Alabama Administrative Code › Title 580 - ALABAMA DEPARTMENT OF MENTAL HEALTH › Chapter 580-9-44 - PROGRAM OPERATIONS › Section 580-9-44-.29 - Level I-O: Opioid Maintenance Therapy

Current through Register Vol. 42, No. 9, June 28, 2024
(1)
			 Rule Compliance. Each Level I-O Opioid Maintenance Therapy Program shall comply
			 with all applicable rules and the rules specified in this chapter:
(a) Program Description. The entity shall
			 develop, maintain and implement a written program description that defines its
			 Level I-O Opioid Maintenance Therapy Program.
1. Location. The entity shall specifically
			 identify and describe the setting in which the Level I-O Program 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.
2. Admission Criteria.
			 The entity shall develop, maintain and document implementation of written
			 criteria for admission to its Level I-O Program, in compliance with the
			 requirements of Rule
			 580-9-44-.13(9) and the following specifications:
(i) The
			 entity's admission criteria shall specify the target population for its Level
			 I-O Program, which shall include, at a minimum:
(I) Individuals who are currently
			 physiologically dependent upon an opiate drug and who became physiologically
			 dependent at least one (1) year prior to seeking admission to Opioid
			 Maintenance Therapy.
(II) Other
			 individuals, as authorized by the entity's medical director, who have a history
			 of Opioid use and are susceptible to relapse to Opioid addiction leading to
			 high risk behaviors with potentially life-threatening consequences, but who do
			 not present with a one (1) year history of addiction, including:
I. Pregnant women.
II. Individuals who have been released from a
			 penal institution within six (6) months of the current admission request, if
			 the client was eligible for admission prior to incarceration.
III. Individuals who have had a previous
			 admission to Opioid maintenance therapy of at least six (6) months duration
			 that occurred within two (2) years of the current admission request.
IV. Individuals who are HIV
			 positive.
(ii)
			 The entity shall provide written documentation in each individual clinical
			 record that each client admitted to a Level I-O Program for Opioid Maintenance
			 or Withdrawal Therapy meets the criteria for Opioid Dependence Disorder, as
			 according to the specific diagnostic criteria given in the most recent edition
			 of the Diagnostic and Statistical Manual of Mental Disorders of the American
			 Psychiatric Association.
(iii) The
			 entity shall provide written documentation in each individual case record that
			 each client admitted to a Level I-O Program meets the dimensional criteria for
			 admission to this level of care as defined in the most recent edition of the
			 ASAM PPC-2R.
(iv) Medical necessity
			 of each admission to a Level I-O Program shall be established by the program's
			 medical director or a physician authorized by the program's medical director
			 and documented in the clinical record.
(v) Adolescent Specific Criteria. An entity
			 shall not admit an individual under age eighteen (18) to a Level I-O Program
			 for Opioid Maintenance Therapy unless the entity can document that:
(I) The client has had two (2) unsuccessful
			 attempts at drug-free treatment within a twelve (12) month period of time;
			 or
(II) The client has had two (2)
			 unsuccessful attempts at short-term detoxification.
(III) The entity has obtained written
			 authorization of the admission from the State Opioid Treatment Authority
			 (SOTA).
I. The entity shall develop, maintain
			 and document implementation of written policies and procedures which govern the
			 process utilized to request and obtain written authorization from the SOTA
			 prior to admission of an individual under age eighteen 18 to a Level I-O
			 Program.
3. Core Services. Each Level I-O Program
			 shall demonstrate the capacity to provide a basic regimen of treatment services
			 appropriate to the client's developmental and cognitive levels and other
			 assessed needs.
(i) At a minimum, the entity
			 shall demonstrate and document its capacity to provide the following core
			 services:
(I) Placement assessment.
(II) Medication management.
(III) Medication administration.
(IV) Alcohol and/or drug
			 screening/testing.
(V) Individual
			 counseling.
(VI) Group
			 counseling.
(VII) Family
			 counseling.
(VIII)
			 Psychoeducation.
(IX) Case
			 management:
I. Case planning.
II. Linkage.
III. Advocacy.
IV. Monitoring.
(ii) Medical Services. The entity shall have
			 medical protocols established for I-O Level of Care by a licensed physician or
			 staff or under contract with the entity as the medical director. The medical
			 protocol shall be in compliance with the program standards, ethics and
			 licensure requirements of the medical profession.
(iii) Mental Health Services. The entity
			 shall develop, maintain and document implementation of policies and procedures
			 to ensure that clients with mental health needs are identified through
			 assessment services and have access to appropriate care concurrently with
			 Opioid Maintenance or Withdrawal Therapy.
(iv) Family Support. The entity shall
			 initiate and document in the client record:
(I) Continuous efforts to involve the
			 client's family and other natural supports in the treatment process.
(II) Family and other natural supports'
			 participation in the client's treatment process.
4. Therapeutic Component Implementation.
(i) Each Level I-O Program shall provide
			 written documentation of compliance with all applicable local, state and
			 federal regulations, including Federal Regulation 42 CFR Part 8, DEA,
			 Certificate of Need, etc. in addition to all applicable sections of the rules
			 set forth, herein.
(ii) Each Level
			 I-O Program shall establish a written schedule of operating hours and services
			 that shall:
(I) Provide for dosing and
			 counseling services seven (7) days each week.
(II) Establish hours of operation that are
			 flexible to accommodate the majority of client school, work and family
			 responsibility schedules.
(III)
			 Provide access to clinical services personnel twenty-four (24) hours a day,
			 seven (7) days a week.
I. The physical plant
			 is of adequate size to accommodate the proposed number of clients, required
			 program activities, and provide a safe, therapeutic environment that supports
			 enhancement of each client's well-being and affords protection of privacy and
			 confidentiality.
(iii) Counseling Services: The entity shall
			 document the provision of scheduled counseling and recovery support services
			 and activities that shall, at a minimum, include:
(I) Interventions that address:
I. Emotional and psychological
			 needs.
II. Health
			 education.
III. Medication
			 administration and monitoring.
5. Assessment: The entity shall comply with
			 all standards set forth in Rule
			 580-9-44-.13(7) of these rules and in addition, shall comply with the requirements of this
			 section:
(i) Before an entity admits an
			 individual to a Level I-O Program, the program's medical director, or a
			 physician or physician extender properly authorized by the medical director,
			 shall conduct and document the findings of a medical evaluation.
