Ala. Admin. Code r. 580-9-44-.29

Current through Register Vol. 43, No. 1, October 31, 2024

Section 580-9-44-.29 - [Effective until 1/16/2025] Level I-O: Opioid Treatment Program (OTP)

1. Rule Compliance. Each Level I-O Opioid Treatment Program (OTP) 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 Treatment Program (OTP).

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.

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:

(i) The recipient meets diagnostic criteria for a moderate to severe Opioid Use Disorder or

(ii) The recipient has an active moderate to severe Opioid Use Disorder, or

(iii) Opioid Use Disorder, or

(iv) Is at high risk for recurrence or overdose.

(v) Recipient voluntarily chooses treatment with MOUD and that all relevant facts concerning the use of Medication for Opioid Disorder (MOUD) are clearly and adequately explained to the recipient and each recipient provides informed consent to treatment.

(v) Adolescent Specific Criteria. An individual fourteen (14) 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 fourteen (14) 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

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.

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 OTP 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 recipients with mental health needs are identified through assessment services and have access to appropriate care concurrently with Opioid Treatment Program

iv. Family Support. The entity shall initiate and document in the recipient record:

I. Continuous efforts to involve the recipient's family and other natural supports in the treatment process.

II. Family and other natural supports' participation in the recipient's treatment process.

4. Therapeutic Component Implementation.

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.

ii. Each Level I-O OTP 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 recipient 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 recipients, required program activities, and provide a safe, therapeutic environment that supports enhancement of each recipient'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. Required services.

(i) General. OTPs shall provide adequate:

(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.

(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.

(III) The program sponsor, in any event, shall be able to document that these services are fully and reasonably available to recipients.

(ii) Initial medical examination.

(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:

I. A screening examination to ensure the recipient meets criteria for admission and that there are no contraindications to treatment with MOUD; and

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.

(II) No contraindications present, a recipient may commence treatment with MOUD after the screening examination has been completed.

I. Both the screening examination and full examination shall be completed by appropriately licensed practitioner.

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.

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.

(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.

(IV) Serology testing and other testing as deemed medically appropriate by the licensed OTP practitioner based on the screening or full history and examination, drawn not more than thirty (30) days prior to admission to the OTP, may form part of the full history and examination.

(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.

(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.

(I) Pregnancy should be confirmed if possible. Refusal of pregnancy test shall not result in the denial of access to treatment to include MOUD.

(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.

(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.

(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.

(iv) Initial and periodic physical and behavioral health assessment services.

(I) Each recipient admitted to an OTP shall be given a physical and behavioral health assessment, which includes but is not limited to:

I. Screening from imminent risk of harm to self or others, within fourteen (14) calendar days of admission, and periodically by appropriately licensed/credentialed person.

II. These assessments must address the need and/or response to treatment, adjust treatment interventions, including MOUD, as necessary, and provide person-centered plan of care.

III. Preparation of a care 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:

A. Harm reduction interventions.

B. The recipient's needs and goals in the areas of education, vocational training, and employment.

C. The medical and psychiatric, psychological, economic, legal, housing, and other recovery supported services that a recipient needs and wishes to pursue.

D. The care plan also shall identify the recommended frequency with which services are to be provided.

E. The 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.

(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:

I. MOUD dosing,

II. Treatment response,

III. Other substance use needs,

IV. Responses and recipient identified goals, and

V. Other relevant physical and psychiatric treatment needs and goals.

VI. The periodic physical examination shall be documented in the recipient record.

(v) Counseling and psychoeducational services.

(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.

(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 care plan for the recipient and to monitor and update recipient progress.

(III) Recipient refusal of counseling shall not preclude them from receiving MOUD.

(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.

(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.

5. Assessment: The entity shall comply with all standards set forth in 580-2-20-.09 (10) 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 OTP, 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.

6. Recipient Orientation:

i. All recipients shall be oriented to the Medication for Opioid Use Disorder (MOUD) process prior to administration of any medication.

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:

I. Signs and symptoms of overdose and when to seek emergency assistance.

II. A description of the Medication for Opioid Use Disorder (MOUD) to be administered by the program, including potential:

I. Benefits.

II. Risks.

III. Side effects.

IV. Drug interactions.

III. Common myths about Opioid Use Disorder Treatment and Medication for Opioid Use Disorder (MOUD) 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 580-2-20-.09 (17) 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 recipient 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. Fentanyl.

