Ala. Admin. Code r. 580-9-44-.28

Level 3.7-D: Medically Monitored Residential Detoxification Program And Level 3.7-D NTP: Medically Monitored Residential Detoxification Narcotic Treatment Program

This regulation establishes operating standards for Alabama's Level 3.7-D Medically Monitored Residential Detoxification Programs and Level 3.7-D NTP Medically Monitored Residential Detoxification Narcotic Treatment Programs. Operators must meet detailed requirements for admission criteria, core services, therapeutic components, staffing (including a licensed medical director and 24/7 nursing coverage), clinical documentation, and support systems. Level 3.7-D NTP programs must additionally comply with federal opioid treatment standards (42 CFR Part 8), DEA registration requirements, and SAMHSA accreditation elements, and are restricted to using buprenorphine or buprenorphine combination products unless separately certified to dispense methadone as an OTP.

Ala. Admin. Code r. 580-9-44-.28 - Level 3.7-D: Medically Monitored Residential Detoxification Program And Level 3.7-D NTP: Medically Monitored Residential Detoxification Narcotic Treatment Program 

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(1)

 Scope. This Chapter establishes rules for the operation of Medically Monitored
 Residential Detoxification Programs (Level 3.7-D) and Medically Monitored
 Residential Detoxification Programs designated as Narcotic Treatment Programs
 (Level 3.7-D NTP).

(2)
 Definitions.
 The following definitions apply to this Chapter: 
 
(a)
 Accreditation elements: The standards
 that are developed and adopted by an accreditation body and approved by the
 Substance Abuse and Mental Health Services Administration (SAMHSA).

(b)
 Detoxification: The dispensing of
 medication, approved for such purposes, in decreasing doses to an individual to
 alleviate adverse physical or psychological effects incident to withdrawal from
 the continuous or sustained use of alcohol and/or other relevant addictive
 drugs. Detoxification functions, also, as a method of bringing the individual
 to a drug-free state within such period.

(c)
 Federal opioid treatment standards:
 42 CFR
 
8.12
.

(d)
 Level 3.7-D Medically Monitored
 Residential Detoxification Program: An organized regimen of services provided
 by nursing and medical professionals, which provides for 24-hour medically
 supervised alcohol or other drug withdrawal management with medication approved
 for such use.

(e)
 Level 3.7-D NTP
 Medically Monitored Residential Detoxification Program: An organized regimen of
 services provided by nursing and medical professionals, which provides for
 24-hour medically supervised opioid withdrawal management utilizing
 buprenorphine or a buprenorphine combination product approved for treatment of
 opioid use disorders by the Food and Drug Administration (FDA). A Level 3.7-D
 NTP may not dispense Methadone unless the entity is certified by the Alabama
 Department of Mental Health to operate an Opioid Treatment Program in
 compliance with Chapter
 
580-9-44-.29
 of these rules and
 holds a valid Certificate of Need for the operation of a Methadone Treatment
 Program issued by the Alabama State Health Planning and Development
 Agency.

(f)
 Long-term
 detoxification: Detoxification treatment services provided for a period more
 than 30 days, but not in excess of 180 days.

(g)
 Medical director: A physician, licensed
 to practice medicine in Alabama, who assumes responsibility for administering
 all medical services performed by the program, either by performing them
 directly or by delegating specific responsibility to authorized program
 physicians and healthcare professionals functioning under the medical
 director's direct supervision.

(h)

 Program sponsor: The individual, named in the entity's application for
 certification by SAMHSA as according to
 42 CFR
 
8.11
, who is responsible for the operation of
 the Level 3.7-D NTP. The sponsor assumes responsibility for all of the entity's
 employees, including any practitioners, agents, or other persons providing
 medical, rehabilitative, or counseling services.

(i)
 Short-term detoxification: Detoxification
 treatment for a period not in excess of 30 days.

(3)
 Rule Compliance. 
 
(a)
 In addition to compliance with the rules
 as specified in this chapter, each Level 3.7-D and 3.7-D NTP shall comply with
 the rules as specified in the following chapters:
 
580-9-44-.02
 Personnel,
 
580-9-44-.03
 Client Rights,
 
580-9-44-.04
 Abuse and Neglect,
 
580-9-44-.05
 Grievances,
 Complaints and Appeals,
 
580-9-44-.06
 Confidentiality and
 Privacy, 
580-9-44-.07
 Seclusion and
 Restraint,
 
580-9-44-.08
 Child and Adolescent
 Seclusion and Restraint,
 
580-9-44-.09
 Incident Reporting,
 
580-9-44-.10
 Infection Control,
 
580-9-44-.il
 Performance Improvement,
 
580-9-44-.12
 Operational Policies
 and Procedures Manual, and
 
580-9-44-.13
 Program
 Description.