(ii) A pregnancy test shall be completed, and
			 the results documented, for each female of childbearing potential prior to the
			 initiation of Opioid Maintenance Therapy, or any medically assisted withdrawal
			 or detoxification procedures.
(iii)
			 A comprehensive medical examination that includes the following components, at
			 a minimum, shall be completed and documented in the clinical record, within
			 fourteen (14) days of each admission:
(I) A
			 complete medical history.
(II) A
			 tuberculosis (TB) skin test or chest x-ray if the skin was ever previously
			 positive.
(III) Screening tests for
			 STDs.
(IV) Other laboratory tests
			 as clinically indicated by the client's history and physical
			 examination.
(iv) An
			 annual medical examination shall be conducted and documented in the clinical
			 record by the program's medical director, or a physician or physician extender
			 authorized by the program's medical director.
6. Client Orientation:
(i) All clients shall be oriented to the
			 Opioid Therapy process prior to administration of any medication.
(ii) The entity shall provide written
			 documentation that each client, upon admission and throughout the treatment
			 process, receives oral and written information that explains in a manner
			 understood by the client:
(I) Signs and
			 symptoms of overdose and when to seek emergency assistance.
(II) A description of the medications to be
			 administered by the program, including potential:
I. Benefits.
II. Risks.
III. Side effects.
IV. Drug interactions.
(III) Common myths about Opiate Maintenance
			 Therapy and medications used in the treatment and withdrawal process.
(IV) The nature of addictive
			 disorders.
(V) The goals and
			 benefits of medication assisted treatment and the process of
			 recovery.
(VI) Noncompliance and
			 discharge procedures, including administrative withdrawal from
			 medication.
(VII) Toxicology
			 testing procedures.
(VIII)
			 Medication dispensing procedures.
7. Drug Testing: The entity shall develop,
			 describe in writing and document implementation of an organized process to
			 monitor drug use by program participants, which shall, at a minimum, comply
			 with the standards provided in Rule
			 580-9-44-.13(25),
			 and include the following specifications:
(i)
			 The results of a drug test shall be utilized as a guide to review and modify
			 treatment approaches and not as the sole criterion to discharge a client from
			 treatment.
(ii) Baseline toxicology
			 tests shall be completed on the day of Diagnostic Interview Examination that
			 shall, at a minimum, screen for:
(I)
			 Opiates.
(II) Methadone.
(III) Benzodiazepines.
(IV) Barbiturates.
(V) Cocaine.
(VI) Amphetamines.
(VII) Tetrahydrocannabinol.
(VIII) Alcohol.
(IX) Any other drug known to be frequently
			 abused in the locality of the Opiate Maintenance Therapy
			 Program.
(iii) Random
			 drug tests shall be conducted at least once per month throughout the duration
			 of each client's participation in Opioid Maintenance Therapy. A minimum of
			 twelve (12) drug tests shall be conducted per year.
(iv) The entity shall document the provision
			 of a minimum of two (2) drug tests per month for each client during the first
			 ninety (90) days in Opioid Maintenance Therapy and for those, otherwise, in
			 Phase 1 of the program.
(v) The
			 entity shall document the utilization of drug testing cutoff concentrations as
			 follows:
(I) Marijuana: 100 ng/ml
(II) Cocaine: 300 ng/ml
(III) Opiate: 300 ng/ml
(IV) Amphetamine/methamphetamine: 1000
			 ng/ml
(V) Benzodiazepine: 200
			 ng/ml
(VI) Methadone: 300
			 ng/ml
(VII) Barbiturates: 200
			 ng/ml
(VIII) Alcohol: .03
			 gm/dl
(IX) In cases where Opiate
			 Maintenance drugs other than methadone are being used, the clinic should
			 contact the State Opioid Treatment Authority to determine the acceptable
			 immunoassay cut-off concentrations.
(vi) The entity shall provide documentation
			 that all drug tests are conducted by a laboratory certified by an independent,
			 federally approved accreditation entity.
(vii) The results of all drug tests shall be
			 filed in the clinical record.
8. Procedure for Addressing Positive
			 Toxicology Reports. The entity shall develop, maintain and document
			 implementation of written policies and procedures that establish protocols for
			 addressing positive toxicology results for illicit drugs and negative results
			 for drugs administered by the Opioid Maintenance Therapy Program that shall, at
			 a minimum, include the following specifications:
(i) Baseline drug testing results shall be
			 discussed with the client and documentation of this discussion recorded as a
			 progress note in the clinical record.
(ii) At his/her next scheduled clinic visit
			 after receiving a positive alcohol/drug screen, clients shall be informed of
			 drug testing results that are positive for substances of abuse, or negative for
			 Opioid Maintenance Therapy medication. Following client notification, the
			 entity shall implement the following procedures, as appropriate:
(I) New Clients. During the first ninety (90)
			 days of treatment, the first drug testing report that is positive for
			 substances of abuse or negative for treatment medication, after baseline
			 testing, shall result in a meeting between the client and the client's primary
			 counselor to review the treatment plan, and to modify or intensify treatment
			 services as appropriate to the client's current needs.
(II) Clients with take-home privileges.
I. A positive toxicology report for illicit
			 drugs or a negative toxicology result for treatment medication shall require
			 that the client with take-home privileges, at a minimum:
A. Be placed on probation for ninety (90)
			 days.
B. Receive a minimum of two
			 (2) random drug screens per month during the probationary period.
C. Collaborate with his/her primary counselor
			 for discussion of the toxicology results and for service plan modification as
			 according to the client's needs.
II. A second toxicology result that is
			 positive for substances of abuse or negative for treatment medication during a
			 probationary period shall require that the client with take-home privileges, at
			 a minimum:
A. Transfer to a lower dosing
			 phase.
B. Receive a minimum of two
			 (2) random drug screens per month.
C. Participate in a clinical staffing. Mental
			 Health Chapter
			 580-9-44 Revised 3/17/23
			 9-44-173
D. Collaborate with the treatment team to
			 develop and implement a plan for remedial action.
(III) Subsequent Drug Tests for All Clients.
