1. (1) Rule Compliance. Each Level I-O Opioid Treatment Program (OTP) shall comply with all applicable rules and the rules specified in this chapter:
2. (a) Program Description. The entity shall develop, maintain, and implement a written program description that defines its Level I-O Opioid Treatment Program (OTP):
3. 1.  Location. The entity shall specifically identify and describe the setting in which the Level I-O Opioid Treatment Program (OTP)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.

4. 2. Admission Criteria. The entity shall develop, maintain and document implementation of written criteria for admission to its Level I-O Opioid Treatment Program (OTP), the following specifications: Comprehensive Physical Assessment in addition to the required ADMH Placement Assessment. An OTP shall maintain current procedures to ensure that recipients admitted to treatment by qualified personnel who have determined, using acceptable medical criteria, the recipient meets the following and shall be documented in the recipient’s record:

   1. (i)     The recipient meets diagnostic criteria for a moderate to severe Opioid Use Disorder (OUD) or
5. (ii)    The recipient has an active moderate to severe OUD, or
6. (iii)    Opioid Use Disorder, or
7. (iv)    Is at high risk for recurrence or overdose.
8. (v)     Recipient voluntarily chooses treatment with Medication for Opioid Disorder (MOUD) and that all relevant facts concerning the use of MOUD are clearly and adequately explained to the recipient and each recipient provides informed consent to treatment.
9. (vi)     Adolescent Specific Criteria.  An individual eighteen (18) years of age or older, may consent to OTP treatment and the consent of no other person shall be deemed necessary, no person under the age of eighteen (18) may be admitted to OTP treatment unless a parent, legal guardian, or responsible adult designated by the relevant State authority consents in writing to such treatment.
10. 3.     Core Services. Each Level I-O OTP shall demonstrate the capacity to provide a basic regimen of treatment services appropriate to the recipient’s developmental and cognitive levels and other assessed needs.
11. (i)     At a minimum, the entity shall demonstrate and document its capacity to provide the following core services:
12. (I)     Placement assessment.
13. (II)    Medication management.
14. (III)   Medication administration.
15. (IV)    Alcohol and/or drug screening/testing.
16. (V)     Individual counseling.
17. (VI)    Group counseling.
18. (VII)   Family counseling.
19. (VIII)  Psychoeducation.
20. (IX)    Case management:
21. I.     Case planning.
22. II.    Linkage.
23. III.   Advocacy.
24. IV.    Monitoring.
25. (ii)   Medical Services. The entity shall have medical protocols established for OTP by a licensed physician who is full-time, part-time 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.
26. (iii)   Mental Health Services. The entity shall develop, maintain and document implementation of policies and procedures to ensure that recipients with mental health needs are identified through assessment services and have access to appropriate care concurrently with OTP.
27. (iv)   Family Support. The entity shall initiate and document in the recipient record:
28. (I)     Continuous efforts to involve the recipient’s family and other natural supports in the treatment process, with recipient’s consent.
29. (II)    Family and other natural supports’ participation in the recipient’s treatment process, with recipient’s consent.
30. 4.     Therapeutic Component Implementation.
31. (i)    Each Level I-O OTP 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.
32. (ii)   Each Level I-O OTP shall establish a written schedule of operating hours and services that shall:
33. (I)    Provide for dosing and counseling services not less than five (5) days per week, unless there are closures state and/or federal holidays, and/or emergency closings.
34. (II)   Establish hours of operation that are flexible to accommodate the majority of recipients.
35. (III)  Provide access to clinical services personnel twenty-four (24) hours a day, seven (7) days a week.
36. (iii)   Counseling Services:    The entity shall document the provision of scheduled counseling and recovery support services and activities that shall, at a minimum, include:
37. (I)    Interventions that address:
