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2018 Billing and Coding Guide for

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Table of Contents

1. Introduction

2. Coding Quick Reference Guide

3. Coding for Probuphine® (buprenorphine) implant

• National Drug Codes (NDC)1

• Healthcare Common Procedure Coding System(HCPCS)2

• International Classification of Diseases, ClinicalModification codes (ICD-10 CM)3

• Current Procedural Terminology (CPT®) code4

4. Sites of Service

• Provider office, community based provider: CMS-1500claim form5

• Hospital outpatient clinic: UB-04/CMS 14506 claim form

5. Titan Access Program

• Patient Enrollment Order Form

6. Important Safety Information for Probuphine

PRO-18EBA006 08/2018

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Introduction The general coding and billing information contained in this guide was compiled from public sources and is provided to help you understand the availability of reimbursement related to Probuphine (buprenorphine) implant. This guide is provided as general information only and is not intended as coverage or coding advice, nor is it intended to increase or maximize reimbursement by any payor. Titan cannot provide specific reimbursement rates, and does not guarantee any level of reimbursement. Titan makes no other representations or warranties regarding the selection of codes for procedures or compliance of the information in this guide with any other billing protocols or requirements.

Similarly, all CPT, HCPCS and ICD-10-CM codes are supplied for information purposes only and represent no statement, promise or guarantee by Titan that these codes will be appropriate or that reimbursement will be made. As with all claims, individual hospitals and physicians are responsible for exercising independent clinical judgment in selecting the codes that most accurately reflect a patient’s condition and the procedures performed. Laws, regulations, and policies concerning coding and payment are complex and subject to change. Physicians and hospitals should refer to current, complete, and authoritative publications, such as AMA CPT® lists, Medicare transmittals, and third-party payor policies as the basis for selecting codes that describe care rendered to an individual patient, and may wish to contact individual Medicare contractors or other third-party insurers as needed.

Probuphine® (buprenorphine) implant for subdermal administration

INDICATIONS AND USAGE

PROBUPHINE contains buprenorphine, a partial opioid agonist. Probuphine is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet equivalent or generic equivalent).

PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support.

PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet equivalent or generic equivalent.

Please see IMPORTANT SAFETY INFORMATION including BOXED WARNING on

pages 14 & 15

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Coding Quick Guide

Item Code Description HCPCS1 Code J0570 Buprenorphine implant, 74.2 mg

HCPCS Code G0516 Insertion of non-biodegradable drug delivery implants, 4 or more (services for subdermal rod implant)

HCPCS Code G0517 Removal of non-biodegradable drug delivery implants, 4 or more (services for subdermal implants)

HCPCS Code G0518 Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more (services for subdermal implants)

CPT® Code 17999 Unlisted procedure, skin, mucous membrane and subcutaneous

Potential ICD-10-CM3

Codes

F11.10 Opioid Abuse Uncomplicated

F11.20 Opioid Dependence Uncomplicated

F11.21 Opioid Dependence in Remission

11 Digit NDC4 58284-0100-14

Each Probuphine System Kit contains: 4 Probuphine non-biodegradable implantable rods (a subdermal implant containing 74.2 mg of buprenorphine which is the equivalent of 80 mg of buprenorphine hydrochloride); and one Probuphine Applicator

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National Drug Codes: NDC The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and

Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated,

compounded, or processed by it for commercial distribution. (See Section 510 of the Federal

Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported

using a unique, three-segment number, called the National Drug Code (NDC), which serves as a

universal product identifier for drugs. FDA publishes the listed NDC numbers and the

information submitted as part of the listing information in the NDC Directory which is updated

daily.

