SUB-REGIONAL ENTITY (SRE) GUIDELINES AND PROTOCOLS FOR THE IMPLEMENTATION OF METHADONE-ASSISTED TREATMENT FOR OPIOID/OPIATE DEPENDENCE

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1 SUB-REGIONAL ENTITY (SRE) GUIDELINES AND PROTOCOLS FOR THE IMPLEMENTATION OF METHADONE-ASSISTED TREATMENT FOR OPIOID/OPIATE DEPENDENCE Effective: April 2014 Revised: July 2014 (Included Medicaid Provider Manual) Revised: November 2014 (changed CA to SRE)

2 Table of Contents Introduction.3 Special Note.4 Service Definition General Minimum Service Requirements for Authorizing..5 Included Services...6 Eligibility Criteria...7 Expectations on Methadone-assisted Treatment...7 Comprehensive Recovery Plan. 8 Behavioral Contracts.9 Ninety (90) Day Induction Period for Methadone-assisted Treatment....9 Ongoing Recovery after Ninety (90) Day Induction for Methadone-assisted Treatment.. 10 Continuation of Medically Necessary Services..11 Discontinuation/Termination/Readmission...11 Block Grant Methadone-assisted Treatment Waiting List Regulatory Compliance...15 Provider Requirements Staff Credentials and Program Supervision Requirements.16 Authorization Parameters.. 16 Implementation Guidance..16 Expectations on Methadone-assisted Treatment Form...18 Methadone-assisted Treatment Services Behavioral Contract Flow Chart...20 Page 2 of 21

3 INTRODUCTION Methadone is an opioid medication used in the treatment and recovery of opioid dependence to prevent withdrawal symptoms and opioid cravings, while blocking the euphoric effects of opioid drugs. In doing so, methadone stabilizes the individual so that other components of the treatment and recovery experience, such as counseling, case management, and recovery supports, are maximized in order to enable the individual to reacquire life skills and recovery. Methadone is not a medication for the treatment and recovery from non-opioid drugs. (State Enrollment Criteria, October 1, 2012). Methadone treatment is designed to address the individual s needs in order to achieve improvements in his/her level of functioning, including elimination of illicit opiates and other drug abuse inclusive of alcohol. The primary focus of methadone treatment is to diminish an individual s harmful activities (such as criminal activity, drug selling, unsafe sexual activity, needle sharing and communicable disease risk behaviors, high-risk health behaviors, etc.) that support continued illicit substance use/misuse and increase risk to the individual, thereby affecting the individual s health, employment, housing, child custody, family, community, etc. This document establishes technical and service requirements that must be incorporated into the design and delivery of all methadone-assisted treatment (MAT) (methadone for purposes of this document) services funded through Community Mental Health Authority of Clinton, Eaton, and Ingham Counties/Coordinating Agency (CMHA/CEI/SRE). Methadone-assisted treatment Providers and Outpatient Providers coordinating with methadone-assisted providers are required to adopt these protocol guidelines in their entirety while addressing major lifestyle, attitudinal, and behavioral issues which can undermine the goals of treatment and inhibit the individual s ability to cope with major life tasks. Opioid/opiate addiction has been steadily increasing over the past decade, especially among adolescents and young adults, as citizens in our communities have fairly easy access to such physician-prescribed opioid/opiate medications as oxycodone (Oxycontin), hydrocodone (Vicodin) and morphine. Traditional approaches to opioid/opiate addiction have historically included repeated cycles of sub-acute detoxification in a residential treatment setting followed by transfer to another level of care. With the introduction of Methadone Maintenance Treatment in 1968, a reliable and effective treatment for chronic, long-term opioid/opiate users became available. An individual today may have polysubstance abuse/dependence along with opioid/opiate dependence. It is the intention of CMHA/CEI/SRE to provide methadone dosing as a pharmacological tool used as an adjunct for the treatment of opioid/opiate dependence, along with other evidence-based treatment to help the committed individual who wants help to reduce/abstain from all illicit drugs and alcohol. It is the expectation that treatment modalities involved, as reflected in the individualized treatment plan, will identify and address the individual s polysubstance use, addictive behaviors, opioid/opiate addiction, and need for quality-of-life improvement. Treatment will occur at the appropriate intensity, scope, duration, and may include multiple providers in order for the individual to reach his/her goal of recovery. Medication Assisted Treatment (MAT) (methadone) for opioid/opiate dependence may be available once clinical eligibility has been determined via appropriate screening and assessment of the individual for clinical and medical appropriateness for MAT services. Page 3 of 21