38. I.     Emotional and psychological needs.
39. II.    Health education.
40. III.   Medication administration and monitoring.
41. 5.     Required services.
42. (i)    General. OTPs shall provide adequate:
43. (I)    Medical, counseling, vocational, educational, and other screening, assessment, and treatment services to meet the recipient’s needs, with the combination and frequency of services tailored to each individual recipient based on individual assessment and the recipient’s care plan that was created after shared decision making between the recipient and the clinical team.
44. (II)   These services shall be available at the primary facility, except where the program sponsor has entered into a documented agreement with a private or public organization, practitioner, or institution to provide these services to recipients enrolled in the OTP.
45. (III)  The program sponsor, in any event, shall be able to document that these services are fully and reasonably available to recipients.
46. (ii)   Initial medical examination.
47. (I)    OTPs shall require each recipient to undergo an initial medical examination by the program’s medical director, or a physician or physician extender properly authorized by the medical director and per State law. The initial medical examination shall be comprised of two (2) parts:
48. I.     A screening examination to ensure the recipient meets criteria for admission and that there are no contraindications to treatment with MOUD; and
49. II.    A full history and examination, to determine the recipient’s broader health status, with lab testing as determined to be required by an appropriately licensed practitioner. A recipient’s refusal to undergo lab testing for co-occurring physical health conditions should not preclude them from access to treatment, provided such refusal does not have potential to negatively impact treatment with medications.
50. (II)     No contraindications present, a recipient may commence treatment with MOUD after the screening examination has been completed.
51. I.   Both the screening examination and full examination shall be completed by appropriately licensed practitioner.
52. II.   If the licensed practitioner is not an OTP practitioner, the screening examination shall be completed no more than seven (7) days prior to OTP admission.
53. III.   Where the examination is performed outside the OTP, the written results and narrative of the examination as well as available lab testing results, shall be transmitted consistent with applicable privacy laws, to the OTP, and verified by an OTP practitioner.
54. (III)   A full in-person physical examination, including the results of serology and other tests that are considered to be clinically appropriate shall be completed within fourteen (14) calendar days following a recipient’s admission to the OTP. The full exam is verified by a licensed OTP practitioner as being true and accurate and transmitted in accordance with applicable privacy laws.
55. (IV)   Serology testing and other testing as deemed medically appropriate by the licensed OTP practitioner based on the screening or full history and examination, collected not more than thirty (30) days prior to admission to the OTP, may form part of the full history and examination.
56. (V)    The screening and full examination may be completed via telehealth for those recipients being admitted for treatment at the OTP with either buprenorphine or methadone, if a practitioner or primary care provider determines that an adequate evaluation of the recipient can be accomplished via telehealth and according to state and federal law.
57. (iii)   Special services for pregnant recipients. OTPs shall maintain current policies and procedures that reflect the special needs and priority for treatment admission of recipients with MOUD who are pregnant.
58. (I)  Pregnancy should be confirmed if possible. Refusal of pregnancy test shall not result in the denial of access to treatment to include MOUD.
59. (II)    Evidenced-based treatment protocols for the pregnant recipient, such as split dosing regimens, shall be instituted after assessment by the OTP practitioner and documentation that confirms the clinical appropriateness of such an evidenced-based treatment protocol.
60. (III)   Prenatal care and other sex-specific services, including reproductive health services, for pregnant and postpartum recipients shall be provided and documented either by the OTP or by referral to the appropriate healthcare practitioners.
