Part 822 Chemical Dependence Outpatient And Opioid Treatment Programs (11/15)

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PART 822

GENERAL SERVICE STANDARDS FOR CHEMICAL DEPENDENCE OUTPATIENT

(CD-OP) AND OPIOID TREATMENT PROGRAMS (OTP)

[Statutory Authority: Mental Hygiene Law Sections 19.07(c), 19.07(e), 19.09(b), 19.16,

19.21(b), 19.21(d), 19.40, 32.01, 32.05(b), 32.07(a) 32.09(b), 22.07(c); Penal Law Section

220.78; Public Health Law Section 3309]

Section:

822.1 Background

822.2 Legal base

822.3 Applicability

822.4 Savings and renewal clause

822.5 Definitions

822.6 Standards pertaining to Medicaid reimbursement

822.7 General program standards

822.8 Admission, initial services, transfers and readmissions

822.9 Treatment / Recovery plan

822.10 Case records

822.11 Documentation of services

822.12 Discharge planning

822.13 Continuing care in CD-OP

822.14 Additional locations

822.15 Additional requirements for chemical dependence outpatient rehabilitation

services

822.16 Additional requirements for opioid treatment programs

822.17 Severability

822.1 Background

This Part contains requirements applicable to chemical dependence outpatient programs (CD-

OP) and opioid treatment programs (OTP) certified by the Office of Alcoholism and Substance

Abuse Services (Office) and the services provided by such programs. For purposes of this Part,

chemical dependence is a chronic illness that can be treated effectively with counseling,

approved medications used consistent with their pharmacological efficacy, and supportive

services such as treatment for co-occurring disorders, medical services and vocational

rehabilitation.

822.2 Legal base

(a) Section 19.07(c) of the Mental Hygiene Law (MHL) charges the Office with the

responsibility to ensure that persons who abuse or are dependent on alcohol and/or substances

and their families are provided with care and treatment that is effective and of high quality.

(b) Section 19.07(e) of the MHL authorizes the commissioner to adopt standards including

necessary rules and regulations pertaining to chemical dependence treatment services.

and proper to implement any matter under his/her jurisdiction.

(d) Section 19.16 of the MHL requires the commissioner to establish and maintain, either

directly or through contract, a central registry for purposes of preventing multiple enrollments in

opioid treatment programs (OTPs) and provide medication dosage information during an

emergency situation, when displaced patients may seek treatment from an alternate OTP.

(e) Section 19.21(b) of the MHL requires the commissioner to establish and enforce

regulations concerning the licensing, certification, and inspection of chemical dependence

treatment services.

(f) Section 19.21(d) of the MHL requires the Office to establish reasonable performance

standards for providers of services certified by the Office.

(g) Section 19.40 of the MHL authorizes the commissioner to issue operating certificates for

the provision of chemical dependence treatment services.

(h) Section 22.07(c) of the Mental Hygiene Law authorizes the commissioner to promulgate

rules and regulations to ensure that the rights of individuals who have received, and are

receiving, chemical dependence services are protected.

(i) Section 32.01 of the MHL authorizes the commissioner to adopt any regulation

reasonably necessary to implement and effectively exercise the powers and perform the duties

conferred by Article 32 of the MHL.

(j) Section 32.05(b) of the MHL provides that a controlled substance designated by the

commissioner of the New York State Department of Health (DOH) as appropriate for such use

may be used by a physician to treat a chemically dependent individual pursuant to section

32.09(b) of the MHL.

(k) Section 32.07(a) of the MHL authorizes the commissioner to adopt regulations to

effectuate the provisions and purposes of Article 32 of the MHL.

(l) Section 32.09(b) of the MHL provides that the commissioner may, once a controlled

substance is approved by the commissioner of DOH as appropriate for such use, authorize the

use of such controlled substance in treating a chemically dependent individual.

(m) Section 220.78 of the Penal Law affords limited protections from prosecution for persons

seeking medical attention for accidental overdose.

(n) Section 3309 of the Public Health Law authorizes the DOH to establish standards for

approval of any opioid overdose prevention program.

822.3 Applicability

(a) Part 822 applies to any person or entity organized in accordance with this Part, operating

pursuant to the provisions of this Title and certified by the Office to operate a CD-OP or an OTP.

Except as indicated in subdivision (b) of this section, to provide services pursuant to this Part,

each provider must obtain and maintain an operating certificate pursuant to Part 810 of this Title.

OTPs must additionally obtain approval from a federally-approved accrediting body, and all

other applicable regulatory entities.

(b) The provision of opioid treatment services within local correctional facilities shall not

require certification by the Office; however, local correctional facilities must be in compliance

with any other applicable state and federal regulations. The Office reserves the right to review

protocols, delivery of services and discharge planning procedures of OTPs within local

correctional facilities.

822.4 Savings and renewal clause

Any operating certificate issued by the Office prior to the promulgation of this Part for the

operation of a program subject to regulations of the former Part 822 shall remain in effect until

the term of such operating certificate has been renewed or such operating certificate is suspended

or revoked through process of law, at which time any recertification of such program or renewal

of such operating certificate shall be pursuant to the provisions of this Part.

822.5 Definitions

As used in this Part, unless otherwise indicated, the following terms shall be applicable to both

CD-OP and OTP programs:

(a) “Accrediting Body” means an entity approved by the federal Substance Abuse Mental

Health Services Administration (SAMHSA) to accredit all OTPs pursuant to 42 CFR Part 8.1

through 8.6 using opioid agonist treatment medications.

(b) “Active treatment” is the period from admission through discharge.

patient and clinical staff for the purpose of determining a preliminary diagnosis, appropriateness

for service, initial plan of treatment, including identifying problem areas to be addressed in the

treatment/recovery plan, and the type and level of services needed by the patient.

(d) “Ancillary withdrawal” is a service whereby patients in mild to moderate or persistent

withdrawal receive symptom relief and/or addiction medications after an assessment of the level

of withdrawal determined by the use of a standardized assessment instrument. Providers must

receive Office approved designation to provide this service.

(e) “Approved medications” means: (1) for an OTP, any agent approved for opioid treatment

by federal authorities; and (2) for CD-OPs, buprenorphine or any medication appropriate for the

treatment of chemical dependence in this setting (excluding methadone unless being used for

pain management).

(f) “Brief intervention” is a face-to-face pre-admission service between a prospective patient

and clinical staff when screening results indicate at risk behavior. The brief intervention educates

patients about their substance use, alerts them to possible consequences, and is intended to

motivate them to change their behavior.

(g) “Brief treatment” is a face-to-face service between an active patient and clinical staff and

must include a target behavior and an evidence-based or clinical practice upon which the

treatment is based. Brief treatment may be used throughout the course of treatment to meet

specific goals, motivate patients or support medicated supported recovery.

(h) “Central registry system” means the central registry established and maintained by the

Office pursuant to section 19.16 of the Mental Hygiene Law.

