14-118-5 Me. Code R. § 19

Current through 2024-25, June 19, 2024

Section 118-5-19 - SUBSTANCE ABUSE TREATMENT SERVICES

19.1Medically Managed Intensive Inpatient Detoxification Programs (ASAM Level IV-D).

19.1.1 Definition. Medically managed intensive inpatient detoxification programs provide services to persons who are experiencing severe withdrawal symptoms and therefore require full medical acute care services in a twenty-four hour hospital setting. Services include a biopsychosocial evaluation, medical observation, monitoring, and treatment, counseling, and follow-up referral. Services shall be delivered in an appropriately licensedcertified acute care inpatient setting, adhering to medically-approved procedures and protocols.

19.1.2 Services provided. Medically managed intensive inpatient detoxification programs will provide immediate medical evaluation and continued medical management, including:

19.1.2.1 Highly individualized biomedical, emotional, behavioral, and addiction treatment. This includes the management of all concomitant biomedical, emotional, behavioral, and cognitive conditions in the context of addiction treatment;

19.1.2.2 Availability of hourly or more frequent nurse monitoring;

19.1.2.3 A range of cognitive, behavioral, medical, mental health, and other therapies, to enhance the client's understanding of addiction, the completion of the detoxification process, and referral for continuing treatment and support;

19.1.2.4 Health education services;

19.1.2.5 Services to families and significant others;

19.1.2.6 Availability of specialized medical consultation. Providers of detoxification services shall make and maintain arrangements with external clinicians and facilities for referral of the client for specialized services beyond the capability of the program;

19.1.2.7 Full medical acute care services;

19.1.2.8 Intensive care, as needed;

19.1.2.9 Nutritional services, including special diets, as needed.

19.1.3 Staff.

19.1.3.1 Medically managed intensive inpatient detoxification programs shall be staffed by physicians or physician extenders who are available 24 hours a day as an active member of an interdisciplinary team of appropriately trained professionals, and who medically manage the care of the client.

19.1.3.2 A registered nurse or other licensed and credentialed nurse shall be available for primary nursing care and observation 24 hours a day.

19.1.3.3 An alcohol and drug counselor shall be available 8 hours a day to administer planned interventions according to the assessed needs of the client.

19.1.3.4 An interdisciplinary team of appropriately trained clinicians shall be available to assess and treat the client with a substance-related disorder, or an addicted client with a concomitant acute biomedical, emotional, or behavioral disorder.

19.1.4 Client records.

19.1.4.1 Elements of the assessment and treatment plan will include, but not be limited to:

19.1.4.1.1 A comprehensive nursing assessment, performed at admission;

19.1.4.1.2 Approval of the admission by a physician;

19.1.4.1.3 A record of a comprehensive history and physical examination performed within 24 hours of admission, accompanied by appropriate laboratory and toxicology tests OR the evaluation of the records of a physical examination administered within the preceding 7 calendar days prior to admission, by a physician or physician extender;

19.1.4.1.4 An addiction-focused history, obtained as part of the initial assessment and reviewed by a physician during the admission process;

19.1.4.1.5 Sufficient biopsychosocial screening assessments to determine placement, and for the individualized care plan to address treatment priorities. This assessment must be completed as soon as the client is medically stable, but no later than the fourth day of admission, to include screening for history of abuse or trauma;

19.1.4.1.6 An individualized treatment plan, including problem identification, treatment goals, measurable treatment objectives, and activities designed to meet those objectives.

19.1.4.2 Other documentation will include:

19.1.4.2.1 Progress notes entered by clinical staff at least once in each 24 hour period that clearly reflect implementation of the treatment plan and the client's response to treatment, as well as subsequent amendments to the plan;

19.1.4.2.2 Detoxification rating scale tables and flow sheets, as needed;

19.1.4.2.3 Physician services, documented in the client record as they occur;

19.1.4.2.4 Notes of client progress entered by nurses at least once each shift or every 8 hours;

19.1.4.2.5 A record of discharge/transfer planning, beginning at admission.

19.1.5 Methadone detoxification. Persons presenting symptoms of severe opiate withdrawal in a residential setting may require the use of methadone to facilitate a successful withdrawal. The administration of methadone to facilitate detoxification will require compliance with a variety of Federal and State of Maine laws, and will also involve oversight by Federal and State agencies to monitor compliance with these laws. The detoxification process using methadone involves the reduction of dosage from the stabilization dosage to a zero dosage upon discharge. Methadone detoxification programs must meet the following requirements:

19.1.5.1 Programs using methadone must include documentation of approval from and compliance with regulations of the Substance Abuse and Mental Health Services Administration (SAMHSA), the Federal Drug Enforcement Administration, the Maine State Pharmacy Board, and the Maine Department of Health and Human Services, Division of Licensing and Regulatory Services.

19.1.5.2 Also required is proof of appropriate accreditation by the Joint Commission for the Accreditation of Health Care Organizations, or the Commission on Accreditation of Rehabilitation Facilities. Detoxification programs that employ the services of a physician certified by the American Society of Addiction Medicine must provide a copy of such certificate.

19.1.5.3 Programs using methadone must submit de-identified client data to the Office of Substance Abuse on forms provided by the office. This data will be made available only for research and program evaluation functions.

19.2Freestanding Residential Detoxification Programs

(ASAM Level III 7-D/medically monitored inpatient detoxification).

19.2.1 Definition. Freestanding residential detoxification programs provide care to persons whose withdrawal signs and symptoms indicate the need for 24-hour residential care. Services include a biopsychosocial evaluation, medical observation, monitoring, and treatment, counseling, and follow-up referral. However, the full resources of an acute care general hospital or a medically managed intensive inpatient treatment program are not necessary. Services must be conducted in a freestanding or other appropriately licensedcertified healthcare or addiction treatment facility.

19.2.2 Services provided. The freestanding residential detoxification program will provide immediate medical evaluation and continued medical management, including:

19.2.2.1 group therapies, and withdrawal support;

19.2.2.2 Availability of hourly or more frequent nurse monitoring;

19.2.2.3 A range of cognitive, behavioral, medical, mental health, and other therapies, designed to enhance the client's understanding of addiction, the completion of the detoxification process, and referral for continuing treatment and support;

19.2.2.4 Health education services;

19.2.2.5 Services to families and significant others;

19.2.2.6 Availability of specialized clinical consultation and supervision for biomedical, emotional, and behavioral and cognitive problems. Providers of detoxification services shall make and maintain arrangements with external clinicians and facilities for referral of the member for specialized services beyond the capability of the program;

19.2.2.7 Direct affiliation with other levels of care;

19.2.2.8 Ability to conduct or arrange for appropriate laboratory and toxicology tests;

19.2.2.9 Nutritional services, including special diets, as needed.

19.2.3 Staff.

19.2.3.1 Freestanding residential detoxification programs shall be staffed by physicians or physician extenders who are available 24 hours a day by telephone.

