PART 816 CHEMICAL DEPENDENCE CRISIS SERVICES

[Statutory Authority: Mental Hygiene Law Sections 19.09, 19.15. 19.40, 21.09. 23.02]

Notice: The following regulations are provided for informational purposes only. The Office of Alcoholism and Substance Abuse Services makes no assurance of reliability. For assured reliability, readers are referred to the Official Compilation of Rules and Regulations.

Sec.
816.1 Background and intent
816.2 Legal base
816.3 Applicability
816.4 Definitions
816.5 Standards applicable to all chemical dependence crisis services
816.6 Standards applicable to medically managed detoxification services
816.7 Standards applicable to medically supervised withdrawal services
816.8 Standards applicable to medically monitored withdrawal services
816.9 Standards pertaining to Medicaid reimbursement 816.10 Waiver

Section 816.1 Background and intent.

(a) These regulations set forth minimum standards for the provision of crisis services for persons suffering from chemical abuse or dependence. Chemical dependence crisis services are designed to provide a range of service options, or levels of care, to persons who are intoxicated or incapacitated by their use of alcohol and/or substances.

(b) The primary purpose of any chemical dependence crisis service is the management and treatment of alcohol and/or substance withdrawal, as well as disorders associated with alcohol and/or substance use, resulting in a referral to continued care. Certified providers of chemical dependence crisis services can be authorized to provide one or more of the following:

(1) medically managed detoxification services;

(2) inpatient/residential medically supervised withdrawal services;

(3) outpatient medically supervised withdrawal services; and/or

(4) medically monitored withdrawal services.

(c) Chemical dependence crisis services can serve as the initial step in the recovery and rehabilitation process and must be provided in an atmosphere which is humane and protects the patient's dignity, as well as encourages the patient's continued participation in treatment after discharge from the crisis service. For purposes of this Part, the provision of crisis services alone, without follow-up to another appropriate level of care, is not appropriate.

816.2 Legal base.

(a) Section 19.09 of the Mental Hygiene Law authorizes the Commissioner of the Office of Alcoholism and Substance Abuse Services to adopt regulations necessary and proper to implement any matter under his or her jurisdiction.

(b) Section 19.15 of the Mental Hygiene Law bestows upon the Commissioner of such Office the responsibility of promoting, establishing, coordinating, and conducting programs for the prevention, diagnosis, treatment, aftercare, rehabilitation, and control in the field of chemical abuse or dependence.

(c) Section 19.40 of the Mental Hygiene Law authorizes the Commissioner of such Office to issue operating certificates for the provision of chemical dependence services.

(d) Sections 21.09 and 23.02 of the Mental Hygiene Law direct the Commissioner of such Office to promulgate regulations regarding the disposition of alcoholic beverages and substances, respectively, when brought by a person needing or seeking emergency treatment into a facility.

816.3 Applicability.

This Part applies to any person or entity organized and operating pursuant to the provisions of this Title and certified by the Office to provide a chemical dependence crisis service.

816.4 Definitions.

(a) Chemical dependence means the repeated use of alcohol and/or one or more substances to the extent that there is evidence of physical or psychological reliance on alcohol and/or substances, the existence of physical withdrawal symptoms from alcohol and/or one of more substances, a pattern of compulsive use, and impairment of normal development or functioning due to such use in one or more of the major life areas including but not limited to the social, emotional, familial, educational, vocational, or physical. The term "chemical dependence" shall mean and include alcoholism and/or substance dependence.

(b) Chemical dependence services means examination, diagnosis, level of care determination, treatment, rehabilitation, or habilitation of persons suffering from chemical abuse or dependence and their significant others, and shall mean and include the provision of alcoholism and/or substance abuse services. Education regarding the effects of alcohol and substances on significant others may also be provided to such persons as a component of chemical dependence services.

(c) Clinical staff member means an individual employed by the governing authority who is regularly supervised and receives regularly scheduled in service training, and provides clinical services as required by this part.

(d) Commissioner means the Commissioner of the Office of Alcoholism and Substance Abuse Services.

(e) Governing authority means the overall policy making authority, whether an individual or group, that exercises general direction over the affairs of a provider of services and establishes policies concerning its operation.

(f) HIV infection means infection with the human immunodeficiency virus that may result from or be associated with HIV infection.

(g) Medical director means a physician who is affiliated with the service and is responsible for the overall direction of the medical procedures provided in the crisis service.

(h) Medical services are provided by medical staff in accordance with the terms and conditions of their authorizing licenses and may include, but are not limited to:

(1) physical examination for the purpose of identifying the nature and extent of chemical dependence;

(2) physical examination to determine the nature and extent of any physical disease or disabling condition either related or unrelated to the individual's chemical dependence; and

(3) ongoing care and treatment of physical conditions including prescribing and administering of medication.

(i) Medical staff mean physicians, nurse practitioners, registered nurses, licensed practical nurses, registered physician's assistants, and other health care professionals licensed and certified by the New York State Education Department practicing in accordance with the terms of conditions of such licenses and certifications.

(j) Multi-disciplinary team means a team of qualified health professionals including at least one medical staff member, one credentialled alcoholism and substance abuse counselor and one other staff member who is a qualified health professional as defined in this Section, in a discipline other than alcoholism and substance abuse counseling.

(k) Office means the Office of Alcoholism and Substance Abuse Services.

(l) Pharmacological services means the prescription of medications.