61. (IV)    Specific services, including reproductive health services for pregnant and postpartum recipients shall be provided and documented either by the OTP or by referral to appropriate healthcare practitioner.
62. (iv)   Initial and periodic physical and behavioral health assessment services.
63. (I)   Each recipient admitted to an OTP shall be given a physical and behavioral health assessment, which includes but is not limited to:
64. I.   Screening from imminent risk of harm to self or others, within fourteen (14) calendar days of admission, and periodically by Qualified Substance Use Professional I (QSUP I) and/or Qualified Substance Use Professional II (QSUP II).
65. II.   These assessments must address the need and/or response to treatment, adjust treatment interventions, including MOUD, as necessary, and provide person-centered treatment plan.
66. III.  Preparation of a treatment plan that includes the recipient’s goals and mutually agreed upon actions for the recipient to meet those goals in addition to requirements of 580-2-20-.08, including:
67. A.   Harm reduction interventions.
68. B.   The recipient’s needs and goals in the areas of education, vocational training, and employment.
69. C.   The medical and psychiatric, psychological, economic, legal, housing, and other recovery supported services that a recipient needs and wishes to pursue.
70. D.    The treatment plan also shall identify the recommended frequency with which services are to be provided.
71. E.    The treatment plan shall be reviewed and updated to reflect responses to treatment and recovery support services, and adjustments made that reflect changes in the context of the recipient’s life, their current needs for and interests in medical, psychiatric, social, and psychological services, and current needs for and interests in education, vocational training, and employment services.
72. (II)  The periodic physical examination shall not occur less than one time each calendar year and be conducted by an OTP practitioner.  The periodic physical examination shall include review of:
73. I.    MOUD dosing,
74. II.   Treatment response,
75. III.  Other substance use needs,
76. IV.   Responses and recipient identified goals, and
77. V.    Other relevant physical and psychiatric treatment needs and goals.
78. VI.    The periodic physical examination shall be documented in the recipient record.
79. (v)    Counseling and psychoeducational services.
80. (I)    OTPs shall provide adequate substance use disorder counseling and psychoeducation to each recipient as clinically necessary and mutually agreed upon, including harm reduction education and recovery-oriented counseling.
81. (II)    This counseling shall be provided by program counselor, qualified by education, training, or experience to assess the psychological and sociological background of recipients, engage with recipients, to contribute to the appropriate treatment plan for the recipient and to monitor and update recipient progress.
82. (III)  Recipient refusal of counseling shall not preclude them from receiving MOUD.
83. (IV)    OTPs shall provide counseling on preventing exposure to, and the transmission of, human immunodeficiency virus (HIV), viral hepatitis, and sexually transmitted infections (STIs) and either directly provide services and treatments or actively link to treatment each recipient admitted or readmitted to treatment who has received positive test results for these conditions form initial and/or periodic medical examinations.
84. (V)     OTPs shall provide directly, or through referral to adequate and reasonably accessible community resources, vocational training, education, and employment services for recipients who request such services or for whom these needs have been identified and mutually agreed upon as beneficial by the recipient and the program staff.
85. 6.     Recipient Orientation:
86. (i)    All recipients shall be oriented to the MOUD process prior to administration of any medication.
87. (ii)   The entity shall provide written documentation that each recipient, upon admission and throughout the treatment process, receives oral and written information that explains in a manner understood by the recipient:
88. (I)    Signs and symptoms of overdose and when to seek emergency assistance.
