Billing and CodingGuide for SUBLOCADE (buprenorphine extended‑release)WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION;SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass uponcontact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events,including life threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration,SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program.Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this programand comply with the REMS requirements.Please see accompanying full Prescribing Information, includingBOXED WARNING, and Medication Guide or go to SUBLOCADEHCP.com.P-BAG-US-01048EXPIRY December 2023
This brochure is designed to help appropriate and eligible patients get access to Indivior medications by providing reimbursementinformation for healthcare providers (HCPs). HCPs are responsible for ensuring all information submitted on or with the claim isaccurate, complete, and applicable to the claim being filed. Indivior makes no representations or warranties or guarantees of any kindrelating to access, coverage, or reimbursement.INSUPPORT was created by Indivior to provide information on the accessand reimbursement processes on behalf of patients seeking treatment withSUBLOCADE (buprenorphine extended-release). INSUPPORT providesinformation for HCPs and their offices in support of these patients, including:BENEFIT COVERAGE INFORMATION Conduct a benefit investigation of the patient’s insurance coverage forSUBLOCADE for the patient’s current site of care Provide information on the prior authorization and appeals process and confirmproduct acquisition requirements from the patient’s health insurance provider If applicable, determine eligibility and enroll an eligible patient for the CopayAssistance Program for SUBLOCADE, or provide alternate funding informationCOPAY ASSISTANCE PROGRAM Designed to help eligiblea patients with the out-of-pocket costs for SUBLOCADE Eligiblea patients may pay as little as 0 per injection of SUBLOCADE for the first 2injections. Restrictions applyTRANSITION OF CARE Assistance in the transition process for patients who are receiving treatmentwith SUBLOCADE and transitioning to a new healthcare setting to continueSUBLOCADE treatmentPATIENT ACCESS SPECIALIST (PAS) A local specialist that can provide information about INSUPPORT, includingpatient insurance benefits and requirementsINSUPPORT ONLINE Enroll patients electronically in any INSUPPORT program option onwww.INSUPPORTportal.com, including Benefit Investigation, Copay Assistance,and Transition of Care Find information about the steps in the patient access program, utilize tools, andaccess other resources on www.INSUPPORT.comaThe INSUPPORT Copay Assistance Program is valid ONLY for patients with private insurance who are prescribed SUBLOCADE foron-label use. Patients with government insurance are not eligible for the Copay Assistance Program, including, but not limited to,Medicare, Medicaid, Medigap, VA, DoD, TRICARE, CHAMPVA, or any other federally or state-funded government-assisted program. Otherrestrictions apply. See insert or visit www.INSUPPORT.com to view complete Terms & Conditions.For BOXED WARNING, refer to front page. Please see accompanying full Prescribing Information,including BOXED WARNING, and Medication Guide or go to SUBLOCADEHCP.com.P-BAG-US-01048EXPIRY December 2023
INTERNATIONAL CLASSIFICATION OFDISEASES, 10 th REVISION (ICD-10) CODESFOR OPIOID DEPENDENCE1SUBLOCADE (buprenorphine extended-release) is indicated for the treatment of moderate to severe opioiduse disorder in patients who have initiated treatment with a transmucosal buprenorphine-containingproduct, followed by dose adjustment for a minimum of 7 days.SUBLOCADE should be used as part of a complete treatment program that includes counseling andpsychosocial support.ICD-10 CODESF11.20Opioid dependence, uncomplicatedF11.21Opioid dependence, in remissionF11.220Opioid dependence with intoxication, uncomplicatedF11.221Opioid dependence with intoxication, deliriumF11.222Opioid dependence with intoxication with perceptual disturbanceF11.229Opioid dependence with