(m) Qualified health professional means any of the professions listed below, who are currently in good standing with the appropriate licensing or certifying authority, as applicable, with at least one year of experience or a training program in the treatment of alcoholism, substance abuse and/or chemical dependence:

(1) a credentialled alcoholism and substance abuse counselor who has a current valid credential issued by the Office;

(2) a certified social worker licensed and currently registered by New York State Education Department;

(3) a certified nurse practitioner who is licensed and currently registered by the New York State Education Department as a professional nurse;

(4) an occupational therapist licensed and currently registered by the New York State Education Department;

(5) a physician licensed and currently registered by the New York State Education Department;

(6) a physician's assistant licensed and currently registered as such by the New York State Education Department and whose practice is in conformity with section 3701 of the Public Health Law;

(7) a professional nurse licensed and currently registered by the New York State Education Department;

(8) a psychologist licensed and currently registered by the New York State Education Department;

(9) a rehabilitation counselor certified by the Commission on Rehabilitation Counselor Certification;

(10) a therapeutic recreation therapist who holds a baccalaureate degree in a field allied to therapeutic recreation and, either before or after receiving such degree, has five years of full-time, paid work experience in an activities program for the aged, ill or handicapped in a health care setting or an equivalent combination of advanced training, specialized therapeutic recreation education and experience, or is a certified recreational therapist;

(11) a family therapist who is currently accredited by the American Association for Marriage and Family Therapy; or

(12) a counselor certified by and currently registered with the National Board for Certified Counselors.

(n) Quality improvement means an ongoing process by which a chemical dependence service systematically assesses the adequacy and appropriateness of the services provided to clients and provides for recommendations for improvement.

(o) Social services means a psychosocial evaluation of family and social supports, and provision of assistance with affairs of daily living, including referrals for social, financial, housing, aftercare, parenting skills, educational, employment and/or vocational assistance, as needed.

(p) Substance shall mean:

(1) any controlled substance listed in Section 3306 of the Public Health Law;

(2) any substance listed in Section 3380 of the Public Health Law; or

(3) any substance, except alcohol and tobacco, as listed in the published rules of the Office which has been certified to the Commissioner of Health as having the capability of causing physical and/or psychological dependence.

816.5 Standards applicable to all chemical dependence crisis services.

(a) Goals and objectives. All providers of chemical dependence crisis services shall include among their goals and objectives:

(1) the safe and effective withdrawal from alcohol and/or substances of persons who are intoxicated or incapacitated therefrom, and the minimization of the multiple impacts of withdrawal on a chemically dependent person;

(2) the promotion of abstinence from alcohol and all substances, except those lawfully prescribed and monitored by a physician, or a nurse practitioner or physician's assistant working under the supervision of a physician knowledgeable about the patient's chemical dependence;

(3) the screening and referral to other appropriate health or mental hygiene service providers, if such services cannot be provided by the chemical dependence crisis service; and

(4) the initial development of short term goals which support the development of abstinence, and the attainment and promotion of recovery, including appropriate referrals to continuing treatment and rehabilitation.

(b) Linkages with other providers of services. To facilitate continued participation in the rehabilitation process, all providers of chemical dependence crisis services must develop formal linkages with other chemical dependence treatment providers as well as with other appropriate health, mental hygiene, and human service providers, including referral sources. Such formal linkages may take the form of written agreements among providers, or other documentation of established relationships.

(c) Development of clinical protocol and medical care policies and procedures. A provider of chemical dependence crisis services must establish clinical protocols, which must be approved by such provider's governing authority.

(1) Only protocols of established safety and efficacy shall be used in routine clinical practice.

(2) The clinical protocols must include at least the following:

(i) protocols for the clinical assessment and management of alcohol and/or substance specific withdrawal syndromes, to include the use of standardized withdrawal assessment instruments, where available;

(ii) appropriate staffing;

(iii) screening and referral for physical conditions and/or mental disabilities;

(iv) infection control;

(v) protocols for public health education and screening with regard to tuberculosis, sexually transmitted diseases, hepatitis, and HIV prevention and harm reduction;

(vi) procedures for cooperation with other providers of services;

(vii) quality assurance and utilization review procedures; and

(viii) procedures for managing or transferring persons incapacitated by alcohol and/or substances.

(3) A provider of services offering a chemical dependence crisis service must also establish medical care policies and procedures for the service, which must be approved by such provider's governing authority, and medical director where appropriate. Such policies and procedures shall include at least the following:

(i) identification of those symptoms and/or syndromes which necessitate a referral for acute medical and mental hygiene services;

(ii) a schedule for taking all patients' vital signs, including the staff positions responsible, frequency and documentation required;

(iii) a schedule for monitoring and observing any changes in the patient's condition during withdrawal, including but not limited to respiratory, circulatory, neurological, and/or digestive functions.

(A) Such schedule shall include identifying the staff positions responsible for observing the patient, frequency of observation, and documentation required.

(B) All changes in patient condition and appropriate actions taken shall be noted in the patient's record.

(iv) a procedure for providing pharmacological services, including a requirement that they shall be based on a history, whenever possible, and physical examination and be provided only on order by a physician, nurse practitioner, or a physician's assistant working under the supervision of a physician and in accordance with the terms and conditions of their respective licenses.

(A) These services may be monitored by a nurse practitioner, physician's assistant, registered nurse, or licensed practical nurse.

(B) Procedures for the storing and dispensing of any medication must be developed in accordance with applicable state and federal regulations, including but not limited to other regulations of this Part, 21 C.F.R. 1301.72-1301.76, and 21 C.F.R. Part 291, as applicable, and established medical practice.

(C) Such procedures shall ensure the continuity of administration of previous prescriptions, which have been lawfully prescribed for the patient.