			 For subsequent drug testing results that are positive for substances of abuse
			 or negative for treatment medication the entity shall take steps to provide
			 assistance for each client, as according to assessed needs, that shall include
			 but shall not be limited to:
I. Treatment team
			 staffings in collaboration with the client.
II. Continued assessment services of the
			 client's biopsychosocial needs and levels of functioning.
III. Re-evaluation of the client's medication
			 dosage, plasma levels, metabolic responses and adjustment of the dosage for
			 adequacy and client comfort.
IV.
			 Assessment for co-occurring disorders, prescribing therapy and
			 psycho-pharmacotherapy as needed.
V. Intensify counseling or add of other types
			 of services.
VI. Treatment of
			 medical or other associated problems.
VII. Consideration of alternative opiate
			 addiction treatment medications.
VIII. Detoxification from substances of abuse
			 while maintaining the client on Opioid pharmacotherapy.
IX. Initiating a change of counselors when
			 indicated.
X. Providing family
			 intervention.
(IV) If any
			 client has six (6) or more consecutive toxicology results that are positive for
			 substances of abuse or negative for treatment medication, the entity shall
			 inform the client that administrative withdrawal procedures will begin
			 immediately and a referral will be made to an appropriate level of care unless
			 the entity's medical director:
I. Provides
			 objective clinical contraindications of the need for this action.
II. Develops a written intervention plan in
			 consultation with the client and the client's treatment team that shall at a
			 minimum, include provisions for:
A.
			 Detoxification from substances other than the maintenance therapy drug; and/
			 or
B. Intensified counseling and
			 other services.
III.
			 Documents all actions taken, in this regard, as appropriate.
IV. The entity shall maintain a data base of
			 drug testing results which shall at a minimum:
V. List each client by unique client
			 identifier, date of birth, gender, date of each drug test, identify each drug
			 for which tests are completed and the results of each test.
VI. Allow for development of aggregate
			 reports of each variable as well sorting of data by each
			 variable.
9. Take Home Medication: The entity shall
			 develop, maintain and document implementation of written policies and
			 procedures that govern the processes utilized to provide clients with
			 unsupervised use of program dispensed Opioid treatment medication. At a
			 minimum, these policies and procedures shall include the following
			 specifications:
(i) The entity's medical
			 director, in consultation with the client's treatment team, shall make all
			 decisions relative to dispensing Opioid treatment medication to clients for
			 unsupervised use, in consideration of the following minimum criteria:
(I) Absence of recent abuse of drugs
			 (narcotic or non-narcotic), including alcohol.
(II) Regularity of clinic
			 attendance.
(III) No observed,
			 reported, or otherwise known serious behavioral problems.
(IV) Absence of known recent criminal
			 activity, e.g., drug dealing.
(V)
			 Stability of the client's home environment and social relationships.
(VI) Length of time in treatment.
(VII) Assurance that take-home medication can
			 be safely stored within the client's home.
(VIII) Whether the rehabilitative benefit to
			 the client derived from decreasing the frequency of clinic attendance outweighs
			 the potential risks of diversion.
(ii) Decisions to approve unsupervised use of
			 Opioid medications, including the rationale for the approval, shall be
			 documented in the clinical record.
(iii) Patients must have in their possession
			 a secure locking storage device in order to receive take-home medication. There
			 are no exceptions.
(iv) The amount
			 of take-home medication shall be based on the clinical judgment of the
			 physician in consultation with the multidisciplinary treatment team. If it is
			 determined that a client meets the criteria for unsupervised dosing the supply
			 shall be limited to the following schedule:
(I) Phase 1 Treatment. Clients who are not
			 eligible for any take home medication shall be designated by the program as in
			 Phase 1 of Opioid Maintenance Therapy.
I.
			 During the first ninety (90) days of treatment, clients shall not be eligible
			 for any take home medication.
II.
			 Twice-a-month drug tests shall document that each client in Phase I is free of
			 all substances of abuse including alcohol and positive for the prescribed
			 maintenance drug for at least ninety (90) consecutive days in order to be
			 eligible for consideration for unsupervised dosing.
(II) Phase 2 Treatment. Clients in treatment
			 between ninety-one (91) and one hundred eighty (180) days, who satisfy the
			 criteria specified in Rule
			 580-9-44-.29 8(i)(II) shall be
			 eligible for a take-home supply that shall not exceed two (2) doses per week.
I. Clients who are eligible for a two (2) day
			 take home medication supply shall be designated by the program as in "Phase
2"
of Opioid Maintenance Therapy.
II. A minimum of one (1) random drug test per
			 month must be conducted while the patient is in Phase 2.
III. It shall be documented that the client
			 is free of all substances of abuse including alcohol and positive for the
			 prescribed maintenance drug for at least ninety (90) consecutive days in order
			 to be considered for Phase 2 unsupervised dosing.
(III) Phase 3 Treatment. Clients in treatment
			 between one hundred eighty-one (181) and two-hundred seventy (270) days, who
			 satisfy the criteria specified in Rule
			 580-9-44-.29 8(i)(II) shall be
			 eligible for a take-home supply that shall not exceed three (3) doses per week.
I. Clients who are eligible for a three (3)
			 day take home medication supply shall be designated by the program as in Phase
			 3 of Opioid Maintenance Therapy.
II. A minimum of one (1) random drug test per
			 month must be conducted while the patient is in Phase 3.
III. It shall be documented that the client
			 is free of all substances of abuse including alcohol and positive for the
			 prescribed maintenance drug for at least one hundred eighty (180) consecutive
			 days in order to be considered for Phase 3 unsupervised
			 dosing.
(IV) Phase 4
			 Treatment. Clients in treatment between two hundred seventy-one (271) and three
			 hundred sixty-five (365) days, who satisfy the criteria specified in Rule
			 580-9-44-.29 8(i)(II) shall be
			 eligible for a take-home supply that shall not exceed six (6) doses per week
I. Clients who are eligible for a six (6) day
			 take home medication supply shall be designated by the program as in Phase 4 of
			 Opioid Maintenance Therapy.
II. A
			 minimum of one (1) random drug test per month must be conducted while the
			 patient is in Phase 4.
