ModifiedPremera BluecrossPolicy N/A

Growth hormone therapy (somatropin and related products) — coverage criteria

Clinical coverage policy for use of growth hormone products in pediatric and adult indications, specifying medical necessity, reauthorization, limitations, and coding guidance for providers and reviewers.

Policy Summary

PayerPremera Bluecross

PolicyGrowth hormone therapy (somatropin and related products) — coverage criteria

Policy CodePolicy N/A

Change TypeCriteria updates and product/quantity limits

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, required stimulation testing or IGF-1 results, and product-specific quantity/requested duration (non-formulary exceptions may be approved up to 12 months).

SourceLink

POLICY UPDATE CHANGES

Growth hormone may be approved up to age 14 and annually thereafter in individuals with Turner or Noonan syndromes.

An indication was added for Zomacton for the treatment of short stature or growth failure associated with SHOX deficiency.

2019 AACE guideline changes were adopted recommending against arginine, levodopa, and clonidine testing for adult-onset GHD and added an IGF-1 treat-to-target (age-adjusted within 2 SD) for re-authorization.

Absolute contraindications updated to add children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment and individuals with active or severe diabetic retinopathy; removed acute third-degree burns, multiple traumas, and chronic illness as absolute contraindications.

Glucagon was added to the list of appropriate stimulation tests for children because it is less risky than insulin-induced hypoglycemia and suitable for infants and young children.

Ngenla (somatrogon-ghla) was added as a second-line agent for treatment of GHD.

Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

Skytrofa (lonapegsomatropin-tcgd) coverage criteria were updated to include treatment of adults with growth hormone deficiency.

Coverage criteria for Serostim (somatropin) were updated to include a quantity limit of 28 vials per 28 days.

Policy was reformatted with no change to criteria except where noted.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

28 vialsSerostim limit

1 courseShort bowel lifetime max

12 monthsTypical approval period

<10 ng/mLPediatric GH threshold

<5 ng/mLAdult GH threshold

annualReview frequency

Coverage Criteria and Medical Necessity

Infantile hypoglycemia

Genotropin (somatropin) and Omnitrope (somatropin) may be medically necessary for the treatment of infantile hypoglycemia associated with panhypopituitarism when ALL of the following criteria are met:

Demonstrated blood sugar is less than 40 mg/dL

Serum growth hormone level is less than 10 ng/mL on all samples obtained during a hypoglycemic episode OR during one appropriate stimulation study

Coding, Testing Thresholds, and Limits

HCPCSHCPCS

J2941	Injection, somatropin (use to report: Omnitrope, Zomacton, Nutropin, Serostim, Saizen, Genotropin and Humatrope), 1 mg
J3590	Unclassified biologics (use to report: Sogroya, Skytrofa and Ngenla)

Referenced HCPCS/administrative codesHCPCS

J3590

Not otherwise classified biologics (used historically to capture newer GH agents like Ngenla per history notes)

Stimulation test thresholds — pediatric and adult

Pediatric thresholdSerum GH <10 ng/mL on two separate appropriate stimulation studies (or low IGF-1)

Adult thresholdSerum GH <5 ng/mL on stimulation testing (e.g., glucagon or insulin per policy)

Pediatric stimulation methodsAcceptable pediatric stimulation tests include l-dopa, clonidine, arginine, glucagon, or insulin-induced hypoglycemia

Weight loss threshold for AIDS wasting

Weight-loss criterionUnintentional loss of at least 10% of body weight

Alternative metricBody weight ≤90% of ideal body weight

Clinical exclusionsWeight loss must not be due to treatable conditions (e.g., depression, chronic infection, malignancy except limited Kaposi's)

Age for SGA catch-up

SGA catch-up timingNo catch-up growth by age 2–4 years

FDA contextChildren born SGA with no catch-up growth by age 2–4 years are an FDA‑indicated group for GH therapy

Recommended treatment windowOptimal age for treatment generally between ~5 years and early puberty per consensus guidance

Height SDS threshold for ISS consideration

ISS height SDS rangeConsider GH when height is approximately -2 to -3 standard deviation score

Guidance on ageOptimal age for treatment is between about 5 years and early puberty per GHRS consensus

Psychosocial considerationPsychological issues should be considered; GH not routinely recommended for unconcerned children

IGF-1 re-authorization target

IGF-1 re-authorization targetAge-adjusted mean serum IGF-1 within ±2 standard deviations of the norm

PurposeUsed as a treat-to-target biomarker in re-authorization of adult GH therapy per 2019 AACE guidance

DocumentationRe-authorization should include evidence that IGF-1 is within the age-adjusted ±2 SD target

Serostim quantity limit

Quantity limitSerostim limited to 28 vials per 28 days

Authorization noteReauthorization requires documented clinical benefit after the first 6 weeks (per policy criteria)

Denial riskRequests exceeding 28 vials per 28 days may be denied or require non-formulary exception review

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Benefit application and coverage exclusions

Growth hormone may be covered under either the pharmacy or medical benefit depending on the member contract. Most member contracts specifically exclude coverage of growth hormone for idiopathic short stature (ISS); be prepared to deny when the indication is ISS.

