Billing And Coding Guide - OTIPRIO

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Billing andCoding GuideUpdated July 1, 2016UPDATED INFORMATION:Please see coding sections for updatedinformation regarding reimbursement for OTIPRIO.Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.1

OTIPRIO (ciprofloxacin otic suspension) 6%DisclaimerThis guide is intended solely for educational purposes regarding possible codes that may be available forOTIPRIO. The information provided contains general reimbursement information only and represents Otonomy’sunderstanding of current reimbursement policies as of July 1, 2016. This coding and reimbursement informationis subject to change and may become outdated. Information should not be construed as legal advice nor is itadvice about how to code, complete, bill, or submit any particular claim for payment. It is important to checkwith the health plan directly to confirm coverage for individual patients. Information provided is not intendedto increase or maximize reimbursement by any payer.Otonomy disclaims any responsibility for claims submitted by providers or physicians. The information providedin this Guide is not a guarantee of coverage in any individual case. It is the provider’s and physician’s responsibilityto determine appropriate codes, charges, and modifiers, and to submit bills for services and products consistentwith what was rendered as well as the patient’s insurer requirements. Third-party payers may have different coverageand reimbursement policies and coding requirements. Such policies can change over time. Providers are encouragedto contact third-party payers for each patient to verify specific information on their coding policies.Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.2

Billing and Coding GuideContentsOTIPRIO Indications and Important Safety Information. . . . . . . . . . . . . . . . . . 4Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Reimbursement Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Private/Commercial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Medicaid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Medicare. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Coding for OTIPRIO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7HCPCS Level II Codes for OTIPRIO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7About Transitional Pass-Through Payment . . . . . . . . . . . . . . . . . . . . . . . . . . 8National Drug Code (NDC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Coding for Physician Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Potential CPT Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Potential ICD-9-CM and ICD-10-PCS Procedure Codes . . . . . . . . . . . . . . . 9Coding for the Patient’s Disease/Condition. . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Potential ICD-10-CM Diagnosis Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Frequently Asked Questions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.3

OTIPRIO (ciprofloxacin otic suspension) 6%INDICATIONS AND USAGEOTIPRIOTM (ciprofloxacin otic suspension) 6% is a fluoroquinolone antibacterial indicated for the treatmentof pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONSOTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones,or to any of the components of OTIPRIO.WARNINGS AND PRECAUTIONSPotential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi.If such infections occur, institute alternative therapy.ADVERSE REACTIONSAdverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were:nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).USE IN SPECIFIC POPULATIONSPediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have notbeen established.Please see accompanying full Prescribing Information.4

Billing and Coding GuideIntroductionOtonomy, Inc. has developed this reference guide to provide general billing and coding information related toOTIPRIO for physician and hospital billing staff when used in the ambulatory surgical center (ASC), hospitaloutpatient department (HOPD), or hospital inpatient setting. To assist you in preparing claims, this guidecontains the following:uReimbursement OverviewuBilling and Coding InformationuFrequently Asked Questions (FAQs)Reimbursement OverviewCoverage and coding guidelines for OTIPRIO and its administration will differ by insurer and are updated regularly.In addition, payment rates may vary by insurer and are frequently established by the provider’s specific contract.It is a best practice to contact your patient’s health insurance company directly to ensure that you have themost recent local billing, coding, and coverage policy information, as well as answer any payment inquiries.Codes allow healthcare providers to communicate with insurance companies to facilitate the reimbursementprocess and explain why the patient needed treatment, what drugs and services were provided, and whereservices were rendered. Coding guidelines may differ by insurer and are often updated regularly to reflect theaddition and deletion of applicable codes. The following table provides an overview of the different codesand their description that may be applicable when billing for items and services related to OTIPRIO.Code SetDescription/PurposeCPT 1 Codes(Level I HCPCS Codes)Numeric coding system used to report medical services and procedures provided by healthcare professionals;includes CPT E/M codes, which are numeric codes used to report office visit services provided by physiciansHCPCS Level II CodesAlpha-numeric coding system used to report specific drugs, supplies, and other healthcare equipmentICD-9-CM/ICD-10-CMDiagnosis CodesNumeric and alpha-numeric codes used to report diagnosisICD-9-CM/ICD-10-PCSProcedure CodesNumeric and alpha-numeric codes used to report procedures, services, devices, and drugs in acute-carehospitals and other facility-based settingsNDCNumeric product identifier used to report human drugsRevenue CodesNumeric codes used by hospitals to report services and supplies to specific cost centersLegendCPT : Current Procedural TerminologyHCPCS: Healthcare Common Procedure Coding SystemICD-9-CM: International Classification of Diseases, 9th Revision, Clinical ModificationICD-10-CM: International Classification of Diseases, 10th Revision, Clinical ModificationICD-10-PCS: International Classification of Diseases, 10th Revision, Procedure Coding SystemNDC: National Drug CodeCPT copyright 2014 American Medical Association. All rights reserved.CPT is a registered trademark of the American Medical Association.1 Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.5