19.2.3.2 A registered nurse or other licensed and credentialed nurse shall be available to conduct a nursing assessment on admission.

19.2.3.3 A nurse shall be on site at all times, and shall be responsible for overseeing the monitoring of the client's progress and medication administration on an hourly basis, as needed.

19.2.3.4 Appropriately licensed and credentialed staff shall be available to administer medications in accordance with physician orders. The level of nursing care must be appropriate to the severity of client need.

19.2.3.5 Appropriately credentialed alcohol and drug counselors shall provide evaluation and treatment services for clients, and family support as needed.

19.2.3.6 An interdisciplinary team of appropriately trained clinicians shall be available to assess and treat the client and to obtain and interpret information regarding the client's needs. The number and disciplines of team members are appropriate to the range and severity of the client's problems.

19.2.4 Client records.

19.2.4.1 Elements of the assessment and treatment plan will include, but not be limited to:

19.2.4.1.1 An addiction-focused history, obtained as part of the initial assessment and reviewed by a physician during the admission process;

19.2.4.1.2 A record of a physical examination by a physician or physician extender, performed within 48 hours of admission, accompanied by appropriate laboratory and toxicology tests OR the evaluation of the records of a physical examination administered within the preceding 7 calendar days prior to admission, by a physician or physician extender;

19.2.4.1.3 Sufficient biopsychosocial screening assessments to determine the level of care in which the client should be placed and for the individualized care plan to address treatment priorities;

19.2.4.1.4 An individualized treatment plan, including problem identification, treatment goals, measurable treatment objectives, and activities designed to meet those objectives.

19.2.4.2 Other documentation will include:

19.2.4.2.1 Progress notes that clearly reflect implementation of the treatment plan and the client's response to treatment, as well as subsequent amendments to the plan;

19.2.4.2.2 Detoxification rating scale tables and flow sheets, as needed;

19.2.4.2.3 Physician services, documented in the client record as they occur;

19.2.4.2.4 Notes of client progress entered by nurses at least once each shift or every 8 hours;

19.2.4.2.5 Notes of client progress entered by clinical staff at least once in each 24 hour period;

19.2.4.2.6 A record of discharge/transfer planning, beginning at admission.

19.2.5 Methadone detoxification. Persons presenting symptoms of severe opiate withdrawal in a residential setting may require the use of methadone to facilitate a successful withdrawal. The administration of methadone to facilitate detoxification will require compliance with a variety of Federal and State of Maine laws, and will also involve oversight by Federal and State agencies to monitor compliance with these laws. The detoxification process using methadone involves the reduction of dosage from the stabilization dosage to a zero dosage upon discharge. Methadone detoxification programs must meet the following requirements:

19.2.5.1 Programs using methadone must include documentation of approval from and compliance with regulations of the United States Food and Drug Administration, the Federal Drug Enforcement Administration, the Maine State Pharmacy Board, and the Maine Department of Health and Human Services, Division of Licensing and Regulatory Services.

19.2.5.2 Also required is proof of appropriate accreditation by the Joint Commission for the Accreditation of Health Care Organizations, or the Commission on Accreditation of Rehabilitation Facilities. Detoxification programs who employ the services of a physician certified by the American Society of Addiction Medicine must provide a copy of such certificate.

19.3Outpatient Detoxification Programs (ASAM Level I-D and Level II-D).

19.3.1 Definition. Outpatient detoxification programs provide services to persons who are experiencing no more than moderate withdrawal symptoms, and do not have co-morbid medical or psychiatric conditions that require 24-hour inpatient care. Services include a biopsychosocial evaluation, medical observation, monitoring, and follow-up referral. Services may be conducted in a freestanding or other appropriately licensed healthcare or addiction treatment facility. Clients experiencing, or at risk of experiencing acute withdrawal syndrome are not appropriate candidates for outpatient detoxification.

19.3.2 Services provided. The outpatient detoxification program shall provide immediate medical evaluation and continued medical management in an ambulatory setting, including:

19.3.2.1 daily medical monitoring and management of acute withdrawal symptoms;

19.3.2.2 biopsychosocial assessment, including assessment of availability of support for the client in the community;

19.3.2.3 appropriate referrals for further mental health or medical consultation;

19.3.2.4 24-hour access to medical care;

19.3.2.5 assessment of clients' medical and behavioral symptoms on at least a daily basis;

19.3.2.6 planning for and referral to further treatment.

19.3.3 Staff.

19.3.3.1 Outpatient detoxification programs will be staffed by physicians or physician extenders who are available 24 hours a day by telephone.

19.3.3.2 A registered nurse or other licensed and credentialed nurse shall be available to conduct a nursing assessment on admission.

19.3.3.3 An interdisciplinary team of appropriately trained clinicians shall be available to assess and treat the client with a substance-related disorder, or an addicted client with a co-occurring acute biomedical, emotional, or behavioral disorder.

19.3.4 Client records.

19.3.4.1 Elements of the assessment and treatment plan will include, but not be limited to:

19.3.4.1.1 An addiction-focused history, obtained as part of the initial assessment and reviewed by a physician during the admission process;

19.3.4.1.2 A record of a physical examination by a physician or physician extender, performed within 24 hours of admission, accompanied by appropriate laboratory and toxicology tests OR the evaluation of the records of a physical examination administered within the preceding 7 calendar days prior to admission, by a physician or physician extender;

19.3.4.1.3 Sufficient biopsychosocial screening assessments to determine the level of care in which the client should be placed and for the individualized care plan to address treatment priorities;

19.3.4.1.4 An individualized treatment plan, including problem identification, treatment goals, measurable treatment objectives, and activities designed to meet those objectives.

19.3.4.2 Other documentation will include:

19.3.4.2.1 Progress notes that clearly reflect implementation of the treatment plan and the client's response to treatment, as well as subsequent amendments to the plan;

19.3.4.2.2 Detoxification rating scale tables and flow sheets, as needed;

19.3.4.2.3 Physician services, documented in the client record as they occur;

19.3.4.2.4 Notes of client progress entered by nurses at least once daily;

19.3.4.2.5 Notes of client progress entered by clinical staff at least once daily;

19.3.4.2.6 A record of discharge/transfer planning, beginning at admission.

19.4Shelter Services.

19.4.1 Definition. Shelter is a service which provides food, lodging and clothing for abusers of alcohol and other drugs, with the purpose of protecting and maintaining life and providing motivation for alcohol and drug treatment.

19.4.2 Services Provided. Services provided will include but not necessarily be limited to:

19.4.2.1 food and beverages when the shelter is in operation;

19.4.2.2 clean clothing, with laundry facilities available on the premises;

19.4.2.3 clean bedding;

19.4.2.4 shower or bathing facilities;

19.4.2.5 supplies for personal hygiene;

19.4.2.6 referral to detoxification or other suitable treatment, as needed;

19.4.2.7 arrangements for needed health care services through written agreements with detoxification centers, hospitals, and other emergency care facilities;

19.4.2.8 encouragement for participation in self-help groups;

19.4.2.9 transportation between the program and emergency healthcare facilities.

19.4.3 Staff. In addition to the General Requirements listed above, staff will receive training:

19.4.3.1 to carry out emergency procedures, including CPR and first aid, and become certified in these procedures;

19.4.3.2 to recognize signs that could indicate the physical deterioration of a client;

19.4.3.3 to recognize suicidal indicators and to notify clinical staff if indicators are present;

19.4.3.4 to motivate the client to accept detoxification or other suitable treatment;

19.4.3.5 in referral procedures;

19.4.3.6 to maintain records of shelter utilization;

19.4.3.7 to identify potentially harmful items and to supervise their use.

19.5Residential Treatment Programs (ASAM Level III).

19.5.1 Definition. Residential treatment programs provide services in a full (24 hours) residential setting. The program shall provide a scheduled treatment regimen which consists of diagnostic, educational, and counseling services; and shall refer clients to support services as needed. Clients are routinely discharged to various levels of follow-up services. There are three categories of residential care:

19.5.2Category I. Category I residential treatment programs maintain a basic focus on early recovery skills, including the negative impact of chemical dependency, tools for developing support, and relapse prevention skills. Examples of Category I programs are extended shelters and residential rehabilitation programs. Category I programs are characterized by the following criteria:

19.5.2.1 The term of residency shall not exceed 45 days without documented assessment of client's need for the extension and a treatment plan indicating goals congruent with the definition and purpose of this component.

19.5.2.2 Individual and group counseling at a minimum of 14 hours per week or 2 hours per day for each client. The qualified staff shall teach attitudes, skills and habits conducive to good health and the maintenance of a substance free life style. The treatment mode may vary with the member's needs and may be in the form of individual, group or family counseling at a minimum of fourteen (14) hours per week.

19.5.2.3 Daily didactic/educational presentations.

19.5.2.4 Programs shall have staff coverage 24 hours a day, including weekend coverage. The program shall maintain a medical staffing pattern that enables it to meet the physical care requirements delineated above. Physician back-up and on-call staff shall be provided to deal with medical emergencies. The program shall not subcontract any of its obligations and rights pertaining to medical services described in this section. For the purposes of this section, physician consultant services are not considered subcontracting.

19.5.3Category II. Category II programs provide a structured residential milieu, to help clients transition from a substance abusing lifestyle to a solid recovery environment. Clients may initially receive a treatment focus similar to that of Category I programs, but will transition to a treatment focus that addresses the cultural, social, educational, and vocational needs of the client. An example of a Category II program is a halfway house. Category II programs are characterized by the following criteria:

19.5.3.1 length of treatment: up to 180 days duration

19.5.3.2 group/individual/family treatment sessions appropriate to the phase of treatment

19.5.3.3 living skills training according to the phase of treatment

19.5.3.4 vocational assessment and preparation

19.5.3.5 supervised housekeeping responsibilities

19.5.4Category III. Category III programs provide a long-term supportive and structured environment for chemically dependent clients with extensive substance abuse debilitation. These programs provide a supervised living experience within the program. Qualified staff shall teach attitudes, skills and habits conducive to facilitating the member's transition back to the community. The treatment mode may vary with the member's needs and may be in the form of individual, group or family counseling. Outcome goals may range from custodial care to further treatment services and recovery. Examples of Category III programs are adolescent long-term rehabilitation or an extended care program. Category III programs are characterized by the following criteria:

19.5.4.1 length of treatment: over 180 days duration

19.5.4.2 group/individual/family treatment sessions appropriate to the phase of treatment

19.5.4.3 living skills training according to the phase of treatment

19.5.4.4 vocational assessment and preparation

19.5.4.5 supervised housekeeping responsibilities

19.5.4.6 transportation shall be available 24 hours a day. A written agreement shall provide for transportation between the program and emergency care facilities.

19.5.4.7 The program shall have a written agreement with an ambulance service to assure twenty-four (24) hour access to transportation to emergency medical care facilities for clients requiring such transport. Physician back-up and on-call staff shall be provided to deal with medical emergencies.

19.5.4.8 A program shall not subcontract any of its obligations and rights pertaining to medical services described in these regulations with the exception of physician consultant services.

19.5.4.9 Extended care services shall provide a scheduled therapeutic plan consisting of treatment services designed to enable the member to sustain a substance free life style within a supportive environment.

19.5.5 Services provided. The services shall depend upon the treatment needs of the individual clients. Services provided either on site or through referral shall include but not be limited to:

19.5.5.1 Evaluation of the client's medical and psycho-social needs;

19.5.5.2 A medical examination by the program's physician within 5 days of admission unless the physician has approved a prior examination conducted within the last 30 days;

19.5.5.3 Opportunities for learning basic living skills, such as personal hygiene skills, knowledge of proper diet and meal preparation, constructive use of leisure time, money management, and interpersonal relationship skills;

19.5.5.4 Clinical services, including individual and group counseling;

19.5.5.5 Provisions for family involvement;

19.5.5.6 Educational services, vocational placement and training, and recreational opportunities as appropriate to the client group to be served;

19.5.5.7 Encouragement for participation in self-help groups. The program shall make agreements with community resources to provide client services through referrals when the program is unable to provide them.

19.6Intensive Outpatient Programs (iop) (ASAM Level II.1).

19.6.1 Definition. Intensive Outpatient Programs provide an intensive and structured program of alcohol and other drug assessment and group treatment services in a setting which does not include an overnight stay. These programs include a structured sequence of multi-hour clinical and educational sessions scheduled for a minimum of six (6) and maximum of twenty (20) hours per week per client. Any exceptions to these time frames must be approved in advance by OSA.

19.6.2 Services Provided.

19.6.2.1 procedures to determine the client's medical needs. The program will determine the necessity for medical examination and further consultation. The medical assessment will be part of the client record;

19.6.2.2 biopsychosocial assessment, as outlined in Section 15.7;

19.6.2.3 clinical services, to include daily didactic and counseling groups;

19.6.2.4 educational chemical dependency groups;

19.6.2.5 involvement of affected others;

19.6.2.6 planning for and referral to further treatment, as needed.

19.7Outpatient Care (ASAM Level I).

19.7.1 Definition. Outpatient Care provides assessment and counseling services to chemically dependent clients and affected others.

19.7.2 Services provided.

19.7.2.1 services offered according to client need on a scheduled or emergency basis;

19.7.2.2 individual, group, and family counseling;

19.7.2.3 procedures to determine the client's medical needs. The program will determine the necessity for medical examination and further consultation. The medical assessment will be part of the client record;

19.7.2.4 biopsychosocial assessment, as outlined in Section 15.6. The program will make appropriate referrals for further mental health consultation;

19.7.2.5 services to the client, through referral, in the area of educational enrichment, vocational placement and training, legal services, and money management, as dictated by client needs;

19.7.2.6 planning for and referral to further treatment;

19.7.2.7 education about chemical abuse.

19.8Opioid Treatment Program (OTP)

(Opioid Supervised Withdrawal and Maintenance Treatment Module).

19.8.1Opioid Treatment. Opioid supervised withdrawal and maintenance are adjunctive treatments for individuals with a current serious physiological opiate addiction. A client must have an addiction of at least one year duration in order to qualify for maintenance treatment. Opioid maintenance and treatment involves the administration of specific opioid agonists under the supervision of the program Medical Director.

19.8.2Federal and State Authority. The administration of opioid agonists will require compliance with a variety of Federal and Maine State laws, and will also involve oversight by Federal and State agencies to monitor compliance with these laws and regulations.

19.8.2.1 Compliance. OTP compliance with federal and state laws shall be subject to the review and independent verification of the Licensing Authority.

19.8.2.2 OTPs shall demonstrate compliance with:

19.8.2.2.1 Federal Certificate. 42 CFR Chapter 1, Subchapter A, Part 8, as amended, including but not limited to, possession of a current, valid certificate from the Substance Abuse and Mental Health Services Administration within the U.S. Department of Health and Human Services (SAMHSA), which shall be the demonstration of compliance with Sections 303(g)(1) of the Controlled Substances Act (21 United States Code (USC) Section 823(g)(1) ), as amended, to dispense opioid drugs in the treatment of opioid addiction. This will depend upon the OTP obtaining accreditation from an accreditation body that has been approved by SAMHSA; and

19.8.2.2.2 Maine Criminal Code and Maine State Pharmacy Act. Chapter 45 of the Maine Criminal Code ( 17-A M.R.S.A. §1101 et seq.), as amended, and the Maine State Pharmacy Act ( 32 M.R.S.A §13731(2) ), as amended, and Sections 2.19 of these rules.

19.8.2.2.3 Diversion Control Plan. As part of the quality assurance plan required by 42 CFR §8.12(c)(2), OTPs shall maintain a current Diversion Control Plan. (See 19.8.3.7).

19.8.2.2.4 USFDA Consent to Treatment Form. Acquire and maintain documentation that shall include the USFDA Form 2635 "Consent to Treatment with an Approved Narcotic Drug." (See 19.8.3.10.4)

19.8.3Waivers.

19.8.3.1Program-size Waiver. Waivers may be granted by the licensing authority to authorize specific OTP licensed program sites to exceed the 500-client maximum if the program meets the following requirements:

19.8.3.1.1 The physical plant is adequate to accommodate the proposed number of clients;

19.8.3.1.2 The program has the ability to hire and retain adequate numbers of qualified staff to meet the standards in this rule;

19.8.3.1.3 A demonstrated need for increased services that cannot be reasonably met except by expansion of the program size; and

19.8.3.1.4 Written agreement by the program to accept the conditions of the waiver as enforceable as rule.

19.8.3.2Caseload-size Waiver.

19.8.3.2.1 A temporary, time-limited, waiver may be granted by the licensing authority to authorize a specific OTP licensed program site to exceed the 50-client maximum for any counselor employed by the OTP on a full-time basis when the OTP is actively recruiting replacement staff. (See 19.8.8.6.3)

19.8.3.2.2 Unless the licensing authority grants a waiver, caseloads shall not exceed 35 clients for counselors employed by the OTP on a full-time basis who have not completed 2000 hours of substance abuse practice under clinical supervision. (See 19.8.8.6.4)

19.8.4General Requirements. Opioid Treatment Programs (OTPs) shall meet the following requirements, in addition to the requirements of Sections 2 through 19 of these rules:

19.8.4.1 An OTP may exist in a number of settings, including, but not limited to, intensive outpatient, residential, and hospital settings. Types of treatment may include medical maintenance, medically supervised withdrawal, and detoxification, either with our without various levels of medical, psychosocial, and other types of care.

19.8.4.2 OTPs shall be open seven days weekly, including all holidays;

19.8.4.3 Program size. OTPs shall limit their program size to no more than 500 clients at each licensedcertified site, unless a waiver is granted. (See 19.8.3.1)

19.8.4.4 Prior to admitting a client, OTPs shall submit client data to the Office of Substance Abuse (OSA) according to specifications as shall be determined by OSA. The specifications shall include content, form, format, frequency, and due date for submission. This data will be made available only for research and program evaluation functions.

19.8.4.5 Prior to admission to an OTP, the OTP shall confirm using OSA's data collection system that the client is not currently enrolled in another OTP. In the event that the data collection system is inoperable or unavailable, the OTP shall check with all other OTPs within three calendar days of admission to the OTP.

19.8.4.5.1 The OTP shall obtain from the client all releases of information necessary to conduct this confirmation.

19.8.4.5.2 Documentation that such a confirmation has been made shall be noted in the client record.

19.8.4.6 Diversion Control Plan. As part of the quality assurance plan required by 42 CFR §8.12(c)(2), OTPs shall maintain a current Diversion Control Plan that contains specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use, and that assigns specific responsibility to the medical director and the program manager for carrying out the diversion control measures and functions described in the Diversion Control Plan.

19.8.4.7 Emergency Administration of Medications Plan. There shall be a current plan for emergency administration of medications in case the program is required to close temporarily on an emergency basis, including how clients are to be informed of these emergency arrangements.

19.8.4.8 Disaster Plan. There shall be a current disaster plan, that shall address at least the following:

19.8.4.8.1 Natural disasters and man-made disasters, or other serious events;

19.8.4.8.2 Disasters that may occur when the OTP is open and when it is closed;

19.8.4.8.3 Security of medication and records;

19.8.4.8.4 Safety of clients and staff, including an evacuation plan; and

19.8.4.8.5 Any other situation that is unique to the OTP.

19.8.4.9 Informed Consent. There shall be current procedures to ensure that the informed written consent to treatment of clients is received. Specifically, the OTP shall:

19.8.4.9.1 Ensure that admission is voluntary;

19.8.4.9.2 Ensure that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the client. This will include, but not necessarily be limited to, the risks and benefits of treatment, other treatment options, and the fact that opioid agonist drugs cause dependence and dosage tolerance;

19.8.4.9.3 Ensure that the reasons for and ramifications of administrative supervised withdrawal are explained to the client; and

19.8.4.9.4 Acquire and maintain documentation that shall include the Client Rights and Responsibility Disclosure Forms signed by the client, and USFDA Form 2635 "Consent to Treatment with an Approved Narcotic Drug."

19.8.4.10 Transfers. OTPs shall develop and follow policies and procedures to effect orderly transfers of clients between substance abuse programs. Records shall be provided promptly to the receiving substance abuse program. Records shall be complete at the time of transfer. Reports to OSA data collection system shall be completed at the time of transfer.

19.8.4.11 Administrative Withdrawal. OTPs shall develop and follow policies and procedures, consistent with best practices and applicable law and rule, governing administrative withdrawal. Administrative withdrawal may not be used by OTPs to discipline clients for minor infractions of program policy. Clients who are involuntarily withdrawn from treatment for administrative reasons shall be treated with compassion, respect and dignity. Dosage withdrawal schedules shall be developed and documented for each individual client being administratively withdrawn, considering the maintenance dosage, individual tolerance of dosage reduction, and psychiatric and medical comorbidities.

19.8.4.12 Critical Incident Reporting. OTPs shall adhere to critical incident reporting procedures required by OSA. (See section 5.2 )

19.8.4.13 OTPs shall invite the public, municipal officials including but not limited to elected officials, public health and public safety officials to an annual meeting with clinic management and Office of Substance Abuse staff to discuss the clinic's impact on the municipality.

19.8.5Required Services. OTPs shall provide adequate medical, counseling, vocational, educational and other assessment and treatment services that are fully and reasonably available to clients.

19.8.5.1 The services may be provided by the OTP at the OTP primary site or through a contracted staff agreement. All assessments, evaluations and interventions shall be documented in the client record.

19.8.5.2Medical examinations. Initial medical examinations are required at the time of admission to the OTP. The examination may be conducted by the OTP physician, a primary care physician, or a physician extender as permitted by rule and law.

19.8.5.2.1 The examination shall include serology and other relevant tests. The examination shall be completed within fourteen (14) days following admission, including the review of results of serology and other tests.

19.8.5.2.2 Testing shall be conducted for tuberculosis, syphilis, and liver function. Further testing for Hepatitis B and C shall be available if indicated.

19.8.5.2.3 Voluntary screening for Human Immunodeficiency Virus (HIV) and other sexually transmitted infections shall be available. When appropriate, referral to other providers of these services shall be made and documented in the client record.

19.8.5.2.4 Clients shall be provided with all baseline testing recommended in pharmaceutical inserts of medications being considered for use.

19.8.5.2.5 All female clients of childbearing potential shall be tested for pregnancy upon admission to the OTP and as needed during the course of treatment. Pregnant clients shall be referred to prenatal care.

19.8.5.2.6 Results of examinations completed within the prior 12 months may be used for clients readmitted to a program within 3 months of discharge.

19.8.5.2.7 Clients transferring from another program shall complete all screening and admission procedures except in documented emergencies.

19.8.5.3Initial Assessments. Initial assessments shall include a detailed bio-psycho-social evaluation, which shall provide supportive evidence that opioid agonist treatment is the medically appropriate treatment for the client. The evaluation shall include documentation of any previous treatment experiences.

19.8.5.4Rehabilitation Counseling. Unless an exception is granted under section 19.8.1 1.3, rehabilitation counseling services shall be provided by the OTP staff and shall be consistent with the client's treatment plan. The client record shall include documentation of the provision of counseling and the results of counseling. This counseling shall be in addition to the face-to-face evaluation done at the time of dosing.

19.8.5.5Phase 1 - Initiation or Induction

19.8.5.5.1 Duration- Minimum 45 days

19.8.5.5.2 Counseling Requirement - Total 4 (four) hours of counseling that could include individual counseling, group counseling, psycho-educational, psychodynamic or support group sessions.

19.8.5.5.3 Individual counseling may be provided in either 15 or 30 minute sessions.

19.8.5.5.4 Required Goals for Phase 1 Completion

19.8.5.5.4.1 initially prescribing a medication dosage that minimizes sedation and other undesirable side effects

19.8.5.5.4.2 assessing the safety and adequacy of each dose after administration

19.8.5.5.4.3 rapidly but safely increasing dosage to suppress withdrawal symptoms and cravings and discourage patients from self-medicating with illicit drugs or alcohol or by abusing prescription medications

19.8.5.6Phase 2 - Acute Treatment

19.8.5.6.1 Duration- Minimum 60 days

19.8.5.6.2 Counseling Requirement - Total 6 (six) hours of counseling that could include individual counseling, group counseling, psycho-educational, psychodynamic or support group sessions.

19.8.5.6.3 Individual counseling may be provided in either 15 or 30 minute sessions.

19.8.5.6.4 Required Goals for Phase 2 Completion

19.8.5.6.4.1 elimination of symptoms of withdrawal, discomfort, or craving for opioids

19.8.5.6.4.2 providing or referring patients for services to lessen the intensity of co-occurring disorders and medical, social, legal, family, and other problems associated with opioid addiction

19.8.5.6.4.3 helping patients identify high-risk situations for drug and alcohol use and develop alternative strategies for coping with cravings or compulsions to abuse substances.

19.8.5.6.4.4 satisfaction of basic needs for food, shelter, and safety.

19.8.5.7Phase 3 - Rehabilitation

19.8.5.7.1 Duration - Minimum 90 days

19.8.5.7.2 Counseling Requirement - Total 6 (six) hours of counseling that could include individual counseling, group counseling, psycho-educational, psychodynamic or support group sessions.

19.8.5.7.3 Individual counseling may be provided in either 15 or 30-minute sessions.

19.8.5.7.4 Required Goals for Phase 3 Completion

19.8.5.7.4.1 abstinence from illicit opioids and from abuse of opioids normally obtained by prescription, as evidenced by drug tests

19.8.5.7.4.2 amelioration of signs of opioid withdrawal

19.8.5.7.4.3 reduction in physical drug craving

19.8.5.7.4.4 elimination of illicit-opioid use and reduction in other substance use, including abuse of prescription drugs and alcohol

19.8.5.7.4.5 completion of medical and mental health assessment

19.8.5.7.4.6 development of a treatment plan to address psychosocial issues such as education, vocational goals, and involvement with criminal justice and child welfare or other social service agencies as needed

19.8.5.8Phase 4 - Supportive Care

19.8.5.8.1 Duration-ongoing 90 day periods

19.8.5.8.2 Counseling Requirement - Total 3 (three) hours of counseling that could include individual counseling, group counseling, psycho-educational, psychodynamic or support group sessions.

19.8.5.8.3 Individual counseling may be provided in either 15 or 30 minute sessions.

19.8.5.8.4 Required Goals for Phase 4 Completion

19.8.5.8.4.1 engagement with treatment staff in assessment of medical, mental health, and psychosocial issues as evidenced by kept appointments and clinic attendance

19.8.5.8.4.2 stable living conditions in an environment free of substance use

19.8.5.8.4.3 stable and legal source of income

19.8.5.8.4.4 involvement in productive activities (e.g., employment, school, volunteer work)

19.8.5.8.4.5 no criminal or legal involvement

19.8.5.9Phase 5 - Medical Maintenance

19.8.5.9.1 Duration - ongoing 90 day periods

19.8.5.9.2 Counseling Requirement - Total 1 (one) hour and will include time spent to review the treatment plan and could include individual counseling, group counseling, psycho-educational, psychodynamic or support group sessions.

19.8.5.9.3 Individual counseling may be provided in either 15 or 30 minute sessions.

19.8.5.9.4 Required Goals for Phase 5 Completion

19.8.5.9.4.1 two (2) years of continuous treatment

19.8.5.9.4.2 abstinence from illicit drugs and from abuse of prescription drugs (as evidenced by drug tests) for at least 2 years for a full 30-day maintenance dosage.

19.8.5.9.4.3 no alcohol use problem

19.8.5.9.4.4 stable living conditions in an environment free of substance use

19.8.5.9.4.5 stable and legal source of income

19.8.5.9.4.6 involvement in productive activities (e.g. employment, school, volunteer work)

19.8.5.9.4.7 no criminal or legal involvement for at least 3 years and no current parole o probation status

19.8.5.9.4.8 adequate social support system and absence of significant un-stabilized co-occurring disorders

19.8.5.10Education on HIV. Education on HIV and Hepatitis shall be provided to all clients. Additional education on other infectious diseases shall be provided by the OTP to clients, as dictated by client need. Education shall be documented in the client record.

19.8.6Treatment Plans. Treatment plans shall be developed to describe the most appropriate combination of services and treatment.

19.8.6.1 The initial treatment plan shall be in writing and completed within 7 calendar days of admission. It shall be developed and signed by the client, the primary counselor and the medical director.

19.8.6.2 The treatment plan shall include both short and long term goals, the services and/or steps necessary to achieve the goals, the frequency with which the services are provided, and the staff position or entity assuming responsibility for the provision of the services.

19.8.6.3 Updates to the plan shall be in writing and shall reflect the client's personal history, current needs, and degree of achievement of short and long term goals.

19.8.6.4 Updates shall be completed no less frequently than every 90 days. They shall be reviewed and revised if needed whenever there is a significant change in the client's status. They shall be signed by the primary counselor and client.

19.8.6.5 Treatment plans shall include the rationale for the use of the dosage plan. This shall be documented by a physician or physician extender. Initial doses of methadone shall not exceed 30 milligrams unless the physician documents the need for a higher dose.

19.8.6.6 Results of drug tests shall be documented in the client record and there shall be a clear indication in the client record that the results of drug testing have been reviewed and considered as part of the treatment planning process and decisions for take-home dosing.

19.8.6.7 The medical director shall review and sign treatment plans on an annual basis.

19.8.7 Requirements for Maintenance Programs. All maintenance treatment programs shall operate as follows:

19.8.7.1 Population to be served.

19.8.7.1.1 Addiction status. Clients shall be currently addicted to an opioid drug and shall have become addicted at least one (1) year before admission for treatment.

19.8.7.1.2 Age. Clients will be 18 years of age or older, unless approved by the Office of Substance Abuse, and the following requirements are met:

19.8.7.1.2.1 Clients under the age of 18 may not be admitted unless a parent, legal guardian, or responsible adult approved by OSA consents in writing to such treatment; and

19.8.7.1.2.2 Clients under the age of 18 are required to have had two documented unsuccessful attempts at short-term supervised withdrawal or drug-free treatment within a 12 month period.

19.8.7.1.3 Priority Clients. Pregnant clients and those who are HIV positive will be considered priority clients. Pregnant clients, regardless of age, may be placed on a regimen of opioid agonists, provided that the medical director certifies to the pregnancy, and documents that the treatment is medically justified.

19.8.7.1.4 If clinically appropriate, the OTP physician may-dispense with the requirement of a 1 year history of addiction for clients released from penal institutions (if within 6 months after release), for pregnant clients (if the pregnancy has been certified) and for previously treated clients (up to 2 years after discharge).

19.8.7.2 Drug Testing Services. The OTP shall develop and follow policies and procedures, consistent with best practices and applicable law and rule, governing drug testing practices. The policy and procedure shall be approved by OSA. At minimum, drug testing policies shall include the following:

19.8.7.2.1 Prompt Testing. All drug testing samples shall be tested promptly. Testing facilities shall be qualified to conduct testing.

19.8.7.2.2 Drug Testing at Admission. All clients will have a drug test at admission. A positive test is not a requirement for admission to the OTP.

19.8.7.2.3 Required Screens. All required drug tests shall include screening for opiates, methadone, cocaine, benzodiazepines and other substances of abuse prevalent in the community.

19.8.7.2.3.1 Additionally, the drug test at admission shall include screening for cannabis.

19.8.7.2.3.2 Random drug samples shall be collected no less frequently than every 30 days unless the individual treatment plan indicates more collections are necessary. If the admission drug test was positive for cannabis, periodic screens for cannabis shall be conducted and documented.

19.8.7.2.3.3 Drug tests in addition to those required by this rule need to include only those screens specific to the individual client's treatment needs.

19.8.7.2.4 Use of Results. Results of drug testing shall be used as a factor in making treatment decisions. Results of drug testing shall not be used in a punitive manner. There shall be a clear indication in the client record that the results of drug testing have been reviewed and considered as part of the treatment planning process and decisions for take-home dosing.

19.8.7.2.5 Sample Integrity. Adequate and appropriate steps shall be taken to prevent falsification or substitution in sample collection.

19.8.7.2.5.1 The routine use of observation techniques such as cameras and windows is prohibited.

19.8.7.2.5.2 The use of observation shall be clinically substantiated and gender appropriate.

19.8.8Staff Requirements.

19.8.8.1 The Medical Director shall be a physician licensed to practice in the State of Maine, and in addition shall be certified b the American Society of Addiction Medicine (ASAM) or otherwise qualified through education, experience and training in addictions.

19.8.8.1.1 The medical director shall assume responsibility for administering all medical services performed by the OTP, either by performing them directly or by delegating specific responsibility to authorized program physicians and healthcare professionals functioning under the medical director's direct supervision. The medical director shall meet the requirements described at Section 10 of these rules.

19.8.8.1.2 The medical director shall review all treatment plans at least once annually and indicate written approval.

19.8.8.1.3 The medical director shall review and approve in writing all OTP policies.

19.8.8.1.4 The OTP shall notify the Office of Substance Abuse of the resignation or replacement of a Medical Director within five days of such resignation or replacement.

19.8.8.2 Physician extenders as defined in Section 1.51 may be utilized at an OTP under the following conditions:

19.8.8.2.1 Physicians Assistants (PAs) may practice as described at 02-373 Code of Maine Rules (CMR) Chapter 2, as amended, under the supervision of the Medical Director.

19.8.8.2.2 Nurse Practitioners (CNPs) may practice as described at 02-373 CMR Chapter 3, as amended, and 02-380 CMR Chapter 8, as amended, under the supervision of the Medical Director.

19.8.8.3 The Nursing Supervisor will be a Registered Professional Nurse licensed according to Maine law and who will have education, experience and training in the treatment of substance abuse or mental health or both. The nursing staff may include Licensed Practical Nurses licensed according to Maine law.

19.8.8.4 The Pharmacist will be licensed to engage in the practice of Pharmacy in the State of Maine.

19.8.8.5 There shall be a Clinical Supervisor who meets the requirements of Section 11. of these rules.

19.8.8.6 OTPs shall employ an adequate number of counselors, qualified pursuant to 32 M.R.S.A. Chapter 81, as amended.

19.8.8.6.1 Caseloads for individual counselors shall be comprised of clients in varying stages of treatment.

19.8.8.6.2 Caseloads shall be prorated for counselors employed by the OTP on a part time basis.

19.8.8.6.3 Caseloads shall not exceed 50 clients for any counselor employed by the OTP on a full time basis, unless a waiver is granted. (See Section 19.8.3.2.1 ).

19.8.8.6.4 Unless the licensing authority grants a waiver, caseloads shall not exceed 35 clients for counselors employed by the OTP on a full time basis who have not completed 2000 hours of substance abuse practice under clinical supervision. (See Section19.8.3.2.2 )

19.8.8.7 Training. In addition to the training requirements of Section 13.5 of these rules, staff will receive:

19.8.8.7.1 An intensive program of training specific to opioids and opioid agonist issues. The training plan will be developed by the OTP and staff will have updates annually;

19.8.8.7.2 Training on the subject of HIV infection and treatment of HIV infected clients; and

19.8.8.7.3 Training on the subject of Hepatitis B and C and treatment and prevention of Hepatitis.

19.8.8.8 Background Checks. Background checks, including but not necessarily limited to conviction of offenses related to the possession, use, sale or distribution of controlled substances shall be conducted.

19.8.8.8.1 The expense of such background checks shall be borne by the OTP.

19.8.8.8.2 Persons who have been convicted of any felony, or an offense related to the possession, use, sale, or distribution of controlled substances, may be employed by the OTP in a position with access to a scheduled or prescription drug or controlled substance only if the OTP documents in the person's personnel file the offense and sanction, the OTP's assessment of the seriousness of the factual basis for the offense, and the agency's rationale for hiring and/or retaining the person.

19.8.8.8.3 OTPs shall not engage in any capacity any person if there exists a reasonable articulable suspicion of current use of illicit substances or criminal activity related to possession, use, sale or distribution of controlled substances.

19.8.9Medication Administration at the OTP. OTPs shall develop and follow policies and procedures that are adequate to ensure that treatment medication used by the program is administered and dispensed in accordance with approved product labeling and that the following dosage form and initial dosing requirements are met:

19.8.9.1 The OTP shall utilize an effective procedure to ensure that client identity and the correct dose and medication are being verified prior to medication administration. Ingestion and swallowing shall be observed by the staff person who administered the medication, who shall document the administration of the medication in the record.

19.8.9.2 At the time of dosing there shall be a face to face clinical evaluation by qualified staff that may be short in duration. If the evaluation indicates the need for further evaluation or intervention, the evaluation or intervention shall be documented in the client record.

19.8.9.3 Medication may be withheld when the OTP physician or physician extender determines that administration of the medication would not be medically or clinically appropriate. The withholding of medication shall be substantiated in the record and signed by the authorizing practitioner.

19.8.9.4 When clients transfer from one OTP to another, medication doses may be communicated from medical personnel at the discharging program to medical personnel at the admitting program, as may be permitted by applicable law and rule.

19.8.9.5 OTPs shall develop and follow policies and procedures regarding courtesy dosing. Policies shall address situations in which the OTP is requesting courtesy dosing for a client and when it is providing courtesy dosing. Policies shall be based on best practice standards. Policies shall address verification of client identify, verification of dose and medication, documentation of medication administration.

19.8.10Unsupervised or Take-Home Use. The OTP shall develop and follow policies and procedures regarding take-home privileges. The policy shall ensure the following:

19.8.10.1 All decisions regarding take-home privileges shall be documented in the client record and shall comply with the requirements cited in 42 CFR Chapter 1, Subchapter A, Part 8.

19.8.10.2 Medication shall be dispensed only in oral form.

19.8.10.2.1 Methadone shall be dispensed in liquid form only in single dose containers, or in dry form only in multiple dose containers.

19.8.10.2.2 Other medications shall be dispensed according to federal regulations and manufacturer's recommendation.

19.8.10.3 Clients will not be allowed take-home privileges during the first ninety (90) continuous days of treatment.

19.8.10.4 After ninety (90) continuous days of treatment, clients may be allowed take-home privileges no greater than the following schedule:

19.8.10.4.1 From the ninety first (91st) to the one hundred eightieth (180th) continuous days of treatment, one take-home dose per week is permitted;

19.8.10.4.2 From the one hundred eighty first (181st) to the two hundred seventieth (270th) continuous days of treatment, two take-home doses per week are permitted;

19.8.10.4.3 From the two hundred seventy first (271st) to the three hundred sixtieth (360th ) continuous days of treatment, three take-home doses per week are permitted;

19.8.10.4.4 From the three hundred sixty first (361st) continuous day of treatment onward, six take-home doses per week are permitted.

19.8.11 Exception Request and Record of Justification for client exceptions. OTPs are responsible for providing documentation supporting the clinical justification for requested exceptions. Requests for exceptions and the documentation required to demonstrate clinical justification shall be delivered to OSA in the form and format required by OSA no later than five business days prior to the day the requested exception is to take effect.

19.8.11.1 Split-dose exception. A federal exception request must be secured from the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Administration, and approved by OSA, before an OTP is authorized to dispense a split-dose to a client. For purposes of this section, a split-dose is defined as the balance of a dose that shall be taken by a client off the site of the OTP, after the initial dose is administered on site. Split-dosing may only be authorized if medically necessary. Acceptable documentation that the OTP received the federal and state response to the requested exception must be placed in the client's file.

19.8.11.2 Home schedule exception. Exceptions to take-home schedules required by state rules that are stricter than federal rules must be approved by OSA. When an exception to a federal requirement is requested, the OTP must secure an exception from the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Administration, and have it approved by OSA, before an OTP is authorized to grant the exception. Acceptable documentation that the OTP received the federal and state response, as applicable, to the requested exception must placed in the client's file.

19.8.11.3 Rehabilitation counseling exception. OSA is authorized to grant an exception to rehabilitation counseling requirements established by state rules that are stricter than federal rules. An exception must be time-limited and based on a client's inability to attend the counseling sessions due to illness or injury. The OTP must secure a written OSA exception for the client before the OTP is authorized to adjust the hours of rehabilitation counseling required by Phase 1, 2, 3, 4, or 5 of sections 19.8.5.5, 19.8.5.6, 19.8.5.7, 19.8.5.8, and 19.8.5.9. Documentation of the OSA granted exception must be placed in the client's file. No client will be allowed to advance to a higher phase of treatment until the minimum rehabilitation counseling and goals for their current phase of treatment have been completed.

19.8.12Emergencies. In emergencies, take-home doses may be provided under the following circumstances:

19.8.12.1 The program has made reasonable, documented attempts to contact OSA for permission;

19.8.12.2 The nature of the emergency has been verified by the program and documented in the record;

19.8.12.3 The client has met the minimum requirements for take-home privileges; and

19.8.12.4 The program director and the medical director document this decision in the record. Documentation of this decision shall be submitted to OSA by the program director within one business day.

19.9Social Setting Detoxification Programs

(Clinical Managed Residential Detoxification, ASAM Level III.2-D).

19.9.1 Definition: Social Setting Detoxification Programs provide services to persons who are experiencing withdrawal symptoms that require 24-hour structure and support but don't require full resources of Medically Managed Intensive Detoxification or Freestanding Residential Detoxification, recognizing that the emphasis is more on the counseling program as a treatment agent as opposed to professional intervention and/or medical detoxification. Services must be conducted in a licensed health care or addiction treatment facility.

19.9.2 Services provided. Social Setting Detoxification Programs shall provide immediate medical evaluation, diagnosis and care, including:

19.9.2.1 Access to immediate medical monitoring on a 24-hour per day basis;

19.9.2.2 Supervision of clients by properly trained staff until the client is no longer intoxicated;

19.9.2.3 Referral to other services not provided by the Social Setting Detoxification Program.

19.9.2.4 A physical examination by a physician or physician's assistant within 48 hours of admission;

19.9.2.5 Written arrangements for hospital care for medical services beyond the capability of the program

19.9.2.6 Nutritional services, including special diets as needed. In addition to the requirements in Sections 17.2.5 - 17.2.5.5 of these regulations, the kitchen shall be capable of providing for preparation of snacks, soup and sandwiches, decaffeinated coffee, and juices which shall be available for clients.

19.9.2.7 Individual and group counseling, or provision of such counseling through other resources;

19.9.2.8 A supportive environment which offers a controlled group living experience;

19.9.2.9 Opportunities for family involvement and referral of family to counseling when appropriate;

19.9.2.10 Motivational counseling to seek further treatment;

19.9.2.11 Planning for and referral to further substance abuse treatment; and

19.9.2.12 Transportation support shall be available 24 hours a day. A written agreement shall provide for transportation between the program and emergency health care facilities;

19.9.3 Staff.

19.9.3.1 Social Setting Detoxification rogram shall be staffed by physicians or physician extenders who are available 24-hours a day by telephone.

19.9.3.2 A registered nurse or other licensed and credentialed nurse shall be available to conduct a nursing assessment on admission. The level of nursing care must be appropriate to the severity of client need.

19.9.3.3 Appropriately trained and certified/credentialed staff shall be available to administer medications in accordance with physician orders.

19.9.3.4 Appropriately credentialed alcohol and drug counselors shall provide evaluation and treatment services for clients, and family support as needed.

19.9.3.5 An interdisciplinary team of appropriately trained clinicians shall be available to assess and treat the client and to obtain and interpret information regarding the client's needs. The number and disciplines of team members are appropriate to the range and severity of the client's problems.

19.9.3.6 Staff involved with clients shall be highly skilled, specially selected, and trained to recognize impending alcohol/other drug emergencies, and have the capability to refer clients evidencing such impending emergencies to an alternative medical emergency back-up facility.

19.9.3.7 All personnel providing client care shall have completed, prior to employment, the standard first aid and cardiopulmonary resuscitation (CPR) certification, or its equivalents, and shall complete, within six months of their employment, the advanced first aid class or its equivalent.

19.9.3.8 Clinical supervision shall be provided to all staff on a weekly basis.

19.9.4 Medication.

19.9.4.1 Nothing in this section shall be construed as authorizing or permitting any person to do any act outside of federal or state laws.

19.9.4.2 No medication should be taken without medical direction. If the client brings drugs into the program for previously existing disorders:

19.9.4.2.1 The actual medication must be identified by a physician or a pharmacist, and

19.9.4.2.2 A physician must approve the prescribed dose, and

19.9.4.2.3 These drugs shall be stored in accordance with Section 17.7 through 17.7.1.9 of these rules.

19.9.4.3 Clients shall self-administer their medication. Self-administration of medication is defined as giving the client the opportunity of taking medications according to prescription so long as the client is determined to be mentally and physically capable of doing so by the medical director.

19.9.4.4 If the medical director determines the client needs supervision in the administration of the medication, the medical director shall so indicate in the medical orders.

19.9.5 Client records shall contain but not be limited to the following documentation:

19.9.5.1 Notes of client progress shall be entered by clinical staff at least once daily;

19.9.5.2 Elements of the assessment and treatment plan including, but not be limited to:

19.9.5.2.1 An addiction-focused history, obtained as part of the initial assessment and reviewed by a physician during the admission process;

19.9.5.2.2 A record of a physical examination by a physician or physician extender, performed within 48 hours of admission, accompanied by appropriate laboratory and toxicology tests OR the evaluation of the records of a physical examination administered within the preceding 7 calendar days prior to admission, by a physician or physician extender;

19.9.5.2.3 Sufficient biopsychosocial screening assessments to determine the level of care in which the client should be placed and for the individualized care plan to address treatment priorities;

19.9.5.2.4 An individualized treatment plan, including problem identification, treatment goals, measurable treatment objectives, and activities designed to meet those objectives.

19.9.5.3 Other documentation including, but not limited to:

19.9.5.3.1 Progress notes that clearly reflect implementation of the treatment plan and the client's response to treatment, as well as subsequent amendments to the plan;

19.9.5.3.2 Detoxification rating scale tables and flow sheets, as needed;

19.9.5.3.3 Physician services, documented in the client record as they occur;

19.9.5.3.4 A record of discharge/transfer planning, beginning at admission.

19.9.6Program Completion Criteria.

19.9.6.1 Programs shall describe in detail the indicators used to determine satisfactory completion of the detoxification process.

19.9.6.2 Programs shall describe conditions under which clients will be discharged before successful program completion.

19.10 Medication Assisted Treatment (MAT).

19.10.1 MAT is a treatment for addiction and COD that includes medication (e.g. psychotherapeutic medications, methadone, buprenorphine, naltrexone, accomprosate, vivitrol). MAT is intended to help stabilize addiction and COD symptoms

19.10.2 MAT and Opiate Treatment Programs (OTP). An OTP is a treatment program certified by the federal Substance Abuse and Mental Health Services Administration (SAMHSA) in conformance with 42 Code of Federal Regulations (C.F.R.), Part 8, to provide supervised assessment and MAT for clientswho are opioid addicted.

19.10.3 MAT may be provided in an OTP or an OTP medication unit (pharmacy, physician's office) or, for buprenorphine and other medications, a physician's office or other healthcare setting.

19.10.4 Types of MAT. Comprehensive maintenance, medical maintenance, interim maintenance, detoxification, and medically supervised withdrawal are types of MAT.

14-118 C.M.R. ch. 5, § 19