Currentmedical mutual - ohioPolicy N/A

Somatropin, mecasermin, somapacitan and related growth hormone products

Defines prior authorization and coverage criteria, dosing, continuation criteria, preferred product formulary rules, site-of-care restrictions, and exclusions for recombinant human growth hormone products and IGF-1 (mecasermin) across pediatric and adult indications. This part (1 of 2) contains indications, detailed clinical criteria for approval/continuation, dosing guidance, preferred product rules and a list of conditions not recommended for approval.

Policy Summary

Payermedical mutual - ohio

PolicySomatropin, mecasermin, somapacitan and related growth hormone products

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for some or all procedure codes listed; initial and renewal requests are subject to site-of-care management and approvals are generally provided for 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes — policy content remains consistent with prior guidance.

9Major covered indications listed (pediatric GHD, CKD/Noonan/Turner/SGA/Prader-Willi, adult GHD, SHOX, HIV wasting, IGF-1 deficiency, short bowel)

15+Conditions specifically excluded or not recommended

1 yearTypical approval duration

4HCPCS codes requiring prior approval

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.

20+Conditions listed as Not Recommended

Coverage Summary

Scope: This policy covers FDA‑approved uses of recombinant human growth hormone (somatropin and analogs) and recombinant IGF‑1 (mecasermin) including pediatric growth hormone deficiency (GHD), growth failure due to chronic kidney disease, Turner syndrome, Noonan syndrome, small for gestational age/intrauterine growth restriction (including Silver‑Russell), Prader‑Willi syndrome, adult GHD (including transition patients), SHOX deficiency, HIV‑associated wasting (Serostim), severe primary IGF‑1 deficiency (Increlex), and short bowel syndrome (Zorbtive and selected GH products).

Prior authorization requirement and duration: Prior authorization is required for the listed HCPCS codes and for covered products; approvals are generally provided for 1 year unless otherwise noted (e.g., Serostim initial approval is 3 months, short bowel initial approval is 4 weeks).

Prescriber and site‑of‑care rules: Somatropin, mecasermin and somapacitan must be prescribed by or in consultation with a physician who specializes in the condition being treated (for example, an endocrinologist; nephrologist involvement required for chronic renal disease). Initial and renewal requests are subject to site‑of‑care management and, when billed under the medical benefit, administration is restricted to non‑hospital facility‑based locations unless a site‑of‑care exception is met.

Preferred product and formulary rules: Formulary rules prioritize Genotropin and Omnitrope as preferred products. For some formularies (Basic vs National Preferred/ACA Advantage) non‑preferred agents (e.g., Humatrope, Norditropin, Nutropin, Saizen, Zomacton, others) require prior trial of the preferred products before approval for pharmacy benefit requests.

Claim handling: Prior approval is required for HCPCS codes J2170, J2940, J2941, and Q0515 and authorizations are generally annual; pediatric authorization may be approved by nurse reviewers when documentation meets policy, adult requests are routed to specialty‑matched physician reviewers.

High-level thresholds & durations

Typical approval duration1 year for most indications

Serostim (HIV wasting) initial approval3 months (renewable)

Prior authorization frequencyAnnual prior authorization required (every 12 months)

HCPCS prior auth count4 codes requiring prior approval: J2170, J2940, J2941, Q0515

Specialist requirementPrescriber must be a specialist (endocrinologist) or in consultation with one

Initial Therapy Criteria

General Policy Statement / Prior Authorization

Prior authorization is required. Initial approvals are for 1 year unless otherwise noted. Prescriber must be a specialist in the condition being treated (e.g., pediatric endocrinologist or endocrinologist). Site-of-care requirements apply.

