65D-30.0142. Clinical and Operational Standards for Medication-Assisted Treatment for Opioid Use Disorders

(1) General Requirements.

(a) Methadone Medication-Assisted Treatment Program Sponsor. The methadone medication-assisted treatment sponsor, as defined in subsection 65D-30.002(42), F.A.C., of a new provider shall be a licensed health professional and shall have worked in the field of substance use treatment at least five (5) years. The sponsor is responsible for the program operation and assumes responsibility for all its employees, including any practitioners, agents, or other persons providing medical, rehabilitative, or counseling services at the program or any of its medication units. The program sponsor need not be a licensed physician but shall employ a licensed physician for the position of medical director.

(b) Medical Director. The medical director of a provider shall have a minimum of two (2) years’ experience treating substance use disorders.

(c) Special Permit and Consultant Pharmacist.

1. Special Permit.

a. All providers shall obtain a special pharmacy permit from the State of Florida Board of Pharmacy. New applicants shall be required to obtain a special pharmacy permit prior to licensure by the Department.

b. Providers obtaining a special pharmacy permit shall hire a consultant pharmacist licensed by the state of Florida.

2. Consultant Pharmacist. The responsibilities of the consultant pharmacist include the following:

a. Develop policies and procedures relative to the supervision of the compounding and dispensing of all medications dispensed in the facility;

b. Provide ongoing pharmaceutical consultation;

c. Develop operating procedures for maintaining all medication records and security in the area within the facility in which the compounding, storing, and dispensing of medications occur;

d. Meet face-to-face, at least quarterly, with the medical director to review the provider’s pharmacy practices. Meetings shall be documented in writing and signed and dated by both the consultant pharmacist and the medical director;

e. Prepare written reports regarding the provider’s level of compliance with established pharmaceutical procedures. Reports shall be prepared at least semi-annually and submitted, signed, and dated by the consultant pharmacist and submitted to the medical director; and

f. Physically visit the provider at least every two (2) weeks to ensure that established procedures are being followed, unless otherwise stipulated by the state Board of Pharmacy. A log of such visits shall be maintained, signed, and dated by the consultant pharmacist at each visit.

3. Change of Consultant Pharmacist. The provider’s medical director shall notify the Board of Pharmacy within 10 days of any change of consultant pharmacists and provide a copy of such notification to the Substance Abuse and Mental Health Program Office and the SOTA.

(d) Providers shall develop policies and procedures for the treatment of pregnant women.

1. Prior to the initial dose, each female shall be fully informed of the risks of taking and not taking methadone during pregnancy, including possible adverse effects on the mother or fetus. If the medication is not taken, risk includes withdrawal syndrome which has been associated with fetal demise. The individual shall sign and date a statement acknowledging this information. Pregnant women shall be seen by the physician or their qualified designee as clinically advisable. The physician or qualified medical designee must document in the clinical record that the pregnant individual was informed of the risks in this paragraph.

2. Pregnant individuals shall be informed of the opportunity and need for prenatal care by referral to publicly or privately funded health care providers. The provider shall establish a documented system for referring individuals to prenatal care.

3. In the event there are no publicly funded prenatal referral resources to serve those who are indigent, or if the individual refuses the services, the provider shall offer her basic prenatal instruction on maternal, physical, and dietary care as part of its counseling service. The nature of prenatal support shall be documented in the clinical record.

4. When the individual is referred for prenatal services, the practitioner to whom she is referred shall be notified that she is undergoing methadone medication-assisted treatment and provided treatment plans addressing pregnancy and post-partum care. Documentation of referral shall be kept in the clinical record. If a pregnant individual refuses referral and prenatal instruction and counseling, the provider shall obtain a signed statement from the individual acknowledging that she had the opportunity for the prenatal care but declined.

5. The physician shall sign or countersign and date all entries related to prenatal care.

6. Treating physicians or their qualified designee shall consult with other treating medical staff providing care and medications to ensure that prescribed medication protocols are not contraindicated.