89. (II)   A description of the MOUD to be administered by the program, including potential:
90. I.     Benefits.
91. II.    Risks.
92. III.   Side effects.
93. IV.    Drug interactions.
94. (III)  Common myths about MOUD used in the treatment and withdrawal process.
95. (IV)   The nature of substance use disorders (SUD).
96. (V)    The goals and benefits of MOUD and the process of recovery.
97. (VI)   Noncompliance and discharge procedures, including administrative withdrawal from medication.
98. (VII)  Toxicology testing procedures.
99. (VIII) Medication dispensing procedures.
100. 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 580-2-20-.09 (17) and include the following specifications:
101. (i)    When conducting random drug testing, OTP/s shall use drug tests that have received the Food and Drug Administration’s (FDA) marketing authorization for commonly used and misused substances that may impact recipient safety, recovery, or otherwise complicate substance use disorder treatment, at a frequency that is in accordance with generally accepted clinical practice and as indicated by a recipient’s response to and stability in treatment but no fewer than eight (8) random drug tests per year, allowing for extenuating circumstances at the individual recipient level.
102. (ii)    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 recipient from treatment.
103. (iii)   Toxicology tests shall be completed within fourteen (14) days of admission, at a minimum, screen for:
104. (I)    Opiates.
105. (II)   Methadone.
106. (III)  Benzodiazepines.
107. (IV)    Cocaine.
108. (V)   Amphetamines/methamphetamine.
109. (VI)  Tetrahydrocannabinol.
110. (VII) Alcohol.
111. (VIII)   Fentanyl.
112. (IX)    Any other drug known to be frequently abused in the locality of the OTP.
113. (iv)    The entity shall document the utilization of drug testing cutoff concentrations as follows:
114. (I)     Opiate:  300 ng/ml
115. (II)    Methadone: 300 ng/ml
116. (III)   Benzodiazepine: 200 ng/ml
117. (IV)    Cocaine: 300 ng/ml
118. (V)     Amphetamine/methamphetamine: 1000 ng/ml
119. (VI)    Tetrahydrocannabinol: 200 ng/ml
120. (VII)   Alcohol: .03 gm/dl
121. (VIII)  Fentanyl: 2 ng/ml.
122. (IX)    Buprenorphine: 5ng/ml.
123. (v)     The OTP shall provide documentation that all drug tests are conducted by a laboratory certified by an independent, federally approved accreditation entity.
124. (vi)   The results of all drug tests shall be filed in the recipient record.
125. 8.     Take Home Medication: The entity shall develop, maintain, and document implementation of written policies and procedures that govern the processes utilized to provide recipients with unsupervised use of program dispensed Opioid treatment medication. At a minimum, these policies and procedures shall include the following specifications:
126. (i)   The entity’s medical director, in consultation with the recipient’s treatment team, shall make all decisions relative to dispensing Medication for Opioid Use Disorder (MOUD) to recipients for unsupervised use or “take-home” medication doses, in consideration of the following minimum criteria:
127. (I)    Any recipient in comprehensive treatment may receive their individualized take-home doses as ordered for days that the clinic is closed for business, State and Federal holidays, no matter their length of time in treatment.
128. (II)   OTP decisions on dispensing MOUD to recipients for unsupervised use beyond that set forth shall be determined by an appropriately licensed OTP medical practitioner or medical director.  In determining which recipients may receive unsupervised medication doses, the medical director or program medical practitioner shall consider among other pertinent factors that indicate that the therapeutic benefits of unsupervised doses outweigh the risks, the following criteria:
129. I.     Absence of active substance use disorders, other physical or behavioral health conditions that increase the risk of recipient harm as it relates to the potential for overdose, or the ability to function safely.
130. II.    Regularity of attendance for supervised medication administration.
131. III.     Absence of serous behavioral problems that endanger the recipient, the public or others.
132. IV.     Absence of known recent diversion activity.
133. V.     Whether take-home medication can be safely transported and stored.