(i) “Chemical dependence outpatient rehabilitation services” (outpatient rehabilitation

services) are services provided by a CD-OP which has been certified to provide outpatient

rehabilitation services; such services are designed to assist individuals with more chronic

conditions who are typically scheduled to attend the outpatient rehabilitation program three to

five days per week for at least four hours per day.

(j) “Chemical dependence outpatient program” (CD-OP) is an Office certified program

which provides outpatient services that assist individuals who suffer from substance use disorder

and their family members and/or significant others; CD-OPs may also provide outpatient

rehabilitation services and/or intensive outpatient services (IOS).

(k) “Collateral person” is a member of a patient’s family or household, significant others, or

persons who are directly affected by regular interaction with the patient, or who have the

capability to affect both the patient’s chemical dependence and recovery.

(l) “Collateral visit” is a face-to-face service between a clinical staff member and a collateral

person for the purpose of providing an intervention in the service of the primary patient’s

progress in treatment.

(m) “Complex care coordination” is a service provided to or on behalf of a patient when a

critical event occurs or the patient’s condition requires significant coordination with other service

providers. Complex care coordination is distinguished from routine case coordination and must

occur within five working days of another service.

(n) “Continuing care treatment” is a treatment protocol that offers clinical support for the

ongoing disease management needs of patients. In an OTP the individual is admitted, has

completed a taper or is no longer receiving prescribed maintenance; in a CD-OP the individual

has completed the goals of active treatment.

(o) “Group counseling” is a face-to-face service between one or more clinical staff and

multiple patients at the same time, to be delivered consistent with patient treatment/recovery

plans, their development or emergent issues. Group counseling sessions must contain no more

than 15 patients.

(p) “Individual counseling” is a face-to-face service between a clinical staff member and a

patient focused on the needs of the patient to be delivered consistent with the treatment/recovery

plan, its development or emergent issues.

(q) “Initial services” are services provided between admission and the development of the

treatment/recovery plan, focusing on issues that need to be addressed to ensure successful

engagement in treatment and any other urgent or emergent issues. Initial services address one or

two priority goals based on presenting problem(s) identified during the patient’s admission

assessment and provide focus for the critical period of treatment engagement.

(r) “Intensive outpatient services” (IOS) is an outpatient treatment service provided by a

team of clinical staff for patients who require a time-limited, multi-faceted array of services,

structure, and support to achieve and sustain recovery. Programs that offer intensive outpatient

treatment schedule a minimum of 9 service hours per week delivered during the day, evening or

weekends. The treatment service must make available individual and group counseling, family

counseling when appropriate, relapse prevention and coping skills training, motivational

enhancement, and drug refusal skills training.

(s) “Medication administration and observation” is face-to-face administration or dispensing

of a medication by medical staff, to be delivered in conjunction with observation of the patient

prior to the administration and after, as appropriate to the medication and patient’s condition.

(t) “Medication supported recovery” (previously “medication assisted treatment”) means

treatment of chemical dependence abuse and concomitant conditions with medications requiring

a prescription or order from an authorized prescribing professional.

(u) “Medication management” is a face-to-face service with a prescribing professional for

one of the following purposes:

(1) evaluation, monitoring, observation or dosage change to a patient’s medication;

(2) a comprehensive medication review of a new patient or any patient who requires a

more extensive review; or

(3) the induction of a patient to a new medication requiring a period of patient

observation.

(v) “NARCAN (naloxone) emergency overdose prevention kit” means a kit as prescribed

pursuant to state law.

(w) “Opioid treatment program” (OTP) means one or more Office-certified sites where

methadone or other approved medications are administered to treat opioid dependency, following

one or more medical treatment protocols as defined in this Part. This term encompasses medical

and support services including counseling, educational and vocational rehabilitation. OTP also

includes the Narcotic Treatment Program (NTP) as defined by the federal Drug Enforcement

Agency (DEA) in 21 CFR Section 1301.

(x) “Opioid detoxification” means a treatment procedure using approved medications

administered in decreasing doses over a limited period of time, for the purpose of detoxification

from opioids consistent with a protocol that has been approved by the Office’s Medical Director.

(y) “Opioid medical maintenance” is a designated Office-based opioid treatment (“OBOT”)

program operated by a certified OTP and is limited to patients who meet specific criteria.

(z) “Opioid taper” means a medical treatment protocol that, after a period of stabilization,

utilizes approved medications in gradually decreasing doses to the point of 0 milligrams (no

dose) followed by continuing care treatment as described in this Part, or discharge.

(aa) “Outreach” is a face-to-face service with a patient provided by clinical staff or a peer

advocate for the purpose of increasing motivation to participate in clinically indicated treatment

for chemical dependence. Patients identified for this intervention must be current patients who

have failed to appear for sessions at the program and are judged to be at risk for prematurely

discontinuing treatment or persons transitioning from another Office-certified program.

(ab) “Patient” is an individual including a significant other who meets with clinical and/or

peer staff for the purpose of assessment or treatment. “Active patient” means a patient who is

admitted to either a CD-OP or OTP and has an active treatment plan.

(ac) “Patient-centered” is a collaborative care approach to individualized treatment resulting

in a treatment/recovery plan that is respectful of the patient’s needs and choices. It is guided by

patients and produced in partnership with care providers for treatment and recovery. It supports

patient preferences and a recovery orientation.

(ad) “Peer support service” is a face-to-face service provided by a peer advocate to a current

patient. Peer support services are services for the purpose of connecting patients to community

based recovery supports consistent with the treatment/recovery plan.

(ae) “Screening” is a face-to-face pre-admission service with a clinical staff member for the

purpose of identifying patients who have alcohol or substance misuse problems. Screening

results must be shared by the clinical staff in an individual face-to-face session.

(ae) “Specialized opioid service” is an approved medical treatment protocol that utilizes an

approved pharmacological agent in the treatment of opioid addiction. The protocol must be

research oriented and must be provided in an ambulatory or residential environment.

(af) “Transfer” means:

(1) in a CD-OP, transfer is an intra-program function (i.e., between outpatient and

outpatient rehabilitation within the same provider); and

(2) in an OTP, transfer may be both an inter-program function (i.e., between two

different providers) or an intra-program function (between different PRUs of the same provider).

(ag) “Treatment/recovery plan” is the plan developed by the responsible clinical staff member

with the patient and based on the admission assessment and initial services.

(ah) “Visit” means one or more services provided to a patient and/or collateral person on a

single day.

822.6 Standards pertaining to Medicaid reimbursement

(a) For purposes of Medicaid billing, a claim may be submitted for services delivered to a

patient, collateral person, or significant other.

(b) Only services delivered by an Office-certified or authorized program are eligible for

Medicaid reimbursement.

record consistent with section 822.11 of this Part.

(d) In order to qualify for reimbursement, each service must be documented as a covered

Medicaid service in accordance with the following:

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

(2) the service must meet the standards established in Part 841 of this Title;

(3) the service must be provided by appropriate staff as required in this Part.

(e) The following services alone do not constitute a service eligible for Medicaid

reimbursement:

(1) nutrition services;

(2) educational and vocational services;

(3) recreational and social activity services;

(4) group meetings, workshops or seminars that are primarily informational or

organizational;

(5) acupuncture;

(6) services that are not provided pursuant to this Part.