X. Any other drug known to be frequently abused in the locality of the Opioid Treatment Program.

iii. Random drug tests shall be conducted at least once per month throughout the duration of each recipient's participation in MOUD. A minimum of twelve (12) drug tests shall be conducted per year.

iv. 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. Fentanyl:

X. In cases where MOUD, other than methadone are being used, the clinic should contact the State Opioid Treatment Authority to determine the acceptable immunoassay cut-off concentrations.

v. The entity shall provide documentation that all drug tests are conducted by a laboratory certified by an independent, federally approved accreditation entity.

vi. The results of all drug tests shall be filed in the recipient 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 MOUD that shall, at a minimum, include the following specifications:

i. Baseline drug testing results shall be discussed with the recipient and documentation of this discussion recorded as a progress note in the recipient record.

ii. At his/her next scheduled clinic visit after receiving a positive alcohol/drug screen, recipients shall be informed of drug testing results that are positive for substances of abuse, or negative for MOUD. Following recipient notification, the entity shall implement the following procedures, as appropriate:

I. New recipients. During the first ninety (90) days of treatment, the first drug testing report that is positive for substances of abuse or negative for MOUD, after baseline testing, shall result in a meeting between the recipient and the recipient's primary counselor to review the treatment plan, and to modify or intensify treatment services as appropriate to the recipient's current needs.

II. Recipients with take-home privileges.

I. A positive toxicology report for illicit drugs or a negative toxicology result for MOUD shall require that the recipient 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 recipient's needs.

II. A second toxicology result that is positive for substances of abuse or negative for MOUD during a probationary period shall require that the recipient 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.

D. Collaborate with the treatment team to develop and implement a plan for remedial action.

III. Subsequent Drug Tests for All Recipients. For subsequent drug testing results that are positive for substances of abuse or negative for Medication for Opioid Use Disorder (MOUD) the entity shall take steps to provide assistance for each recipient, as according to assessed needs, that shall include but shall not be limited to:

I. Treatment team staffing in collaboration with the recipient.

II. Continued assessment services of the recipient biopsychosocial needs and levels of functioning.

III. Re-evaluation of the recipient's medication dosage, plasma levels, metabolic responses and adjustment of the dosage for adequacy and recipient 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 recipient on Medication for Opioid Use Disorder (MOUD).

IX. Initiating a change of counselors when indicated.

X. Providing family intervention.

9. 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:

(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:

(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.

(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:

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.

II. Regularity of attendance for supervised medication administration.

III. Absence of serous behavioral problems that endanger the recipient, the public or others.

IV. Absence of known recent diversion activity.

V. Whether take-home medication can be safely transported and stored.

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

VII. 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, the dispensing restrictions as follows shall apply:

A. During the first fourteen (14) days of treatment, the takehome supply is limited to seven (7) days. It remains with the OTP practitioner's discretion to determine the number of takehome doses up to seven (7) days, but decisions must be based on the criteria set forth in 580-9-444-.29 (1)(a) 9. (i).

The rationale underlying the decision to provide unsupervised doses of methadone or buprenorphine shall be documented in the recipient's record, consistent with 580-9-444-.29 (1)(a) 9. (i).

B. 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, but this determination must be based on the criteria listed in 580-9-444-.29 (1)(a) 9. (i).

The rationale underlying the decision to provide unsupervised doses of methadone or buprenorphine shall be documented in the recipient's record, consistent with 580-9-444-.29 (1)(a) 9. (i).

C. 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, but this determination is based on the criteria listed in 580-9-444-.29 (1)(a) 9. (i). The rationale underlying the decision to provide unsupervised doses of methadone or buprenorphine shall be documented in the recipient's record, consistent with 580-9-444-.29 (1)(a) 9. (i).

(III) Whether the rehabilitative benefit to the recipient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion.

(ii) Decisions to approve unsupervised use of Medication for Opioid Use Disorder (MOUD), including the rationale for the approval, shall be documented in the recipient record.

(iii) recipients 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.

(v) 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 recipient record.

II. A recipient 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.

iv. 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:

V. The need for emergency unsupervised take-home medication shall be clearly delineated with verifiable documentation in the recipient record.

VI. 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.

iv. Hardship Waiver. The entity shall develop, implement, and document implementation of written policies and procedures to address requests for hardship exceptions to include the following:

VII. Specify the conditions under which a recipient may request a hardship waiver and the conditions required for its consideration.

VIII. Describe the process utilized to ensure continuity of care when a recipient is unable, due to a verifiable hardship, to report to the program for routine ingestion of medication.

IX. 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.

X. Include provisions for hardship exception requests to be authorized by the entity's medical director and submitted to the State Opioid Treatment Authority for review and approval.