134. VI.     Any other criteria that the medical director or medical practitioner considers relevant to the recipient’s safety and the public’s health.

     (III).    Such determinations and the basis for such determinations consistent of take-home medications shall be documented in the recipient record.  If it is determined that a recipient is safely able to manage unsupervised doses of MOUD set forth in 580-9-44-.29 (1)(a) 9. (i)(II) I. through IV. , the dispensing restrictions criteria as follows shall apply:

135. I.     During the first fourteen (14) days of treatment, the take-home supply is limited to seven (7) days.  It remains with the OTP practitioner’s discretion to determine the number of take-home doses up to seven (7) days. The rationale underlying the decision to provide unsupervised doses of methadone or buprenorphine shall be documented in the recipient’s record.
136. II.     From fifteen (15) days of treatment the take-home supply is limited to fourteen (14) days. It remains with the OTP practitioner’s discretion to determine the number of take-home doses up to fourteen (14) days. The rationale underlying the decision to provide unsupervised doses of methadone or buprenorphine shall be documented in the recipient’s record.
137. III.      From thirty-one (31) days of treatment, the take-home supply provided to a recipient is not to exceed twenty-eight (28) days.  It remains with the OTP practitioner’s discretion to determine the number of take-home doses up to twenty-eight (28) days. The rationale underlying the decision to provide unsupervised doses of methadone or buprenorphine shall be documented in the recipient’s record.
138. 9.     Diversion Control: OTPs shall maintain current procedures adequate to identify the theft or diversion of take-home medications, including labeling containers with the OTP’s name, address, and telephone number. Programs also shall ensure that each individual take-home dose is packaged in the manner that is designed to reduce the risk of accidental ingestion, including child-proof containers (see Poison Prevention Packaging Act, Pub. L. 91-601 (15 U.S.C. 1471 et seq.). The diversion control plan shall, at a minimum, include the following elements:
139. (i)    A process for routine surveillance and monitoring of the internal and external treatment environment to identify diversion problems.
140. (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.
141. (iv)    A process to address identified diversion problems through corrective and preventive efforts.
142. (vi)     Programs shall provide education to each recipient on: Safely transporting medication from the OTP to their place of residence; and the safe storage of take-home doses at the individual’s place of residence, including child and household safety precautions.  The provision of this education shall be documented in the recipient’s record.
143. 10.    Dosing:     The entity shall develop, maintain and document implementation of written policies and procedures to govern the process of medication dispensing, administration and use that shall, at a minimum, include the following specifications:
144. (i)    OTPs shall ensure that MOUD are administered or dispensed only by a practitioner licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense MOUD, or by an agent of such a practitioner, supervised by and under the order of the licensed practitioner and if consistent with Federal and State law.
145. (ii)    Only Physicians licensed in Alabama can prescribe and modify prescriptions for Methadone.
146. (iii)   Certified Registered Nurse Practitioner shall maintain current Qualified Alabama Controlled Substances Registration Certification (QACSC) can only prescribe Buprenorphine.
147. (iv)    OTPs shall only use those MOUD that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of OUD.  In addition, OTPs who are fully compliant with the protocol of an investigational use of a drug and other conditions set forth in the application may administer a drug that has been authorized by the Food and Drug Administration under an investigational use in the treatment of OUD. Currently the following MOUD will be considered to be approved by the Food and Drug Administration for use in the treatment of OUD:
148. (I)     Methadone.
149. (II)    Buprenorphine and buprenorphine combination products that have been approved for use in the treatment of OUD.
150. (III)   Naltrexone.
151. (v)    OTPs shall maintain current procedures that are adequate to ensure that the following dosage form and initial dosing requirements are met:
152. (I)     Methadone shall be administered or dispensed only in oral form and shall be formulated in such a way as to reduce its potential for parenteral misuse.
153. (II)    For each new recipient enrolled in an OTP, the initial dose of methadone shall be individually determined and shall include consideration of the type(s) of opioid(s) involved in the recipient’s opioid use disorder, other medications or substances being taken, medical history, and severity of opioid withdrawal.
