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L.5.01.558
Nuzyra (omadacycline)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Nuzyra (omadacycline) is a tetracycline antibiotic indicated for the treatment of adult individuals with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nuzyra (omadacycline), it should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Nuzyra (omadacycline) is considered not medically necessary as there is insufficient evidence of greater clinical benefit when compared to other available treatment options for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
State Health Plan (State and School Employees) Participants
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
appropriate with regard to standards of good medical practice; and
not solely for the convenience of the Member, his or her Provider; and
the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
06/30/2020: New policy added.
07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy section revised to state: Nuzyra (omadacycline) is considered not medically necessary as there is insufficient evidence of greater clinical benefit when compared to other available treatment options for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Policy intent unchanged. It previously stated: Nuzyra (omadacycline) is considered not medically necessary as there is insufficient evidence of greater clinical benefit when compared to other available treatment options covered by the Plan for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Added information regarding BCBSMS request for medical records and removed investigative definition. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.
10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated to change "patients" to "individuals." Policy statement unchanged. Sources updated.
09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. PPolicy statement unchanged. Sources updated.
Nuzyra prescribing information. Paratek Pharmaceuticals, Inc. March 2025. Last accessed July 2025.
This may not be a comprehensive list of procedure codes applicable to this policy.
Not Medically Necessary Codes
Code Number | Description |
CPT-4 | |
HCPCS | |
J0121 | Injection, omadacycline, 1 mg |
ICD-10 Procedure | |
ICD-10 Diagnosis |
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