(v) procedures for medical and laboratory tests which must be conducted in accordance with all applicable state and federal requirements and shall include but not be limited to: urine drug screen; blood alcohol content; and tests for tuberculosis and other infectious diseases, including but not limited to sexually transmitted diseases and hepatitis, and pregnancy tests for women of childbearing age. The procedures shall identify the staff responsible for the provision of such procedures, the time frame for testing, and the documentation required.

(vi) a requirement that if acupuncture is provided as an adjunct to the services provided by the chemical dependence crisis service, it must be provided in accordance with Part 830 of this Title.

(vii) a requirement that when HIV infection education, testing and counseling are provided, such services must be provided in accordance with Article 27-F of the Public Health Law and Parts 309 and 1070 of this Title, or the most recent recodification thereof.

(viii) a requirement that if methadone maintenance or other opiod detoxification services are provided as a component of the chemical dependence crisis service, they must be provided in accordance with all federal and state requirements which regulate the use of methadone, including but not limited to regulations of the federal Food and Drug Administration, the United States Drug Enforcement Administration, the New York State Department of Health, and the Office, including but not limited to applicable provisions of this Title.

(ix) all providers of crisis services must have formal written agreements, including procedures for transfer of patients, with one or more general hospitals providing emergency medical/psychiatric services in the same geographic area or to the same population as that of the chemical dependence crisis service.

(4) Capacity approved by the Office may not be exceeded at any time.

(d) Patient admission and evaluation.

(1) Admission to and retention for crisis services shall be made in accordance with Sections 816.6, 816.7, or 816.8, of this Part, as applicable, upon a finding of a diagnosis of chemical dependence identified through the substance dependence diagnostic criteria set forth in either the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition (DSM IV) or International Classification of Diseases, Ninth Edition (ICD 9), or the most recent editions thereof.

(2) Immediately upon admission to a crisis service, each patient shall have presenting problems addressed in accordance with the initial orders and general policy requirements, as documented in the approved protocol developed pursuant to subdivision (c) of this section.

(3) Except as otherwise provided in paragraph (5) of this subdivision, the following information shall be obtained about the patient by a clinical staff member upon admission or as soon thereafter as possible, but under no circumstances shall the evaluation be completed more than three days after admission:

(i) the name, address, and telephone number of the patient;

(ii) the name, address, and telephone number of a relative or close friend;

(iii) information about the patient's recent alcohol and/or substance use;

(iv) biopsychosocial assessment, including but not limited to the patient's history of alcohol and/or substance use, medical history, mental status, educational, vocational, and employment status and history, legal status, and living arrangement; and

(v) any information concerning a disability which may affect communication or other functioning.

(4) If the patient had previously been admitted to the service within 30 days of the current admission, the previous evaluation may be utilized, provided it is appropriately updated.

(5) If a patient is referred from another facility certified by the Office, the information identified in paragraph (3) of this subdivision is not required, provided that a copy of the comprehensive evaluation performed by the referring facility accompanies the patient or is provided by the referral facility at the time of admission.

(e) Individual treatment plan required. A written individual treatment plan shall be developed and implemented no more than three days after admission into the service, and shall be based upon the evaluation conducted.

(1) The individual treatment plan shall:

(i) be developed in collaboration with the patient by a multi-disciplinary team of professionals;

(ii) be based on the admitting evaluations specified for each level of service and any additional evaluations found to be required;

(iii) state measurable short-term goals;

(iv) prescribe an integrated program of therapies, activities and interventions designed to meet goals; and

(v) specify all services provided and schedules for the provision of such services.

(2) The individual treatment plan of a patient previously admitted into the service within thirty days of the current admission, may be utilized, provided it is appropriately updated.

(3) The individual treatment plan must be reviewed by a multi-disciplinary team.

(4) All clinical staff who participate in preparing or reviewing the plan shall have their names recorded on it. The physician and the primary counselor shall both sign the treatment plan upon its completion.

(5) The individual treatment plan of any patient who needs health care or social services which are not available within the crisis service, but can be provided concurrently, shall be developed with the participation of appropriate qualified providers of the additional services and shall specify the additional services to be provided by such other provider or providers, either concurrently or post-discharge.

(6) The individual treatment plan shall be incorporated in the medical record and shall be the basis for written orders, prescriptions and the provision of chemical dependence crisis services.

(7) All components of the individual treatment plan shall be reviewed by a multi-disciplinary team as often as necessary, but no less often than every other day for the first seven days after a patient has been admitted. In the event that an individual's stay is extended in the service beyond seven days, the entire treatment plan must thereafter be reviewed and modified accordingly every three days during the course of the extended stay.

(8) Multidisciplinary treatment team decisions to develop and revise the individual treatment plan shall be reflected in the patient's record.

(f) Recordkeeping.

(1) Providers of chemical dependence crisis services must develop recordkeeping policies and procedures specific to the provision of this service.

(2) Such providers must keep individual case records for each patient who is admitted and provided service. These records must include, at a minimum, all information and documentation required in this Part, including but not limited to:

(i) evaluation at admission;

(ii) level of care determination;

(iii) individual treatment plan and periodic review;

(iv) progress notes;

(v) documentation of HIV infection education and risk reduction and public health education and screening;

(vi) discharge plan and summary; and

(vii) medical orders and prescriptions, and lab results.

(3) Patient records shall be maintained and released in accordance with state and federal laws and regulations governing confidentiality, but not limited to 42 C.F.R., Part 2, Article 27-F of the Public Health Law, and Article 33 of the Mental Hygiene Law.

