Optum 1 By United Behavioral Health U.S. Behavioral Health Plan, California Doing Business as OptumHealth Behavioral Solutions of California ( OHBS-CA ) 2015 Level of Care Guidelines Opioid Treatment Services, Office-Based Opioid Treatment Substance-Related Disorders Office-Based Opioid Treatment includes medication-assisted treatments for members with Opioid-Related Disorders with the use of buprenorphine, naltrexone, or the combination of buprenorphine/naltrexone administered in a physician s office, Intensive Outpatient Program, or Partial Hospital Program. In this form of medication-assisted treatment, an opioid is substituted with the medically-managed use of the following medications: Buprenorphine HCl sublingual tablets Buprenorphine HCl with naloxone HCl dehydrate sublingual tablets (Suboxone ) Oral naltrexone Extended-release injectable naltrexone (Vivitrol ) Opioid Treatment services are delivered as a unique service, or as part of a larger comprehensive treatment plan. Community resources such as selfhelp, peer support groups, consumer-run services, and preventive health programs can augment medication-assisted treatments and support broader recovery/resiliency goals. The course of Office-Based Opioid Treatment is focused on addressing the why now factors that precipitated admission (e.g., changes in the member s signs and symptoms, psychosocial and environmental factors, or level of functioning) to the point that the member s condition can be safely, efficiently and effectively treated in a less intensive level of care. 1. Admission Criteria 1.1. (See Common Criteria for All Levels of Care) 1.2. The member is diagnosed with an Opioid-Related Disorder. 1
1.3. The why now factors leading to admission suggest that there is imminent or current risk of mild withdrawal. Medical complications, if present, can be safely managed. Examples include: 1.3.1. The member has no known contraindications to buprenorphine or naltrexone 1.3.2. The member is not dependent on high doses of benzodiazepines or other central nervous system depressants including alcohol. 1.4. The member is not in imminent or current risk of harm to self, others, and/or property. 2. Continued Service Criteria 2.1. (See Common Criteria for All Levels of Care) 3. Discharge Criteria 3.1. (See Common Criteria for All Levels of Care) 4. Clinical Best Practices 4.1. Evaluation & Treatment Planning 4.1.1. (See Common Clinical Best Practices for All Levels of Care) 4.1.1.1. The provider is a physician who possesses at least one of the following: 4.1.1.1.1. A subspecialty board certification in addiction psychiatry from the American Board of Psychiatry and Neurology; 4.1.1.1.2. An addiction certification from the American Board of Addiction Medicine (ABAM); 4.1.1.1.3. A subspecialty board certification in Addiction Medicine from the American Osteopathic Association (AOA). 4.1.1.2. The provider has at least 8 hours of training on the treatment of opioid dependence provided by a SAMHSA approved organization such as the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, or the American Psychiatric Association. 4.1.1.3. The provider has secured a registration number and unique identification number from the Drug Enforcement Agency in order to administer buprenorphine. 2
4.1.1.4. In accordance with the Drug Addiction Treatment Act of 2000, the provider maintains a caseload of up to 30 patients for the first year after petitioning the Drug Enforcement Agency for approval, and 100 patients thereafter. 4.1.1.5. The provider has the capacity to provide or refer members for necessary ancillary services such as psychotherapy or recovery support services. 4.1.2. Buprenorphine Treatment Protocol 4.1.2.1. Induction Phase 4.1.2.1.1. During the induction phase the member is transitioned from the opioid of abuse to buprenorphine. 4.1.2.1.2. Buprenorphine is first administered during induction after the member has abstained from using opioids for 12-24 hours, and is in the early stages of opioid withdrawal. 4.1.2.1.3. Induction is initiated in the physician s office using 4mg, followed by up to 4mg after 4 hours if needed. Day 1 should not exceed 8mg. 4mg buprenorphine and1mg naloxone in 2-4 hours with additional 4mg buprenorphine 1mg naloxone if indicated for buprenorphine-naloxone is recommended. 