III. It
			 shall be documented that the client is free of all substances of abuse
			 including alcohol and positive for the prescribed maintenance drug two hundred
			 seventy (270) consecutive days in order to be considered for Phase 4
			 unsupervised dosing.
(V)
			 Phase 5 Treatment. After two (2) years of continuous treatment with
			 uninterrupted clean drug screens, client shall be eligible for up to a thirteen
			 (13) day take home medication supply.
I.
			 Clients who are eligible for a thirteen (13) day take home medication supply
			 shall be designated by the program as in Phase 5 of Opioid Maintenance
			 Therapy.
II. A minimum of one (1)
			 random drug test per month must be conducted while the patient is in Phase
			 5.
(iv)
			 Temporary Special Take-Home Medication for Non-Emergency: The entity shall
			 develop, maintain and document implementation of written policies and
			 procedures that govern the process utilized to provide temporary take home
			 medication for exceptional circumstances, which shall at a minimum include the
			 following specifications:
(I) The need for
			 temporary special unsupervised take-home medication shall be clearly delineated
			 with verifiable documentation in the clinical record.
(II) A client seeking approval for temporary
			 special unsupervised take-home medication shall, at a minimum, meet the
			 criteria to determine eligibility for take home medication specified in Rule
			 580-9-44-.29 9.
(III) Requests for temporary special
			 take-home medication shall be approved in writing by the entity's medical
			 director, the State Opioid Treatment Authority and SAMHSA.
(IV) The provision and supply of temporary
			 special unsupervised take-home medication shall be at the direction of the
			 State Opioid Treatment Authority.
(v) Temporary Special Take-Home Medication
			 for Emergency: The entity shall develop, maintain and document implementation
			 of written policies and procedures that govern the process utilized to provide
			 emergency take-home medication for exceptional circumstances, which at a
			 minimum include:
(I) The need for emergency
			 unsupervised take-home medication shall be clearly delineated with verifiable
			 documentation in the client's clinical record.
(II) Requests for emergency take-home
			 medication shall be approved in writing by the entity's Medical Director and
			 shall not exceed a three (3) day medication supply at any one time.
I. Situations that might warrant emergency
			 take-home medication include:
A. Death in the
			 family.
B. Illness.
C. Inclement weather.
D. Other uniquely identified
			 situations.
(vi) Hardship Waiver. The entity shall
			 develop, implement and document implementation of written policies and
			 procedures to address requests for hardship exceptions to the rules for early
			 phase advancement:
(I) Specify the conditions
			 under which a client may request a hardship waiver and the conditions required
			 for its consideration.
(II)
			 Describe the process utilized to ensure continuity of care when a client is
			 unable, due to a verifiable hardship, to report to the program for routine
			 ingestion of medication.
(III)
			 Describe the program's use of Chain-of Custody Record procedures and identify
			 the specific persons/positions responsible in each step of the process, along
			 with the specifications of their duties.
(IV) Include provisions for hardship
			 exception requests to be authorized by the entity's medical director and
			 submitted to the State Opioid Treatment Authority and to SAMHSA for review and
			 approval.
(V) Provide for all
			 considerations given, recommendations for and conditions of hardship waivers,
			 as well as, denials of such to be documented in the clinical
			 record.
(vii) Denial or
			 Rescinding of Take-Home Privileges. The entity shall develop, maintain and
			 document implementation of policies and procedures which govern the process
			 utilized to deny or rescind approval of take-home
			 privileges.
10. Diversion
			 Control: The entity shall develop, maintain and document implementation of a
			 written plan to reduce the possibility of diversion of controlled substances
			 from legitimate treatment to illicit use. The diversion control plan shall, at
			 a minimum, include the following elements:
(i)
			 A process for routine surveillance and monitoring of the internal and external
			 treatment environment to identify diversion problems.
(ii) A process for continuous examination of
			 dosing and take-home dispensing practices to identify weaknesses in the
			 dispensing of medication that could lead to diversion problems.
(iii) Procedures for clients who are
			 dispensed three (3) or more take-home doses to receive a minimum of two (2)
			 call-backs annually.
(iv) A process
			 to address identified diversion problems through corrective and preventive
			 efforts.
(v) Specific assignment to
			 the entity's medical and administrative staff for implementation of the
			 diversion control measures and functions identified in the diversion control
			 plan.
11. Dosing: The
			 entity shall develop, maintain and document implementation of written policies
			 and procedures to govern the process of drug dispensing and administration that
			 shall, at a minimum, include the following specifications:
(i) A standardized process that includes the
			 use of identification by photograph shall be utilized to properly establish the
			 identity of each individual before any Opioid Therapy Medication is
			 administered.
(ii) The entity shall
			 maintain current procedures adequate to ensure that each Opioid dependency
			 treatment medication used by the program is administered and dispensed in
			 accordance with approved product labeling.
(iii) Dosing and administration decisions,
			 including prescribing, reassessment and regulation shall only be made by an
			 authorized program physician who is familiar with the most up-to-date product
			 labeling.
(iv) Any deviations from
			 the approved labeling, including deviations with regard to dose, frequency, or
			 the conditions of use described in the approved labeling shall be specifically
			 documented in the case record.
(v)
			 An authorized program physician shall employ clinical judgment to determine the
			 individual dose of Opioid therapy medication, with consideration of the
			 following stipulations, at a minimum:
(I) The
			 initial dose of methadone administered on the first visit shall not exceed 25
			 mg.
(II) Subsequent doses of
			 medication shall be:
I. Individually
			 determined based upon the physician's evaluation of the history and present
			 condition of the client.
II.
			 Reviewed and updated as according to the client's treatment plan and in
			 consideration of the following criteria:
A.
			 Cessation of withdrawal symptoms.
B. Cessation of illicit Opioid use as
			 measured by:
(A) Negative drug
			 tests.
(B) Reduction of
			 drug-seeking behavior.
C.
			 Establishment of a blockade dose of an agonist.
D. Absence of problematic craving as measured
			 by:
(A) Subjective report.
(B) Clinical
			 observations.
E. Absence
			 of signs and symptoms of too large an agonist dose after an interval adequate
			 for the client to develop complete tolerance to the blocking
			 dose.
(vi) A process shall be established wherein
			 the dosage to be dispensed shall be verified with the current dosage ordered
			 and ingestion observed and documented by the person who administers the Opioid
			 dependency treatment medication.