The NDC for Probuphine® (buprenorphine) implant is:

NDC Number Number Description

11 Digit NDC Number 52440-0100-14

Each Probuphine System Kit

contains: 4 Probuphine non-

biodegradable implantable

rods (a subdermal implant

containing 74.2 mg of

buprenorphine which is the

equivalent of 80 mg of

buprenorphine

hydrochloride); and one

Probuphine Applicator

CMS 1500 Claim Form – 80 Character Abbreviated Descriptor:

NDC Number Number Description

11 Digit NDC Number 52440-0100-14

Each Probuphine Kit

contains: 4 Probuphine non-

biodegradable implants rods

and one Probuphine

Applicator

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Healthcare Common Procedure Coding System

(HCPCS) 1 Codes The HCPCS Level II Code Set is one of the standard code sets used for medical claims processing

of office administered drugs. The HCPCS is divided into two principal subsystems, referred to as

level I and level II of the HCPCS. Level I of the HCPCS is comprised of CPT® (Current Procedural

Terminology), a numeric coding system maintained by the American Medical Association

(AMA). The CPT® is a uniform coding system consisting of descriptive terms and identifying

codes that are used primarily to identify medical services and procedures furnished by

physicians and other health care professionals. These health care professionals use the CPT® to

identify services and procedures for which they bill public or private health insurance programs.

Decisions regarding the addition, deletion, or revision of CPT® codes are made by the AMA. The

CPT® codes are republished and updated annually by the AMA. Level I of the HCPCS, the CPT®

codes, does not include codes needed to separately report medical items or services that are

regularly billed by suppliers other than physicians.

Level II of the HCPCS is a standardized coding system that is used primarily to identify products,

supplies, and services not included in the CPT® codes, such as ambulance services and durable

medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a

physician's office. Because Medicare and other insurers cover a variety of services, supplies,

and equipment that are not identified by CPT® codes, the level II HCPCS codes were established

for submitting claims for these items. The development and use of level II of the HCPCS began

in the 1980's. Level II codes are also referred to as alpha-numeric codes because they consist of

a single alphabetical letter followed by 4 numeric digits, while CPT® codes are identified using 5

numeric digits.

Level II HCPCS Codes for billing Probuphine®

HCPCS Code Description Use

J0570 Buprenorphine implant, 74.2 mg Physician office and Outpatient

Ambulatory Facilities

Probuphine has been assigned a specific J-Code for Probuphine (J0570) beginning January 1, 2017.

This for the drug code only. The Medicare Allowable is per implant (descriptor 74.2mg) and

reimbursed at $1257.11 which is based on ASP. The 2017 ASP Drug Pricing Files can be found at the following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2017ASPFiles.html. Please note that the content provided by the Center for Medicare and Medicaid Services is updated frequently and should be checked quarterly.

Due to the variability of health plan design and reimbursement, the

physician should contact the patient’s payer provider relations

representative prior to implanting Probuphine to determine

reimbursement for the procedure

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Potential Level I Current Procedural Terminology

(CPT®) Administration Codes for billing

Probuphine® (buprenorphine) There are no current administration codes that describe the implantation or removal of

Probuphine®. Probuphine consists of 4 non-biodegradable implants. Providers should consult

with their local carriers to identify the most appropriate administration coding procedures and

required documentation.

The 2017 Medicare Physician Fee Schedule can be found at the following link:

https://www.cms.gov/apps/physician-fee-schedule/license-agreement.aspx

• CPT Copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American

Medical Association. The AMA assumes no liability for data contained or not contained herein.

• # Represents National amounts for the CMS Physician Fees when the service is provided in the physician’s office (non-

facility setting)

Due to the variability of health plan design and reimbursement, the physician

should contact the patient’s payer provider relations representative prior to

implanting Probuphine to determine reimbursement for the procedure

Type of Code Code Number Description

The 2017 Medicare Physician Fee

Schedule HCPCS Code G0516 Insertion of non-biodegradable drug delivery

implants, 4 or more (services for subdermal rod implant)

HCPCS Code G0517 Removal of non-biodegradable drug delivery implants, 4 or more (services for subdermal implants)

