Notice of Emergency Rule

Jurisdiction
Florida
Publication
Issue 228
Volume 47
Published November 24, 2021
Rule Type
Emergency Rule
Issuing Body
Department of Children and Families
Substance Abuse Program

Notice Text

Notice of Emergency Rule DEPARTMENT OF CHILDREN AND FAMILIES Substance Abuse Program RULE NO.: RULE TITLE: 65DER21-2 Clinical and Operational Standards for Medication-Assisted Treatment for Opioid Use Disorders. SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: On May 03, 2017, the Governor of the State of Florida signed an executive order declaring that the opioid epidemic threatens the State of Florida with an emergency. This executive order was extended eleven times. Also, on April 01, 2019, the Governor signed an additional order creating the Statewide Task Force on Opioid Abuse to combat the opioid epidemic. Florida currently ranks second in the nation for overdose deaths, and deaths from a drug overdose increased in Florida by 37 percent from 2019. The Department has determined that the concern in the increase of overdose and deaths due to opioid use necessitates revising the methadone treatment procedures. REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The procedure is fair and necessary under the circumstances because it ensures equitable treatment of medication-assisted treatment providers in enabling them to increase access to care for individuals in the community and decrease chances of opioid related overdoses and deaths. Proposed changes in this emergency rule focus on changing the following: the criteria for methadone take-home privileges and the requirement on conducting face-to-face assessments. SUMMARY: This rule makes changes to permanent Rule 65D-30.0142, F.A.C., relating to clinical and operational requirements for medication-assisted treatment for opioid use disorders. Changes are necessary to address an immediate danger to the public health by modifying the requirements related to conducting assessment services through telehealth and by adjusting the methadone take-home standards to reflect the current federal guidance. This rule reflects the Substance Abuse and Mental Health Services Administration's temporary extension of the federal methadone take-home flexibility issued on March 2020 and extended on November 18, 2021. THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Danielle Thompson. Danielle can be reached at Danielle.Thompson@myflfamilies.com
THE FULL TEXT OF THE EMERGENCY RULE IS: 65DER21-2 (65D-30.0142) Clinical and Operational Standards for Medication-Assisted Treatment for Opioid Use Disorders. (1) General Requirements. (a) through (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. In addition, the responsibilities of the physician include the following: 1. through 4. No change. 5. To ensure that ana face-to-face assessment is conducted, either face-to-face 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 initial assessment for methadone medication-assisted treatment shall be conducted face-to-face. 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) through (h) No change. (2) Maintenance Treatment Standards. (a) through (f) No change. (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. through b. No change. c. Dates and results of last three (3) drug screens, for individuals in treatment longer than 90 days; d. through f. are redesignated c. through e. No change. 2. through 5. No change. (h) Take-home Phases. To be considered for take-home privileges, all individuals shall be in compliance with the following criteria:as stated in 42 CFR 8.12(i)(2). 1. No Change. 2. Take-home privileges shall be in accordance with the following: a. Under this rule, stable individuals are individuals who have completed a minimum of 60 days in treatment, and whose medical record fully documents all of the following: (I) The benefits of providing unsupervised doses to an individual outweigh the risks; (II) The individual demonstrates total adherence per the provider's discretion with their treatment plan for at least 60 days; (III) The individual maintained negative toxicology tests for 60 calendar days; (IV) An absence of serious behavioral problems; (V) Stability in the individual's living arrangements and social relationships; (VI) An absence of substance misuse-related behaviors; (VII) An absence of recent diversion activity; and (VIII) The individual provided assurance that the medication can be safely stored. b. Under this rule, less stable individuals are individuals who have completed a minimum of 30 days in treatment, and whose medical record fully documents all of the following: (I) The benefits of providing unsupervised doses of methadone to the individual outweigh the risks; (II) The individual demonstrated partial adherence with their treatment plan for at least 30 days; (III) The individual maintained 30 days of negative toxicology tests; (IV) An absence of recent diversion activity; and (V) The individual provided assurance that the medication can be safely stored. c. The provider may request blanket exceptions for stable individuals in a methadone medication-assisted treatment program to receive 28 days of take-home doses of the individual's medication for opioid use disorder. d. The provider may request up to 14 days of take-home medication for those individuals who are less stable but who the provider believes can safely handle this level of take-home medication. 2. No take-homes shall be permitted during the first 30 days following placement, unless approved by both the state and federal authorities. a. Phase I. Following 30 consecutive days in treatment, the individual may be eligible for one (1) take-home per week from day 31 through day 90, provided that the individual has had negative drug screens and is following program requirements for the preceding 30 days. b. Phase II. Following 90 consecutive days in treatment, the individual may be eligible for two (2) take-homes per week from day 91 through day 180, provided that the individual has had negative drug screens for the preceding 60 days. c. Phase III. Following 180 consecutive days in treatment, the individual may be eligible for three (3) take-homes per week with no more than a two (2)-day supply at any one time from day 181 through one (1) year, provided that the individual has had negative drug screens for the preceding 90 days. d. Phase IV. Following one (1) year in continuous treatment, the individual may be eligible for four (4) take-homes per week through the second year of treatment, provided that the individual has had negative drug screens for the preceding 90 days. e. Phase V. Following two (2) years in continuous treatment, the individual may be eligible for five (5) take-homes per week, provided that the individual has had negative drug screens for the preceding 90 days. f. Phase VI. Following three (3) years in treatment, the individual may be eligible for six (6) take-homes per week provided that the individual had all negative drug screens for the past year. 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. 3. Methadone Medical Maintenance. Providers may place an individual on methadone medical maintenance in cases where it can be demonstrated that the potential benefits of medical maintenance to the individual exceed the potential risks, in the professional judgment of the physician. Only a physician may authorize placement of an individual on medical maintenance. The physician shall provide justification in the clinical record regarding the decision to place an individual on medical maintenance. The following conditions shall apply to medical maintenance. a. To qualify for partial medical maintenance, an individual may receive no more than 13 take-homes and must have been in continuous treatment for four (4) years with negative drug screens for the previous two (2) years. b. To qualify for full medical maintenance an individual may receive no more than 27 take-homes and must have been in continuous treatment for five (5) years with negative drug screen for the prious two (2) years. c. All individuals in medical maintenance will receive their medication orally in the form of liquid, diskette or tablet. Diskettes and tablets are allowed if formulated to reduce potential parenteral abuse. d. All individuals will participate in a "call back" program by reporting back to the provider upon notice for a medication count. e. All criteria for take-homes as listed under paragraph (2)(g) shall continue to be met. (i) through (r) No change. (3) through (5) No change. (6) This emergency rule will become effective on November 25, 2021 and expire 90 days later. Rulemaking Authority 397.321(5) FS. Law Implemented 397.311(26), 397.321, 397.410, 397.427 FS. History-New 8-10-20. Amended______ THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE. EFFECTIVE DATE: November 25, 2021