CurrentAvMedPolicy N/A

Nuzyra (omadacycline) medical prior authorization — coverage criteria

Prior authorization and step-edit requirements for outpatient/inpatient medical use of Nuzyra (omadacycline) for AvMed members, covering indications, required documentation, and criteria for approval for ABSSSI and CABP in adults.

Policy Summary

PayerAvMed

PolicyNuzyra (omadacycline) medical prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionProvider must submit member/prescriber info, dosing, length of therapy, diagnosis and supporting labs including cultures within 7 days showing sensitivity or documented trials/failures of listed antibiotics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+member age requirement for new starts

14dauthorization length for new starts

72hminimum inpatient use for continuation

7dculture recency accepted

Coverage Criteria for Nuzyra (omadacycline)

Continuation Therapy

Covered when ALL of the following are met for continuation after inpatient administration:

Continuation after inpatient: Member is currently on Nuzyra for more than 72 hours inpatient (progress notes must be submitted); member has a diagnosis of ABSSSI or CABP without multidrug-resistant organisms; provider has submitted inpatient lab culture sensitivity results retrieved during the inpatient admission which show resistance to ALL preferred antibiotics except for Nuzyra (Nuzyra sensitive).>72 hours

Length of Authorization: date of service; progress notes and inpatient culture sensitivity results required

Use of drug samples to start therapy is specifically excluded from meeting the step-edit or preauthorization requirements. Providers should not rely on sample medications as evidence of prior trials or failures when requesting authorization for Nuzyra; supporting documentation must come from medical records or pharmacy claims as described in the request requirements.

Coding and Clinical Data Requirements

Policy Summary

PayerAvMed

PolicyNuzyra (omadacycline) medical prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Provider Actions, Documentation & Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Nuzyra IV (omadacycline) J0121. The prescribing physician must sign and clearly print their name (preprinted stamps not valid) on the prior authorization request. Fax completed requests to 1-877-535-1391. Authorization decisions may be delayed if the submission is incomplete, incorrect, or illegible.

Drug: Nuzyra ® (omadacycline) IV (J0121)
Fax: 1-877-535-1391
Prescriber signature required (no preprinted stamps)

Documentation Required

Approval Requirements & Required Evidence

All approval requests must include documented clinical evidence supporting necessity. For initial therapy, provide either culture evidence showing the organism is sensitive to Nuzyra or chart notes documenting trials and failures of all listed preferred antibiotics per diagnosis. For continuation requests, submit inpatient progress notes showing member received Nuzyra inpatient >72 hours and culture sensitivity demonstrating resistance to all preferred antibiotics except Nuzyra. Provide all supporting documentation (lab results, diagnostics, chart notes) or the request may be denied.

ABSSSI initial: lab cultures from current admission/visit within 7 days showing sensitivity to Nuzyra OR chart notes showing trial/failure of ALL listed oral antibiotics (penicillin VK, amoxicillin, amoxicillin-clavulanate, dicloxacillin, cephalexin, clindamycin, doxycycline, trimethoprim-sulfamethoxazole, linezolid) OR IV trial/failure list as applicable
CABP initial: lab cultures from current admission/visit within 7 days showing sensitivity to Nuzyra OR chart notes showing trial/failure of ALL listed oral antibiotics (amoxicillin, amoxicillin-clavulanate, dicloxacillin, doxycycline, azithromycin, cefdinir, cefpodoxime, levofloxacin, ciprofloxacin) OR IV trial/failure list as applicable
Continuation: member on Nuzyra >72 hours inpatient with progress notes and culture sensitivity showing resistance to all preferred antibiotics except Nuzyra

Documentation Required

Provider Submission Requirements

To avoid delays, include complete member and prescriber information, full drug details, dosing and duration, diagnosis with ICD code, and all supporting clinical documentation at time of submission. Incomplete fields or missing labs/notes may delay or prevent authorization.

Member name, AvMed ID, date of birth
Prescriber name, NPI, prescriber signature, office contact, phone and fax
Drug form/strength, dosing schedule, length of therapy
Diagnosis and ICD code
Weight (if applicable) and date weight obtained
All relevant lab results, culture sensitivity reports (collected within last 7 days), and chart notes

Denial Risk

Incomplete Submissions May Delay Authorization

Authorization can be delayed or denied if information is incomplete, incorrect, or illegible. Missing lab results, diagnostics, or chart notes that support trials/failures or culture sensitivities will delay the decision. Ensure all required elements are legible and included with the faxed request.

Incomplete/illegible submissions may delay authorization
Missing culture sensitivity reports or trial/failure documentation may result in denial
Ensure prescriber signature is present and legible

Definitions

inv-13: New Start definition — age requirement and supporting cultures/diagnosis for initiating outpatient Nuzyra therapy

Age requirementMember must be 18 years of age or older.

IndicationsDiagnosis must be ABSSSI or CABP without multidrug-resistant organisms (per respective New Start criteria).

Supporting microbiologyProvider must submit lab cultures from current hospital admission or office visit collected within the last 7 days showing bacteria sensitive to Nuzyra.

Alternative pathwayApproval may be supported by cultures showing resistance to all listed comparator antibiotics or documented trial and failure of listed oral/IV antibiotics as specified in the New Start criteria.

inv-14: Continuation definition — requirements for requests to continue Nuzyra after inpatient initiation, including >72 hours inpatient use and progress notes

Inpatient duration prerequisiteMember must have received Nuzyra inpatient for more than 72 hours to qualify for continuation.

DocumentationSubmit inpatient progress notes verifying >72 hours of inpatient Nuzyra administration.

Microbiology for continuationProvider must submit inpatient culture sensitivity results showing resistance to all preferred antibiotics except Nuzyra (Nuzyra sensitive).

Covered diagnosesContinuation applies for ABSSSI or CABP without multidrug-resistant organisms when continuation criteria are met.

Background

Nuzyra (omadacycline) is an oral and intravenous tetracycline-class antibiotic indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) in adults. Authorization for outpatient Nuzyra requires that the member be aged 18 years or older, and requests must include recent culture data (collected within 7 days) demonstrating susceptibility to omadacycline or documented trials and failures of the listed comparator antibiotics. The policy’s duration for new outpatient starts is the date of service (14 days), and continuation requests following inpatient initiation have separate inpatient-duration and documentation requirements.