4.1.2.1.4. Induction continues in the physician s office with daily administration of increasing dosages of buprenorphine until a therapeutic dose is achieved. 4.1.2.1.5. During induction the physician monitors the member s response to treatment and continued motivation to participate in comprehensive treatment that includes psychosocial interventions alongside buprenorphine 4.1.2.2. Stabilization Phase 4.1.2.2.1. During the stabilization phase, the provider monitors the member s response to treatment and level of motivation. 4.1.2.2.2. The frequency of office visits lessens, and the member may be transitioned to a prescription for use at home. 4.1.2.2.3. The standard dose is 12-16mg per day, although some members may need up to 32mg per day. The schedule of administration changes alternate days and the dose is increased to 24mg. 3
4.1.2.2.3.1. The dose may be increased if the member experiences withdrawal symptoms or feels compelled to use opioids. 4.1.2.2.3.2. Administration of up to 24 mg on alternate days may be indicated when the member s condition has stabilized. 4.1.2.2.4. Use of buprenorphine at home is indicated when: 4.1.2.2.4.1. The member abstains from using drugs and alcohol; 4.1.2.2.4.2. The member regularly has regularly participated in Office-Based Opioid Treatment; 4.1.2.2.4.3. There are no significant behavioral problems; 4.1.2.2.4.4. There is no evidence of criminal activity; 4.1.2.2.4.5. There are no psychosocial or environmental problems; 4.1.2.2.4.6. The member can safely store the buprenorphine; 4.1.2.2.4.7. There is no risk that the buprenorphine will be diverted; 4.1.2.2.4.8. The member is participating in psychosocial interventions as per the treatment plan; 4.1.2.3. Maintenance Phase 4.1.2.3.1. The maintenance phase begins when the member is: 4.1.2.3.1.1. On a stable dose of buprenorphine; 4.1.2.3.1.2. No longer experiencing withdrawal, side effects, or cravings for opioids; 4.1.2.3.1.3. Addressing psychosocial issues as part of the comprehensive treatment plan. 4.1.2.3.2. During the maintenance phase, the provider continues to monitor the member s response to treatment and level of motivation. 4.1.2.3.3. The frequency of office visits during the maintenance phase is further reduced, and if indicated, the member continues to self-administer buprenorphine. 4.1.2.3.4. When the end of treatment is indicated, tapering occurs over a 2-3 week period. If significant withdrawal symptoms emerge, doses are split into 2-3 smaller doses until buprenorphine can be safely discontinued. 4
4.1.3. Oral Naltrexone Treatment Protocol 4.1.3.1. Oral naltrexone is indicated when: 4.1.3.1.1. The member has completed detoxification 7-10 days prior to naltrexone therapy. 4.1.3.1.2. There is no evidence that the member has resumed using opioids. 4.1.3.1.3. The member is medically clear (e.g., normal liver functioning tests, negative toxicology screenings, negative pregnancy screening). 4.1.3.1.4. The member is motivated, or has a responsible person who is willing to monitor the member s compliance with 4.1.3.1.5. The member is not anticipating surgery or has a medical condition for which opioids may be prescribed; 4.1.3.1.6. The member is willing to participate in psychosocial 4.1.3.2. The initial oral naltrexone dose is 50mg/day in a single tablet. For members at risk (e.g., women, younger members, members with shorter abstinence) 12.5mg/day should be given for 1 week, with gradual weekly increases up to 50mg/day. 4.1.3.3. The dose remains 50mg/day for up to 3 months and oral maintenance may last up to 1 year. 4.1.3.4. Discontinuation is not associated with withdrawal so it is not necessary to taper the dose. The provider should remind the member that opioid medications should not be taken for at least 3 days following discontinuation as the member may be more sensitive to the medication s effects. 4.1.4. Extended-Release Injectable Naltrexone (Vivitrol) Treatment Protocol 4.1.4.1. Extended-release injectable naltrexone is indicated when: 4.1.4.1.1. The member has not responded to other pharmacological and/or non-pharmacological forms of treatment, and not able to comply with oral naltrexone 4.1.4.1.2. The member has completed detoxification 7-10 days prior to naltrexone therapy. 4.1.4.1.3. There is no evidence that the member has resumed using opioids. 5