822.7 General program standards

(a) Policies and procedures. The program sponsor must approve written policies, procedures,

and methods governing the provision of services to patients in compliance with Office

regulations including a description of each service provided. These policies, procedures, and

methods must address, at a minimum:

(1) admission and discharge, including specific criteria relating thereto, as well as transfer

and referral procedures;

(2) treatment/recovery plans;

(3) services to be provided by contract or subcontract including methods for coordinating

service delivery and a description of core groups offered and procedures for coordinating group,

individual, and family treatment (if offered);

(4) a schedule of fees for services rendered;

(5) compliance with other requirements of state and federal laws, regulations and

OASAS guidance documents including HIV/AIDS education, testing and counseling and the use

of alcohol and other drug screening and toxicology tests, and medication and the use of

medication supported recovery;

(6) infection control procedures;

(7) staffing, including but not limited to, training and use of student interns, peers and

volunteers;

(8) Waiting lists. Programs must maintain a waiting list of eligible prospective patients.

When an opening is available programs must make at last one good faith attempt to contact the

next prospective patient on the waiting list.

(i) In determining certified capacity, OTPs may exclude continuing care patients, patients

confirmed to be maintained on appropriate medications in hospital, nursing home or correctional

facility and are expected to return to the OTP within 12 months upon discharge from such

facility;

(ii) CD-OPs may include in a waiting list patients previously deemed ineligible for

admission for reasons other than behavioral concerns.

(b) Emergency medical kit. All programs must maintain an emergency medical kit at each

certified location; such kit must include basic first aid and at least one Narcan emergency

overdose prevention kit the use of which is subject to applicable laws and regulations. Programs

must develop and implement a plan to have staff trained in the prescribed use of a Narcan kit

such that it is available for use during all program hours of operation.

(1) All staff and patients should be notified of the existence of the Narcan overdose

prevention kit and the authorized administering staff.

(2) Nothing in this regulation shall preclude patients from becoming authorized in the

administration of the Narcan emergency overdose prevention kit, provided however, the program

director must be notified of the availability of any additional authorized users.

process, a quality improvement committee, and a written plan that identifies key performance

measures for that particular program.

(d) OTP diversion control. Each OTP must develop and implement a diversion control plan

(DCP) as part of its quality improvement plan, such DCP to include specific measures to reduce

the possibility for diversion of controlled substances from legitimate treatment use, and shall

assign specific responsibility to the medical and administrative staff of the OTP for carrying out

the diversion control measures and functions described in the DCP.

(e) OTP continuous services. OTPs must develop necessary procedures to assure continuous

OTP services in emergencies or disruption of operations in accordance with Office guidelines

and accreditation standards.

(f) OTP community relations. OTPs must develop and implement a community relations

plan that describes actions responsive to reasonable community needs; such plans may include,

but not be limited to, formation of community patrols to ensure that patients are not loitering, and

formation of a Community Committee that meets regularly to discuss actions to improve

community relations.

(g) Required services. Each program must directly provide the following:

(1) admission assessment, including a screen for problem gambling;

(2) treatment/recovery planning and review;

(3) individual counseling;

(4) group counseling;

(5) toxicology testing (not required for significant others unless clinically indicated):

(i) Each program must conduct toxicology tests for the presence of benzodiazepines,

cocaine, opioids, and a 4th panel to be determined by the provider. At least eight random

toxicology tests must be conducted per year, per patient in treatment, as clinically appropriate or

as required by federal law. For OTPs, if during a three month period, toxicology testing

indicates use of illicit drugs, a patient’s take home schedule and treatment/recovery plan must be

assessed accordingly as clinically indicated.

(ii) Each program must review and discuss with the patient each positive toxicology

result for illicit drugs or negative toxicology results for approved medications.

(iii) Each program must inform patients of positive toxicology test results for illicit drugs

or negative toxicology results for approved medications.

(iv) Each program must implement procedures, such as random collection of samples, to

effectively minimize the possibility of false samples.

(v) Laboratories used for toxicology testing must be approved by the New York State

Department of Health or, in the City of New York, the New York City Department of Health and

Mental Hygiene.

(vi) Each program must use a method approved by the Food and Drug Administration

(FDA) and Center for Substance Abuse Treatment (CSAT) for toxicology testing.

(6) discharge planning; and

(7) OTPs must provide:

(i) medication administration and observation; and

(ii) medication management.

(h) Optional Services. Each program may, at its option, directly provide any of the following:

(1) brief intervention;

(2) brief treatment;

(3) collateral visits;

(4) complex care coordination;

(5) outreach;

(6) peer support services;

(7) screening;

(8) medication administration and observation;

(9) medication management;

(10) intensive outpatient services (IOS);

(11) ancillary withdrawal (requires Office approved designation); or

(12) other services which may be identified by the Office from time to time.

(i) Problem gambling. A CD-OP program that has been granted a waiver to admit and treat

individuals for problem gambling only (persons who do not have a co-occurring chemical

dependency diagnosis) and/or a significant other who has been affected by problem gambling,

shall provide services in accordance with Part 857 of this Title.

(j) Telepractice. The Office may designate services that may be provided by the use of

telepractice as such practice may be defined by the Office.

(k) Staffing. Each program must provide clinical supervision and ensure and document a

plan for staff training based on individual employee needs. Subject areas appropriate for training

shall be identified by the Office. Staffing requirements include:

(1) Clinical Director. Each program must have a qualified health professional designated

as the full-time on-site clinical director who is responsible for the daily activities and supervision

of services provided. Such person must have at least three years of full-time clinical work

experience in the chemical dependence field, at least one year of which must be supervisory,

prior to appointment as clinical director. An OTP may have a part-time on-site clinical director

only if the OTPs certified capacity is less than 100 patients and the OTP is part of a multiple

OTP system or part of a larger health, mental health or chemical dependence service. Such an

OTP must designate and assign all clinical director responsibilities to another staff member

qualified and capable of completing all duties.

(2) Medical Director. Each program must have a Medical Director as defined in Part 800

of this Title.

(3) Medical staff, as defined in Part 800 of this Title.

(i) The medical staff must be trained in emergency response treatment and must

complete regular refresher courses/ drills on handling emergencies.

(ii) In a CD-OP a physician, registered physician's assistant or nurse practitioner must

provide on-site coverage for a minimum of one hour per week for up to 25 active patients and an

additional hour for each additional 25 active patients or part thereof.

(iii) In OTPs, prescribing professionals may be used to meet physician staffing

requirements provided that no less than one third of the required 35 hours per 300 patients is

fulfilled by the attendance of the physician and no more than two-thirds of such time is filled by

other prescribing professionals. In addition, anytime an OTP is open and a physician is not

present, a physician must be available for consultation and to attend to any emergency situation.

(iv) OTPs must have at least the equivalent of two full-time on-site nurses for up to 300

patients, one of whom shall be a registered nurse. Programs approved to serve more than 300

patients must have one additional full-time nurse for each additional 150 patients or part thereof.

