Policy Name: Policy Number: Responsible Department(s): CLINICAL MEDICAL POLICY Vivitrol (Extended-release injectable naltrexone) MP-072-MD-DE Provider Notice Date: 04/15/2018 Issue Date: 05/15/2018 Effective Date: 05/15/2018 Annual Approval Date: 03/13/2019 Revision Date: Products: Application: Medical Management; Clinical Pharmacy N/A Page Number(s): 1 of 6 Highmark Health Options Medicaid All participating hospitals and providers DISCLAIMER Highmark Health Options medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions. POLICY STATEMENT Highmark Health Options may provide coverage under the medical or pharmacy benefits of the Company s Medicaid products for medically necessary injectable naltrexone (e.g., Vivitrol). This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records. The qualifications of the policy will meet the standards of the National Committee for Quality Assurance (NCQA) and the Delaware Department of Health and Social Services (DHSS) and all applicable state and federal regulations. DEFINITIONS Behavioral Health Providers Providers identified in one of the following specialties: Psychiatry, Neuropsychiatry, Addiction Medicine, Behavioral Health, Eating Disorder, Substance Abuse. Policy No. MP-072-MD-DE Page 1 of 6
PROCEDURES 1. Vivitrol (injectable naltrexone) is considered medically necessary for the initial treatment of opioid and/or alcohol dependence when the following criteria are met: A. The patient has a documented diagnosis of opioid and/or alcohol dependence; AND B. The patient is 18 years of age or older; AND C. Prescriber must be a Behavioral Health Provider or In-Network/Participating Provider; AND D. The dosing schedule is 380 mg IM every 4 weeks (within FDA-approved dosing guidelines); AND E. There is documentation that the patient has been evaluated for any other mental health condition and, if diagnosed, the patient is receiving treatment (counseling, medication, etc.) for it; AND F. Certain criteria must be met based upon the patient s diagnosis: 1) Alcohol dependence a. The patient is not actively consuming alcohol at the time of therapy initiation; AND b. The patient is not currently on opioid analgesics (e.g., for pain management), physiologically dependent on opioids, or in acute opioid withdrawal; AND c. An attestation is provided indicating the patient has been opioid-free for a minimum of 7-10 days prior to therapy initiation including having pertinent laboratory testing (e.g., a recent urine drug screen for opioids, naloxone challenge test) done; AND 2) Opioid dependence a. The patient is not currently on opioid analgesics (e.g., for pain management), physiologically dependent on opioids, or in acute opioid withdrawal; AND b. An attestation is provided indicating the patient has been opioid-free for a minimum of 7-10 days prior to therapy initiation including having pertinent laboratory testing (e.g., a recent urine drug screen for opioids, naloxone challenge test) done; AND G. Documentation is provided demonstrating tolerability to oral naltrexone; AND H. The provider attests to the patient being evaluated by a behavioral health provider or a provider licensed for drug and alcohol services (D&A provider), or that the patient has been referred to or has an appointment scheduled with that provider, for the purposes of determining a treatment plan 2. Vivitrol (injectable naltrexone) is considered medically necessary for the reauthorization of treatment of opioid and/or alcohol dependence when the following criteria are met: A. The patient has been consistently receiving injectable naltrexone, as verified by pharmacy claims, and if the patient has not refilled the medication in the last 45 days, the initial criteria will apply 3. Contraindications Vivitrol (injectable naltrexone) is contraindicated in: Patients receiving opioid analgesics Patients with current physiologic opioid dependence Policy No. MP-072-MD-DE Page 2 of 6