ALL of the following

Patient/provider has submitted a prior authorization request for somatropin, mecasermin, somapacitan or other listed growth hormone product (Genotropin, Omnitrope, Humatrope, Norditropin, Nutropin/Nutropin AQ, Saizen, Zomacton, Skytrofa, Ngenla, Sogroya)
Prescriber is a physician who specializes in the diagnosis and management of the condition being treated or therapy is prescribed in consultation with such a specialist
Specialist documentation (signature/consult note) must be included
Preferred Product Criteria have been applied for pharmacy benefit requests (e.g., Genotropin and Omnitrope preferred; exceptions documented)

Continuation / Renewal Criteria

1. Pediatric Growth Hormone Deficiency - Continuing Therapy

ALL of the following

One of (A,B,C)
- A: Patients < 12 years: height increased ≥ 2 cm/year in most recent year≥ 2 cm/yr
- B: Adolescents 12–18 years: height increased ≥ 2 cm/year in most recent year AND epiphyses open≥ 2 cm/yr
- C: Adolescents/young adults > 18 years: height increased ≥ 4 cm/year AND epiphyses open AND mid-parental height not attained

Unproven / Exclusions

Conditions Not Recommended for Approval (Exclusions)

Excluded/Not Recommended Conditions

Idiopathic Short Stature (ISS): Non-Growth Hormone Deficient Short Stature (Idiopathic Short Stature)
Constitutional Delay of Growth and Puberty (CDGP)
Acute critical illness due to complications following surgery, multiple accidental trauma, or acute respiratory failure (increased mortality in trials)
Aging/anti-aging: Aging / Anti-aging / Improve functional status in elderly / Somatopause

Applicable Codes

Products / covered drugs referencedNDC|mixedCovered

Genotropin	somatropin product listed as preferred
Omnitrope	somatropin product listed as preferred
Humatrope	somatropin
Norditropin	somatropin
Nutropin	somatropin
Nutropin AQ	somatropin
Saizen	somatropin
Zomacton	somatropin
Skytrofa	weekly human growth hormone product for pediatric patients ≥1 year and ≥11.5 kg
Ngenla	lonapegsomatropin (weekly GH)

1–10 of 15

1/2

Prior approval required HCPCSHCPCSCovered

J2170	Injection, mecasermin, 1 mg
J2940	Injection, somatrem, 1 mg
J2941	Injection, somatropin, 1 mg
Q0515	Injection, semorelin acetate, 1 microgram

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior approval is required for some or all procedure codes listed in this Corporate Drug Policy. Initial and renewal requests are subject to site-of-care management. Approvals are generally provided for 1 year unless otherwise noted.

Prior authorization required for selected HCPCS/CPT codes associated with somatropin, mecasermin, somapacitan and related products
Initial and renewal requests subject to site-of-care; see Site of Care Medical Necessity Criteria for exceptions
Typical approval duration: 1 year

Documentation Required

Specialist evaluation required

Because of the specialized skills required to evaluate and diagnose patients treated with growth hormone products and the monitoring required for safety and efficacy, initial prescriptions must be from or in consultation with an appropriate specialist.

Prescriber must be an endocrinologist for most growth hormone indications

Clinical Evidence & Diagnostic Thresholds

Clinical‑evidence and regulatory context: The document emphasizes that clinical use is grounded in FDA‑approved indications for specific somatropin products and for mecasermin (Increlex) for severe primary IGF‑1 deficiency. Federal law prohibits dispensing human growth hormone for non‑approved uses such as anti‑aging or athletic enhancement. The policy bases coverage on specified diagnostic and laboratory thresholds and requires specialist evaluation and involvement for initial and continuing therapy.

Specialist involvement and site‑of‑care management: Because diagnosis, monitoring, and adverse‑event management require specialized skills, initial approvals require a prescribing physician who specializes in the treated condition (endocrinologist; nephrologist for CKD), and therapy is subject to site‑of‑care management with restrictions on facility type for administration when billed to the medical benefit.

Operational controls: Prior authorization is required for designated HCPCS codes and requests are reviewed annually; pediatric approvals may be authorized by nurse reviewers when documentation meets policy criteria while adult requests are routed to specialty‑matched physician reviewers.

Diagnostic / biochemical numeric thresholds

Pediatric provocative test peak GHPeak GH response < 10 ng/mL (requirement: any 2 tests)

Adult insulin tolerance testPeak response ≤ 5.0 mcg/L

Background

Therapeutic context: Exogenous growth hormone (recombinant human growth hormone, rhGH) and recombinant IGF‑1 are peptides used to replace or supplement endogenous pathways to promote linear growth and to mediate metabolic effects. rhGH stimulates production of IGF‑1 and influences bone, cartilage, muscle and metabolic processes; rhIGF‑1 is the principal mediator of GH’s statural effects and is used when IGF‑1 production is inadequate.