A nurse must be present at all times when medication is being administered. A registered nurse

or nurse practitioner must be present or immediately available by telephone when services are

provided by a licensed practical nurse.

(4) Health coordinator. Each program must designate a health coordinator to assure the

provision of education, risk reduction, counseling and referral services to all patients regarding

HIV/AIDS, tuberculosis, hepatitis, sexually transmitted diseases, and other communicable

diseases.

(5) Counselors. In every program there must be an adequate number of counselors

sufficient to carry out the objectives of the program and to assure the outcomes of the program

are addressed. The Office will review factors in determining whether the program's outcomes

are being addressed, which may include but shall not be limited to:

(i) retention of patients in treatment;

(ii) patients’ successful completion of treatment or referral to more appropriate levels of

care; and

(iii) attainment of remission from substance use disorder.

(6) Full-time staffing requirements. There must be at least one full-time Credentialed

Alcoholism and Substance Abuse Counselor (CASAC); and there must be at least one full-time

qualified health professional, as defined in Part 800 of this Title, qualified in a discipline other

than substance use disorder counseling.

(7) Qualified health professional requirements. At least 50 percent of all clinical staff

must be qualified health professionals. CASAC trainees (CASAC-T) may be counted towards

satisfying the 50 percent requirement; however such individuals may not be considered qualified

health professionals for any other purpose under this Part. Clinical staff members who are not

qualified health professionals must have qualifications appropriate to their assigned

responsibilities as set forth in the personnel policies of the program and must be subject to

appropriate staff supervision and continuing education and training.

(8) Each program must notify the Office within seven (7) days of any change in medical

director, on-site physician(s), or program sponsors.

(l) Other staffing requirements.

(1) If other specialized services are directly provided by the program, staff must be

appropriately qualified to provide such services.

(2) Unpaid volunteers and student interns. In addition to staffing requirements of this

Part, a program may utilize unpaid volunteers and unpaid student interns. Such volunteers or

student interns must receive supervision, training, or didactic education consistent with their

assigned tasks and the services they are expected to provide.

(3) Peer Advocates. Peer advocates, as defined in Part 800 of this Title, must be

supervised by a clinical staff member who is credentialed or licensed and participate in a training

plan appropriate to their needs. Peer advocates may provide peer support and outreach services

based on clinical needs as identified in the patient’s treatment/recovery plan.

(4) OTP security guards. OTPs may employ security guards who are not clinical staff to

protect persons, property and program operations. Security guards may not be involved in

clinical services and must receive training on confidentiality of patient information and adhere to

such federal laws.

(m) Program hours of operation. Each CD-OP must operate at least five days per week

providing structured treatment services in accordance with treatment/recovery plans. OTPs

must be open at least six days per week and must obtain prior approval of the Office before

changing program or medication hours and must provide patients at least one month notice prior

to implementing the approved change.

822.8 Admission, Initial Services, Transfers and Readmissions

(a) Admission requirements for all programs. The admission assessment or decision to admit

must include identification of initial services needed until the development of the

treatment/recovery plan.

(1) If the presenting individual is determined to be inappropriate for admission to the

program, a referral to a more appropriate service must be made, unless the individual is already

receiving chemical dependence services from another provider. Individuals deemed ineligible

for admission must be informed of the reason.

(2) No individual may be denied admission to a program based solely on the individual's:

(i) prior treatment history;

(ii) referral source;

(iii) pregnancy;

(iv) history of contact with the criminal justice system;

(v) HIV and AIDS status;

(vi) physical or mental disability;

(vii) lack of cooperation by significant others in the treatment process; or

(viii) medication supported recovery for opioid dependence prescribed and monitored by

a physician, physician's assistant or nurse practitioner.

(3) All prospective patients must be informed that admission to a program is on a

voluntary basis and a prospective patient is free to discharge him/herself from the service at any

time. For prospective patients under an external mandate, the potential consequences for

premature discharge must be explained, including that the external mandate does not alter the

voluntary nature of admission and continued treatment. This provision shall not be construed to

preclude or prohibit attempts to persuade a prospective patient to remain in the program in

his/her own best interest.

(4) Prior to admission, all programs must:

(i) conduct a communicable disease risk assessment (HIV/AIDS, tuberculosis, hepatitis,

or other communicable diseases) to determine whether or not the individual appears to be free of

serious communicable disease that can be transmitted through ordinary contact;

(ii) conduct a toxicology screen pursuant to provisions of this Part as clinically

appropriate or as required by federal law.

(5) If clinically indicated, as soon as possible after admission, all programs must:

(i) recommend HCV testing; testing may be done on site or by referral;

(ii) conduct an intradermal skin or blood based Tuberculosis test; testing may be done on

site or by referral with results as soon as possible after admission but no later than finalization of

the treatment recovery plan;

(iii) recommend HIV testing; testing may not be conducted without patient written

informed consent except in situations specifically authorized by law. HIV testing may be done

on site or by referral;

(iv) explain any blood and skin test results to the patient within 3 weeks of the test;

(6) As soon as possible after admission, for those patients who have not had a physical

examination within one year prior to admission, each such patient must either be assessed face-

to-face by a member of the medical staff to ascertain the need for a physical examination or

referred for a physical examination. For those patients who have had a physical examination

within one year prior to admission, or for those patients being admitted directly to the outpatient

program from another chemical dependence service authorized by the Office, the existing

medical history and physical examination documentation may be used to comply with the

requirements of this subdivision, provided such documentation has been reviewed by a medical

staff member and determined to be current.

(7) Any significant medical issues identified prior to or after admission must be

addressed in the treatment recovery plan and documented in the patient case record.

(8) A significant other may be admitted to a program regardless of whether the

abusing/dependent individual with whom they are associated is in treatment. A significant other

is not appropriate for admission to an outpatient rehabilitation service.

(b) Additional admission requirements for a CD-OP.

(1) The program must document that the individual is determined to have a substance use

disorder based on the criteria in the most recent version of the Diagnostic and Statistical Manual

(DSM) or the International Classification of Diseases (ICD). If an individual has been referred

by an Office approved Driving While Intoxicated (DWI) provider/practitioner, any assessment

created by such provider which meets the requirements of this section may be used to admit the

patient.

(2) The decision to admit an individual must be made by a clinical staff member who is a

qualified health professional and must be documented by the dated signature (physical or

electronic signature) of the qualified health professional and include the basis for admitting the

patient.

the requirements of paragraph (a) of this section, an individual must also meet the criteria in

Section 822.15 of this Part to be admitted to an outpatient rehabilitation service.

(d) Additional admission requirements for an OTP.

