Billing and Coding Guide - OTIPRIO

Billing and Coding Guide

Effective January 1, 2016

Please see Indication and Important Safety Information for OTIPRIO on page 4, and accompanying full Prescribing Information.

OTIPRIOTM (ciprofloxacin otic suspension) 6%

Disclaimer

This guide is intended solely for educational purposes regarding possible codes that may be available for OTIPRIO. The information provided contains general reimbursement information only and represents Otonomy's understanding of current reimbursement policies as of January 1, 2016. This coding and reimbursement information is subject to change and may become outdated. Information should not be construed as legal advice nor is it advice about how to code, complete, bill, or submit any particular claim for payment. It is important to check with the health plan directly to confirm coverage for individual patients. Information provided is not intended to increase or maximize reimbursement by any payer.

Otonomy disclaims any responsibility for claims submitted by providers or physicians. The information provided in this Guide is not a guarantee of coverage in any individual case. The key in all coding and billing to payers is to be truthful and not misleading, and to 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.

Please see Indication and Important Safety Information for OTIPRIO

on page 4, and accompanying full Prescribing Information.

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Billing and Coding Guide

Contents

OTIPRIO Indication and Important Safety Information. . . . . . . . . . . . . . . . . . . 4 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Reimbursement Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Private/Commercial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Medicaid. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Medicare. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Coding for OTIPRIO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 HCPCS Level II Codes for OTIPRIO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 National Drug Code (NDC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Coding for Physician Administration Services . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Potential CPT? Codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Potential ICD-9-CM and ICD-10-PCS Procedure Codes . . . . . . . . . . . . . . . 8 Coding for the Patient's Disease/Condition. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Potential ICD-9-CM and ICD-10-CM Diagnosis Codes . . . . . . . . . . . . . . . . 9 Frequently Asked Questions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Please see Indication and Important Safety Information for OTIPRIO

on page 4, and accompanying full Prescribing Information.

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OTIPRIOTM (ciprofloxacin otic suspension) 6%

INDICATIONS AND USAGE

OTIPRIOTM (ciprofloxacin otic suspension) 6% is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS OTIPRIO 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 nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy. ADVERSE REACTIONS Adverse 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 POPULATIONS Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established. Please see accompanying full Prescribing Information.

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Billing and Coding Guide

Introduction

Otonomy, Inc. has developed this reference guide to provide general billing and coding information related to OTIPRIO for physician and hospital billing staff when used in the ambulatory surgical center (ASC), hospital outpatient department (HOPD), or hospital inpatient setting. These materials are provided as information only. To assist you in preparing claims, this guide contains the following: u Reimbursement Overview u Billing and Coding Information u Frequently Asked Questions (FAQs)

Reimbursement Overview

Coverage and coding guidelines for OTIPRIO and its administration will differ by insurer and are updated regularly. In addition, payment methodologies and rates may vary by insurer and are frequently dictated 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 the most 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 reimbursement process and explain why the patient needed treatment, what drugs and services were provided, and where services were rendered. Coding guidelines may differ by insurer and are often updated regularly to reflect the addition and deletion of applicable codes. The following table provides an overview of the different codes and their description that may be applicable when billing for items and services related to OTIPRIO.

Code Set CPT?1 Codes

(Level I HCPCS Codes)

HCPCS Level II Codes

ICD-9-CM / ICD-10-CM Diagnosis Codes

ICD-9-CM / ICD-10-PCS Procedure Codes

NDC

Revenue Codes

Description / Purpose

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 physicians Alpha-numeric coding system used to report specific drugs, supplies, and other healthcare equipment

Numeric and alpha-numeric codes used to report diagnosis

Numeric and alpha-numeric codes used to report procedures, services, devices, and drugs in acute-care hospitals and other facility-based settings Numeric, universal, and unique 3-segment product identifier used to report human drugs Numeric codes used by hospitals to report services and supplies to specific cost centers

Legend

CPT?: Current Procedural Terminology HCPCS: Healthcare Common Procedure Coding System

ICD-9-CM: International Classification of Diseases, 9th Revision, Clinical Modification ICD-10-CM: International Classification of Diseases, 10th Revision, Clinical Modification ICD-10-PCS: International Classification of Diseases, 10th Revision, Procedure Coding System

NDC: National Drug Code

1 C PT? copyright 2014 American Medical Association. All rights reserved. CPT? is a registered trademark of the American Medical Association.

Please see Indication and Important Safety Information for OTIPRIO

on page 4, and accompanying full Prescribing Information.

5

OTIPRIOTM (ciprofloxacin otic suspension) 6%

In addition, coverage and payment will also vary based on individual patient insurance details and provider contracts. An overview of the major insurer types is provided below.

Private/ Commercial Private insurance coverage policies for OTIPRIO and its administration may vary. Each private insurer determines its own coverage policies for drugs and procedures. In addition, most insurers offer multiple plans; coverage for procedures and/or drugs may vary depending on the details of that exact plan.