4 Special Note Methadone-assisted treatment for opioid/opiate dependence is intended to stabilize an individual and foster readiness to make continued treatment and recovery decisions. An individual currently abusing opioids/opiates and seeking treatment services may not be initially capable of making decisions regarding his/her continuing treatment needs. Not every individual is appropriate for MAT, although an individual may meet clinical and medical criteria. The CMHA/CEI/SRE expects providers to assess and to determine readiness for change of an individual as a means of ensuring that the provision of MAT services will best meet the individual s needs. An individual identified as having a diagnosis of opioid/opiate dependence and who is in the preparation or action stage of change may be authorized for admission to MAT services. An individual identified as having a diagnosis of opioid/opiate abuse or opioid/opiate dependence and as being in the pre-contemplation or contemplation stages of change will not be authorized for admission to MAT services. Such individual will be offered by CMHA/CEI/SRE s access center for substance use disorder (SUD), called the Care Coordination Center (CCC), other treatment options to best meet his/her individual needs. Individuals receiving methadone as treatment for an opioid addiction may need pain medication in conjunction with this adjunct therapy. The use of non-opioid analgesics and other non-medication therapy is recommended whenever possible. Opioid analgesics as prescribed for pain by the individual s primary care physician (or dentist, podiatrist) can be used; they are not a reason to initiate detoxification to a drug-free state, nor does their use make the individual ineligible for using methadone for the treatment of opioid addiction. The methadone used in treating opioid addiction does not replace the need for pain medication. It is recommended that an individual informs his/her prescribing practitioner(s) that he/she is on methadone, as well as any other medications. On-going coordination (or documentation of efforts if prescribing practitioners do not respond) between the OTP physician and the prescribing practitioner is required for continued services at the OTP and for any off-site dosing including Sunday and holidays. (BSAAS Treatment Policy #05, Criteria for Using Methadone for Medication-assisted Treatment and Recovery, p. 3 of 11) Although CMHA/CEI/SRE realizes that opioid/opiate addiction may be a brain disease that can last a lifetime, it is not the intention of CMHA/CEI/SRE to approve payment for methadone-assisted treatment indefinitely. It is our intention to provide intensive methadone-assisted treatment to an individual with opioid/opiate dependence in order to enable him/her to reacquire the life skills as well as the degree of recovery to assume financial responsibility for his/her own treatment. SERVICE DEFINITION According to the Treatment Improvement Protocol #43, as published by the U.S. Department of Health and Human Services (US HHS), Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT) the definition of Medication Assisted Treatment for opioid/opiate, dependence is clarified as follows: Distinctions between dependence and addiction vary across treatment fields. This TIP uses the term dependence to refer to physiological effects of substance abuse and addiction for physical dependence on and subjective need and craving for a psychoactive substance either to experience its positive effects or to avoid negative effects associated with withdrawal from that substance (p. 2). A patient s daily pattern of opioid abuse should be determined. Regular and frequent use to offset withdrawal is a clear indicator of physiological dependence. In addition, people who are opioid addicted spend increasing amounts of time and energy obtaining, using, and responding to the effects of these drugs (p. 48). Page 4 of 21

5 Medication- assisted treatment for opioids/opiates using methadone must be provided in a licensed and state-regulated outpatient treatment provider (OTP). Individual needs and rate of progress vary from person-to-person and, as such, treatment and recovery must be individualized and treatment and recovery plans must be based on the needs and goals of the individual (Treatment Policy #06: Individualized Treatment Planning). Referrals for medical care, mental health issues, vocational and educational needs, spiritual guidance, and housing are required, as needed, based on the information gathered as part of the assessment and other documentation completed by the individual. The use of case managers, care coordinators, and recovery coaches is recommended for individuals whenever possible (BSAAS Treatment Policy #08: Substance Abuse Case Management Requirements). Increasing the individual s recovery capital through these supports, will assist the recovery process and help the individual to become stable and more productive within the community. The minimum required services for MAT are outlined in Federal regulations (42 Code of Federal Regulations [CFR], Part 8). The Michigan Department of Community Health-Bureau of Substance Abuse and Addiction Services has published Treatment Policies for methadone. All Treatment Policies referenced in this protocol are identified in the reference section of this document and are available on the MDCH website. Methadone-assisted treatment Providers must inform every individual of daily attendance requirements, mandatory counseling requirements, toxicology testing requirements, and other program participation requirements outlined in this protocol document upon admission and the outpatient Providers will inform every individual receiving methadone throughout the course of treatment. The CMHA/CEI/SRE requires that methadone-assisted treatment Providers offer at least the following services: General minimum service requirements for authorizing treatment for methadone-assisted treatment services are as follows: Comprehensive biopsychosocial assessment with an initial diagnosis of opioid/opiate dependency of at least one-year duration. Coordination of care with all prescribing physicians, treating physicians, dentists and other health care providers. Compliance with the individualized treatment and recovery plan, which includes referrals and follow up as needed. Physical examination upon admission and as appropriate during the course of treatment. Mandatory four-month reviews to determine continued eligibility. Daily attendance requirements for medication dispensing. Must be used as an adjunct to opioid/opiate treatment which must include a counseling component. Counseling services should be conducted by the OTP that is providing the methadone whenever possible and appropriate. When the ASAM LOC is not outpatient or when a specialized service is needed, separate service locations for methadone dosing and other substance use disorder services are acceptable, as long as coordinated care is present and documented in the individual s record. (Criteria for Using Methadone for Medication-Assisted Treatment and Recovery #P-T-05, effective 10/1/2012). The Medicaid covered substance use disorder benefit for methadone services includes the provision and administration of methadone, nursing services, physician encounters, physical examinations, lab tests (including initial blood work, toxicology screening, and pregnancy tests) and physician-ordered tuberculosis (TB) skin tests. The medical necessity requirements and services also apply to every non-medicaid covered individual (Criteria for Using Methadone for Medication-Assisted Treatment and Recovery, Policy #05, effective 10/1/2012, p. 1). Random toxicology screening to be conducted at a rate of no less than once per month; more if toxicology screening indicates possible relapse; toxicology screening must assay for methadone metabolites, opioids, cannabinoids, benzodiazepines, cocaine, amphetamines, and barbiturates (Criteria for Using Methadone for Medication-Assisted Treatment and Recovery, Policy #05, effective 10/1/2012, p. 1). Identification of co-occurring disorders and neuropsychological problems. Page 5 of 21

6 Counseling to stop substance abuse, manage drug cravings and urges, and improve the individual s quality of life and recovery. Evaluation of and interventions to address family problems. Screening and referral for HIV and hepatitis virus testing, education, counseling, and referral for care. Referral for additional services as needed. CMHA/CEI/SRE requires every potential individual seeking methadone-assisted treatment services to be screened and assessed to include an individual brief history, including any prior treatments, drug use and/or abuse history, presenting problems, provisional diagnoses, and an evaluation of Stage of Change. INCLUDED SERVICES Methadone-assisted treatment (for opioid/opiate dependence) in an outpatient setting is intended for the purpose of 1) managing the effects of withdrawal from opioids/opiates or 2) stabilizing the individual and providing maintenance treatment. Ancillary services such as individual counseling and therapy, group counseling and therapy, recovery supports and/or case management should be made available during an individual s episode of care. Reviews to determine continued eligibility for methadone dosing and counseling services must occur at least every four months by the OTP physician during the first two years of service. Covered services for methadone and pharmacological supports and laboratory services, as required by Federal regulations, Administrative Rules for Substance Abuse Service Programs in Michigan, and the Medicaid Provider Manual include: Methadone medication Nursing services Physical examination Physician encounters (monthly) Laboratory tests TB skin test (as ordered by physician) The opioid/opiate-dependent individual may be provided methadone-assisted treatment as an adjunct to therapy. Provision of such services must meet the following criteria: Services must be provided under the supervision of a physician licensed to practice medicine in Michigan. The physician must be licensed to prescribe controlled substances, as well as 1) licensed to work at a methadone program, and/or 2) Approved to prescribe buprenorphine. The medication component of the substance abuse treatment program must be licensed as such by the state and be certified by the OPAT/CSAT and licensed by the Drug Enforcement Administration (DEA) as appropriate. Methadone must be administered by an MD/DO, physician s assistant, nurse practitioner, registered nurse, licensed practical nurse, or pharmacist. It is expected that all MAT providers contracted with CMHA/CEI/SRE will offer many various services such as; individual and group counseling and therapy, recovery support, and case management. CMHA/CEI/SRE believes that there is great therapeutic value to the individuals to be included in Page 6 of 21

7 group sessions with other individuals. CMHA/CEI/SRE promotes the use of group counseling and therapy in methadone-assisted treatment. All services provided must be documented clearly in the record of the individual served. Ongoing methadone-assisted treatment authorization is dependent in part upon the results of the bi-monthly physician review. As an individual is unique and presents with individual concerns, the CEI/CMH/CA encourages contact with the CCC to discuss exceptions on a caseby-case basis. ELIGIBILITY CRITERIA To be eligible for methadone-assisted treatment services funded through CMHA/CEI/SRE, the intended individual must meet clinical criteria as set forth in the American Society of Addiction Medicine Patient Placement Criteria (ASAM PPC-2R). Further, the intended individual should be assessed for ability to benefit from methadone-assisted treatment services, including the stage of change in which the individual presents. Determination of eligibility for MAT services and determination of a level of care is done by the methadone-assisted treatment Provider or outpatient treatment Provider, using a standardized assessment tool for alcohol and drug abuse/dependence. If the assessment is performed by the outpatient treatment provider, the assessment will be sent to the CCC, with a release, for review and determination. Every individual is afforded a choice of provider upon determination of appropriate level of care. The individual s choice must be documented in the individual s permanent record. Persons presenting for treatment are admitted to treatment in the following order: 1. Pregnant injecting drug users. 2. Pregnant substance abusers. 3. Injecting drug users. 4. Parents whose children have been removed from the home or are in danger of being removed from the home due to the parents substance abuse. 5. All others. According to TIP 43, Studies also have found that methadone maintenance treatment reduces criminality, noncompliance with HIV/AIDS therapy, seroconversion to HIV/AIDS, and mortality associated with opioid addiction (p 63). Therefore, consideration will be given to an individual s overall health and wellness to include risk for communicable disease; history of legal problems as a result of use and/or current illegal activity, such as prostitution; prior treatment attempts with reasons for discharge; pain management issues, medical necessity, ASAM criteria, and DSM factors. Admission procedures for methadone-assisted treatment require a physical examination. This examination must include a medical assessment to confirm the current DSM diagnosis of opioid/opiate dependency, as identified in the screening process. The physician may refer the individual to other care providers (dentists, PCP, or other health care providers) for further medical assessment as indicated. EXPECTATIONS ON METHADONE ASSISTED TREATMENT Upon assessment, every individual wishing to enter or re-enter methadone-assisted treatment will be provided with, informed of adherence with, and given an explanation of the Expectations on Methadone-assisted Treatment form. Upon admission to the methadone-assisted treatment Page 7 of 21