OTIPRIO (ciprofloxacin otic suspension) 6%In addition, coverage and payment will also vary based on individual patient insurance parameters and providercontracts. An overview of the major insurer types is provided below.Private/ CommercialPrivate insurance coverage policies for OTIPRIO and its administration may vary. Each private insurer determinesits own coverage policies for drugs and procedures. In addition, most insurers offer multiple plans; coverage forprocedures and/or drugs may vary depending on the details of that exact plan.MedicaidIn general, state Medicaid programs will cover drugs for their FDA-approved indications. It will be important tounderstand your state Medicaid program’s specific coverage criteria for OTIPRIO and its administration as eachstate’s Medicaid agency determines its own coverage and payment policies. Medicaid recipients may also havethe opportunity to enroll in managed care organizations (MCOs) offered in a particular state. Typically, ManagedMedicaid guidelines for coverage are similar to private or commercial insurers and often vary by plan.MedicareTraditional or fee-for-service Medicare consists of beneficiaries who receive their medical benefits throughthe following:u MedicarePart A: Inpatient services, hospitalizations, hospice care, skilled nursing facility stays, and somehome health servicesu MedicarePart B: Physician and outpatient services, durable medical equipment (DME), and some homehealth care, laboratory serviceCurrently, there is no Medicare national coverage determination (NCD) for OTIPRIO. As with most Part Bcovered drugs, local Medicare contractors have the discretion to develop local coverage determinations(LCDs) if necessary.Formal published guidelines may be developed for certain products and procedures when insurers are concernedabout appropriate utilization and costs; published policies regarding coverage for OTIPRIO may not be available.Contacting each patient’s insurance company to understand the specific guidelines for OTIPRIO is recommended.Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.6

Billing and Coding GuideCoding for OTIPRIORegardless of the setting of care in which the drug was administered, most payers require providers to listan HCPCS code and the NDC code on the claim form when billing for a particular drug.HCPCS Level II Codes for OTIPRIOMost payers recognize Healthcare Common Procedure Coding System (HCPCS) Level II national codes toidentify and report drugs.Effective July 1, 2016, the Centers for Medicare & Medicaid Services (CMS) granted transitional pass-throughstatus for OTIPRIO. When pass-through status is granted, CMS creates a unique HCPCS code, or “C-Code,”which billers can use to identify the drug on the claim form. For more information on pass-through payment,please see page 8.HCPCS CodeDescriptionC9479*Instillation, ciprofloxacin otic suspension, 6 mgJ3490†Unclassified drugs* Note on reporting C9479: Each vial of C9479 contains 60 mg. If one single-use vial is used for both patient’s ears with the remainder of the drug in the vialunused, then two units of C9479 should be reported on the claim form as administered to the patient; any discarded amount should be reported with theJW modifier according to the Medicare Claims Processing Manual, Chapter 17, Drugs and Biologicals; Section 40, Discarded Drugs and Biologicals.† Note on reporting J3490: If the patient’s insurer does not accept C9479, you may need to report OTIPRIO using J3490. Report only one unit of J3490on the claim form per single-patient use vial. Do not bill wastage.Please consult payer-specific guidelines for the appropriate code to use for OTIPRIO to communicate whichdrug was provided and how much was administered.Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.7

OTIPRIO (ciprofloxacin otic suspension) 6%About Transitional Pass-Through PaymentTransitional pass-through status is a temporary payment policy granted by the Centers for Medicare & MedicaidServices (CMS), the federal agency that administers the Medicare program. When a drug is granted pass-throughstatus by CMS, ambulatory surgery centers and other outpatient facilities are eligible to receive separate paymentfor the drug, in addition to the payment received for the patient encounter for Medicare patients. Pass-throughstatus remains in effect for 2 to 3 years.When pass-through status is granted, CMS creates a temporary, unique Healthcare Common Procedure CodingSystem (HCPCS) code, or “C-Code,” which billers use to identify the drug on the claim form.Pass-through status is applicable to Medicare patients only. However, some Medicaid and commercial plans mayallow providers that treat non-Medicare patients to use the C-Code when billing, in lieu of an unlisted “J-Code”– and even more, some may recognize Medicare’s pass-through status policy and allow for separate payment fordrugs with pass-through status which would otherwise not be allowed separate reimbursement.Ambulatory surgery centers (ASCs) and other hospital outpatient departments (HOPDs) may be eligible to receiveseparate payment for OTIPRIO, in addition to the payment received for the patient encounter when providers billfor OTIPRIO using HCPCS code C9479.National Drug Code (NDC)The FDA and the manufacturer assign drugs/biologics a unique, 3-segment number, known as the National DrugCode (NDC). Many NDCs (including the one assigned to OTIPRIO) are displayed in a 10-digit format on theFDA-approved product labelling. Proper billing for most payers or electronic data interchange systems requiresthat the NDC be submitted in the 11-digit numeric 5-4-2 format (ie, 55555-4444-22). Converting a 10-digit NDCto 11-digit format requires a strategically placed zero preceding the section that does not comply with the5-4-2 format. Do not use hyphens when entering the actual data on your claim.For example:10-Digit FormatOTIPRIO10-Digit NDC11-Digit FormatOTIPRIO11-Digit NDCReporting onclaim Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.8

Billing and Coding GuideCoding for Physician ServicesCoding procedures may vary depending on the setting of care. In the physician office, HOPD, and ASC, CPT codesare used to describe procedures. In the hospital inpatient department, billers are required to use ICD-10-PCS codesto bill for procedures.Potential CPT CodesCurrent Procedural Terminology (CPT ) codes are used to identify professional services (ie, drug administration).According to the CPT instructions for use of the CPT codebook, select the name of the procedure or service thataccurately identifies the service performed. Do not select a CPT code that merely approximates the service provided.When provided during tube placement surgery, the administration of OTIPRIO is considered inclusive of the primaryprocedure and therefore not coded separately. Providers should use the appropriate tympanostomy CPT code thatbest describes the services provided. Also, when performed bilaterally, report with modifier 50.CPT CodeDescription69433Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia69436Tympanostomy (requiring insertion of ventilating tube), general anesthesiaPotential ICD-9-CM and ICD-10-PCS Procedure CodesICD-9-CM and ICD-10-PCS codes are typically used to bill for procedures performed on inpatients. EffectiveOctober 1, 2015, all Health Insurance Portability and Accountability Act (HIPAA)-covered entities were requiredto transition from the ICD-9-CM coding system and bill procedures using ICD-10-PCS.There is no category-specific code for drugs administered via intratympanic administration. Hospitals maytherefore choose the code that best describes the procedure. Below is a list of the existing ICD-9-CM code andthe ICD-10-PCS Crosswalk that may be applicable for describing the administration of OTIPRIO when administeredduring tube placement surgery.ICD-9-CM Procedure CodeICD-10-PCS3E0B7GC Introduction of other therapeutic substance into ear, via natural or artificial opening20.94 Injection of tympanum3E0B3GC Introduction of other therapeutic substance into ear, percutaneous approach3E0BXGC Introduction of other therapeutic substance into ear, external approach099500Z Drainage of right middle ear with drainage device, open approach20.01 Myringotomy withinsertion of tube099600Z Drainage of left middle ear with drainage device, open approach099770Z Drainage of right tympanic membrane with drainage device, via natural or artificial opening099870Z Drainage of left tympanic membrane with drainage device, via natural or artificial openingPlease see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.9

OTIPRIO (ciprofloxacin otic suspension) 6%Coding for the Patient’s Disease/ConditionPotential ICD-10-CM Diagnosis CodesICD-10-CM diagnosis codes are used to report diseases and conditions and identify why a patient needs treatment.OTIPRIO is indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoingtympanostomy tube placement. The following ICD-9-CM diagnosis codes and the equivalent ICD-10-CM crosswalkbelow are examples of some codes that may be appropriate to describe a patient’s chief complaint.Diagnosis Code SystemCodeDescriptionICD-9-CM381.00Acute nonsuppurative otitis media, unspecifiedICD-9-CM382.00Acute suppurative otitis media without spontaneous rupture of ear drumICD-10-CMH65.191–H65.199Other acute nonsuppurative otitis mediaICD-10-CMH66.001–H66.009Acute suppurative otitis media without spontaneous rupture of ear drumPlease see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.10

Billing and Coding GuideFrequently Asked QuestionsQ1: What HCPCS code do I use to bill for OTIPRIO?Effective July 1, 2016, the Centers for Medicare & Medicaid Services (CMS) granted transitional pass-through statusfor OTIPRIO. When pass-through status is granted, CMS creates a unique Healthcare Common Procedure CodingSystem (HCPCS) code, or “C-Code,” which billers can use to identify the drug on the claim form. Some insurerswill not accept C-Codes and require providers to bill using an unclassified HCPCS code or “unlisted J-Code” whena permanent “J-Code” is not available. These coding options are available on page 7 of the billing and coding guide.Please consult payer-specific guidelines for the appropriate code to use for OTIPRIO to communicate which drugwas provided and how much was administered.Q2: My patient’s insurer won’t allow me to bill using the OTIPRIO C-Code and says I must bill usingthe unclassified HCPCS drug code J3490. What else do I need to know about coding OTIPRIO withan unclassified HCPCS drug code?OTIPRIO was approved in 2015. Not all insurers will be familiar with OTIPRIO. Hence, the product may be billedusing an unclassified drug code until OTIPRIO is assigned its own product-specific code.2 The patient’s insurer mayneed more information if they are unfamiliar with OTIPRIO; therefore, the provider’s billing staff should be preparedto submit the following information if requested:uDrug name (brand/generic)uRoute of administrationuDrug strength and dosageu11-digit National Drug Code (NDC)uCustomized letter of medical necessityuInvoiceuFDA approval letteruPackage insertuChart notesuLaboratory test resultsu Patientumedical history and documentation of medical necessityPrior therapiesu Supportingpeer-reviewed medical journals and other clinical literatureUnclassified codes do not have “unit values” and are generally reported as “1 Unit” on the claim form or its electronic equivalent,regardless of the amount of drug administered. Check payer guidelines for appropriate reporting of units for an unclassified code.2 Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.11

OTIPRIO (ciprofloxacin otic suspension) 6%Frequently Asked Questions (cont.)Q3: What CPT code do I use to bill for the administration of OTIPRIO in the ASC or HOPD?When provided during tube placement surgery, the administration of OTIPRIO is considered inclusive of theprimary procedure and therefore not coded separately. Providers should use the appropriate tympanostomyCPT code (69433 or 69436) that best describes the services provided. Also, when performed bilaterally,report with modifier 50.It is important to remember that insurers’ billing and coding guidelines may vary. Please contact the patient’sinsurer if you have any questions related to coding.Q4: How do I know if OTIPRIO is covered for my patient?Otonomy does not anticipate that many payers will develop a formal policy regarding coverage for OTIPRIO.In general, it is a good rule of thumb to contact each payer to verify coverage parameters prior to the procedure.Q5: What is the reimbursement for OTIPRIO?Reimbursement for OTIPRIO will be based on the contracted arrangement between the provider and the payer.Please contact your patient’s insurer for specific information on payment rates and to understand how OTIPRIOis reimbursed.Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.12

For additional support or questions,please visit www.OTIPRIO.com or contactby e-mail at Reimbursement@Otonomy.comor by phone at 1-800-826-6411. 2016 Otonomy, Inc. All rights reserved.OTIPRIO is a trademark of Otonomy, Inc.1-OTI16039-v1Please see Indication and Important Safety Information for OTIPRIOon page 4. Please see accompanying full Prescribing Information.13