4.1.4.1.4. The member is medically clear (e.g., normal liver functioning tests, negative toxicology screenings, negative pregnancy screening). 4.1.4.1.5. The member does not have a bleeding disorder, is not obese, or otherwise has a condition that prevents deep IM injections. 4.1.4.1.6. The member is not anticipating surgery or has a medical condition for which opioids may be prescribed; 4.1.4.1.7. The member is willing to participate in psychosocial 4.1.4.2. Naltrexone is administered by intramuscular (IM) gluteal injection every 4 weeks at a dose of up to 380mg. If a dose is delayed or missed, the next injection is administered as soon as possible. 4.1.4.3. There is no clearly defined duration of treatment with IM naltrexone however a provider may consider discontinuation once the member s condition has stabilized, the member is able to maintain abstinence, has a support and recovery plan, and there is a reduced risk of relapse. 4.1.4.4. The provider should remind the member that opioid medications should not be taken for at least 30 days following discontinuation as the member may be more sensitive to the medication s effects. 4.1.5. Psychosocial Interventions 4.1.5.1. Pharmacotherapy alone is rarely a sufficient treatment for Opioid-Related Disorders. Psychosocial interventions vary according to a member s needs and may include: 4.1.5.1.1. Facilitation of access to behavioral health and medical services; 4.1.5.1.2. Individual or group participation in Motivational Enhancement Therapy, Cognitive Behavioral Therapy, or other therapies; 4.1.5.1.3. Coordination of behavioral health and medical services; 4.1.5.1.4. Psychoeducation; 4.1.5.1.5. Linking the member with peer services and other community resources such as a sobriety support group or an accountability partner. 4.2. Discharge Planning 6
4.2.1. (See Common Criteria for All Levels of Care) References 1. American Academy of Child and Adolescent Psychiatry. (2001). Practice Parameter for the Assessment and Treatment of Children and Adolescents with Suicidal Behaviors. Retrieved from: http://www.aacap.org/. 2. American Academy of Child & Adolescent Psychiatry. (2007). Practice Parameter for the Treatment of Substance Abuse Disorders. Retrieved from: http://www.aacap.org/. 3. American Psychiatric Association. (2006). Practice Guideline for the Treatment of Patients with Substance Use Disorders. Retrieved from: http://psychiatryonline.org/guidelines. 4. American Psychiatric Association. (2007). Practice Guideline for the Treatment of Patients with Substance Use Disorders, Guideline Watch. Retrieved from: http://psychiatryonline.org/guidelines. 5. Department of Veterans Affairs/Department of Defense. (2009). Clinical Practice Guideline, Management of Substance Use Disorders. Retrieved from: http://www.healthquality.va.gov/. 6. Mee-Lee, D, Shulman GD, Fishman MJ, Gasfriend, DR, Mill MM, eds. The ASAM Criteria: Treatment Criteria for Addictive, Substance-Related, and Co-Occurring Conditions. 3rd ed. Carson City, NV: The Change Companies; 2013. 7. Substance Abuse and Mental Health Services Administration. (2010). An Introduction to Extended-Release Injectable Naltrexone for the Treatment of People with Opioid Dependence. Retrieved from: http://store.samhsa.gov/list/series?name=tip-series-treatment- Improvement-Protocols-TIPS-. 8. Substance Abuse and Mental Health Service Administration. (2009). Treatment Improvement Protocol 43, Medication Assisted Treatment for Opioid Addiction in Opioid Treatment Programs. Retrieved from: http://store.samhsa.gov/list/series?name=tip-series-treatment- Improvement-Protocols-TIPS-. 9. Substance Abuse and Mental Health Services Administration. (2012). Treatment Improvement Protocol 40, Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Retrieved from: http://store.samhsa.gov/list/series?name=tip-series-treatment- Improvement-Protocols-TIPS-. 7