For the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement

Reimbursement

Important Safety Information and Indications

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

OTIPRIO (ciprofloxacin otic suspension) 6% is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO

Reimbursement Tools and Information

J-Code for OTIPRIO: J7342
Description: Instillation, ciprofloxacin otic suspension, 6 mg. Please refer to the Billing and Coding Guide below for more information.

Otonomy has developed various resources to assist providers with reimbursement-related questions about OTIPRIO. For additional assistance, please call our Customer Service Center at (800) 826-6411.
Materials and information provided are intended solely for educational purposes regarding possible codes to report for use of OTIPRIO. The information provided contains general reimbursement information only and represents Otonomy’s understanding of current reimbursement policies at the time of the material publication. Information should not be construed as legal advice nor is it advice about how to code, complete, or submit any particular claim for payment. Coding and reimbursement information is subject to change. Information provided is not intended to increase or maximize reimbursement by any payer.

Otonomy disclaims any responsibility for claims submitted by providers or physicians. All coding and billing to payers must be truthful and not misleading and make full disclosures to the payer about the product and the procedures associated with its use when seeking reimbursement for any product or procedure. It is the provider’s and physician’s responsibility to determine appropriate codes, charges, and modifiers, and to submit bills for services and products consistent with what was rendered as well as the patient’s insurer requirements. Third-party payers may have different coverage and reimbursement policies and coding requirements. Such policies can change over time. Providers are encouraged to contact third-party payers for each patient to verify specific information on their coding policies.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATONS

OTIPRIO (ciprofloxacin otic suspension) 6% is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO

WARNINGS AND PRECAUTIONS

Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of non-susceptible bacteria and fungi. If such infections occur, institute alternative therapy.

ADVERSE REACTIONS

Bilateral otitis media with effusion clinical trials: Adverse reactions (incidence at least 3%) with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).

Acute otitis externa clinical trial: Adverse reactions (incidence at least 2%) with OTIPRIO vs sham were: ear pruritus (2% vs 2%), headache (2% vs 1%), otitis media (2% vs 1%), and ear discomfort (2% vs 0%).

USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement and acute otitis externa.

INDICATIONS AND USAGE

OTIPRIO (ciprofloxacin otic suspension) 6% is a fluoroquinolone antibacterial indicated for:

  • The treatment of pediatric patients (6 months of age and older) with bilateral otitis media with effusion undergoing tympanostomy tube placement
  • The treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus