The Department intends to amend Rule 65D-30.0142, F.A.C., Clinical and Operational Standards for Medication-Assisted Treatment for Opioid Use Disorders. This rule amendment will reduce staffing and fiscal burdens on providers ....

 

DEPARTMENT OF CHILDREN AND FAMILIES

Substance Abuse Program

RULE NO.:RULE TITLE:

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

PURPOSE AND EFFECT: The Department intends to amend Rule 65D-30.0142, F.A.C., Clinical and Operational Standards for Medication-Assisted Treatment for Opioid Use Disorders. This rule amendment will reduce staffing and fiscal burdens on providers of Medication-Assisted Treatment for Opioid Use Disorders, while implementing new evidence-informed practices for individuals receiving these services.

SUMMARY: The proposed rule amendment adopts a rule substantively identical to the federal regulations adopted by the Substance Abuse and Mental Health Services Administration at Title 42 Code of Federal Regulations, Section 8.12(i)(3) (42 C.F.R 8.12(i)(3)), aligns the maximum caseload requirements for counselors with other rule chapter service components, and allows physicians to conduct annual assessments through telehealth.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

A SERC Checklist was prepared and a SERC is not required.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The Department used a checklist to conduct an economic analysis and determine if there is an adverse impact or regulatory costs associated with this rule that exceeds the criteria in section 120.541(2)(a), F.S. Based upon this analysis, the Department has determined that the proposed rule is not expected to require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 397.321(5), FS.

LAW IMPLEMENTED: 397.311(26), 397.321, 397.410, 397.427, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME:

PLACE:

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Elizabeth Floyd. Elizabeth Floyd can be reached at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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 an a 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 criteria as stated in 42 CFR 8.12(i)(2).

1. No change.

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.

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.

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 (m) No change.

(n) Caseload. No full-time counselor shall have a caseload that exceeds the equivalent of 50 32 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.

4. As an example, a counselor has a caseload of 15 individuals that are seen weekly (counts as an equivalent of 15), 30 individuals seen biweekly (counts as an equivalent of 15), and 8 individuals seen monthly (counts as an equivalent of 2). The counselor would have a total caseload of 53 individuals equaling 32 equivalent individuals.

(o) through (r) No change.

(3) through (5) No change.

(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 ______

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Chris Weller

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Shevaun L. Harris

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 28, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 6, 2022