(e) Minimum Responsibilities of the Physician. Physicians must adhere to best practice standards for an individual receiving methadone medication-assisted treatment. Best practices are evidence-based practices which are subject to scientific evaluation for effectiveness and efficacy. Best practice standards may be established by entities such as the Substance Abuse and Mental Health Services Administration, national trade associations, accrediting organizations recognized by the Department, or comparable authorities in substance use treatment. In addition, the responsibilities of the physician include the following:

1. To ensure that evidence of current physiological addiction, history of addiction, and exemptions from criteria for admission are documented in the clinical record before the individual receives the initial dose of medication;

2. To sign or countersign and date all medical orders, including the initial prescription, all subsequent prescription changes, and all changes in the frequency of take-home medication;

3. To ensure that justification is recorded in the clinical record for any change to the frequency of visits to the provider for observed medication ingesting, including cases involving the need for exemptions, or when prescribing medication for physical or emotional problems;

4. To review, sign or countersign, and date treatment plans at least annually; and

5. The initial assessment for methadone medication-assisted treatment shall be conducted in person. Each subsequent assessment shall be conducted, either in-person or via telehealth, with each individual at least annually, including evaluation of the individual’s physical/medical status, progress in treatment, and justification for continued maintenance or medical clearance for voluntary withdrawal or a dosage reduction protocol. The assessment shall be conducted by a physician or a P.A. or A.P.R.N. under the supervision of a physician. The protocol shall include criteria and the conditions under which the assessment would be conducted more frequently.

(f) Central Registry.

1. Providers shall register and participate in the Department-approved electronic registry system for individuals receiving methadone medication-assisted treatment services. The registry is used to prevent the enrollment of individuals at more than one (1) provider and to facilitate continuity of care in the event of program closure and guest dosing verification. The registry shall be implemented in compliance with 42 Code of Federal Regulations, §2.13. The provider must submit to information gathering activities by the SOTA for state planning purposes.

2. Methadone shall not be administered or dispensed to an individual who is known to be currently enrolled with another provider. Providers shall develop policies and procedures to ensure compliance with 42 C.F.R. 8.12(g)2. If an individual changes providers, the current provider shall assist with coordinating the transfer to another provider. The evidence of linkage to care shall be noted in the clinical record. Upon notification that an individual is being admitted to a new provider, it is the responsibility of the original admission site to discharge an individual from the Central Registry.

3. Individuals applying for methadone medication-assisted treatment shall be informed of the registry procedures and shall be required to sign a consent form before receiving services. Individuals who apply for services and do not consent to the procedures will not be enrolled.

4. If an individual is found trying to secure or has succeeded in obtaining duplicate doses of methadone or other medication, the individual shall be referred back to the original provider. A written statement documenting the incident shall be forwarded to the original provider and, if the individual succeeded in obtaining the duplicate dose, the incident must be reported in the Department-approved incident reporting system by the provider who dispensed the duplicate dose. The physician of the original provider or their qualified designee shall evaluate the individual as soon as medically feasible for continuation of treatment. In addition, a record of violations by individuals must become part of the clinical record maintained by all participating providers and shall be made available to Department staff upon request.

5. With the application for licensure, providers shall submit with the application for licensure written plans for participating in registry activities.

(g) Wait lists.

1. Providers must maintain wait list data for individuals seeking care but unable to enroll within 24 hours of first contact requesting initiation of treatment.

2. When an opening is available, providers must make at least one (1) attempt to contact the next prospective individual on the waiting list and maintain a system of documenting attempts. Documentation shall include at a minimum: date of attempted contact, individual’s name, date of birth, address, and contact information.

3. Priority must be given to pregnant woman and HIV-positive individuals.

(h) Operating Hours and Holidays.

1. Providers shall post operating hours in full view of the public. This information shall include hours for counseling and administering medication.

2. All providers shall be open Monday through Saturday. Providers shall have medicating hours and counseling hours that accommodate individuals, including two (2) hours of medicating time accessible daily outside the hours of 9:00 a.m. to 5:00 p.m.