(4) Patient records shall be available to all staff involved in the treatment of such patient and to professional staff of other providers involved in the care of such patient, in accordance with applicable state and federal laws and regulations governing the confidentiality of alcoholism and substance abuse treatment records. In the event that more than one chemical dependence crisis service is offered by a facility, the patient record shall be easily identifiable according to the service in which the patient is currently participating.

(5) The service shall include in its recordkeeping policies and procedures, provisions for recording information about persons not admitted for service, persons referred elsewhere for service, and significant others who are provided educational services.

(6) Progress notes shall be written, signed and dated by clinical staff members.

(7) Progress notes shall give a chronological picture of the patient's progress and must be sufficiently detailed to delineate the course and results of treatment, including, at a minimum, information regarding the attainment of the short-term goals of the plan.

(8) The frequency of progress notes shall be based on the condition of the patient. In an outpatient crisis service, progress notes shall be documented no less often than once per day; in all other crisis services, progress notes shall be documented no less often than once per shift for the first five days and no less often than once per day thereafter.

(g) Discharge planning.

(1) Discharge planning shall begin as soon as the patient is free of impairment and/or intoxication and capable of communication, and shall include the patient.

(2) The discharge plan shall be based on:

(i) assessment of the home environment, vocational/educational/employment setting, and relationships with significant others to establish the level of social resources available to the patient and the need for services to significant others; and

(ii) identification of other treatment and rehabilitation services the patient will need after discharge.

(3) The discharge plan shall include, but not be limited to:

(i) identification of one or more appropriate treatment providers of the services needed as well as one or more alternative providers in the event space is not available in the identified programs;

(ii) specific referrals and linkages to identified providers of services, including options for post-discharge referrals; and

(iii) periodic revisions, as needed, based on patient progress, services provided and treatment goal attainment.

(4) No patient shall be approved for discharge unless the discharge plan is complete with referrals necessary for post-discharge services and a staff member is assigned to follow up on those referrals, except for patients discharged for non-cooperation or misconduct.

(5) Discharge planning and determination of the need for continued stay shall be closely coordinated with individual treatment planning.

(6) The discharge plan shall be presented to and approved by a multi-disciplinary team prior to discharge of the patient.

(7) A final and complete discharge plan shall be included in the patient's record.

(8) Except as provided in paragraph (11) of this subdivision, a discharge summary must be prepared and included in each patient's record upon discharge.

(9) The portion of the discharge plan which includes but is not limited to the referrals for continuing care shall be given to the patient upon discharge.

(10) With the appropriate patient consent, the final discharge plan shall be forwarded to the subsequent providers of service.

(11) For patients whose treatment plan involves an uninterrupted transition from a chemical dependence crisis service to another level of care within the same facility, the service may, at its discretion, substitute a revision of the interdisciplinary treatment plan with updated treatment goals and treatments, for a formal discharge plan and discharge summary at the time of transition.

(h) Quality improvement and utilization review.

(1) Each chemical dependence crisis service shall establish and implement a quality improvement plan and utilization review plan in accordance with this section to consider each patient's need for continued treatment the extent of each patient's chemical dependence problem, and the continued effectiveness of and progress in treatment. The quality improvement process must be performed by the service, provided, however, the utilization review requirement may be met by the following:

(i) The service may perform its utilization review process internally; or

(ii) Upon the approval of the Office, the service may enter into an agreement with another organization competent to perform utilization review to complete its utilization review process.

(2) The utilization review plan shall include procedures for ensuring that all admissions are appropriate, that retention criteria are met, and that discharges occur based upon the discharge criteria.

(3) Except for patients who have been admitted to an outpatient service, no patient may be continued in the crisis service beyond the seventh day after admission unless there is a reasonable probability that discharge criteria will be met within an additional seven days and at least one of the following criteria is met:

(i) current evidence documents a level of instability requiring continued stay for adjustment of medication or attainment of a level of stability to enable functioning outside a structured setting; and/or

(ii) progress notes document that treatment goals have not been attained to a sufficient extent that continued rehabilitation is probable after discharge from the structured setting; and

(a) there is medical evidence of moderate to severe organ damage related to alcohol and/or other substance use; or

(b) the patient is pregnant and continued stay is necessary to insure stabilization and/or completed referral to continuing treatment; or

(4) Each chemical dependence crisis service shall establish a written quality improvement plan in accordance with this section.

(i) The quality improvement plan shall identify clinically relevant quality indicators, based upon professionally recognized standards of care. This process shall include but not be limited to:

(a) periodic self-evaluations to ensure compliance with applicable regulations;

(b) findings of other management activities, including but not limited to; utilization reviews, incident reviews, and reviews of staff training, development and supervision needs;

(d) analysis of treatment outcome data.

(ii) The chemical dependence crisis service shall prepare an annual report and submit it to the governing authority. This report shall document the effectiveness and efficiency of the chemical dependence crisis service in relation to its goals and indicate any recommendations for improvement in its services to patients, as well as recommended changes in its policies and procedures.

(i) Assignment and training of staff.

(1) Staff may be either specifically assigned to the chemical dependence crisis service or may be part of the staff of the facility within which the chemical dependence crisis service is located, provided, however, if staff members are part of the general facility staff:

(i) they must have specific training and experience in the treatment of chemical dependence, including the treatment needs of patients withdrawing from alcohol and/or substances, specific to the services provided; and

(ii) the service must identify and document the percentage of time that each shared staff is assigned to each service.