(vii) Methadone shall be dispensed in oral
			 form in one liquid dose per container.
(viii) Buprenorphine shall be dispensed in
			 sublingual tablets.
(ix) A process
			 shall be established to address the entity's response, in regard to dosing, to
			 individuals who are objectively intoxicated or who are experiencing other
			 problems that would render the administration of methadone
			 unsafe.
12. Split Dosing:
			 The organization shall have a written split dosage policy that shall:
(i) Include input from the program physician
			 in consultation with the multidisciplinary treatment team and the
			 SOTA.
(ii) Accurately reflect that
			 split dosing is guided by outcome criteria that shall include:
(I) The client complains that the dosage
			 level is not holding.
(II) The
			 client exhibits signs and symptoms of withdrawal.
(III) The physician employs peak and trough
			 criteria for split dosing, if appropriate.
(IV) The physician is unable to obtain a peak
			 and trough ration for 2.0 or lower, increasing intervals of dosing may be
			 appropriate.
(V) Addressing the
			 failure of all avenues of stabilization.
(VI) Addressing stabilization failures with
			 the client involving the physician and multidisciplinary
			 team.
(iii) Include
			 provisions for education of the client on the rationale for split dosing and
			 take-home medication.
13.
			 Guest Dosing: The entity shall develop, maintain and document implementation of
			 dosing policies and procedures for the provision of medication to a guest
			 client in a program in which the client is not enrolled that shall, at a
			 minimum specify:
(i) The sending program's
			 responsibilities to, at a minimum:
(I) Develop
			 a document to utilize in transmitting all relevant client and dosing
			 information to the receiving agency to request guest dosing
			 privileges.
(II) Forward this
			 document to the receiving program.
(III) Provide the client with a copy of the
			 document that was sent to the receiving agency.
(IV) Verify receipt of the information sent
			 to the receiving program.
(V)
			 Verify that the client understands all stipulations of the guest dosing process
			 including, but not limited to, fees, receiving program contacts, dosing times
			 and procedures.
(VI) Accept the
			 client upon return from guest dosing unless other arrangements have been
			 made.
(VII) Document all procedures
			 implemented in the guest dosing process in each client's case
			 record.
(ii) The
			 receiving program's responsibilities to, at a minimum:
(I) Verify receipt of the sending program's
			 request for guest dosing privileges and acceptance or rejection of the client
			 for guest medication within forty-eight (48) hours of the request.
(II) Communicate any requirements of the
			 receiving program that have not been specified on the document submitted by the
			 sending program.
(III) Establish a
			 process for medical personnel to verify dose prior to dosing.
(IV) Document all procedures implemented in
			 the guest dosing process in each client's case record.
(iii) If guest dosing exceeds fourteen (14)
			 days, a drug screen shall be obtained.
(iv) Guest dosing shall not exceed
			 twenty-eight (28) days.
14. Multiple Client Enrollments: The entity
			 shall develop, maintain and document implementation of written policies and
			 procedures established to ensure that it does not admit or provide medication
			 for an individual who is enrolled in another Opioid Treatment Program. The
			 policies and procedures shall include the following components, at a minimum:
(i) The State Opioid Treatment Authority
			 shall establish written guidelines, incorporated herein by reference, for
			 participation in a central registry process to aid in the prevention of
			 multiple enrollment of a client in more than one Opioid Maintenance Therapy
			 Program at the same time. Each OMT Program shall provide written documentation
			 of adherence to the State Opioid Treatment Authority guidelines that shall, at
			 a minimum, include the following specifications:
(I) The entity shall make a disclosure to the
			 central registry at each of the following occurrences:
I. A client is admitted for Opioid
			 Maintenance Therapy.
II. A client
			 is transferred to another provider for Opioid Maintenance Therapy.
III. A client is discharged from Opioid
			 Maintenance Therapy.
(II)
			 The entity shall make disclosures in the format and within timeframes
			 established by the State Methadone Authority.
(III) The entity shall limit disclosures to
			 client identifying information and the dates of admission, transfer and
			 discharge.
(IV) The entity shall
			 obtain the client's written consent, in accordance with 42 CFR Part 2, prior
			 to making any disclosures to the central registry.
(V) The entity shall inform each client of
			 the required written consent for participation in the central registry before
			 services are initiated.
(VI) The
			 entity shall deny admission to individuals who refuse to provide written
			 consent for disclosures to the central registry and shall document these
			 denials in the case record.
(ii) The entity shall obtain the client's
			 written consent, in accordance with 42 CFR Part 2, to photograph the applicant
			 at the time of admission. The photograph shall be maintained in the client's
			 case record.
(iii) The entity shall
			 require that all clients show proof of identification in the form of an
			 official state driver's license or a non-driver's license issued by the state's
			 Department of Public Safety. A copy of current identification will be
			 maintained in the clinical record.
15. Medically Supervised Withdrawal: The
			 entity shall develop, maintain and document implementation of written policies
			 and procedures that govern the processes utilized to withdraw clients from
			 Opioid maintenance medication. At a minimum, the policies and procedures shall
			 include the following specifications:
(i) A
			 process for voluntary medically supervised withdrawal shall be established that
			 shall:
(I) Acknowledge that participation in
			 Opioid Maintenance Therapy is voluntary and that a client is free to leave
			 treatment at any time.
(II)
			 Identify the steps to be taken by the entity when a client and program
			 personnel agree on a need to initiate withdrawal procedures.
(III) Identify the steps to be taken by the
			 entity when the client requests withdrawal against the medical advice of the
			 program's personnel.
(IV) Ensure
			 the availability of a variety of supportive options to improve the chances of a
			 successful episode of medically supervised withdrawal.
(V) Establish the protocol wherein the Opioid
			 Maintenance Therapy Program resumes medication assisted treatment if the client
			 experiences impending or actual relapse.
(ii) A process for involuntary medically
			 supervised withdrawal shall be established that shall:
(I) Identify the circumstance under which
			 involuntary administrative withdrawal procedures will be implemented.
(II) Identify the steps to be taken and
			 delineate the responsibilities of program personnel in implementation of
			 involuntary administrative withdrawal procedures.
(III) Ensure the availability of a variety of
			 supportive options to improve the chances of a successful episode of medically
			 supervised withdrawal.