HCPCS Code G0518 Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more (services for subdermal implants)

CPT® Code 11981 Insertion of single non-biodegradable implant $143.91#

CPT® Code 11982 Removal of single non-biodegradable implant $163.29#

CPT® Code 11983 Removal and re-insertion of single non-biodegradable implant

$230.41#

CPT® Code 17999 unlisted procedure, skin, mucous membrane and subcutaneous

Payor Specific

$239.40#

$263.16#

$454.31#

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International Classification of Diseases, 10th

Revision, Clinical Modification (ICD-10-CM) 6 Codes

that may be appropriate for use when billing a

claim for Probuphine® (buprenorphine)

The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is

a system used by physicians and other healthcare providers to classify and code all diagnoses,

symptoms and procedures recorded in conjunction with hospital care in the United States.

ICD-10-CM is composed of codes with 3, 4, 5, 6 or 7 characters. Codes with three characters are

included in ICD-10-CM as the heading of a category of codes that may be further subdivided by

the use of fourth, fifth, sixth or seventh characters to provide greater specificity. A three-

character code is to be used only if it is not further subdivided. While diagnosis coding to the

correct level of specificity is the goal for all claims, for 12 months after ICD-10 implementation,

if a valid ICD- 10 code from the right family (see question 5) is submitted, Medicare fee-for-

service will process and not audit valid ICD-10 codes unless such codes fall in.

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Potential ICD-10-CM Codes for use when billing a claim

for Probuphine ® (buprenorphine) use most specific sub-coding possible

ICD-10-CM Code Code description

F11 Opioid related disorders

F11.1 Opioid abuse

F11.10 Opioid abuse uncomplicated

F11.2 Opioid dependence

F11.20 Opioid dependence uncomplicated

F11.21 Opioid dependence in remission

F11.24 Opioid dependence with opioid-induced mood

disorder

F11.25 Opioid dependence with opioid-induced psychotic

disorder

F11.29 Opioid dependence with other opioid-induced

disorder with unspecified opioid-induced disorder

F11.9 Opioid use, unspecified

F11.90 Opioid use, unspecified uncomplicated

F11.99 Opioid use, unspecified with unspecified opioid-

induced disorder

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2017 Physician Office Sample Claim Form:

CMS-15005, 6 Item 19 - When billing HCPCS J0570, some payers may ask providers to specify Probuphine®

(subdermal buprenorphine implant) with dosage administered and NDC 52440-0100-14, Kit or

number of units, e.g. 4 Buprenorphine Implants 74.2mg

NOTE: Some payers require alternate product codes (i.e., Medicaid claims). Please consult with

your local payers or contact the Titan Access Program at 1-844-859-6341 for further

information.

Item 21 - Indicate diagnosis/diagnoses using appropriate ICD-10-CM codes, such as F11.10

(Opioid Abuse Uncomplicated), F11.20 (Opioid dependence, uncomplicated) or F11.21 (Opioid

Dependence in Remission).

Item 24D - Indicate appropriate HCPCS and CPT codes and modifiers if required. Be sure to enter either the procedure HCPCS codes of G0516-G0518 or the procedure CPT codes of 11981-11983 or the unlisted CPT code 17999 (unlisted procedure, skin, mucous membrane and subcutaneous).

NOTE: Individual payers will require documentation to adjudicate any claim billed with an

unlisted CPT code. Please consult with your local payer or contact the Titan Access Program at

1-844-859-6341 for further information. Additional information on the procedure may be

placed in Item 19.

Item 24E - Refer to the diagnosis for this service (see box 21). Enter only one diagnosis pointer

per line.

