Section 284.51 - Electroencephalogram combined transcranial magnetic stimulation treatment pilot program(1) As used in this section, the term: (a) "Division" means the Division of Risk Management at the Department of Financial Services.(b) "Electroencephalogram combined Transcranial Magnetic Stimulation" or "eTMS" means treatment in which transcranial magnetic stimulation frequency pulses are tuned to the patient's physiology and biometric data.(c) "First Responder" has the same meaning as provided in s. 112.1815(1).(d) "Veteran" means: 1. A veteran as defined in 38 U.S.C. s. 101(2);2. A person who served in a reserve component as defined in 38 U.S.C. s. 101(27); or3. A person who served in the National Guard of any state.(2) The division shall select a provider to establish a statewide pilot program to make eTMS available for veterans, first responders, and immediate family members of veterans and first responders with: (a) Substance use disorders.(d) Traumatic brain injuries.(f) Post-traumatic stress disorder and accompanying comorbidities.(i) Quality of life issues affecting human performance, including issues related to or resulting from problems with cognition and problems maintaining attention, concentration, or focus.(3) The provider must display a history of serving veteran and first responder populations at a statewide level. The provider shall establish a network for in person and offsite care with the goal of providing statewide access. Consideration shall be provided to locations with a large population of first responders and veterans. In addition to traditional eTMS devices, the provider may utilize non-medical Portable Magnetic Stimulation devices to improve access to underserved populations in remote areas or to be used to serve as a pre-post treatment or a stand-alone device. The provider shall be required to establish and operate a clinical practice and to evaluate outcomes of such clinical practice.(4) The pilot program shall include: (a) The establishment of a peer-to-peer support network by the provider made available to all individuals receiving treatment under the program.(b) The requirement that each individual who receives treatment under the program also must receive neurophysiological monitoring, monitoring for symptoms of substance use and other mental health disorders, and access to counseling and wellness programming. Each individual who receives treatment must also participate in the peer-to-peer support network established by the provider.(c) The establishment of protocols which include the use of adopted stimulation frequency and intensity modulation based on EEGs done on days 0, 10, and 20 and motor threshold testing, as well as clinical symptoms, signs, and biometrics.(d) The requirement that protocols and outcomes of any treatment provided by the clinical practice shall be collected and reported by the provider quarterly to the division, the President of the Senate, and the Speaker of the House of Representatives. Such report shall include the bio-data metrics and all expenditures and accounting of the use of funds received from the department.(e) The requirement that protocols and outcomes of any treatment provided by the clinical practice shall be collected and reported to the University of South Florida and may be provided by the provider to any relevant Food and Drug Administration studies or trials.(5) The division may adopt rules to implement this section.(6) This section expires July 1, 2025.Added by 2024 Fla. Laws, ch. 228,s 62, eff. 7/1/2024.