(IV) Provide
			 for referral or transfer of the client to an appropriate treatment program upon
			 completion of the withdrawal process.
(iii) The entity's medical director shall
			 approve all requests for voluntary and involuntary withdrawal from Opioid
			 Therapy medication.
(iv) Clients
			 who have been determined by the program's medical director or other authorized
			 program physician to be currently physiologically dependent on Opioids may
			 participate in medically supervised withdrawal, regardless of age.
(v) The entity's medical director shall
			 establish each individual's withdrawal schedule in accordance with sound
			 medical treatment and ethical considerations.
(vi) No set dosage reduction schedules shall
			 be established for any patient whether voluntarily or involuntarily
			 participating in medically supervised withdrawal. Dosage reduction schedules
			 shall be based upon objective assessment of each client's unique
			 needs.
(vii) A medically supervised
			 withdrawal schedule for administrative withdrawal shall be for a time period of
			 not less than thirty (30) days, unless otherwise clinically contraindicated. In
			 cases of clinical contraindication, supporting documentation shall be entered
			 in the client's case record by the medical director or a program physician
			 operating under the supervision and authority of the medical
			 director.
(viii) Take-home
			 medications shall not be allowed during medically supervised
			 withdrawal.
(ix) A history of one
			 (1) year physiologic dependence shall not be required for admission to an
			 Opioid Maintenance Therapy Program for supervised withdrawal.
(x) Clients who have two (2) or more
			 unsuccessful detoxification episodes within a twelve (12) month period shall be
			 assessed by the entity's medical director for other forms of
			 treatment.
(xi) An entity shall not
			 admit a client for more than two (2) detoxification episodes in one (1)
			 year.
(xii) Drug screens during
			 detoxification shall be performed as follows:
(I) An initial drug screen shall be performed
			 at the beginning of the detoxification process.
(II) At least one (1) random screen shall be
			 performed monthly during the detoxification
			 process.
16.
			 Women and Pregnancy Services: The entity shall develop, maintain and document
			 implementation of written policies and procedures to address the needs of women
			 which shall, at a minimum, include the following requirements:
(i) The entity shall acknowledge by policy
			 and practice that pregnant women are the number one treatment priority and
			 cannot be denied treatment access solely because of pregnancy.
(I) When an organization is unable to provide
			 services for a pregnant woman, the State Opioid Treatment Authority shall be
			 contacted immediately for assistance with placement.
(ii) The entity shall have a written
			 description of the procedures utilized to:
(I)
			 Inform each female client of the possible risks and benefits of the use of
			 Opioid Maintenance Therapy during pregnancy.
(II) Document in the case record that this
			 information has been provided to the client.
(iii) The entity shall describe in writing
			 and document implementation of the process used to provide pregnant clients
			 with access or referral to:
(I) Prenatal
			 care.
(II) Pregnancy/parenting
			 education.
(III) Postpartum
			 follow-up.
(iv) The
			 nature of services provided in relation to a client's pregnancy shall be
			 documented in the case record and signed or countersigned by the entity's
			 medical director.
(v) When the
			 woman consents to a referral for pregnancy related care, or if the woman is
			 already under the care of a physician for her pregnancy, the entity shall
			 obtain the woman's informed consent to ensure reciprocity in the exchange of
			 pertinent clinical information between the woman's perinatal specialist or
			 obstetrician and the OMT Program.
(vi) When the woman refuses an appropriate
			 referral for prenatal services, the entity shall:
(I) Utilize informed consent procedures to
			 have the client formally acknowledge, in writing, that the Opioid Maintenance
			 Therapy Program offered a referral to prenatal services, but the client refused
			 the offer.
(II) Provide the client
			 with basic prenatal instruction on maternal, physical, and dietary care as part
			 of the Opioid Maintenance Therapy Program counseling services and document
			 service delivery in the clinical record.
(vii) The entity shall provide written
			 documentation of implementation of the following procedures in regard to care
			 for pregnant women:
(I) Clients who become
			 pregnant during treatment shall be maintained on the pre-pregnancy dosage, if
			 effective as determined by the entity's medical director and the client and
			 shall apply the same dosing principles as used with any other non-pregnant
			 person served.
(II) The initial
			 methadone dose and the subsequent induction and maintenance dosing strategy for
			 a person who is newly admitted and pregnant shall reflect the same effective
			 dosing protocols used for all other persons served.
(III) The methadone dose shall be monitored
			 carefully, especially during the third trimester and adjustments made as
			 needed.
(viii) The entity
			 shall describe in writing and document in the clinical record the process
			 utilized if a pregnant woman elects to withdraw from methadone which shall, at
			 a minimum, include the following requirements:
(I) A physician experienced in addiction
			 medicine shall supervise the withdrawal process.
(II) Regular fetal assessments, as
			 appropriate for gestational age, shall be part of the withdrawal
			 process.
(III) Education shall be
			 provided on medically supervised withdrawal and the impact of medically
			 supervised withdrawal services on the health and welfare of unborn
			 children.
(IV) Withdrawal
			 procedures shall adhere to accepted medical standards of care for women who are
			 pregnant.
(V) Withdrawal procedures
			 shall adhere to accepted medical standards regarding adequate dosing
			 strategies.
(VI) When providing
			 medically supervised withdrawal services to pregnant women whose withdrawal
			 symptoms cannot be eliminated, referrals to inpatient medical programs shall be
			 made.
(ix) The entity
			 shall describe in writing and document implementation of policies and
			 procedures, including informed consent, to ensure appropriate post-pregnancy
			 follow-up and primary care for the new mother and well-baby care for the
			 infant.
17. Medication
			 Management: The entity shall comply with all standards set forth in Rule
			 580-9-44-.13 (23-24) of these
			 rules, and, in addition, shall comply with the requirements of this section:
(i) The entity's clinical records and client
			 outcomes shall indicate that medications used in the Opioid Maintenance Therapy
			 Program are sufficient to:
(I) Produce the
			 desired response.
(II) Provide
			 freedom from adverse abstinence symptoms for the desired length of
			 time.
(III) Block the effects of
			 other Opiates without producing euphoria or other undesirable
			 effects.
