber has provided information to support the efficacy of the requested nonpreferred agent over the preferred agent for the intended diagnosis (medical record required).

Length of Approval: 4 weeks for SBS
12 months for other indications

The use of human growth hormone for any other condition other than those listed above is considered not medically necessary and therefore, non-covered.

Procedure Codes

J9241

Children – Reauthorization Criteria

Human growth hormone may be considered medically necessary in the treatment of children when ALL of the following are met:

The individual has been previously approved for therapy with GH through Blue Cross Blue Shield of North Dakota's prior authorization process; and
The individual is a child (as defined by the prescriber); and
ONE of the following:
- The request is for a preferred agent; or
- The request is for a nonpreferred agent and ONE of the following:
  1. The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to a preferred agent that is not expected to occur with the requested nonpreferred agent (medical record required); or
  2. The prescriber has provided information to support the efficacy of the requested nonpreferred agent over the preferred agent for the intended diagnosis (medical record required); and
ONE of the following:
- The individual has a diagnosis of short bowel syndrome (SBS) AND has shown clinical benefit from treatment with growth hormone; or
- The individual has any other diagnosis AND ALL of the following:
  1. The individual does not have closed epiphyses; and
  2. The individual’s height has increased or height velocity has improved since initiation or last GH approval; and
The individual is being monitored for adverse effects of GH; and
The individual does NOT have any FDA labeled contraindications to the requested agent; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., endocrinologist) or has consulted with a specialist in the area of the individual’s diagnosis; and
The requested quantity (dose) does not exceed the maximum FDA labeled dose for the requested indication.

Length of Approval: 4 weeks for SBS
12 months for other indications

The use of human growth hormone for any other condition other than those listed above is considered not medically necessary and therefore, non-covered.

Procedure Codes

J9241

Adults – Initial Criteria

Human growth hormone may be considered medically necessary in the treatment of adults when ALL of the following are met

The individual is an adult (as defined by the prescriber); and
The individual has ONE of the following diagnoses:
- The individual has a diagnosis of AIDS wasting/cachexia AND ALL of the following:
  1. The individual is receiving antiretroviral therapy and GH concurrently; and
  2. BOTH of the following:
    1. ONE of the following:
      1. The individual has had weight loss that meets ONE of the following:
        
        10% unintentional weight loss over 12 months; or
        7.5% unintentional weight loss over 6 months; or
      2. The individual has a body cell mass (BCM) loss ≥ 5% within 6 months; or
      3. The individual is male and has BCM < 35% of total body weight and body mass index (BMI) < 27 kg/m²; or
      4. The individual is female and has BCM < 23% of total body weight and BMI < 27 kg/m²; or
      5. The prescriber has provided information that the individual’s BCM < 35% or < 23% and BMI < 27 kg/m² are medically appropriate for diagnosing AIDS wasting/cachexia for the individual’s gender; or
      6. The individual’s BMI is < 20 kg/m²; and
    2. All other causes of weight loss have been ruled out; or
- The individual has a diagnosis of short bowel syndrome (SBS) AND is receiving specialized nutritional support; or
- The individual has a diagnosis of growth hormone deficiency (GHD) AND ONE of the following:
  1. The individual had a diagnosis of childhood-onset growth hormone deficiency AND has failed at least one growth hormone (GH) stimulation test as an adult; or
  2. The individual has a low insulin-like growth factor-1 (IGF-1) level AND ONE of the following:
    1. Organic hypothalamic-pituitary disease; or
    2. Pituitary structural lesion or trauma; or
    3. The individual has panhypopituitarism or multiple (≥ 3) pituitary hormone deficiency; or
  3. The individual has an established causal genetic mutation OR hypothalamic-pituitary structural defect other than ectopic posterior pituitary; or
  4. The individual has failed at least two growth hormone (GH) stimulation tests as an adult; or
  5. The individual has failed at least one GH stimulation test as an adult AND the individual has an organic pituitary disease; and
The individual does NOT have any FDA labeled contraindications to the requested agent; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., endocrinologist) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
The requested quantity (dose) does not exceed the maximum FDA labeled dose for the requested indication; and
ONE of the following:
- The request is for a preferred agent; or
- If the request is for a nonpreferred agent, ONE of the following:
  - The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to a preferred agent that is not expected to occur with the requested nonpreferred agent (medical record required); or
  - The prescriber has provided information to support the efficacy of the requested nonpreferred agent over the preferred agent for the intended diagnosis (medical record required).

