Section 5902.09 | Transcranial magnetic stimulation pilot program.
(A) As used in this section:
"Electroencephalogram (EEG) combined transcranial magnetic stimulation" means treatment in which transcranial magnetic stimulation (TMS) frequency pulses are tuned to the patient's physiology and biometric data, at the time of each treatment, using a pre- and post-TMS EEG.
"First responder" has the meaning defined in section 2903.01 of the Revised Code.
"Law enforcement officer" has the meaning defined in section 9.69 of the Revised Code.
(B) The directors of veterans services and mental health and addiction services shall establish a pilot program to make electroencephalogram (EEG) combined transcranial magnetic stimulation available for veterans, first responders, and law enforcement officers with substance use disorders, mental illness, sleep disorders, traumatic brain injuries, sexual trauma, post traumatic stress disorder and accompanying comorbidities, concussions or other brain trauma, or other issues identified by the individual's qualified medical practitioner as issues that would warrant treatment under the program. The program shall be operated in conjunction with a supplier selected under this section.
(C) The directors by mutual agreement shall choose a location for the pilot program and for up to ten branch sites, and shall enter into a contract for the purchase of services related to the pilot program. A branch site may be a mobile unit or an EEG combined neuromodulation portable unit if the directors determine that mobile units or EEG combined neuromodulation portable units are necessary to expand access to care. The contract shall include provisions requiring the supplier to create and conduct a clinical trial, to establish and operate a clinical practice, to evaluate outcomes of the clinical trial and the clinical practice, to expend payments received from the state as needed for purposes of the program, and to report quarterly regarding the pilot program to the president of the senate and to the standing committee of the senate that generally considers legislation regarding veterans affairs.
(D) There is the electroencephalogram (EEG) combined transcranial magnetic stimulation fund in the state treasury. It shall consist of moneys appropriated to it by the general assembly. The directors, with the approval of the controlling board, may authorize a disbursement from the fund for services rendered under the contract.
(E) One or both of the directors shall adopt rules under Chapter 119. of the Revised Code as necessary to administer this section.
(F) The supplier, in conducting the clinical trial and in operating the clinical practice, shall adhere to all of the following:
(1) The United States food and drug administration regulations governing the conduct of clinical practice and clinical trials;
(2) A peer-to-peer support network shall be made available by the supplier to any individual receiving treatment under the program.
(3) The program protocol shall use adapted stimulation frequency and intensity modulation based on EEG and motor threshold testing as well as clinical symptoms and signs, and biometrics.
(4) Each individual who receives treatment under the program also shall receive pre- and post-neurophysiological monitoring, with EEG and autonomic nervous systems assessments, daily checklists of symptoms of alcohol, opioid, or other substance use, and weekly medical counseling and wellness programming, and also shall participate in the peer-to-peer support network established by the supplier.
(5) Clinical protocols and outcomes of the clinical trial, and of any treatment provided by the clinical practice, shall be collected and reported quarterly in a report provided by the supplier to the directors of veterans services and mental health and addiction services and to the United States food and drug administration.
(6) Any individual who receives treatment at the clinical practice shall be eligible for a minimum of two electroencephalograms during the course of the individual's treatment.
(7) The report required by this section shall include a thorough accounting of the use and expenditure of all funds received from the state under this section.
(G) Contracts entered into under this section are subject to section 9.231 and Chapter 125. of the Revised Code.
Last updated July 30, 2021 at 4:13 PM