FDA‑approved products (high level): The policy references multiple FDA‑approved somatropin products (examples include Genotropin, Humatrope, Norditropin, Nutropin/Nutropin AQ, Saizen, Omnitrope, Zomacton, Serostim, Zorbtive, Skytrofa, Ngenla, Sogroya) and the rhIGF‑1 product Increlex. Skytrofa and lonapegsomatropin (Ngenla) and somapacitan (Sogroya) are noted as longer‑acting or indication‑specific formulations.

Regulatory prohibition on non‑approved uses: The policy highlights that human growth hormone is FDA‑approved for a limited set of indications and that federal law prohibits dispensing GH for non‑FDA‑approved uses (for example, anti‑aging or performance enhancement).

Emphasis on specialist care and site‑of‑care: Given diagnostic complexity and monitoring requirements, prescribers must be specialists or consult with specialists, and site‑of‑care medical necessity criteria apply to initiation and reauthorization of therapy.

Epiphyses open: Radiographic confirmation that growth plates are not fused; this is required for pediatric therapy continuation and for some initial approvals in patients aged ≥10 years.

Mid‑parental height: Calculated as the father's height plus the mother's height divided by 2, then add 2.5 inches if the child is male or subtract 2.5 inches if the child is female; used to assess attainment of expected genetic target height for continuation decisions.

Note: These definitions are used in the policy to determine eligibility and continuation of pediatric growth hormone therapy and are part of the diagnostic and response documentation reviewers may request.

Appeals, Documentation & Claims Workflow

Prior Approval Requirements

ALL of the following

HCPCS codes: Prior approval is required for HCPCS Codes J2170, J2940, J2941 and Q0515
Children routing: Children (<17 years): prior approval required; requests may be authorized by a nurse reviewer if documentation meets Corporate Medical Policy criteria; prior approval required yearlyyearly
Adults routing: Adults (>18 years): prior approval required; requests forwarded to a specialty-matched physician reviewer; prior approval required yearlyyearly

Revision History

Policy Summary

Payermedical mutual - ohio

PolicySomatropin, mecasermin, somapacitan and related growth hormone products

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for some or all procedure codes listed; initial and renewal requests are subject to site-of-care management and approvals are generally provided for 1 year.

SourceLink

On This Page

Site of care requirements have been met or an approved exception documented

Preferred Product Criteria

Preferred product and formulary rules apply to initial therapy requests. For some formularies, non-preferred products require trial and failure of preferred agents or an exception.

ALL of the following

For pharmacy benefit requests, patient has trialed and failed (or has documented intolerance/contraindication to) the preferred products when required by the member's formulary (e.g., Genotropin and Omnitrope)
Document prior trials, dates, and reasons for discontinuation
If product is non-formulary on the member's plan (National Preferred/ACA Advantage), a covered formulary product must be used unless an exception is approved
Exceptions to preferred product requirements may be granted for clinical reasons; supporting documentation required

1. Pediatric Growth Hormone Deficiency - Initial Therapy

Approve for 1 year when ALL of the following A, B, C and D are met.

ALL of the following

A
- Patient's height is below the 3rd percentile for age and gender
- Growth velocity is subnormal (≥2 standard deviations below the age-related mean)
- Delayed skeletal maturation ≥2 standard deviations below the age/gender-related mean
B. Epiphyses are confirmed open in patients ≥10 years of age
C. Patient has been evaluated by an endocrinologist
D
- Growth hormone deficiency confirmed by any two provocative stimulation tests (e.g., levodopa, insulin-induced hypoglycemia, arginine, clonidine, glucagon); peak GH response <10 ng/mL. NOTE: one test that co-administers two agents counts as meeting this requirement
- Low IGF-1 and low IGFBP-3 levels consistent with GH deficiency
- For Ngenla requests: documentation of hypophysectomy resulting in inadequate GH secretion if other criteria are not met

2. Growth failure due to specific pediatric conditions (CRF, Noonan, Turner, SGA/IUGR including Silver-Russell, Prader-Willi)

Growth failure due to specific pediatric conditions is covered when criteria for the listed diagnosis are met and other general requirements (specialist evaluation, preferred product/site-of-care) are satisfied.