(2) A chemical dependence crisis service shall have regular, scheduled, and documented training made available in the following:

(i) chemical dependence;

(ii) signs and symptoms of withdrawal;

(iii) complications of withdrawal; and

(iv) tuberculosis, sexually transmitted diseases, hepatitis, HIV infection and Acquired Immune Deficiency Syndrome (AIDS), and infection control procedures.

(3) Whenever a service provider's vehicle is transporting one or more intoxicated persons, there shall be at least two staff present in the vehicle, one of whom shall be a licensed driver and one of whom shall be either a nurse practitioner, registered nurse, a licensed practical nurse, or an emergency medical technician.

(4) Additional staffing requirements specific to the type of chemical dependence crisis service provided shall be met in accordance with Sections 816.6, 816.7, and 816.8 of this Part, as applicable.

(5) At least one of the qualified health professionals on staff shall be designated as the HIV coordinator to provide HIV infection education, risk reduction, counseling and referral services to all patients.

(j) Procedure for disposal of alcohol and/or substances.

(1) Except as otherwise provided in paragraph (3) of this subdivision, if a person presenting for a crisis service possesses substances, as defined in section 816.4 of this Part, the individual in possession of such substance or substances shall destroy or dispose of such substances in the presence of a clinical supervisor and one other staff member.

(2) If a person presenting for a crisis service possesses alcoholic beverages, such beverage shall be confiscated and immediately disposed of by service staff.

(3) If a person enters the service with a supply of medications prescribed by an outside physician, the service shall handle such medications in accordance with the service's policy and procedure, which shall include the destruction of the medications, after consultation with the prescribing physician, if the patient's treatment plan does not include the use of the medications after discharge.

816.6 Standards applicable to medically managed detoxification services.

(a) Applicability. Medically managed detoxification services shall be provided in facilities certified by the Office to provide a chemical dependence crisis service and certified by the Department of Health as a general hospital pursuant to Article 28 of the Public Health Law. A provider of medically managed detoxification services must demonstrate to the Office that it can meet the applicable standards of this section.

(b) Purpose of service. Medically managed detoxification services are designed for patients who are acutely ill from alcohol-related and/or substance-related addictions or dependence, including the need for medical management of persons with severe withdrawal or risk of severe withdrawal symptoms, and may include individuals with or at risk of acute physical or psychiatric comorbid condition. Individuals who are incapacitated to a degree which requires emergency admission, may be admitted to such facility in accordance with Section 21.09 or 23.02 of the Mental Hygiene Law. Such services shall not be provided on an ambulatory basis.

(c) Requisite services. Medically managed detoxification services must provide, at a minimum, all of the following services:

(1) medical management of acute intoxication and withdrawal conditions;

(2) medical assessment within twenty-four hours of admission;

(3) biopsychosocial assessment;

(4) stabilization of medical/psychiatric problems;

(5) individual and group counseling;

(6) pharmacological services, as defined in Section 816.4 of this Part, shall be provided as a means of reasonably controlling, or preventing, active withdrawal symptoms and /or avert life threatening medical crisis or major suffering and disability;

(7) level of care determination;

(8) referral and linkage to all non-crisis services which are needed by the patient; and

(9) referral and linkages to other appropriate and necessary services.

(d) Admission and retention.

(1) A patient shall be admitted to a medically managed detoxification service by a physician, or nurse practitioner, or registered physician's assistant working under the supervision of a physician, provided, however, that each such patient must be seen by a physician.

(2) Except as otherwise provided in paragraph (3) of this subdivision, all admissions shall be voluntary and a patient shall be free to discharge himself or herself from the service at any time.

(i) This provision shall not preclude or prohibit attempts to persuade a patient to remain in the service in his or her own best interest.

(ii) Any person brought to the service who previously objected to being brought there, or who objects to admission to the service, or who desires to leave the service, shall be examined as soon as possible by an examining physician, nurse practitioner, or a physician's assistant working under the supervision of a physician.

(3) In accordance with the provisions of Section 21.09 or 23.02 of the Mental Hygiene Law, if a person is incapacitated by alcohol and/or substances to the degree that he or she may endanger himself or herself or other persons, the examining physician may determine that he or she may be retained for emergency treatment over his or her objection.

(i) In no event may such person be retained over his or her objection beyond whichever occurs first of the following:

(a) the time that he or she is no longer incapacitated by alcohol and/or substances to the degree that he or she may endanger himself or herself or other persons; or

(b) forty-eight hours.

(ii) If any person is retained in the service over his or her objection, prompt notification must be given to the person's closest relative or friend with his or her consent, and, if so requested by such person, to his or her attorney and personal physician.

(4) A person shall be admitted to a medically managed detoxification service upon identification of at least one of the following, which shall be determined through the use of guidelines issued by the Office, in conjunction with the New York State Department of Health:

(i) the presence of severe withdrawal symptoms;

(ii) reasonable expectation of severe withdrawal symptoms, based on the amounts of alcohol and/or substances and/or psychological disorders requiring a medically managed level of care;

(iii) the presence or significant risk of comorbid physical and/or psychiatric disorders requiring a medically managed level of care; or

(iv) the presence of a physical condition requiring medically managed level of care for alcohol and/or substance withdrawal, including, but not limited to, pregnancy.

(5) A patient shall be retained for a medically managed detoxification service only after an evaluation has identified that such patient:

(i) has or is at significant risk of an acute physical or psychiatric comorbidity with chemical dependence; or

(ii) is being medicated for withdrawal and medication is being adjusted to complete the withdrawal so that the patient can be transferred to a lower level of care.