3. Providers are required to medicate on Sundays according to the needs of the individual. This includes individuals on Phase 1, individuals on a 30 to 180-day detoxification regimen, and individuals who need daily observation. Providers shall develop policies and procedures for Sunday coverage.

4. In case of impending disaster, providers shall implement disaster preparedness policies and procedures as necessary regarding operating hours and dosing.

5. When holidays are observed, all individuals shall be given a minimum of a seven (7)-day notice of any changes to the hours of operation.

6. When applying for a license, providers shall inform the respective program offices of their intended holidays. In no case shall two (2) or more holidays occur in immediate succession unless the provider is granted an exemption by the state and federal authority. Take-out privileges shall be available to all eligible individuals during holidays, if clinically advisable. Services shall be accessible to individuals for whom take-home medication is not clinically advisable. Individuals who fall into this category shall receive a minimum of seven (7) days notification regarding arrangements and exact hours of operation.

(2) Maintenance Treatment Standards.

(a) Standards for Placement.

1. Determining Addiction and Placement.

a. An individual aged 18 or over shall be placed in treatment only if the physician, or their qualified designee identified in accordance with the medical protocol established in subsection 65D-30.004(7), F.A.C., determines that the individual is currently physiologically addicted to opioid drugs and became physiologically addicted at least one (1) year before placement in methadone medication-assisted treatment.

b. A one (1)-year history of addiction means that individuals seeking placement in methadone medication-assisted treatment were physiologically addicted to opioid drugs at least one (1) year before placement and were addicted continuously or episodically for most of the year immediately prior to placement with a provider.

c. In the event the exact date of physiological addiction cannot be determined, the physician or their qualified designee may admit the individual to treatment if, by the evidence presented and observed, and utilizing reasonable clinical judgment, the physician or their qualified designee concludes that the individual was physiologically addicted during the year prior to placement. Such observations shall be recorded in the clinical record by the physician or their qualified designee.

d. Individuals with a chronic immune deficiency or who are pregnant must be screened and admitted on a priority basis.

e. Individuals seeking admission with only a primary medical diagnosis of a chronic pain condition must be referred to specialists qualified to treat chronic pain conditions and are not eligible for admission. Individuals who are diagnosed with a primary opioid use disorder and a chronic pain condition are eligible for admission.

2. Placement of Individuals Under 18 Years of Age.

a. An Individual under 18 is required to have had two (2) documented unsuccessful attempts at short-term detoxification or substance use treatment within the last year to be eligible for treatment.

b. The physician or their qualified designee shall document in the clinical record that the individual continues to be or is again physiologically dependent on opioid drugs and is appropriate for placement.

c. Treatment standards in this rule are not intended to limit current best practice protocols for this population.

3. Evidence of Addiction.

a. In determining the current physiological addiction of the individual, the physician or their qualified designee shall consider signs and symptoms of drug intoxication, evidence of use of drugs through a urine drug screen, and needle marks.

b. Other evidence of current physiological dependence shall be considered by noting early signs of withdrawal, such as cramping, lachrymation, rhinorrhea, pupilary dilation, pilo erection, body temperature, pulse rate, elevated blood pressure, and increased respiratory rate.

(b) Individual Consent. In addition to the minimum requirements for completing a treatment plan, providers shall conduct the following:

1. Individuals shall be advised of the benefits of therapeutic and supportive rehabilitative services, and that the goal of methadone medication-assisted treatment is stabilization of functioning. The individual shall be fully informed of the risks and consequences of methadone medication-assisted treatment.

2. Each provider shall provide a thorough explanation of all program services, as well as state and federal policies and regulations, and obtain a voluntary, written, and signed program-specific statement of fully informed consent from the individual at admission.

3. During treatment plan review, the counselor shall re-assess present level of functioning, course of treatment, and identify future goals.

4. No individual under 18 years of age shall be placed in methadone medication-assisted treatment unless a parent or legal guardian provides written consent.