(1) The decision to admit a prospective patient for treatment is finalized on the date of

administration of the initial approved medication dose after satisfaction of all applicable

requirements of this Part. Prospective patients with a chronic immune deficiency or prospective

patients who are pregnant and have a current opioid or past opioid dependency must be screened

and admitted on a priority basis. A prospective patient with only a primary medical diagnosis of

a chronic pain condition must be referred to specialists qualified to treat chronic pain conditions

and are not eligible for admission to an OTP. No person under the age of 16 may be admitted to

an OTP without the prior approval of the Office. The following requirements must be met for an

individual to be admitted to an OTP:

(2) In order to provide the first medication dose, a physician must make an in person

evaluation of each prospective patient within 72 hours of the first on-site visit to determine that

the prospective patient has had a physiological dependence on opioids for at least the previous

12-month period, and must diagnose and document an addiction or dependence, provided

however:

(i) a prospective patient may be admitted who voluntarily completed treatment in

another OTP without confirming current opioid dependence if the OTP confirms that the:

(A) voluntary completion of treatment occurred within the previous 24 months; and

(B) previous treatment lasted at least 6 months;

(ii) a prospective patient who is less than 18 years of age may be admitted if such patient

has had at least two prior unsuccessful treatment episodes at a chemical dependence withdrawal

and stabilization service or inpatient service within a 12-month period and a current

physiological dependence to opioids for a minimum period of 24 months;

(iii) a prospective patient who resided in a correctional or chronic care facility for at

least one month, if assessed within 6 months after release or discharge, may be admitted if the

prospective patient would have been eligible for admission prior to residing in such facility.

(e) Initial services in an OTP. (1) The prescribing professional must conduct a full physical

examination, including required laboratory tests or screens, and any other test as clinically

indicated or as may be required by the Office, during the first week after admission to determine

the patient’s overall health. A prescribing professional must annually repeat the physical

examination required at admission. A patient may choose to have a licensed practitioner outside

the OTP complete the annual physical examination to determine health condition and OTP

clinical staff shall make diligent efforts to record all required results, including ordered tests, in

the patient’s case record.

(2) Each OTP must orient each patient to treatment within one week after admission by

providing education and information to support patient rehabilitation including pharmacology of

approved medications (methadone and buprenorphine must be included in this review), available

services, operating and medicating hours, alternative medicating procedures for emergencies,

treatment expectations, hepatitis B and C (incidence, detection and treatment options) and key

OTP procedures and guidelines. A physician must ensure that prior to first dose; the prospective

patient is provided and signs (physical or electronic signature) an informed written consent to

participate in opioid treatment, which shall include notice of the risks and benefits of a

prescribed medicine.

(3) Each OTP must issue a photo-identification card to each patient within two weeks

after admission; patients may carry the identification or, at the patient’s option, have the

identification maintained at the OTP.

(f) OTP Readmissions. Opioid treatment programs need not repeat admission procedures

for any patient who is being re-admitted within three months of discharge and need not repeat a

medical and laboratory examination if the patient received a medical and laboratory exam within

the previous year, provided:

(1) The patient’s prior medical records must be combined with the new medical records

within thirty days of the patient’s readmission;

(2) each OTP must immediately readmit patients who were previously discharged from

that OTP:

(i) after a stay of 30 days or more in a hospital, nursing home, or other health care

facility, if such patient is still being maintained on an approved medication, and/or meets the

eligibility requirements when released; or

(ii) after an extended incarceration (including KEEP), if clinically appropriate when such

patient is released.

(g) OTP transfers. (1) Each OTP must develop procedures regarding the permanent transfer

of patients which must ensure that the OTP shall:

(i) not deny a reasonable request for transfer;

(ii) not include “temporary-to-permanent” conditions;

(iii) regard transferred patients as continuing in treatment by incorporating their length of

treatment and treatment/recovery plans from the referring OTP. Admission procedures and

physical exams need not be repeated for transferring patients if medical/lab exam were

completed within the previous year;

(iv) send or receive the reason for the transfer and provide the most current medical,

counseling, and laboratory information within 14 days of the request. Receipt of this information

is not required prior to acceptance and the failure to receive this information will not preclude

acceptance; and

(v) continue the patient’s approved medication dosage and take-home schedule unless

new medical or clinical information requires medical staff to review and subsequently order a

change.

(2) Each OTP must develop procedures for the temporary transfer of patients which must

ensure that the:

(i) transferring OTP forward information on fees, contact person, time and dose of

medication to the receiving OTP;

(ii) OTPs sends or receives prior to the patient’s arrival the reason for the temporary

transfer including temporary dates and approved medication dose;

(iii) OTPs shall not deny a reasonable request for a temporary transfer;

(iv) transferring OTP remains responsible for the patient’s overall treatment. The

receiving OTP may deliver any necessary service after consultation with the transferring OTP;

and

(v) receiving OTP prescribing professional must write an order to continue the patient’s

medication dose and take-home schedule.

822.9 Treatment / recovery plan

(a) Each patient must have a written patient-centered treatment/recovery plan developed by

the responsible clinical staff member and patient as soon as possible after admission but not later

than 30 calendar days after admission. Standards for developing a treatment/recovery plan

include, but are not limited to:

(1) If the patient is a minor, the treatment/recovery plan must also be developed in

consultation with his/her parent or guardian unless the minor is being treated without parental

consent as authorized by Mental Hygiene Law section 22.11.

(2) For patients moving directly from one program to another, the existing

treatment/recovery plan may be used if there is documentation that it has been reviewed and, if

necessary, updated within 14 days of transfer.

(b) The treatment/recovery plan must:

(1) include each diagnosis for which the patient is being treated;

(2) address patient identified problem areas specified in the admission assessment and

concerns which may have been identified subsequent to admission, and identify methods and

treatment approaches that will be utilized to achieve the goals developed by the patient and

primary counselor;

(3) identify a single member of the clinical staff responsible for coordinating and

managing the patient's treatment who shall approve and sign (physical or electronic signature)

such plan; and

(4) be reviewed, approved and signed (physical or electronic signature) within 10 days of

the development of the treatment plan by a either a physician, physician’s assistant, licensed

psychologist, nurse practitioner, or licensed clinical social worker.

reviewed, and revised if necessary, at least once within every 90 calendar days from the date of

admission for the first year and at least once within every 180 calendar day window period

thereafter. Reviews should occur more frequently when a patient is not responding to treatment

as planned or if a significant incident occurs. Reviews of the treatment plan shall be signed

(physical or electronic signature) by either a physician, physician’s assistant, licensed

psychologist, nurse practitioner, or licensed clinical social worker.

(d) The program’s multidisciplinary team, as defined in Part 800 of this Title, shall meet on a

regularly scheduled basis for the purpose of reviewing a sample of cases for the purpose of

clinical monitoring of practice. This meeting shall be documented as to date, attendance, cases

reviewed and recommendations.

(e) Referrals and Readmissions. If a patient is referred directly to the CD-OP from another

service certified by the Office, including an office approved DWI provider/practitioner, or is

readmitted to the same CD-OP within 60 days of discharge, any assessment created by such

provider may be used, provided documentation is maintained demonstrating a review and update.

(f) Pregnancies. Treatment/recovery plans must include provisions for pre-natal care for all

patients who are pregnant or become pregnant. If a pregnant patient refuses or fails to obtain

such care, the provider must have the patient acknowledge in writing that pre-natal care was

offered but refused.