Coverage may be pharmacy or medical benefit per member contract
ISS is commonly excluded by member contracts

Documentation Required

Annual review and reauthorization

Individual enrollees receiving synthetic growth hormone should be reviewed at least annually to ensure appropriate benefit application and continued medical necessity. Annual reauthorization may be approved for up to 12 months when reauthorization criteria are met and chart notes document continued clinical benefit.

Review synthetic growth hormone recipients at least annually

Background and Context

Growth hormone is produced by the pituitary gland and is a key regulator of linear growth in children and of metabolism in both children and adults. Deficiency may result from pituitary or hypothalamic disease, congenital conditions, or other causes and is diagnosed by clinical features and biochemical testing where appropriate.

The policy aligns indications for treatment with FDA‑labeled pediatric conditions (for example, GHD, chronic renal failure prior to transplant, Turner and Noonan syndromes, Prader‑Willi syndrome, and SGA with inadequate catch‑up growth) and with guideline recommendations for testing and monitoring, including specialist involvement and baseline testing where applicable.

Definitions and Key Terms

Chronic renal insufficiency — definition

Serum creatinine definitionSerum creatinine >1.5 mg/dL (or >1.4 mg/dL for women, >1.7 mg/dL for men)

Creatinine clearanceCreatinine clearance ≤75 mL/min/1.73 m2

Discontinuation pointsGH discontinued at time of transplant or when growth velocity <2 cm/year, epiphyseal fusion, or height reaches 5th percentile of adult height

Idiopathic short stature (ISS) — definition

DefinitionIdiopathic short stature (ISS): very short children with normal GH levels and no known cause of shortness (non‑GH‑deficient short stature)

Coverage stanceISS may be FDA‑labeled but most member contracts specifically exclude coverage for ISS; review member contract

Policy Revision History

2014policy_update

Added approval language allowing growth hormone to be approved up to age 14 and annually thereafter for individuals with Turner or Noonan syndromes.

2018policy_update

Added an indication for Zomacton for treatment of short stature or growth failure associated with SHOX deficiency and clarified lipid laboratory requirements for adults.

2020policy_update

Adopted 2019 AACE guidance to discontinue arginine, levodopa, and clonidine testing for adult-onset GHD and added an IGF‑1 treat-to-target (age‑adjusted mean within ±2 SD) for reauthorization.

Policy Summary

PayerPremera Bluecross

PolicyGrowth hormone therapy (somatropin and related products) — coverage criteria

Policy CodePolicy N/A

Change TypeCriteria updates and product/quantity limits

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Reauthorization approvals may be for up to 12 months when criteria met

Billing Rule

Prior authorization duration and coding updates

Non-formulary exception reviews and prior authorization decisions for drugs listed in this policy may be approved for up to 12 months. Authorizations and coverage decisions should follow current HCPCS/J‑code handling and updated prescribing information; verify applicable codes during submission.

Non-formulary exception approvals may be up to 12 months
Verify HCPCS/J-code and billing guidance at time of request
Follow current product prescribing information for dosing and administration

Denial Risk

Short bowel therapy and Serostim quantity limits

For short bowel syndrome, approval is limited to one four-week course of growth hormone therapy (lifetime maximum) because evidence does not support additional benefit from further courses. For Serostim, quantity is limited to 28 vials per 28 days.

Short bowel syndrome: single 4-week course lifetime maximum
Serostim (somatropin) limited to 28 vials per 28 days

Denial Risk

Denial triggers: quantity limits and missing exceptions/documentation

Exceeding product-specific quantity limits or requesting non-preferred products without an approved non‑formulary exception will be grounds for denial. Denials may also be triggered by lack of required supporting documentation or failure to meet reauthorization criteria (e.g., insufficient growth response in pediatrics).

Requests exceeding product quantity limits will be denied
Non-preferred product use requires non‑formulary exception approval
Insufficient documentation of required clinical response may trigger denial

Documentation Required

Required supporting clinical documentation and prescribing information

Prescribers must document baseline and follow-up testing as specified in the criteria (e.g., appropriate stimulation testing or IGF‑1, baseline lipid panel or bone density in adults, bone age/epiphyseal status in children). Consult each product’s FDA prescribing information for dosing, admixture, and administration instructions.

Document appropriate stimulation testing results or IGF‑1 as specified
Adults: baseline lipid panel or bone density scan required
Pediatric reauthorization: height velocity and bone age/epiphyseal status must be documented
Refer to product Prescribing Information for dosing and admixture

Documentation Required

Pediatric monitoring and reauthorization requirements

Pediatric patients must show objective growth response for reauthorization: typically growth of ≥2.5 cm over the prior year (or height velocity criteria per condition) and documentation of open epiphyses/bone age when age criteria apply. Include bone age (wrist film) or other confirmation of open epiphyses as required.

