CurrentHealth NetPolicy CP.PHAR.203

Clinical Policy: Cosyntropin (Cortrosyn)

Policy governs coverage and prior authorization criteria for cosyntropin (Cortrosyn) used as a diagnostic agent for screening adrenocortical insufficiency across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Cosyntropin (Cortrosyn)

Policy CodePolicy CP.PHAR.203

Change TypeAnnual reviewmaterial updates include dosing and line-of-business addition

Effective Date04.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation showing the request is for diagnostic testing of adrenocortical insufficiency and that dosing and medication selection criteria are met (use generic cosyntropin unless contraindicated).

SourceLink

POLICY UPDATE CHANGES

Added Commercial line of business and updated maximum dosing in those age 2 years and older to 0.25 mg as a single-dose per updated prescribing information.

Added generic redirection for Cortrosyn requests (use generic cosyntropin unless contraindicated).

Removed inactive HCPCS code J0833.

0.25 mgadult & pediatric ≥2 yrs dose

0.125 mgpediatric <2 yrs dose

J0834HCPCS code

Commercial, HIM, Medicaid

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Coverage Criteria for Diagnostic Cosyntropin (Cortrosyn)

Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval for diagnostic use: Prescribed for diagnostic testing of adrenocortical insufficiency.

Medication selection: If Cortrosyn is requested, member must use generic cosyntropin unless contraindicated or clinically significant adverse effects are experienced.

Dosing constraints

Pediatric < 2 years: Single dose ≤ 0.125 mg (1 vial).
Pediatric ≥ 2 years: Single dose ≤ 0.25 mg (1 vial).
Adults: Single dose ≤ 0.25 mg (1 vial).

Approval duration: Approval is for a single dose; re-authorization is not permitted.

Other Diagnoses/Indications

Requests for other diagnoses/indications must meet one of the following:

Formulary/PDL drugs: Follow the no coverage criteria policy for the relevant line of business: CP.CPA.190 (Commercial), HIM.PA.33 (Health Insurance Marketplace), or CP PMN.255 (Medicaid).

Non-formulary/Non-PDL drugs: Follow the non-formulary policy for the relevant line of business: CP.CPA.190 (Commercial), HIM.PA.103 (Health Insurance Marketplace), or CP PMN.16 (Medicaid).

Recent label change: If the drug has undergone a label change within the last 6 months (new indication, age expansion, or dosing change) not yet reflected in this policy, refer to the appropriate formulary or non-formulary policy as above.

Off‑label uses: If the requested use (diagnosis, age, dosing) is not listed under non‑coverage and initial approval criteria do not apply, refer to the off‑label use policy for the relevant line of business: CP.CPA.09 (Commercial) or HIM.PA.154 (Health Insurance Marketplace).

Requests for uses of cosyntropin that are not FDA-approved and are not specifically addressed in this policy are not covered unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid).

When cosyntropin is requested for a non‑FDA approved indication, coverage may only be considered if the request follows the applicable off‑label use policy and includes the required supporting clinical documentation showing that the use meets the off‑label criteria for safety and efficacy.

Coding and Dosing

HCPCS CodesHCPCS

J0834

Injection, cosyntropin, 0.25 mg

Maximum single diagnostic dose

Maximum single diagnostic dose — adults and pediatric >=2 years0.25 mg (single dose, 1 vial)

Maximum single diagnostic dose — pediatric <2 years0.125 mg (single dose, 1 vial)

Approval duration1 dose

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for diagnostic cosyntropin (cosyntropin/Cortrosyn). The prior authorization must document the medical necessity for use in diagnostic testing of adrenocortical insufficiency and substantiate that the member meets the approval criteria in this policy.

PA required for diagnostic testing of adrenocortical insufficiency
Requests for Cortrosyn brand redirected to generic cosyntropin unless contraindicated or adverse reaction documented
Approval duration for initial use: single dose (see dosing limits)

Note

Generic Product Required When Appropriate

Providers must prescribe generic cosyntropin rather than the Cortrosyn brand unless the provider documents a medical contraindication or a clinically significant adverse reaction to the generic product. If brand product is requested, submit documentation explaining the clinical rationale for brand selection.

Require generic cosyntropin unless contraindicated or adverse reaction documented

Background

Cosyntropin (Cortrosyn) is a synthetic analog of adrenocorticotropic hormone (ACTH) used as a diagnostic agent in the evaluation of adrenocortical function. It is administered as a single intravenous or intramuscular diagnostic dose and is used, in combination with other tests, to screen for adrenocortical insufficiency.

Definitions

Cosyntropin (Cortrosyn) — definition and administration

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

Typical useUsed as a diagnostic agent to screen for adrenocortical (adrenal) insufficiency.

Typical administration route and doseSingle dose administered by IV or IM injection: adults and pediatric >=2 years 0.25 mg; pediatric <2 years 0.125 mg.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Cosyntropin (Cortrosyn)

Policy CodePolicy CP.PHAR.203

Change TypeAnnual reviewmaterial updates include dosing and line-of-business addition

Effective Date04.01.16

Next Review Date

SourceLink

On This Page

Redirect Cortrosyn brand requests to generic cosyntropin

Documentation Required

Providers must submit supporting documentation with the prior authorization request. Acceptable documentation includes office chart notes, lab results (e.g., baseline cortisol levels), diagnostic test orders/results, and other clinical information demonstrating the need for cosyntropin for diagnostic testing of adrenocortical insufficiency. Include dose and age of the patient to confirm dosing limits.

Acceptable documentation: office chart notes, laboratory results, diagnostic test reports, and other clinical information
Specify patient age and requested dose to confirm it does not exceed the single-dose limits

Denial Risk

Denial Risk if Documentation or Indication Is Insufficient

Coverage decisions may be denied if the required supporting documentation is not provided or does not substantiate that the member meets the approval criteria (e.g., indication for diagnostic testing of adrenocortical insufficiency, use of generic cosyntropin unless contraindicated, and dosing within policy limits). Re-authorization is not permitted; only a single initial dose is approvable when criteria are met. Off‑label or non‑FDA indications are not covered unless supported per the referenced off‑label use policies.

Denial risk if documentation is incomplete or does not support medical necessity
Re-authorization not permitted — only initial single-dose approval when criteria met
Non‑FDA indications require separate justification per off‑label policies