CurrentmhnPolicy CP.PHAR.388

Chloramphenicol Sodium Succinate (IV) coverage

Defines medical necessity criteria, dosing limits, approval durations, and administrative requirements for coverage of intravenous chloramphenicol sodium succinate for members under the payer's lines of business.

Policy Summary

Payermhn

PolicyChloramphenicol Sodium Succinate (IV) coverage

Policy CodePolicy CP.PHAR.388

Change TypeNo material changes

Effective DateDec 1, 2018

Next Review Date

Key ActionProvider must submit clinical documentation (office chart notes, lab results or other information) demonstrating that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

100 mg/kg/dayMax adult/pediatric dose

50 mg/kg/dayMax neonatal dose

6 monthsInitial approval duration

12 monthsContinued therapy duration

J0720HCPCS

Coverage Criteria for Intravenous Chloramphenicol Sodium Succinate

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inv-01: Initial Approval Criteria — FDA‑Approved Indications

Covered when ALL of the following are met:

Initial approval requirements: 1) Prescribed by or in consultation with an infectious disease specialist; 2) Request is for continuation of intravenous therapy initiated in an acute care hospital from which member was discharged; 3) Dose does not exceed one of the following: a) Adults and pediatrics: 100 mg/kg per day; b) Neonates: 50 mg/kg per day.see dosing thresholds

Applies to FDA‑approved indications only

inv-02: Continued Therapy — FDA‑Approved Indications

Covered when ALL of the following are met:

Continued therapy requirements: 1) Member meets one of the following: a) currently receiving medication via Centene benefit or previously met initial approval criteria; b) member is enrolled in a state/product with continuity‑of‑care regulations; c) request is for continuation of therapy initiated in an acute care hospital from which member was discharged; 2) Member is responding positively to therapy; 3) If request is for a dose increase, new dose does not exceed: a) Adults and pediatrics: 100 mg/kg per day; b) Neonates: 50 mg/kg per day.see dosing thresholds

Continuation criteria and dose limits enforced

inv-03: Other Diagnoses/Indications

When requested use is not an FDA‑approved indication listed in this policy:

Alternate routing: 1) If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, refer to the appropriate formulary/no‑coverage or non‑formulary policy for the relevant line of business (see policy references); 2) If the requested use (diagnosis, age, dosing) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer the request to the off‑label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable).N/A

References to specific formulary/off‑label policies provided

Coverage is not authorized for non‑FDA approved indications that are not addressed in this policy unless the request includes sufficient documentation of efficacy and safety consistent with the payer's off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid) or is supported by the member's evidence of coverage documents.

Chloramphenicol sodium succinate is not authorized for treatment of trivial infections or conditions where it is not indicated (for example, routine colds, influenza, or throat infections), for use as prophylaxis to prevent bacterial infections, or in patients with a history of prior hypersensitivity or toxic reaction to chloramphenicol; these uses are contraindicated per Appendix C.

This clinical policy is intended as a guide to medical necessity and does not guarantee payment. Coverage determinations and administration of benefits remain subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements.

For Medicaid members, if state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage provisions.

Requests for non‑FDA uses that are not addressed in this policy will be excluded unless the submission provides adequate clinical documentation demonstrating efficacy and safety per the referenced off‑label use policies and the member's evidence of coverage. Additionally, uses that are contraindicated in Appendix C (including prior hypersensitivity/toxic reactions, trivial or non‑indicated infections, and prophylactic use) are not supported by this policy.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization governed by benefit documents

Prior authorization is governed by the member’s benefit documents (e.g., evidence of coverage, certificate of coverage, policy or contract). Coverage decisions and administration of benefits are subject to all terms, conditions, exclusions, and limitations of those documents, as well as applicable state and federal requirements and Health Plan-level administrative policies and procedures.

Coverage is not guaranteed by this clinical policy; check the member’s EOC and plan-level policies for final determination.

Prior Authorization

Formulary / Off‑label routing

If the requested indication, age group, dosing regimen, or other use is not listed in this policy or the policy has not yet incorporated a recent FDA label change, route the request per formulary and off‑label use policies for the applicable line of business. Use the formulary/non‑formulary policies for formulary placement issues and the off‑label use policies when the use is non‑FDA or otherwise not specifically covered by this policy.

Formulary/non‑formulary policies: CP.CPA.190 (commercial), HIM.PA.33 or HIM.PA.103 (health insurance marketplace as applicable), CP.PMN.255 or CP.PMN.16 (Medicaid)
Off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), CP.PMN.53 (Medicaid)

Documentation Required

Required clinical documentation and non‑FDA indication risk

Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) supporting that the member has met all approval criteria. Requests for non‑FDA indications may be denied unless sufficient documentation is provided per the applicable off‑label use policy.

Include relevant hospital discharge summaries when requesting continuation of IV therapy initiated in an acute care setting.
Provide documentation of response to therapy for continuation requests as described in Continued Therapy criteria.

Note

Provider responsibility and documentation context

Providers are expected to exercise professional medical judgment and remain responsible for treatment decisions. This policy is a guide to medical necessity and does not guarantee payment or replace statutes, contractual terms, or regulatory requirements.

Health Plan may change, amend or withdraw this clinical policy; providers should confirm current requirements prior to submission.

Definitions

Chloramphenicol sodium succinate — drug definition and indications summary

Drug class / mechanismAn antibiotic prodrug (chloramphenicol sodium succinate) that binds to bacterial 50S ribosomal subunits

Primary FDA‑approved indicationsTreatment of acute infections caused by Salmonella typhi and serious infections caused by susceptible strains (e.g., Salmonella species, H. influenzae [meningeal infections], Rickettsia, lymphogranuloma‑psittacosis group, various gram‑negative bacteremia/meningitis)

Other indicated usesUsed for other susceptible organisms resistant to other appropriate antimicrobials and in certain cystic fibrosis regimens

Limitation of useNot recommended for routine treatment of the typhoid carrier state

Clinical policy — definition that policy is guidance not a contract or treatment recommendation

Purpose of the clinical policyProvides guidance on medical necessity to assist coverage decisions and benefit administration; not a guarantee of payment

Not medical advice or treatment directiveDoes not constitute medical advice, medical treatment, or medical care and is not intended to dictate how providers practice medicine

Provider responsibilityProviders must exercise professional medical judgment and are solely responsible for clinical care and treatment decisions

OpenPayer

Chloramphenicol Sodium Succinate (IV) coverage

Coverage Criteria for Intravenous Chloramphenicol Sodium Succinate

Coding and Dosing Information

Provider Actions, Authorization, and Documentation

Definitions

Background