DEPARTMENT OF CHILDREN AND FAMILIES
RULE NO.:RULE TITLE:
65D-30.014Standards for Medication-Assisted Treatment for Opiodid Use Disorders
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 55, March 20, 2019 issue of the Florida Administrative Register.
65D-30.014 Standards for Medication-Assisted Treatment for Opioid Use Disorders.
(1) State Authority. The state authority is the Office of Substance Abuse and Mental Health. The State Opioid Treatment Authority (SOTA) is the individual designated by the Office of Substance Abuse and Mental Health to exercise the state’s authority and responsibilities in governing opiate treatment by opioid treatment programs. The SOTA acts as the state's coordinator for the development and regulatory monitoring of opioid treatment programs and serves as a liaison with the appropriate federal, state and local agencies.
(2) No change.
(3) Determination of Need
(a) The Department shall annually perform the assessment detailed in the
“Methodology of Determination of Need Methadone Medication-Assisted Treatment,” CF-MH 4038, (insert date), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXX. The Department shall publish the results of the assessment in the Florida Administrative Register by June 30. Facilities owned and operated by the Florida Department of Corrections are exempt from the needs assessment process. However, these facilities must apply for a license to deliver this service.
(b) The publication shall direct interested parties to submit a letter of intent to apply for licensure to provide medication-assisted treatment for opioid use disorders to the Regional Office of Substance Abuse and Mental Health where need has been demonstrated.
1. No change.
2. Interested parties Applicants must identify the fiscal year of the needs assessment to which they are responding and the number of awards they are applying for per county identified in the assessment in their letter of intent.
(c) Within seven (7) business days of the closing date, the Regional Office shall notify parties who submitted a letter of intent on how to proceed.
1. No change.
2. If the number of letters of intent exceeds the determined need, parties shall be invited to submit a “Methadone Medication-Assisted Treatment (MAT) Application to Proceed to Licensure Application” form, CF-MH 4041, (insert date), incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXX. Applications may not be rolled over for consideration in response to a needs assessment published in a different year and may only be submitted for a current fiscal year needs assessment.
a. through b. No change.
c. Applicants with the highest-scored applications in each county shall be awarded the opportunity to apply for licensure for the number of programs specified in their letter of intent to meet the need of that county. If there is unmet need, the next highest scored applicant(s) will receive an award(s) based on the remaining need and the number of programs specified in their letter of intent. This process will continue until the stated need is met. Regional offices shall inform the highest-scoring applicant(s) applicants in writing of the award.
d. No change.
(d) Awarded applicants must receive at least a probationary license within two (2) years of the published needs assessment connected to their application. See Rule 65D-30.0036, F.A.C. for licensure application requirements. Applicants may submit a request to the State Authority and Substance Abuse and Mental Health Program Office for an exception if unable to meet timeframes due to a natural disaster that causes physical damage to the applicant’s building(s). Proof of natural disaster and impact on physical property must accompany the request. Upon receipt of the request for exception and accompanying proof, a one-time extension shall be granted for six (6) months. Providers who are delayed for a reason other than a natural disaster may petition the Department for a rule waiver pursuant to s. 120.542, F.S.
(4) 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) No change.
(c) Special Permit and Consultant Pharmacist.
1. through 2. No change.
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 State Opioid Treatment Authority (SOTA).
(d) No change.
(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. mean practices that meet or exceed the standards established by nationally-recognized, research-validated substance use disorder-specific program standards regarding the types of services, hours of clinical care, and credentials of staff for levels of care. In addition, the responsibilities of the physician include the following:
1. through 4. No change.
5. To ensure that a face-to-face assessment is conducted 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. A.R.N.P. 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 Part 2. The provider must submit to information gathering activities by the SOTA for state planning purposes.
2. Providers must maintain the registry by recording and updating identifying, demographic, emergency contact, dosing, and relevant medical information for all individuals receiving methadone medication-assisted treatment.
a. Each business day, providers shall monitor individuals enrolled in more than one (1) site and discharge any individuals attempting to enroll in another location. Individuals shall not be dual enrolled in any two (2) locations for longer than three (3) days. Providers shall monitor the following reports quarterly to ensure compliance with no higher than a five (5) percent rate for missing data for the following data reports:
i. Missing Photos;
ii. Missing Zip Codes;
iii. Missing Dosing Summary;
iv. Missing Mileage Information;
v. Missing County Information;
vi. Missing Emergency Medication Information;
b. Providers shall monitor the following reports quarterly and ensure data is accurate:
i. Pregnancy Status. Providers must maintain accurate data on pregnancy status.
ii. Emergency Consent. Providers must make monthly attempts to add emergency contact for individuals who have not provided consent to be contacted during an emergency facility closure. Refusals must be documented. Providers shall ensure accuracy of emergency contact information quarterly.
iii. Emergency Dosing Projected Inventory Requirements. Providers must ensure they maintain an inventory of methadone onsite to dispense in the event of a natural or manmade disaster.
3. Program directors must certify monthly, via the Central Registry, the accuracy of census data.
24. 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 individual shall always report to the same provider unless prior approval is obtained from the original provider for treatment at another provider. Permission to report for treatment with another provider shall be granted only when the multi-disciplinary treatment team, in their professional judgement, determine it is in the best interest of the individual. The permission, supporting clinical documentation, and 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.
35. No change.
46. 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.
57. With the application for licensure, pProviders shall submit with the application for licensure written plans for participating in registry activities, maintaining accurate data on staff and individuals in treatment, and ensuring annual training for all staff on reporting and disaster preparedness procedures.