XI. Provide for all considerations given, recommendations for and conditions of hardship waivers, as well as denials of such to be documented in the recipient record.

iv. 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. 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 childproof 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:

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 recipients 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.

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.

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 MOUD is administered.

ii. The entity shall maintain current procedures adequate to ensure that each MOUD 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) Medication administration, dispensing, and use.

(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.

(II) Only Physicians licensed in Alabama can prescribe and modify prescriptions for Methadone.

(III) Certified Registered Nurse Practitioner shall maintain current Qualified Alabama Controlled Substances Registration Certification (QACSC) can only prescribe Buprenorphine.

(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:

I. Methadone.

II. Buprenorphine and buprenorphine combination products that have been approved for use in the treatment of OUD.

III. Naltrexone.

(V) OTPs shall maintain current procedures that are adequate to ensure that the following dosage form and initial dosing requirements are met:

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.

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.

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.

(VI) 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.

v. 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 MOUD.

vi. Methadone shall be dispensed in oral form in one liquid or one dissolvable diskette dose per container.

vii. Buprenorphine and buprenorphine products shall be dispensed per FDA rules and regulations.

viii. 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 or buprenorphine 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 recipient complains that the dosage level is not holding.

II. The recipient 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 recipient involving the physician and multidisciplinary team.

iii. Include provisions for education of the recipient 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 MOUD to a guest recipient in a program in which the recipient 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 recipient and dosing information to the receiving agency to request guest dosing privileges.

II. Forward this document to the receiving program.

III. Provide the recipient 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 recipient understands all stipulations of the guest dosing process including, but not limited to, fees, receiving program contacts, dosing times and procedures.

VI. Accept the recipient upon return from guest dosing unless other arrangements have been made.

VII. Document all procedures implemented in the guest dosing process in the recipient's 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 recipient for guest medication within fortyeight (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 the recipient's 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 unless approved by ADMH.

14. Multiple recipient 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 enrollments of a recipient in more than one at the same time. Each OTP 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 recipient is admitted for MOUD.

II. A recipient is transferred to another provider for MOUD.

III. A recipient is discharged from OTP.

II. The entity shall make disclosures in the format and within timeframes established by the State Opioid Treatment Authority.

III. The entity shall limit disclosures to recipient identifying information and the dates of admission, transfer, and discharge.

IV. The entity shall obtain the recipient'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 recipient 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 recipient record.

ii. 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.

iii. The entity shall require that all recipient 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 recipient 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 recipient from MOUD. 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 OTP is voluntary and that a recipient is free to leave treatment at any time.

II. Identify the steps to be taken by the entity when recipient and program personnel agree on a need to initiate withdrawal procedures.

III. Identify the steps to be taken by the entity when the recipient 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 OTP resumes medication assisted treatment if the recipient 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 recipient 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 MOUD.

iv. Recipient who has 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 recipient whether voluntarily or involuntarily participating in medically supervised withdrawal. Dosage reduction schedules shall be based upon objective assessment of each recipient'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 recipient's 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 OTP for supervised withdrawal.

x. recipients 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 recipient 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 recipient of the possible risks and benefits of the use of MOUD during pregnancy.

II. Document in the recipient record that this information has been provided to the recipient.

iii. The entity shall describe in writing and document implementation of the process used to provide pregnant recipients 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 recipient'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 OTP.

vi. When the woman refuses an appropriate referral for prenatal services, the entity shall:

I. Utilize informed consent procedures to have the recipient formally acknowledge, in writing, that the OTP offered a referral to prenatal services, but the recipient refused the offer.

II. Provide the recipient with basic prenatal instruction on maternal, physical, and dietary care as part of the OTP counseling services and document service delivery in the recipient record.

vii. The entity shall provide written documentation of implementation of the following procedures in regard to care for pregnant women:

I. recipient 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 recipient 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 recipient 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 the requirements of this section:

i. The entity's recipient records, and recipient outcomes shall indicate that medications used in the OTP 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 OTP 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 OTP, 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 recipient record.

II. Ensures that each dose is recorded in the recipient record of the person served.

III. Ensures that take-home medications are properly labeled, which shall include, at a minimum:

I. Name of OTP prescribing clinic.

II. Address of OTP prescribing clinic.

III. Telephone number of OTP prescribing clinic.

IV. Recipient'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 recipient for whom it was prescribed.

iv. Ensure that that take-home medication is packaged in childproof containers designed to reduce the risk of accidental ingestion.