HIGHLIGHTS OF PRESCRIBING INFORMATION----------------------DOSAGE FORMS AND STRENGTHS--------------------These highlights do not include all the information needed to use OTIPRIOsafely and effectively. See full prescribing information for OTIPRIO.Otic Suspension: Each OTIPRIO vial contains 1 mL of 6% (60 mg/mL) ciprofloxacinotic suspension. ---------------------------OTIPRIOTM (ciprofloxacin otic suspension), for intratympanic useOTIPRIO is contraindicated in patients with a history of hypersensitivity tociprofloxacin, to quinolones, or to any component of OTIPRIO. (4)Initial U.S. Approval: 1987---------------------------INDICATIONS AND -----WARNINGS AND PRECAUTIONS----------------------OTIPRIO is a fluoroquinolone antibacterial indicated for the treatment of pediatricpatients with bilateral otitis media with effusion undergoing tympanostomy tubeplacement. (1)Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth ofnon-susceptible bacteria and fungi. (5.1)-----------------------DOSAGE AND ----------------ADVERSE REACTIONS---------------------------· OTIPRIO is for intratympanic administration only. (2.1)The most frequently occurring adverse reactions (with an incidence rate greaterthan 3%) were nasopharyngitis and irritability. (6.1)· OTIPRIO is intended for single-patient use with two 0.1 mL doses availablein each vial. (2.1)To report SUSPECTED ADVERSE REACTIONS, contact Otonomy at 1-800-826-6411or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.· Administer OTIPRIO as a single intratympanic administration of one 0.1 mL(6 mg) dose into each affected ear, following suctioning of the middle eareffusion. (2.1)See 17 for PATIENT COUNSELING INFORMATION.· See Full Prescribing Information for directions for OTIPRIO dose preparation.(2.2)Revised: 12/20151112FULL PRESCRIBING INFORMATION: CONTENTS*1234568INDICATIONS AND USAGEDOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSCONTRAINDICATIONSWARNINGS AND PRECAUTIONS5.1 Potential for Microbial OvergrowthADVERSE REACTIONSUSE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use13141617DESCRIPTIONCLINICAL PHARMACOLOGY12.1 Mechanism of Action12.3 Pharmacokinetics12.4 MicrobiologyNONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or PharmacologyCLINICAL STUDIESHOW SUPPLIED/STORAGE AND HANDLINGPATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.1