intoxication, unspecifiedF11.24Opioid dependence with intoxication with opioid-induced mood disorderF11.250Opioid dependence with opioid-induced psychotic disorder with delusionsF11.251Opioid dependence with opioid-induced psychotic disorderwith hallucinationsF11.259Opioid dependence with opioid-induced psychotic disorder, unspecifiedF11.281Opioid dependence with other opioid-induced sexual dysfunctionF11.282Opioid dependence with other opioid-induced sleep disorderF11.288Opioid dependence with other opioid-induced disorderF11.29Opioid dependence with unspecified opioid-induced disorderThe individual or entity submitting a claim using INSUPPORT reimbursement and coding information mustensure that all information submitted on or with the claim is accurate, complete, and applicable to the claimbeing filed.The above-listed codes are provided for informational, nonpromotional purposes only. Third-party coverageand reimbursement are complex and may change frequently. Providers are responsible for determining andsubmitting appropriate codes and charges and appropriate medical services and products in accordancewith providers’ independent professional judgment.Indivior makes no representations or warranties or guarantees of any kind relating to access, coverage,or reimbursement.The appropriateness of filing any particular claim is and remains the responsibility of that claim’s submitterbased on the submitter’s own judgment.For BOXED WARNING, refer to front page. Please see accompanying full Prescribing Information,including BOXED WARNING, and Medication Guide or go to SUBLOCADEHCP.com.P-BAG-US-01048EXPIRY December 2023
BILLING CODESNATIONAL DRUG CODES (NDCs)2 FOR SUBLOCADE (buprenorphine extended‑release) AND FORMATTING ONMEDICAL CLAIMSNDCMILLIGRAMSNDC FORMATFOR CLAIMSNDC LOCATION ONCLAIM FORMS12496-0100-01100 mgN412496010001 CMS-1500: Box 24A CMS-1450: Field 4212496-0300-01300 mgN412496030001 CMS-1500: Box 24A CMS-1450: Field 42CURRENT PROCEDURAL TERMINOLOGY (CPT) CODE3CPT CODEaDESCRIPTION96372Therapeutic, prophylactic, or diagnostic injection(specify substance or drug); subcutaneous or intramuscularSUBLOCADE should be administered by an HCP by subcutaneous injection only. Do notadminister SUBLOCADE intravenously or intramuscularly.aCPT Copyright 2021 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.The individual or entity submitting a claim using INSUPPORT reimbursement and coding informationmust ensure that all information submitted on or with the claim is accurate, complete, and applicable to theclaim being filed. The above-listed codes are provided for informational, nonpromotional purposes only.The information provided is accurate on the publication date, but it should be independently verified. Theappropriateness of filing any particular claim is and remains the responsibility of that claim’s submitter basedon the submitter’s own judgment.PRODUCT-SPECIFIC HEALTHCARE COMMON PROCEDURECODING SYSTEM (HCPCS) CODES FOR SUBLOCADE4HCPCS CODEDESCRIPTIONNUMBER OF UNITSQ9991Injection, buprenorphine extended-release(Sublocade), less than or equal to 100 mg1Q9992Injection, buprenorphine extended-release(Sublocade), greater than 100 mg1Q-codes are primarily applicable to the physician office or hospital outpatient clinic settings.Please note that some payers, including state Medicaid programs, require HCPs to report the 11-digitversion of the NDC compliant with the Health Insurance Portability and Accountability Act (HIPAA)(5-4-2 format) for a physician-administered drug along with its HCPCS code on paper claim forms and theirelectronic equivalents.5For BOXED WARNING, refer to front page. Please see accompanying full Prescribing Information,including BOXED WARNING, and Medication Guide or go to SUBLOCADEHCP.com.P-BAG-US-01048EXPIRY December 2023