ANY of the following

Chronic Renal Failure (CRF): Growth failure due to chronic renal insufficiency or chronic renal failure; documentation of renal disease and growth impairment with specialist evaluation
Noonan syndrome: Diagnosis of Noonan syndrome with growth failure and endocrine assessment supporting GH therapy
Turner syndrome: Diagnosis of Turner syndrome with documented short stature and specialist recommendation for growth hormone therapy
Small for Gestational Age (SGA) / Intrauterine Growth Restriction (IUGR) including Silver-Russell syndrome: History of SGA/IUGR or Silver-Russell with persistent short stature not corrected by age and meeting accepted growth criteria per endocrinology
Prader-Willi syndrome: Diagnosis of Prader-Willi syndrome with growth failure; must meet syndrome-specific safety monitoring and specialist management requirements

3. Adult Growth Hormone Deficiency (Initial Therapy)

Adult GHD initial therapy: approve for 1 year when diagnosis and biochemical testing requirements met.

ALL of the following

Diagnosis consistent with adult growth hormone deficiency (e.g., pituitary disease, hypothalamic disease, multi‑hypopituitarism, prior cranial irradiation, traumatic brain injury)
Testing requirements
- Documentation of two provocative GH stimulation tests showing peak GH below the laboratory/assay-specific threshold for adult GHD
- OR documented low IGF-1 level in the context of proven hypothalamic-pituitary disease and multiple pituitary hormone deficiencies (one test may be acceptable as per endocrinology guidance)
Prescribed by or in consultation with an endocrinologist
Preferred product and site-of-care requirements met

4. SHOX deficiency in children/adolescents

Initial therapy approval (children/adolescents) — approve for 1 year when ALL A–E are met.

ALL of the following

A. Diagnosis of SHOX deficiency confirmed by appropriate genetic testing (SHOX gene mutation/deletion)
B. Short stature or growth failure documented by growth parameters and endocrinology assessment
C. Epiphyses are open
D. Prescribed by or in consultation with a pediatric endocrinologist
E. Preferred product and site-of-care requirements met

5. HIV-associated wasting/cachexia (Serostim)

Initial approval for HIV-associated wasting/cachexia (Serostim) — approve up to 3 months when ALL A–F are met.

ALL of the following

A. Documented diagnosis of HIV-associated wasting or cachexia with clinically significant involuntary weight loss or failure to gain weight
B. Other reversible causes of weight loss have been evaluated and addressed
C. Baseline weight and weight loss documentation provided
D. Therapy prescribed by or in consultation with an infectious disease specialist or endocrinologist experienced in HIV care
E. Documentation of planned duration (initial trial up to 3 months) and monitoring plan for adverse effects
F. Preferred product and site-of-care requirements met

6. Severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies (Increlex)

Initial therapy approval for severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies (mecasermin/Increlex) — approve for 1 year when ALL A–I are met.

ALL of the following

A. Diagnosis of severe primary IGF-1 deficiency (SPIGFD) or documented GH gene deletion with neutralizing antibodies to GH
B. Height is ≤-3 standard deviations for age and gender or growth failure meeting specialist criteria
C. Low serum IGF-1 levels appropriate for age and sex
D. Evidence that recombinant GH therapy is ineffective or contraindicated (e.g., neutralizing antibodies to GH)
E. Care provided by or in consultation with a pediatric endocrinologist
F. Baseline assessments completed (e.g., glucose tolerance, IGF-1, growth measurements) and monitoring plan in place
G. Counseling provided regarding hypoglycemia risk with mecasermin and caregiver education documented
H. Preferred product and site-of-care requirements met
I. For continuation, demonstrate clinical benefit per established criteria

7. Short Bowel Syndrome (Zorbtive and selected GH products)

Initial approval for short bowel syndrome (Zorbtive and selected GH products) — approve up to 4 weeks when ALL A–C are met.