(b)
 Each Level 3.7-D
 NTP shall comply with all regulations enforced by the DEA under 21 CFR Chapter
 
II
, and must be registered by the DEA before administering or dispensing opioid
 agonist treatment medications.

(c)

 Each Level 3.7-D NTP must operate in accordance with Federal opioid treatment
 standards and approved accreditation elements.

(4)
 Program Description. The entity shall
 develop, maintain and implement a written program description that defines its
 Level 3.7-D program or Level 3.7-D NTP, as according to Rule
 
580-9-44-.13
 and the following
 specifications:
(a)
 Location. The entity shall
 specifically identify and describe the setting in which the Level 3.7-D Program
 or Level 3.7-D NTP is provided. Services may be provided in any facility that
 meets all applicable federal, state and local certification, licensure,
 building, life-safety, fire, health and zoning regulations including the DMH
 facility certification standards.

(b)
 Admission Criteria: 
 
1.
 Level 3.7-D. The entity's admission
 criteria shall specify the target population for the Level 3.7-D Program, which
 shall include, at a minimum, individuals who are experiencing signs and
 symptoms of withdrawal, or for whom there is evidence that a withdrawal
 syndrome is imminent, and who have a history of insufficient skills and
 supports to complete detoxification at a less intense level of care. 
 
(i)
 The entity shall provide written
 documentation in individual case records that each patient admitted to receive
 Level 3.7-D services meets the diagnostic criteria for a Substance Related
 Disorder as defined in the most recent edition of the Diagnostic and
 Statistical Manual of Mental Disorders of the American Psychiatric
 Association.

(ii)
 The entity shall
 provide written documentation in individual case records that each patient
 admitted to receive Level 3.7-D services meets the dimensional criteria for
 admission to this level of care as defined in the most recent edition of the
 ASAM Criteria.

2.
 Level
 3.7-D NTP. The entity's admission criteria shall specify the target population
 for the Level 3.7-D NTP Program, which shall include, at a minimum, individuals
 who are experiencing signs and symptoms of opioid withdrawal, or for whom there
 is evidence that a withdrawal syndrome is imminent; and who have a history of
 insufficient skills and supports to complete detoxification at a less intense
 level of care.
(i)
 The entity shall provide
 written documentation in individual case records that each patient admitted to
 receive Level 3.7-D NTP services meets the diagnostic criteria for an Opioid
 Related Disorder as defined in the most recent edition of the Diagnostic and
 Statistical Manual of Mental Disorders of the American Psychiatric
 Association.

(ii)
 The entity shall
 provide written documentation in individual case records that each patient
 admitted to receive Level 3.7-D NTP services meets the dimensional criteria for
 admission to this level of care as defined in the most recent edition of the
 ASAM Criteria.

(iii)
 The entity
 shall not admit a patient for more than two detoxification treatment episodes
 in one year. Patients with two or more unsuccessful detoxification episodes
 within a 12-month period must be assessed by the program's Medical Director or
 other authorized medical professional for other forms of treatment.

(c)
 Core Services: At a
 minimum, each Level 3.7-D Program and 3.7D NTP shall document the capacity to
 provide the following core services:
1.

 Placement assessment.

2.
 Individual
 counseling.

3.
 Group
 counseling.

4.

 Psychoeducation.

5.
 Family
 counseling.

6.
 Peer
 support.

7.
 Medical and somatic
 services.

8.
 Medication
 administration.

9.
 Medication
 monitoring.

10.
 Alcohol and/or drug
 screening/testing.

11.
 Case
 management, including:
(i)
 Case
 planning.

(ii)
 Linkage,

(iii)
 Advocacy.

12.
 Patient Progress Monitoring.

(d)
 Therapeutic Component
 Implementation: The entity shall document implementation of medical and other
 clinical services organized to enhance the patient's understanding of
 addiction, support completion of the detoxification process and initiate
 transfer to an appropriate level of care for continued treatment. At a minimum,
 this shall include the following therapeutic components: 
 
1.
 For each Level 3.7-D program: 
 
(i)
 Completion of a comprehensive medical
 history and physical examination of the patient at admission.

(ii)
 Protocols established by the entity's
 medical director, for management of detoxification from each major drug
 category of abused drugs that are consistent with guidelines published by
 nationally recognized organizations (e.g., SAMHSA, ASAM, American Academy of
 Addiction Psychology) and with product labeling of medications
 utilized.

(iii)
 Level 3.7-D
 Programs that utilize benzodiazepines in the detoxification protocol shall
 have:
(I)
 Written protocols and procedures to
 show that all doses or amounts of benzodiazepines are carefully monitored and
 are slowly reduced as appropriate.