8 Provider, the individual will sign the Expectations on Methadone-assisted Treatment form assuring his/her understanding of the expectations, which include the following and will be reviewed annually or as necessary by the outpatient treatment Provider (if applicable) and methadone-assisted treatment Provider : Discontinuation of the use of all illicit and non-prescribed drugs and alcohol. Regular attendance at the methadone-assisted treatment provider for dosing (daily, until such time that the individual meets criteria for takehome dosages in the case of methadone, and as clinically and medically appropriate for buprenorphine) dosing (with the possible exception of Sundays and holidays. Submit to toxicology sampling as requested. Attendance and active participation at all group and/or individual treatment sessions or other clinical activities. Comply with the individualized treatment and recovery plan, inclusive of following through on other treatment and recovery plan related referrals. Repeated failure should be considered on an individual basis and only after the methadone-assisted treatment Provider and outpatient treatment Provider (if applicable) have taken steps to assist the individual to comply with activities. Adherence to all program rules and policies. Manage medical concerns/conditions, including adherence to physician treatment and recovery services and use of prescription medications that may interfere with the effectiveness of methadone and may present a physical risk to the individual. Provide the names, addresses, and phone numbers of all medical, dental, and pharmacy providers. Produce valid prescription or medication bottles with the physician s name on the label for all controlled substances within one week of admission. If the individual tests positive for a controlled substance that he/she has not previously provided a valid prescription for, the individual agrees to present a valid prescription or current medication bottle(s) with the physician s name on the label for the controlled substance before the individual may receive his/her next regular or full methadone dose. Prescribed medications may have to be changed in order to better coordinate treatment. Sign Authorizations to Release Information with medical, dental and pharmacy providers in order to better coordinate treatment. If an individual refuses to meet these expectations, it could negatively impact the individual s success with treatment. Enrollment in one medication-assisted treatment Provider only (methadone and/or buprenorphine). If an individual is enrolled in more than one (1) medication-assisted treatment Provider at a time (methadone and/or buprenorphine), the individual may be detoxed and removed from the methadone program. Evidence of continued work toward goals outlined in treatment plan. No altered urine screens or non-compliance with drug testing. COMPREHENSIVE RECOVERY PLAN The CMHA/CEI/SRE expects the provider to begin working on a comprehensive recovery plan with EVERY individual immediately upon admission and be able to show documentation of assisting the individual with developing a comprehensive recovery plan, which includes but should not be limited to: Abstain from illicit drug use Abstain from alcohol use Build a recovery support network Develop a relapse prevention plan Achieve a stable living environment Page 8 of 21

9 Secure stable employment Improve overall quality of life Page 9 of 21

10 Progress/improvement will be measured by the documentation of active participation in substance use disorder treatment as evidenced by the following AND as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable: Quantifiable evidence of progress toward goals and objectives on a collaborative recovery plan designed to address treatment and promote recovery and self-sufficiency. Quantifiable evidence of decrease in problem severity. Negative toxicology screens and/or evidence of engagement in strategies to address recovery. BEHAVIORAL CONTRACTS It is CMHA/CEI/SRE's expectation that every individual will follow the rules and expectations of the outpatient treatment Provider and methadoneassisted treatment Provider, inclusive of his/her treatment plan. Not following the rules and expectations is considered non-compliant behavior. Dependent on the progress the individual is making, an individual may be placed on Concern Phase or Jeopardy Phase, or both. The individual that is non-compliant will be subject to placement on a behavioral contract according to the stipulations below: Ninety (90) Day Induction Period for Methadone-assisted Treatment Upon admission and during the first ninety (90) days in treatment, called the induction period, an individual is expected to work towards the reduction of and eventual elimination of the use of other drugs (non-prescribed) and/or alcohol. CMHA/CEI/SRE recognizes that the induction period may be difficult for the individual as he/she works to eliminate illicit-opioid use and other drugs/alcohol, lessen the intensity of other problems associated with his/her addiction, and change behaviors that may have taken years to learn. During the induction period, it is CMHA/CEI/SRE s expectation that outpatient treatment Providers and methadone-assisted treatment Providers actively collaborate and work with the individual to avoid non-compliant behaviors and progress in his/her recovery. Progress during treatment at both the outpatient treatment Provider and methadone-assisted treatment Provider is seen in the following: 1. Achieving consecutive non-positive urine drug screens with the only drug shown positive in the drug screen is methadone; and 2. If individual is taking other prescribed medications, it is reflected in the drug screen and there is no evidence of abuse; and 3. Alcohol metabolites are tested and should not be present and breath analyzers are utilized to reflect alcohol negativity. Following the initial ninety (90) day induction period, the individual who successfully completes 1, 2, and 3 above AND, as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, will move to the ongoing recovery stage of treatment. However, the individual who continues to test positive for the use of non-prescribed drugs and/or alcohol will be placed, by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, on a 90 day behavioral contract, also known as Concern Phase. After the 90 day Concern Phase and the individual shows little or no progress according to 1, 2, and 3 above AND as determined by the methadoneassisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, the individual will be placed by the outpatient treatment Provider or methadone-assisted treatment Provider on a 60 day behavioral contract or clinical discharge, (also referred to as, Administrative Discharge in the Medicaid Provider Manual) or Jeopardy Phase. During the 60 days, the individual s methadone dosage level will be tapered. The individual will be prepared for a clinical discharge and/or transferred to another treatment Provider during the Jeopardy Page 10 of 21