Medicaid In general, state Medicaid programs will cover drugs for their FDA-approved indications. It will be important to understand your state Medicaid program's specific coverage criteria for OTIPRIO and its administration as each state's Medicaid agency determines its own coverage and payment policies. Medicaid recipients may also have the opportunity to enroll in managed care organizations (MCOs) offered in a particular state. Typically, Managed Medicaid guidelines for coverage are similar to private or commercial insurers and often vary by plan.

Medicare Traditional Medicare consists of beneficiaries who receive their medical benefits through the following: u Medicare Part A: Inpatient services, hospitalizations, hospice care, skilled nursing facility stays, and some home

health services u Medicare Part B: Physician and outpatient services, durable medical equipment (DME), and some home health

care, laboratory service Currently, there is no Medicare national coverage determination (NCD) for OTIPRIO. As with most Part B covered drugs, local Medicare contractors have the discretion to develop local coverage determinations (LCDs) if necessary.

Regardless of the insurer type, formal published guidelines are typically developed for highly controversial or costly products and procedures; 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 OTIPRIO

on page 4, and accompanying full Prescribing Information.

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Billing and Coding Guide

Coding for OTIPRIO

Regardless of the setting of care in which the drug was administered, most payers require providers to list an HCPCS code and the NDC code on the claim form when billing for a particular drug.

HCPCS Level II Codes for OTIPRIO Most payers recognize Healthcare Common Procedure Coding System (HCPCS) Level II national codes to identify and report drugs. Approved by the US Food and Drug Administration (FDA) on December 11, 2015, OTIPRIO has not yet been assigned a permanent, unique HCPCS code. Until a permanent code is assigned for OTIPRIO, payers may accept the following unclassified (miscellaneous) HCPCS codes:

HCPCS Code

J3490 C93992

Description

Unclassified drugs Unclassified drugs or biologicals

Please consult payer-specific guidelines for the appropriate code to use for OTIPRIO to communicate which drug was provided and how much was administered.

National Drug Code (NDC)

The FDA and the manufacturer assign drugs/biologics a unique, 3-segment number, known as the National Drug Code (NDC). Many NDCs (including the one assigned to OTIPRIO) are displayed in a 10-digit format on the FDAapproved prescribing information. Proper billing for most payers or electronic data interchange systems requires that the NDC be submitted in the 11-digit numeric 5-4-2 format (ie, 55555-4444-22). Converting a 10-digit NDC to 11-digit format requires a strategically placed zero preceding the section that does not comply with the 5-4-2 format. Do not use hyphens when entering the actual data on your claim.

For example:

10-Digit Format

5-3-2

OTIPRIO 10-Digit NDC

69251-201-01

11-Digit Format

5-4-2

OTIPRIO 11-Digit NDC

69251-0201-01

Reporting on claim form

69251020101

2 N ote: C-codes are used for billing Medicare in the hospital outpatient setting. Please review private payer and Medicaid guidelines for your non-Medicare patients prior to utilizing the C-code to bill for OTIPRIO.

Please see Indication and Important Safety Information for OTIPRIO

on page 4, and accompanying full Prescribing Information.

7

OTIPRIOTM (ciprofloxacin otic suspension) 6%

Coding for Physician Administration Services

Coding for the administration of OTIPRIO may vary depending on the setting of care. In the physician office, HOPD, and ASC, CPT? codes are used to describe procedures. In the hospital inpatient department, billers are required to use ICD-10-PCS codes to bill for procedures.

Potential CPT? Codes

Current 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 that accurately 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 primary procedure and therefore not coded separately. Providers should use the appropriate tympanostomy CPT? code that best describes the services provided. Also, when performed bilaterally, report with modifier 50.

CPT? Code

69433 69436

Description

Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia Tympanostomy (requiring insertion of ventilating tube), general anesthesia

Potential ICD-9-CM and ICD-10-PCS Procedure Codes

ICD-9-CM and ICD-10-PCS codes are typically used to bill for procedures performed on inpatients. Effective October 1, 2015, all Health Insurance Portability and Accountability Act (HIPAA)-covered entities were required to 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 may therefore choose the code that best describes the procedure. Below is a list of the existing ICD-9-CM code and the ICD-10-PCS Crosswalk that may be applicable for describing the administration of OTIPRIO when administered during tube placement surgery.

ICD-9-CM Procedure Code ICD-10-PCS

3E0B7GC Introduction of other therapeutic substance into ear, via natural or artificial opening

20.94 Injection of tympanum

3E0B3GC Introduction of other therapeutic substance into ear, percutaneous approach

3E0BXGC Introduction of other therapeutic substance into ear, external approach

099500Z Drainage of right middle ear with drainage device, open approach

20.01 Myringotomy with insertion of tube

099600Z Drainage of left middle ear with drainage device, open approach 099770Z Drainage of right tympanic membrane with drainage device, via natural or artificial opening

099870Z Drainage of left tympanic membrane with drainage device, via natural or artificial opening

Please see Indication and Important Safety Information for OTIPRIO

on page 4, and accompanying full Prescribing Information.

8

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