CurrentmhnPolicy CP.PHAR.203

Clinical Policy: Cosyntropin (Cortrosyn)

Policy governing medical necessity and coverage criteria for cosyntropin (Cortrosyn) when used as a diagnostic agent for screening adrenocortical insufficiency in adult and pediatric members; applies to providers submitting prior authorization for affiliated health plans.

Policy Summary

Payermhn

PolicyClinical Policy: Cosyntropin (Cortrosyn)

Policy CodePolicy CP.PHAR.203

Change TypeDose and generic redirection updates

Effective DateApr 1, 2016

Next Review Date

Key ActionProvider must submit supporting documentation (office chart notes, lab results, or other clinical information) demonstrating that the member meets all approval criteria for diagnostic testing of adrenocortical insufficiency.

SourceLink

POLICY UPDATE CHANGES

Added generic redirection for Cortrosyn requests (prefer generic cosyntropin unless contraindicated or adverse effects experienced).

Modified dosing limits for pediatric patients younger than or equal to 2 years to 0.125 mg and for patients 2 years and older to 0.25 mg as a single dose per updated prescribing information.

Added Commercial line of business to applicability.

0.25 mgstandard adult & pediatric ≥2y dose

0.125 mgpediatric <2y dose

Single doseapproval duration

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Coverage Criteria for Diagnostic Cosyntropin (Cortrosyn)

Initial Approval — Presumed Adrenocortical Insufficiency

Covered when ALL of the following are met:

Presumed Adrenocortical Insufficiency: 1) Prescribed for diagnostic testing of adrenocortical insufficiency; 2) If Cortrosyn is requested, member must use generic cosyntropin unless contraindicated or clinically significant adverse effects are experienced; 3) Dose does not exceed a single dose as follows: if age < 2 years: 0.125 mg (1 vial); if age ≥ 2 years: 0.25 mg (1 vial).single dose per dosing regimen

Approval duration: 1 dose

Other Diagnoses/Indications

Consideration when use is not directly addressed in this policy:

Other diagnoses/indications: 1) If the drug has had a label change within the last 6 months not yet reflected in this policy, follow the referenced formulary or non‑formulary/no‑coverage policy for the member's line of business (see policy numbers listed in document); OR 2) If the requested use (e.g., diagnosis, age, dosing regimen) is not listed under section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (see policy numbers listed in document).

Refer to specific policy numbers listed in document

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy for the member's line of business (see policies CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documentation.

For presumed adrenocortical insufficiency, prior authorization is limited to a single diagnostic dose when all initial approval criteria are met. The dosing limits are 0.125 mg for patients younger than 2 years (one vial) and 0.25 mg for patients aged 2 years and older (one vial). Re‑authorization is not permitted; members must meet the initial approval criteria for each request and approval duration is limited to the single diagnostic dose.

Coding and Dosage Limits

HCPCS Codes referencedHCPCS

J0834

Injection, cosyntropin, 0.25 mg

Maximum single-dose by age — cosyntropin

Pediatric < 2 years — maximum single dose0.125 mg (single IV or IM diagnostic dose)

Pediatric ≥ 2 years — maximum single dose0.25 mg (single IV or IM diagnostic dose)

Adults — maximum single dose0.25 mg (single IV or IM diagnostic dose)

Provider Requirements and Authorization Instructions

Prior Authorization

Prior Authorization Required

Prior authorization is required for diagnostic cosyntropin (cosyntropin/Cortrosyn) testing. Requests must include documentation that the criteria for diagnostic use are met. Approval, when granted, is for a single diagnostic dose.

Approval duration: 1 dose
Diagnostic use only

Billing Rule

Generic Substitution Requirement

When Cortrosyn is requested, the provider must use generic cosyntropin unless there is a documented contraindication or the member has experienced clinically significant adverse effects with generic cosyntropin.

Generic substitution required for Cortrosyn requests

Background

Cosyntropin is a synthetic adrenocorticotropic hormone (ACTH) subunit used as a diagnostic agent to screen for adrenocortical insufficiency in adults and children. It is administered as a single IV or IM injection as part of adrenal function testing to assess adrenal cortisol response.

Definitions

Cosyntropin (Cortrosyn) — definition and clinical role

DefinitionCosyntropin (Cortrosyn) is a synthetic subunit of adrenocorticotropic hormone (ACTH).

Clinical roleUsed as a diagnostic agent for screening adrenocortical (adrenal) insufficiency by administering a single IV or IM injection and measuring cortisol response.

Typical dosing regimen for diagnostic testingSingle dose administered IV or IM: adults 0.25 mg; pediatric <2 years 0.125 mg; pediatric 2–17 years 0.25 mg.