Ala. Admin. Code r. 580-9-44-.29 - Level I-O: Opioid Maintenance Therapy
(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.
Notes
Author: Substance Abuse Services Division
Statutory Authority: Code of Ala. 1975, ยง 22-50-11.
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No prior version found.