(c) Exemption from Minimum Standards for Placement.

1. An individual who has resided in a penal or chronic-care institution for one (1) month or longer may be placed in treatment within 14 days before release or within 6 months after release from such institution. This can occur without documented evidence to support findings of physiological addiction, providing the individual would have been eligible for placement before incarceration or institutionalization, and in the reasonable clinical judgment of the physician or their qualified designee, methadone medication-assisted treatment is medically justified.

2. Evidence of prior residence in a penal or chronic-care institution, evidence of all other findings, and the criteria used to determine the findings shall be recorded by the physician or their qualified designee in the clinical record.

3. The physician or their qualified designee shall sign and date these entries before the initial dose is administered.

(d) Pregnant individuals.

1. Pregnant individuals, regardless of age, who have had a documented addiction to opioid drugs in the past and who may be in direct jeopardy of returning to opioid drugs, may be placed in methadone medication-assisted treatment. For such individuals, evidence of current physiological addiction to opioid drugs is not needed if a physician or their qualified designee certifies the pregnancy and, in utilizing reasonable clinical judgment, finds treatment to be medically justified.

2. Pregnant individuals may be placed on a medication-assisted treatment regimen using a medication other than methadone only upon the written order of a physician who determines this to be the best choice of therapy for that individual.

3. Evidence of current or prior addiction and criteria used to determine such findings shall be recorded in the clinical record by the admitting physician or their qualified designee. The physician or their qualified designee shall sign and date these recordings prior to administering the initial dose.

(e) Readmission to Treatment.

1. Up to 2 years after discharge or detoxification for opioid use disorders, and individual who has been previously involved in methadone medication-assisted treatment may be readmitted without evidence to support findings of current physiological addiction. This can occur if the provider is able to document prior maintenance treatment of six (6) months or more and the physician or their qualified designee, utilizing reasonable clinical judgment, finds readmission to treatment to be medically justified.

2. Evidence of prior treatment and the criteria used to determine such findings shall be recorded in the clinical record by the physician or their qualified designee. The physician or their qualified designee shall sign and date the information recorded in the clinical record.

(f) Denying an Individual Treatment.

1. If an individual will not benefit from a treatment regimen that includes the use of methadone or other opioid treatment medications, or if treating the individual would pose a danger to others, the individual may be refused treatment. This is permitted even if the individual meets the standards for placement.

2. The physician or their qualified designee shall make this determination and shall document the basis for the decision to refuse treatment.

(g) Methadone Take-home Privileges.

1. Take-home doses of methadone are permitted only for individuals participating in a methadone medication-assisted treatment program. Requests for take-home doses greater than the amount allowed, as stipulated in paragraph (2)(h) of this rule, must be entered into the Substance Abuse and Mental Health Services Administration/Center for Substance Abuse Treatment (SAMHSA/CSAT) Opioid Treatment Program Extranet for federal and state approval. The following must be indicated on the exception request:

a. Dates of Exception:  not to exceed a 12-month period of time per request;

b. Justification;

c. Indicate compliance with securing methadone in a lockable secure container;

d. Statement of supporting documentation on file; and

e. Any other information the provider deems necessary in support of the request.

2. The medical director shall make determinations based on take-home criteria as stated in 42 CFR 8.12(i)(2).

3. When considering an individual’s responsibility in handling methadone, the physician shall consider the recommendations of other staff members who are most familiar with the relevant facts regarding the individual.

4. The requirement of time in treatment and participation is a minimum reference point after which an individual may be eligible for take-home privileges. The time in treatment reference is not intended to mean that an individual in treatment for a particular length of time has a right to take-home methadone. Regardless of time in treatment, the physician, state or federal authorities with cause, may deny or rescind the take-home privileges of an individual.

5. In the event of a disaster that prompts a program-wide exemption authorized by SAMHSA and the SOTA in advance, providers must make appropriate arrangements for unstable individuals to obtain their medication.