Item 24G – One Probuphine kit contains 4 subdermal implants (74.2 mg of Buprenorphine or 80

mg Buprenorphine HCL each). CMS has designated each Buprenorphine implant to represent 1

unit. For all payers, whether performed in the outpatient clinic or a physician’s office, the entity

should code for 4 units of J0570 unless otherwise directed by the payer.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-

MLN/MLNMattersArticles/Downloads/MM9930.pdf

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Sample CMS-1500 claim form (physician office

billing)

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2017 HOPD Sample Claim Form:

UB-04/CMS 14507,6 Locator Box 42 – Enter appropriate revenue code, such as:

• For Medicare, revenue code 0636 (drugs that require detailed coding)

• For non-Medicare payers, revenue code 0250 (general pharmacy)

• Injection services may be reported with revenue code 0510 (clinic, general

service)

Locator Box 43 - Describe the implant procedure

Locator Box 44 - indicate appropriate CPT and HCPCS codes and modifiers if required. The HCPCS codes G0516, G0517, or G0518 may be considered for documenting the procedural service. The following CPT codes may be considered for documenting the procedural service: 11981, 11982, 11983 or the unlisted CPT code 17999 (unlisted procedure, skin, mucous

membrane and subcutaneous). Additional information on the procedure may be placed in

Locator Box 80. Medicare and Private Payer claims will require HCPCS J0570 as of January 1,

2017.

NOTE: Individual payers will require documentation to adjudicate any claim billed with an

unlisted CPT code. Please consult with your local payer or The Titan Access Program at

1-844-859-6341 to confirm payer requirements.

Locator Box 46 - Enter 1 unit for the kit of 4 Probuphine subdermal implants (296.8 mg of

Buprenorphine or 320 mg Buprenorphine HCL).

Locator Box 47 - indicate total charges.

Locator Box 67 - Indicate diagnosis/diagnoses using appropriate ICD-10-CM codes, either

F11.10 (Opioid Abuse Uncomplicated), F11.20 (Opioid dependence, uncomplicated) or F11.21

(Opioid Dependence in Remission).

Locator Box 80 - When billing a not-otherwise-classified HCPCS code like J3490, some payers

may ask providers to specify Probuphine® (subdermal buprenorphine implant) with dosage

administered and NDC 52440-0100-14.

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Sample UB-04 (CMS-1450) claim form

(institutional billing)

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Indication & Important Safety InformationINDICATIONS AND USAGEPROBUPHINE ® (buprenorphine) is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet equivalent or generic equivalent).

PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support.

PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet or generic equivalent.

IMPORTANT SAFETY INFORMATIONWARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE

DAMAGE ASSOCIATED WITH INSERTION and REMOVAL

Risk Associated with Insertion and Removal

Insertion and removal of PROBUPHINE are associated with the risk of implant migration, protrusion, expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion.

Because of the risks associated with insertion and removal, PROBUPHINE is available only through a restricted program called the PROBUPHINE REMS Program. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing PROBUPHINE implants. Patients must be monitored to ensure that PROBUPHINE is removed by a healthcare provider certified to perform insertions.

PROBUPHINE is contraindicated in patients with a history of hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).

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SUMMARY OF WARNINGS AND PRECAUTIONS

• Serious Complications from Insertion and Removal: Rare but serious complicationsincluding nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion, and expulsion. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program prior to performing insertions or prescribing PROBUPHINE implants.

• Addiction, Abuse, and Misuse: Buprenorphine can be abused in a manner similar to otheropioids. Monitor patients for conditions indicative of diversion or progression of opioiddependence and addictive behaviors.

• Respiratory and CNS Depression: Life-threatening respiratory depression and death haveoccurred in association with buprenorphine use.

• Concomitant Use of Benzodiazepines or other CNS Depressants: concomitant use increasesthe risk of adverse reactions including overdose and death. Ensure that other healthcareproviders prescribing benzodiazepines or other CNS depressants are aware of the patient’sbuprenorphine treatment and coordinate care to minimize this risk.

• Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome(NOWS) isan expected and treatable outcome of prolonged use of opioids during pregnancy.

• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids,and wean patient off of the opioid.