Length of Approval: 4 weeks for SBS;
12 weeks for AIDS wasting/cachexia;
12 months for other indications

The use of human growth hormone for any other condition other than those listed above is considered not medically necessary and therefore, non-covered.

Procedure Codes

J9241

Adults – Reauthorization Criteria

Human growth hormone may be considered medically necessary in adults when ALL of the following are met:

The individual has been approved for therapy with GH previously through Blue Cross Blue Shield of North Dakota's prior authorization process; and
The individual is an adult (as defined by the prescriber); and
ONE of the following:
- The request is for a preferred agent; or
- The request is for a nonpreferred agent AND ONE of the following:
  1. The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to a preferred agent that is not expected to occur with the requested nonpreferred agent (medical record required); or
  2. The prescriber has provided information to support the efficacy of the requested nonpreferred agent over the preferred agent for the intended diagnosis (medical record required)
ONE of the following:
- The individual has a diagnosis of short bowel syndrome (SBS) AND has shown clinical benefit from treatment with growth hormone; or
- The individual has a diagnosis of AIDS wasting/cachexia AND BOTH of the following:
  1. The individual continues to receive concurrent antiretroviral therapy; and
  2. The individual shows evidence of benefit of GH treatment (weight increase or weight stabilization); or
- The individual has any other diagnosis AND ALL of the following:
  1. The individual's IGF-I level has been evaluated to confirm the appropriateness of the current dose; and
  2. The individual has had benefits from GH therapy in any of the following response parameters; body composition, hip-to-waist ratio, cardiovascular health, bone mineral density, serum cholesterol, physical strength, or quality of life; and
The individual does NOT have any FDA labeled contraindications to the requested agent; and
The prescriber is a specialist in the area of the individual’s diagnosis (e.g., endocrinologist) or has consulted with a specialist in the area of the individual’s diagnosis; and
The requested quantity (dose) does not exceed the maximum FDA labeled dose for the requested indication; and
The individual is being monitored for adverse effects of GH.

Length of Approval: 4 weeks for SBS;
12 weeks for AIDS wasting/cachexia;
12 months for other indications

The use of human growth hormone for any other condition other than those listed above is considered not medically necessary and therefore, non-covered.

Procedure Codes

J9241

Agent	Contraindicatios
Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton	Acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure Children with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment Active malignancy Active proliferative or severe non-proliferative diabetic retinopathy Children with closed epiphyses Hypersensitivity to somatropin or diluents/excipients
Serostim	Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure Active malignancy Active proliferative or severe non-proliferative diabetic retinopathy Hypersensitivity to somatropin or diluent
Zorbtive	Acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure Active neoplasia Known hypersensitivity to growth hormone

