Criteria for Prior Authorization — Growth Hormone Agents
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Defines prior authorization requirements for pediatric and adult growth hormone therapy, including indication-specific clinical criteria, dosing limits, prescriber qualifications, and renewal conditions for KDHE members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Growth Hormone Therapy
inv-01: General pediatric initiation — ALL must be met
General criteria for initiation of growth hormone in children (ALL must be met):
inv-02: Pediatric GHD — must meet ALL of the following groups
Pediatric Growth Hormone Deficiency (GHD) — must meet ALL of the following groups:
inv-03: Newborn GHD — must meet all criteria
Growth hormone deficiency in newborns (must meet all):
inv-04: CKD-related growth failure — must meet all criteria
Growth failure secondary to chronic kidney disease (must meet all):
inv-05: Turner syndrome — must meet all criteria
Turner syndrome (must meet all):
inv-06: Noonan syndrome — must meet all criteria
Noonan syndrome (must meet all):
inv-07: Prader-Willi syndrome — must meet all criteria
Prader-Willi syndrome (must meet all):
inv-08: Small for gestational age (SGA) — must meet all criteria
Small for gestational age (SGA) (must meet all):
inv-09: SHOX deficiency — must meet all criteria
SHOX deficiency (must meet all):
inv-10: Adult GHD and approved adult indications — general initial criteria (ALL must be met)
General criteria for initial prior authorization for growth hormone in adults (must meet all):
inv-11: Initial Therapy — Covered when ALL of the following are met for initial authorization
Covered when ALL of the following are met for initial authorization:
Initial PA main criteria
- Prescriber and PDL: Prescribed by or in consultation with an endocrinologist; preferred PDL drug required unless non-preferred PDL PA criteria are met
chunk 18
- Diagnostic criteria: Diagnosis of at least one condition in Table 3 AND IGF-1 < -2.0 SDS AND GH stimulation test meeting one of the numeric cutoffs (insulin tolerance ≤5 mcg/L; glucagon ≤3 mcg/L for BMI<25 or ≤1 mcg/L for BMI≥25; macimorelin ≤2.8 mcg/L).IGF-1 < -2.0 SDS; GH cutoffs as specified
chunks 18,19,20
inv-12: Continuation/Renewal Therapy — Renewal covered when ALL of the following are met
Renewal covered when ALL of the following are met:
inv-13: Not Medically Necessary / Administrative Exclusion — 1 top-level node
Administrative denial
Prior authorization is required for all current and future dose forms of the listed growth hormone agents. For pediatric requests, the preferred PDL drug that covers the indication must be used when applicable unless the patient meets the non-preferred PDL prior authorization criteria. Pediatric approvals must meet the general initiation requirements including indication, age/epiphyseal status, prescriber specialty, baseline endocrine evaluations, and dosing limits in Table 2.
Growth hormone treatment when requested for the diagnosis of idiopathic short stature (ISS) is not considered medically necessary and is not covered under the Pharmacy benefit. This is an administrative denial and the review is not based on medical necessity.
Requests that propose pediatric dosing above the limits specified in Table 2 will require clinical justification. Per the renewal criteria, dose increases above Table 2 must include supporting clinical rationale and documentation of ≥90% adherence in the prior year; absent adequate justification and documentation, such requests may be denied.
Use of growth hormone for the purpose of diagnosing or treating idiopathic short stature (ISS) is explicitly excluded: ISS is not considered medically necessary and is not covered under the Pharmacy benefit (administrative denial).
Dosing Limits and Clinical Thresholds
Provider Requirements, Documentation, and Denial Risks
Prior authorization required for all GH agents; PDL preference
Prior authorization is required for all current and future dose forms of the listed growth hormone agents; pediatric drug-specific indications and doses are defined in Table 1 and dosing limits in Table 2. The preferred PDL drug that covers the indication is required when applicable unless the patient meets non-preferred PDL prior authorization criteria.
Product-specific prior authorization for adults
Adult requests must be for one of the approved products: Omnitrope®, Humatrope®, Norditropin®, Nutropin®, Saizen®, Genotropin®, Sogroya® or Zomacton®; include this product selection on the PA request.
Initial PA: endocrinologist involvement and diagnostic documentation
Initial prior authorization for growth hormone requires that the request be prescribed by or in consultation with an endocrinologist, include a qualifying diagnosis (see Table 3), and document IGF-1 < -2.0 SDS plus GH stimulation test results that meet the specified numeric cutoffs.
Preferred product required when available
Use the preferred PDL drug that covers the indication when available; a non-preferred PDL agent will only be approved if the patient meets the non-preferred PDL prior authorization criteria.
Preferred drug required when available
Prescribers must use the preferred PDL drug when it is applicable to the indication; non-preferred agents require meeting the non-preferred PDL PA criteria for approval.
Pediatric GH renewal documentation requirements
For pediatric renewal, submit history and physical and a growth curve from a pediatric endocrinologist dated within 6 months, documentation of catch-up growth unless at target height percentile, and that the member's growth rate is ≥ 2 cm/year (or clinical justification for lack of efficacy).
- History and physical and growth curve from pediatric endocrinologist dated within 6 months of request
- Documented catch-up growth unless at target height percentile
- Member's growth rate ≥ 2 cm/year or documented clinical reason for lack of efficacy
Baseline endocrine and testing documentation
Baseline clinical documentation must include guideline-recommended evaluations such as assessment of the adrenal and thyroid axes; for adults include baseline QoL-AGHDA score and IGF-1 and GH stimulation test results.
- Assessment and addressing of adrenal and thyroid axes as appropriate
- Baseline QoL-AGHDA score (adults)
- IGF-1 and GH stimulation test results
Required documentation and prescriber specialty
The prescriber must be an endocrinologist or document consultation with an endocrinologist and submit IGF-1 results, GH stimulation test results meeting specified numeric cutoffs, and a diagnosis consistent with Table 3.
- Prescribed by or in consultation with an endocrinologist
- Submit IGF-1 results and GH stimulation test results (e.g., insulin tolerance ≤5 mcg/L; glucagon ≤3 mcg/L BMI<25 or ≤1 mcg/L BMI≥25; macimorelin ≤2.8 mcg/L)
- Provide diagnosis consistent with Table 3 and QoL-AGHDA (if applicable)
Denial risk: unmet pediatric initiation criteria
Requests for pediatric initiation that do not meet the general pediatric initiation criteria — including patient age/epiphyseal status, prescriber qualification, required baseline evaluations, dosing limits, or indication-specific criteria — are subject to denial.
Denial risk: unmet adult initiation criteria
Adult requests lacking required endocrinologist involvement, a qualifying diagnosis, IGF-1 < -2.0 SDS, and a GH stimulation test meeting the numeric cutoffs risk denial.
ISS (idiopathic short stature) is not covered
Use of growth hormone for the diagnosis of idiopathic short stature (ISS) is not considered medically necessary and is not covered under the Pharmacy benefit; such requests are administratively denied.
Background and Context
Growth hormone therapy is used in both pediatric and adult populations for confirmed growth hormone deficiency and several genetic or syndromic short-stature conditions. Diagnostic evaluation typically includes auxologic assessment, recent linear growth parameters, assessment of IGF-1 and, when indicated, provocative GH stimulation testing; baseline assessment of the adrenal and thyroid axes is required. Pediatric requests must be evaluated by a pediatric endocrinologist (or a pediatrician limiting practice to pediatric endocrinology) and meet indication-specific criteria and dosing limits.
Definitions and Test Cutoffs
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