• Unintentional Pediatric Exposure: In the event an implant protrudes or comes out, keepthe implant away from children. Buprenorphine can cause severe, possibly fatal, respiratorydepression in children.

• Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with PROBUPHINE istemporarily interrupted or discontinued, monitor patients for withdrawal and treatappropriately.

• Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and duringtreatment and evaluate suspected hepatic events.

• Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient isclinically stable on transmucosal buprenorphine and not dependent on full agonists beforeinserting PROBUPHINE.

• Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic wheneverpossible. If opioid therapy is required, monitor patients closely because higher doses may berequired for analgesic effect.

• Impairment of Ability to Drive and Operate Machinery: PROBUPHINE may impair theabilities required for potentially dangerous tasks such as driving a car or operatingmachinery, especially for the first 24-48 hours following initial insertion.

Adverse events commonly associated with PROBUPHINE administration (>10% of subjects) were implant-site pain, pruritus, and erythema, as well as non-implant-site related events (≥5%) of headache, depression, constipation, nausea, vomiting, back pain, toothache, and oropharyngeal pain.

To report SUSPECTED ADVERSE REACTIONS, contact Titan at 1-844- 859-6341 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING and MEDICATION GUIDE.

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Footnotes 1. NDC National Drug Code: The Drug Listing Act of 1972 requires registered drug establishments to provide the

Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated,compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, andCosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segmentnumber, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDApublishes the listed NDC numbers and the information submitted as part of the listing information in the NDCDirectory which is updated daily. The information submitted as part of the listing process, the NDC number,and the NDC Directory are used in the implementation and enforcement of the Act.

2. HCPCS Level II Coding Process & Criteria: The Centers for Medicare and Medicaid (CMS) published on August17, 2000 (45 CFR 162.10002) to implement the HIPAA requirement for standardized coding systems establishedthe HCPCS level II codes as the standardized coding system for describing and identifying health careequipment and supplies in health care transactions that are not identified by the HCPCS level I, CPT codes. TheHCPCS level II coding system was selected as the standardized coding system because of its wide acceptanceamong both public and private insurers. Public and private insurers were required to be in compliance with theAugust 2000 regulation by October 1, 2002. The HCPCS Level II Coding Process/Criteria document describesHCPCS level II coding procedures and coding criteria.

3. ICD-10-CM: The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is asystem used by physicians and other healthcare providers to classify and code all diagnoses, symptoms andprocedures recorded in conjunction with hospital care in the United States. The Centers for Disease Controldeveloped and maintains the ICD-10-CM code set. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational-Tool-ICN900943.pdf

4. CPT®, Current Procedural Terminology: The American Medical Association developed and maintains theofficial Current Procedural Terminology (CPT®) code set. Please refer to AMA website with any questions at thefollowing link: https://www.ama-assn.org/practice-management/cpt-frequently-asked-questions The CPT isthe most widely accepted medical nomenclature used to report medical procedures and services under publicand private health insurance programs. CPT is maintained by the CPT Editorial Panel, which meets three timesa year to discuss issues associated with new and emerging technologies as well as difficulties encountered withprocedures and services and their relation to CPT codes.

5. CMS 1500 Form: The Form CMS-1500 is the standard paper claim form to bill Medicare Fee-For-Service (FFS)Contractors when a paper claim is allowed. In addition to billing Medicare. Form CMS-1500 may be suitable forbilling various government and some private insurers. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/form_cms-1500_fact_sheet.pdf

6. Developed by Alchemy Healthcare Solutions LLC, 5/2016

7. UB-04 (CMS-1450) Form: The Form CMS-1450, also known as the UB-04, is the standard claim form to billMedicare Administrative Contractors (MACs) when a paper claim is allowed. In addition to billing Medicare, the837I and Form CMS- 1450 may be suitable for billing various government and some private insurers.https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/837I-FormCMS-1450-ICN006926.pdf

PRO-18EBA006 08/2018