Triptodur® (triptorelin) (Intramuscular) — Coverage Criteria
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Defines Viva Health prior authorization, dosing, indications, renewal, billing codes, and clinical criteria for Triptodur® (triptorelin) intramuscular 6-month formulation for members, including pediatric central precocious puberty and gender dysphoria indications.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Therapy — Central Precocious Puberty (CPP)
Covered when ALL of the following are met
Initial Therapy — Gender Dysphoria
Covered when ALL of the following are met
Continuation / Renewal Criteria
Renewal authorization provided when ALL of the following are met
For Central Precocious Puberty (CPP) initial authorization, Triptodur must not be used in combination with growth hormone. This exclusion is a required element of the CPP initial-therapy criteria and claims that include concurrent growth hormone for CPP initial approval do not meet the coverage criteria.
The policy lists ICD-10 diagnosis codes in Appendix 1 for covered indications. Note that F64.9 (Gender identity disorder, unspecified) is identified in the appendix as Discontinued effective 10/1/26 and therefore is not retained as a continuing code after that date.
Coding and Billing
| J3316 | Injection, triptorelin, extended-release, 3.75 mg; 1 billable unit = 3.75 mg |
| 24338-0150-xx | Triptodur 22.5 mg single-use kit NDC |
| E30.1 | Precocious puberty |
| E30.8 | Other disorders of puberty |
| F64.0 | Transsexualism |
| F64.1 | Dual role transvestism |
| F64.2 | Gender identity disorder of childhood |
| F64.8 | Other gender identity disorders |
| F64.9 | Gender identity disorder, unspecified (Discontinued effective 10/1/26) |
| F64.A | Gender identity disorder, in remission (Effective 10/1/26) |
Provider Actions and Prior Authorization
Obtain prior authorization (initial 12 months)
Prior authorization is required for Triptodur; initial PA validity will be provided for 12 months (365 days) and may be renewed every 12 months (365 days) thereafter.
PA may be required per NQTL factors
Prior authorization may be required based on the indication and cost considerations identified in the NQTL checklist; utilization review (including PA) may be applied as part of those processes.
NQTL rationale — PA due to cost/indication
Prior authorization is applied as a utilization management non-quantitative treatment limitation (NQTL) primarily because the drug's indication and cost were considered; no specific step-therapy sequence is specified in this document.
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Submit required clinical documentation with PA
For initial authorization include documentation of the member's age and clinical findings (e.g., onset of secondary sexual characteristics, pubertal LH response to GnRH stimulation, advanced bone age), confirmation of diagnosis by the appropriate specialists (qualified MHP for gender dysphoria; pediatric endocrinologist for CPP/adolescents), and diagnostic testing to rule out tumors (brain imaging, pelvic/testicular/adrenal ultrasound, and hCG levels).
- Age and pubertal staging (e.g., Tanner stage, onset of secondary sexual characteristics)
- Pubertal LH response to GnRH stimulation and sex steroid levels
- Bone age assessment (advanced >2 SD for CPP)
- Tumor exclusion testing: brain imaging, pelvic/testicular/adrenal ultrasound, hCG levels
- Specialist confirmation: pediatric endocrinologist for CPP/adolescents; qualified MHP for gender dysphoria
Follow Medicare Part B coverage determinations when applicable
Medicare Part B coverage rules may apply; comply with CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) where applicable and use the CMS coverage database link provided for reference.
- Search NCD/LCD/LCA documents at https://www.cms.gov/medicare-coverage-database/search.aspx
- Follow applicable Medicare coverage and billing guidance for outpatient (Part B) drugs
Monitor for toxicity — may cause renewal denial
Renewal may be denied if the member experiences unacceptable toxicity from the drug; examples include psychiatric events, convulsions, severe cutaneous adverse reactions (e.g., SJS/TEN, DRESS, AGEP), or signs/symptoms of pseudotumor cerebri/idiopathic intracranial hypertension.
- Psychiatric events (emotional lability, irritability, anger, aggression)
- Convulsions
- Severe cutaneous adverse reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis, DRESS, AGEP)
- Signs/symptoms of pseudotumor cerebri / idiopathic intracranial hypertension (headache, papilledema, blurred vision, diplopia, vision loss, eye pain, tinnitus, dizziness, nausea)
Expect utilization management per NQTLs
Prior authorization may be applied because the NQTL checklist identified the drug's indication and cost as considerations; utilization management (including PA) is applied comparably to MH/SUD and medical/surgical drugs.
Initial Therapy
Initial Therapy
Initial authorization is provided when indication-specific clinical criteria are met (see respective criteria sets).
Continuation Therapy
Continuation Therapy
Renewal/continuation requires ongoing clinical benefit and absence of unacceptable toxicity.
Step Therapy
| Step | Requirement / Notes | Coverage Label |
|---|---|---|
| 1 | No specific step therapy sequencing is defined in this policy document. Instead, utilization management is applied via prior authorization as a non‑quantitative treatment limitation (NQTL), primarily driven by drug cost considerations as described in Appendix A. | |
| Prior authorization may be required to determine medical necessity and appropriate specialist documentation; the policy applies utilization review comparably to MH/SUD and M/S drugs. | ||
| Providers should submit required clinical documentation (age, pubertal staging, diagnostic testing, specialist confirmation, and tumor exclusion when applicable) with PA requests per the policy's documentation requirements. |
Quantity Limits and Dosing
Site of Care
Office administration and dosing interval
Administered by a healthcare provider as a single intramuscular injection once every 24 weeks (22.5 mg per dose).
Medicare site-of-care billing considerations
Medicare Part B rules and any applicable Local Coverage Determinations/Articles may affect site-of-care billing and coverage for outpatient (Part B) drugs; consult CMS guidance and local contractor policies.
Background
Triptodur (triptorelin) is a six-month extended-release gonadotropin-releasing hormone (GnRH) agonist formulated for intramuscular administration to suppress pubertal progression. It is indicated in this policy for treatment of central precocious puberty (CPP) and for pubertal suppression in adolescents with gender dysphoria, with clinical assessment and diagnostic confirmation required prior to initiation.
Definitions
Medicare Local Coverage and Contractors
Medicare coverage documentation
Medicare Part B coverage rules may apply; compliance with applicable NCDs, LCDs, and LCAs is required and CMS coverage documents can be searched at the CMS coverage database link provided.
- https://www.cms.gov/medicare-coverage-database/search.aspx
Medicare Part B coverage rules and Local/National Coverage Determinations may apply to outpatient drugs. Appendix 2 directs users to the CMS coverage database (https://www.cms.gov/medicare-coverage-database/search.aspx) and lists Medicare Administrative Contractor (MAC) jurisdictions and contractors by jurisdiction identifiers and covered states. Examples include National Government Services, Inc., Noridian Healthcare Solutions, LLC, Wisconsin Physicians Service Insurance Corp (WPS), Novitas Solutions, Inc., First Coast Service Options, Inc., Palmetto GBA, and CGS Administrators, LLC, among others; providers should consult the CMS database and the listed MACs for jurisdiction-specific billing and coverage guidance.
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