Patients in acute opioid withdrawal Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids Patients who have previously exhibited hypersensitivity to naltrexone, polylactide-coglycolide (PLG), carboxymethylcellulose, or any other components of the diluent In acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. 4. When the naltrexone (Vivitrol) injection services are not covered The administration of naltrexone is not covered for conditions other than those listed above because the scientific evidence has not been established. Coverage may be provided for any non-fda labeled indication or a medically accepted indication that is supported by nationally recognized pharmacy compendia or peer-reviewed medical literature for treatment of the diagnosis (es) for which it is prescribed and will be reviewed on a case-by-case basis to determine medical necessity. When non-formulary prior authorization criteria are not met, the request will be forwarded to a Medical Director for review. The physician reviewer must override criteria when, in their professional judgement, the requested medication is medically necessary. 5. Post-payment Audit Statement The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Highmark Health Options at any time pursuant to the terms of your provider agreement. 6. Place of Service The place of service for the administration of naltrexone (Vivitrol) is inpatient and/or outpatient. GOVERNING BODIES APPROVAL The FDA approved an injectable (intramuscular), long-acting form of naltrexone (Vivitrol ) in April 2006. In October 2010, the FDA expanded the indication of Vivitrol to include the prevention of relapse to opioid dependence, following opioid detoxification. CODING REQUIREMENTS Covered Procedure Codes CPT Codes Description J2315 Injection, naltrexone, depot form, 1 mg [Vivitrol ] Covered Diagnosis Codes ICD-10 Codes Description F10.10 Alcohol abuse, uncomplicated F10.11 Alcohol abuse, in remission F10.120 Alcohol abuse with intoxication, uncomplicated Policy No. MP-072-MD-DE Page 3 of 6
F10.121 Alcohol abuse with intoxication delirium F10.129 Alcohol abuse with intoxication, uncomplicated F10.14 Alcohol abuse with alcohol-induced mood disorder F10.150 Alcohol abuse with alcohol-induced psychotic disorder with delusions F10.151 Alcohol abuse with alcohol-induced psychotic disorder with hallucinations F10.159 Alcohol abuse with alcohol-induced psychotic disorder, unspecified F10.180 Alcohol abuse with alcohol-induced anxiety disorder F10.181 Alcohol abuse with alcohol-induced sexual dysfunction F10.182 Alcohol abuse with alcohol-induced sleep disorder F10.188 Alcohol abuse with other alcohol-induced disorder F10.19 Alcohol abuse with unspecified alcohol-induced disorder F10.20 Alcohol dependence, uncomplicated F10.21 Alcohol dependence, in remission F10.220 Alcohol dependence with intoxication, uncomplicated F10.221 Alcohol dependence with intoxication delirium F10.229 Alcohol dependence with intoxication, unspecified F10.230 Alcohol dependence with withdrawal uncomplicated F10.231 Alcohol dependence with withdrawal delirium F10.232 Alcohol dependence with withdrawal with perceptual disturbance F10.239 Alcohol dependence with withdrawal, unspecified F10.24 Alcohol dependence with alcohol-induced mood disorder F10.250 Alcohol dependence with alcohol-induced psychotic disorder with delusions F10.251 Alcohol dependence with alcohol-induced psychotic disorder with hallucinations F10.259 Alcohol dependence with alcohol-induced psychotic disorder, unspecified F10.26 Alcohol dependence with alcohol-induced persisting amnestic disorder F10.27 Alcohol dependence with alcohol-induced persisting dementia F10.280 Alcohol dependence with alcohol-induced anxiety disorder F10.281 Alcohol dependence with alcohol-induced sexual dysfunction F10.282 Alcohol dependence with alcohol-induced sleep disorder F10.288 Alcohol dependence with other alcohol-induced disorder F10.29 Alcohol dependence with unspecified alcohol-induced disorder F10.920 Alcohol use, unspecified with intoxication, uncomplicated F10.921 Alcohol use, unspecified with intoxication, delirium F10.929 Alcohol use, unspecified with intoxication, unspecified F10.94 Alcohol use, unspecified with alcohol-induced mood disorder F10.950 Alcohol use, unspecified with alcohol-induced psychotic disorder with delusions F10.951 Alcohol use, unspecified with alcohol-induced psychotic disorder with hallucinations F10.959 Alcohol use, unspecified with alcohol-induced psychotic disorder, unspecified F10.96 Alcohol use, unspecified with alcohol-induced persisting amnestic disorder F10.97 Alcohol use, unspecified with alcohol-induced persisting dementia F10.980 Alcohol use, unspecified with alcohol-induced anxiety disorder F10.981 Alcohol use, unspecified with alcohol-induced sexual dysfunction F10.982 Alcohol use, unspecified with alcohol-induced sleep disorder Policy No. MP-072-MD-DE Page 4 of 6
