CurrentEmblemHealthPolicy MG.MM.PH.53

Baxdela (delafloxacin) for injection

Defines medical necessity, dosing limits, authorized indications, and coding for Baxdela (delafloxacin) injection for adult members when used to treat ABSSSI or CABP caused by susceptible bacteria.

Policy Summary

PayerEmblemHealth

PolicyBaxdela (delafloxacin) for injection

Policy CodePolicy MG.MM.PH.53

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit clinical evidence showing age ≥18, diagnosis of ABSSSI or CABP, and culture & sensitivity demonstrating pathogen susceptibility to delafloxacin for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

14 daysMax duration (ABSSSI)

10 daysMax duration (CABP)

18+Age requirement

C9462Primary procedure code

70842-0102-03NDC

Coverage Criteria

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Medical Necessity Criteria

Covered when ALL of the following are met:

Age: Patient is 18 years of age or older>=18 years

Indication: Diagnosis of acute bacterial skin and skin structure infection (ABSSSI) OR community-acquired bacterial pneumonia (CABP)

Microbiology: Current culture and sensitivity (C&S) report shows isolated pathogen is a gram-positive or gram-negative organism susceptible to delafloxacin, unless provider documents that obtaining a C&S is not possibleC&S susceptible to delafloxacin

Dosing limits & duration: Dosing limited per policy: ABSSSI — approval up to 14 days; CABP — approval up to 10 daysABSSSI: 14 days; CABP: 10 days

Subsequent approvals require a new authorization

Use Baxdela (delafloxacin) only for infections that are proven or strongly suspected to be caused by bacteria. This restriction supports antibiotic stewardship and helps reduce the development of drug-resistant organisms.

Any authorization beyond the initial approval period is not automatic. Subsequent approvals require a new authorization, and requests must be submitted and reviewed separately.

Coding

Applicable Procedure CodesHCPCS | mixed

C9462	Injection, delafloxacin, 1 mg
J3490	Unclassified drugs

Applicable NDCsNDC

70842-0102-03

Baxdela 300 mg Solution Reconstituted

ICD-10 Diagnoses (selected list)ICD-10

A46	Erysipelas
A48.1	Legionnaires' disease
A49.01	Methicillin susceptible Staphylococcus aureus infection, unspecified site
A49.02	Methicillin resistant Staphylococcus aureus infection, unspecified site
A49.1	Streptococcal infection, unspecified site
H00.031	Abscess of right upper eyelid
H05.011	Cellulitis of right orbit
J13	Pneumonia due to Streptococcus pneumoniae
J14	Pneumonia due to Hemophilus influenzae
J15.0	Pneumonia due to Klebsiella pneumoniae

1–10 of 15

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Provider Actions and Requirements

Documentation Required

Required clinical evidence submission

The treating physician or primary care provider must submit clinical evidence that the member meets the policy criteria. This documentation must be provided to EmblemHealth (or ConnectiCare, as applicable) for preauthorization or for post-payment review. Without adequate clinical evidence, EmblemHealth may be unable to properly review the request and may deny authorization or payment.

Submit documentation showing member meets criteria (age, diagnosis, culture & sensitivity where available).
Documentation may be requested preauthorization or as part of post-payment review.

Note

Bacterial infection requirement

Use of Baxdela (delafloxacin) is limited to infections that are proven or strongly suspected to be bacterial to help reduce development of drug-resistant organisms. Requests must indicate the bacterial infection diagnosis (ABSSSI or CABP) and, when available, include current culture & sensitivity results demonstrating pathogen susceptibility to delafloxacin.

Allowed diagnoses: acute bacterial skin and skin structure infection (ABSSSI) or community-acquired bacterial pneumonia (CABP).
Include current culture & sensitivity (C&S) showing pathogen susceptible to delafloxacin, unless provider documents that obtaining C&S is not possible.

Prior Authorization

Authorization requirements and limits

Prior authorization is required. Requests must document the member is ≥18 years old, has a qualifying diagnosis (ABSSSI or CABP), and include current culture & sensitivity demonstrating susceptibility to delafloxacin when available. Approval durations: 14 days for ABSSSI and 10 days for CABP. Subsequent courses require a new authorization.

Age requirement: ≥18 years.
Diagnosis requirement: ABSSSI or CABP.
Duration limits: ABSSSI = 14 days; CABP = 10 days.
Subsequent approvals require new authorization.

Denial Risk

Missing clinical documentation

Failure to submit required clinical documentation during preauthorization or post-payment review may result in denial of the request or claim. EmblemHealth may request additional information; absent timely submission, the request may not be approved.

Missing documentation may prevent approval or lead to claim denial.
Provide requested information promptly if EmblemHealth asks for additional details.

Definitions

Delafloxacin (Baxdela) — definition and indications

Drug classFluoroquinolone (Baxdela, delafloxacin)

Approved indicationsAcute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP)

Age groupAdults (18 years and older)

Pathogen requirementFor use when infections are caused by designated susceptible bacteria

Use limitation to prevent resistanceShould be used only for infections proven or strongly suspected to be bacterial to reduce development of drug‑resistant bacteria

Policy scope summaryCovers delafloxacin injection for adult ABSSSI or CABP when pathogen susceptibility is documented or C&S cannot be obtained

OpenPayer

Baxdela (delafloxacin) for injection

Coverage Criteria

Coding

Provider Actions and Requirements

Definitions

Background