(h) Take-home Phases. To be considered for take-home privileges, all individuals shall be in compliance with criteria as stated in 42 CFR 8.12(i)(2).

1. Differences in the nature of abuse potential in opioid treatment medications determine the course of treatment and subsequent take-home privileges available to the individual based on progress, participation, and circumstances. The assessment and decision approving all take-homes shall be documented in the individual’s clinical record, signed and dated by the physician.

2. Take-home privileges shall be limited to the following:

a. During the first 90 days of treatment, the take-home supply is limited to a single dose each week. The individual shall ingest all other doses under appropriate medical supervision.

b. In the second 90 days of treatment, the take-home supply is limited to two doses per week.

c. In the third 90 days of treatment, the take-home supply is limited to three doses per week.

d. In the remaining months of the first year, an individual may be given a maximum of six-day supply of take-home medication.

e. After one year of continuous treatment, an individual may be given a maximum two-week supply of take-home medication.

f. After two years of continuous treatment, an individual may be given a maximum of one-month supply of take-home medication, but must make monthly visits.

3. Diversion Control Requirements.

a. All individuals in medical maintenance shall receive their medication orally in the form of liquid, diskette or tablet. Diskettes and tablets are allowed if formulated to reduce potential parenteral abuse.

b. All individuals will participate in a “call back” program by reporting back to the provider upon notice for a medication count.

c. All criteria for take-home privileges as listed under paragraph (2)(g) shall continue to be met.

(i) Caseload. No full-time counselor shall have a caseload that exceeds the equivalent of 50 currently participating individuals. Participating individual equivalents are determined in the following manner.

1. An individual seen once per week would count as 1.0 equivalent.

2. An individual seen bi-weekly would count as a .5 equivalent.

3. An individual seen monthly or less would count as a .25 equivalent.

(j) Termination from Treatment.

1. There will be occasions when individuals will need to be terminated from treatment. Individuals who fall into this category are those who:

a. Attempt to sell or deliver their prescribed medication or any other drugs;

b. Become or continue to be actively involved in criminal behavior;

c. Consistently fail to adhere to the requirements of the provider;

d. Persistently use illicit substances; or

e. Do not effectively participate in treatment programs to which they are referred.

Such individuals shall be withdrawn in accordance with a dosage reduction schedule prescribed by the physician or qualified designee and referred to other treatment, as clinically indicated. This action shall be documented in the clinical record by the physician or their qualified designee.

2. Providers shall establish criteria for involuntary termination from treatment. All individuals shall be given a copy of these criteria upon placement and shall sign and date a statement that they have received the criteria.

(k) Withdrawal from Maintenance.

1. The physician or qualified designee shall ensure that all individuals in methadone medication-assisted treatment receive an annual assessment. This assessment may coincide with the annual assessment of the treatment plan and shall include an evaluation of the individual’s progress in treatment and the justification for continued maintenance. The assessment and recommendations shall be recorded in the clinical record.

2. All providers shall develop policies and procedures that establish a process to assist individuals served in attaining recovery goals, thereby enabling transition to a lower level of care. At least annually, during the treatment plan review, the provider shall assess the individual’s readiness and desire to transition to a lower level of care and shall provide information about the titration of medication to maintain therapeutic levels or to withdraw from the medication with the least necessary discomfort. Transition is gradual, individualized, and actively involves the individual served and the next provider to ensure effective coordination and engagement.

3. An individual being withdrawn from treatment shall be closely supervised during withdrawal. A dosage reduction schedule shall be established by the physician or qualified designee and documented in the clinical record. In the event withdrawal is clinically inadvisable, justification must be kept in the clinical record, signed and dated by the physician or qualified designee and the individual.

(l) Services.

1. Comprehensive Services. A comprehensive range of services shall be available to each individual as required in Section 397.427(1), F.S. The type of services to be provided shall be determined by individual needs, the characteristics of individuals served, and the available community resources.