11 Phase. However, if at any time during the 60 day clinical discharge period/jeopardy Phase, the individual begins to show significant progress according to 1, 2, and 3 above AND as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, the individual may be placed by the outpatient treatment Provider or methadone-assisted treatment Provider on a new 90 day behavioral contract/concern Phase at the discretion of the methadone-assisted treatment Provider with CMHA/CEI/SRE coordination. An individual continuing to produce positive urine drug screens during this second 90-day behavioral contract/concern Phase will begin a final 60 day tapering of methadone and be administratively discharged from the program. If at the end of the 90 days/second Concern Phase the individual shows progress according to 1, 2, and 3 above AND as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, the individual on the second Concern Phase will be removed from that phase by the outpatient treatment Provider or methadone-assisted treatment Provider. Please refer to the Methadone-assisted Treatment Services Behavioral Contract Process Flow Chart located on the last page of this document. Ongoing Recovery After 90 Day Induction for Methadone-assisted Treatment Once an individual successfully completes the ninety (90) day induction period according to 1, 2, and 3 above, he/she continues in the ongoing recovery stage of treatment. During ongoing recovery, the expectations and requirements to be followed by every individual expand to include all expectations and requirements within this document. It is CMHA/CEI/SRE s hope that every individual will successfully reach his/her goals for recovery. However, if at any time during the ongoing recovery stage of treatment, the individual is not making progress according to the expectations and requirements within this document AND as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, he/she may be placed by the outpatient treatment Provider or methadone-assisted treatment Provider on a 90 day behavioral contract, also known as Concern Phase. After the 90 day behavioral contract/concern Phase, the individual showing progress according to the expectations and requirements within this document AND as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, may be removed from the Concern Phase by the outpatient treatment Provider or methadone-assisted treatment Provider. If during the 90 day behavioral contract/concern Phase, the individual shows little or no progress according to the expectations and requirements within this document AND as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, he/she will be placed by the outpatient treatment Provider or methadone-assisted treatment Provider, on a 60 day tapering of methadone, known as a clinical discharge (also referred to as, Administrative Discharge in the Medicaid Provider Manual) or Jeopardy Phase. The individual will be prepared for a clinical discharge and/or transferred to another treatment Provider during the Jeopardy Phase. However, if at any time during the 60 day clinical discharge period/jeopardy Phase, the individual begins to show progress according to the expectations and requirements within this document AND as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable, the individual may be placed by the outpatient treatment Provider or methadone-assisted treatment Provider on a second 90 day behavioral contract/concern Phase. If during the second 90 day behavioral contract/concern Phase the individual does not show progress according to the expectations and requirements within this document AND as determined by the methadone-assisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable Page 11 of 21

12 AND in coordination with the CMHA/CEI/SRE, the individual will begin a final 60 day tapering of methadone and be clinically discharged from the program. If the individual shows no progress according to the expectations and requirements within this document AND as determined by the methadoneassisted treatment Provider s Medical Director, in consultation with the outpatient treatment Provider(s) if applicable AND in coordination with the CMHA/CEI/SRE, during the 60 day clinical discharge period/jeopardy Phase, he/she may be discharged. Note: for the time period during the induction and after the induction, the methadone-assisted treatment Provider will provide to both the outpatient treatment Provider, if applicable, and the CMHA/CEI/SRE a list of all clients on each Concern Phase and Jeopardy Phase as requested by either the outpatient treatment Provider or CMHA/CEI/SRE. Documentation of the Behavioral Contract, individual s response, and detailed discharge reasons must be included in the individual s file and shared with the outpatient treatment Provider, as applicable, as well as with the CMHA/CEI/SRE. CONTINUATION OF MEDICALLY NECESSARY SERVICES Continuation of medically necessary services will be contingent upon the individual s progress. The CMHA/CEI/SRE will consider exceptions for the individual that have: 1. Evidence of attempts (successful or otherwise) of tapering of methadone dosing, under the supervision of the clinic physician, or compelling rationale for not tapering. 2. Either maintained, gained, or actively seeking employment (with documentation) during the 12-month period prior to extension review. 3. Achieved no less than 6 months of consecutive negative urine drug screens in the 6 months (or longer) immediately preceding anticipated termination of Block Grant funding for methadone services. If an individual presents as pregnant, an immediate exception will be approved. The individual presenting as pregnant will be expected to apply for Medicaid. An individual being funded through Medicaid for methadone may continue treatment according to his/her specific Medicaid benefit as long as medically and clinically appropriate. Failure to follow program rules and lack of continued clinical and medical appropriateness for treatment are reasons for program discharge, regardless of funding source. DISCONTINUATION/TERMINATION/READMISSION According to the Medicaid Provider Manual (methadone-assisted treatment Provider is referred to as OTP), 12.2.F. Discontinuation/Termination Criteria, and applicable for all individuals, discontinuation/termination from methadone treatment refers to the following situations: Beneficiaries must discontinue treatment with methadone when treatment is completed with respect to both the medical necessity for the medication and for counseling services. Beneficiaries may be terminated from services if there is clinical and/or behavioral noncompliance. If a beneficiary is terminated,: The OTP must attempt to make a referral for another LOC assessment or for placing the beneficiary at another OTP. The OTP must make an effort to ensure that the beneficiary follows through with the referral. Page 12 of 21