(6) A person suffering from severe withdrawal, at risk of severe withdrawal or suffering a related acute disorder shall not be denied admission to a facility wherein medically managed detoxification services are provided solely because of the lack of administrative or other criteria irrelevant to the primary purpose of the service, including but not limited to:

(i) motivation toward long-term recovery;

(ii) a previous history of admission to the service, regardless of clinical outcome;

(iii) maintenance on methadone or other medication prescribed and monitored by a physician familiar with the patient's condition;

(iv) pregnancy; and/or

(v) HIV infection status.

(7) The individual treatment plan prepared for a person readmitted to a service providing medically managed detoxification services shall identify earlier periods of treatment.

(8) The service shall be managed so as to permit admissions 24 hours a day, seven days a week.

(9) A provider of medically managed detoxification services may provide either maintenance on methadone while a patient is being detoxified from other substances or detoxification from methadone provided the program administering such service meets all federal and state requirements which regulate the use of methadone including regulations of the federal Food and Drug Administration, the United States Drug Enforcement Administration, the Office, and the New York State Department of Health.

(e) Staffing.

(1) The director of a medically managed detoxification service shall be a physician with at least one year of experience in the treatment of chemical dependence.

(2) A physician shall be on duty or on call at all times and available within 15 minutes if needed.

(3) There shall be registered nursing personnel immediately available to all patients at all times. Nursing services shall be under the direction to a registered professional nurse who has at least one year of experience in the nursing care and treatment of chemical dependence and related illnesses.

(4) There shall be sufficient hours of qualified psychiatric time to meet the evaluation and treatment needs of those patients with other psychiatric disorders in addition to chemical dependence. If the psychiatrist is not a staff member of the service, psychiatric services shall be provided through a formal written agreement with another appropriate and qualified provider of psychiatric services.

(5) There shall be sufficient clinical staff to both maintain a ratio of one counselor for each 10 beds and be scheduled so as to be available for one and one-half shifts, seven days per week, at least fifty percent of the clinical staff shall be qualified health professionals.

(6) One of the full-time equivalent qualified health professionals employed by the service shall have been designated to provide social services to persons suffering from chemical dependence, as needed. There shall be additional staff assigned to achieve a ratio of one staff member with experience in providing social services for each 20 beds.

(7) The director of a medically managed detoxification service may also serve as director of another service provided by the same governing authority.

816.7 Standards applicable to medically supervised withdrawal services.

(a) Applicability. Medically supervised withdrawal services can only be delivered by a provider of services which is certified by the Office to provide residential, inpatient or outpatient chemical dependence treatment services in order to assure appropriate continuation in treatment.

(b) Purpose of services.

(1) Medically supervised withdrawal services can be provided in an inpatient, residential, or outpatient setting.

(2) Whether provided on an inpatient, residential, or outpatient basis, such services must be provided under the supervision and direction of a licensed physician, and shall include medical supervision of persons undergoing moderate withdrawal or who are at risk of moderate withdrawal, as well as persons experiencing non-acute physical or psychiatric complications associated with their chemical dependence.

(3) Such services are appropriate for persons who are intoxicated by alcohol and/or substances, who are suffering from mild withdrawal, coupled with situational crisis, or who are unable to abstain with an absence of past withdrawal complications.

(c) Requisite services for inpatient/residential medically supervised withdrawal services. All inpatient/residential medically supervised withdrawal services must provide at least all of the following:

(1) medical assessment within 24 hours of admission;

(2) medical supervision of intoxication and withdrawal conditions, including monitoring of withdrawal symptoms and vital signs;

(3) biopsychosocial assessment;

(4) pharmacological services, as defined in Section 816.4 of this Part, shall be provided as a means of reasonably controlling, or preventing, active withdrawal symptoms and/or avert life threatening medical crisis or major suffering and disability;

(5) individual and group counseling;

(6) level of care determination; and

(7) referral and linkages to other appropriate and necessary services, including all non-crisis services which are needed by the patient.

(d) Admission and retention requirements for inpatient/residential medically supervised withdrawal services:

(1) Each person admitted to a medically supervised withdrawal service must be seen by a physician.

(2) A provider of inpatient/residential medically supervised withdrawal services may provide either maintenance on methadone while a patient is being detoxified from other substances or detoxification from methadone, provided the program administering such service meets all federal and state requirements which regulate the use of methadone, including regulations of the federal Food and Drug Administration, the United States Drug Enforcement Administration, the Office, and the New York State Department of Health.

(3) All admissions shall be voluntary and a patient shall be free to discharge himself or herself from the service at any time.

(i) This provision shall not preclude or prohibit attempts to persuade a patient to remain in the service in his or her own best interest.

(ii) Any person who desires to leave the service should be offered an examination as soon as possible by medical personnel of the service.

(iii) If the service's medical personnel determine upon examination that such person is incapacitated by alcohol and/or substances to the degree that he or she may endanger himself or herself or other persons, or that there is an acute need for medical or psychiatric intervention, a referral to a medically managed detoxification service or other appropriate referral shall be made in accordance with Section 816.6 (d)(3) of this Part.

(4) A person shall be admitted to an inpatient/residential medically supervised withdrawal service upon identification of at least one of the following:

(i) the presence of moderate withdrawal symptoms judged to be treatable at a medically supervised level of care;

(ii) the expectation of moderate level of withdrawal symptoms based on the amount of alcohol and/or other substances ingested by the patient, history of past withdrawal syndromes and/or medical condition of the patient;

(iii) the failure of detoxification or withdrawal services at a less intensive level of care;

(iv) the patient is not in need of medically managed level of detoxification services; and/or

(v) the patient is judged not to be manageable in a medically supervised outpatient service.