822.10 Case records

(a) All programs must maintain a case record (either electronic or paper) for each patient

who receives services. The case record must demonstrate a chronological pattern of delivered

medical and treatment services consistent with the patient’s prior treatment history, if any, and

the patient’s evolving treatment/recovery plan.

(b) The case record must include, at a minimum, the following:

(1) a notation that, prior to the first treatment visit, the patient received a copy of the

program’s rules and regulations, including patient's rights (Part 815) and a summary of the

federal confidentiality requirements, that such rules and regulations were discussed with the

patient, and that the patient indicated he/she understood them;

(2) the source of referral, if applicable;

(3) any clinical or non-clinical documentation or determination applicable to the delivery

of medical and treatment services for a particular patient and/or supporting the patient’s evolving

treatment/recovery plan;

(4) the individual treatment/recovery plan and all reviews and updates thereto;

(5) signed releases of consent for information;

(6) documentation of services in accordance with 822.11.

(7) level of care determinations using the OASAS level of care protocol.

(8) discharge plan and summary, including the circumstances of the discharge; and

(9) if the patient is a minor being treated without parental consent, documentation

establishing that the provisions of Mental Hygiene Law section 22.11 have been met.

in the patient record, and document within 30 days of occurrence unless otherwise specified:

(1) information and documentation required in screening and admission;

(2) all lab results;

(3) current approved medication dose and justification for any changes;

(4) include an order sheet that is displayed in the case record and signed (physical or

electronic signature) by any medical professional licensed under the appropriate state law

authorizing such change and noting the date for each approved medication order and dose

change; and

(5) discharge information, including but not limited to, a complete medication list, reason

for discharge and any referrals made.

(d) Transfers. If patients are transferred between CD-OPs and outpatient rehabilitation

services within the same provider, a single case record may be maintained provided that it

includes clinical justification for the transfer, the effective date of the transfer and a revised

treatment/recovery plan, signed (physical or electronic signature) by the responsible clinical staff

member and their supervisor within seven days of the transfer.

(e) Confidentiality. Case records maintained by the program are confidential and may only

be disclosed consistent with the Health Insurance Portability and Accountability Act (HIPAA)

and the federal regulations governing the confidentiality of alcohol and drug abuse patients'

records as set forth in 42 CFR Part 2 and other applicable law.

(f) Records retention. Case records must be retained for six years after the date of discharge

or last contact, or three years after the patient reaches the age of eighteen, whichever time period

is longer.

(g) Patient deaths. If a patient dies while in active treatment any known details must be

documented in the case record.

822.11 Documentation of services

(a) Unless otherwise indicated, the type, content, duration and outcome of each service

delivered to or on behalf of a patient must be documented in the patient’s case record, described

and verified as follows:

(1) be written and signed (physical or electronic signature) by the staff member providing

the service;

(2) indicate the date the service was delivered;

(3) record the relationship to the patient’s developing treatment goals described in the

treatment/recovery plan;

(4) include any recommendations or determinations for initial, continued or revised

patient goals and/or treatment.

822.12 Discharge planning

(a) Discharge criteria. Individuals entering treatment should progress by meeting treatment

milestones including: stabilization; engagement; goal setting; remission of substance use

disorder; and attainment of goals supporting recovery. Individuals should be considered for

discharge once they have stabilized, met remission criteria for substance use disorder, and

attained the support necessary to support long term remission. An individual discharged from a

program must be discharged for a documented reason. Individuals discharged involuntarily must

be discharged consistent with Part 815 of this Title.

(b) A discharge plan must be developed in collaboration with the patient and any collateral

person(s) the patient chooses to involve. The discharge plan shall specify needed referrals with

appointment dates and times, all known medications (including frequency and dosage) and

recommendations for continued care. If the patient is a minor, the discharge plan must also be

developed in consultation with his or her parent or guardian, unless the minor is being treated

without parental consent as authorized by Mental Hygiene Law section 22.11.

approved by the responsible clinical staff member and the clinical supervisor prior to the

discharge. This requirement does not apply to patients who stop attending, refuse continuing care

planning, or otherwise fail to cooperate. That portion of the discharge plan which includes

referrals for continuing care must be given to the patient upon discharge.

(d) Within 45 days of discharge, a discharge summary must be prepared and included in each

patient's record. The discharge summary must address and measure progress toward attainment

of treatment goals.

822.13 Continuing care in CD-OP

(a) Individuals may be admitted to continuing care when they have been discharged from

active treatment and there is a documented clinical need for ongoing clinical support to prevent

relapse or to maintain gains made in active treatment.

(b) The purpose of continuing care is to provide ongoing disease management services

including management of life stressors, urges and cravings, mood and interpersonal relationships

and to maintain gains made in active treatment.

(d) Individuals in continuing care may receive rehabilitative support services including case

management and medication management services as needed.

822.14 Additional locations

(a) A certified provider of a CD-OP service may operate at one or more additional locations

with the approval of the commissioner pursuant to Part 810 of this Title.

(1) For purposes of this section, an “additional location” is a provider site providing

chemical dependence outpatient treatment services which reports to a primary certified program

for its operation, administration and supervisory activities. The additional location must be

operated in the same county or in a county contiguous to the primary certified program and may

not exceed the volume of services provided at the primary certified program.

(2) The primary certified provider must apply for additional location approval by

completing an application approved by the commissioner and clearly indicating the need for

access to outpatient services at the site proposed, the financial and programmatic ability to

provide such service, the characteristics of the space, the schedule of services, and the staffing.

The application will be reviewed in accordance with the administrative review process pursuant

to Part 810 of this Title.

(b) Each additional location must directly provide the following:

(1) assessment;

(2) treatment/recovery planning; and

(3) individual and/or group counseling.

(1) certified providers of outpatient rehabilitation services; or

(2) certified providers of opioid treatment services.

822.15 Additional requirements for chemical dependence outpatient rehabilitation

services

(a) As defined in 822.6 of this Part, outpatient rehabilitation services for individuals with

more chronic conditions emphasize development of basic skills in prevocational and vocational

competencies, personal care, nutrition, and community competency. The individual must have

an inadequate support system and either substantial deficits in interpersonal and functional skills

or health care needs requiring attention or monitoring by health care staff. These services are

provided in combination with all other clinical services provided by CD-OPs. It is expected that

services will be provided three to five days per week for at least four hours per day.

(b) Programs must be certified by the Office to provide outpatient rehabilitation services.

20 patients receiving outpatient rehabilitation services. If volunteers or student interns are used,

they may not be counted in the counselor-to-patient ratio. In addition to the staffing required in

section 822.7 of this Part, the following additional staff members are required:

(1) at least one half-time therapeutic recreation therapist or occupational therapist or

vocational specialist, certified as a rehabilitation counselor or qualified health professional with

one year of experience and/or training in providing recreation, occupation and/or rehabilitation

services; and

(2) at least one part-time nurse practitioner, registered physician's assistant, or registered

nurse, or a licensed practical nurse supervised by a registered nurse employed by the governing

authority.