(II)
 Written longer-term detoxification
 protocols and procedures that adhere to general principles of management,
 including clear indications of benzodiazepine dependence, clear intermediate
 treatment goals and strategies, regular review and methods to prevent diversion
 from the plan.

2.
 For each Level 3.7-D NTP: 
 
(i)
 The Level 3.7-D NTP shall maintain
 current procedures that are designed to ensure that patients are admitted to
 short- or long-term detoxification treatment by a program physician, who
 determines that such treatment is appropriate for the specific patient by
 applying established diagnostic criteria.

(ii)
 Each patient must undergo a complete,
 fully documented physical evaluation by a program physician or a primary care
 physician, or an authorized healthcare professional under the supervision of a
 program physician, before admission to the Level 3.7-D NTP. The full medical
 examination, including the results of serology and other tests, must be
 completed within 14 days following admission.

(iii)
 The program must maintain current
 policies and procedures that reflect the special needs of patients who are
 pregnant. Prenatal care and other gender specific services for pregnant
 patients must be provided either by the Level 3.7-D NTP or by referral to
 appropriate healthcare providers.

(iv)
 The entity shall maintain current
 procedures adequate to ensure that each buprenorphine and/or buprenorphine
 combination product used by the program is administered and dispensed in
 accordance with its approved product labeling. Dosing and administering
 decisions shall be made by a program physician familiar with the most
 up-to-date product labeling.

(v)

 Medication orders and changes in dosage shall be written on an acceptable order
 sheet and signed by a program physician or through utilization of a comparable
 electronic signatory process.

(vi)

 Policies and procedures for medication administration, dispensing, and use
 shall ensure that buprenorphine and buprenorphine combination products are
 administered or dispensed only by a physician, pharmacist, registered nurse, or
 licensed practical nurse.

(vii)
 At
 least one (1) initial drug test should be conducted for patients in short-term
 detoxification_treatment for analysis of illicit drug use or prescription drug
 misuse.

(viii)
 Buprenorphine and/or
 buprenorphine combination products shall only be dispensed or administered to
 patients who are admitted to the Level 3.7-D NTP. The entity shall not
 prescribe or dispense buprenorphine and/or buprenorphine combination products
 for unsupervised and/or take home use or for use in another level of
 treatment.

3.
 Each Level
 3.7-D Program and Level 3.7-D NTP shall provide: 
 
(i)
 On duty awake staff shall provide
 supervision each patient's health, welfare and safety twenty-four (24) hours a
 day, seven (7) days a week.

(ii)

 On-site physician care and phone availability twenty-four (24) hours a day,
 seven (7) days a week.

(iii)
 Nurse
 monitoring, assessment and management of signs and symptoms of intoxication and
 withdrawal twenty-four (24) hours a day, seven (7) days a week.

(iv)
 A pregnancy test for females of
 childbearing age prior to administration of medication.

(v)
 Medication administration and monitoring
 services, including specific procedures for pregnant women.

(vi)
 Continuous assessment.

(vii)
 Planned counseling and other
 therapeutic interventions.

(viii)

 Motivational enhancement therapy.

(ix)
 Peer support services.

(x)
 Relapse prevention counseling.

(xi)
 Overdose prevention education.

(xii)
 Direct affiliation with other levels of
 care.

(e)

 Documentation:
1.
 Each Level 3.7-D Programs-
 and Level 3.7-D NTP shall provide the following clinical record documentation: 
 
(i)
 Documentation of each
 clinical/therapeutic intervention provided.

(ii)
 Daily assessment of progress, including
 response to medication, which also notes any treatment changes.

(iii)
 Monitoring of vital signs, at a
 minimum, every eight (8) hours until discharge.

(iv)
 The use of detoxification rating scale
 tables and flow sheets.

2.
 Each Level 3.7-D NTP. 
 
(i)
 The entity shall establish and maintain a
 recordkeeping system that is adequate to document and monitor patient care that
 complies with all Federal and State reporting requirements relevant to opioid
 drugs approved for use in treatment of opioid addiction. All records are
 required to be kept confidential in accordance with all applicable Federal and
 State requirements.

(ii)
 The Level
 3.7 NTP shall include, as an essential part of the recordkeeping system,
 documentation in each patient's record that the entity made a good faith effort
 to review whether or not the patient is enrolled in an Opioid Treatment Program
 (OTP) or taking other opioids that would contraindicate buprenorphine
 treatment.

