Growth hormone (somatropin) therapy reimbursement
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Defines UHA reimbursement criteria, prior authorization requirements, limitations, monitoring, and continuation rules for growth hormone (somatropin) therapy for pediatric and adult indications.
No material clinical or coverage changes in this revision.
Coverage Criteria for Growth Hormone (Somatropin)
Coverage Criteria by Indication
Initial therapy is covered for the pediatric and adult indications listed below when the specified biochemical, auxologic/radiologic, and clinical criteria are met. Continuation of therapy requires documented response and adherence to monitoring requirements.
ALL of the following
Pediatric: Growth Hormone Deficiency (GHD) - Biochemical criteria (ANY of the following):
- Documentation of abnormal responses to two GH stimulation tests, defined as <10 ng/mL (or laboratory-defined cutoff).
- At least one GH stimulation test <15 ng/mL AND both IGF-1 and IGFBP-3 levels below normal for age and gender.
- One GH stimulation test <10 ng/mL in the setting of defined CNS pathology, history of cranial irradiation, or genetic conditions associated with GHD.
- Two or more documented pituitary hormone deficiencies (other than GH).
- Abnormally low GH level documented in association with neonatal hypoglycemia.
Pediatric: Growth Hormone Deficiency - Auxologic/radiologic criteria (ALL of the following as applicable):
- Height ≤ -2 standard deviations for age and gender; OR height ≤ -1 SD with growth velocity ≤ -1 SD for age and gender.
- Either: (A) minimum of one year of growth data with measurements ≥6 months apart performed by an endocrinologist; OR (B) four or more height determinations measured ≥6 months apart by the primary care physician over at least two years demonstrating a consistent growth pattern.
- Radiologic documentation of open growth plates in patients over 12 years of age (when applicable).
Pediatric: Idiopathic/familial short stature or SGA with failure of catch-up growth by age 2 (ALL):
- Height ≤ -2.25 standard deviations for age and gender measured per auxologic criteria above.
- Growth velocity ≤ -1 SD for age and gender measured per auxologic criteria above.
- Radiologic documentation of open growth plates in patients over 12 years of age (when applicable).
Pediatric: Turner, Noonan, or Prader‑Willi syndromes (ALL):
- Radiologic documentation of open growth plates in patients over 12 years of age (when applicable).
- Height below the 10th percentile for age.
Pediatric: Chronic renal insufficiency (ALL):
- Creatinine clearance ≤75 mL/min/1.73 m2 OR serum creatinine >3.0 mg/dL OR dialysis dependence.
- Radiographic documentation of open growth plates in patients over 12 years of age (when applicable).
Pediatric: AIDS wasting (ALL):
- Greater than 10% of baseline weight loss unexplained by concurrent illness other than HIV infection.
- Concurrent treatment with antiviral agents.
Pediatric: Burn patients (ANY of the following):
- Extensive third-degree burns.
- Burns ≥40% total body surface area.
Pediatric: Short bowel syndrome (ALL):
- Receiving specialized nutritional support.
- Optimal medical/nutritional management of short bowel syndrome.
ALL of the following
- Measure serum IGF-1 two months after starting therapy to assess adequacy of treatment (no prior authorization required).
- Once IGF-1 is in normal range, repeat testing every 6 to 12 months (no prior authorization required).
Limitations and Administrative Requirements
Coverage is subject to authorization durations, exclusions, and administrative requirements described below.
ALL of the following
- Initial authorization: up to 12 months for indications meeting criteria; exception — burn patients: initial authorization up to 4 weeks.
- Continuation: may be approved in 12-month increments for many pediatric and adult indications with documentation (e.g., growth velocity ≥2 cm/year, open growth plates if >12 years, and height less than fifth percentile of normal adult height where specified).
- Continuation NOT approved: burn patients, AIDS wasting, and short bowel syndrome do not meet criteria for ongoing (continuation) authorization.
ALL of the following
- Therapy is covered only for listed indications when all specific criteria are met; uses outside these indications or without required documentation are excluded.
ALL of the following
- Serum IGF-1 testing at two months after initiation and every 6–12 months thereafter when normalized is covered and does not require prior authorization.
ALL of the following
- Prior authorization is required for GH therapy; requests must be submitted via UHA's online portal. If login has not been established, contact UHA at 808-532-4000 to establish one.
- Initial and continuation authorizations are issued per the durations and documentation requirements specified above; some indications have specific administrative restrictions on continuation (see authorization durations and continuation restrictions).
Coding and Diagnostic Thresholds
| J2941 | Injection, somatropin, 1 mg |
Prior Authorization, Billing, and Authorization Durations
Prior authorization required — submission and billing details
Prior authorization is required for growth hormone (somatropin) therapy. Submit requests through UHA's online portal; if you do not have a login, call UHA at 808-532-4000 to establish one. Use HCPCS code J2941 (Injection, somatropin, 1 mg) when billing; include applicable NDC when required.
- Submit prior authorization requests via UHA online portal.
- To establish a portal login, contact UHA at 808-532-4000.
- Billing code: J2941 (Injection, somatropin, 1 mg); include NDC as applicable.
Authorization durations and continuation restrictions
Initial authorizations vary by indication: up to 12 months for most indications and up to 4 weeks for burn patients. Continuation approvals are issued in 12-month increments for applicable indications and require current documentation of clinical response (e.g., growth velocity ≥2 cm/year, open growth plates for children >12 years, and height criteria); continuation is not approved for burn patients, AIDS wasting, or short bowel syndrome.
- Initial authorization: up to 12 months for most indications; burn patients: initial authorization up to 4 weeks. [[CITATION]]
- Continuation: approved in 12-month increments with documentation such as growth velocity ≥2 cm/year, open growth plates if >12 years, and height <5th percentile of normal adult height where specified.
- Continuation not approved for burn patients, AIDS wasting, and short bowel syndrome.
Definitions
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