(5) Based on a medical and biopsychosocial evaluation, a provider of services otherwise certified by the Office may retain an individual for inpatient/residential medically supervised withdrawal services if:

(i) the person is suffering moderate alcohol and/or substance withdrawal, or mild withdrawal when moderate withdrawal is probable; or

(ii) the person is being medicated for symptoms of withdrawal and the medication is being reduced to complete the withdrawal; and

(iii) the person is not otherwise too ill to benefit from the care that can be provided by the inpatient/residential medically supervised withdrawal service; and

(iv) the person does not meet either the criteria for admission to a medically managed detoxification service or the criteria for admission to an outpatient medically supervised withdrawal service.

(e) Staffing requirements for inpatient/residential medically supervised withdrawal services:

(1) Each inpatient/residential medically supervised withdrawal service shall have a service director who is a qualified health professional, as defined in Section 816.4 of this Part. Such service director shall have at least one year of full-time clinical work experience in the chemical dependence treatment field prior to appointment as service director, and may also serve as director of another service provided by the same governing authority.

(2) There shall be a physician, nurse practitioner, and/or physicians assistant under the supervision of a physician, on staff sufficient hours to perform the initial medical examination on all patients and to prescribe any and all necessary pharmacological medications necessary to secure safe withdrawal.

(3) There shall be registered nursing personnel, licensed practical nurses, nurse practitioner or physicians assistants available to all patients during all hours of operation.

(4) Clinical staff shall be available to both maintain a ratio of one staff for each ten patients and be scheduled so as to be available for one and one-half shifts, seven days per week at least fifty percent of the clinical staff shall be qualified health professionals.

(5) One of the full time equivalent qualified health professionals employed by the service shall be designated to provide social services to persons suffering from chemical dependence as needed.

(f) Requisite services for outpatient medically supervised withdrawal services. All providers of outpatient medically supervised withdrawal services must, at a minimum, provide the following services:

(1) medical supervision of intoxication and withdrawal conditions, including monitoring of withdrawal symptoms and vital signs, including regularly scheduled toxicology screens;

(2) biopsychosocial assessment, including medical examination within 24 hours of admission;

(3) individual and group counseling;

(4) level of care determination, discharge planning; and

(5) referral and linkages to other appropriate and necessary services.

(g) Admission and retention of patients in outpatient medically supervised withdrawal services.

(1) Each patient admitted to an outpatient medically supervised withdrawal service must be seen by a physician.

(2) A provider of outpatient medically supervised withdrawal services may provide maintenance on methadone while a patient is being detoxified from other substances, provided the administering service meets all federal and state requirements which regulate the use of methadone, including regulations of the federal Food and Drug Administration, the United States Drug Enforcement Administration, the Office, and the New York State Department of Health.

(3) All admissions shall be voluntary and a patient shall be free to discharge himself or herself from the service at any time.

(i) This provision shall not preclude or prohibit attempts to persuade a patient to remain in the service in his or her own best interest.

(ii) Any person who desires to leave the service should be offered an examination as soon as possible by medical personnel of the service.

(iii) If the service's medical personnel determine upon examination that such person is incapacitated by alcohol and/or substances or that there is an acute need for medical or psychiatric intervention, a referral to a medically managed detoxification service or other appropriate referral shall be made.

(4) Based on a medical and biopsychosocial evaluation, a provider of services otherwise certified by the Office may provide outpatient medically supervised withdrawal services to a patient if:

(i) the patient is suffering moderate alcohol or substance withdrawal or both, or mild withdrawal when moderate withdrawal is probable;

(ii) there is an expectation of a moderate level of withdrawal symptoms based on the amount of alcohol and/or other substances ingested by the patient, history of past withdrawal syndromes and/or medical condition of the patient;

(iii) the patient does not meet either the admission criteria for medically managed detoxification services, or for medically supervised withdrawal services in an inpatient or residential setting; and

(iv) the patient is assessed as having, and responding positively to, emotional support and a home environment able to provide an atmosphere conducive to ambulatory withdrawal leading to recovery.

(5) A patient shall be retained in outpatient medically supervised withdrawal services if:

(i) such patient is receiving medication to treat symptoms of withdrawal, and such medication is being reduced to complete withdrawal; and

(ii) such patient is not otherwise too ill to benefit from the care that can be provided by the medically supervised withdrawal service.

(h) Special services required for outpatient medically supervised withdrawal services.

(1) Patients must be seen by the physician or nurse practitioner or physicians assistant every day or more often as is warranted, based on the patient's physical and emotional condition.

(2) A medical and biopsychosocial evaluation must be completed on each patient, and referral for and linkage to ongoing treatment made as indicated.

(3) Individual and group counseling sessions, as well as family counseling and educational services, must be provided based upon the identified needs of the patient and family.

(4) The patient and family member, when available, must be informed, both verbally and in writing, of the signs and symptoms of withdrawal, under what circumstances to call for advice, when to take another dose of medication, and under what circumstances to go to the nearest emergency room. The provider of services must provide or make available a 24 hour telephone crisis line to help facilitate the provision of this information.

(5) If the patient fails to keep appointments, uses alcohol or substances, fails to comply with schedules or dosages of prescribed medications, has a medical or psychiatric crisis during the medically supervised withdrawal regimen, or otherwise repeatedly acts in a noncompliant manner, arrangements must be made for immediate referral to an appropriate level of care.