ALL of the following

A. Documented diagnosis of short bowel syndrome with clinical malabsorption requiring parenteral support
B. Therapy prescribed by or in consultation with a gastroenterologist or specialist experienced in short bowel management
C. Site-of-care and preferred product requirements met; documentation of planned short-term use (up to 4 weeks) and monitoring

Mid-parental height calculation as defined

D: Preferred Product Criteria must be met (pharmacy benefit requests)

E: Site of care criteria must be met

Approval Duration: Approve for 1 year when criteria met1 year

Context: Applies to patients established on therapy ≥ 10 months≥ 10 months

2. Continuation criteria for Growth failure in specified pediatric conditions

Continuation specifics: Continuation renewable in presence of open epiphyses and growth response of 4.5 cm/yr (prepubertal) or 2.5 cm/yr (post-pubertal); Prader-Willi renewable with increase in lean body mass or decrease in fat mass4.5 or 2.5 cm/yr

3. Adult/Transition - Continuing Therapy

ALL of the following

Established therapy: Patient established on somatropin/somapacitan/lonapegsomatropin for ≥ 10 months≥ 10 months
A: Diagnosis of GHD (childhood-onset or adult-onset as defined)
B: Patient evaluated by an endocrinologist or in consultation with an endocrinologist
C: Physician certifies somatropin not used for anti-aging or athletic enhancement/body building
D: Site of care criteria must be met
Approval Duration: Approve for 1 year when A-D are met and reassessed every 12 months1 year

Diagnostic testing (adults) reference: Continuing criteria rely on prior demonstration of GHD per adult diagnostic thresholds as specified in testing criteria

SHOX - Continuation

ALL of the following

A: Benefit approved for 1 year if patient's height increased ≥ 2.5 cm/yr in most recent year≥ 2.5 cm/yr
B: Epiphyses are open
C: Site of care criteria must be met
Approval Duration: Approve for 1 year when A-C are met1 year

Context: Applies to SHOX deficiency continuation

5. HIV-associated wasting - Continuation

ALL of the following

A: Benefit renewable for 3 months in presence of weight stabilization or increase3 months
B: Patient has been off therapy for at least 1 month before renewal≥ 1 month
C: Site of care criteria must be met

Context: Applies to Serostim (HIV-associated wasting) continuation

6. Increlex continuation

ALL of the following

A: Open epiphyses and growth response of 4.5 cm/yr (prepubertal) or 2.5 cm/yr (post-pubertal)4.5 cm/yr or 2.5 cm/yr
B: Site of care criteria must be met
Approval Duration: Benefit approved for 12 months and renewable with response12 months

Applicability: Applies to Increlex continuation for severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies

7. Short bowel - Continuation

ALL of the following

Renewal criterion: Benefit renewable for 1 month when patient is deriving clinical benefit (e.g., decrease in IV nutrition requirements)1 month
Site of care criteria must be met

Context: Applies to Short Bowel continuation (Zorbtive and selected GH products)

Measurable continuation & baseline thresholds

Pediatric general continuing velocityHeight increase ≥ 2 cm/year (children & adolescents criteria)

Pediatric continuation — specified conditionsGrowth response ≥ 4.5 cm/yr (prepubertal) or ≥ 2.5 cm/yr (post‑pubertal) for SGA/Turner/Noonan/CKD

SHOX continuationHeight increase ≥ 2.5 cm/yr (SHOX continuation)

Increlex baseline requirementBaseline height SDS ≤ -3.0 for Increlex initiation

Adult stimulation test thresholdsInsulin tolerance ≤ 5.0 mcg/L; glucagon ≤ 3.0 mcg/L (BMI ≤25) or ≤1.0 mcg/L (BMI >25); arginine ≤ 0.4 mcg/L; macimorelin < 2.8 ng/mL

HIV wasting criteriaUnintentional weight loss ≥ 10% OR weight ≤ 90% of lower limit ideal body weight OR BMI ≤ 20 kg/m2

Athletic enhancement: Athletic ability enhancement / body building / performance enhancement

Bony dysplasias (e.g., achondroplasia, hypochondroplasia) — not recommended outside research

Extensive burn injury (children/adults) — evidence limited; high-dose GH in critically ill non-burn patients associated with harm

Cardiac transplantation — limited information; recommend study enrollment

Central precocious puberty — insufficient evidence for combination therapy efficacy/safety

Chronic fatigue: Chronic Fatigue Syndrome

Corticosteroid-induced short stature — not routinely recommended; consider study enrollment