BILLING SUBLOCADE (buprenorphine extended‑release)BILLING IN MEDICARE VS OTHER PAYERSThe table below highlights the codes and associated descriptions.Claim FormMEDICARE6ProfessionalServicesSUBLOCADEALL SPITALOUTPATIENTCMS-1500CMS-1500CMS-1450G2086 and G208796372Q9991 or Q9992Q9991 or CADEQ9991 or Q9992Q9991 or Q9992Q9991 or Q9992G CODE DESCRIPTIONS IN OPIOID TREATMENT PROGRAM (OTP)AND PHYSICIAN OFFICE SETTINGS6The table below notes the relevant G codes for an episode of care in the OTP or physician office setting.Please note the G codes are for weekly episodes of care.G CODEDESCRIPTIONWeekly Codes in OTP SettingG2069Medication assisted treatment, buprenorphine (injectable); weekly bundle including dispensing and/or administration, substance use counseling, individual and group therapy, and toxicology testing ifperformed (provision of the services by a Medicare-enrolled Opioid Treatment Program)G2074Medication assisted treatment, weekly bundle not including the drug, including substance usecounseling, individual and group therapy, and toxicology testing if performed (provision of the servicesby a Medicare-enrolled Opioid Treatment Program)Monthly Codes in Physician Office SettingG2086Office-based treatment for opioid use disorder, including development of the treatment plan, carecoordination, individual therapy and group therapy and counseling; at least 70 minutes in the firstcalendar monthG2087Office-based treatment for opioid use disorder, including care coordination, individual therapy and grouptherapy and counseling; at least 60 minutes in a subsequent calendar monthMedicare reimburses OTPs with a bundled payment for opioid use disorder treatment services.6 An OTPis defined as “a program or practitioner engaged in opioid treatment of individuals with an opioid agonistmedication.”7 The Substance Abuse and Mental Health Services Administration (SAMHSA) certifies andrequires that OTPs must: Be accredited by a federally deemed accrediting body Be accredited under the Behavioral Health Care accreditation program (if the OTP “is part of anorganization accredited under a different program by The Joint Commission”) Have an active patient eligible for survey7For BOXED WARNING, refer to front page. Please see accompanying full Prescribing Information,including BOXED WARNING, and Medication Guide or go to SUBLOCADEHCP.com.P-BAG-US-01048EXPIRY December 2023
ADDITIONAL RESOURCESINSUPPORT PatientEnrollment FormINSUPPORTResources &Tools for HCPsList of NetworkSpecialty Distributorsfor SUBLOCADEFor more information on the INSUPPORT program, call INSUPPORTat 844-INSPPRT (844-467-7778) or visit www.INSUPPORT.com.REFERENCES1. Centers for Medicare & Medicaid Services. ICD-10-CM tabular list of diseases and injuries. 2010. Accessed November 29, 2021. s/6 i10tab2010.pdf 2. Sublocade. Prescribing information. Indivior Inc; 2021. 3. 2021 Professional Edition, Current Procedural Terminology(CPT). Copyright 2021. American Medical Association; 2021. All rights reserved. 4. Centers for Medicare & Medicaid Services (CMS). HCPCS Workgroup. October2021 Quarterly Update File. September 09, 2021. Accessed November 29, 2021. cing-file.zip 5. Centers forMedicare & Medicaid Services. Medicare Learning Network. MLN Matters Number: SE1234. Important information concerning the Medicare crossover processand state Medicaid agency requirements for National Drug Codes (NDCs) associated with physician-administered Part B drugs. September 5, 2012. AccessedNovember 29, 2021. hs-guidance-documents/SE1234.pdf 6. Centers for Medicare & Medicaid Services.Revisions to payment policies under the Medicare Physician Fee Schedule, Quality Payment Program and other revisions to Part B for CY 2020. AccessedNovember 29, 2021. on-Notices-Items/CMS-1715-F.7. The Joint Commission. Opioid Treatment Program (OTP) Accreditation. Accessed November 29, 2021. t-program-accreditation/Please see accompanying full Prescribing Information, includingBOXED WARNING, and Medication Guide or go to SUBLOCADEHCP.com.P-BAG-US-01048 EXPIRY December 2023SUBLOCADE and INSUPPORT are registered trademarks of Indivior UK Limited. 2021 Indivior PLC INDIVIOR is a registered trademark of Indivior UK Limited All rights reserved.
12496-0100-01 100 mg N412496010001 CMS-1500: Box 24A CMS-1450: Field 42 12496-0300-01 300 mg N412496030001 CMS-1500: Box 24A CMS-1450: Field 42. CURRENT PROCEDURAL TERMINOLOGY (CPT) CODE. 3. CPT CODE. a. DESCRIPTION. 96372. Therapeutic, prophylactic, or diagnostic