(i) Staffing for outpatient medically supervised withdrawal services.

(1) Each outpatient medically supervised withdrawal service shall have a service director who is a qualified health professional, as defined in Section 816.4 of this Part. Such service director shall have at least one year of full-time work experience in the chemical dependence treatment field prior to appointment as service director and may also serve as director of another service provided by the same governing authority.

(2) There shall be a physician, nurse practitioner and/or physician's assistant under the supervision of a physician, on staff sufficient hours to perform the initial medical examination of all patients and to prescribe any and all necessary pharmacological medications necessary to secure safe withdrawal.

(3) There shall be nurse practitioners, registered nursing personnel, licensed practical nurses, or physicians assistants available to all patients during all hours of operation.

(4) There shall be sufficient qualified clinical staff to achieve a ratio of one counselor to 15 patients: 50 percent of such staff shall be qualified health professionals.

(5) One of the full time equivalent qualified health professional's employed by the service shall be designated to provide social services to persons suffering from chemical dependence, as needed.

816.8 Standards applicable to medically monitored withdrawal services.

(a) Applicability. Medically monitored withdrawal services can be provided by any provider of services certified by the Office to provide inpatient or residential chemical dependence services.

(b) Purpose of service. Medically monitored withdrawal services are designed for persons intoxicated by alcohol and/or substances, or who are suffering from mild withdrawal coupled with situational crisis, or who are unable to abstain with an absence of past withdrawal complications, or who are individuals in danger of relapse. Such services do not require physician direction or direct supervision by a physician, and are designed to provide a safe environment in which a person may complete withdrawal and secure a referral to the next level of care.

(1) assessment;

(2) monitoring of withdrawal symptoms and vital signs;

(3) individual and group counseling;

(4) level of care determination; and

(5) referral and linkages to other appropriate and necessary services.

(d) Admission and retention.

(1) All admissions of patients shall be voluntary and a patient shall be free to discharge himself or herself at any time. This provision shall not preclude or prohibit attempts to persuade a patient to remain in the service in his or her own best interest.

(2) Providers of medically monitored withdrawal services shall admit only persons in need of the level of care provided. No person shall be admitted unless observation and evaluation document all of the following:

(i) the person is intoxicated, experiencing a situational crisis, and/or is suffering or is at risk of suffering mild withdrawal;

(ii) the person is unable to abstain without admission to a medically monitored withdrawal service;

(iii) the person is likely to complete needed withdrawal and enter into continued treatment; and

(iv) the person is not otherwise too ill to benefit from the care that can be provided by the medically monitored withdrawal service.

(3) A patient may be retained in the medically monitored withdrawal service if he or she is awaiting a scheduled admission into appropriate treatment upon discharge. Such retention must be documented and may not exceed 14 days from date of admission.

(e) Staffing.

(1) Each medically monitored withdrawal service of 10 beds or more shall have a full-time service director who is a qualified health professional as defined in Section 816.4 of this Part. The service director shall have at least one year of full-time work experience in the chemical dependence treatment fields prior to appointment as service director. A medically monitored withdrawal service with fewer than 10 beds shall have a similarly qualified service director who shall serve on at least a part-time basis.

(2) Each medically monitored withdrawal service shall employ a sufficient number of staff to adequately serve all patients and to meet the requirements of this Part.

(i) On each shift, there shall be coverage by a registered physician's assistant under the supervision of a physician, nurse practitioner, a registered nurse, or a licensed practical nurse, seven days per week.

(ii) There shall be at least two patient care staff on duty at all times.

(iii) There shall be sufficient clinical staff to achieve a ratio of one counselor for each 10 beds, scheduled so as to be on duty at least one and one-half shifts per day, seven days per week.

(3) All patient care staff of the service shall have current certification in cardiopulmonary resuscitation from the American Red Cross or the American Heart Association within 90 days after hiring and thereafter, to be renewed as needed.

816.9Standards pertaining to Medicaid reimbursement.

(a) Medicaid reimbursement will be provided in accordance with the provisions of this Title and 18 NYCRR Part 505.

(b) In order to qualify for reimbursement each occasion of service must be documented as a covered medical service in accordance with the following:

(1) The service must meet the standards established in this Part;

(2) The service must be documented in the patient's record;

(3) The service must be provided by service staff as required by this Part.

(1) visits to the premises of a chemical dependence crisis service for the sole purpose of attending meetings of a self-help group;

(2) any visits which include only companionship, recreation, and/or social activity;

(3) treatment provided in a medically monitored withdrawal service; and/or

(4) services provided in a facility which is not enrolled in the medical assistance program pursuant to Title 11 of the Social Services Law and Title 18 NYCRR.

816.10 Waiver.

(a) The Commissioner may grant a waiver of a requirement not specifically required by law, including but not limited to Title XIX of the Federal Social Security Act and the New York State Social Services Law, if such Commissioner determines that:

(1) meeting the requirement would impose an unreasonable hardship;

(2) the health and safety of patients would not be diminished; and

(3) the best interests of the patients and the service would be served.

(b) In considering a request for a waiver, the Commissioner will consider such factors as special needs of the populations to be served, geographic distances and transportation problems, staff availability, long range plans of the service, alternatives, and any other relevant information.

(c) A request for a waiver must be submitted in writing, must contain substantial documentation to support the need for the waiver and include such other information as the Commissioner may require.

(d) Special limits or conditions may be established by the Commissioner in granting a waiver.

(e) A waiver shall be in effect for no longer than the duration of the operating certificate or certificate of approval held by the provider of chemical dependence crisis services for which such waiver is granted.