Crohn's disease — insufficient long-term evidence for final adult height benefit

Cystic fibrosis: Cystic Fibrosis — modest short-term gains; insufficient evidence for lung function/long-term benefit

Dilated cardiomyopathy/heart failure: Dilated cardiomyopathy and heart failure — no demonstrated benefit except with pre-existing deficiency

Down syndrome: Down's Syndrome — short-term growth acceleration observed but no prospective studies to assess final adult height

Coverage note: Coverage not recommended for circumstances not listed in Recommended Authorization Criteria; criteria updated as new data available

Excluded/Not Recommended Conditions — explanation: The policy lists multiple conditions for which somatropin (and related products) are not recommended because available evidence does not support a demonstrated long‑term clinical benefit or safety. These exclusions include, but are not limited to, Crohn’s disease (no demonstrated improvement in final adult height in children and limited adult data), cystic fibrosis (modest short‑term gains in height/weight without consistent lung function or quality‑of‑life benefit), and dilated cardiomyopathy or heart failure in patients without pre‑existing GHD (randomized trials have not shown benefit).

Down syndrome and growth: Children with Down syndrome may have short‑term growth acceleration with somatropin, but there are no prospective studies assessing effects on final adult height; therefore the policy does not recommend routine approval.

Obesity and metabolic indications: Somatropin is not recommended for treatment of obesity in persons without GHD; low GH is a consequence of obesity and somatropin has not shown significant long‑term weight loss or benefit and long‑term safety is unknown.

Osteoporosis and bone disorders: Somatropin is not included in guidelines for osteoporosis and trial data are inconclusive regarding fracture outcomes; few and short‑term studies in osteogenesis imperfecta or X‑linked hypophosphatemic rickets show limited or uncertain long‑term benefit and these uses are not routinely recommended pending further data.

Congenital adrenal hyperplasia (CAH) guidance: The Endocrine Society recommends against routine GH use for most children with CAH due to steroid 21‑hydroxylase deficiency; growth‑promoting treatments may only be considered in controlled trials for children with predicted adult height SD ≤ -2.25.

General statement: The policy explicitly states that coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; uses not enumerated in the authorization criteria are considered not recommended pending new published evidence and criteria updates.

For growth failure related to chronic kidney disease (CKD), prescriber may be a nephrologist

Documentation Required

Diagnostic testing documentation

Providers must retain and provide documentation to support clinical necessity when requested. Required diagnostic testing and documentation for initial requests include the following.

Provocative growth hormone stimulation test results (two tests or one combined test as allowed by policy) with peak GH values noted
Serum IGF-1 level and IGFBP-3 when indicated
Assessment of bone age / epiphyseal status (radiographic documentation)
Growth velocity data and baseline height percentiles for age and gender

Billing Rule

Site of care restriction

When billed under the medical benefit, administration of the medication is restricted to non-hospital facility-based locations unless the member meets site-of-care exception criteria.

Allowed locations under medical benefit: home infusion provider, provider office, free-standing ambulatory infusion center
Hospital outpatient administration requires meeting site-of-care exception criteria

Step Therapy

Formulary preferred products

The plan requires trial of formulary preferred products prior to coverage of non-preferred somatropin products for pharmacy benefit requests; formularies vary by plan.

Required trial of preferred products: Genotropin and Omnitrope (exceptions per formulary rules)
Basic Formulary: may require trial of both Genotropin and Omnitrope prior to approving non-preferred products
National Preferred/ACA Advantage Formulary: non-formulary products require use of a covered formulary product (Genotropin or Omnitrope) prior to approval

Denial Risk

Exclusionary uses

Certain uses are considered exclusionary and are high risk for denial. The FDA has not approved human growth hormone for anti-aging, athletic performance enhancement, or many other non-approved indications.

Denial likely for anti-aging, longevity, cosmetic, or athletic enhancement uses
Idiopathic short stature (ISS) without meeting specific criteria is typically not covered
Constitutional delay of growth and puberty (CDGP) and many other non-GHD conditions without objective diagnostic criteria are exclusionary

Documentation Required

Continuation evidence required

Continuation/renewal requests require submission of evidence demonstrating ongoing benefit and safety. Providers should include clinical measurements and other condition-specific data on renewal requests.