FULL PRESCRIBING INFORMATION31Otic Suspension: Each 1 mL of OTIPRIO contains a white, preservative-free, sterileotic suspension consisting of 6% (60 mg/mL) ciprofloxacin in a single-patient useglass vial.INDICATIONS AND USAGEOTIPRIO is indicated for the treatment of pediatric patients with bilateral otitismedia with effusion undergoing tympanostomy tube placement.4DOSAGE FORMS AND STRENGTHSCONTRAINDICATIONS2DOSAGE AND ADMINISTRATION2.1Dosage and Important Administration Instructions···OTIPRIO is for intratympanic administration only.OTIPRIO is intended for single-patient use, discard unused portion.Administer OTIPRIO as a single intratympanic administration of one 0.1 mL(6 mg) dose into each affected ear, following suctioning of middle eareffusion.5WARNINGS AND PRECAUTIONS5.1Potential for Microbial Overgrowth2.2Preparation of OTIPRIO6ADVERSE REACTIONS6.1Clinical Trials ExperienceOTIPRIO is contraindicated in patients with a history of hypersensitivity tociprofloxacin, to other quinolones, or to any of the components of OTIPRIO.OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If suchinfections occur, institute alternative therapy.Directions for OTIPRIO dose preparation and handling is illustrated in Figure 1below.Because clinical studies are conducted under widely varying conditions,adverse reaction rates observed in the clinical studies of a drug cannot be directlycompared to rates in the clinical studies of another drug and may not reflect therates observed in practice.In two randomized, sham-controlled Phase 3 clinical trials, 530 pediatric patientswith bilateral otitis media with effusion undergoing tympanostomy tube placementwere treated with OTIPRIO or sham administered intra-operatively as a singledose. The median age of the pediatric patients enrolled in the clinical trials was1.5 years; 62% of patients were 6 months through 2 years of age and 38% ofpatients were greater than 2 years of age.Adverse reactions that occurred in at least 3% of OTIPRIO patients and at anincidence greater than sham are presented in Table 1.Figure 1: Directions for OTIPRIO Dose PreparationSTEP 1 PreparationMaterials needed:1 vial of OTIPRIO (enough for 2 doses); Two 1 mLluer lock syringes; Two 18G-21G preparationneedles; Two 20-24G, 2-3 inch blunt, flexibleadministration needles; Alcohol pads; Optional:ice pack and drape to keep OTIPRIO vial coldKeep product cold during preparation. IfOTIPRIO thickens during preparation, placethe vial back in refrigeration.Table 1:Adverse ReactionsSTEP 2 OTIPRIO MixingTo keep the vial cold during shaking, holdthe OTIPRIO vial by the aluminum seal toprevent gelation. Shake the vial for 5 to8 seconds to mix well until a visuallyhomogenous suspension is obtained.Always hold the vial by the aluminumseal to prevent RIO(N 357)Sham(N 173)5%5%3%4%3%2%8USE IN SPECIFIC POPULATIONS8.1PregnancyRisk SummaryAnimal reproduction studies have not been conducted with OTIPRIO. No adequateand well-controlled studies have been performed in pregnant women. Becauseof the negligible systemic exposure associated with clinical administration ofOTIPRIO, this product is expected to be of minimal risk for maternal and fetaltoxicity when administered to pregnant women.STEP 3 OTIPRIO RemovalUsing an 18-21G needle, withdraw 0.3 mLof the suspension into the 1 mL syringe.8.2STEP 4 Replace with the Administration NeedleReplace the needle with a 20-24G, 2-3 inch blunt,flexible needle to be used for administration.LactationRisk SummaryCiprofloxacin is excreted in human milk with systemic administration. However,because of the negligible systemic exposure after otic application, nursing infantsof mothers receiving OTIPRIO should not be affected.8.4Pediatric UseThe safety and effectiveness of OTIPRIO in infants below six months of age havenot been established.The safety and effectiveness of OTIPRIO was established in 530 pediatric patientswith bilateral otitis media with middle ear effusion undergoing myringotomy withtympanostomy tube placement. The median age of patients enrolled in theclinical trials was 1.5 years; 62% of patients were 6 months through 2 years ofage and 38% of patients were greater than 2 years of age [see Adverse Reactions(6.1) and Clinical Studies (14)].STEP 5 Priming the SyringePrime the needle leaving a dose of0.1 mL (0.1 cc).STEP 6 Preparing Second Dosefor Bilateral Administration OnlyRepeat Steps 3, 4, and 5 using thesame vial to prepare a secondsyringe for the other ear and disposeof the vial.Use a different syringe for each ear.After preparation, syringes can be keptat room temperature or in the refrigeratorprior to administration.Keep syringes on their side.Discard syringes if not administered in 3 hours.Adverse Reactions in Phase 3 Trials11DESCRIPTIONOTIPRIO (ciprofloxacin otic suspension) 6% contains the synthetic fluoroquinoloneantibacterial, ciprofloxacin. OTIPRIO is for intratympanic administration. OTIPRIOis supplied as a white, preservative-free, sterile otic suspension of 6% (w/v)ciprofloxacin in a neutral pH, buffered, isotonic solution in a single-patient useglass vial with a rubber stopper containing 1 mL. The inactive ingredients arepoloxamer 407, sodium chloride, tromethamine, hydrochloric acid and water forinjection (WFI).The thermosensitive suspension exists as a liquid at room temperature or belowand gels when warmed [see How Supplied/Storage and Handling (16)].2

Fertility studies performed in rats at oral doses of ciprofloxacin up to100 mg/kg/day revealed no evidence of impairment. This would beapproximately 80 times the maximum recommended clinical dose of ototopicalciprofloxacin based upon bo

Jul 01, 2016 · HCPCS Level II Codes Alpha-numeric coding system used to report specific drugs, supplies, and other healthcare equipment ICD-9-CM/ICD-10-CM Diagnosis Codes Numeric and alpha-numeric codes used to report diagnosis ICD-9-CM/ICD-10-PCS Procedure Codes Numeric and alpha-numeric codes used to repo

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