(d) If a CD-OP is providing outpatient rehabilitation services, the following services must be

available either directly or through written agreements:

(1) socialization development;

(2) skill development in accessing community services;

(3) activity therapies; and

(4) information and education about nutritional requirements, including but not limited to

planning, food purchasing, preparation and clean-up.

(e) A provider of outpatient rehabilitation services must assure the availability of one meal to

each patient who receives outpatient rehabilitation services for four or more hours per day.

822.16 Additional requirements for opioid treatment programs

(a) Central registry system. Each OTP must participate in the central registry system

established and maintained by the Office to prevent a patient’s simultaneous enrollment in more

than one OTP and ensure accurate dispensing of medication in accordance with federal

regulations. Each OTP must:

(1) initiate a clearance inquiry to the central registry system by submitting all required

information prior to admitting an applicant to the OTP;

(2) report all admissions, transfers, and discharges immediately to the central registry

system;

(3) verify with the central registry system that the prospective patient is not presently

enrolled in another OTP and this verification must be documented in the clinical record; OTPs

may not admit an applicant who is participating in another OTP; and

(4) report any other information deemed necessary by the Office to comply with state and

federal laws and regulations.

(b) Medication administration. (1) A physician must determine a patient's initial medication

dose and schedule of administration and document such orders in the patient’s record. OTPs

shall not adopt maximum medication dosage limits.

(2) A prescribing professional may report such orders to the registered or licensed

medical personnel supervising medication administration; any subsequent change in approved

medications, dose or schedule must similarly be reported to the pharmacy or to the medical staff

and documented in the record before administration. The prescribing professional may issue

verbal orders in emergencies only and must document such orders in writing within 72 hours.

(3) Unless waived in writing, patients must be informed of their approved medication

dose and of any adjustment prior to administration.

(4) The initial dose of methadone administered for a patient should not exceed 30

milligrams, provided however, the initial dose may exceed 30 milligrams when the physician

documents that the dose is ineffective for relief of withdrawal symptoms. In no circumstances

may the total methadone dose administered to a patient on the first day exceed 40 milligrams.

(5) Unless immediately documented as ineffective for relief of withdrawal symptoms by

a physician, the initial dose of buprenorphine administered to a patient must not exceed 12

milligrams on the first day.

(6) Patients must be properly stabilized with a therapeutic dose of approved medications;

a therapeutic dose means an amount sufficient to maintain comfort for at least 24 hours, alleviate

opioid craving and stop continued opioid use. To assure effectiveness, measuring plasma levels

and/or administering split methadone doses, and/or conducting psychiatric evaluations may be

considered as clinically indicated. Split methadone doses require prior Office approval. Tests for

plasma levels must be taken prior to a request to the Office for split dosing.

(7) The procedure for methadone administration must be as follows:

(i) Administration of methadone at all OTPs must be in liquid form and in single doses

except as permitted in subparagraph (iii) of this paragraph. Take-home bottles must be labeled in

accordance with applicable state and federal law;

(ii) medical staff must observe and verify ingestion to confirm that the correct dose of

ordered methadone is administered to the patient; and

(iii) patients approved to receive take-home medication of 13 or more days may be

administered take-home doses in dry tablet form in a single bottle.

(8) If any medical staff member observes any condition or behavior on the part of a

patient that may contraindicate a regularly scheduled dose of an opioid agonist medication, such

staff member must contact the prescribing professional immediately and advise of the patient’s

condition which may warrant an approved medication delay, withholding or adjustment. The

prescribing professional must:

(i) approve any medication delay, withholding or adjustment; and

(ii) provide follow up consistent with emergency verbal orders as otherwise required by

this section.

(9) If a patient misses more than two consecutive scheduled medication visits, upon the

patient’s next attendance a medical assessment must be made by the prescribing professional to

determine whether a change in dose is indicated and the prescribing professional must write an

appropriate order.

schedule that is most appropriate to clinical need, conducive to treatment progress, and

supportive of rehabilitation. A prescribing professional may reduce a patient’s OTP visit

schedule, when clinically indicated, to accommodate patient changes in need, progress, or

rehabilitation only after assessing patient responsibility in handling approved medication and

taking reasonable precautions to prevent possible misuse.

(2) Any patient may receive a single take-home dose for a day that the clinic is closed for

business, including Sundays and State and Federal holidays.

(3) A physician must review and confirm the appropriateness for take-home medication.

Patients may be granted take-home medication pursuant to the provisions of this subdivision and

consideration of the criteria below:

(i) Absence of recent abuse of drugs (opioid or non-narcotic), including alcohol;

(ii) Regularity of clinic attendance;

(iii) Absence of serious behavioral problems at the clinic;

(iv) Absence of known recent criminal activity, e.g., drug dealing;

(v) Stability of the patient's home environment and social relationships;

(vi) Length of time in comprehensive maintenance treatment;

(vii) Assurance that take-home medication can be safely stored within the patient's

home; and

(viii) Whether the rehabilitative benefit the patient derived from decreasing the frequency

of clinic attendance outweighs the potential risks of diversion.

(4) Such determinations and the basis for such determinations consistent with the criteria

outlined in paragraph (3) of this subdivision shall be documented in the patient's medical record.

If it is determined that a patient is responsible in handling opioid drugs, beyond the 1-day dose

for clinic closure, the following restrictions apply (Note: the following requirements pertain only

to the use of methadone; take-home considerations for buprenorphine are not dependent on the

following time-in-treatment requirements. However, when determining take-home schedules for

patients treated with buprenorphine, OTPs must articulate/document sound clinical judgment

that the patient is appropriate for the amount of buprenorphine dispensed):

(i) During the first 90 days of treatment, the take-home supply is limited to a single dose

each week and the patient shall ingest all other doses under appropriate supervision pursuant to

this Part.

(ii) In the second 90 days of treatment, the take-home supply is two doses per week.

(iii) In the third 90 days of treatment, the take-home supply is three doses per week.

(iv) In the remaining months of the first year, a patient may be given a maximum 6-day

supply of take-home medication.

(v) After 1 year of continuous treatment, a patient may be given a maximum 2-week

supply of take-home medication.

(vi) After 2 years of continuous treatment, a patient may be given a maximum one-

month supply of take-home medication, but must make monthly visits.

(5) No medications shall be dispensed to patients in short-term detoxification treatment

or interim maintenance treatment for unsupervised or take-home use.

(6) Notwithstanding the requirements of this subdivision, a provider may use the practice

of recall to detect diversion of opioid medication. Recall occurs when OTP staff has reasonable

cause to require a particular patient to return to the OTP unexpectedly, within a day or two prior

to the next scheduled visit, and bring in all remaining take-home doses. Remaining doses must

match the prescribed schedule to avoid suspected misuse.

(7) Holidays. Notwithstanding the requirements of this subdivision, a patient may be

provided with extra medication without prior Office approval if the patient's regular OTP visit

schedule falls on a legal or OTP holiday. Designation of an OTP holiday must be approved

annually by the Office at least 30 days in advance of such holiday.