Growth response thresholds: e.g., ≥2 cm/year for children <12 years or ≥4 cm/year for certain older adolescents as specified in policy
Documentation of open epiphyses when required for continuation
For Prader–Willi syndrome: documentation of increased lean body mass and other syndrome-specific monitoring
Preferred product/formulary criteria must be met for pharmacy benefit renewals
Provide any additional requested clinical records promptly upon insurer request

Prior Authorization

Prior authorization required for specified HCPCS

Prior authorization is required for specified HCPCS/administration codes; review routing may differ for pediatric versus adult requests and annual PA requirements apply.

Affects HCPCS: J2170, J2940, J2941, Q0515 (verify codes on claim)
Pediatric reviews may be routed to pediatric specialty review; adult reviews to adult specialty review
Annual prior authorization required for continued coverage

Billing Rule

Claims editing, documentation on request, write-off and appeals

Operational and claims-related requirements: providers must supply documentation on request; claims are subject to editing and adjudication rules; non-covered services should be written off; appeals follow standard payer processes.

Provide supporting clinical documentation upon request to substantiate medical necessity
Claims are subject to coding edits and adjudication per payer rules; ensure correct benefit (medical vs pharmacy) and HCPCS/NDC coding
If a service or supply is non-covered, providers should not balance-bill members and may need to write off non-covered charges per contract
Denied or partially paid claims may be appealed following the payer's standard appeals routing and timelines

Glucagon stimulation test

Peak response ≤ 3.0 mcg/L (BMI ≤25) or ≤ 1.0 mcg/L (BMI >25)

Arginine alone testPeak response ≤ 0.4 mcg/L (when ITT and glucagon contraindicated)

Macimorelin (Macrilen) testPeak response < 2.8 ng/mL (and BMI ≤ 40 kg/m2)

Increlex baseline SDSHeight SDS ≤ -3.0 required for initiation

Pediatric velocity numeric thresholdsGeneral ≥ 2 cm/yr; prepubertal ≥ 4.5 cm/yr; post‑pubertal ≥ 2.5 cm/yr

HIV wasting numeric definitionsUnintentional weight loss ≥10% OR weight ≤90% of lower limit ideal body weight OR BMI ≤20 kg/m2

SHOX diagnostic numericBaseline height < 3rd percentile and continuation ≥ 2.5 cm/yr

Reviewer requirement: Requests for members >18 years must be reviewed by a specialty-matched physician consultant

Applicability: Prior approval frequency: annual for covered HCPCS; routing differs for children vs adults as describedannual

Edits and Claims Adjudication

ALL of the following

Claims edits: Claims with HCPCS Codes J2170, J2940, J2941 and Q0515 will edit with Remark Code M3M or M4M and be adjudicated per Corporate Medical Policy
Legacy treatment grandfathering: If a course of treatment was initiated prior to April 1, 2009 for idiopathic short stature or constitutional delayed growth, members currently taking growth stimulating drugs will continue to receive benefits based on reimbursement policies in place at the time the course of treatment was approved

Note: Adjudication performed in accordance with Corporate Medical Policy

Appeals and Review Workflow

ALL of the following

Children appeals: Children (<17 years): appeals may be approved by a nurse reviewer if documentation meets policy; otherwise forwarded to Chief Medical Officer or specialty matched physician consultant
Adult appeals: Adults (>18 years): appeals forwarded to Chief Medical Officer or specialty-matched physician reviewer
Liability: Participating providers must write off charges denied as not medically necessary

Process note: Appeals routing differs by age and may escalate to physician-level review as specified

Documentation Requirements

ALL of the following

Documentation that may be requested: Company may request patient records, test results (provocative GH stimulation tests, IGF-1, IGFBP-3), bone age/epiphyseal status, growth velocity, baseline height percentiles, and provider credentials
Consequences: Company may deny reimbursement when services are not medically necessary, investigational/experimental, not within member benefits, or when a pattern of inappropriate/excessive billing is identified
Availability: Additional documentation supporting medical necessity must be made available upon request

Policy discretion: Company reserves right to request additional documentation and to modify, revise, change, apply and interpret this policy at its sole discretion