2. Counseling.

a. Each individual receiving methadone medication-assisted treatment shall receive regular counseling. A minimum of one (1) counseling session per week shall be provided to individuals through the first 90 days. A minimum of two (2) counseling sessions per month shall be provided to individuals who have been in treatment for at least 91 days and up to one (1) year. A minimum of one (1) counseling session per month shall be provided to individuals who have been in treatment for longer than one (1) year.

b. A counseling session shall be at least 30 minutes in duration, conducted in a private room, and shall be documented in the clinical record.

c. Any entity or qualified professional who has entered into a written agreement with a licensed provider is bound by these regulations.

(m) Overdose Prevention.

1. All licensed providers must develop overdose prevention plans. Overdose prevention plans must be shared with individuals upon admission and discharge from medication-assisted treatment, regardless of the reason for discharge. Plans must also be shared with individuals placed on a waitlist to receive treatment services. Overdose prevention plans shall include, at a minimum:

a. Education about the risks of overdose, including having a lower tolerance for opioids once the individual is no longer on medication-assisted treatment;

b. Information about Naloxone, the medication that reverses opioid overdose, including where and how to access Naloxone in the county of residence;

c. For providers who maintain an emergency overdose prevention kit, a developed and implemented plan to have staff trained in the prescribed use and the availability of the kit for use during all program hours of operation.

(3) Medication Units.

(a) A provider that currently holds a state license and who has either exceeded site capacity or has a significant proportion of individuals in treatment with a travel burden, may apply to the SOTA to establish a medication unit. The provider must be in compliance with the Department and applicable regulating agencies. The licensed provider and medication unit must be owned by the same provider.

(b) A medication unit’s services shall comply with the requirements 42 CFR 8.2 and 42 CFR 8.11(i).

(c) Providers interested in establishing a medication unit must submit a written proposal to the state authority for review and approval. Proposals must include the following for consideration of approval:

1. Description of proposed medication unit. Include description of target population, geographical catchment area, physical location/address, proposed capacity, and hours of operation;

2. Justification of need for medication unit. Provide explanation on why currently licensed facilities are insufficient and how the proposed medication unit addresses unmet need;

3. Copy of state license and federal certifications;

4. Required qualifications and job description for Medical Director, clinical on-site Director or Manager, and proposed staffing for the medication unit;

5. Implementation plan, including timeframes for securing federal approvals for a medication unit and anticipated start date of services;

6. Plans to secure proper zoning before medication unit opening; and

7. Plans on how medication unit will ensure individuals receive comprehensive support services such as counseling.

8. An affirmative statement that the primary full-service program agrees to retain responsibility for care;

9. An affirmative statement that the medication unit is limited to administering and dispensing the narcotic treatment medications and collecting samples for drug screening or analysis.

(d) Medication units must open within two (2) years of receiving approval. Providers who are delayed for a reason other than a natural disaster may petition the Department for a rule waiver pursuant to Section 120.542, F.S.

(4) Best Practices. All licensed providers shall comply with best practices as defined in paragraph (4)(e) of this rule.

(5) Other Medications.

(a) Buprenorphine Products. Qualified medical personnel licensed to practice in the state of Florida and meeting all federal requirements can prescribe buprenorphine to individuals under their license. Medical personnel shall comply with federal regulations related to buprenorphine products.

(b) Naltrexone Products. Naltrexone can be prescribed by any healthcare provider who is licensed to prescribe medications. Healthcare providers must meet all federal requirements and shall conform to federal regulations related to naltrexone products.

(c) Providers shall adhere to the prevailing federal and state requirements regarding the use of opioid treatment medications in the maintenance treatment of individuals who are or become pregnant during the course of treatment.

This rule shall remain in effect for a period of five years after its effective date and shall be reviewed by the Department for its continued necessity at least 90 days before its expiration.

(6) This rule will be reviewed and repealed, modified, or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 397.321(5) FS. Law Implemented 397.311(26), 397.321, 397.410, 397.427 FS. History–New 8-10-20, Amended 5-19-22.