(8) Exceptional circumstances. Notwithstanding the requirements of this subdivision, a

prescribing professional, based on reasonable clinical judgment, may order up to thirty (30) take-

home doses at any one time if a patient is unable to conform to the applicable mandatory

schedule requirements due to exceptional circumstances such as illness, personal or family crisis,

travel, employment, medical, or hardship, and the prescribing professional determines the patient

is also responsible in handling approved medication. Such order shall not be construed as a

permanent schedule change. The prescribing professional must immediately document in the

patient record the reasons for the order.

(9) Release of medication to designated third party. OTP medical staff may release

medication to a designated third party other than the patient only when the patient is considered

physically compromised and unable to attend the OTP. The decision to permit such release to

non-OTP medical staff must be based on the reasonable clinical judgment of the prescribing

professional and the consent of the patient, both of which must be documented in the patient’s

record. All designated third parties must receive prior Office approval.

(10) Patients readmitted to an OTP after an approved voluntary discharge may be

granted the same take-home schedule at the time of discharge provided all criteria other than

length of treatment are satisfied.

(d) Medication security. (1) Access to controlled substances, including approved

medications, shall be limited to authorized persons in accordance with applicable state and

federal law. The areas where controlled medication stocks are maintained, dispensed, or

administered must be physically separated and secure from patient areas in accordance with

applicable state and federal law.

(2) Each OTP must conduct frequent and regular checks of medication and maintain a

daily narcotic inventory.

(3) The medical area of the OTP must contain, at least, the following equipment and

supplies:

(i) medical supplies and instruments suitable for required examinations and foreseeable

emergency procedures, including, at a minimum a stethoscope and ophthalmoscope; and

(ii) resuscitation equipment consisting of, at a minimum, two (2) ambu-bag and masks,

and oral pharyngeal airways.

(4) Immediately after administration, drug containers must be purged by rinsing,

inversion, or by an acceptable alternative method that must effectively prevent the accumulation

of residual methadone. Containers used in the OTP or for take-home medications may not be

reused and must be destroyed. Each OTP must assure patients’ take-home bottles and used

containers are disposed of properly. Patients should return take-home bottles before receiving

any subsequent take-home medication.

(5) Any theft or loss of approved medications must be immediately reported in

accordance with applicable state and federal law.

(e) Residential OTPs. A residential OTP shall:

(1) comply with all applicable requirements of this Part;

(2) comply with all requirements of this Title applicable to chemical dependence

residential services;

(3) not dispense take-home medications to any patient; and

(4) include material and schedules for development and review of treatment/recovery

plans as required by regulations applicable to chemical dependence residential services, rather

than the requirements of this Part.

(f) Opioid taper. (1) Voluntary Taper. Each OTP must provide an opioid taper at the OTP

or arrange for taper at another OTP or in a facility approved to provide tapering with methadone

as is medically and clinically appropriate:

(i) Patients may request a voluntary taper at any time and may discuss reasons and

circumstances with OTP staff who must provide clinical feedback regarding patient readiness.

No reasonable request shall be denied;

(ii) Each OTP must administer a voluntary taper at a pace tailored to the patient’s

individual needs, based on clinical judgment, medical evaluation, patient input and feedback at

the start of the taper and continuously throughout;

(iii) A patient’s request for a voluntary taper may be contraindicated based on past

treatment response or unresolved medical or clinical reasons. A prescribing professional must

inform such a patient of current contraindications. After continued informed discussions, a

prescribing professional must make a taper available to the patient if the patient wishes. The

OTP must document when the patient’s voluntary taper is against medical advice.

(iv) A voluntary methadone taper is generally designed to help a patient reach zero

milligrams in accordance with the patients’ wishes and abilities. Once at zero milligrams, a

patient may remain enrolled in continuing care treatment or be discharged from the OTP in

accordance with the taper treatment/recovery plan. The pace of a voluntary taper is determined

by the prescribing physician in consultation with the patient.

(v) For a voluntary buprenorphine taper, the dosage may not be reduced by more than

one to two milligrams every three days without the prior approval of the Office.

(2) Involuntary Taper. Each OTP may discharge a patient who is unresponsive to

treatment in accordance with the requirements of Office regulations regarding patient rights and

must provide an opioid taper onsite, or prearrange for taper at another OTP, or in a facility

approved to provide tapering with methadone, as is medically and clinically appropriate. Under

no circumstance may an involuntary opioid taper occur faster than 10 milligrams every three

days.

(g) Opioid medical maintenance (OMM). (1) Patients admitted to OMM must meet specific

criteria including:

(i) four years of continuous treatment in an OTP;

(ii) three years of no drug abuse including alcohol;

(iii) three years of no criminal involvement;

(iv) three years of continuous gainful employment or productive activity;

(v) three years of emotional stability;

(vi) intent to continue maintenance treatment; and

(vii) verified stability in the Prescription Monitoring Program (“PMP”).

(2) An OMM program requires federal and state approval. The provisions of sections

822.11, 822.12 and 822.13 regarding individualized counseling services and recordkeeping

requirements do not apply to patients in OMM. The individual case record for a patient in OMM

must be updated at least monthly and toxicology tests and/or a check of the PMP must be

conducted as clinically indicated. Programs must verify safe and secure medication storage.

(3) The 30 day medication supply may be dispensed in dry tablet form in a single bottle.

(4) An OMM patient must return to an OTP when, in the prescribing professional’s

clinical judgment, the patient needs OTP maintenance treatment services.

(5) An OMM program has no Office-certified capacity.

(h) Continuing Care Treatment. (1) Each OTP must make continuing care treatment available

to patients who meet the following criteria:

(i) recent completion of a voluntary opioid taper within the last three months;

(ii) absence of patterned drug use, including alcohol;

(iii) demonstrated responsible behavior; and

(iv) commitment to keep OTP appointments at least once per month.

(2) The provisions of sections 822.11, 822.12 and 822.13 regarding individualized

counseling services and recordkeeping requirements do not apply to patients in continuing care

treatment. The individual case record for a patient in continuing care treatment must be updated

at least once a month.

(3) Patients may choose to return to maintenance treatment at any time. OTP staff must

honor such a choice and resume full delivery of all required services.

(4) A continuing care patient must return to an OTP when, in the prescribing

professional’s clinical judgment, the patient needs OTP maintenance treatment services.

(5) Continuing care services must include discharge planning and possible referral to an

alternate level of care, dependent on a patient’s continuing treatment needs.

(i) Specialized opioid services. Specialized opioid services are those not defined in this Part

and are generally research-oriented in nature. Such specialized services shall be reviewed and

approved by the Office prior to implementation and operation in accordance with Office policy,

procedures, and requirements.

822.17 Severability

If any provision of this Part or the application thereof to any person or circumstance is held

invalid, such invalidity shall not affect other provisions or applications of this Part that can be

given effect without the invalid provisions or applications, and to this end the provisions of this

Part are declared to be severable

Part 822 Chemical Dependence Outpatient And Opioid Treatment Programs (11/15)

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