(ii) The program
			 shall provide written documentation, which indicates all medications used in
			 the Opioid Maintenance Therapy Program are:
(I) Approved by the Food and Drug
			 Administration for the treatment of Opioid addiction.
(II) Dispensed according to product
			 labeling.
(III) Managed using
			 written procedures that ensure secure storage, accurate dosage and safe
			 handling,
(IV) Controlled using a
			 method to ensure that an accurate inventory of all medication in stock is
			 available.
(iii) The
			 entity shall develop, maintain and document implementation of written policies
			 and procedures for dispensing medication used in Opioid Maintenance and
			 Withdrawal Therapy, which shall, at a minimum:
(I) Ensure that the program's medical
			 director or other program physician authorized by the medical director:
I. Initiates all medication orders and/or any
			 dosage change.
II. Documents all
			 medication orders and/or any dosage change in the clinical
			 record.
(II) Ensures that
			 each dose is recorded in the clinical record of the person served.
(III) Ensures that take-home medications are
			 properly labeled, which shall include, at a minimum:
I. Name of Opioid Maintenance Therapy
			 prescribing clinic.
II. Address of
			 Opioid Maintenance Therapy prescribing clinic.
III. Telephone number of Opioid Maintenance
			 Therapy prescribing clinic.
IV.
			 Client's name.
V. Medication
			 name.
VI. Dose.
VII. Physician's name.
VIII. Date filled.
IX. Directions for single use.
X. Warning: Caution; Federal law prohibits
			 the transfer of this drug to any person other than the patient for whom it was
			 prescribed.
(iv) Ensure that that take-home medication is
			 packaged in child-proof containers designed to reduce the risk of accidental
			 ingestion.
18. Client
			 Transfers: The Level I-O Program shall develop, maintain and document
			 implementation of written policies and procedures to effect orderly transfer of
			 clients between substance abuse programs, which shall, at a minimum, address
			 the following specifications:
(i) The entity
			 shall meet the standards set forth in these rules for client
			 transfers.
(ii) A client's request
			 for transfer to another Level I-O Program shall be honored without restriction,
			 even if the client has an outstanding financial balance.
(iii) Records to the receiving substance
			 abuse program shall be provided promptly and shall include, at a minimum:
(I) Original date of admission for the
			 current treatment episode.
(II)
			 Current treatment phase and date entering phase.
(III) Urinalysis results for the past twelve
			 (12) months.
(IV) Dose level, to be
			 confirmed by nursing staff at transferring clinic and documented in the
			 clinical record.
(V) Most recent TB
			 test results and date of test.
(VI)
			 Reason for transfer.
(VII) Other
			 information as requested by the receiving program and specified in an
			 appropriate client authorization for release of
			 information.
(iv) All
			 client records shall be complete and up to date at the time of
			 transfer.
(v) Reports to the DMH
			 Central Registry shall be completed at the time of
			 transfer.
19.
			 Documentation: The entity shall comply with all standards set forth in Rule
			 580-9-44-.13(21) of these rules, and, in addition, shall comply with the requirements of this
			 section:
(i) Clinical records of clients
			 receiving Opioid Maintenance or Withdrawal Therapy shall include the following
			 documentation:
(I) That clients have been
			 questioned about being pregnant and informed about pregnancy and physiological
			 implications with Opiate maintenance drugs.
(II) Support services were recommended and
			 utilized when needed.
(III) An
			 individualized clinical note for each occurring clinical or medical
			 encounter.
(IV) Each dose of
			 medication administered, with a copy of the physician's order for
			 medication.
(V) Ongoing
			 communication with physicians prescribing psychoactive and/or control
			 medication to clients receiving Opioid Maintenance Therapy services.
(VI) Ongoing communication with Obstetrics
			 and Gynecology physicians providing medical care to pregnant women receiving
			 Opioid Maintenance Therapy services.
20. Support Systems: The entity shall
			 develop, maintain and document implementation of written policies and
			 procedures that define the process utilized to provide client access to support
			 services.
(i) Support services shall include,
			 at a minimum:
(I) Linkage with or access to
			 psychological, medical and psychiatric consultation.
(II) Linkage with or access to emergency
			 medical and psychiatric care.
(III)
			 Linkage with or access to evaluation and ongoing primary medical
			 care.
(IV) Ability to conduct or
			 arrange for appropriate laboratory and toxicology tests.
(V) Direct affiliation with or coordination
			 through referral to more and less intensive levels of care.
(ii) The entity shall maintain up-to-date,
			 written Memoranda of Understanding, collaborative agreements or referral
			 agreements with support systems.
21. Staffing:
(i) Program Sponsor: The Level I-O Program
			 shall have a program sponsor who shall be an Alabama Licensed Practitioner of
			 the Healing Arts with at least two (2) years supervised work experience in a
			 substance related disorders treatment program.
(I) The entity shall provide written
			 documentation of the program sponsor's responsibilities and the processes
			 through which they are implemented, which shall, at a minimum, include:
I. Ensure compliance with all Federal, State
			 and local laws and regulations regarding the use of Opioid agonist treatment
			 medications in the treatment of Opioid addiction.
II. Assume responsibility for all Level I-O
			 Program employees, including all practitioners, agents, or other persons
			 providing medical, rehabilitative, or counseling services at the
			 program.
III. Assign duties of the
			 program director.
IV. Meet the
			 qualifications of a staff member and be included in the listing of personnel
			 authorized access to the medication unit where he/she has access to the
			 medication unit.
(ii) Program Director: The Level I-O Program
			 shall have a full-time program director.
(I)
			 The Opioid Maintenance Therapy Program director shall be:
I. An Alabama licensed Registered Nurse,
			 Nurse Practitioner, Physician, or Physician's Assistant, who has two (2) years
			 direct care substance related disorders treatment experience, or
II. An individual with a master's degree in a
			 behavioral health related field and at least two (2) years direct care
			 substance use disorders treatment experience.
(II) The entity shall provide written
			 documentation of the program director's responsibilities and the processes
			 through which they are implemented, which shall include, at a minimum:
I. Manage the day to day operation of the
			 program as according to duties delegated by the program sponsor.
II. Maintain regular office hours, which
			 coordinate with the operation of the program.
III. Be readily accessible to the State
			 Opioid Treatment Authority.