18. Recipient: The Level I-O OTP shall develop, maintain, and document implementation of written policies and procedures to effect orderly transfer of recipients 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 recipient transfers.

ii. A recipient's request for transfer to another Level I-O OTP shall be honored without restriction, even if the recipient 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. Urinalysis results for the past twelve (12) months.

III. Dose level, to be confirmed by nursing staff at transferring clinic and documented in the recipient record.

IV. Most recent TB test results and date of test.

V. Reason for transfer.

VI. Other information as requested by the receiving program and specified in an appropriate recipient authorization for release of information.

iv. All recipient 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 5802-20-.08, and, in addition, shall comply with the requirements of this section:

i. Recipient records of recipients receiving MOUD in an OTP shall include the following documentation:

I. That recipients have been questioned about being pregnant and informed about pregnancy and physiological implications with MOUD.

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 recipient receiving MOUD services.

VI. Ongoing communication with Obstetrics and Gynecology physicians providing medical care to pregnant women receiving MOUD services.

20. Support Systems: The entity shall develop, maintain and document implementation of written policies and procedures that define the process utilized to provide recipient 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 OTP 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 MOUD in the treatment of Opioid addiction.

II. Assume responsibility for all Level I-O OTP 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 OTP shall have a full-time program director.

I. The OTP 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 OTP 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-0 OTP medical services performed by the program.

II. Ensure that the Level I-O OTP 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 recipient 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 recipients' physicians regarding the prescription of psychoactive and/or control medication during MOUD, and to coordinate recipient care in regard to other medical needs.

V. Maintain ongoing communication with Obstetrics and Gynecology physicians when providing MOUD services to pregnant women.

VI. Perform recipient physical examinations prior to dosing and provide thorough documentation of each recipient's Opioid use disorder at the time of admission.

VII. Perform annual recipient physical examinations.

1. Authorize:

A. All initial dose orders.

B. All take-home medications.

C. All changes in frequency of take-home medications.

D. Opioid withdrawal protocols.

IX. Delegate responsibility for medical care and procedures to other OTP physicians and physician extenders.

II. The entity shall provide written documentation that the Level I-O OTP'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) recipients enrolled in the program.

iv. Pharmacist: The level I-O OTP 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 MOUD OTP 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-0 OTP's operation.

vi. Clinical Supervision: The entity shall have a clinical director who shall provide routine clinical supervision of each Level I-O OTP 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 OTP as delineated in its operational plan and the rules specified, herein.

ix. All recipients 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 OTP 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 OTP 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. ADMH Integrated Placement Criteria.

VII. Assessment of and service planning to address biopsychosocial needs of individuals with Opioid Use Disorder and related disorders.

iii. Physicians who dispense methadone and other MOUD must receive a minimum of eight (8) hours of training each year relevant to MOUD 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 OTP service intensity, which shall, at a minimum, include the following specifications:

i. The dose and intensity of Level I-O OTP shall be established on the basis of the unique assessed needs of each recipient 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 recipient, appropriate identification shall be documented in the recipient 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 OTP shall vary as determined by:

i. The severity of the recipient's illness.

ii. The recipient'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 recipient's desire to continue treatment.

25. 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.

(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.

(I) At least two (2) drug tests shall be obtained from recipients during the maximum 180 days permitted for interim treatment.

(II) A program shall establish and follow reasonable criteria for establishing priorities for moving recipients from interim to comprehensive treatment.

(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.

(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 ).

(ii) The program shall receive approval from the SOTA prior to the initiation of interim services and notify SOTA when a recipient:

(I) Begins interim treatment,

(II) Leaves interim treatment, and

(III) Before the date of transfer to comprehensive services and shall document such notifications.

(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.

(iv) All requirements for comprehensive treatment apply to interim treatment with the following exceptions:

(I) A primary counselor is not required to be assigned to the recipient, but crisis services, including shelter, support, should be available.

(II) Interim treatment cannot be provided for longer than 180 days in any 12-month period.

(III) By day 120, a plan for continuing treatment beyond 180 days shall be created and documented in the recipient's record.

(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, communitybased resources for ancillary services should be made available to the individual recipients in interim treatment.

Ala. Admin. Code r. 580-9-44-.29

New Rule: Filed January 26, 2012; effective 3/1/2012.

Amended by Alabama Administrative Monthly Volume XLI, Issue No. 04, January 31, 2023, eff. 3/17/2023.

Adopted by Alabama Administrative Monthly Volume XLII, Issue No. 12, September 30, 2024, eff. 9/18/2024; expires 120 days, 1/16/2025 (Emergency).

Author: Substance Abuse Services Division

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