154. (III)    The total dose for the first day should not exceed 50 milligrams unless the OTP physician, licensed under the appropriate State law and registered under the appropriate State and Federal laws to administer or dispense MOUD, finds sufficient medical rationale, including but not limited to if the recipient is transferring from another OTP on a higher dose that has been verified, and documents in the recipient record that a higher dose was clinically indicated.
155. (v)     OTPs shall maintain current procedures adequate to ensure that each MOUD used by the program is administered and dispensed in accordance with its FDA approved product labeling.  The program shall ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the recipient’s record.
156. 11.    Split Dosing means dispensing of a single dose of MOUD as separate portions to be taken within 24-hour period.
157. (i)    Split dosing is indicated among but not limited to those who recipients who:
158. (I)     Possess a genetic variant which increases methadone metabolism;
159. (II)    Concurrently take other medications or drink alcohol that also induce hepatic enzymes leading to more rapid metabolism of methadone;
160. (III)    Who are pregnant; or
161. (IV) For whom methadone or buprenorphine are being used to treat a concurrent pain indication in addition to diagnosis of OUD. This leads to more stable, steady-state medication levels.
162. (ii)    The organization shall have a written split dosage policy that shall include evidenced-based treatment protocols such as split dosing regimens, shall be instituted after assessment by the OTP practitioner and documentation that confirms the clinical appropriateness of such an evidenced-based treatment protocol.
163. 12.    Guest Dosing:     The entity shall develop, maintain and document implementation of dosing policies and procedures for the provision of MOUD to a guest recipient in a program in which the recipient is not enrolled.
164. 13.   Recordkeeping and recipient confidentiality.
165. (i)     OTPs shall establish and maintain a recordkeeping system that is adequate to document and monitor recipient care in addition to the requirements of 580-2-20-.08.
166. 1.     This system is required to comply with all Federal and State reporting requirements, relevant to MOUD approved for use in treatment of OUD.
167. 2.     All records are required to be kept confidential in accordance with all applicable Federal and State requirements.
168. (ii)     OTPs shall include, as an essential part of the recordkeeping system, documentation in each recipient’s record that the OTP made a good faith effort to determine whether the recipient is enrolled in any other OTP. The agency shall check the central registry to monitor for multiple enrollments of a recipient in more than one (1) OTP at the same time.
169. (I)     A recipient enrolled in an OTP shall not be permitted to obtain treatment in any other OTP except in circumstances involving an inability to access care at the recipient’s OTP of record.
170. (II)    Such circumstances include, but are not limited to, travel for work, family events, temporary relocation, or an OTP’s temporary closure.
171. (III)    If the medical director or program practitioner of the OTP in which the recipient is enrolled determines that such circumstances exist, the recipient may seek treatment at another OTP, provided the justification for the particular circumstances are noted in the recipient’s record both at the OTP in which the recipient is enrolled and at the OTP that will provide the MOUD.
172. (iii)    The entity shall obtain the recipient’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 recipient record.
173. (iv)   The entity shall require that all recipients show proof of identification. A copy of current identification will be maintained in the recipient record.
174. 14.    Withdrawal management.  An OTP shall maintain current procedures that are designed to ensure that those recipients who choose to taper from MOUD are provided the opportunity to do so with informed consent and at a mutually agreed-upon rate that minimizes taper-related risk. Such consent shall be documented in the recipient’s record by treating practitioner.
175. 15.    Recipient Transfers: The Level I-O Program shall develop, maintain and document implementation of written policies and procedures to effect orderly transfer of recipients between substance use programs, which shall, at a minimum, address the following specifications:
176. (i)    A recipient’s request for transfer to another MOUD provider shall be honored without restriction, even if the recipient has an outstanding financial balance.
177. (ii)    Records to the receiving MOUD provider shall be provided promptly and shall include, at a minimum:
178. (I)     Dose level, to be confirmed by nursing staff at transferring clinic and documented in the clinical record.
179. (II)   Reason for transfer.
180. (III) Other information as requested by the receiving program and specified in an appropriate recipient authorization for release of information.