8. It is the responsibility of the SOTA to run quarterly reports to identify providers with missing data related to patient identification, dosage information, dual enrollment, pregnancy outcomes, and demographic information. Providers with a higher than five (5) percent non-compliance rate (missing or inaccurate data) will be contacted by the SOTA and/or licensure staff. Pursuant to s. 397.415, F.S., a Class IV fine will be imposed on those providers who do not correct non-compliance issues within five (5) days.
9. Prior to conducting an inspection or program review, an authorized agent of the Department shall contact the SOTA to obtain a compliance report. Non-compliance shall be incorporated into inspection reports and included in corrective action plans.
(g) through (h) No change.
(5) Maintenance Treatment Standards.
(a) Standards for Placement.
1. Determining Addiction and Placement.
a. through d. No change.
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. through 3. No change.
(b) Individual Consent. In addition to the minimum requirements for completing a treatment plan, providers shall conduct the following:
1. through 2. No change.
3. During treatment plan review In full consultation with the individual, the counselor shall re-assess discuss present level of functioning, course of treatment, and identify future goals. Consultations shall occur, at a minimum, quarterly for individuals in year one of treatment, and, at a minimum, bi-annually for individuals in treatment longer than one (1) year. These discussions should not place pressure on the individual to withdraw from or to remain in methadone medication-assisted treatment, unless medically or clinically indicated. Acknowledgement of these discussions shall be documented in the clinical record.
4. No change.
(c) through (e) No change.
(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 subparagraph (5)(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- six (6) month period of time per request;
b. through f. No change.
2. through 4. No change.
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. In the event there are medically unstable individuals, providers are responsible for contacting guest dosing centers (i.e. hospitals) in advance to ensure continuity of care. Providers shall make an effort to identify and provide individuals a list of nearby emergency shelters that will allow individuals to bring medication in a lockable secure container.
(h) through (j) No change.
(k) Exemptions from Take-Home Privileges and Phasing Requirements.
1. No change.
2. Temporary Reduced Schedule of Attendance
a. No change.
b. Any individual using prescription opioid medications or sedative medication not used in the medication-assisted treatment protocols shall provide a legitimate prescription from the prescribing medical professional physician. The physician, or medical designee, shall consult with the prescribing medical professional physician to coordinate care as outlined in medical protocols.
c. The necessity for an exemption from a mandatory schedule is to be based on the reasonable clinical judgment of the physician or qualified designee. Such determination of necessity shall be recorded in the clinical record by the physician or their qualified designee who shall sign and date these entries. An individual A client shall not be given more than a 14-day supply of methadone at any one time unless an exemption is granted by the state methadone authority and by the federal government. The state and federal authorities shall review exemption requests and render a decision in accordance with the criteria identified in 42 CFR 8.12(i)(1) and (2).
3. Travel Distance.
a. No change.
b. The reason for reducing the frequency of attendance shall be documented in the clinical record by the physician who shall sign and date these entries. The state and federal authorities shall review the requests for reducing the frequency of attendance and render a decision in accordance with the criteria identified in 42 CFR 8.12(i)(1) and (2). These requests shall be reviewed and a decision rendered by state and federal authorities.
4. Other Travel.
a. Any exemption that is granted to an individual travel shall be documented in the clinical record. Such documentation shall include tickets prior to a trip, copies of boarding passes, copies of fuel receipts, lodging receipts, or other verification of the individual’s arrival at the approved destination. If travel is due to medical treatment, documentation shall include a physician’s note or related documentation from the physician or qualified designee. Generally, special take-homes shall not exceed 27 doses at one (1) time. Request for take-homes in excess of 27 doses must be submitted for approval through SAMHSA/CSAT Opioid Treatment Program Extranet for federal and state approval. The state and federal authorities shall review these requests for take-homes in excess of 27 doses and render a decision in accordance with the criteria identified in 42 CFR 8.12(i)(1) and (2).
b. No change.
(l) Random Drug Screening.
1. through 3. No change.
4. The physician or their qualified designee shall review all positive drug screens from illicit substances in accordance with the medical protocol established in subsection 65D-30.004(7), F.A.C.
(m) No change.
(n) Caseload. No full-time counselor shall have a caseload that exceeds the equivalent of 32 currently participating individuals clients. Participating individual equivalents are determined in the following manner.
1. through 4. No change.
(o) 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. through e. No change.
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 qualified designee.
2. No change.
(p) 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. All providers shall develop policies and procedures that allow for systemic withdrawal of individuals as part of on-going services of the program. At least annually, the provider shall provide the individual with documentation that explains the titration of medication to maintain therapeutic levels or to withdraw from the medication with the least necessary discomfort. The provider shall discuss the advantages and potential problems associated with withdrawal. The provider shall document the request for titration in the clinical record with course of action and shall be signed by individual and consulting staff.
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.
(q) Services.
1. No change.
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 clients who have been in treatment for longer than one (1) year.
b. through c. No change.
(r) No change.
(6) Medication Units.
(a) No change.
(b) A medication unit’s services shall comply with the requirements are limited to medication dosing and drug screening as defined in 42 CFR 8.2 and 42 CFR 8.11(i).
(c) No change.
(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 s. 120.542, F.S.
(7) through (8) No change.
Changes have also been made to forms CF-MH 4040, Methadone Medication Assisted Treatment (MAT)
Application Evaluation, and CF-MH 4041, Methadone Medication Assisted Treatment (MAT)
Application to Proceed to Licensure Application.