F10.988 Alcohol use, unspecified with other alcohol-induced disorder F10.99 Alcohol use, unspecified with unspecified alcohol-induced disorder F11.10 Opioid abuse, uncomplicated F11.11 Opioid abuse, in remission F11.120 Opioid abuse with intoxication, uncomplicated F11.121 Opioid abuse with intoxication delirium F11.122 Opioid abuse with intoxication with perceptual disturbance F11.129 Opioid abuse with intoxication, unspecified F11.14 Opioid abuse with opioid-induced mood disorder F11.150 Opioid abuse with opioid-induced psychotic disorder with delusions F11.151 Opioid abuse with opioid-induced psychotic disorder with hallucinations F11.159 Opioid abuse with opioid-induced psychotic disorder, unspecified F11.181 Opioid abuse with opioid-induced sexual dysfunction F11.182 Opioid abuse with opioid-induced sleep disorder F11.188 Opioid abuse with other opioid-induced disorder F11.19 Opioid abuse with unspecified opioid-induced disorder F11.20 Opioid dependence, uncomplicated F11.21 Opioid dependence, in remission F11.220 Opioid dependence with intoxication, uncomplicated F11.221 Opioid dependence with intoxication delirium F11.222 Opioid dependence with intoxication with perceptual disturbance F11.229 Opioid dependence with intoxication, unspecified F11.23 Opioid dependence with withdrawal F11.24 Opioid dependence with opioid-induced mood disorder F11.250 Opioid dependence with opioid-induced psychotic disorder with delusions F11.251 Opioid dependence with opioid-induced psychotic disorder with hallucinations F11.259 Opioid dependence with opioid-induced psychotic disorder, unspecified F11.281 Opioid dependence with opioid-induced sexual dysfunction F11.282 Opioid dependence with opioid-induced sleep disorder F11.288 Opioid dependence with other opioid-induced disorder F11.29 Opioid dependence with unspecified opioid-induced disorder F11.90 Opioid use, unspecified, uncomplicated F11.920 Opioid use, unspecified with intoxication, uncomplicated F11.921 Opioid use, unspecified with intoxication delirium F11.922 Opioid use, unspecified with intoxication with perceptual disturbance F11.929 Opioid use, unspecified with intoxication, unspecified F11.93 Opioid use, unspecified with withdrawal F11.94 Opioid use, unspecified with opioid-induced mood disorder F11.950 Opioid use, unspecified with opioid-induced psychotic disorder with delusions F11.951 Opioid use, unspecified with opioid-induced psychotic disorder with hallucinations F11.959 Opioid use, unspecified with opioid-induced psychotic disorder, unspecified F11.981 Opioid use, unspecified with opioid-induced sexual dysfunction F11.982 Opioid use, unspecified with opioid-induced sleep disorder F11.988 Opioid use, unspecified with opioid-induced with other opioid-induced disorder Policy No. MP-072-MD-DE Page 5 of 6
F11.99 Opioid use, unspecified with unspecified opioid-induced disorder Z71.41 Alcohol abuse counseling and surveillance of alcoholic Z71.51 Drug abuse counseling and surveillance of drug abuser REIMBURSEMENT Participating facilities will be reimbursed per their Highmark Health Options contract. POLICY SOURCE(S) The ASAM National Practice Guideline. Accessed online May 17, 2017. http://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asamnational-practice-guideline-supplement.pdf?sfvrsn=24. SAMHSA/CSAT Treatment Improvement Protocols. Accessed online May 17, 2017 and available at: http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=hssamhsatip&part=a7256. Nicholas L, Bragaw L, Ruetsch C. Opioid Dependence Treatment and Guidelines. Accessed online May 17, 2017 available at: http://www.amcp.org/data/jmcp/s14-s21.pdf. Vivitrol [package insert] Waltham, MA. Alkermes, December 2015. Policy History Date Activity 11/14/2017 Initial policy developed 03/13/2018 QI/UM Committee approval 05/15/2018 Provider effective date Policy No. MP-072-MD-DE Page 6 of 6