181. 16.    Documentation:     The OTP shall comply with all standards set forth in Rule 580-2-20-.08 of these rules, and, in addition, shall comply with the requirements of this section:

182. Clinical records of clients receiving MOUD shall include the following documentation:

183. (I)     Each dose of medication administered, with a copy

     of the physician’s order for medication.

184. (II)     Coordination of care with physicians prescribing psychoactive and/or control medication to recipients receiving MOUD services.
185. 17.    Administrative and organizational structure. An OTP’s organizational structure and facility shall be adequate to ensure quality recipient care and to meet the requirements of all pertinent Federal, State, and local laws and regulations.  At a minimum, each OTP shall formally designate:
186. (i)  Program Sponsor is responsible for the operation of the OTP and who resumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, behavioral health, or social services at the program or any of its medication units.
187. 1.    The program sponsor shall ensure a physician who is licensed to practice in the State of Alabama occupies the position of medical director within the OTP.
188. 2.    The program sponsor responsible for the OTP operation shall agree on behalf of the OTP to adhere to all requirements set forth in these standards.
189. 3.    If the Program Sponsor meets the requirements for Executive Director set forth in Rule 580-2-20-.03 (1), they may serve as both the Program Sponsor and the Executive Director.
190. (ii)  Medical Director. The medical director, who shall be a physician who is licensed to practice in the State of Alabama, shall assume responsibility for all medical and behavioral health services performed by the OTP. In addition, the medical director shall be responsible for ensuring that the OTP is in compliance with all Federal, State, and local laws and regulations.
191. (iii)     Pharmacist:  The agency shall follow Alabama Board of Pharmacy requirements.
192. (iv)     Nursing Personnel:   The entity shall have Alabama licensed nurses to assure that all MOUDs utilized during OTP are administered in compliance with Alabama Board of Nursing regulations.
193. (I)     There shall be a Registered Nurse (RN) or Licensed Practical Nurse (LPN) on site during administration and dispensing of MOUDs.
194. (v)     All recipients will be assigned to the caseload of a primary counselor who meets the qualifications of a QSUP I or QSUP II. The caseload of each primary counselor shall not exceed fifty (50) recipients.
195. 18.    Interim treatment means that on a temporary basis, a recipient may receive some services from OTP, while awaiting access to more comprehensive treatment services. The duration of interim services is limited to 180 days. Comprehensive treatment is treatment that includes the continued use of MOUD provided in conjunction with an individualized range of appropriate harm reduction, medical, behavioral health, and recovery support services.
196. (i)     The program sponsor of an OTP may admit an individual, who is eligible for admissions to comprehensive treatment, into interim treatment if comprehensive services are not readily available within a reasonable geographic area and within fourteen (14) days of individual’s seeking treatment.
197. (I)     At least two (2) drug tests shall be obtained from recipients during the maximum 180 days permitted for interim treatment.
198. (II)     A program shall establish and follow reasonable criteria for establishing priorities for moving recipients from interim to comprehensive treatment.
199. (III)     These transition criteria shall be in writing and shall include, at a minimum, prioritization of pregnant recipients in admitting recipients to interim treatment and from interim to comprehensive treatment.
200. (IV)     Interim treatment shall be provided in a manner consistent with applicable Federal and State laws, including sections 123, 1227(a), and 1976 of the Public Health Service Act 921 U.S.C 300x-23, 300x-27(a), and 300y-11).
201. (ii)     The program shall receive approval from the SOTA prior to the initiation of interim services and notify SOTA when a recipient:
202. (I)     Begins interim treatment,
203. (II)     Leaves interim treatment, and
204. (III)     Before the date of transfer to comprehensive services and shall document such notifications.
205. (iii)     Interim authorization may be revoked if the program fails to comply with these provisions or fails to be in compliant with Federal and State laws and regulations.
206. (iv)     All requirements for comprehensive treatment apply to interim treatment with the following exceptions:
207. (I)     A primary counselor is not required to be assigned to the recipient, but crisis services, including shelter, support, should be available.
208. (II)     Interim treatment cannot be provided for longer than 180 days in any 12-month period.
209. (III)     By day 120, a plan for continuing treatment beyond 180 days shall be created and documented in the recipient’s record.
210. (IV)    Formal counseling, vocational training, employment, economic, legal, educational, and other recovery support services are not required to be offered to the recipient. However, information pertaining to locally available, community-based resources for ancillary services should be made available to the individual recipients in interim treatment.

Author: DMH/MR Office of Certification

Statutory Authority: Code of Ala. 1975, §22-50-11.

History: New Rule: Filed January 26, 2012; effective March 1, 2012. Amended: Published January 31, 2023; Effective March 17, 2023. Amended: Published December 31, 2025; effective February 14, 2026.