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J2941

B20	C75.1	C75.2	C79.9	D33.0	D33.1	D33.2
D35.2	D35.3	D44.3	D44.4	D49.7	E22.8	E22.9
E23.0	E23.1	E23.3	E23.6	E23.7	E24.1	E78.71
E78.72	E89.3	K91.2	N18.1	N18.2	N18.30	N18.31
N18.32	N18.4	N18.5	N18.6	N18.9	N28.9	P05.00
P05.01	P05.02	P05.03	P05.04	P05.05	P05.06	P05.07
P05.08	P05.09	P05.10	P05.11	P05.12	P05.13	P05.14
P05.15	P05.16	P05.17	P05.18	P05.19	P05.2	P50.9
Q55.4	Q82.5	Q85.00	Q85.01	Q85.02	Q85.03	Q85.09
Q85.8	Q85.9	Q87.11	Q87.19	Q87.2	Q87.3	Q87.5
Q87.81	Q87.89	Q89.2	Q89.8	Q96.0	Q96.1	Q96.2
Q96.3	Q96.4	Q96.8	Q96.9	R62.0	R62.50	R62.51
R62.52	R64	T20.30XA	T20.30XD	T20.30XS	T20.311A	T20.311D
T20.311S	T20.312A	T20.312D	T20.312S	T20.319A	T20.319D	T20.319S
T20.33XA	T20.33XD	T20.33XS	T20.34XA	T20.34XD	T20.34XS	T20.35XA
T20.35XD	T20.35XS	T20.36XA	T20.36XD	T20.36XS	T20.37XA	T20.37XD
T20.37XS	T20.39XA	T20.39XD	T20.39XS	T22.30XA	T22.30XD	T22.30XS
T22.311A	T22.311D	T22.311S	T22.312A	T22.312D	T22.312S	T22.319A
T22.319D	T22.319S	T22.321A	T22.321D	T22.321S	T22.322A	T22.322D
T22.322S	T22.329A	T22.329D	T22.329S	T22.331A	T22.331D	T22.331S
T22.332A	T22.332D	T22.332S	T22.339A	T22.339D	T22.339S	T22.341A
T22.341D	T22.341S	T22.342A	T22.342D	T22.342S	T22.349A	T22.349D
T22.349S	T22.351A	T22.351D	T22.351S	T22.352A	T22.352D	T22.352S
T22.359A	T22.359D	T22.359S	T22.361A	T22.361D	T22.361S	T22.362A
T22.362D	T22.362S	T22.369A	T22.369D	T22.369S	T22.391A	T22.391D
T22.391S	T22.392A	T22.392D	T22.392S	T22.399A	T22.399D	T22.399S
T23.302A	T23.302D	T23.302S	T23.309A	T23.309D	T23.309S	T23.311A
T23.311D	T23.311S	T23.312A	T23.312D	T23.312S	T23.319A	T23.319D
T23.319S	T23.321A	T23.321D	T23.321S	T23.322A	T23.322D	T23.322S
T23.329A	T23.329D	T23.329S	T23.331A	T23.331D	T23.331S	T23.332A
T23.332D	T23.332S	T23.339A	T23.339D	T23.339S	T23.341A	T23.341D
T23.341S	T23.342A	T23.342D	T23.342S	T23.349A	T23.349D	T23.349S
T23.351A	T23.351D	T23.351S	T23.352A	T23.352D	T23.352S	T23.359A
T23.359D	T23.359S	T23.361A	T23.361D	T23.361S	T23.362A	T23.362D
T23.362S	T23.369A	T23.369D	T23.369S	T23.371A	T23.371D	T23.371S
T23.372A	T23.372D	T23.372S	T23.379A	T23.379D	T23.379S	T23.391A
T23.391D	T23.391S	T23.392A	T23.392D	T23.392S	T23.399A	T23.399D
T23.399S	T24.302A	T24.302D	T24.302S	T24.309A	T24.309D	T24.309S
T24.311A	T24.311D	T24.311S	T24.312A	T24.312D	T24.312S	T24.319A
T24.319D	T24.319S	T24.321A	T24.321S	T24.322A	T24.322D	T24.322S
T24.329A	T24.329D	T24.329S	T24.331A	T24.331D	T24.331S	T24.332A
T24.332D	T24.332S	T24.339A	T24.339D	T24.339S	T24.391A	T24.391D
T24.391S	T24.392A	T24.392D	T24.392S	T24.399A	T24.399D	T24.399S
T25.311A	T25.311D	T25.311S	T25.312A	T25.312D	T25.312S	T25.319A
T25.319D	T25.319S	T25.321A	T25.321D	T25.321S	T25.322A	T25.322D
T25.322S	T25.329A	T25.329D	T25.329S	T25.331A	T25.331D	T25.331S
T25.332A	T25.332D	T25.332S	T25.339A	T25.339D	T25.339S	T25.391A
T25.391D	T25.391S	T25.392A	T25.392D	T25.392S	T25.399A	T25.399D
T25.399S	Z92.3

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2020 Adopt policy to mirror pharmacy policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

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