13 These efforts must be documented in the medical record. The OTP must follow the procedures of the funding authority in coordinating these referrals. Any action to terminate treatment of a Medicaid beneficiary requires a "notice of action" be given to the beneficiary and the parent, legal guardian, or responsible adult (designated by the relevant state authority/cps). The beneficiary and the parent, legal guardian, or responsible adult (designated by the relevant state authority/cps) has a right to appeal this decision. Services must continue and dosage levels maintained while the appeal is in process, unless the action is being carried out due to administrative discontinuation criteria outlined in the subsection titled Administrative Discontinuation. Services are discontinued/terminated either by Completion of Treatment or through Administrative Discontinuation. Refer to the following subsections for additional information. Services are discontinued/terminated either by Completion of Treatment or through Administrative Discontinuation. Refer to the following subsections for additional information F.1. COMPLETION OF TREATMENT The decision to discharge a beneficiary must be made by the OTP's physician, with input from clinical staff, the beneficiary, and the parent, legal guardian, or responsible adult (designated by the relevant state authority/cps). Completion of treatment is determined when the beneficiary has fully or substantially achieved the goals listed in their individualized treatment and recovery plan and no longer needs methadone as a medication. As part of this process, a reduction of the dosage to a medication-free state (tapering) should be implemented within safe and appropriate medical standards F.2. ADMINISTRATIVE DISCONTINUATION Administrative discontinuation relates to non-compliance with treatment and recovery recommendations, and/or engaging in activities or behaviors that impact the safety of the OTP environment or other individuals who are receiving treatment. The OTP must work with the beneficiary and the parent, legal guardian, or responsible adult (designated by the relevant state authority/cps) to explore and implement methods to facilitate compliance. Non-compliance is defined as actions exhibited by the beneficiary which include, but are not limited to: The repeated or continued use of illicit opioids and non-opioid drugs (including alcohol). Toxicology results that do not indicate the presence of methadone metabolites. (The same actions are taken as if illicit drugs, including non-prescribed medication, were detected.) In both of the aforementioned circumstances, OTPs must perform toxicology tests for methadone metabolites, opioids, cannabinoids, benzodiazepines, cocaine, amphetamines, and barbiturates (Administrative Rules for Substance Use Disorder Service Programs in Michigan, R ). OTPs must test the beneficiary for alcohol if use is prohibited under their individualized treatment and recovery plan or the beneficiary appears to be using alcohol to a degree that would make dosing unsafe. Repeated failure to submit to toxicology sampling as requested. Repeated failure to attend scheduled individual and/or group counseling sessions, or other clinical activities such as psychiatric or psychological appointments. Page 13 of 21

14 Failure to manage medical concerns/conditions, including adherence to physician treatment and recovery services and use of prescription medications that may interfere with the effectiveness of methadone and may present a physical risk to the individual. Repeated failure to follow through on other treatment and recovery plan related referrals. (Repeated failure should be considered on an individual basis and only after the OTP has taken steps to assist beneficiaries to comply with activities.) The commission of acts by the beneficiary that jeopardize the safety and well-being of staff and/or other individuals, or negatively impact the therapeutic environment, is not acceptable and can result in immediate discharge. Such acts include, but are not limited to, the following: Possession of a weapon on OTP property. Assaultive behavior against staff and/or other individuals. Threats (verbal or physical) against staff and/or other individuals. Diversion of controlled substances, including methadone. Diversion and/or adulteration of toxicology samples. Possession of a controlled substance with intent to use and/or sell on agency property or within a one-block radius of the clinic. Sexual harassment of staff and/or other individuals. Loitering on the clinic property or within a one-block radius of the clinic. Administrative discontinuation of services can be carried out by two methods: Immediate Termination - This involves the discontinuation of services at the time of one of the above safety-related incidents or at the time an incident is brought to the attention of the OTP. Enhanced Tapering Discontinuation - This involves an accelerated decrease of the methadone dose (usually by 10 mg or 10 percent a day). The manner in which methadone is discontinued is at the discretion of the OTP physician to ensure the safety and well-being of the beneficiary. It may be necessary for the OTP to refer beneficiaries who are being administratively discharged to the local access management system for evaluation for another level of care. Justification for non-compliance termination must be documented in the beneficiary's chart. If an individual being terminated from the methadone-assisted treatment Provider wishes to be readmitted to another methadone-assisted treatment Provider, a re-assessment will be performed by a non-methadone treatment Provider to determine appropriate level of care. The individual must sign a contract with the newly admitted methadone-assisted treatment Provider stating he/she understands all of the expectations listed under the above Expectations on Methadone-assisted Treatment section and will be immediately placed on a probationary period behavior contract/concern Phase of not less than 90 days. Both Concern Phase and Jeopardy Phase will apply as written above (refer to Medicaid Provider Manual, 12.2.F. Discontinuation/Termination Criteria). If a client is being clinically discharged (also known referred to as, Administrative Discharge in the Medicaid Provider Manual), the methadoneassisted treatment Provider is to refer the individual to the Care Coordination Center for evaluation for admission to another level of care at a nonmethadone-assisted treatment Provider. Justification for clinical discharge at the methadone-assisted treatment Provider must be documented in the individual s chart (refer to Medicaid Provider Manual, 12.2.F.2 Administrative Discontinuation). Page 14 of 21