(f)
 Support Systems: Each Level 3.7-D Program
 and 3.7-D NTP shall develop, maintain, and document implementation of written
 policies and procedures utilized to provide patient access to support services
 on site, or through consultation or referral, which shall minimally include: 
 
1.
 Specialized clinical consultation for
 biomedical, emotional, behavioral and cognitive problems.

2.
 Appropriate laboratory and toxicology
 testing.

3.
 Psychological and
 psychiatric services.

4.

 Transportation.

5.
 Twenty four (24)
 hour access to emergency medical services.

(g)
 Staff Requirements. 
 
1.
 Each Level 3.7-D and 3.7-D NTP shall, at a
 minimum, maintain the following positions as part of its staff: 
 
(i)
 Medical Director. The medical director
 shall be a physician licensed to practice in the State of Alabama, who has a
 minimum of one (1) year experience treating substance related disorders. The
 medical director shall be responsible for admission, diagnosis, medication
 management, patient care, and for ensuring that the program is in compliance
 with all Federal, State, and local laws and regulations.

(ii)
 Each Program shall be coordinated by a
 full-time employee who is an Alabama licensed Registered Nurse, Nurse
 Practitioner, Physician, or Physician's Assistant, with two (2) years direct
 care experience treating substance related disorders.

(iii)
 Nursing Services Director. Program
 shall have a nursing services director who shall be a Registered Nurse licensed
 according to Alabama law, with training and work experience in behavioral
 health.

(iv)
 There shall be a
 Registered Nurse (RN) or Licensed Practical Nurse (LPN) on site during all
 hours of the Program's operation.

(v)
 Direct Care Personnel. All direct care
 personnel must have sufficient education, training, and experience, or a
 combination thereof, to enable that person to perform the assigned job
 responsibilities. All physicians, nurses, and other licensed professional care
 providers, including certified addiction counselors, must comply with the
 credentialing requirements of their respective professions.

(vi)
 The entity shall maintain an adequate
 number of personnel, including physicians, nurses, counselors and case managers
 to sustain the Program as delineated in its operational plan.

(vii)
 Administrative Support Personnel. The
 entity shall maintain an adequate number of support personnel to sustain the
 Program's administrative functions.

(h)
 Training: Each Level 3.7-D and 3.7-D
 NTP_shall provide written documentation that: 
 
1.
 All program personnel satisfy the
 requirements of the core training curriculum, as specified in Rule
 
580-9-44-.02
(3)
.

2.
 All clinical and medical services staff
 receive training during the initial twelve (12) months employment and develop
 basic competencies in the following areas:
(i)

 Biopsychosocial dimensions of substance related disorders.

(ii)
 The signs and symptoms of alcohol and
 other drug intoxication and withdrawal.

(iii)
 Evidence-based treatment and monitoring
 strategies for alcohol and other drug intoxication and withdrawal.

(iv)
 Continuing care motivational and
 engagement strategies.

(v)

 Pharmacotherapy.

(vi)
 ASAM
 Criteria.

(vii)
 Assessment of and
 service planning to address biopsychosocial needs.

(i)
 Service Intensity: The entity
 shall document in the clinical record that the intensity of Level 3-D Services
 and Level 3.7-D NTP is established on the basis of the unique needs of each
 served.

(j)
 Length of Service: The
 entity shall provide written documentation in the clinical record that the
 duration of treatment in each Level 3.-D Program and 3.7-D NTP varies as
 determined by the patient's assessed needs, and that the patient continues in
 treatment until:
1.
 Withdrawal signs and
 symptoms are sufficiently resolved; or

2.
 Withdrawal signs and symptoms have failed
 to respond to treatment and have intensified warranting a transfer to a more
 intense level of care; or

3.
 The
 patient is, otherwise, unable to complete detoxification at this level of care.

(k)
 Diversion Control
 Plan. Each Level 3.7-D NTP shall maintain a current Diversion Control Plan
 (DCP) as part of its quality assurance program that, at a minimum: 
 
1.
 Contains specific measures to reduce the
 possibility of diversion of controlled substances from legitimate use,
 and

2.
 Assigns specific
 responsibility to the medical and administrative staff of the Level 3.7-D NTP
 for carrying out the diversion control measures and functions described in the
 DCP.
(1)
 Emergency Administration of
 Medication. Each Level 3.7-D program and Level 3.7-D NTP shall maintain
 policies and procedures for administration of patient medication in the event
 of an emergency leading to the temporary closure of the program.

Notes

Ala. Admin. Code
 r. 
580-9-44-.28

 New Rule: Filed January
 26, 2012; effective March 1, 2012.

Amended by
 
Alabama
 Administrative Monthly Volume XXXV, Issue No. 03, December 30,
 2016
, eff. 
1/22/2017
.

Author:
 Substance Abuse Services Division

Statutory Authority:

Code of Ala.
 1975
, §
 
22-50-11
.

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