Pediatric reauthorization commonly requires ≥2.5 cm growth over prior year
For individuals ≥10 years, bone age <18 years or epiphyses confirmed open
Height velocity and bone age documentation must be in chart notes

Note

Retesting recommendations for childhood-onset GHD transitioning to adult care

Individuals with childhood-onset GHD transitioning to adult care should be retested for adult GHD unless they have known mutations, embryopathic lesions, or irreversible structural damage; retesting methods and preferences are described in the guideline updates.

Retest childhood-onset GHD patients when transitioning to adult care unless persistent GHD is certain
Preferred tests: ITT or GHRH‑arginine (with caveats); follow guidelines for adult testing

Step Therapy

Preferred-product requirement and second-line agent designation

Ngenla (somatrogon‑ghla) and other products have been added or reclassified over time as second-line agents in the policy; sequencing or requirement to try preferred agents (e.g., Genotropin, Omnitrope) first is enforced except when intolerance, inadequate response, or documented inability to use preferred devices exists.

Ngenla added as a second-line agent
Preferred first‑line agents include Genotropin and Omnitrope
Second‑line use generally requires intolerance, inadequate response, or documented inability to use preferred device

Note

First-line vs second-line historical notes and implications

The policy documents first-line vs second-line designations historically and notes additions to the formulary (e.g., Sogroya, Skytrofa, Ngenla). Prescribers should follow the sequencing requirements in the criteria and consult history/updates for recent changes.

First-line and second-line product lists have been updated over time (e.g., Sogroya, Skytrofa additions)
Check policy history for recent formulary or sequencing changes

Treatment considerationConsider shared decision‑making; not routinely treat every child with height SDS ≤ -2.25

Small for gestational age (SGA) — definition and catch-up timing

DefinitionSmall for gestational age (SGA): children born small for gestational age with no catch‑up growth by age 2–4 years

FDA indicationSGA with no catch‑up by 2–4 years is an FDA‑indicated group for GH therapy

Consensus noteGHRS notes continue to support considering treatment in this population and timing of optimal treatment age

Adult-onset GHD — definition and testing note

DefinitionAdult‑onset GHD: growth hormone deficiency in adults where traditional tests (arginine, levodopa, clonidine) are discouraged per 2019 AACE guidance

Diagnostic noteDiagnosis confirmed by stimulation test with peak GH <5 ng/mL (e.g., glucagon or insulin) or assumed if pituitary removed/destroyed or panhypopituitarism since birth

MonitoringBaseline lipid panel or bone density scan required; therapy prescribed by or in consultation with an endocrinologist

Glucagon stimulation test (pediatric) — recommended stimulation test detail

Recommended pediatric testGlucagon stimulation test is an appropriate pediatric stimulation test and is less risky than insulin‑induced hypoglycemia

Use casesPreferred choice for infants and young children as added to pediatric stimulation options

Other acceptable testsPediatric stimulation testing may also include l‑dopa, clonidine, arginine, or insulin-induced hypoglycemia per policy criteria

2021policy_update

Revised absolute contraindications to add severely obese Prader‑Willi children with severe respiratory impairment and individuals with active or severe diabetic retinopathy; added glucagon as an appropriate pediatric stimulation test.

2023-12-01policy_update

Added Ngenla (somatrogon‑ghla) as a second‑line agent for treatment of growth hormone deficiency and incorporated it into HCPCS coding (J3590).

2025policy_update

Expanded Skytrofa (lonapegsomatropin‑tcgd) coverage criteria to include adults and clarified that non‑formulary exception authorizations may be approved for up to 12 months.

2026-03-01policy_updateLatest

Updated Serostim (somatropin) coverage criteria to include a quantity limit of 28 vials per 28 days and reformatted the medical policy.

2016-10-01administrative

Annual review and updates to reauthorization criteria for adult growth hormone use; minor editorial edits later in 2016.

2017-12-01administrative

Interim review with clarifications to pediatric growth hormone deficiency criteria and removal of select CPT/ICD-10 codes.

2021-03-01administrative

Interim review added Sogroya (somapacitan‑beco) as a second‑line agent and added HCPCS code J3590.

2023-07-01administrative

Annual review completed June 26, 2023 with no changes to policy statements noted in the record; later that year Ngenla was added to HCPCS J3590 (12/01/23).

2024-08-01administrative

Annual review (approved July 8, 2024) with no changes to policy statements.

2025-08-01administrative

Interim actions in 2025 removed Nutropin from the policy after market withdrawal and updated Skytrofa criteria (approved July–September 2025).

2026-03-01administrativeLatest

Annual review approved February 10, 2026 documenting the Serostim quantity limit and policy reformatting (administrative record entry).