15 BLOCK GRANT METHADONE-ASSISTED TREATMENT WAITING LIST At times, the demand for an individual funded through Block Grant and seeking methadone services may exceed capacity. When this occurs, the CCC will place the individual on a waiting list. Census of the Block Grant funded individual must remain static. As such, methadone-assisted treatment providers may admit an individual approved by the CCC, only when a treatment slot becomes available. Such admission slots become available only when an existing individual funded through Block Grant is discharged from treatment services; whether due to program non-compliance, transfer to self-pay status, obtaining Medicaid, or successful program completion. The individual funded through Block Grant and placed on the waiting list should 1) be encouraged to go to local Outpatient treatment services while on the waiting list, 2) be encouraged to apply for Medicaid, and 3) be told to contact the CCC if he/she obtains Medicaid and is still interested in receiving methadone-assisted treatment services. An individual on the Block Grant waiting list will be admitted to methadone-assisted treatment services according to his/her current priority status on the waiting list. When treatment becomes available, the CCC will make three attempts to contact the next individual on the Block Grant waiting list (according to priority status) via telephone. If unable to make contact with the individual via telephone, the CCC will mark that individual as inactive in the Block Grant methadone waiting list database and move to the next individual according to priority status and repeat the above process until an individual is successfully contacted. An individual so contacted will be screened to ensure continued appropriateness for methadone-assisted treatment. If approved, the individual will be warm-transferred to a methadone-assisted treatment provider of his/her choice to arrange for an admission appointment. At this time, the CCC will mark the individual as "inactive" in the Block Grant methadone waiting list database. An individual contacted will have 14 days from the date of initial contact to be admitted into methadone-assisted treatment services. After 14 days have elapsed, the methadone-assisted treatment Provider will contact the CCC indicating whether the individual failed to present for admission. If the individual fails to present at the methadone-assisted treatment provider within 14 days of initial contact by the CCC, the provider will inform the CCC. The CCC marks the individual as inactive in the Block Grant methadone waiting list database and moves to the next individual according to priority status and repeats the above process until the next individual is successfully admitted. If the individual presents at the methadone-assisted treatment provider within 14 days, the provider will inform the CCC of the individual s admission date. The CCC will then enter the individual s admission date into the methadone waiting list database. A Block Grant-funded individual meeting criteria for urgent priority population (pregnant intravenous drug user or pregnant drug user) will be allowed direct admission into methadone-assisted treatment, if appropriate, and will not be placed on the Block Grant waiting list. An individual funded through Medicaid will not be placed on the Block Grant waiting list. Such individual will be required to contact the CCC for a full screening to determine clinical appropriateness for this level of care. An individual determined to meet eligibility criteria for this level of care will be directed to the provider of his/her choice. Access to other appropriate treatment will be coordinated whenever an individual loses his/her Medicaid benefit. Page 15 of 21

16 The provider will be responsible for collecting co-pays and billing CMHA/CEI/SRE accordingly. The provider will be responsible for making sure that every individual receiving Block Grant funding will be made aware of their co-pay responsibility upon admission and throughout the course of treatment. REGULATORY COMPLIANCE All methadone-assisted treatment providers must obtain every individual s consent to contact other medication-assisted treatment providers within 200 miles to have the ability to regularly monitor for enrollment in other medication-assisted treatment programs. Evidence of such must be included in the individual s file (BSAAS Treatment Policy #05, Criteria for Using Methadone for Medication-assisted Treatment And Recovery, October 1, 2012, p. 5 of 11) Legally prescribed medication, including controlled substances, must be presented to the physician, who will decide whether these prescriptions are appropriate for the individual who is taking opioid replacement medications. Coordination of care with the prescribing physician is essential and expected. All methadone-assisted treatment providers will require that every individual provides a complete list of all prescribed medications. Legally prescribed medication including controlled substances must not be considered as illicit substances when the provider has documentation that it was prescribed for the individual. Legally prescribed medications that are not being used as prescribed will be treated as illicit substances. Such information must be documented in the individual s file. Approved examples of documentation include copies of the prescription label, pharmacy receipt, pharmacy printout, or a Michigan Automated Prescription System (MAPS) report. According to BSAAS Treatment and Recovery Policy #05: Criteria for Using Methadone for Medication-Assisted Treatment and Recovery, p. 5 of 11, "Michigan law allows for individuals with the appropriate physician approval and documentation to use medical marijuana. Although there are no prescribers of medical marijuana in Michigan, individuals are authorized by a physician to use marijuana per Michigan law. For enrolled individuals, there must be a copy of the MDCH registration card for medical marijuana issued in the individuals names in the [individuals] chart or the prescribed medication log". A copy of the individual s' registration card must be included in the individuals charts. According to Treatment and Recovery Policy #05: Criteria for Using Methadone for Medication-Assisted Treatment and Recovery, p. 5 of 11, "A MAPS report must be completed at admission. A MAPS report should be completed before off-site doses, including Sundays and holidays, are allowed and must be completed when coordination of care with other physicians could not be accomplished. Copies of the prescription label, pharmacy receipt, pharmacy print out, or a Michigan Automated Prescription System (MAPS) report must be included in the individual s chart or kept in a prescribed medication log that must be easily accessible for review. Outpatient treatment Providers collaborating with the methadone-assisted treatment Provider will be responsible for following Administrative Rule : Methadone treatment; voluntary withdrawal; discontinuation of use as follows: A client in treatment shall be given careful consideration for discontinuation of methadone use. Social rehabilitation shall have been maintained for a reasonable period of time. A client shall be encouraged to pursue the goals of eventual voluntary withdrawal from methadone and of becoming completely drug-free. Upon successfully reaching a drugfree state, the client shall be retained in the program for as long as necessary to assure stability in the drug-free state, with the frequency of his or her required visits adjusted in accordance with the treatment plan. Maintenance treatment shall be discontinued within 2 years after such treatment has begun, unless, based on the recorded clinical judgment of the staff physician, justification is provided to continue maintenance beyond the 2- year limitation. This justification shall be reviewed and updated every year thereafter by the staff physician. Page 16 of 21