(iii) Medical Director: The Level I-O Program
			 shall have a medical director who shall be a physician who is licensed to
			 practice in the State of Alabama and who has a minimum of one (1) year
			 experience in the treatment of Opioid dependency.
(I) The entity shall provide written
			 documentation of the medical director's responsibilities and the processes
			 through which they are implemented, which shall, at a minimum, include:
I. Administration of all Level I-O medical
			 services performed by the program.
II. Ensure that the Level I-O Program
			 complies with all applicable federal, state and local laws and regulations
			 relative to medical care.
III.
			 Attend weekly staffings with counselors, or document in the client record
			 alternative and equivalent supervisory contact on a weekly basis.
A. When the medical director is unable to
			 attend a weekly staffings, the entity must date the occurrence and provide
			 written documentation of how equivalent supervisory contact was accomplished,
			 e.g., by phone, electronic correspondence, etc.
IV. Maintain ongoing communication with
			 clients' physicians regarding the prescription of psychoactive and/or control
			 medication during Opioid Maintenance Therapy, and to coordinate client care in
			 regard to other medical needs.
V.
			 Maintain ongoing communication with Obstetrics and Gynecology physicians when
			 providing Opioid Maintenance Therapy services to pregnant women.
VI. Perform client physical examinations
			 prior to dosing and provide thorough documentation of each client's Opioid
			 dependency at the time of admission.
VII. Perform annual client physical
			 examinations.
VIII. Authorize:
A. All initial dose orders.
B. All dose and phase changes.
C. All take-home medications.
D. All changes in frequency of take-home
			 medications.
E. Opioid withdrawal
			 protocols.
IX. Delegate
			 responsibility for medical care and procedures to other Opioid Maintenance
			 Therapy Program physicians and physician extenders.
(II) The entity shall provide written
			 documentation that the Level I-O Program's medical director, or a staff
			 physician supervised and assigned by the medical director, is physically
			 present in the clinic a minimum of two (2) hours per week for each fifty (50)
			 clients enrolled in the program.
(iv) Pharmacist: The Level I-O Program shall
			 have an Alabama licensed pharmacist on its staff.
(I) The entity shall provide written
			 documentation of the pharmacist's responsibilities and the processes through
			 which they are implemented, which shall, at a minimum, include:
I. Prepare all take-home
			 medication.
II. Conduct, at a
			 minimum, an annual physical drug inventory.
III. Assist in the development of program
			 policies and procedures governing medication administration, dispensing, use
			 and security.
(v) Nursing Personnel: The entity shall have
			 an adequate number of Alabama licensed nurses to assure that all medications
			 utilized during Opioid Maintenance and Withdrawal Therapy are administered in
			 compliance with Alabama Board of Nursing regulations.
(i) Supervise and delegate responsibilities
			 to the Licensed Practical Nurses (LPNs) on staff.
(ii) There shall be a Registered Nurse (RN)
			 or Licensed Practical Nurse (LPN) on site during all hours of the Level I-O
			 Program's operation.
(vi)
			 Clinical Supervision: The entity shall have a clinical director who shall
			 provide routine clinical supervision of each Level I-O Program employee who
			 provides treatment and recovery support services.
(vii) All direct care personnel shall have
			 the qualifications as a qualified paraprofessional to provide the specific
			 services delineated in the entity's program description for this level of
			 care.
(viii) The entity shall
			 document the daily availability of an adequate number of personnel to sustain
			 the Level I-O Program as delineated in its operational plan and the rules
			 specified, herein.
(ix) All clients
			 will be assigned to the caseload of a primary counselor. The caseload of each
			 primary counselor shall not exceed forty (40) individuals.
(x) The entity shall document the daily
			 availability of the medical director, or a physician under the supervision and
			 authority of the medical director, during medication dispensing and clinic
			 operating hours, either in person or by telephone.
(xi) The entity shall establish a written
			 protocol for notifying the State Opioid Treatment Authority, within forty-eight
			 (48) hours, of any replacement or other change in the status of the program
			 sponsor or medical director.
22. Training. The entity shall provide
			 written documentation that:
(i) All Level I-O
			 Program personnel complete the core training curriculum, as specified in Rule
			 580-9-44-.02(3).
(ii) The entity shall provide written
			 documentation that all clinical and medical services staff in a Level I-O
			 Program receive training during the initial twelve (12) months employment and
			 develop basic competencies in the following areas:
(I) Opioid addiction treatment
			 methodologies.
(II) Regulatory
			 requirements for Opioid addiction treatment.
(III) Biopsychosocial dimensions of alcohol
			 and drug use disorders.
(IV)
			 Motivational and engagement strategies.
(V) Pharmacotherapy for Opioid
			 dependency.
(VI) ASAM Patient
			 Placement Criteria.
(VII)
			 Assessment of and service planning to address biopsychosocial needs of
			 individuals with Opioid dependency and related disorders.
(iii) Physicians who dispense methadone and
			 other Opiate replacement drugs must receive a minimum of eight (8) hours of
			 training each year relevant to Opioid Maintenance Therapy approved by SAMHSA
			 and the State Opioid Treatment Authority.
23. Service Intensity: The entity shall
			 develop, maintain and document implementation of written policies and
			 procedures relative to Level I-O service intensity, which shall, at a minimum,
			 include the following specifications:
(i) The
			 dose and intensity of Level I-O Treatment Services shall be established on the
			 basis of the unique assessed needs of each client served.
(ii) The program shall demonstrate
			 appropriate staffing to provide core counseling services.
(I) Issues identified through the assessment
			 and ongoing reassessment process must be addressed directly in a therapeutic
			 setting or referred to an appropriate, qualified entity.
(II) If no clinical services are indicated
			 for a client, appropriate identification shall be documented in the clinical
			 record.
(III) In no case shall
			 counseling services be scheduled less frequent than one session (individualized
			 or group) per month.
24. Length of Service: The entity shall
			 provide written documentation that the duration of treatment in each Level I-O
			 Program shall vary as determined by:
(i) The
			 severity of the client's illness.
(ii) The client's ability to comprehend the
			 information provided and use that information to implement treatment strategies
			 and attain treatment goals.
(iii)
			 The appearance of new problems that require another level of care.
(iv) The client's desire to continue
			 treatment.