The proposed amendments will allow appropriately trained and supervised occupational therapists to use a neurofeedback device to treat patients. A “neurofeedback device” is a device that provides immediate feedback from a computer-based program ...

 

DEPARTMENT OF HEALTH

Board of Occupational Therapy

RULE NO.:RULE TITLE:

64B11-4.001Use of Prescription Devices

PURPOSE AND EFFECT: The proposed amendments will allow appropriately trained and supervised occupational therapists to use a neurofeedback device to treat patients. A “neurofeedback device” is a device that provides immediate feedback from a computer-based program that measures brainwave activity with the use of sound, visual and/or tactile input to cue the brain to reorganize and retrain itself.

SUMMARY: The proposed amendments pertain to use of a neurofeedback device by an Occupational Therapist or Occupational Therapy Assistant.

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.

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: During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

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: 468.203(4), 468.204 FS.

LAW IMPLEMENTED: 468.203(4) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Allen Hall, Executive Director, Board of Occupational Therapy/MQA, 4052 Bald Cypress Way, Bin # C05, Tallahassee, Florida 32399-3253.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B11-4.001 Use of Prescription Devices.

(1) through (2) No change.

(3) Neurofeedback Device.

(a) Use of a neurofeedback device for which a prescription is required by Federal law, 21 C.F.R. §801.109, is expressly prohibited by Section 468.203(4), F.S., except by an occupational therapist or occupational therapy assistant who has received training as prescribed in this rule.

(b) For purposes of this rule, a “neurofeedback device” is any device that provides immediate feedback from a computer-based program that measures brainwave activity with the use of sound, visual and/or tactile input to cue the brain to reorganize and retrain itself.

(c) The training required for students, postgraduates, and licensees to qualify for the use of a neurofeedback device shall include didactic training of at least sixteen (16) hours and performance of at least five (5) treatments under supervision. The required training may be obtained through educational programs, workshops, or seminars offered at a college or university approved for training of occupational therapists by the American Occupational Therapy Association or of physical therapists by the American Physical Therapy Association or at clinical facilities affiliated with such accredited colleges or universities or educational programs offered through the American Society of Hand Therapists or Florida Occupational Therapy Association. Online courses are not approved for the didactic or performance training.

(d) Supervised treatment sessions shall be conducted under the personal supervision of licensed occupational therapists and occupational therapy assistants who have completed sixteen (16) hours of coursework in the use of neurofeedback devices and five (5) supervised treatments, licensed physical therapists and physical therapist assistants who have completed sixteen(16) hours of coursework in the use of neurofeedback devices and five (5) supervised treatments, medical doctors trained in the use of neurofeedback devices, psychologists trained in the use of neurofeedback devices, or other licensed healthcare professionals trained in the use of neurofeedback devices. Treatment supervisors must have a minimum of 24 months prior experience in the use of neurofeedback devices. Personal supervision means that the supervisor is in the room with the trainees and actively provides guidance and supervision of the performance treatments.

(e) The training provided which teaches the therapeutic uses of neurofeedback devices shall provide for the following minimum competency level:

1. Standards.

a. The expected outcome of training with neurofeedback devices must be consistent with the goals of treatment.

b. Training with neurofeedback devices must be safely administered to the scalp.

c. Training with neurofeedback devices must be adequately documented.

2. Instrumentation.

a. Ability to describe core concepts, methods, and instrumentation of neurofeedback

b. Ability to interpret the EEG (electroencephalogram) with respect to signal integrity and the presence of artifacts

c. Ability to understand and describe concepts of frequency and amplitude

d. Ability to create, adjust and adapt training protocols based on the EEG, clinical observation, and response to training 

e. Ability to describe equipment characteristics, indications and contraindications for training

3. Preparation for Training. Ability to prepare the patient for training through positioning and adequate instruction.

4. Determination of training duration and intensity

a. Ability to discern when a trainee exhibits limited tolerance for an extended training session

b. Ability to judge the pacing of training sessions based on tolerance and response to the training session 

5. Training Administration. Ability to administer neurofeedback training through identification of controls, sequence of operation, and application of all safety rules and precautions.

6. Documentation of Neurofeedback Training. Ability to document training, including immediate and long-term effects of clinical neurofeedback training.

(f) Any occupational therapist or occupational therapy assistant who uses such neurofeedback device shall, upon request of the Board, or the Department, present proof that he or she has obtained the training required by this rule.

Rulemaking Authority 468.203(4), 468.204 FS. Law Implemented 468.203(4) FS. History–New 1-1-88, Formerly 21M-15.001, 61F6-15.001, Amended 12-4-95, Formerly 59R-63.001, Amended 8-9-99, 7-2-00, 4-1-13,                           .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Occupational Therapy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Occupational Therapy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 24, 2020

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 26, 2020