17 PROVIDER REQUIREMENTS Methadone-assisted treatment Providers must have an appropriate license issued by the State of Michigan and a contract with CMHA/CEI/SRE in order to be reimbursed for methadone-assisted treatment and outpatient treatment through CMHA/CEI/SRE. The Michigan Department of Community Health, Behavioral Health and Developmental Disabilities Administration (MDCH/BHDDA) requires that: 1) The program must be identifiable and distinct with the agency s service configuration; and 2) The agency must offer or purport to offer MAT services as a separate and distinct program among any other program services that may be offered. Providers must base their program of services on the principles detailed in Treatment Improvement Protocol (TIP) 43, Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs and Treatment Improvement Protocol (TIP) 40, "Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid/Opiate Addiction". Individuals employed by provider organizations must be appropriately credentialed to provide the services described in this document (see Staff Credential and Program Supervision Requirements below). STAFF CREDENTIALS AND PROGRAM SUPERVISION REQUIREMENTS Methadone-assisted treatment for opioid/opiate Addiction services must be delivered by individuals in provider organizations who have been credentialed as a Certified Addictions Counselor or Certified Advanced Addictions Counselor, or an individual who has a registered Development Plan with the Michigan Certification Board for Addiction Professionals. Supervision of an identifiable MAT program within a licensed provider organization must be by an individual credentialed as a Certified Clinical Supervisor, or an individual who has a registered Development Plan for Certification as a Clinical Supervisor with the Michigan Certification Board for Addiction Professionals. MAT services must be provided under the supervision of a physician licensed to practice medicine in Michigan. The physician must be licensed to prescribe controlled substances. Within a methadone program, the physician must be specifically licensed to work at a methadone program. Methadone must be administered by an MD/DO, physician s assistant, nurse practitioner, registered nurse, licensed practical nurse, or pharmacist. A physician prescribing buprenorphine/naloxone must have completed all certification requirements mandated by the State of Michigan. AUTHORIZATION PARAMETERS Services such as medication reviews, drug screens, and actual dosing may vary depending on the service provider. However, every individual must complete an initial assessment prior to admission into a methadone-assisted treatment program. Assessing for continuing care is an ongoing process. IMPLEMENTATION GUIDANCE The U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment, has issued treatment improvement protocols (TIPs) to assist with the implementation of these services. Page 17 of 21

18 Treatment Improvement Protocol #43 (TIP-43), Medication-Assisted Treatment for Opioid/Opiate Addiction in Opioid/Opiate Treatment Programs ", Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment. Substance Abuse Treatment/Recovery Policy # 5, Criteria for Using Methadone for Medication - Assisted Treatment/Recovery", Michigan Department of Community Health, Bureau of Substance Abuse and Addiction Services. Additional resources used in the development of this treatment protocol include: Michigan Medicaid Provider Manual. American Society of Addiction Medicine Patient Placement Criteria-2R. River Haven Coordinating Agency, Instructions and Protocols for the Implementation of Medication-assisted Treatment for Opioid/Opiate Dependence, January 1, =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=- As always, CMHA/CEI/SRE welcomes the opportunity to take into account your experience and input, and together to expand our partnership for the benefit of individuals with substance use disorders who require our services. Should you have any comments or suggestions for improving this protocol, please contact CMHA/CEI/SRE at (517) or Page 18 of 21

19 EXPECTATIONS ON METHADONE ASSISTED TREATMENT FORM Client Printed Name Provider Name Upon assessment, every individual wishing to enter or re-enter methadone-assisted treatment will be provided with, informed of adherence with, and given an explanation of the Expectations on Methadone-assisted Treatment form. Upon admission to the methadone-assisted treatment Provider, the individual will sign the Expectations on Methadone-assisted Treatment form assuring his/her understanding of the expectations, which include the following and will be reviewed annually or as necessary by the outpatient treatment Provider (if applicable) and methadone-assisted treatment Provider: 1. Discontinuation of the use of all illicit and non-prescribed drugs and alcohol. 2. Regular attendance at the methadone-assisted treatment provider for dosing (daily, until such time that the individual meets criteria for take-home dosages in the case of methadone, and as clinically and medically appropriate for buprenorphine) dosing (with the possible exception of Sundays and holidays. 3. Submit to toxicology sampling as requested. 4. Attendance and active participation at all group and/or individual treatment sessions or other clinical activities. 5. Comply with the individualized treatment and recovery plan, inclusive of following through on other treatment and recovery plan related referrals. Repeated failure should be considered on an individual basis and only after the methadone-assisted treatment Provider and outpatient treatment Provider (if applicable) have taken steps to assist the individual to comply with activities. 6. Adherence to all program rules and policies. 7. Manage medical concerns/conditions, including adherence to physician treatment and recovery services and use of prescription medications that may interfere with the effectiveness of methadone and may present a physical risk to the individual. 8. Provide the names, addresses, and phone numbers of all medical, dental, and pharmacy providers. 9. Produce valid prescription or medication bottles with the physician s name on the label for all controlled substances within one week of admission. If the individual tests positive for a controlled substance that he/she has not previously provided a valid prescription for, the individual agrees to present a valid prescription or current medication bottle(s) with the physician s name on the label for the controlled substance before the individual may receive his/her next regular or full methadone dose. 10. Prescribed medications may have to be changed in order to better coordinate treatment. 11. Sign Authorizations to Release Information with medical, dental and pharmacy providers in order to better coordinate treatment. If an individual refuses to meet these expectations, it could negatively impact the individual s success with treatment. Page 19 of 21

20 12. Enrollment in one medication-assisted treatment Provider only (methadone and/or buprenorphine). If an individual is enrolled in more than one (1) medication-assisted treatment Provider at a time (methadone and/or buprenorphine), the individual may be detoxed and removed from the methadone program. 13. Evidence of continued work toward goals outlined in treatment plan. 14. No altered urine screens or non-compliance with drug testing. Client agrees, understands, and will practice the above expectations. Client Signature Date Reviewer Date Please check appropriate box: Reviewed during assessment: Reviewed during treatment admission: Page 20 of 21

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